title: Impact of a Physical Activity Program on Bone Mineral Density (BMD) in Children / Adolescents With Chronic Inflammatory Bowel Disease (IBD): Crohn's Disease, Ulcerative Colitis, Unclassified Chronic Colitis

acronym: PROPHYSICOS

summary: Muscle and physical activity play an important role in in growth, development and bone health in healthy children, especially during puberty. Children with inflammatory bowel disease (IBD) have lower level and intensity of physical compared to a control group. Several studies have shown that children with IBD have a lower bone mineral density (BMD) than general population, due to risk factors such as corticosteroid use, disease intensity, inflammation, malnutrition and a vitamin D deficiency. This low BMD is associated with an increased risk of fracture. A recent observational study found a positive and significant correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.

ReferenceCitation: Vanhelst J, Coopman S, Labreuche J, Dupont C, Bertrand V, Djeddi D, Turck D, Ley D. Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease. BMJ Open. 2020 May 18;10(5):e036400. doi: 10.1136/bmjopen-2019-036400.

family: Vanhelst

full_name: Jérémy Vanhelst

given: Jérémy

family: Coopman

full_name: Stéphanie Coopman

given: Stéphanie

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Dupont

full_name: Claire Dupont

given: Claire

family: Bertrand

full_name: Valérie Bertrand

given: Valérie

family: Djeddi

full_name: Djamal Djeddi

given: Djamal

family: Turck

full_name: Dominique Turck

given: Dominique

family: Ley

full_name: Delphine Ley

given: Delphine

journal_name: BMJ Open

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

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Lille

location_facility:
Chu Amiens Picardie
Hop Jeanne de Flandre Chu Lille


title: Biological and Functional Determinants of the Endothelial and Vascular Response to Exercise Training in COPD Patients

acronym: cDysEndoBPCO

summary:
Vascular comorbidities constitute a major burden in COPD patients. The atherosclerosis process is preceded by the onset of an endothelial dysfunction (assessed by the flow-mediated dilatation (FMD)), which is a risk factor for later ischemic vascular complications and death. In COPD, this endothelial dysfunction could be explained by intrinsic endothelial cell properties, or the effect of a pathogenic endothelial cell microenvironment (inflammation and/or oxidative stress). Exercise training constitue a powerful stimulus for the endothelial function, and could be mediated by the mobiliaztion and function of endothelial progenitors. While exercise training is an efficient intervention in COPD patients, its vascular effect appear blunted. The endothelial function response to training has appeared heterogeneous in COPD patients, and possibly linked to the endothelial cel lesion. Thus, endothelial function (assessed by the FMD) response to exercise training would be lower in COPD patients with a baseline impairment of the their FMD. In addition, of biological and functional factors could explained the magnitude of the FMD response in COPD patients.The aim of the study are thus :

To compare the FMD change in COPD patients with FMD above (FMD+) and under the median FMD (FMD-) after 4 weeks of exercise training in the whole study population.

To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects, the endothelial inflammation and senescence at baseline and the endothelial progenitor mobilization and function change induced by exercise (maximal exercise test and training).

To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects the effect of the endothelial microenvironment on the cellular pathways regulating the endothelial function in vitro at baseline and changes after exercise training.

To test in COPD patients the association between the magnitude of the FMD changes after training and biological, functional and clinical factors (inflammation oxidative stress markers, endothelial biomarkers, pulmonary impairment and phenotype, cardiovascular risks factors, vascular function, metabolic markers, physical activity level, …)

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: University Hospital, Montpellier

location_facility: Montpellier and Nimes University Hospitals

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers

acronym: MetLung

summary: Our project, established through collaboration between clinicians (Oscar Lambret Center-University Hospital) and scientists (IBL), aims to evaluate the expression of Met fragments in the lung cancer (LC). Unlike previous studies on Met by sequencing, in situ hybridization or immunohistochemistry, the investigators propose a protein analysis by Western blot of tumor samples and healthy tissue. This approach will evaluate the expression of full-length receptor, the potential presence of intracellular fragments, and their phosphorylation status.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Régional et Universitaire

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial

acronym: APAPI

summary:
The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.

