title: Randomized Controlled Study on the Efficacy of the NECT Program (Cognitive Therapy and Narrative Development) on Improving Social Functioning in People With Severe Psychic Disorders

acronym: NECT

summary:
Self-stigma refers to the transformation process wherein a person's previously held social identity is progressively replaced by a devalued and stigmatized view of oneself termed "illness identity". Self-Stigma is a severe problem in Serious Mental Illness (SMI). Self-stigma prevalence is high (41.7% of the 1229 participants with SZ and 21.7% of the 1182 participants with mood disorders had moderate to high levels of IS in the GAMIAN-Europe study). Self-stigma was negatively associated with self-esteem, social function, wellbeing, quality of life or personal recovery and positively associated with psychiatric symptoms and depression. Several psychosocial interventions (mostly combinations of psychoeducation and cognitive behaviour therapy) have been designed to reduce self-stigma and its impact on clinical and functional outcomes, with preliminary effects on self-stigma, insight and self-efficacy.

Narrative Enhancement and Cognitive Therapy (NECT) is a manualized structured 20-session group-based intervention . Conducted by two trained facilitators the sessions combine psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma. Developed in USA, NECT was adapted in Israel and Sweden. NECT showed effectiveness in reducing self-stigma and in improving self-esteem and quality of life. Despite being effective on changing coping strategies, NECT effectiveness on social function is still unclear.

The present study aims to validate NECT French adaptation and to evaluate its effectiveness on social function, self-stigma, psychiatric symptoms, self-esteem, wellbeing, quality of life and personal recovery in SMI participants (schizophrenia, bipolar disorder, borderline personality disorder)

ReferenceCitation: Bellack AS, Brown SA. Psychosocial treatments for schizophrenia. Curr Psychiatry Rep. 2001 Oct;3(5):407-12. Review.

ReferenceCitation: Brohan E, Elgie R, Sartorius N, Thornicroft G; GAMIAN-Europe Study Group. Self-stigma, empowerment and perceived discrimination among people with schizophrenia in 14 European countries: the GAMIAN-Europe study. Schizophr Res. 2010 Sep;122(1-3):232-8. doi: 10.1016/j.schres.2010.02.1065. Epub 2010 Mar 26.

ReferenceCitation: Corrigan PW, Larson JE, Rüsch N. Self-stigma and the "why try" effect: impact on life goals and evidence-based practices. World Psychiatry. 2009 Jun;8(2):75-81.

ReferenceCitation: Corrigan PW, Kosyluk KA, Rüsch N. Reducing self-stigma by coming out proud. Am J Public Health. 2013 May;103(5):794-800. doi: 10.2105/AJPH.2012.301037. Epub 2013 Mar 14. Review.

ReferenceCitation: Dixon LB, Dickerson F, Bellack AS, Bennett M, Dickinson D, Goldberg RW, Lehman A, Tenhula WN, Calmes C, Pasillas RM, Peer J, Kreyenbuhl J; Schizophrenia Patient Outcomes Research Team (PORT). The 2009 schizophrenia PORT psychosocial treatment recommendations and summary statements. Schizophr Bull. 2010 Jan;36(1):48-70. doi: 10.1093/schbul/sbp115. Epub 2009 Dec 2. Review.

ReferenceCitation: Fung KM, Tsang HW, Cheung WM. Randomized controlled trial of the self-stigma reduction program among individuals with schizophrenia. Psychiatry Res. 2011 Sep 30;189(2):208-14. doi: 10.1016/j.psychres.2011.02.013. Epub 2011 Mar 5.

ReferenceCitation: Lysaker PH, Bond G, Davis LW, Bryson GJ, Bell MD. Enhanced cognitive-behavioral therapy for vocational rehabilitation in schizophrenia: Effects on hope and work. J Rehabil Res Dev. 2005 Sep-Oct;42(5):673-82.

ReferenceCitation: Lysaker PH, Roe D, Yanos PT. Toward understanding the insight paradox: internalized stigma moderates the association between insight and social functioning, hope, and self-esteem among people with schizophrenia spectrum disorders. Schizophr Bull. 2007 Jan;33(1):192-9. Epub 2006 Aug 7.

ReferenceCitation: Rüsch N, Lieb K, Bohus M, Corrigan PW. Self-stigma, empowerment, and perceived legitimacy of discrimination among women with mental illness. Psychiatr Serv. 2006 Mar;57(3):399-402.

ReferenceCitation: Vauth R, Kleim B, Wirtz M, Corrigan PW. Self-efficacy and empowerment as outcomes of self-stigmatizing and coping in schizophrenia. Psychiatry Res. 2007 Feb 28;150(1):71-80. Epub 2007 Jan 30.

ReferenceCitation: Yanos PT, Roe D, Markus K, Lysaker PH. Pathways between internalized stigma and outcomes related to recovery in schizophrenia spectrum disorders. Psychiatr Serv. 2008 Dec;59(12):1437-42. doi: 10.1176/appi.ps.59.12.1437.

ReferenceCitation: Livingston JD, Boyd JE. Correlates and consequences of internalized stigma for people living with mental illness: a systematic review and meta-analysis. Soc Sci Med. 2010 Dec;71(12):2150-61. doi: 10.1016/j.socscimed.2010.09.030. Epub 2010 Oct 12. Review.

family: Livingston

full_name: James D. Livingston

given: James D.

family: Boyd

full_name: Jennifer E. Boyd

given: Jennifer E.

journal_name: Social Science & Medicine

title: Correlates and consequences of internalized stigma for people living with mental illness: A systematic review and meta-analysis

ReferenceCitation: Lucksted A, Drapalski AL, Brown CH, Wilson C, Charlotte M, Mullane A, Fang LJ. Outcomes of a Psychoeducational Intervention to Reduce Internalized Stigma Among Psychosocial Rehabilitation Clients. Psychiatr Serv. 2017 Apr 1;68(4):360-367. doi: 10.1176/appi.ps.201600037. Epub 2016 Dec 1.

name: Dr. Lucksted, Ms. Charlotte, and Ms. Fang are with the Department of Psychiatry, Division of Psychiatric Services Research, and Dr. Brown is with the Department of Epidemiology and Public Health, all at the University of Maryland School of Medicine, Baltimore (e-mail: ). Dr. Drapalski is with the Mental Illness Research, Education and Clinical Center, U.S. Department of Veterans Affairs Maryland Health Care System, Baltimore. Ms. Wilson is with the Department of Psychology, University of Maryland...

family: Lucksted

full_name: Alicia Lucksted

given: Alicia

family: Drapalski

full_name: Amy L. Drapalski

given: Amy L.

family: Brown

full_name: Clayton H. Brown

given: Clayton H.

family: Wilson

full_name: Camille Wilson

given: Camille

family: Charlotte

full_name: Melanie Charlotte

given: Melanie

family: Mullane

full_name: Audrina Mullane

given: Audrina

family: Fang

full_name: Li Juan Fang

given: Li Juan

journal_name: Psychiatric Services

publisher: American Psychiatric Association Publishing

ReferenceCitation: Roe D, Hasson-Ohayon I, Mashiach-Eizenberg M, Derhy O, Lysaker PH, Yanos PT. Narrative enhancement and cognitive therapy (NECT) effectiveness: a quasi-experimental study. J Clin Psychol. 2014 Apr;70(4):303-12. doi: 10.1002/jclp.22050. Epub 2013 Oct 2.

family: Roe

full_name: David Roe

given: David

family: Hasson-Ohayon

full_name: Ilanit Hasson-Ohayon

given: Ilanit

name: Max Stern Academic College of Emek Yezreel

family: Mashiach-Eizenberg

full_name: Michal Mashiach-Eizenberg

given: Michal

name: Israeli Psychiatric Rehabilitation Association

family: Derhy

full_name: Oren Derhy

given: Oren

name: Roudebush VA Medical Center; Indiana University School of Medicine

family: Lysaker

full_name: Paul H. Lysaker

given: Paul H.

family: Yanos

full_name: Philip T. Yanos

given: Philip T.

title: Narrative Enhancement and Cognitive Therapy (NECT) Effectiveness: A Quasi-Experimental Study

ReferenceCitation: Dubreucq J, Faraldo M, Abbes M, Ycart B, Richard-Lepouriel H, Favre S, Jermann F, Attal J, Bakri M, Cohen T, Cervello C, Chereau I, Cognard C, De Clercq M, Douasbin A, Giordana JY, Giraud-Baro E, Guillard-Bouhet N, Legros-Lafarge E, Polosan M, Pouchon A, Rolland M, Rainteau N, Roussel C, Wangermez C, Yanos PT, Lysaker PH, Franck N. Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial. Trials. 2021 Feb 8;22(1):124. doi: 10.1186/s13063-021-05067-1.

location_facility: Hopital La Colombière, University Hospital Montpellier


title: Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group

acronym: MIRAS

summary:
This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.

400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.

Retrospective cases of patients (100 cases in total) will be identified in all centers through the GSF/GETO clinical databases already setted up (including the clinical base Conticabase).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancerologie de L'Ouest - Site Rene Gauducheau

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: PREdiction of Chronic LUng Allograft Dysfunction

acronym: PRELUD

summary: Chronic lung allograft dysfunction (CLAD) is the leading cause of long-term mortality after lung transplantation. Several risk factors for CLAD have been identified, but the exact pathophysiology and triggering molecular factors remain largely unknown. Moreover, in clinical practice, no integration of the different risk factors is achieved. CLAD is therefore diagnosed most often late with the persistent decline in respiratory function, revealing a profound and irreversible alteration of the pulmonary graft. Several blood biomarkers that can predict the occurrence of CLAD more than 6 months before clinical diagnosis have been identified and validated. From these preliminary results, a composite score is being developed from independent samples from the COLT (COhort in Lung Transplantation) cohort. The main objective of this project is to validate this robust and predictive composite score (biological and clinical) of CLAD.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Nantes University Hospital

location_facility:
AP-HM
CHU de Nantes
Hôpital Bichat
CHU de Bordeaux
CHU de Grenoble
CHRU de Strasbourg
Centre Chirurgical Marie Lannelongue
CHU de Lyon
Hôpital Foch
CHU de Toulouse

lead_sponsor_type: academique


design_allocation: Randomized

intervention_type: Drug

lead_sponsor: Hospices Civils de Lyon

primary_purpose: Treatment

acronym: EPICURE

location_facility: Hôpital Femme-Mère-Enfant-Centre de Référence pour la maladie de Rendu-Osler

ipd_sharing: No

type: EudraCT Number

source: euctr

title: Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease. A National, Randomized, Multicentre Phase II Study

summary:
The recognized manifestations of HHT are all due to abnormalities in vascular structure. Epistaxis are spontaneous, very variable, may occur as often as several times every day, and are recurrent in 90% of patients and associated with chronic and severe anemia in 2-10%. They also significantly reduce quality of life.

