acronym: FIBRECHO

summary:
The non-invasive assessment of liver fibrosis in chronic viral hepatitis B and C is now entering clinical practice. It is based on blood tests, especially FibroMetre® and Fibrotest® and on elastography with the Fibroscan®. Despite the overall satisfactory diagnostic performance for all of these tests (AUROC ranging from 0.80 to 0.90 depending on the study) for the discrimination of F≤1 versus F≥2, the positive and negative predictive values , however, are far from be perfect in a given patient. With these technique, failures are also possible and the measures do not meet quality standards that increase the risk of misclassification. It would be particularly useful to have new generation techniques with a better diagnostic performance.

In this project, in response to the problems presented above, we propose to evaluate the diagnostic performance of five innovative ultrasonic techniques for the non-invasive diagnosis of fibrosis.


title: Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation: FACT STUDY

acronym: FACT

summary: French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Ferring Pharmaceuticals

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.

acronym: CIRCUP

summary: Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not yet been studied. Through a prospective randomised trial of children with posterior urethral valves the investigators wish to determine the effect of circumcision on the risk of presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24 months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will also be monitored. The relative risk of presenting a febrile UTI in each group will be determined. Clinical, radiological and antenatal data concerning each child will be analysed. At 24 months follow-up, an "impact on family scale" survey (IOFS) will be proposed parents.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Woolf AS, Thiruchelvam N. Congenital obstructive uropathy: its origin and contribution to end-stage renal disease in children. Adv Ren Replace Ther. 2001 Jul;8(3):157-63. Review.

ReferenceCitation: Parkhouse HF, Barratt TM, Dillon MJ, Duffy PG, Fay J, Ransley PG, Woodhouse CR, Williams DI. Long-term outcome of boys with posterior urethral valves. Br J Urol. 1988 Jul;62(1):59-62.

ReferenceCitation: Singh-Grewal D, Macdessi J, Craig J. Circumcision for the prevention of urinary tract infection in boys: a systematic review of randomised trials and observational studies. Arch Dis Child. 2005 Aug;90(8):853-8. Epub 2005 May 12. Review.

ReferenceCitation: Simforoosh N, Tabibi A, Khalili SA, Soltani MH, Afjehi A, Aalami F, Bodoohi H. Neonatal circumcision reduces the incidence of asymptomatic urinary tract infection: a large prospective study with long-term follow up using Plastibell. J Pediatr Urol. 2012 Jun;8(3):320-3. doi: 10.1016/j.jpurol.2010.10.008. Epub 2010 Nov 5.

ReferenceCitation: Mukherjee S, Joshi A, Carroll D, Chandran H, Parashar K, McCarthy L. What is the effect of circumcision on risk of urinary tract infection in boys with posterior urethral valves? J Pediatr Surg. 2009 Feb;44(2):417-21. doi: 10.1016/j.jpedsurg.2008.10.102.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Department of pediatric surgery, Bordeaux hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: EudraCT Number

title: Pilot Study to Assess the Efficacy and Tolerance to a QUadruple Therapy With Asunaprevir , Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a, in HIV-HCV Genotype 1 or 4 Coinfected Patients Previously Null Responders to a Standard Pegylated Interferon -Ribavirin Regimen

acronym: QUADRIH

summary:
Evaluation of efficacy and tolerance to a QUadruple therapy with Asunaprevir , Daclatasvir, Ribavirin and pegylated Interferon alpha-2a, in HIV-HCV genotype 1 or 4 coinfected patients previously null responders to a standard Pegylated Interferon -Ribavirin regimen.

The proportion of patients presenting cirrhosis (defined by a METAVIR F4 score on liver biopsy and/or with hepatic impulse elastometry ≥ 15 kPa) will be limited to 50% of all of the patients included

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Piroth L, Paniez H, Taburet AM, Vincent C, Rosenthal E, Lacombe K, Billaud E, Rey D, Zucman D, Bailly F, Bronowicki JP, Simony M, Diallo A, Izopet J, Aboulker JP, Meyer L, Molina JM; ANRS HC30 QUADRIH Study Group. High Cure Rate With 24 Weeks of Daclatasvir-Based Quadruple Therapy in Treatment-Experienced, Null-Responder Patients With HIV/Hepatitis C Virus Genotype 1/4 Coinfection: The ANRS HC30 QUADRIH Study. Clin Infect Dis. 2015 Sep 1;61(5):817-25. doi: 10.1093/cid/civ381. Epub 2015 May 14.

family: Piroth

full_name: Lionel Piroth

given: Lionel

sequence: first

family: Paniez

full_name: Hubert Paniez

given: Hubert

sequence: additional

family: Taburet

full_name: Anne Marie Taburet

given: Anne Marie

family: Vincent

full_name: Corine Vincent

given: Corine

family: Rosenthal

full_name: Eric Rosenthal

given: Eric

family: Lacombe

full_name: Karine Lacombe

given: Karine

family: Billaud

full_name: Eric Billaud

family: Rey

full_name: David Rey

given: David

family: Zucman

full_name: David Zucman

family: Bailly

full_name: François Bailly

given: François

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

family: Simony

full_name: Mélanie Simony

given: Mélanie

family: Diallo

full_name: Alpha Diallo

given: Alpha

family: Izopet

full_name: Jacques Izopet

given: Jacques

family: Aboulker

full_name: Jean-Pierre Aboulker

family: Meyer

full_name: Laurence Meyer

given: Laurence

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Infectious Diseases

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Prospective Registry in Patients With Unprotected Left Main Disease Treated by Percutaneous Coronary Intervention: The ALMA (Angioplasty of Left Main - lAriboisiere) Registry

acronym: ALMA

summary: In patients with unprotected left main disease (ULMD), angioplasty is emerging as an alternative technique. The investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ULMD in a "real world" registry.

lead_sponsor: Hopital Lariboisière

location_facility: Departement of Cardiology, Laribosiere Hospital, APHP


ReferenceCitation: Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

name: Département de Médecine Périopératoire, Université Clermont Auvergne, Centre national de la recherche scientifique, Inserm, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

name: Section d’Anesthésie and Département Anesthésie et Réanimation, Centre Hospitalier Universitaire Nîmes, Nîmes, France

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

name: Département Anesthésie et Réanimation, Centre Hospitalier Universitaire Amiens, Amiens, France

family: Guinot

full_name: Pierre-Gregoire Guinot

given: Pierre-Gregoire

family: Godet

full_name: Thomas Godet

given: Thomas

family: Lorne

full_name: Emmanuel Lorne

family: Cuvillon

full_name: Philippe Cuvillon

given: Philippe

family: Bertran

full_name: Sebastien Bertran

given: Sebastien

name: Service Anesthésie et Réanimation, Assistance Publique Hôpitaux de Marseille, Hôpital Nord, Université Aix Marseille, Marseille, France

family: Leone

full_name: Marc Leone

given: Marc

family: Pastene

full_name: Bruno Pastene

given: Bruno

name: Service d’Anesthésie-Réanimation, Université Claude Bernard Lyon-1, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Lyon, France

family: Piriou

full_name: Vincent Piriou

given: Vincent

name: Département Anesthésie-Réanimation, Centre Hospitalier Universitaire Saint-Etienne, Saint-Étienne, France

family: Molliex

full_name: Serge Molliex

given: Serge

name: Service Anesthésie et Réanimation, Assistance Publique Hôpitaux de Marseille, Hôpital de la Conception, Marseille, France

family: Albanese

full_name: Jacques Albanese

name: Anesthésie et Réanimation, Clinique du Parc, Castelnau-Le-Lez, France

family: Julia

full_name: Jean-Michel Julia

name: Pôle Anesthésie-Réanimation, Centre Hospitalier Universitaire Lille, Lille, France

family: Tavernier

full_name: Benoit Tavernier

given: Benoit

family: Imhoff

full_name: Etienne Imhoff

given: Etienne

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Constantin

full_name: Jean-Michel Constantin

name: Biostatistic Unit, Centre Hospitalier Universitaire Clermont-Ferrand, Direction de la Recherche Clinique, Clermont-Ferrand, France

family: Pereira

full_name: Bruno Pereira

name: Département Anesthésie et Réanimation B, Centre Hospitalier Universitaire Montpellier, Hôpital Saint-Eloi, and INSERM U-1046, Montpellier, France

family: Jaber

full_name: Samir Jaber

given: Samir

journal_name: JAMA

oa_colors: green other

oa_host_type: publisher;repository

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)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

title: Effectiveness of Noradrenaline to Control Intraoperative Arterial Pressure in High-risk Surgical Patients: A Multicentre Prospective Randomized Controlled Trial

summary: The purpose of this study is to evaluate whether a preventive strategy of intraoperative arterial hypotension using noradrenaline can reduce the incidence of postoperative organ failure.


title: Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration

acronym: MEMANTINE

summary: The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.

primary_purpose: Prevention

ReferenceCitation: Morel V, Joly D, Villatte C, Dubray C, Durando X, Daulhac L, Coudert C, Roux D, Pereira B, Pickering G. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients. PLoS One. 2016 Apr 6;11(4):e0152741. doi: 10.1371/journal.pone.0152741. eCollection 2016.

family: Morel

full_name: Véronique Morel

given: Véronique

family: Joly

full_name: Dominique Joly

given: Dominique

family: Villatte

full_name: Christine Villatte

given: Christine

family: Dubray

full_name: Claude Dubray

given: Claude

family: Durando

full_name: Xavier Durando

given: Xavier

family: Daulhac

full_name: Laurence Daulhac

family: Coudert

full_name: Catherine Coudert

given: Catherine

family: Roux

full_name: Delphine Roux

given: Delphine

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Pickering G, Morel V, Joly D, Villatte C, Roux D, Dubray C, Pereira B. Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial. Trials. 2014 Aug 20;15:331. doi: 10.1186/1745-6215-15-331.