The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.

design_allocation: Randomized

primary_purpose: Treatment

location_facility:
Hôpital Roger Salengro, CHU
Chu Amiens Picardie

intervention_type: Procedure


title: Directed Donation of Untreated Milk or Milk Processed by the Breast-milk : Prospective Evaluation in Older Premature

acronym: ADiLL

summary: The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of essential fatty acids (EFA) in a population of premature infants.

status: Unknown status

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
Centre Hospitalier Universitaire
Centre Hospitalier Regional

status_simplified: Unknown


title: Randomized Prospective Trial Evaluating the Efficacy of a Dedicated Therapeutic Education Program on the Blood Pressure and Other Cardiovascular Risk Factors Control in General Practice Patients at High Cardiovascular Risk

summary: A dedicated therapeutic education program is an essential tool in the management of hypertension as well as in the control of other cardiovascular risk factors. The purpose of this study is therefore to evaluate the effect of such a therapeutic education program in general practice patients at high cardiovascular risk.

primary_purpose: Prevention

location_facility:
General Practice Office
General practice office


title: Randomized Prospective Clinical Study Evaluating the Usefulness of Fibrin Glue (TISSEEL® KIT) to Prevent Gastric Fistula, Intra Abdominal Haemorrhage and Intra Abdominal Loco Regional Collections After Laparoscopic Sleeve Gastrectomy

acronym: TISSEEL

summary: Laparoscopic Sleeve Gastrectomy has emerged over the last 20 years as a treatment of choice in the surgical management of patients with morbid obesity. However, this restrictive procedure is accompanied by outcomes such as gastric fistula (5%), postoperative hemorrhage (1%) and intra-abdominal loco regional collections (1%). At present, there is no sufficiently reliable technique to prevent these complications.

ReferenceType: background

ReferenceCitation: Pequignot A, Fuks D, Verhaeghe P, Dhahri A, Brehant O, Bartoli E, Delcenserie R, Yzet T, Regimbeau JM. Is there a place for pigtail drains in the management of gastric leaks after laparoscopic sleeve gastrectomy? Obes Surg. 2012 May;22(5):712-20. doi: 10.1007/s11695-012-0597-0.

ReferenceCitation: Péquignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.

ReferenceCitation: Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016.

ReferenceCitation: Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.

ReferenceCitation: Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.

ReferenceType: derived

ReferenceCitation: Rebibo L, Dhahri A, Chati R, Cosse C, Huet E, Regimbeau JM. Effectiveness of Fibrin Sealant Application on the Development of Staple Line Complications After Sleeve Gastrectomy: A Prospective Randomized Trial. Ann Surg. 2018 Nov;268(5):762-768. doi: 10.1097/SLA.0000000000002892.

family: Rebibo

full_name: Lionel Rebibo

given: Lionel

sequence: first

family: Dhahri

full_name: Abdennaceur Dhahri

given: Abdennaceur

sequence: additional

family: Chati

full_name: Rachid Chati

given: Rachid

family: Cosse

full_name: Cyril Cosse

given: Cyril

family: Huet

full_name: Emmanuel Huet

given: Emmanuel

family: Regimbeau

full_name: Jean-Marc Regimbeau

given: Jean-Marc

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Charles Nicolle Universitary Hospital
North Universitary Hospital


title: Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer? Pilot Study.

acronym: MIRHO

summary:
This is a biomedical and prospective study of interventional type. The trial will include 29 patients over a period of 15 months + 24 months of follow up maximum.

The study will be conduct in womens with metastatic invasive breast cancer or locally advanced breast cancer and for which treatment with tamoxifen or anti aromatase (first line hormone therapy for metastatic breast cancer) is indicated.

The main objective of this pilot study is to evaluate the feasibility to detect in the circulating blood of patients, before treatment (T0), the presence of the fifteen tissular microRNAs described in preclinical studies as possibly involved in hormone resistance/sensitivity.

In parallel of the detection of these specific miRNAs, we will conduct a larger scale analysis of circulating miRNAs in these patients before (T = 0) and after one month of treatment (T28).