Blood transfusions are sometimes required in 10-30% of patients. Previous studies showed that antiangiogenic treatments such as anti-VEGF treatment (bevacizumab) administered intravenously was efficient on epistaxis and dramatically reduced nosebleeds.

Tyrosine kinase inhibitors are anti-angiogenic molecules which are available orally and could therefore overcome the difficulties encountered with bevacizumab. The investigator hypothesized that nintedanib, acting by indirect inhibition of the VEGF receptor should allow a reduction of epistaxis in HHT patient.

Nintedanib has been used in one HHT patient following the diagnosis of Insterstitial Pulmonary Fibrosis (published case report in 2017, Kovacs et al) with encouraging results.

The aim is to evaluate efficacy of nintedanib for the treatment of epistaxis in HHT patients


title: Development and Validation of a Diagnosis Questionnaire of Primary Parkinsonian Pain: the 3 PDQ Primary Parkinsonian Pain Diagnostic Questionnaire

summary: Development and validation of a diagnosis questionnaire of parkinsonian primary pain: the "Primary Parkinsonian Pain Diagnostic Questionnaire" (3PDQ)

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Toulouse

location_facility:
Neurolgoy service
Neurology service
Neurology Service

intervention_type: Diagnostic Test


type: Other Identifier

title: A European, Multicenter, Prospective Clinical Study to Evaluate Cysteamine Toxicity on Human Osteoclasts. The CYSTEA-BONE Clinical Study.

acronym: CYSTEA-BONE

summary:
Nephropathic Cystinosis (NC) is an orphan inherited autosomal recessive disease characterised as a generalized lysosomal storage disease due to a deficiency of the cystine lysosomal transport protein, cystinosin.

Patients with NC usually receive cysteamine. Bone impairment was recently recognized as a late complication of NC, occurring at adolescence or early adulthood. Even though the exact underlying pathophysiology is unclear, at least six hypotheses are discussed, and mainly cysteamine toxicity and/or direct bone effect of the Cystinosin (CTNS) mutation. Because of the potential dramatic impact on quality of life of this novel complication, research should aim to better understand bone disease in NC.

The primary objective of this study is to evaluate the action of cysteamine on osteoclastic differentiation and resorption activity of NC patients, depending on the underlying genotype. The Secondary objective is to describe the clinical bone status of NC patients depending on their underlying genotype.

status: Unknown status

location_country: Italy Germany Turkey France

location_facility: Hacettepe University Faculty of Medicine

location_facility: Klinik für Pädiatrische Nieren-, Leber- und Stoffwechselerkrankungen

location_facility: CHU Bordeaux - Hôpital Pellegrin tripode

location_facility: CHU Paris - Hôpital Necker-Enfants Malades

status_simplified: Unknown


title: Major Depressive Disorder: Early Prediction of Non-response to Antidepressant Therapy Via a Mobile Digital Scale

acronym: REDRESS

summary:
Major Depressive Disorder (MDD) is a debilitating disease characterized by a depressed mood, diminished interests, impaired cognitive function and vegetative symptoms, such as disturbed sleep or appetite. MDD occurs about twice as often in women than it does in men and affects about 6% of the adult population worldwide each year.

Standard symptoms scales like the Hamilton Depression Rating Scale or the Montgomery-asberg Depression Rating Scale, the Self-Report 16-item Quick Inventory of Depressive Symptomatology were initially developed for the evaluation of a therapeutic intervention or a pharmacological treatment and are routinely used by clinicians in the assessment of Treatment Resistant Depression (TRD) occurrence. In parallel, patient-reported outcomes have gained increasing importance and are widely recommended by health authorities in the assessment of depression. The same institutions insist on the collection of real-world data to provide clinicians with ecological measurements. It has been demonstrated that an early response to an AntiDepressant (AD) treatment can be seen as early as week 2 and is not related to a placebo-effect. While there is no consensus on the exact cut-off values, several factors emerge as early predictors of a later treatment response, such as:

Improvement in emotional processing of happy facial expressions after 1 week of treatment,
Circa 20% improvement in Hamilton Depression Rating Scale-17 item (HDRS-17) at week 2. The hypothesis is therefore that repeated, systematic and real-time, contextualized and multimodal collection of depressive symptoms from patients at home will establish a threshold score that can predict a subsequent response to their treatment.

REDRESS was inspired by several standard depression scales used and recommended by the French Health Authority, augmented with digital active and passive activity monitoring, speech analysis and emotional processing assessment. Another important assumption is that honesty and willingness to disclose personal or embarrassing things will be best achievable via a digital solution.

To test this assumption, the overall scores and each subscores on the REDRESS numerical scale will be compared in people with MDD showing adequate response to those showing insufficient response.

The response to treatment at week 6 will be studied (end of Phase 1). Non-responders and responders to the first treatment round will be enrolled in a 6-week extension phase (Phase 2). Non-responders will receive another treatment course (Other AD, combination, etc.). Responders will just be followed up and will keep the same treatment. The REDRESS scores will be analysed in this population and will allow us to test the investigator's assumption in people with treatment resistant depression. This study will also allow to assess patients' quality of life at the end of each phase of treatment and to compare results with REDRESS scores.

lead_sponsor: Ad scientiam

location_facility:
CHU Toulouse
Centre Hospitalier Guillaume Régnier
CH Cholet
Centre hospitalier Henri Laborit
Centre hospitalier Saint-Antoine
CHU Clermont-Ferrand
Hôpital de la Pitié Salpêtrière
CHU Grenoble
CHRU Tours
CHU Nantes - CAPPA Jacques Prévet


title: Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.

summary:
This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT).

The main endpoint will be evaluated by a blinded endpoint committee.

ReferenceType: background

ReferenceCitation: Le Duc G, Miladi I, Alric C, Mowat P, Bräuer-Krisch E, Bouchet A, Khalil E, Billotey C, Janier M, Lux F, Epicier T, Perriat P, Roux S, Tillement O. Toward an image-guided microbeam radiation therapy using gadolinium-based nanoparticles. ACS Nano. 2011 Dec 27;5(12):9566-74. doi: 10.1021/nn202797h. Epub 2011 Nov 9.

ReferenceCitation: Lux F, Tran VL, Thomas E, Dufort S, Rossetti F, Martini M, Truillet C, Doussineau T, Bort G, Denat F, Boschetti F, Angelovski G, Detappe A, Crémillieux Y, Mignet N, Doan BT, Larrat B, Meriaux S, Barbier E, Roux S, Fries P, Müller A, Abadjian MC, Anderson C, Canet-Soulas E, Bouziotis P, Barberi-Heyob M, Frochot C, Verry C, Balosso J, Evans M, Sidi-Boumedine J, Janier M, Butterworth K, McMahon S, Prise K, Aloy MT, Ardail D, Rodriguez-Lafrasse C, Porcel E, Lacombe S, Berbeco R, Allouch A, Perfettini JL, Chargari C, Deutsch E, Le Duc G, Tillement O. AGuIX(®) from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine. Br J Radiol. 2019 Jan;92(1093):20180365. doi: 10.1259/bjr.20180365. Epub 2018 Sep 18. Review.

ReferenceCitation: Verry C, Dufort S, Barbier EL, Montigon O, Peoc'h M, Chartier P, Lux F, Balosso J, Tillement O, Sancey L, Le Duc G. MRI-guided clinical 6-MV radiosensitization of glioma using a unique gadolinium-based nanoparticles injection. Nanomedicine (Lond). 2016 Sep;11(18):2405-17. doi: 10.2217/nnm-2016-0203. Epub 2016 Aug 16.

lead_sponsor: University Hospital, Grenoble

location_facility: Centre hospitalier universitaire Grenoble-Alpes

location_facility: Hospices Civils de Lyon-Hôpital Lyon Sud

intervention_type: Radiation


title: A Prospective Multicenter, Comparative, Randomized, Single-blind, Non-inferiority Study of Eyestil Protection® Unidose Versus Vismed® Unidose in Patients With Moderate to Severe Dry Eye Syndrome

summary:
This is a national, prospective, multicenter, comparative, randomized, single-blinded non-inferiority study performed in two parallel groups.

3 months (plus a run in period of 15 days prior inclusion) Patients with moderate to severe dry eye syndrome.

status: Suspended

lead_sponsor: SIFI SpA

location_country: France Spain

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Device


title: A Randomized Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With or Without Durvalumab (MEDI4736) in Oligometastatic Recurrent Hormone Sensitive Prostate Cancer Patients

acronym: POSTCARD

summary:
As in other solid tumours, increasing evidence indicates that patients diagnosed with a limited number of prostate cancer metastases, so-called oligometastases, have a better prognosis compared with patients with extensive metastatic disease.

Survival of patients with three or fewer metastases was superior compared with patients with more than three lesions.

The introduction of novel imaging modalities such as Fluorocholine (FCH), Fuciclovine or Ga-PSMA PET CT has increased the detection of oligometastatic prostate cancer (PCa) recurrence, potentially justifying the use of a metastasis-directed therapy with radiotherapy (RT).

Based on several studies, SBRT is now considered as a strongly validated option in oligometastatic prostate cancer.