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


title: Does Goal-directed Hemodynamic Therapy Driven by Endotracheal Cardiac Output Monitoring System During Surgical Intervention Reduce Hospital Stay and Major Adverse Cardiac Events Following Cardiac Surgery?

acronym: ECOMIII

summary:
Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic optimizations are more efficient when based on the dynamic parameters than when based on the statics ones, and the major dynamic criteria is the cardiac output. Unfortunately, transpulmonary thermodilution, the device considered as "The gold standard" to evaluate cardiac output is associated with many complications.Furthermore, devices commercialized in the past decade were not able to replace the transpulmonary thermodilution.

As all monitoring devices aren't reliable enough to be widely used in practice they are left aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on the analysis of several clinical parameters seems to guarantee good cares thanks to a favorable benefits/risks balance, it could be improved by new plug and play mini-invasive systems.

In the investigators opinion, the ECOM system seems able to provide a monitoring tool which responds to all the expectations of a modern hemodynamic monitoring device. It uses a well known technique, the bioimpedance. The investigators suppose this device should be more efficient than the one that has been used before. Indeed, as the system is build on the endotracheal tube, it comes closer to the aorta, where all the measures are made, and the recorded signal should be less affected by the passage through the surrounding tissues.

This randomized and controlled trial will study Patients scheduled for elective coronary surgery with cardiopulmonary bypass.

The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed hemodynamic therapy based on the ECOM cardiac output measure on mortality and major postoperative cardiac morbidity after coronary surgery, when compared with a standard management strategy.

Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard management strategy, applied to the control group, will be set and led by the attending anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke volume variation.

The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure will reduce mortality and morbidity after cardiac surgery.

lead_sponsor: University Hospital, Caen

intervention_type: Behavioral


title: Comparison of Cardiac Output Measurement Between Invasive Method (Transpulmonary Thermodilution) and Non Invasive Method (Photoplethysmography) : an Observational Study

acronym: PANEX

summary: Monitoring could secure management for patient but stay invasive. The purpose of this study was to compare,after cardiac surgery, the cardiac output measurement between transpulmonary thermodilution(reference method) and digital photoplethysmography (non invasive) for absolute value and dynamics changes before and after fluid expansion for patients with indication of fluid challenge.


type: Other Identifier

title: Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus

acronym: PARADYSAM

summary: If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more and more important. Treatment of patients presenting TMD is based on conservative and reversible therapeutics. The behavioural reeducation of these patients which aims at decreasing their parafunctions is a treatment often performed.

lead_sponsor: Rennes University Hospital


title: Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomised, Controlled, Double-blind, European Multicentre Clinical Trial

summary: The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.

ReferenceCitation: Maunoury F, Oury A, Fortin S, Thomassin L, Bohbot S; Explorer Study. Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France. PLoS One. 2021 Jan 22;16(1):e0245652. doi: 10.1371/journal.pone.0245652. eCollection 2021.

family: Maunoury

full_name: Franck Maunoury

given: Franck

family: Oury

full_name: Anaïs Oury

given: Anaïs

family: Fortin

full_name: Sophie Fortin

given: Sophie

family: Thomassin

full_name: Laetitia Thomassin

given: Laetitia

family: Bohbot

full_name: Serge Bohbot

ReferenceCitation: Edmonds M, Lázaro-Martínez JL, Alfayate-García JM, Martini J, Petit JM, Rayman G, Lobmann R, Uccioli L, Sauvadet A, Bohbot S, Kerihuel JC, Piaggesi A. Sucrose octasulfate dressing versus control dressing in patients with neuroischaemic diabetic foot ulcers (Explorer): an international, multicentre, double-blind, randomised, controlled trial. Lancet Diabetes Endocrinol. 2018 Mar;6(3):186-196. doi: 10.1016/S2213-8587(17)30438-2. Epub 2017 Dec 20. Erratum in: Lancet Diabetes Endocrinol. 2018 Mar 6;:.

family: Edmonds

full_name: Michael Edmonds

given: Michael

family: Lázaro-Martínez

full_name: José Luis Lázaro-Martínez

given: José Luis

family: Alfayate-García

full_name: Jesus Manuel Alfayate-García

given: Jesus Manuel

family: Martini

full_name: Jacques Martini

given: Jacques

family: Petit

full_name: Jean-Michel Petit

given: Jean-Michel

family: Rayman

full_name: Gerry Rayman

given: Gerry

family: Lobmann

full_name: Ralf Lobmann

given: Ralf

family: Uccioli

full_name: Luigi Uccioli

given: Luigi

family: Sauvadet

full_name: Anne Sauvadet

given: Anne

family: Kerihuel

full_name: Jean-Charles Kerihuel

given: Jean-Charles

family: Piaggesi

full_name: Alberto Piaggesi

given: Alberto


title: Assessment of the Efficacy and Safety of Diosmin 600mg on Painful Symptomatology in Patients With Chronic Venous Disease of Lower Limbs: a Multicentric, Randomised, Double-blind, Placebo-controlled Trial in Parallel Groups

acronym: EDEN

summary:
Diosmin has a well established use status in improvement of the symptoms of venolymphatic insufficiency: heavy legs, pain, primo-decubitus restlessness and as complement treatment of capillary fragility.

Nevertheless, diosmin 600 mg did not benefit from a rigorous clinical study versus placebo, to establish its efficacy in the pain relief in Chronic Venous Disease (CVD).

The aim of this project led by Dr. Guex is to evaluate the efficacy and safety of diosmin 600 mg - DIOVENOR® on the painful symptoms of CVD of the lower limbs, in a multicentre, controlled, randomised, double blind, placebo-controlled, parallel-group study.

ReferenceCitation: Martinez-Zapata MJ, Vernooij RW, Simancas-Racines D, Uriona Tuma SM, Stein AT, Moreno Carriles RMM, Vargas E, Bonfill Cosp X. Phlebotonics for venous insufficiency. Cochrane Database Syst Rev. 2020 Nov 3;11:CD003229. doi: 10.1002/14651858.CD003229.pub4.

name: Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau); CIBER Epidemiología y Salud Pública (CIBERESP); Barcelona Spain

family: Martinez-Zapata

full_name: Maria José Martinez-Zapata

given: Maria José

name: Department of Nephrology and Hypertension and Julius Center for Health Sciences and Primary Care; University Medical Center Utrecht; Utrecht Netherlands

family: Vernooij

full_name: Robin WM Vernooij

given: Robin WM

name: Cochrane Ecuador. Centro de Investigación en Salud Pública y Epidemiología Clínica (CISPEC). Facultad de Ciencias de la Salud Eugenio Espejo; Universidad Tecnológica Equinoccial; Quito Ecuador

family: Simancas-Racines

full_name: Daniel Simancas-Racines

given: Daniel

name: Preventive Medicine and Public Health; Vall Hebron University Hospital; Barcelona Spain

family: Uriona Tuma

full_name: Sonia Maria Uriona Tuma

given: Sonia Maria

name: Department of Public Health; Universidade Federal de Ciências da Saúde; Porto Alegre Brazil

family: Stein

full_name: Airton T Stein

given: Airton T

name: Angiology, Vascular and Endovascular Surgery; Universitary Hospital La Princesa; Madrid Spain

family: Moreno Carriles

full_name: Rosa Maria M Moreno Carriles

given: Rosa Maria M

name: Hospital Clínico San Carlos. Universidad Complutense de Madrid; Madrid Spain

family: Vargas

full_name: Emilio Vargas

given: Emilio

name: Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Universitat Autònoma de Barcelona; CIBER Epidemiología y Salud Pública (CIBERESP); Barcelona Spain

family: Bonfill Cosp

full_name: Xavier Bonfill Cosp

given: Xavier

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Phlebotonics for venous insufficiency

lead_sponsor: Laboratoire Innotech International


title: A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer

acronym: BEVATOMOX

summary: This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

status: Terminated

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


title: Perception Ortho-nasale du Gras Chez l'Homme Sain : Relations Entre Typages olfactométriques, Sensoriels et Composition de la Salive.

acronym: SensInFat

summary: The perception of fat represents major scientific and nutritional issues. This research aims to identify salivary markers that could predict and possibly explain this perception in healthy human being. This would help to develop nutritional strategies for a more rational consumption of fat.

ipd_sharing: No

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


title: Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult

acronym: PLADSEL

summary:
The primary objective of this study is to analyze the sensitivity of blood pressure to oral salt intake. Matched male and female participants will be selected as normal weight, overweight, and obese.

Participating subjects will have a first visit with blood pressure measurement and a blood sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6 grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.

lead_sponsor: Poitiers University Hospital


title: Oral Sphere: Salivary Markers and Food. A Prospective Study in Children Expressing Oral Disorders

acronym: ORALISENS

summary:
In Human, the oral sphere is the first and main place where sensory stimuli are received and perceived. The phenomena occuring during food breakdown and sensory perception are complex and in this system saliva plays a major role.