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius REGAUD Toulouse
Centre Val d'Aurelle - Paul Lamarque

intervention_type: Drug


title: Insight in Persons Presenting Schizophrenia or Related Troubles During Hospitalization in Psychiatry

summary:
Therapeutic alliance, and drug observance are major difficulties in the care of persons presenting schizophrenic symptomatology. They appear to be linked to insight, the consciousness that one has of his troubles. Nurse care in psychiatry aims at improving it, but usually without using specific evaluation tool. Insight is usually not evaluated during care, and its evolution is also not known, although it is highly probable that a positive evolution of insight for a person in hospital correlated to an adapted and optimal care by the medical and nursing teams. The investigators do not know examples of insight evaluation during a sequence of hospital care, or any evidence of insight variation in relation to evolution abilities of some schizophrenic patients cared in hospital.

The investigators propose here to evaluate insight in people presenting schizophrenia or related troubles, at the beginning of hospitalization (I1) and 1 month later (I2), to better characterize insight variations, and identify the sociodemographic, clinical and therapeutic variables linked to it.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Esquirol

location_facility:
Centre Hospitalier Esquirol
Centre Hospitalier La Vallette


title: Treatment for Opiate Addiction: Prognostic fActors of Responsiveness to Maintenance Treatment

acronym: TOPAZE

summary: A global and integrative treatment of opioid-use disorders (OUD) with opiate maintenance therapy (OMT) and psychosocial interventions is recommended by all current guidelines. Treatment of OUD aim at prevents risks and consequences of opioid use (death by overdose, contamination with infectious diseases, mental and physical degradation, social exclusion and decrease of quality of life). OMT are approved since more than 20 years for OUD and a large number of patients have been treated. Nevertheless, identification of prognosis factors associated with good outcome is still limited. OMT duration, high dosages of OMT and patient good consistency have been identified as good prognosis factors but other individual factors could be involved and explain why OMT isn't as effective for all patients. The investigators assume that social environment, other addictive behaviors, psychiatric comorbidities, personality disorders and pharmacogenetics parameters might be of interest. Association between phenotype/ genotype, safety of OMT and therapeutic outcome will be especially assessed. For voluntary patients specific tools for risk reduction will be implemented (screening of infectious diseases with blood tests and fibrosis with fibroscan). Thus, the aim of TOPAZE study is to highlight prognosis factors for good outcome in the treatment of OUD moderate to severe at 12 months follow-up. Three main axes will be considered: clinical, pharmacological and pharmacogenetics.

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
Grall Bronnec
OPPELIA-Le triangle


title: A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study

acronym: Epidrum-Tho

summary: The purpose of this study is to evaluate the use of the Epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia.

lead_sponsor: Hopital Foch

location_facility:
CHU Marseille
Hopital Foch

intervention_type: Device


title: Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps

acronym: STEREO-HBM

summary: This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases

ReferenceCitation: Lesueur P, Kao W, Leconte A, Geffrelot J, Lequesne J, Lacroix J, Brachet PE, Hrab I, Royer P, Clarisse B, Stefan D. Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial. BMC Cancer. 2020 Feb 22;20(1):147. doi: 10.1186/s12885-020-6569-1.

family: Lesueur

full_name: Paul Lesueur

given: Paul

family: Kao

full_name: William Kao

given: William

family: Leconte

full_name: Alexandra Leconte

given: Alexandra

family: Geffrelot

full_name: Julien Geffrelot

family: Lequesne

full_name: Justine Lequesne

given: Justine

family: Lacroix

full_name: Joëlle Lacroix

given: Joëlle

family: Brachet

full_name: Pierre-Emmanuel Brachet

given: Pierre-Emmanuel

family: Hrab

full_name: Ioana Hrab

given: Ioana

family: Royer

full_name: Philippe Royer

given: Philippe

family: Clarisse

full_name: Bénédicte Clarisse

given: Bénédicte

family: Stefan

full_name: Dinu Stefan

given: Dinu

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Francois Baclesse

location_facility:
Institut de Cancérologie de Lorraine
Centre François Baclesse

intervention_type: Radiation


title: Effects of Oral Citrulline Supplementation in Sarcopenia for Patients With Severe Chronic Respiratory Failure by COPD

summary:
Because of its very high bioavailability and its specific and direct action on protein synthesis, the investigators hypothesize that citrulline supplementation would be an innovative nutritional strategy to improve the peripheral muscle mass and strength in COPD patients with severe chronic respiratory failure.