It is increasingly understood that cancers are recognized by the immune system, and, under some circumstances, the immune system may control or even eliminate tumors.

Programmed death-ligand 1 (PD-L1) is transmembrane protein that has been speculated to play a major role in suppressing the immune system during particular events.

PD-L1 is expressed in a broad range of cancers. Based on these findings, an anti-PD-L1 antibody could be used therapeutically to enhance antitumor immune responses in patients with cancer.

Experimental data from multiple cancer models have provided cumulative evidence of an interaction of ionizing radiation with the systemic antitumor immunity and this has created several opportunities in the field.

The oligometastatic setting appears to be the most relevant clinical situation to evaluate the immune response generated by radiotherapy and immune modifiers in patients with an intact immune system. The hypothesize is that Durvalumab will enhance immune response following SBRT targeting oligometastatic lesions. In this randomized 2:1 phase II trial of Stereotactic Body Radiation Therapy with or without durvalumab in oligometastatic hormone sensitive prostate cancer patients, Durvalumab will be started one month prior to SBRT to be able to evaluate PSA and immune response to the drug. It will be combined with SBRT and then given adjuvantly for a total of 12 months.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre Léon Bérard
Institut de Cancérologie de Montpellier
Hospices Civils de Lyon
Centre Oscar Lambret
Centre Georges François Leclerc
Chbs Lorient
Institut de Cancérologie de Loire
CHRU de Brest
ICO
Institut Bergonie

intervention_type: Combination Product


title: Therapeutic Drug Monitoring of Sunitinib and Pazopanib in Advanced or Metastatic Renal Cell Carcinoma

acronym: SUP-R

summary:
This pilot study is an open-label interventional study, prospective, non-comparative, sequential (two stages), national, multicenter study.

Patients starting therapy with sunitinib or pazopanib as standard first line treatment for advanced or metastatic renal cell carcinoma will enter the study in one of the two cohorts (115 patients will be treated by sunitinib and 99 patients will be treated by pazopanib).

The purpose of this study is to examine the feasibility of sunitinib and pazopanib dose individualisation based on therapeutic drug monitoring (TDM) and to assess the benefit of this approach in terms of tolerance and efficacy compared with the current empirical method based only on tolerance observation.

status: Completed

study_completion_date_type: Actual

design_allocation: Non-Randomized

location_facility:
Institut Regional Du Cancer Montpellier
CHU DE BORDEAUX - Hôpital Saint-André
CH RODEZ
Institut Claudius Regaud
Institut Paoli Calmettes
Centre Leon Berard
CHU DE LIMOGES - Hôpital Dupuytren
Institut Bergonie

status_simplified: Completed


ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Italy
Switzerland
France
Spain
Germany
United Kingdom

acronym: EMBRACE

ipd_sharing: Yes

type: Registry Identifier

title: A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life

summary:
This is a Phase 4, multi-center, randomized, placebo-controlled, double-blind study of the impact of apremilast on quality of life, efficacy, and safety in subjects with manifestations of plaque psoriasis and impaired quality of life.

Approximately 255 subjects will be randomized 2 (apremilast):1 (placebo) in approximately 6 to 10 countries in Western Europe. Subjects will be block-randomized equally to each of the manifestations of psoriasis (scalp psoriasis, nail psoriasis, palmoplantar psoriasis, genital psoriasis, and psoriasis in visible locations). If subjects present with multiple manifestations, they will be allocated to the manifestation which is most severe, as determined by the subject.

However, all manifestations will be assessed for efficacy at each study visit.


title: Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR)

acronym: Cohorte-SRPR

summary:
Non-interventional cohort study (on data), prospective national multicenter. Inclusion of patients as they enter in a post-intensive care rehabilitation unit (SRPR) .

Collection of data after inclusion, from patients' records during their stay (weekly follow-up) to the SRPR and at their discharge, to D28, D90 and at 1 year after their hospitalization from hospital reports or call of the attending physician.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Raymond Poincaré - SRPR pédiatrique

location_facility: Hôpital Raymond Poincaré de Garches - SRPR neurologique

location_facility: Hôpital d'instruction des armées - Percy


title: Liquid Biopsies in Patients With Advanced Non-small Cell Lung Cancer

acronym: LIBIL

summary: The goal of this project is to characterize the genetic profile of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) using liquid biopsies

lead_sponsor: Centre Leon Berard

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' With Cancer, a Multicenter Pilot Study

acronym: PROADAPT

summary:
With the conjunction of increased life expectancy and the increasing incidence of cancer with aging, older patient represent an increasing proportion of cancer patients. Increasing age is also associated with increased risk of co-morbidities as well as a decline of functional reserve of multiple organ systems, eventually leading in the context of the disease-and/or the treatment-related stress to functional deconditioning or organ failure.

Surgery or complex medico-surgical procedures - that associate chemotherapy and/or radiotherapy and surgery, can be considered as one proof-of principle of such risks, since major cancer surgery the older population is at higher risk of morbi-mortality and unplanned hospitalization for geriatric events In order to reduce complications after surgery, prehabilitation has often been considered, and 71% of the surgeons would accept a 4 weeks delay before surgery to improve patients' outcomes if shown to be beneficial. However, the actual level of evidence depends on the interventions: high for pre-operative nutrition, but low for physical exercise, due to heterogeneous programs with often bad adherence. In addition, geriatric validated interventions, in order to prevent iatrogenic event, may be added in a multi-interventional model of intervention.

primary_purpose: Health Services Research

ReferenceType: derived

ReferenceCitation: Roche M, Ravot C, Malapert A, Paget-Bailly S, Garandeau C, Pitiot V, Tomatis M, Riche B, Galamand B, Granger M, Barbavara C, Bourgeois C, Genest E, Stefani L, Haïne M, Castel-Kremer E, Morel-Soldner I, Collange V, Le Saux O, Dayde D, Falandry C; PROADAPT working group. Feasibility of a prehabilitation programme dedicated to older patients with cancer before complex medical-surgical procedures: the PROADAPT pilot study protocol. BMJ Open. 2021 Apr 2;11(4):e042960. doi: 10.1136/bmjopen-2020-042960.

family: Roche

full_name: Mélanie Roche

given: Mélanie

sequence: first

family: Ravot

full_name: Christine Ravot

given: Christine

sequence: additional

family: Malapert

full_name: Amélie Malapert

given: Amélie

family: Paget-Bailly

full_name: Sophie Paget-Bailly

given: Sophie

family: Garandeau

full_name: Charlène Garandeau

given: Charlène

family: Pitiot

full_name: Virginie Pitiot

given: Virginie

family: Tomatis

full_name: Mélanie Tomatis

family: Riche

full_name: Benjamin Riche

given: Benjamin

family: Galamand

full_name: Béatrice Galamand

given: Béatrice

family: Granger

full_name: Marion Granger

given: Marion

family: Barbavara

full_name: Claire Barbavara

given: Claire

family: Bourgeois

full_name: Chrystelle Bourgeois

given: Chrystelle

family: Genest

full_name: Evelyne Genest

given: Evelyne

family: Stefani

full_name: Laetitia Stefani

given: Laetitia

family: Haïne

full_name: Max Haïne

given: Max

family: Castel-Kremer

full_name: Elisabeth Castel-Kremer

given: Elisabeth

family: Morel-Soldner

full_name: Isabelle Morel-Soldner

given: Isabelle

family: Collange

full_name: Vincent Collange

given: Vincent

family: Le Saux

full_name: Olivia Le Saux

given: Olivia

family: Dayde

full_name: David Dayde

family: Falandry

full_name: Claire Falandry

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

title: Feasibility of a prehabilitation programme dedicated to older patients with cancer before complex medical–surgical procedures: the PROADAPT pilot study protocol

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

location_facility: Centre Hospitalier Lyon Sud, Service de Gériatrie

location_facility: Centre hospitalier Universitaire de Saint Etienne


lead_sponsor: University Hospital, Lille

acronym: SEAT

location_facility:
Hôpital Roger Salengro, CHU
CH Roubaix
Ch Dr.Schaffner de Lens
CH ARRAS
CH Dunkerque
Centre hospitalier de valenciennes
CH de DOUAI
Centre Hospitalier Dr Schaffner
CHU de Rouen
Ch Tourcoing

title: Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.

summary:
Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse.

The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality.

To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.


title: Dexmedetomidine After Cardiac Surgery for Prevention of Delirium: The Exactum Study a Randomised Double Blind Controlled Trial

acronym: EXACTUM

summary: We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU de Nantes
Hôpital Privé Jacques Cartier
CHU Poitiers
Clermont Ferrand university hospital
CHU de Grenoble
CHU la Pitié Salpétrière
Angers university hospital
CHRU de Brest
Hôpital Européen Georges Pompidou
CHU de Rennes


title: Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study

acronym: StimO

summary: Medically intractable pain caused by occipital neuralgia can be very difficult to control with traditional pain management. Peripheral nerve stimulation which is used in migraines and cluster headache can be an alternative for these patients with occipital neuralgias when medical treatment and traditional pain management have failed (drugs for neuropathic pain, infiltrations, psychobehavioral approaches and multidisciplinary approach in a pain center). Occipital nerve stimulation consists to put a lead subcutaneously in front of the occipital nerve and to connect the lead to a pulse generator. A retrospective study of 60 patients was conducted in Nantes University Hospital. The results were good with the Visual Analog Scale (VAS) decreased from 8.4 preoperatively to 2.85 postoperatively. The medical quantification scale (MQS) was reduced to about 50% (18 preoperatively versus 9.9 postoperatively). Stimulation was quiet stable over time with a mean follow-up of 24 months (range 6 to 72 months). The aim of StimO is to confirm this result through a national controlled randomized multicenter study where occipital nerve stimulation will be compared to the optimal medical management.

status: Terminated

location_facility:
Hôpital Pierre Wertheimer
CHU de Caen
CHU Limoges
CHU de Nantes
Hôpitaux Civils de Colmar
CHU de Nice
CHU de Clermont-Ferrand
CHU de Poitiers
Hôpital Foch
Hôpital Lariboisière


title: Comparaison de la Douleur Lors de la Pose Des DIU et SIU Entre la méthode Classique et la méthode Directe

acronym: KIDDS

summary:
The so-called "direct" method of intrauterine device (IUD) and intraintuerine system (IUS) insertion is increasingly used. A study has shown that it is technically simpler and assumes less painful than the classic pose.