In the neonatal period, severe digestive diseases require the cessation of all oral feeding and the use of enteral or parenteral nutrition for prolonged periods to ensure the growth and development of children while their disease is active. The early stages of sensory oral exposures and their consequences on the development of eating habits of these children are poorly documented. It is likely that the process of acquisition of preferences and eating habits is atypical because of a "bypass" of the oral sphere during the early stages of feeding. Thus, if not orally fed, children do not get exposed to a wide variety of tastes and textures in the first year of life, which may impact on their oral acceptance at a later age. These oral disorders (OD) are expressed by a refusal to eat, a heightened gag reflex, a refusal of certain consistencies and difficulties in chewing and swallowing. Few data are available on food typically accepted by these children.

Finally, oral sensory phenotypes of OD children (gustatory sensitivity ...) have not been described yet. It is likely that they may differ significantly from those of healthy (NOD).

In this context, a population of OD children is particularly interesting for studying the effects of the absence of these learning stages and their consequences in the development of sensory perception and eating habits.

The investigators formulate the hypothesis that the lack of exposure to a standard oral diet would modify the development of their "oro-sensory systems" including saliva.

Studying such a population is a great opportunity to assess the influence of non oral food exposures and diet on saliva characteristics.

Saliva has recently received attention as a potential easy to collect source of biomarkers in several conditions excluding OD.

The potential impact of OD on salivary composition has never been studied. Several studies linking saliva and perception or preferences have been conducted in the UMR CSGA (Unité Mixte de Recherche du Centre des Sciences du Goût et de l'Alimentation). They have already contributed to highlight the great inter-individual variability for a number of saliva markers and a change in saliva protein profiles in response to taste stimulation They also underlined the remarkable intra-stability for saliva flow and composition during a one year study.

This study intends to prove the concept that it is relevant to relate saliva characteristics to food intake behaviour or food habits The first hypothesis to be tested in this study is that salivary profiles (biological signatures) can discriminate two groups of children differing by their orality.

The second hypothesis to be tested is that these specific biological biological signatures may be correlated to certain food habits associated or not with oral disorders.

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Morzel M, Truntzer C, Neyraud E, Brignot H, Ducoroy P, Lucchi G, Canlet C, Gaillard S, Nicod F, Nicklaus S, Peretti N, Feron G. Associations between food consumption patterns and saliva composition: Specificities of eating difficulties children. Physiol Behav. 2017 May 1;173:116-123. doi: 10.1016/j.physbeh.2017.02.005. Epub 2017 Feb 6.

family: Morzel

full_name: Martine Morzel

given: Martine

family: Truntzer

full_name: Caroline Truntzer

given: Caroline

family: Neyraud

full_name: Eric Neyraud

given: Eric

family: Brignot

full_name: Hélène Brignot

given: Hélène

family: Ducoroy

full_name: Patrick Ducoroy

given: Patrick

family: Lucchi

full_name: Géraldine Lucchi

given: Géraldine

family: Canlet

full_name: Cécile Canlet

given: Cécile

family: Gaillard

full_name: Ségolène Gaillard

given: Ségolène

family: Nicod

full_name: Florian Nicod

given: Florian

family: Nicklaus

full_name: Sophie Nicklaus

given: Sophie

family: Peretti

full_name: Noël Peretti

given: Noël

family: Feron

full_name: Gilles Feron

given: Gilles

journal_name: Physiology & Behavior

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Gastroentérologie, hépatologie et nutrition Hopital Femme Mere Enfant


title: Fampridine Pregnancy Exposure Registry

summary: This is a global pregnancy registry to evaluate the outcomes of pregnancy in women with multiple sclerosis who have been exposed to prolonged-release fampridine since the first day of their last menstrual period prior to conception or at any time during pregnancy.

lead_sponsor: Biogen


title: Effect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy Subjects

summary: The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067 pharmacokinetics in healthy subjects.

lead_sponsor: Bial - Portela C S.A.


title: Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects

summary: The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline pharmacokinetics in healthy subjects.


title: A Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women

summary: The purpose of this study is to evaluate the effect of BIA 9-1067 on the cardiac repolarization in adult healthy men and women volunteers.


title: Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa

acronym: STIMOREX

summary:
Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory" high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN.

This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS.

Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described).

Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.

lead_sponsor: University Hospital, Rouen

intervention_type: Procedure


title: COMPARAISON D'EFFICACITÉ ENTRE LA CRYOTHÉRAPIE GAZEUSE HYPERBARE ET LA CRYOTHÉRAPIE CONVENTIONNELLE DANS LE TRAITEMENT DES ENTORSES EXTERNES DE LA CHEVILLE Étude randomisée auprès d'Une Population de Militaires

acronym: TUNEMAS

summary:
Introduction: The military population is at high-risk for injury with by painful sprains, especially of the ankle. The referenced treatment method for pain is the cryotherapy, consisting in applying cold-packs to the injured ankle several times a day. However, another pain treatment has been developed and is commonly used by high-level sports teams and rheumatologists but its efficacy has never been assessed within a military population, i.e. the hyperbaric CO2 cryotherapy, also called the neurocryostimulation.

Research design: This study was carried out on a French multicenter basis, the study consisting in a randomized controlled superiority trial and open-label prospective analysis in the treatment of 40-year-old military patients or younger suffering from acute ankle sprains. Two groups were made: patients were treated either by neurocryostimulation or by the referenced cryotherapy (cold-packs). The care protocol for both groups consisted in six supervised 30 minute-sessions within a period of three consecutive days.

Hypothesis: Neurocryostimulation is more effective in the treatment of pain severity resulting from an ankle sprain than the referenced treatment by cold-packs. Moreover, we theorized that the total consumption of paracetamol and the number of days of temporary inaptitude and of work exemption were lower in patients treated by neurocryostimulation.

Outcomes:

For each session, pain severity is assessed on a 100-mm Visual Analog Scale at the beginning and at the end of session 20 minutes later after a four-step walk.

enrollment_type: Anticipated

lead_sponsor: Direction Centrale du Service de Santé des Armées

intervention_type: Device


title: Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)

acronym: FRIDA-Rea

summary: Difficult intubation is challenging in intensive care units. There are limited data regarding risk factors of difficult intubation in ICU. The primary purpose of the investigators study is to assess the risk factors of difficult airway in adults in ICU.

ReferenceCitation: Perbet S, De Jong A, Delmas J, Futier E, Pereira B, Jaber S, Constantin JM. Incidence of and risk factors for severe cardiovascular collapse after endotracheal intubation in the ICU: a multicenter observational study. Crit Care. 2015 Jun 18;19:257. doi: 10.1186/s13054-015-0975-9.

family: Perbet

full_name: Sebastien Perbet

given: Sebastien

family: De Jong

full_name: Audrey De Jong

given: Audrey

family: Delmas

full_name: Julie Delmas

given: Julie

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Jaber

full_name: Samir Jaber

given: Samir

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

currency_apc_doaj: GBP

journal_name: Critical Care

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: De Jong A, Molinari N, Pouzeratte Y, Verzilli D, Chanques G, Jung B, Futier E, Perrigault PF, Colson P, Capdevila X, Jaber S. Difficult intubation in obese patients: incidence, risk factors, and complications in the operating theatre and in intensive care units. Br J Anaesth. 2015 Feb;114(2):297-306. doi: 10.1093/bja/aeu373. Epub 2014 Nov 27.

full_name: A. De Jong

given: A.

family: Molinari

full_name: N. Molinari

given: N.

family: Pouzeratte

full_name: Y. Pouzeratte

given: Y.

family: Verzilli

full_name: D. Verzilli

given: D.

family: Chanques

full_name: G. Chanques

given: G.

family: Jung

ReferenceCitation: De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRéa Network for the Frida-Réa Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.

journal_name: American Journal of Respiratory and Critical Care Medicine

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

title: Early Identification of Patients at Risk for Difficult Intubation in the Intensive Care Unit

location_facility: University Hospital of Montpellier, Saint Eloi


title: Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects

summary: The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary supplement, on glycemic control of overweight prediabetic subjects.

ReferenceCitation: Liu Y, Cotillard A, Vatier C, Bastard JP, Fellahi S, Stévant M, Allatif O, Langlois C, Bieuvelet S, Brochot A, Guilbot A, Clément K, Rizkalla SW. A Dietary Supplement Containing Cinnamon, Chromium and Carnosine Decreases Fasting Plasma Glucose and Increases Lean Mass in Overweight or Obese Pre-Diabetic Subjects: A Randomized, Placebo-Controlled Trial. PLoS One. 2015 Sep 25;10(9):e0138646. doi: 10.1371/journal.pone.0138646. eCollection 2015. Erratum in: PLoS One. 2015;10(12):e0145315.

family: Liu

full_name: Yuejun Liu

given: Yuejun

family: Cotillard

full_name: Aurélie Cotillard

given: Aurélie

family: Vatier

full_name: Camille Vatier

given: Camille

family: Bastard

full_name: Jean-Philippe Bastard

given: Jean-Philippe

family: Fellahi

full_name: Soraya Fellahi

given: Soraya

family: Stévant

full_name: Marie Stévant

given: Marie

family: Allatif

full_name: Omran Allatif

given: Omran

family: Langlois

full_name: Clotilde Langlois

given: Clotilde

family: Bieuvelet

full_name: Séverine Bieuvelet

given: Séverine

family: Brochot

full_name: Amandine Brochot

given: Amandine

family: Guilbot

full_name: Angèle Guilbot

given: Angèle

family: Clément

full_name: Karine Clément

given: Karine

family: Rizkalla

full_name: Salwa W. Rizkalla

given: Salwa W.