This supplementation would be more effective if the pathology is severe and the chronic systemic inflammation important. The benefits of this supplementation could help the most severe patients break out of the cycle of inactivity and thus optimize their quality of life.

The main objective of this study is to evaluate the impact of 45-day nutritional supplementation with Citrulline (10 g / day) on the body composition (lean body mass) in malnourished COPD patients with severe chronic respiratory failure.

study_start_date_type: Anticipated

ReferenceCitation: Schols AM, Ferreira IM, Franssen FM, Gosker HR, Janssens W, Muscaritoli M, Pison C, Rutten-van Mölken M, Slinde F, Steiner MC, Tkacova R, Singh SJ. Nutritional assessment and therapy in COPD: a European Respiratory Society statement. Eur Respir J. 2014 Dec;44(6):1504-20. doi: 10.1183/09031936.00070914. Epub 2014 Sep 18.

ReferenceCitation: Cano NJ, Roth H, Court-Ortuné I, Cynober L, Gérard-Boncompain M, Cuvelier A, Laaban JP, Melchior JC, Pichard C, Raphaël JC, Pison CM; Clinical Research Group of the Société Francophone de Nutrition Entérale et Parentérale. Nutritional depletion in patients on long-term oxygen therapy and/or home mechanical ventilation. Eur Respir J. 2002 Jul;20(1):30-7.

ReferenceCitation: Woo J, Leung J, Morley JE. Validating the SARC-F: a suitable community screening tool for sarcopenia? J Am Med Dir Assoc. 2014 Sep;15(9):630-4. doi: 10.1016/j.jamda.2014.04.021. Epub 2014 Jun 16.

lead_sponsor: University Hospital, Grenoble

location_facility: Hôpital François Mitterrand - CHU de Dijon


title: Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation

summary: The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed. Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization . This project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The aim of the study is to study the effectiveness of the prototype (interactive walking mobile robot).

lead_sponsor: Rennes University Hospital

location_facility: Centre Mutualiste de Rééducation et Réadaptation fonctionnelles de Kerpape


title: Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Non-metastatic Breast Cancer at the Beginning Weekly Taxol Adjuvant Chemotherapy (Www.Bouge-coaching.Com)

acronym: BOUGE CANCER

summary: Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of breast cancer patients

lead_sponsor: University Hospital, Brest

location_facility:
CHU de Morlaix
CHRU de Brest


title: Cough Determinants in Mechanically Ventilated Patients: a Physiological Study

acronym: Extu-Cough

summary: In our knowledge there is only few data about the cough determinants in mechanically ventilated patients. However some failure of extubation is due to inefficiency cough. In order to determine some determinants of cough, the investigators propose to evaluate systematically different physiological parameters before and after extubation.

ReferenceCitation: Terzi N, Lofaso F, Masson R, Beuret P, Normand H, Dumanowski E, Falaize L, Sauneuf B, Daubin C, Brunet J, Annane D, Parienti JJ, Orlikowski D. Physiological predictors of respiratory and cough assistance needs after extubation. Ann Intensive Care. 2018 Feb 5;8(1):18. doi: 10.1186/s13613-018-0360-3.

family: Terzi

full_name: Nicolas Terzi

given: Nicolas

family: Lofaso

full_name: Frédéric Lofaso

given: Frédéric

family: Masson

full_name: Romain Masson

given: Romain

family: Beuret

full_name: Pascal Beuret

given: Pascal

family: Normand

full_name: Hervé Normand

given: Hervé

family: Dumanowski

full_name: Edith Dumanowski

given: Edith

family: Falaize

full_name: Line Falaize

given: Line

family: Sauneuf

full_name: Bertrand Sauneuf

given: Bertrand

family: Daubin

full_name: Cédric Daubin

given: Cédric

family: Brunet

full_name: Jennifer Brunet

given: Jennifer

family: Annane

full_name: Djillali Annane

given: Djillali

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Orlikowski

full_name: David Orlikowski

given: David

journal_name: Annals of Intensive 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 - memSIC

repositories:
HAL
PubMed Central

location_facility:
University Hospital, Caen
University Hospital, Garches


title: Development and Evaluation of a New Diagnostic Test in Female Urinary Stress Incontinence

acronym: IEUF

summary:
The investigators hypothesize that an innovative test device simulating transvaginal tape support will increase the performance and reproducibility of the diagnosis of urethral hypermobility before surgery for urinary incontinence.