It seems interesting to compare the pain felt by the patients during IUD / IUS insertion in these two methods of placement and also to confirm that there is no more malposition with the direct method.

study_start_date_type: Anticipated

ReferenceCitation: Golightly E, Gebbie AE. Low-lying or malpositioned intrauterine devices and systems. J Fam Plann Reprod Health Care. 2014 Apr;40(2):108-12. doi: 10.1136/jfprhc-2013-100684. Epub 2014 Jan 6. Review.

ReferenceCitation: Heinemann K, Reed S, Moehner S, Minh TD. Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices. Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.

ReferenceCitation: Braaten KP, Benson CB, Maurer R, Goldberg AB. Malpositioned intrauterine contraceptive devices: risk factors, outcomes, and future pregnancies. Obstet Gynecol. 2011 Nov;118(5):1014-1020. doi: 10.1097/AOG.0b013e3182316308.

ReferenceCitation: Teal SB, Romer SE. Awareness of long-acting reversible contraception among teens and young adults. J Adolesc Health. 2013 Apr;52(4 Suppl):S35-9. doi: 10.1016/j.jadohealth.2013.01.013. Review.

location_facility:
Medical Practice General Practice
Hôpital Trousseau
ACSBE-La place santé
CIVG Hôpital Avicenne
Centre de Santé Gatineau Saillant
Medical Office Gynecology
CIVG Hôpital Louis Mourier
CPEF
Liberal Cabinet Midwife


title: Doppler Flow Classification of Saint-Bonnet : A Non Interventional Clinical Trial

acronym: Saint-Bonnet

summary: Observational Study that evaluates the interest of Doppler waveforms classification in Peripheral Artery disease

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Caen
CH de Vichy
CHU de Saint-Etienne
CHU de Limoges
CHU de Bordeaux
CHU de Grenoble
CHU de Rennes
CHU Brest
CHU Amiens
CHU de Toulouse


title: Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors

acronym: STEREOLIVER

summary: Intervention research involving the human person, phase II, prospective, multicentric, non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so every patient, able to be treated by SBRT and unable to participate in another trial (non eligible patient or non included centers), can be included in this national study, in a prospective way.

lead_sponsor: Centre Oscar Lambret

location_facility: Institut Régional du Cancer de Montpellier


type: Other Grant/Funding Number

title: Bisphenol A Exposure, Ovarian Function and Assisted Reproductive Technology Outcome.

acronym: FIVPHENOL

summary: Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. In order to reduce the confusion factors, the population study is limited to young women (aged 28 to 34), with regular menstrual cycles and without any medical event that could affect the implantation process

primary_purpose: Basic Science

ReferenceCitation: Corbel T, Gayrard V, Viguié C, Puel S, Lacroix MZ, Toutain PL, Picard-Hagen N. Bisphenol A disposition in the sheep maternal-placental-fetal unit: mechanisms determining fetal internal exposure. Biol Reprod. 2013 Jul 18;89(1):11. doi: 10.1095/biolreprod.112.106369. Print 2013 Jul.

ReferenceCitation: Leandri RD, Gachet A, Pfeffer J, Celebi C, Rives N, Carre-Pigeon F, Kulski O, Mitchell V, Parinaud J. Is intracytoplasmic morphologically selected sperm injection (IMSI) beneficial in the first ART cycle? a multicentric randomized controlled trial. Andrology. 2013 Sep;1(5):692-7. doi: 10.1111/j.2047-2927.2013.00104.x. Epub 2013 Jun 21.

location_facility: CHRU Brest Hôpital Morvan, Service de Médecine de la Reproduction


ReferenceCitation: Mélet J, Mulleman D, Goupille P, Ribourtout B, Watier H, Thibault G. Rituximab-induced T cell depletion in patients with rheumatoid arthritis: association with clinical response. Arthritis Rheum. 2013 Nov;65(11):2783-90. doi: 10.1002/art.38107.

lead_sponsor: University Hospital, Tours

acronym: LYRITUX

location_facility:
Rhumatologie, CHRU de POITIERS
Rhumatologie, CHRU de BREST
Rhumatologie, CHRU de NANTES
Rhumatologie, CHD LA ROCHE SUR YON
Rhumatologie / IPROS, CHR d'ORLEANS
Rhumatologie, CHR du MANS
Rhumatologie, CHRU de TOURS
Rhumatologie, CHRU de ROUEN

title: Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)

summary:
Rituximab, an anti CD-20 monoclonal antibody targeting B lymphocytes is prescribed in rheumatoid arthritis (RA) patients refractory to TNF alpha antagonists. According to previous studies, 25 to 50% of patients have an insufficient or absence of response to rituximab at week 24.

In a recent retrospective study, a CD4+ T-lymphocytes depletion was observed after a first course of rituximab in RA patients. The absolute CD4+ number at week 12 was 37% (±33) of the baseline value, leading to < 200 cells/µL in 5% of patients. Interestingly the absence of CD4+ T-lymphocytes depletion was observed in clinical non-responders, suggesting the involvement of T-lymphocytes in the mechanism of action of rituximab. So far no prospective study have supported the usefulness of lymphocyte phenotyping, in particular T-lymphocytes, to monitor rituximab-treated RA patients.


title: Pharmacokinetics and Safety of Roledumab, a Fully Human Recombinant Monoclonal Anti-RhD Antibody, in RhD-negative Pregnant Woman Carrying an RhD-positive Foetus: a Phase IIb, Multicenter, Open-label Study

summary:
The aim of this study is to assess the pharmacokinetic profile of Roledumab 300μg IM / IV in RhD-negative pregnant women carrying an RhD-positive foetus.

To assess the safety of Roledumab in RhD-negative pregnant women and in RhD-positive fetus and newborns.

In addition the efficacy of Roledumab 300μg IM and IV to prevent RhD alloimmunisation in RhD-negative pregnant women carrying an RhD-positive fetus and the immunogenicity of Roledumab will be assessed.

primary_purpose: Prevention

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_facility:
University Hospital Center
Maison Blanche Hospital
Poissy-Saint-Germain-en-Laye Hospital
Armand-Trousseau Hospital
Jeanne de Flandre Hospital
Croix-Rousse Maternity
Paule de Viguier Hospital
Port-Royal Maternity


title: PROPHY-VAP: Prevention of Early Ventilation Acquired Pneumonia (VAP) in Brain Injured Patients by a Single Dose of Ceftriaxone

acronym: PROPHY-VAP

summary:
Ventilation-associated pneumonia (VAP) is the main site of healthcare-associated infections in the brain injured patients, with an incidence rate of 22% to 58%. VAP increases morbi-mortality, length of stay in intensive care and overall management costs. The prevention of ICU nosocomial infections depends on several measures : orotracheal intubation route, maintaining tube cuff pressure between 25 and 30 cm of water (H2O), maintaining a semi-seated position >= 30°, nasal and oropharyngeal care at regular intervals, striving to avoid unscheduled extubation, and use of a written sedation-analgesia algorithm allowing for early weaning from ventilation. Two randomized study show that administration of antibiotic therapy after intubation reduces the risk of early VAP incidence. However, in clinical practice, its administration solely purposes of limiting VAP occurence is not presently recommended. Indeed, to date no placebo blind controlled study was been realized and the fear of development of bacterial resistance remains stronger than the efficiency of this prevention measure. This aim of the present study is to show by a placebo randomized study that 2g of Ceftriaxone within 8 hours post-intubation after a brain injury decrease the risk of occurence an early VAP.

Ancillary study An ancillary study is performed in 2 centres which routinely practice rectal swabs at admission and discharge of ICU, to survey intestinal flora (CHU of Angers and CHU of Rennes). The goal of this study is to compare the incidence of acquired cephalosporin resistant gram negative bacteria at the discharge of ICU between the 2 groups of patients, receiving or not ceftriaxone.

ReferenceCitation: Dahyot-Fizelier C, Frasca D, Lasocki S, Asehnoune K, Balayn D, Guerin AL, Perrigault PF, Geeraerts T, Seguin P, Rozec B, Elaroussi D, Cottenceau V, Guyonnaud C, Mimoz O; PROPHY-VAP Study group, ATLANREA group. Prevention of early ventilation-acquired pneumonia (VAP) in comatose brain-injured patients by a single dose of ceftriaxone: PROPHY-VAP study protocol, a multicentre, randomised, double-blind, placebo-controlled trial. BMJ Open. 2018 Oct 18;8(10):e021488. doi: 10.1136/bmjopen-2018-021488.

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

family: Frasca

full_name: Denis Frasca

given: Denis

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Balayn

full_name: Dorothée Balayn

given: Dorothée

family: Guerin

full_name: Anne-Laure Guerin

given: Anne-Laure

family: Perrigault

full_name: Pierre-François Perrigault

given: Pierre-François

family: Geeraerts

full_name: Thomas Geeraerts

given: Thomas

family: Seguin

full_name: Philippe Seguin

given: Philippe

family: Rozec

full_name: Bertrand Rozec

given: Bertrand

family: Elaroussi

full_name: Djilali Elaroussi

given: Djilali

family: Cottenceau

full_name: Vincent Cottenceau

family: Guyonnaud

full_name: Clément Guyonnaud

given: Clément

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Poitiers University Hospital

location_facility:
Djilali ELAROUSSI
University Hospital of Angers
University Hospital of Poitiers
CHRU
University Hospital of Rennes
Thomas GEERAERTS
University Hospital of Nantes
CHU


title: Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease

acronym: PneumoMICI

summary:
This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is much weaker than in the general population. There are two types of anti-pneumococcal vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate, Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of PSV-23® after an interval of two months. In the case of young children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.

Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine, PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We also want to evaluate the immunological impact of these different strategies in their capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim, we are studying all immunological functional aspects of the antibodies and B lymphocytes induced by the two vaccine strategies.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
APHP - Hôpital Cochin
Hôpital de l'Archet II
CHU Amiens-Picardie
Hôpital Saint-Eloi
CHU de Saint-Etienne
Centre Hospitalier Lyon Sud
Hôpital Charles Nicolle
Hôpital Jean Minjoz

intervention_type: Biological


title: Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty

summary: This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.

lead_sponsor: Corin

location_facility: Centre Hospitalier Régionnal d'Orléans - Site La Source

location_facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin


title: Project to Accelerate the Diagnosis of TTR Amyloidosis by Use of Molecular Biology in First Intention

acronym: ADDITION

summary:
Peripheral neuropathies are diseases that affect the nervous system outside the brain and spinal cord, their prevalence is 1% in the general population, the causes are extremely varied with more than 200 identified causes; the main ones are diabetes, excessive alcohol consumption and chemotherapy. They may be sometimes disabling but generally preserve autonomy.

Transthyretin amyloidosis is a rare multisystematic hereditary disease with autosomal dominant transmission. They present usually as a peripheral neuropathies (FAP). They are due to a point mutation of the transthyretin gene (chr 18q). FAP is secondary to endoneurial amyloid deposits and are characterized by a slowly progressive sensory, motor and autonomic. FAP is the most severe hereditary polyneuropathy of the adult are irreversible and fatal within 5 to 12 years from onset.

Most frequent mutation of TTR gene is located on the second exon; but more than 100 mutations have been reported.

Prevalence of FAP is 1 per 1 million inhabitants. They have been reported until 1990s' in four endemic areas North of Portugal, Sweden, Japan and Majorca. In these areas, diagnosis is facilitated because of the stereotypical presentation : a length-dependent polyneuropathy with predominant involvement of thermal and pain sensations and autonomic dysfunction, early onset in the third decade and a predominant Met30 TTR mutation. Positive family history is frequent 85% (one of the parents is affected). Diagnosis requires detection of TTR mutation by molecular biology (blood sample) and characterization of amyloid deposit on labial salivary gland biopsy.

location_facility:
CHRU Lille
Hopital guy-de-Chauliac
CHU Dupuytren
CHU Saint Etienne
Hopital de Hautepierre
CHU La Timone
CHU Martinique
CHU Grenoble
Hôpital de La Salpetrière
Chu Bicetre


title: Application of Telemedicine to the Management of Aggressive Lymphomas: a Regional Comparative Study

acronym: AMA

summary: The purpose of this study is to evaluate the value of AMA in a comparative multicenter regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This study consider that the AMA support should allow a significant improvement of the RDI compared to the control group and thus impact the duration without progression. The study covers 350 patients recruited from 10 regional centers.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital Bordeaux
Clinique Claude Bernard
Hospital
Bayonne Hospital
Rodez Hospital
University Hospital of Toulouse
Clinique Saint Jean
Clinique Marzet
Tarbes Hospital


title: PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study

acronym: PETRA

summary:
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. EMA's approvals were obtained on phase I pharmacokinetic equivalence trials and phase III clinical trials based on efficacy primary endpoints in the neoadjuvant setting and on Overall Response Rate in metastatic setting. Safety was a secondary endpoints in these trials.

Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab.

A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines.

PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de lutte contre le Cancer JEAN PERRIN, CLERMONT-FERRAND


title: French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease

acronym: EFN-VALID

summary: Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.

lead_sponsor: University Hospital, Grenoble

location_facility:
University hospital grenoble
CHU de Bordeaux-Hôpital Pellegrin
Hospices Civils Lyon (HCL)
CHU Clermont-Ferrand
CHRU Strasbourg
CHU Amiens


title: Effect of IntraoperatiVe High Positive End-ExpirAtory Pressure (PEEP) With ReCruitment MAneuveRs vs Low PEEP on Major Postoperative Pulmonary Complications and Death After On-pump Cardiac Surgery in High-risk Patients: the VACARM Study

acronym: VACARM

summary: Controversies remain concerning the best intraoperative mechanical ventilation regimen for major cardiac surgery. While the use of intra operative low tidal volumes is now standard practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac surgery patients at risk of postoperative pulmonary complications

primary_purpose: Supportive Care

location_facility:
CHU Angers
CHRU Brest
CHU Poitiers
CHU Nantes
CHU Rennes
CHRU Tours

intervention_type: Procedure


title: Doxycycline Versus Placebo in COVID-19 + Patients Without Hospitalization Criteria: Prospective, Multicenter, Randomized, Double-blind Study

acronym: DYNAMIC

summary:
The aim of the study is to compare a treatment with doxycycline vs a placebo as soon as the patient is confirmed COVID-19 + and before the onset of oxygen dependence with the aim of reducing or even abolishing the cytokine explosion and thus the evolution towards a serious form of the disease which can lead to death.

Three criteria support the rational use of tetrcycline in COVI-19 (1) The coronaviruses is known to bind to metalloproteases (MMPs) of the host, in particular to ensure viral survival. Tetracyclines are known to chelate zinc from MMPs. Their chelating activity may help inhibit COVID19 infection by limiting its ability to replicate in the host. (2) Tetracyclines may also be able to inhibit the replication of positive-polarity single-stranded RNA viruses, such as COVID19 (demonstrated on the dengue virus). (3) In addition, tetracyclines are modulators of innate immunity (anti-inflammatory activity), a property used in the treatment of inflammatory skin diseases for many years. These modulating effects are noted on several targets of innate immunity: They can decrease the expression of NFKB, the release of inflammatory cytokines such as TNF-α, IL-1β and IL-6, inhibit granulomas inflammatory and free radical release.

Tetracyclines could therefore participate in limiting the cytokine release induced by COVID19. Their lipophilic nature and their strong pulmonary penetration could allow them to inhibit viral replication.

lead_sponsor: Nantes University Hospital

location_facility:
CHU Caen
CHU Bordeaux
CHU Grenoble
CHU Dijon
CHU Nantes
CHU Avicenne - APHP


title: Prospective Description Study of the Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19

summary:
This is a prospective multicenter cohort study. The question arises as to whether treatment with protease inhibitors (PIs) could have a preventive role for COVID-19 infection, especially since patients living with HIV (PLWHIV) have not been described as more at risk of developing COVID-19 infection.

The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Hopital universitaire de Hotel Dieu
CHI Créteil
CHU Henri Mondor
Centre hospitalier de Melun (GHSIF)
Hopital Universitaire de Necker
CHI Villeneuve St Georges


title: Prospective Evaluation of a Predictive Toxicity Test Post Radiotherapy After Mastectomy With Immediate Implant Reconstruction

acronym: PRETORIA

summary: This study evaluates the capacity of the NovaGray RILA Breast® test to predict the toxicity linked to radiotherapy and the impact of implant breast reconstruction.

ReferenceCitation: Nègre G, Balcaen T, Dast S, Sinna R, Chazard E. Breast reconstruction in France, observational study of 140,904 cases of mastectomy for breast cancer. Ann Chir Plast Esthet. 2020 Feb;65(1):36-43. doi: 10.1016/j.anplas.2019.07.014. Epub 2019 Aug 2.

ReferenceCitation: Ng SK, Hare RM, Kuang RJ, Smith KM, Brown BJ, Hunter-Smith DJ. Breast Reconstruction Post Mastectomy: Patient Satisfaction and Decision Making. Ann Plast Surg. 2016 Jun;76(6):640-4. doi: 10.1097/SAP.0000000000000242.

ReferenceCitation: Howes BH, Watson DI, Xu C, Fosh B, Canepa M, Dean NR. Quality of life following total mastectomy with and without reconstruction versus breast-conserving surgery for breast cancer: A case-controlled cohort study. J Plast Reconstr Aesthet Surg. 2016 Sep;69(9):1184-91. doi: 10.1016/j.bjps.2016.06.004. Epub 2016 Jun 18.

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717.

ReferenceCitation: Ricci JA, Epstein S, Momoh AO, Lin SJ, Singhal D, Lee BT. A meta-analysis of implant-based breast reconstruction and timing of adjuvant radiation therapy. J Surg Res. 2017 Oct;218:108-116. doi: 10.1016/j.jss.2017.05.072. Epub 2017 Jun 15. Review.

ReferenceType: result

ReferenceCitation: Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20. Review.

family: Barry

full_name: M Barry

given: M

family: Kell

full_name: M. R. Kell

given: M. R.

journal_name: Breast Cancer Research and Treatment

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

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

location_facility:
Centre Léon Bérard
Institut du Cancer de Montpellier
Institut de Cancérologie de l'Ouest
Hôpital Tenon
Centre Oscar Lambret
Institut Paoli Calmette


title: Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases

acronym: PIMABOD

summary:
The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure.

Such imaging will also offer the advantage of being non-irradiating and without contrast products, which will ultimately allow CT to be replaced by MRI in the follow-up of bronchial obstructive patients, thus avoiding the risks associated with repeated exposure to ionizing radiation.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre de Pneumologie Bordeaux Rive droite


title: Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy

acronym: IPPACTTO

summary: The rise of oral therapies in the management of cancers has considerably changed the patient care path. If the oral route is preferred by patients because it offers a better quality of life, it is not without impact for patients and the health professionals involved in their management in their care. Indeed, the use of the oral route shifts part of the responsibility for monitoring treatment towards the patient, thereby leading to compliance problems, drug interactions and the management of adverse effects.These risks can cause complications or compromise the effectiveness of treatment, and generate additional costs for the investigator's health system. The study proposes to involve Healthcare Facilities Pharmacist and the Dispensary Pharmacist with all other health professionals.First, the hospital pharmacist will operate before the initiation of an oral route to perform a clinical pharmaceutical analysis of drug prescriptions. Then after the primary prescription and finally during a follow-up consultation 3 months after the initiation of treatment. The hypothesis of the study is that the coordinated intervention of the hospital pharmacist and of the dispensary pharmacist would improve the tolerance of oral treatments by reducing the number of serious adverse effects found, as well as improve the, quality of life, patient and professional satisfaction

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Ch Le Mans
Ch Cholet
Institut de Cancérologie de l'Ouest
Chu Nantes
Groupe Confluent
Clinique Victor Hugo

intervention_type: Behavioral


title: Evaluation of Positioning Protocols With an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke

acronym: POSIT-HEMI

summary: The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre de Rééducation et de Réadaptation Fonctionnelles

location_facility: Groupement Hospitalier Intercommunal du Vexin


title: Efficacy of an Infrared Visualization Technique for the Identification of the Peripheral Venous Access Site in Patients With Cystic Fibrosis Aged 12 Years and Older

acronym: MUCOVEINE

summary:
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.

Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.

Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.

This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).

location_facility: Hôpital enfant la Timone - CRCM pédiatrique Marseille


title: EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer

summary: 5 to 10% of cancers are due to the presence of a constitutional genetic alteration. It can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). In both cases, this genetic alteration is constitutional and transmissible to descendants. It is hereditary. When an hereditary early form is suspected, several well-known genes generally involved in genetic predispositions to cancer are found by a technique called " gene panel ". However, this analysis does not always identify the genetic predisposing factors for cancer. New techniques called "high-throughput exome sequencing (SHD-E)", allow more than the analysis of the the gene panel. These analysis allow to identify alterations in other genes that could contribute to the development of cancer. The objective of the Ex²trican study is to show, from patients with early cancer (sporadic or familial form), that this approach to exome sequencing can be effective to identify new genetic risk of cancer, when the first panel analysis of genes is negative.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Georges-François Leclerc
CHU de Reims
CHU de Dijon
CHRU Jean Minjoz
CH de Troyes
Polyclinique de Courlancy

intervention_type: Genetic


lead_sponsor: Centre Leon Berard

acronym: MegaMOST

location_facility:
Centre Léon Bérard
Institut Claudius Regaud
Centre Antoine LACASSAGNE
Institut Curie
Institut Paoli Calmettes
Institut Bergonié

title: MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations /Characteristics in Advanced / Metastatic Tumors.

summary:
This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment.

Patients will be assigned to a treatment cohort based on molecular alterations/characteristics detected on tumor sample from primary tumor or metastatic lesion.

In this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced/metastatic cancers.

All eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent.

Patients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor:

Evidence of clinical benefit as assessed by the investigators,
Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease,
No decline in ECOG Performance Status (PS) that can be attributed to disease progression.


title: Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer

summary: This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

lead_sponsor: ABX advanced biochemical compounds GmbH

location_facility: Hôpitaux de Brabois (Vandoeuvre-les-Nancy)


title: Coats Plus Syndrome and LCC Syndrome: Series of 10 Pediatric Cases. Review of Literature and Natural History

acronym: COATS+

summary:
Coats plus syndrome is a very rare and serious disease, caused by premature telomere shortening. It is a pediatric, multi-systemic disease, the main features of which are retinal vasculopathy and neurological disorders, associated with brain calcification and leukodystrophy. Its precise genetic etiology was discovered in 2012: autosomal recessive mutation of the CTC1 gene.

Publications about this syndrome are very few, and consist only of case reports, or small series of cases. This is explained by the rarity of occurrence of this syndrome. Since 1988, 57 cases of Coats plus syndrome have been published, with case series of up to 13 patients. Only 28 cases were detailed concerning the precise clinical presentation in the literature.

The general characteristics of this syndrome are known and, in addition to the ophthalmological and neurological damage, the various publications have been able to report a digestive attack (hemorrhages), hematological damage (central cytopenias), or increased bone fragility. No treatment is currently available to cure patients.

The natural history of this disease is poorly known. However, the most accurate knowledge possible of this disease, and its natural history, is essential. It would allow an easier identification of this rare syndrome, the establishment of a management (monitoring and therapeutic) adapted, and a more accurate genetic counseling in case of need of a prenatal diagnosis.

The description of a new series of unpublished cases, as well as a comprehensive review of the literature on Coats plus syndrome, will provide a more comprehensive and informed view of this disease.

Moreover, LCC syndrome (leukoencephalopathy with calcifications and cysts) is an autosomal recessive disorder linked to a mutation in the SNORD118 gene, which has the particularity of presenting the same neurological (neuro-radiological and clinical) characteristics, but without associating the others. ophthalmological and systemic disorders. It constitutes the differential radiological diagnosis of Coats plus syndrome. In this, the collection of medical data of French pediatric cases presenting this syndrome will allow a more detailed analysis of the differences and similarities between these two syndromes.

time_perspective: Retrospective

lead_sponsor: University Hospital, Limoges

location_facility:
Hospices civils de Lyon
CHU de Limoges
Fondation Adolphe de ROTHSCHILD
Hopital Kremlin Bicêtre
Hopital Robert Debré
CHU de Rennes


title: Evaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort

acronym: ChewingHort

summary: It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA).

location_facility:
CH St Antoine
CHU Limoges
CHU de Nantes
CH Valenciennes
CHU Tours
CH Avignon


title: Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis

acronym: SYNOFRESH

summary: To study the diagnostic performance of infrared spectroscopy on fresh synovial fluids in early septic arthritis diagnosis in patients with acute joint effusion

lead_sponsor: Rennes University Hospital

location_facility:
CHU Angers
CHRU Brest
CHU Clermont-Ferrand
CHU Nantes
CHU de Rennes
CHRU Tours


title: Validity, Reliability and Responsiveness to Change of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population.

summary: The aim of this study is to present the French translation of the Drooling Impact Scale (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of children with Cerebral Palsy (CP)

lead_sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre d'Education Motrice Henry Gormand

location_facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

location_facility: Centre d'Education Motrice Jean-Marie Arnion - Odynéo

location_facility: Centre Hospitalier Universitaire Hôpital Nord


title: Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers

acronym: PROMESSE

summary:
Prospective memory (PM) is the ability to implement intended actions in the future. It allows maintaining and retrieving future plans, goals, and activities (i.e., remember to remember). PM is associated with most everyday memory problems . PM is crucial to correctly respond to all the social, occupational and working demands of everyday life, to perform many deferred health-related actions and is involved in therapeutic adherence .

Indeed, PM errors are an important part of the aging memory complaints. The prevalence of self-reported PM failures is also significant among young adults, compared with self-reported retrospective memory (RM) failures .Yet, PM errors are major sources of frustration and embarrassment .

In oncology, recently investigated the self-reported memory complaints in a 80 case-healthy-control study breast patients . Subjective memory complaints were assessed using the Prospective and Retrospective Memory Questionnaire . Results from the Paquet et al. study show that all participants (i.e., both patients and matched-controls) reported more PM than RM failures in daily-life (p<.001). Breast cancer patients reported more RM and PM failures than controls. However, this group effect was no longer statistically significant when controlling for depression and fatigue.

These findings are consistent with the view that memory complaints are closely associated with depression and cancer-related fatigue, and more generally with psychopathological variables .As underlined by Paquet et al. subjective memory complaints should be investigated because they refer to some aspects of the cancer experience that could potentially be linked to quality of life. Thus, it is important to explore psychopathological basis such as depression, anxiety and fatigue while investigating self-reported memory failures in cancer patients.

Despites the importance of PM, there have been, to our knowledge, only few studies evaluating PM complaints or PM functioning in patients diagnosed with an intracerebral tumor (such as Diffuse Low-Grade Glioma- DLGG- or glioblastome- GB) or extra-cerebral tumor (such as breast cancer - BC). Therefore, the investigators thought it would be useful, as a first step, to conduct a study to explore and to manage the PM and RM subjective complaints in cancer patients compared to another chronic disease, such as HIV. In fine, these data will help to identify a new target for psychological management focused on either psychopathological or neuropsychological rehabilitation

ReferenceCitation: Bedard M, Verma S, Collins B, Song X, Paquet L. Prospective memory impairment in chemotherapy-exposed early breast cancer survivors: Preliminary evidence from a clinical test. J Psychosoc Oncol. 2016 Jul-Aug;34(4):291-304. doi: 10.1080/07347332.2016.1181133. Epub 2016 Apr 28.

ReferenceCitation: Boone M, Roussel M, Chauffert B, Le Gars D, Godefroy O. Prevalence and profile of cognitive impairment in adult glioma: a sensitivity analysis. J Neurooncol. 2016 Aug;129(1):123-30. doi: 10.1007/s11060-016-2152-7. Epub 2016 May 30.

ReferenceCitation: Brem S, Meyers CA, Palmer G, Booth-Jones M, Jain S, Ewend MG. Preservation of neurocognitive function and local control of 1 to 3 brain metastases treated with surgery and carmustine wafers. Cancer. 2013 Nov 1;119(21):3830-8. doi: 10.1002/cncr.28307. Epub 2013 Aug 23.

ReferenceCitation: Cheng H, Yang Z, Dong B, Chen C, Zhang M, Huang Z, Chen Z, Wang K. Chemotherapy-induced prospective memory impairment in patients with breast cancer. Psychooncology. 2013 Oct;22(10):2391-5. doi: 10.1002/pon.3291. Epub 2013 May 15.

ReferenceCitation: Crawford JR, Henry JD, Ward AL, Blake J. The Prospective and Retrospective Memory Questionnaire (PRMQ): latent structure, normative data and discrepancy analysis for proxy-ratings. Br J Clin Psychol. 2006 Mar;45(Pt 1):83-104.

ReferenceCitation: de Frias CM, Dixon RA, Bäckman L. Use of memory compensation strategies is related to psychosocial and health indicators. J Gerontol B Psychol Sci Soc Sci. 2003 Jan;58(1):P12-22.