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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


title: A Single-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Subjects

summary: This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).

lead_sponsor: Hoffmann-La Roche


title: DIetary Supplements, Executive funcTions and Vitamin D (DIET-D): a Double-blind Randomized Controlled Trial

acronym: DIET-D

summary: The purpose of this study is to compare the effect after 12 weeks of the oral intake of Lecitone®Se + 200UI/day of D3 vitamin with the effect of a placebo on changes in cognitive performance in Trial Making Test score part B (this test evaluate executive functions of mental flexibility) in older adults with Mild Cognitive Impairment (MCI).

lead_sponsor: University Hospital, Angers


title: Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled

acronym: CsAStroke

summary:
The main objective of this study is to determine whether a single injection of CsA after intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day 30 ± 15 assessed with Flair MRI.

Secondary objectives are to determine whether a single injection of CsA after intravenous thrombolysis is safe and effective regarding to death and disability.

ReferenceCitation: Nighoghossian N, Berthezène Y, Mechtouff L, Derex L, Cho TH, Ritzenthaler T, Rheims S, Chauveau F, Béjot Y, Jacquin A, Giroud M, Ricolfi F, Philippeau F, Lamy C, Turc G, Bodiguel E, Domigo V, Guiraud V, Mas JL, Oppenheim C, Amarenco P, Cakmak S, Sevin-Allouet M, Guillon B, Desal H, Hosseini H, Sibon I, Mahagne MH, Ong E, Mewton N, Ovize M. Cyclosporine in acute ischemic stroke. Neurology. 2015 Jun 2;84(22):2216-23. doi: 10.1212/WNL.0000000000001639. Epub 2015 May 6.

family: Nighoghossian

full_name: N. Nighoghossian

given: N.

family: Berthezene

full_name: Y. Berthezene

family: Mechtouff

full_name: L. Mechtouff

given: L.

family: Derex

full_name: L. Derex

family: Cho

full_name: T. H. Cho

given: T. H.

family: Ritzenthaler

full_name: T. Ritzenthaler

given: T.

family: Rheims

full_name: S. Rheims

given: S.

family: Chauveau

full_name: F. Chauveau

given: F.

family: Bejot

full_name: Y. Bejot

family: Jacquin

full_name: A. Jacquin

given: A.

family: Giroud

full_name: M. Giroud

given: M.

family: Ricolfi

full_name: F. Ricolfi

family: Philippeau

full_name: F. Philippeau

family: Lamy

full_name: C. Lamy

given: C.

family: Turc

full_name: G. Turc

family: Bodiguel

full_name: E. Bodiguel

given: E.

family: Domigo

full_name: V. Domigo

given: V.

family: Guiraud

full_name: V. Guiraud

family: Mas

full_name: J.-L. Mas

family: Oppenheim

full_name: C. Oppenheim

family: Amarenco

full_name: P. Amarenco

given: P.

family: Cakmak

full_name: S. Cakmak

family: Sevin-Allouet

full_name: M. Sevin-Allouet

family: Guillon

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Cyclosporine in acute ischemic stroke


title: Clinical Evaluation of Brain-Computer Interface for Helping Communication of Quadriplegic Patients

acronym: PVCRoBIK

summary: This is multi-center prospective randomized trial evaluating the effectiveness of a new brain-computer interface for communication of quadriplegic patients in a clinical context. This performance of this will compared to traditional assistive technology (scanning system) and to performance of a healthy volunteer population.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Assessment of the Effect of an Intervention (Periodontal Scaling + Mouthwash + Toothpaste) to Reduce the Load on Oral Bacterial Activity of Rheumatoid Arthritis: a Randomized Trial Nested in the Cohort ESPOIR

acronym: BHYRRA

summary: The purpose of this study is to assess the impact of an intervention (scaled every 06 months associated with the use of mouthwash with essential oils (toothpaste and Listerine® 2 times / day containing polymer Triclosan (Colgate Total®)) on the activity of rheumatoid arthritis

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Rotschild - Service d'Odontologie


title: Identification of Implantable Cardioverter Defibrillator Patients With Remote Follow up That Requires an Onsite Visit

summary:
With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years. This has resulted in an increase of the number of follow-up (FU) to be performed and a growing workload for centers. Remote FU system such as the Medtronic Carelink system allows to check remotely the proper functioning of self evaluating devices and give informations of some clinical events.

The objective of this study is to define which patients with a remote follow-up need additional onsite visit and to assess to which extent remote FU can be an alternative to onsite visit.

lead_sponsor: Medtronic Bakken Research Center


title: Comparison of Subgluteal Sciatic Nerve Block Duration in Type-2 Diabetic and Non Diabetic Patients

acronym: Diabeteblock

summary: Diabete animal studies demonstrated a longer period recovery after local anesthetic injection (perineural administration). No clinical study demonstrated a prolonged nerve block duration in diabete type 2 patients after peripheral nerve block. The investigators hypothesized that block recovery is delayed in diabetic patients.

ReferenceCitation: Cuvillon P, Reubrecht V, Zoric L, Lemoine L, Belin M, Ducombs O, Birenbaum A, Riou B, Langeron O. Comparison of subgluteal sciatic nerve block duration in type 2 diabetic and non-diabetic patients. Br J Anaesth. 2013 May;110(5):823-30. doi: 10.1093/bja/aes496. Epub 2013 Jan 24.

family: Cuvillon

full_name: P. Cuvillon

family: Reubrecht

full_name: V. Reubrecht

family: Zoric

full_name: L. Zoric

family: Lemoine

full_name: L. Lemoine

family: Belin

full_name: M. Belin

family: Ducombs

full_name: O. Ducombs

given: O.

family: Birenbaum

full_name: A. Birenbaum

family: Riou

full_name: B. Riou

given: B.

family: Langeron

full_name: O. Langeron

journal_name: British Journal of Anaesthesia

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Pierre and Marie Curie University


title: Prospective Phase II Study Evaluating the Feasibility of a Conformational Pelvic and Prostatic Radiotherapy With Simultaneous Integrated Boost Modulated-intensity Arctherapy (SIB-IMAT) in Combination With Long Term Androgen Deprivation for High Risk Localized Prostate Cancer.

summary: The purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (SIB-IMRT)combined with long-term androgen deprivation for patients with high risk localized prostate cancer

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Radiation


acronym: HiFloLUS

summary: This is a prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.

lead_sponsor: University Hospital, Clermont-Ferrand


title: C Terminal Peptide Variants of the Fsh Receptor in Women Involved in an Assisted Reproduction Programm : Mechanistic Approach

summary:
Follicle-stimulating hormone (FSH) is used in medically assisted procreation, to induce an ovarian stimulation in women. However, the FSH dose that has to be injected is quite hard to adjust, because an excess of exogenous hormone could lead to very severe complications for patient. This hormone acts on its cognate receptor, the FSHR, present on the granulosa cells surface, and which regulation involve the intra-cytoplasmic carboxy-terminus domain.

The investigators first aimed to research in the c-terminus part of the receptor the presence of allelic variants that could explain the variations of response to FSH stimulation.

The investigators also would want to complete the data already known on a functionally determinant single nucleotide polymorphism on 680 position in the c-terminus part of the hFSHR.

Then, the investigators would analyze the entire sequence of the hFSHR of patients presenting an unusual phenotype in response to FSH treatment, in order to detect a potential mutation involved in the receptor functionality.

The results of this study could allow us to increase our knowledge on the hFSHR physiology and functionality, in order to adjust treatment to the genetic profile of patients.

lead_sponsor: University Hospital, Tours


title: Predictive Factors of a Successful Implant of the CapsureFix MRI Model 5086

summary:
Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.

Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances.

These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history).

Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086.

This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.

location_facility: Centre Hospitalier Regionnal d'Orléans La Source


title: Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité

summary: The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.

lead_sponsor: Centre Jean Perrin


title: Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study

acronym: NEOPAC

summary:
The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).

This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.

lead_sponsor: Institut Paoli-Calmettes


title: Phase II Study of Tolerance and Efficacy of Subcutanous Low Doses Rituximab Given as Consolidation Treatment to Chronic Lymphocytic Leukaemia (CLL) Patients Responding to Induction Therapy

acronym: LLCRlowdoz

summary:
Chronic Lymphocytic Leukemia (CLL) is still an incurable disease. However recent advances have established correlation between the quality of the response (in particular achievement of negativity of minimal residual disease (MRD) and progression free and overall survival. That is why MRD negative complete remission (CR) is the current goal in CLL treatment.

The association of Rituximab fludarabine cyclophosphamide leads to the best response rate with 52 to 72% CR in "medically" fit untreated CLL patients. MRD results in this setting are still preliminary and around 50%. However many other situations (unfit, elderly, relapse, haematological toxicity leading to early interruption of treatment…) are associated with much lower response rate that would be improved by consolidation treatment.