The main objective of this study is to compare two prognostic tests in their ability to predict the success (or failure) of the implementation of a suburethral TVT (tension-free vaginal tape) or TOT (trans-obturator tape) treatment for stress urinary incontinence in women. The Q-tip test (test mentioned in the French and international recommendations) is compared to test a new test (clip strip).

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


type: Registry Identifier

title: Post Therapeutic Support and Rehabilitation Protocol in Hydrothermal Centers for Breast Cancer Patients in Complete Remission: a Multicenter Prospective Randomized Trial Testing the Intervention Versus Best Supportive Care

summary:
Many breast cancer patients (BCP) will gain weight during chemotherapy and about 10% of them are able to find back to their initial weight after all treatments are finished. Other studies have shown that overweight at diagnosis was associated to a twice higher risk of relapse while a weight gain during treatments increased by 30% to 50% the risk of relapse. In western countries, 75% of BCP have insufficient physical activity. Dietary and activity programs seem to be able to significantly reduce the mortality risk after breast cancer.

The investigators performed a prospective randomized trial consisting in dietary counseling, physical training and physiotherapy in hydrothermal centers. Intervention were delivered in small group session lasting 12 days. SPA cares were offered to patients. Patients in the control group also received dietary counseling given by a dietetician inside anticancer hospital, and were asked to perform more physical activities. Main endpoints of the trial addressed quality of life (SF36) one year after inclusion, weight reduction, anxiety/depression (HAD), sleep quality and long term compliance to instructions. An economic study was associated to the protocol, for volunteers only.

lead_sponsor: Centre Jean Perrin

location_facility:
Pole Santé-République
Centre Jean Perrin

intervention_type: Behavioral


title: Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques

summary: The main objective of this study is to compare results for the detection of circulating melanoma cells (CMC) using CellSearch versus EPISPOT (EPithelial ImmunoSPOT) techniques between a group of patients with metastatic melanoma and a group of hospitalized control patients.


title: The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency

acronym: MACIVC

summary: The main objective of this study is to obtain data to determine, in each individual with and without wearing compression stockings of different strengths and during different postures, the relationship between interface pressure and the area and circumference of the great saphenous vein and posterior tibial veins in the calf and ankle.

time_perspective: Cross-Sectional

ReferenceCitation: Mestre S, Triboulet J, Demattei C, Veye F, Nou M, Pérez-Martin A, Dauzat M, Quéré I. Noninvasive measurement of venous wall deformation induced by changes in transmural pressure shows altered viscoelasticity in patients with chronic venous disease. J Vasc Surg Venous Lymphat Disord. 2021 Jul;9(4):987-997.e2. doi: 10.1016/j.jvsv.2020.11.010. Epub 2020 Nov 21.

family: Mestre

full_name: Sandrine Mestre

given: Sandrine

family: Triboulet

full_name: Jean Triboulet

given: Jean

family: Demattei

full_name: Christophe Demattei

given: Christophe

family: Veye

full_name: Florent Veye

given: Florent

family: Nou

full_name: Monira Nou

given: Monira

family: Pérez-Martin

full_name: Antonia Pérez-Martin

given: Antonia

family: Dauzat

full_name: Michel Dauzat

given: Michel

family: Quéré

full_name: Isabelle Quéré

given: Isabelle

journal_name: Journal of Vascular Surgery: Venous and Lymphatic Disorders

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Endogenous Mechanisms of Inactivation of the Endothelium Tumor

acronym: BreastIls

summary:
The role of immunity in the development of cancers, and the associated escape mechanisms, have attracted renewed interest since the publication of tests testing immunological checkpoint inhibitors. One of the steps in the probably least studied immunological response is the penetration of immunocompetent cells within the tumor across the vascular barrier. This infiltration is suggested as a prognostic and predictive marker of treatment response, particularly in triple negative HER2 (Human Epidermal Growth Factor Receptor-2) overexpressing breast cancers. The methods of evaluating these infiltrates are complex and have been the subject of recommendations.