ReferenceCitation: Dieckmann P, Reddersen S, Wehner T, Rall M. Prospective memory failures as an unexplored threat to patient safety: results from a pilot study using patient simulators to investigate the missed execution of intentions. Ergonomics. 2006 Apr 15-May 15;49(5-6):526-43.

ReferenceCitation: Dubois B, Slachevsky A, Litvan I, Pillon B. The FAB: a Frontal Assessment Battery at bedside. Neurology. 2000 Dec 12;55(11):1621-6.

ReferenceCitation: Fleming J, Ownsworth T, Doig E, Hutton L, Griffin J, Kendall M, Shum DH. The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2017 Jan 5;18(1):3. doi: 10.1186/s13063-016-1758-6.

ReferenceCitation: Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98.

ReferenceCitation: Gentile S, Delarozière JC, Favre F, Sambuc R, San Marco JL. Validation of the French 'multidimensional fatigue inventory' (MFI 20). Eur J Cancer Care (Engl). 2003 Mar;12(1):58-64.

ReferenceCitation: Gonneaud J, Kalpouzos G, Bon L, Viader F, Eustache F, Desgranges B. Distinct and shared cognitive functions mediate event- and time-based prospective memory impairment in normal ageing. Memory. 2011 May;19(4):360-77. doi: 10.1080/09658211.2011.570765.

ReferenceCitation: Guerdoux E, Dressaire D, Martin S, Adam S, Brouillet D. Habit and recollection in healthy aging, mild cognitive impairment, and Alzheimer's disease. Neuropsychology. 2012 Jul;26(4):517-33. doi: 10.1037/a0028718. Epub 2012 May 28.

ReferenceCitation: Guerdoux E, Martin S, Dressaire D, Adam S, Brouillet D. [Memory controlled processes between the young and old: the birth of cognitive complaint?]. Can J Aging. 2009 Mar;28(1):5-20. doi: 10.1017/S0714980809090023. French.

ReferenceCitation: Herrmann C. International experiences with the Hospital Anxiety and Depression Scale--a review of validation data and clinical results. J Psychosom Res. 1997 Jan;42(1):17-41. Review.

ReferenceCitation: Kim HJ, Barsevick AM, Fang CY, Miaskowski C. Common biological pathways underlying the psychoneurological symptom cluster in cancer patients. Cancer Nurs. 2012 Nov-Dec;35(6):E1-E20. doi: 10.1097/NCC.0b013e318233a811. Review.

ReferenceCitation: Kliegel M, Altgassen M, Hering A, Rose NS. A process-model based approach to prospective memory impairment in Parkinson's disease. Neuropsychologia. 2011 Jul;49(8):2166-77. doi: 10.1016/j.neuropsychologia.2011.01.024. Epub 2011 Jan 19.

ReferenceCitation: Kliegel M, Martin M, McDaniel MA, Einstein GO. Varying the importance of a prospective memory task: differential effects across time- and event-based prospective memory. Memory. 2001 Jan;9(1):1-11.

ReferenceCitation: Kvavilashvili L, Kornbrot DE, Mash V, Cockburn J, Milne A. Differential effects of age on prospective and retrospective memory tasks in young, young-old, and old-old adults. Memory. 2009 Feb;17(2):180-96. doi: 10.1080/09658210802194366.

ReferenceCitation: Lange M, Joly F. How to Identify and Manage Cognitive Dysfunction After Breast Cancer Treatment. J Oncol Pract. 2017 Dec;13(12):784-790. doi: 10.1200/JOP.2017.026286.

ReferenceCitation: Martin S, Mazzocco C, Maury P, Grosselin A, Van der Elst W, Dixon RA, Brouillet D. Compensating for memory losses throughout aging: validation and normalization of the memory compensation questionnaire (MCQ) for non-clinical French populations. Arch Gerontol Geriatr. 2015 Jan-Feb;60(1):28-38. doi: 10.1016/j.archger.2014.10.013. Epub 2014 Oct 22.

ReferenceCitation: Meyers CA, Wefel JS. The use of the mini-mental state examination to assess cognitive functioning in cancer trials: no ifs, ands, buts, or sensitivity. J Clin Oncol. 2003 Oct 1;21(19):3557-8. Epub 2003 Aug 11.

ReferenceCitation: Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. Erratum in: J Am Geriatr Soc. 2019 Sep;67(9):1991.

ReferenceCitation: Paquet L, Collins B, Song X, Chinneck A, Bedard M, Verma S. A pilot study of prospective memory functioning in early breast cancer survivors. Breast. 2013 Aug;22(4):455-61. doi: 10.1016/j.breast.2013.04.002. Epub 2013 May 4.

ReferenceCitation: Paquet L, Verma S, Collins B, Chinneck A, Bedard M, Song X. Testing a novel account of the dissociation between self-reported memory problems and memory performance in chemotherapy-treated breast cancer survivors. Psychooncology. 2018 Jan;27(1):171-177. doi: 10.1002/pon.4389. Epub 2017 Feb 10.

ReferenceCitation: Woods SP, Moran LM, Dawson MS, Carey CL, Grant I; HIV Neurobehavioral Research Center (HNRC) Group. Psychometric characteristics of the memory for intentions screening test. Clin Neuropsychol. 2008 Sep;22(5):864-78. doi: 10.1080/13854040701595999.

ReferenceCitation: Razavi D, Delvaux N, Farvacques C, Robaye E. Screening for adjustment disorders and major depressive disorders in cancer in-patients. Br J Psychiatry. 1990 Jan;156:79-83.

ReferenceCitation: Scullin MK, McDaniel MA, Shelton JT. The Dynamic Multiprocess Framework: evidence from prospective memory with contextual variability. Cogn Psychol. 2013 Aug-Sep;67(1-2):55-71. doi: 10.1016/j.cogpsych.2013.07.001. Epub 2013 Aug 3.

ReferenceCitation: Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25.

ReferenceCitation: Smith G, Della Sala S, Logie RH, Maylor EA. Prospective and retrospective memory in normal ageing and dementia: a questionnaire study. Memory. 2000 Sep;8(5):311-21.

ReferenceCitation: Smith T, Gildeh N, Holmes C. The Montreal Cognitive Assessment: validity and utility in a memory clinic setting. Can J Psychiatry. 2007 May;52(5):329-32.

ReferenceCitation: Woods SP, Carey CL, Moran LM, Dawson MS, Letendre SL, Grant I; HIV Neurobehavioral Research Center (HNRC) Group. Frequency and predictors of self-reported prospective memory complaints in individuals infected with HIV. Arch Clin Neuropsychol. 2007 Feb;22(2):187-95. Epub 2007 Feb 6.

ReferenceCitation: Zeintl M, Kliegel M, Rast P, Zimprich D. Prospective memory complaints can be predicted by prospective memory performance in older adults. Dement Geriatr Cogn Disord. 2006;22(3):209-15. Epub 2006 Aug 7.

ReferenceCitation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.

location_facility:
UFR de Psychologie Université de Lille
Hopital saint Louis
CHU D'amiens
CHU Lyon
Icm Val D'Aurelle
Hôpital d'Instruction des Armées


title: Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial

acronym: RESECT COLON

summary:
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.

location_facility:
Jean Mermoz Hospital
Edouard Herriot Hospital
Nancy University Hospital
University Hospital, Limoges
Cochin Hospital
Pontchaillou Hospital


title: A Sorafenib-Regorafenib Sequence Treatment Monitoring Study Using Liquid Biopsy

acronym: HELP

summary: The aim of this trial is to investigate whether quantitative analysis of the total concentration of circulating free deoxyribonucleic acid (cfDNA) and of the cfDNA integrity index (DII) (Intplex®) may reflect hepatocellular carcinoma (HCC) tumor dynamics or response for patients treated by Sorafenib or Regorafenib and if it could be used as a tool for patient management under targeted therapy.

ReferenceCitation: Gupta S, Bent S, Kohlwes J. Test characteristics of alpha-fetoprotein for detecting hepatocellular carcinoma in patients with hepatitis C. A systematic review and critical analysis. Ann Intern Med. 2003 Jul 1;139(1):46-50. Review.

ReferenceCitation: Riaz A, Ryu RK, Kulik LM, Mulcahy MF, Lewandowski RJ, Minocha J, Ibrahim SM, Sato KT, Baker T, Miller FH, Newman S, Omary R, Abecassis M, Benson AB 3rd, Salem R. Alpha-fetoprotein response after locoregional therapy for hepatocellular carcinoma: oncologic marker of radiologic response, progression, and survival. J Clin Oncol. 2009 Dec 1;27(34):5734-42. doi: 10.1200/JCO.2009.23.1282. Epub 2009 Oct 5.

ReferenceCitation: Chan SL, Mo FK, Johnson PJ, Hui EP, Ma BB, Ho WM, Lam KC, Chan AT, Mok TS, Yeo W. New utility of an old marker: serial alpha-fetoprotein measurement in predicting radiologic response and survival of patients with hepatocellular carcinoma undergoing systemic chemotherapy. J Clin Oncol. 2009 Jan 20;27(3):446-52. doi: 10.1200/JCO.2008.18.8151. Epub 2008 Dec 8.

ReferenceCitation: Duvoux C, Roudot-Thoraval F, Decaens T, Pessione F, Badran H, Piardi T, Francoz C, Compagnon P, Vanlemmens C, Dumortier J, Dharancy S, Gugenheim J, Bernard PH, Adam R, Radenne S, Muscari F, Conti F, Hardwigsen J, Pageaux GP, Chazouillères O, Salame E, Hilleret MN, Lebray P, Abergel A, Debette-Gratien M, Kluger MD, Mallat A, Azoulay D, Cherqui D; Liver Transplantation French Study Group. Liver transplantation for hepatocellular carcinoma: a model including α-fetoprotein improves the performance of Milan criteria. Gastroenterology. 2012 Oct;143(4):986-94.e3; quiz e14-5. doi: 10.1053/j.gastro.2012.05.052. Epub 2012 Jun 29.