Monoclonal antibodies are the treatment of choice for consolidation because of sparing marrow and targeting CLL cells. Alemtuzumab has been used for this purpose and results confirm improvement of CR and MRD negative responses but alemtuzumab induced immunodeficiency lead to unacceptable infectious complications. Rituximab monotherapy induces low response rate at standard dose regimen. This is at least partially due to shaving of CD20, mechanism by which CD20 is lost from the leukemic cells but these cells are not cleared. Using low doses of rituximab reduced shaving and allowed CLL cells clearance by the mononuclear phagocytic system. Such low doses of rituximab can be administered subcutaneously.

The investigators then propose subcutaneous low dose rituximab in consolidation to CLL patients responding after induction but having not achieved MRD negative CR.


title: A Randomized, Double Blind, Placebo Controlled, Pilot Study to Evaluate ACute and Chronic Effects of Saxagliptin on Impaired Glucose Tolerance and micro-and Macro-vascular Integrators

acronym: ACCES

summary:
Glucose ACCES study will explore the acute and long term (12-week treatment) effects of saxagliptin in patients with impaired glucose tolerance during fasting and after a standardised breakfast. The investigations will be performed on:

glycemic parameters
on cardiovascular parameters

ReferenceCitation: Rezki A, Cosson E, Fysekidis M, Chiheb S, Vicaut E, Valensi P. Acute and long-term effects of saxagliptin on a set of cardiovascular targets measured at fasting and post-prandially in obese patients with impaired glucose tolerance: A placebo-controlled study. Nutr Metab Cardiovasc Dis. 2021 Sep 22;31(10):2945-2958. doi: 10.1016/j.numecd.2021.06.017. Epub 2021 Jul 1.

family: Rezki

full_name: Amel Rezki

given: Amel

family: Cosson

full_name: Emmanuel Cosson

given: Emmanuel

family: Fysekidis

full_name: Marinos Fysekidis

given: Marinos

family: Chiheb

full_name: Sabrina Chiheb

given: Sabrina

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Valensi

full_name: Paul Valensi

given: Paul

journal_name: Nutrition, Metabolism and Cardiovascular Diseases

ReferenceCitation: Rezki A, Fysekidis M, Chiheb S, Vicaut E, Cosson E, Valensi P. Acute and long-term effects of saxagliptin on post-prandial glycemic response in obese patients with impaired glucose tolerance. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1257-1266. doi: 10.1016/j.numecd.2020.12.025. Epub 2020 Dec 31.

location_facility: Jean Verdier hospital, Department of Endocrinology-Diabetology-Nutrition


title: Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education.

acronym: EDUCA

summary:
To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses. The purpose of this local study, in cardiac surgery department, is to evaluate the therapeutic impact of two methods of comprehensive education, one conventional and performed by nurses service, less elaborate, relying solely on the book Information from The National Security Agency of Medicines and Health Products, the other based on more detailed documents created by a multidisciplinary group. Various studies show that the effect of therapeutic education is observed only during the first six months and then disappears.

This study is the first French study evaluating the impact of a comprehensive education to oral anticoagulation according to the latest recommendations of the National Security Agency of Medicines and Health Products and the French National Health Authority.


title: Paracétamol and Pharmacogenetic in Healthy Volunteers

summary:
Recent works has emphasized that the mechanism of action of paracetamol analgesic depend on its metabolism in the body, since a breakdown product of paracetamol, the AM404 is now considered the analgesic metabolite of paracetamol suggesting as paracetamol may be a pro-drug.

Indeed, it has been shown that paracetamol may have a deleterious effect, especially in vulnerable populations (hepatic insufficiency, elderly). First results showed a very significant decrease in sulfatation and gluthatione and increased phase 1 metabolism of acetaminophen, which involves enzymes such as cytochrome P450.

Multifactorial causes, combining nutrition (depletion of sulfur amino acids), increased detoxification of toxic metabolites of paracetamol, stress or trauma are discussed to explain the results.

Clinical studies showed a great variability of pain assessment by patients and variability in the metabolic response of paracetamol. Genetic factors probably play a role remains largely unknown.

The review of the literature on genetic polymorphism shows the involvement of a number of enzymes that are well known, predominantly on the metabolism of acetaminophen liver, but without connection with its analgesic effect. This is a critical missing link in the understanding of the analgesic effect of paracetamol.

ReferenceCitation: Pickering G, Creveaux I, Macian N, Pereira B. Paracetamol and Pain Modulation by TRPV1, UGT2B15, SULT1A1 Genotypes: A Randomized Clinical Trial in Healthy Volunteers. Pain Med. 2020 Apr 1;21(4):661-669. doi: 10.1093/pm/pnz037.

name: Faculty of Medicine Inserm 1107, Clinical Pharmacology Centre, CPC/CIC Inserm 1405 University Hospital, Clermont-Ferrand, France

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

name: Molecular Biology Department, Faculty of Medicine, University Hospital, Clermont-Ferrand, France

family: Creveaux

full_name: Isabelle Creveaux

given: Isabelle

family: Macian

full_name: Nicolas Macian

given: Nicolas

name: Direction Recherche Clinique, Biostatistics Unit, CHU Clermont-Ferrand, Clermont-Ferrand, France

family: Pereira

full_name: Bruno Pereira

given: Bruno

journal_name: Pain Medicine


title: Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.

acronym: TORSIV

summary:
Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic procedures.

Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication before endoscopy, but practices concerning the use of sedation further to the completion of the endoscopy are very heterogeneous.

We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy

lead_sponsor: Nantes University Hospital


title: Genetic Polymorphisms in Catecholamine Pathway Responsible for the Tako-TSUBO Cardiomyopathy Susceptibly (TAKO-GENE)

summary:
This is a case-control association study with multicentric prospective recruitment.

Tako-TSUBO cardiomyopathy is a new clinical entity mimicking an acute coronary syndrome. It is characterized by reversible left ventricular dysfunction that is frequently precipitated by a stressful event and most of patients are postmenopausal women.

Several hypotheses concerning pathogenesis of Tako-TSUBO cardiomyopathy have been proposed, but at present, exaggerated sympathetic stimulation is the main hypothesis. However, the investigators don't know why some patients with stressful event may present Tako-TSUBO cardiomyopathy whereas most of them don't.

The investigators hypothesize that polymorphisms in the genes involved in the adrenergic pathway resulting in greater catecholamine sensitivity would be associated with an increased risk of Tako-TSUBO cardiomyopathy.

location_facility: Name: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines


title: Fluorescence Angiography With Fluobeam™ Camera (Fluoptics Company): Planning and Monitoring of Perforator Flaps

acronym: AFLU

summary: The purpose of this study is to determine whether fluorescence angiography is an effectiveness technique for the localization of vascular perforators and their area of perfusion and for the postoperative monitoring of flap perfusion.

ReferenceCitation: Koenig A, Hervé L, Gonon G, Josserand V, Berger M, Dinten JM, Boutet J, Peltié P, Coll JL, Rizo P. Fluorescence diffuse optical tomography for free-space and multifluorophore studies. J Biomed Opt. 2010 Jan-Feb;15(1):016016. doi: 10.1117/1.3309738.

lead_sponsor: University Hospital, Grenoble


title: Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer

summary:
Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative.

In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk.

The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments.

This study will evaluate the feasibility and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.

lead_sponsor: Centre Oscar Lambret


title: Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years

acronym: PUPSY

summary:
GnRH agonists are used in the treatment of precocious puberty in order to improve adult height.However,the psychosocial impact of precocious puberty is often used by the clinician at diagnosis to justify treatment, but can not yet be properly assessed. It can not be considered as a rational neither for the indication to treatment, nor to assess its potential efficacy.

The overall objective of this work is to improve the conditions leading to the therapeutic decision and the procedures for monitoring girls with idiopathic central precocious puberty.


title: Impact of Reporting Funding Sources and Conflicts of Interest in RCTs' Abstracts on General Practitioners' Confidence: a 3-arms Randomized Controlled Trial.

acronym: ACOPI

summary:
Objective: The aim of this study is to assess the impact of reporting, in abstracts of randomized controlled trials, 1) the funding sources and 2) the conflicts of interest (COIs) of the authors on General Practitioners' confidence in the abstracts' conclusions.

Design: Randomized Controlled Trial in 3 arms. Participants: General Practitioners (GP). They will be recruited among residents from the Primary Care department of the Paris Descartes University and among a GP network who agreed to participate to research studies.

The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician with a ratio 1: 1: 1. Participants will be blind of the hypothesis and of the randomization. Allocation concealment will be provided because only the statistician will have access to the randomization list.

Methods: Three interventions will be assessed corresponding to three different types of abstracts: 1) abstracts not reporting neither the funding sources neither COIs of authors, 2) abstracts reporting funding sources and 3) abstracts reporting funding sources and COIs of authors.

A sample of abstracts will be selected from published randomized trials, testing superiority, assessing pharmacological treatment, in the field of Primary Care and General Practice and having a conclusion in favor of the beneficial effect of experimental treatment in terms of tolerance and / or efficacy. They will then be standardized and modified to obtain three types of abstracts: 1) with funding sources, 2) with funding sources and COIs and 3) without either source of funding or COIs.

Participants will be asked to assess one abstract of their randomization arm. Outcome: The primary endpoint will be the GPs' confidence in conclusions. The secondary endpoints will be the quality perception of the study and the interpretation of the benefit of experimental treatment. Responses will be ranged by a 10-point numeric scale.

Potential interests: This study takes place in the field of Primary Care. We believe that better understandings of impact of funding sources and conflicts of interests are necessary to allow more transparency in medical research and in his translation into medical practice.