A better understanding of the mechanisms of infiltration of immunity cells within tumors will certainly help to better understand the impact of cancer treatments and develop new therapeutic strategies.

It is this issue of vascular endothelium that Dr. Soncin's team is developing as part of an INCa (Institut National du cancer) project. The egfl7 / VE-statin (vascular endothelial-statin) gene is thought to be involved in transendothelial passage of immune cells from vascular lumen to tumor. Its expression has already been studied in a series of breast cancers. Other markers of endothelial activation are currently being identified.

The main objective of this project will be to better understand the behavior of the endothelium in a population of breast cancer where the infiltrate in immune cells is precisely likely to play a leading role. This retrospective cohort of 250 to 300 cases treated with adjuvant and neoadjuvant will be immunologically characterized using the recommendations of Salgado et al. that a multicentric team of pathologists will take ownership. This evaluation will be counter-appraised.

Once our cohort is immunologically characterized, our project will focus on better understanding the endothelial mechanisms involved: which cells? immunophenotyping of immunity cells. By which vessels? (measurement of densities in blood and lymphatic vessels, density in HEV). By what mechanisms? Do the actors identified in vitro within the Inca project have an in vivo translation

time_perspective: Retrospective

location_facility:
Centre Henri Becquerel
Centre Oscar Lambret


type: EudraCT Number

title: A Dose Escalation Phase I Study of Radiotherapy Administered in Combination With Anti-CTLA4 Monoclonal Antibody (Ipilimumab) in Patients With Unresectable Stage III or Stage IV Advanced Malignant Melanoma

acronym: Mel-Ipi-Rx

summary:
RATIONALE:Anti-melanoma activity of Ipilimumab both as a single therapy and in association with melanoma peptides has been shown as well as synergy between radiation therapy and anti-CTLA-A mAb in several tumor animal models for both local tumor control and distant effects.Radiotherapy increases tumor immunogenicity in several preclinical models by increasing MHC molecules expression and is able to induce significant tumor reduction in around 30% of cases. Thus, combining radiotherapy and administration of ipilimumab could elicit systemic antitumor response. Radiation therapy will expose tumor-associated antigens (TAA) and facilitate antigen presentation, and further blockade of CTLA-4 could amplify the immune antitumor response. In this therapeutical model, the use of the own patient tumor as a source of tumor antigens (in opposition with other vaccination protocols, where TAA are exogenic) is particularly adapted.

PURPOSE: This Phase I trial determines the side effects and best dose of radiation therapy administered in combination with ipilimumab.

ReferenceCitation: Boutros C, Chaput-Gras N, Lanoy E, Larive A, Mateus C, Routier E, Sun R, Tao YG, Massard C, Bahleda R, Schwob D, Ibrahim N, Khoury Abboud RM, Caramella C, Lancia A, Cassard L, Roy S, Soria JC, Robert C, Deutsch E. Dose escalation phase 1 study of radiotherapy in combination with anti-cytotoxic-T-lymphocyte-associated antigen 4 monoclonal antibody ipilimumab in patients with metastatic melanoma. J Immunother Cancer. 2020 Aug;8(2). pii: e000627. doi: 10.1136/jitc-2020-000627.