ReferenceCitation: Personeni N, Bozzarelli S, Pressiani T, Rimassa L, Tronconi MC, Sclafani F, Carnaghi C, Pedicini V, Giordano L, Santoro A. Usefulness of alpha-fetoprotein response in patients treated with sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2012 Jul;57(1):101-7. doi: 10.1016/j.jhep.2012.02.016. Epub 2012 Mar 10.

ReferenceCitation: Yamashita T, Forgues M, Wang W, Kim JW, Ye Q, Jia H, Budhu A, Zanetti KA, Chen Y, Qin LX, Tang ZY, Wang XW. EpCAM and alpha-fetoprotein expression defines novel prognostic subtypes of hepatocellular carcinoma. Cancer Res. 2008 Mar 1;68(5):1451-61. doi: 10.1158/0008-5472.CAN-07-6013.

ReferenceCitation: Sozzi G, Conte D, Mariani L, Lo Vullo S, Roz L, Lombardo C, Pierotti MA, Tavecchio L. Analysis of circulating tumor DNA in plasma at diagnosis and during follow-up of lung cancer patients. Cancer Res. 2001 Jun 15;61(12):4675-8.

ReferenceCitation: Thierry AR, Mouliere F, El Messaoudi S, Mollevi C, Lopez-Crapez E, Rolet F, Gillet B, Gongora C, Dechelotte P, Robert B, Del Rio M, Lamy PJ, Bibeau F, Nouaille M, Loriot V, Jarrousse AS, Molina F, Mathonnet M, Pezet D, Ychou M. Clinical validation of the detection of KRAS and BRAF mutations from circulating tumor DNA. Nat Med. 2014 Apr;20(4):430-5. doi: 10.1038/nm.3511. Epub 2014 Mar 23.

ReferenceCitation: Thierry AR, El Messaoudi S, Gahan PB, Anker P, Stroun M. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Sep;35(3):347-76. doi: 10.1007/s10555-016-9629-x. Review.

ReferenceCitation: Ono A, Fujimoto A, Yamamoto Y, Akamatsu S, Hiraga N, Imamura M, Kawaoka T, Tsuge M, Abe H, Hayes CN, Miki D, Furuta M, Tsunoda T, Miyano S, Kubo M, Aikata H, Ochi H, Kawakami YI, Arihiro K, Ohdan H, Nakagawa H, Chayama K. Circulating Tumor DNA Analysis for Liver Cancers and Its Usefulness as a Liquid Biopsy. Cell Mol Gastroenterol Hepatol. 2015 Jun 17;1(5):516-534. doi: 10.1016/j.jcmgh.2015.06.009. eCollection 2015 Sep.

ReferenceCitation: Jiang P, Chan CW, Chan KC, Cheng SH, Wong J, Wong VW, Wong GL, Chan SL, Mok TS, Chan HL, Lai PB, Chiu RW, Lo YM. Lengthening and shortening of plasma DNA in hepatocellular carcinoma patients. Proc Natl Acad Sci U S A. 2015 Mar 17;112(11):E1317-25. doi: 10.1073/pnas.1500076112. Epub 2015 Feb 2.

ReferenceCitation: Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014 Feb 20;32(6):579-86. doi: 10.1200/JCO.2012.45.2011. Epub 2014 Jan 21. Review.

ReferenceCitation: El Messaoudi S, Mouliere F, Du Manoir S, Bascoul-Mollevi C, Gillet B, Nouaille M, Fiess C, Crapez E, Bibeau F, Theillet C, Mazard T, Pezet D, Mathonnet M, Ychou M, Thierry AR. Circulating DNA as a Strong Multimarker Prognostic Tool for Metastatic Colorectal Cancer Patient Management Care. Clin Cancer Res. 2016 Jun 15;22(12):3067-77. doi: 10.1158/1078-0432.CCR-15-0297. Epub 2016 Feb 4.

ReferenceCitation: Mouliere F, El Messaoudi S, Pang D, Dritschilo A, Thierry AR. Multi-marker analysis of circulating cell-free DNA toward personalized medicine for colorectal cancer. Mol Oncol. 2014 Jul;8(5):927-41. doi: 10.1016/j.molonc.2014.02.005. Epub 2014 Mar 24.

family: Mouliere

full_name: Florent Mouliere

given: Florent

family: El Messaoudi

full_name: Safia El Messaoudi

given: Safia

family: Pang

full_name: Dalong Pang

given: Dalong

family: Dritschilo

full_name: Anatoly Dritschilo

given: Anatoly

family: Thierry

full_name: Alain R. Thierry

given: Alain R.

currency_apc_doaj: USD

journal_name: Molecular Oncology

oa_colors: green hybrid

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Zonta E, Nizard P, Taly V. Assessment of DNA Integrity, Applications for Cancer Research. Adv Clin Chem. 2015;70:197-246. doi: 10.1016/bs.acc.2015.03.002. Epub 2015 Apr 11. Review.

location_facility:
Hôpital Saint-Eloi
CHRU de Lille - Hôpital Claude Duriez
CHRU Nancy - Hôpital Brabois
CHU Grenoble - Hôpital Michalon
Hôpital Hôtel Dieu
Hôpital Beaujon


title: Impact of E-assisted Connected Follow up on the Delay of Management of Postoperative Complications in Digestive Surgery

acronym: SURGICONNECT

summary:
Postoperative management in digestive surgery has been modernized thanks to improved rehabilitation measures. These measures include an earlier refeeding, mobilization, restriction of infusions (out of a total of 22) and showed their benefit in colorectal, gastric and bariatric surgery. It is thus possible to perform sleeve gastrectomy, bypass, restorations of digestive continuity and colectomies with early discharge or one day surgery.

The most serious complications (fistula, sepsis) occur in the first 10 days postoperatively with an average readmission rate of 10%. Their screening is based on clinical signs (tachycardia, pain) or biological (C-Reactive Protein (CRP) assay on Day 3 or Day 4). It is important to manage these complications early so that their morbidity is lower, resulting in shorter stays and less severity.

The monitoring and safety of patients discharged early are therefore essential and for the moment poorly codified, ranging from simple nursing to follow-up via a health provider. Recently, coordination structures including nurse platform and smartphone follow up app have emerged. Thanks to this system, the patient collects his own history and biological results which allows him to be monitored continuously, as in the hospital. In case of no filling or sign of complication, the nurse platform contacts the patient.

This connected follow-up would make it possible to reinforce the safety of the patient discharged early after a complex digestive procedure performed on an outpatient basis. Its benefit has been poorly evaluated but it is however more and more used by surgeons convinced of its interest especially as it goes in the direction of the development of the outpatient activity requested by the High Authority of Health with economic benefits interesting also the administration of the care structures.

The purpose of the investigator's study is to evaluate the impact of e-assessed follow-up during 10 days after surgery compared to a conventional follow-up. The hypothesis is that this connected follow-up would allow earlier detection of complications requiring rehospitalization (within 48 hours), resulting in faster and less severe treatment.

location_facility: Service de Chirurgie Digestive, Hôpital d'Estaing, CHU de Clermont-Fd

location_facility: Service de Chirurgie Générale, Digestive et de la Transplantation Hépatique, Hôpital de la Croix Rousse, Hospices Civils de Lyon

location_facility: Service de Chirurgie Digestive, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon

location_facility: Service de Chirurgie Digestive, Hôpital Le Bocage, CHU Dijon

location_facility: Service de Chirurgie Digestive, Hôpital Edouard Herriot, Hospices Civils de Lyon

location_facility: Département de Chirurgie Digestive, Hôpital Michallon, CHU Grenoble


title: "Impact of Pelvic Floor Prehabilitation Using Biofeedback on the Severity of the Low Anterior Resection Syndrome in Patients Undergoing a Total Mesorectal Excision for Rectal Cancer"

acronym: CONTICARE

summary:
There is currently no specific treatment and only few measures to prevent the low anterior resection syndrome (LARS). The LARS often results in a severe alteration of quality of life. This study is designed to assess pelvic floor prehabilitation using biofeedback in the prevention of LARS following total mesorectal excision for cancer. The pelvic floor rehabilitation with biofeedback has already been tested postoperatively in patients suffering from LARS with heterogeneous results. However, this rehabilitation has never been evaluated in the prevention of LARS.

The prehabilitation is an innovative concept currently evaluated in the prevention of functional complications following orthopedic surgery and also prostate surgery. In high-risk abdominal surgery, cardiopulmonary prehabilitation offers satisfying results in terms of morbidity and mortality rates. This study will be the first to assess pelvic floor prehabilitation in the prevention of LARS.

location_facility:
CHU Angers
CHU de Tours
CHU de Poitiers
APHP-Hôpital Beaujon
Clinic Jules Verne
CHD Vendée


title: Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial

summary: Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury (mTBI). Early identification of patients at risk for UO is crucial for suitable management to be initiated, increasing their chances for a return to a normal life. The investigators previously developed a diagnostic tool enabling early identification (8 to 21 days after the injury) of patients likely to develop UO. In the present study, the investigators examined the value and beneficial effects of early multidimensional management (MM) on prognosis. The investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94% had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for the main confounding factors, was statistically significant (p<0.001). These results show that the initiation of MM after early identification of at-risk mTBI patients can considerably improves their prognosis.

ReferenceCitation: Caplain S, Chenuc G, Blancho S, Marque S, Aghakhani N. Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. Front Neurol. 2019 Sep 4;10:929. doi: 10.3389/fneur.2019.00929. eCollection 2019.

family: Caplain

full_name: Sophie Caplain

given: Sophie

family: Chenuc

full_name: Gaelle Chenuc

given: Gaelle

family: Blancho

full_name: Sophie Blancho

family: Marque

full_name: Sébastien Marque

given: Sébastien

family: Aghakhani

full_name: Nozar Aghakhani

given: Nozar

journal_name: Frontiers in Neurology

license: cc-by

license_normalized: cc-by

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Institut de Recherche sur la Moelle épinière et l'Encéphale

location_facility:
CHU St ANTOINE
Chu Tenon
Chu Rouen
Chu Bichat/Beaujon
Chu Montpellier
Chu Bicetre