Sample size expected: 354 participants.

primary_purpose: Health Services Research

ReferenceCitation: Buffel du Vaure C, Boutron I, Perrodeau E, Ravaud P. Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners' confidence in conclusions, a three-arm randomized controlled trial. BMC Med. 2014 Apr 28;12:69. doi: 10.1186/1741-7015-12-69.

family: Buffel du Vaure

full_name: Céline Buffel du Vaure

given: Céline

family: Boutron

full_name: Isabelle Boutron

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

journal_name: BMC Medicine

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

publisher_dissemination: Springer

publisher_group: Springer

title: Reporting funding source or conflict of interest in abstracts of randomized controlled trials, no evidence of a large impact on general practitioners’ confidence in conclusions, a three-arm randomized controlled trial

lead_sponsor: Hotel Dieu Hospital

location_facility: Centre d'Epidemiologie Clinique, Assistance Publique, Hotel Dieu


title: Phase 1 Impact of Nocturnal Desaturations on Central Motor Drive in COPD Patients: A New Insight on the Systemic Effects of the Disease.

summary: The purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we will look after the role of nocturnal hypoxia in these alterations.

time_perspective: Cross-Sectional

ReferenceCitation: Alexandre F, Heraud N, Sanchez AM, Tremey E, Oliver N, Guerin P, Varray A. Brain Damage and Motor Cortex Impairment in Chronic Obstructive Pulmonary Disease: Implication of Nonrapid Eye Movement Sleep Desaturation. Sleep. 2016 Feb 1;39(2):327-35. doi: 10.5665/sleep.5438.

name: Movement To Health Laboratory, Euromov, University of Montpellier, Montpellier, France

name: Clinique du Souffle La Vallonie, Fontalvie, Lodève, France

family: Alexandre

full_name: Francois Alexandre

given: Francois

name: Clinique du Souffle Les Clarines, Fontalvie, Riom-es-Montagnes, France

family: Heraud

full_name: Nelly Heraud

given: Nelly

name: UMR866 Dynamique Musculaire et Métabolisme, INRA, University of Montpellier, Montpellier, France

name: Laboratoire Performance Santé Altitude, EA 4604, University of Perpignan Via Domitia, Font-Romeu, France

family: Sanchez

full_name: Anthony M.J. Sanchez

given: Anthony M.J.

family: Tremey

full_name: Emilie Tremey

given: Emilie

family: Oliver

full_name: Nicolas Oliver

family: Guerin

full_name: Philippe Guerin

family: Varray

full_name: Alain Varray

given: Alain

journal_name: Sleep

oa_colors: green hybrid

evidence: open (via free article)

repository_institution: Cornell University - arXiv

repository_normalized: arXiv

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

repositories:
HAL
PubMed Central
arXiv

lead_sponsor: 5 Santé


title: Antagonism Research Between Antiemetics Agents (Droperidol, Dexametasone, Ondansetron) and Acetaminophen in Thyroidectomy's Post-operative Analgesia.

acronym: ANPATHY

summary: The purpose of our study is to determine if there is an antagonism between drugs used in the prevention of postoperative nausea and vomiting (PONV) on the analgesia led by acetaminophen after thyroidectomy.

ReferenceCitation: Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8.

ReferenceCitation: Girard P, Pansart Y, Coppé MC, Niedergang B, Gillardin JM. Modulation of paracetamol and nefopam antinociception by serotonin 5-HT(3) receptor antagonists in mice. Pharmacology. 2009;83(4):243-6. doi: 10.1159/000207448. Epub 2009 Mar 9.

ReferenceCitation: Courade JP, Chassaing C, Bardin L, Alloui A, Eschalier A. 5-HT receptor subtypes involved in the spinal antinociceptive effect of acetaminophen in rats. Eur J Pharmacol. 2001 Nov 30;432(1):1-7.

ReferenceCitation: Pickering G, Estève V, Loriot MA, Eschalier A, Dubray C. Acetaminophen reinforces descending inhibitory pain pathways. Clin Pharmacol Ther. 2008 Jul;84(1):47-51. Epub 2007 Oct 24.

ReferenceCitation: Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51.

ReferenceCitation: Apfel CC, Bacher A, Biedler A, Danner K, Danzeisen O, Eberhart LH, Forst H, Fritz G, Hergert M, Frings G, Goebel A, Hopf HB, Kerger H, Kranke P, Lange M, Mertzlufft F, Motsch J, Paura A, Roewer N, Schneider E, Stoecklein K, Wermelt J, Zernak C. [A factorial trial of six interventions for the prevention of postoperative nausea and vomiting]. Anaesthesist. 2005 Mar;54(3):201-9. German.

ReferenceCitation: Kaiser R, Sezer O, Papies A, Bauer S, Schelenz C, Tremblay PB, Possinger K, Roots I, Brockmöller J. Patient-tailored antiemetic treatment with 5-hydroxytryptamine type 3 receptor antagonists according to cytochrome P-450 2D6 genotypes. J Clin Oncol. 2002 Jun 15;20(12):2805-11.

ReferenceCitation: Nielsen M, Olsen NV. Genetic polymorphisms in the cytochrome P450 system and efficacy of 5-hydroxytryptamine type 3 receptor antagonists for postoperative nausea and vomiting. Br J Anaesth. 2008 Oct;101(4):441-5. doi: 10.1093/bja/aen246.

ReferenceCitation: Candiotti KA, Birnbach DJ, Lubarsky DA, Nhuch F, Kamat A, Koch WH, Nikoloff M, Wu L, Andrews D. The impact of pharmacogenomics on postoperative nausea and vomiting: do CYP2D6 allele copy number and polymorphisms affect the success or failure of ondansetron prophylaxis? Anesthesiology. 2005 Mar;102(3):543-9.

ReferenceCitation: Pelissier T, Alloui A, Paeile C, Eschalier A. Evidence of a central antinociceptive effect of paracetamol involving spinal 5HT3 receptors. Neuroreport. 1995 Jul 31;6(11):1546-8.

ReferenceCitation: Pelissier T, Alloui A, Caussade F, Dubray C, Cloarec A, Lavarenne J, Eschalier A. Paracetamol exerts a spinal antinociceptive effect involving an indirect interaction with 5-hydroxytryptamine3 receptors: in vivo and in vitro evidence. J Pharmacol Exp Ther. 1996 Jul;278(1):8-14.

ReferenceCitation: Alloui A, Chassaing C, Schmidt J, Ardid D, Dubray C, Cloarec A, Eschalier A. Paracetamol exerts a spinal, tropisetron-reversible, antinociceptive effect in an inflammatory pain model in rats. Eur J Pharmacol. 2002 May 17;443(1-3):71-7.

ReferenceCitation: Lund I, Lundeberg T, Kowalski J, Sandberg L, Budh CN, Svensson E. Evaluation of variations in sensory and pain threshold assessments by electrocutaneous stimulation. Physiother Theory Pract. 2005 Apr-Jun;21(2):81-92.

ReferenceCitation: Nielsen PR, Nørgaard L, Rasmussen LS, Kehlet H. Prediction of post-operative pain by an electrical pain stimulus. Acta Anaesthesiol Scand. 2007 May;51(5):582-6.

ReferenceCitation: Fujii Y, Nakayama M. Efficacy of dexamethasone for reducing postoperative nausea and vomiting and analgesic requirements after thyroidectomy. Otolaryngol Head Neck Surg. 2007 Feb;136(2):274-7.

ReferenceCitation: Samer CF, Piguet V, Dayer P, Desmeules JA. [Genetic polymorphism and drug interactions: their importance in the treatment of pain]. Can J Anaesth. 2005 Oct;52(8):806-21. Review. French.

ReferenceCitation: Lo Y, Chia YY, Liu K, Ko NH. Morphine sparing with droperidol in patient-controlled analgesia. J Clin Anesth. 2005 Jun;17(4):271-5.

ReferenceCitation: McCleane GJ, Suzuki R, Dickenson AH. Does a single intravenous injection of the 5HT3 receptor antagonist ondansetron have an analgesic effect in neuropathic pain? A double-blinded, placebo-controlled cross-over study. Anesth Analg. 2003 Nov;97(5):1474-1478. doi: 10.1213/01.ANE.0000085640.69855.51.

ReferenceCitation: Andrieu G, Amrouni H, Robin E, Carnaille B, Wattier JM, Pattou F, Vallet B, Lebuffe G. Analgesic efficacy of bilateral superficial cervical plexus block administered before thyroid surgery under general anaesthesia. Br J Anaesth. 2007 Oct;99(4):561-6. Epub 2007 Aug 6.

lead_sponsor: University Hospital, Lille


title: Lipophilic Micronutrients, Adipokines and Gestational Diabetes Mellitus

summary:
Background Gestational diabetes mellitus (GDM) is defined as a defect of glucose tolerance with its onset or its first recognition during pregnancy and that usually disappears, at least temporarily, after delivery. Its prevalence generally ranges between 3 and 6%, but may reach 12 to 15% in high-risk populations or specific ethnic groups. GDM increases the risk of potentially severe maternal, fetal and neonatal complications (gestational hypertension, pre-eclampsia, caesarean delivery; macrosomia; shoulder dystocia). These risks are linearly correlated with the level of maternal hyperglycaemia. GDM is due to a failure of pancreatic beta cells to sustain compensatory insulin secretion for insulin resistance that is physiological in pregnancy but can be much more pronounced in some women, especially in case of overweight or obesity. Maternal obesity is a major risk factor of GDM. Yet, micronutrient deficiencies are frequently reported in obese patients. Some nutritional deficiencies, concerning particularly some lipophilic micronutrients (vitamin A, vitamin D, vitamin E, carotenoids) may be associated with diseases linked to insulin resistance. Numerous studies show an inverse relationship between plasma concentrations and/or dietary intake of these micronutrients and incidence of type 2 diabetes. Vitamin D deficiency could be involved in the pathogenesis of type 2 diabetes through an alteration of insulin secretion and sensitivity. Deficiencies in vitamin A, vitamin E or carotenoids (in particular lycopene and beta carotene) increase oxidative stress and pro-inflammatory status, and could thus be implied in the physiopathology of insulin resistance and glucose intolerance.