family: Boutros

full_name: Celine Boutros

given: Celine

family: Chaput-Gras

full_name: Nathalie Chaput-Gras

given: Nathalie

family: Lanoy

full_name: Emilie Lanoy

given: Emilie

family: Larive

full_name: Alicia Larive

given: Alicia

family: Mateus

full_name: Christine Mateus

given: Christine

family: Routier

full_name: Emilie Routier

family: Sun

full_name: Roger Sun

given: Roger

family: Tao

full_name: Yun Gan Tao

given: Yun Gan

family: Massard

full_name: Christophe Massard

family: Bahleda

full_name: Rastilav Bahleda

given: Rastilav

family: Schwob

full_name: Dominique Schwob

given: Dominique

family: Ibrahim

full_name: Nathalie Ibrahim

family: Khoury Abboud

full_name: Rita Maria Khoury Abboud

given: Rita Maria

family: Caramella

full_name: Caroline Caramella

given: Caroline

family: Lancia

full_name: Andrea Lancia

given: Andrea

family: Cassard

full_name: Lydie Cassard

given: Lydie

family: Roy

full_name: Severine Roy

given: Severine

family: Soria

full_name: J -C Soria

given: J -C

family: Robert

full_name: Caroline Robert

family: Deutsch

full_name: Eric Deutsch

given: Eric

currency_apc_doaj: USD

journal_name: Journal for ImmunoTherapy of Cancer

license: cc-by-nc

license_normalized: cc-by-nc

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Gustave Roussy Cancer Campus
Institut Gustave Roussy


title: Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.

acronym: IRIGA

summary:
This study aims to assess the effect of acute inflammation on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age-, sex- and cardiovascular risk factors-matched controls.

The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).

location_facility: Service de Réanimation Chirurgicale - Hôpital de Pontchaillou

location_facility: Unité d'Investigation Clinique - Hôpital de Pontchaillou


title: Multicentre, Randomized, Placebo-controlled, Double-blind, Phase I/IIa Dose-escalation Clinical Study of a Therapeutic Vaccine (VAC-3S) Intended to Confer Protection Against Immunopathological Effects of HIV-1 in Infected Patients

summary: The purpose of this trial is to evaluate the safety and immunogenicity of the therapeutic vaccine candidate VAC-3S in HIV-1 infected patients under AntiRetroviral Therapy (ART) with undetectable viral loads.

lead_sponsor: InnaVirVax

location_facility:
CIC Cochin Pasteur
Hopital Pitie Salpetriere

intervention_type: Biological


title: Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients

acronym: GLITTER

summary:
Diabetes after kidney transplantation is a frequent complication, the incidence of which varies from 7 to 45% depending on the studies and on the diagnostic criteria used. Post-transplant diabetes is an early complication, most often occurring in the first month after transplantation.

In addition to the additional health costs generated by the appearance of post-transplant diabetes, the risk of graft loss is increased by 60% and the overall mortality risk by 90%. Similarly, the development of glucose intolerance after transplantation is associated with higher mortality.

Tacrolimus treatment is therefore currently one of the most important risk factors for diabetes at the time of transplantation.

Indeed, several in vitro and in vivo animal studies have shown that tacrolimus alters pancreatic endocrine function.

In the final stage, this cellular toxicity leads to diabetes, most often diagnosed on the rise in capillary or venous blood sugar levels after transplantation. This diabetes often requires hypoglycemic treatment with insulin or oral anti-diabetic drugs. for a variable period. The pro-diabetogenic effect of tacrolimus is sometimes irreversible, justifying preventive treatment.

No clinical studies have looked at "sub-clinical" changes in insulin secretion or insulin resistance under tacrolimus prior to the onset of diabetes. The static indices HOMA-β% and HOMA-IR (Homeostasis Model Accessment of insulin resistance) make it possible to estimate insulin secretion and insulin resistance in fasting patients respectively, while the oral glucose disposition index (IDO) makes it possible to study insulin secretion and action dynamically (after a 75 g glucose load), and are calculated as follows:

HOMA IR= Fasting blood glucose (mmol/L) x Fasting insulin (mU/L)/ 22.5 HOMAβ% = 20 x fasting insulinemia (mU/L) / fasting plasma glucose (mmol/L) - 3.5 IDO = (delta insulinemia T30-T0/ delta blood glucose T30-T0)/insulinemia T0

These indices have already been studied in dialysis patients (diabetic and non-diabetic) and may allow a more detailed study of pancreatic response and insulin resistance under tacrolimus in patients prior to renal transplantation. Determining the "pancreatic response" to tacrolimus in patients prior to transplantation would prevent diabetes by adapting immunosuppressive treatment and post-transplant screening modalities in the event of pre-transplant subclinical abnormalities identified in our study. The development of tacrolimus-induced diabetes in pre-transplantation in our study will be a contraindication to tacrolimus at the time of transplantation and ciclosporin therapy will be preferred.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Centre Hospitalier Universitaire Nantes
Centre Hospitalier Départemental Vendée


title: Phase-3 Study, Randomized, Controlled, Multi-center, Double Blind, Comparing Palliative Radiotherapy With or Without Carboplatin

acronym: METAXIOM

summary:
The study population has locally advanced or metastatic bronchial or head and neck cancer.