Some case-control studies find an inverse correlation between the plasma concentrations of vitamin D during pregnancy and the incidence of GDM, independently of age, ethnic origin and of body mass index. Data are scarce for vitamin A and vitamin E, and are lacking for carotenoids. Besides, the few available studies are mainly descriptive ones, without clear explanations on underlying mechanisms. The favourable effects of these micronutrients on insulin sensitivity could be partially mediated by adipokines and/or pro-inflammatory cytokines secreted at the level of the adipose tissue. Numerous studies showed that women developing GDM during their pregnancy presented with a significant decrease in the circulating rates of adiponectin, (that is an adipokine with anti-inflammatory and insulin-sensitizing properties) and a significant increase in the secretion of the pro-inflammatory cytokines implied in the physiopathology of insulin resistance. In our laboratory (INRA unit 1260), we showed in experimental works conducted in vitro in human adipocytes and in vivo in mice that vitamin E could induce the transcription and the secretion of adiponectin; we also showed that vitamin D or lycopene could modulate the inflammatory reaction in the adipose tissue, which is involved in the physiopathology of insulin resistance.

Aims and methods We hypothesise that, in pregnant women, there is a link between plasma concentrations and dietary intakes of lipophilic micronutrients (mainly vitamins A, D, E and carotenoids), secretion of adipokines and pro-inflammatory cytokines, and risk of developing a GDM; we also hypothesise that this relationship is independent of age, body mass index, ethnic origin and other main risk factors of GDM. To test this hypothesis, we aim to lead a transversal monocentric study, within a population of 500 pregnant women submitted to a systematic screening of GDM by an oral glucose tolerance test (OGTT) in the Hôpital Nord of Marseilles.

The main criterion of evaluation of the link between lipophilic micronutrients and GDM will be a nutritional score calculated as follows: for each micronutrient (vitamin A, D, E, lycopene, beta carotene, alpha carotene, lutein), we will attribute 0 point if the patient is situated in the lowest quartile, 1 or 2 points in the following quartiles, and 3 points in the highest quartile. At the end, each patient will thus have a score between 0 and 21 reflecting the global status of these micronutrients.

The main secondary objectives will be to define the relationships between the plasma concentrations and dietary intakes of these micronutrients and 1/the value of glycemia and insulinemia during OGTT 2/the degree of insulin sensitivity estimated by the measure of HOMA index, 3/the circulating rates of some adipokines (mainly adiponectin, leptin, chemerin) and pro-inflammatory cytokines (TNF alpha, IL-1, IL-6), and 4/the children's birth weight.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assitance Publique Hôpitaux de Marseille


title: Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy in Hepatic Metastases of Metastatic Colorectal Cancer: a Phase II Multicentric Study With Patients in Progression After First Line Systemic Chemotherapy

acronym: BEVIAC

summary: The purpose of the study is to assessed the efficiency of treatment based on the objective response rate (RECIST 1.1)

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: To Assess the 12-month Prognostic Significance of Left Ventricular Collagen Markers in Patients With Heart Failure and Preserved Ejection Fraction.

summary: Assessment of cardiac fibrosis by echocardiography (Speckle tracking), IRM (late-enhancement imaging), biology (markers of collagen turn-over) and proteomics

lead_sponsor: University Hospital, Rouen


title: PRODIGE 22-ECKINOXE : Randomized Phase II Trial of Neoadjuvant FOLFOX 4 Versus FOLFOX 4 With Cetuximab Versus Immediate Surgery in Locally Advanced Colon Cancer

acronym: ECKINOXE

summary:
In patients with locally advanced colon cancer (high risk stage II and stage III), curative surgery followed by adjuvant FOLFOX-4 chemotherapy has become the standard of care. However, for 30-40% of these patients, the current curative treatment strategy of surgical excision followed by adjuvant chemotherapy fails either to clear locoregional spread or to eradicate distant micrometastases, leading to disease recurrence. Preoperative chemotherapy is an attractive concept for locally advanced colon cancer and has the potential to impact upon both of these causes of failure. Optimum systemic therapy at the earliest possible opportunity may be more effective at eradicating distant metastases than the same treatment given after the delay and immunological stress of surgery. Added to this, shrinking the primary tumor before surgery may reduce the risk of incomplete surgical excision, and the risk of tumor cell shedding during surgery.

ECKINOXE is a multicenter randomized phase II trial designed to evaluate efficacy (response rate) and feasibility (safety, tolerance) of these two chemotherapy regimens (FOLFOX-4 alone and FOLFOX-4+Cetuximab) in a neoadjuvant strategy in patients with locally advanced colon cancer. Control arm includes patients for whom standard treatment comprises surgery followed by adjuvant FOLFOX-4 chemotherapy. This phase II study will assess the feasibility of a neoadjuvant strategy in these patients and determine which neoadjuvant regimen is the most effective in terms of response rate.

ReferenceCitation: Karoui M, Gallois C, Piessen G, Legoux JL, Barbier E, De Chaisemartin C, Lecaille C, Bouche O, Ammarguellat H, Brunetti F, Prudhomme M, Regimbeau JM, Glehen O, Lievre A, Portier G, Hartwig J, Goujon G, Romain B, Lepage C, Taieb J; for PRODIGE 22 investigators/Collaborators. Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high-risk Stage II and III colon cancers? Three years' follow-up results of the PRODIGE 22 phase II randomized multicentre trial. Colorectal Dis. 2021 Jun;23(6):1357-1369. doi: 10.1111/codi.15585. Epub 2021 Mar 10.

name: Department of Digestive and Oncological Surgery AP‐HP; Hôpital Européen Georges Pompidou Paris University Paris France

family: Karoui

full_name: Mehdi Karoui

given: Mehdi

name: Department of Hepato‐gastroenterology and Digestive Oncology Hôpital Européen Georges Pompidou, AP‐HP Paris University Paris France

family: Gallois

full_name: Claire Gallois

given: Claire

name: Department of Digestive and Oncological Surgery Lille University Hospital Lille France

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

name: Department of Hepato‐gastroenterology and Digestive Oncology CHR La Source Orléans France

family: Legoux

full_name: Jean‐Louis Legoux

given: Jean‐Louis

name: Biostatistics, FFCD, EPICAD INSERM LNC‐UMR 1231 University of Burgundy and Franche Comté Dijon France

family: Barbier

full_name: Emilie Barbier

name: Department of Digestive Surgery Institut Paoli Calmettes Marseille France

family: De Chaisemartin

full_name: Cecile De Chaisemartin

given: Cecile

name: Department of Oncology Polyclinique Bordeaux Nord Bordeaux France

family: Lecaille

full_name: Cedric Lecaille

given: Cedric

name: Department of Digestive Oncology CHU Robert Debré Reims France

family: Bouche

full_name: Olivier Bouche

given: Olivier

name: Department of Medical Oncology CH Beauvais Beauvais France

family: Ammarguellat

full_name: Hanifa Ammarguellat

given: Hanifa

name: Department of Digestive Surgery AP‐HP CHU Henri Mondor Créteil France

family: Brunetti

full_name: Francesco Brunetti

given: Francesco

name: Department of Digestive Surgery CHU Carémeau Nîmes France

family: Prudhomme

full_name: Michel Prudhomme

given: Michel

name: Department of Digestive Surgery Amiens University Hospital France

family: Regimbeau

full_name: Jean‐Marc Regimbeau

given: Jean‐Marc

name: Department of Digestive Surgery CHU Lyon Sud Lyon France

family: Glehen

full_name: Olivier Glehen

name: Department of Gastroenterology CHU Rennes, Rennes 1 University Rennes France

family: Lievre

full_name: Astrid Lievre

given: Astrid

name: Department of Digestive Surgery CHU Rangueil Toulouse France

family: Portier

full_name: Guillaume Portier

name: Department of GastroenterologyInfirmerie Protestante Caluire‐et‐Cuire France

family: Hartwig

full_name: Johannes Hartwig

given: Johannes

name: Department of Gastroenterology Paris VII, AP‐HP BCHU Bichat Paris France

family: Goujon

full_name: Gael Goujon

given: Gael

name: Department of Digestive Surgery CHU Hautepierre Strasbourg France

family: Romain

full_name: Benoit Romain

given: Benoit

name: Hepato‐gastroenterology and Digestive Oncology Department FFCD, EPICAD INSERM LNC‐UMR 1231 CHU Dijon University of Burgundy and Franche Comté Dijon France

family: Lepage

full_name: Come Lepage

given: Come

family: Taieb

full_name: Julien Taieb

given: Julien

family: Ainseba

full_name: N. Ainseba

given: N.

family: Alcaraz

full_name: L. Alcaraz

given: L.

family: Audemar

full_name: F. Audemar

given: F.

title: Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high‐risk Stage II and III colon cancers? Three years' follow‐up results of the PRODIGE 22 phase II randomized multicentre trial

ReferenceCitation: Karoui M, Rullier A, Piessen G, Legoux JL, Barbier E, De Chaisemartin C, Lecaille C, Bouche O, Ammarguellat H, Brunetti F, Prudhomme M, Regimbeau JM, Glehen O, Lievre A, Portier G, Hartwig J, Goujon G, Romain B, Lepage C, Taieb J; for PRODIGE 22 investigators/collaborators. Perioperative FOLFOX 4 Versus FOLFOX 4 Plus Cetuximab Versus Immediate Surgery for High-Risk Stage II and III Colon Cancers: A Phase II Multicenter Randomized Controlled Trial (PRODIGE 22). Ann Surg. 2020 Apr;271(4):637-645. doi: 10.1097/SLA.0000000000003454.

ReferenceCitation: Karoui M, Rullier A, Luciani A, Bonnetain F, Auriault ML, Sarran A, Monges G, Trillaud H, Le Malicot K, Leroy K, Sobhani I, Bardier A, Moreau M, Brindel I, Seitz JF, Taieb J. Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial--the PRODIGE 22--ECKINOXE trial. BMC Cancer. 2015 Jul 10;15:511. doi: 10.1186/s12885-015-1507-3.

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

title: Neoadjuvant FOLFOX 4 versus FOLFOX 4 with Cetuximab versus immediate surgery for high-risk stage II and III colon cancers: a multicentre randomised controlled phase II trial – the PRODIGE 22 - ECKINOXE trial


summary:
The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies.

Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable.

Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties

The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia.

lead_sponsor: Poitiers University Hospital


title: QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

summary:
AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of reference. 3) to determine whether socio-demographic factors, neonatal features and neurocognitive status were impacting their QoL.

METHODS:

Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier, Nantes, Nîmes, Nice and Rouen).
Inclusion criteria: all infants born before 28 weeks of gestation between January 2005 and December 2007, from 7 to 9 years old of age at the time of evaluation.
Written agreement to participate: collected from parents.
Data collection: reports of children's QoL by children and their parents (using standardized validated questionnaires); clinical information about the children, obtained through a medical examination; children neurocognitive profile.
Duration of inclusion: over 24 months.
Population: of the six structures, approximately 300 children will be evaluated consistent with the active files of the participating centres and an attrition rate of 30%.

PERSPECTIVES This is one of the first studies to collect self-reported data on quality of life of school-age children (7-9 years) born before 28 weeks of gestation. A better understanding of demographic and clinical determinants of QOL of school-age very preterm children may help clinicians involved in the care of these children in their ethical and medical considerations.

ReferenceCitation: Gire C, Resseguier N, Brévaut-Malaty V, Marret S, Cambonie G, Souksi-Medioni I, Müller JB, Garcia P, Berbis J, Tosello B, Auquier P; GPQoL study Group. Quality of life of extremely preterm school-age children without major handicap: a cross-sectional observational study. Arch Dis Child. 2019 Apr;104(4):333-339. doi: 10.1136/archdischild-2018-315046. Epub 2018 Jun 30.

family: Gire

full_name: Catherine Gire

given: Catherine

family: Resseguier

full_name: Noémie Resseguier

given: Noémie

family: Brévaut-Malaty

full_name: Véronique Brévaut-Malaty

given: Véronique

family: Marret

full_name: Stéphane Marret

given: Stéphane

family: Cambonie

full_name: Gilles Cambonie

given: Gilles

family: Souksi-Medioni

full_name: Isabelle Souksi-Medioni

given: Isabelle

family: Müller

full_name: Jean-Baptiste Müller

given: Jean-Baptiste

family: Garcia

full_name: Patricia Garcia

given: Patricia

family: Berbis

full_name: Julie Berbis

given: Julie

family: Tosello

full_name: Barthélémy Tosello

given: Barthélémy

family: Auquier

full_name: Pascal Auquier

given: Pascal

journal_name: Archives of Disease in Childhood

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility: Assistance Publique Hopitaux de Marseille


title: Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

summary:
Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor which is part of the hypothalamic-pituitary neuronal network is the key of this surgical procedure.

Purpose: There are no prospective data available about the endocrine effects after ETV in children and adults. The principal aim of this prospective study is to evaluate the variability of hypothalamic-pituitary hormones and clinical effects in children and adults after ETV in order to plan a multicentric study.

lead_sponsor: University Hospital, Toulouse


acronym: METAHEP

summary:
The immune response at primary tumor has a major role in the prognosis of colorectal cancer (CRC). Some studies suggest a prognosis value of cytotoxic T cell and memory T cells at primary tumor greater than tumoral stage. There is no work in the literature that has examined the prognosis value of the immune response in liver metastases. To study immune cells (histology) and inflammatory response (cytokines) in liver metastases is a challenge to understand the effectiveness of chemotherapy used in this situation.

The chemotherapy used in liver metastases of colorectal cancer also have effects on non-tumoral liver tumor and therefore can interfere with postoperative complications of hepatic resection. Sinusoidal dilatation is present in 20% to 80% of patients who received oxaliplatin before hepatectomy. Steatosis is frequently observed after administration of 5-FU alone or in combination with irinotecan. This steatosis may also be accompanied by inflammatory lesions (steatohepatitis), especially after administration of oxaliplatin or irinotecan and is associated with increased postoperative mortality. The hepatic toxicity of new biological agents is not well known (cetuximab and bevacizumab). The mechanisms of chemotherapy-induced toxicities are currently unknown. The main objective is to analyze the profile of the immune response in liver metastases of CRC and find the link with the radiological response. Measurements will be made by quantitative RT-PCR on frozen liver biopsies. Secondary objective is to seek a correlation between the histological lesions induced by chemotherapy and non-invasive tests for liver fibrosis. The secondary endpoints are rate of immune cells, histologic response (percentage of tumor necrosis), disease-free survival, the non-invasive test of fibrosis, the chemotherapy-induced liver injury, cytokines and circulating angiogenic factors.

status: Recruiting

status_simplified: Ongoing


summary:
Prospective Study, monocentric, controlled, randomized study. Evaluating the effectiveness of dermal analgesia provided by the application of Lidocaine and Prilocaine Cream 5% on the puncture site of axillary blocks.Our study includes 70 patients. Number of subjects required for a 50% difference with the standard deviation of the control group, a significance level of 5% for a 80% power, it takes 23 people per group. Objective power of 90% obtained with 35 patients per group.

The expected benefit is the reduction of pain at the skin puncture during the realization of BAX.

Improving professional practice and quality care


title: Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.

acronym: ALTERVOL

summary: Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.

lead_sponsor: Rennes University Hospital


title: Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)

acronym: CT-TAVI

summary: This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).


lead_sponsor: Sanofi

acronym: AFEQT

source: euctr

title: A Multicenter, Single Arm, Open Label Clinical Trial Evaluating Safety and Health Related Quality of Life of Aflibercept in Combination With Irinotecan/5-FU Chemotherapy (FOLFIRI) in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen

summary:
Primary Objective:

To evaluate the safety of aflibercept in participants with mCRC treated with irinotecan/5-Fluorouracil (5-FU) combination (FOLFIRI) after failure of an oxaliplatin-based regimen (participants similar to those evaluated in the VELOUR trial [EFC10262, NCT00561470]) according to side effects prevention and management guidelines.

Secondary Objective:

To document the Health-Related Quality of Life (HRQL) of aflibercept in this participant population.


type: Registry Identifier

title: Medical Economic Evaluation of the Care of the Severe Asthma : Cohort COBRA

acronym: Cobra

summary: The severe asthma is a major source of expenses in term of public health, while it concerns no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations, care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort of more than 500 severe asthmatic patients multicentrique in an already widely established cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a real medical economic variable. The possibility of dynamic follow-up of the expenses compared to the medical data offers perspectives of evaluation cost-efficiency of the informed therapeutic procedures. It is possible to couple in a forward-looking and dynamic way the data of health stemming from a cohort with the economic data stemming from the CPAM. This variable included in a Cluster's algorithm has to allow to identify the interventions the more and the less cost effective. The main objective of this study is to realize a cost estimate of care of the severe asthma. The variation of the costs will be also studied. The recruited patients are patients already included in the cohort COBRA in the centers of Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.

lead_sponsor: University Hospital, Montpellier


title: A Single Center, Randomized, Single Dose, Open-label, Four Period Cross-over Study to Investigate the Relative Bioavailability of RO4917838 and the Effect of Food Following Oral Administration in Healthy Subjects

summary: This single center, randomized, single dose, open-label, four period cross-over study will evaluate the relative bioavailability of RO4917838 and the effect of food following oral administration in healthy volunteers. Subjects will receive in randomized order single oral doses of RO4917838 film coated tablets, either in the fasted or fed condition, or RO4917838 hard gelatin capsules or RO4917838 oral suspension, with a washout period of at least 21 days between treatments. Anticipated time on study will be up to 23 weeks.

lead_sponsor: Hoffmann-La Roche


title: A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Fluvoxamine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

summary: This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a cross-over design. The anticipated time on study treatment is 40 days.