This study assesses the value of concomitant chemo/radiotherapy with carboplatin daily during metastatic radiotherapy versus radiotherapy alone.

The realization of a systemic treatment during the radiotherapy could make it possible to obtain a benefit on the control of the evolution of the metastases and thus of the pains generated, as well as on the quality of life of the patients. In addition, a benefit in overall survival is possible.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Fabrice Denis
Institut de Cancérologie de l'Ouest

intervention_type: Combination Product


title: The ANTARCTIC Study - Assessment of a Normal Versus Tailored Dose of Prasugrel After Stenting in Patients Aged > 75 Years to Reduce the Composite of Bleeding, Stent Thrombosis and Ischemic Complications

acronym: ANTARCTIC

summary: The purpose of this study is to demonstrate the superiority of a strategy of platelet monitoring (Monitoring Arm) with down-adjustment of the dose of prasugrel in high responders and up-adjustment of the dose of prasugrel in low responders as compared to a more conventional strategy of a fixed dose of 5 mg to every patient without monitoring (Conventional Arm) as measured by a reduction in the composite endpoint of, cardiovascular (CV) death, myocardial infarction (MI) , stroke, stent thrombosis (ARC definition type "definite"), urgent revascularisation or bleeding (BARC definition type 2, 3 or 5).

ReferenceType: result

ReferenceCitation: Cayla G, Cuisset T, Silvain J, Leclercq F, Manzo-Silberman S, Saint-Etienne C, Delarche N, Bellemain-Appaix A, Range G, El Mahmoud R, Carrié D, Belle L, Souteyrand G, Aubry P, Sabouret P, du Fretay XH, Beygui F, Bonnet JL, Lattuca B, Pouillot C, Varenne O, Boueri Z, Van Belle E, Henry P, Motreff P, Elhadad S, Salem JE, Abtan J, Rousseau H, Collet JP, Vicaut E, Montalescot G; ANTARCTIC investigators. Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC): an open-label, blinded-endpoint, randomised controlled superiority trial. Lancet. 2016 Oct 22;388(10055):2015-2022. doi: 10.1016/S0140-6736(16)31323-X. Epub 2016 Aug 28.

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Cuisset

full_name: Thomas Cuisset

given: Thomas

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Leclercq

full_name: Florence Leclercq

given: Florence

family: Manzo-Silberman

full_name: Stephane Manzo-Silberman

given: Stephane

family: Saint-Etienne

full_name: Christophe Saint-Etienne

given: Christophe

family: Delarche

full_name: Nicolas Delarche

given: Nicolas

family: Bellemain-Appaix

full_name: Anne Bellemain-Appaix

given: Anne

family: Range

full_name: Grégoire Range

given: Grégoire

family: El Mahmoud

full_name: Rami El Mahmoud

given: Rami

family: Carrié

full_name: Didier Carrié

given: Didier

family: Belle

full_name: Loic Belle

given: Loic

family: Souteyrand

full_name: Geraud Souteyrand

given: Geraud

family: Aubry

full_name: Pierre Aubry

given: Pierre

family: Sabouret

full_name: Pierre Sabouret

family: du Fretay

full_name: Xavier Halna du Fretay

given: Xavier Halna

family: Beygui

full_name: Farzin Beygui

given: Farzin

family: Bonnet

full_name: Jean-Louis Bonnet

given: Jean-Louis

family: Lattuca

full_name: Benoit Lattuca

given: Benoit

family: Pouillot

full_name: Christophe Pouillot

family: Varenne

full_name: Olivier Varenne

given: Olivier

family: Boueri

full_name: Ziad Boueri

given: Ziad

family: Van Belle

full_name: Eric Van Belle

ReferenceCitation: Lattuca B, Cayla G, Silvain J, Cuisset T, Leclercq F, Manzo-Silberman S, Saint-Etienne C, Delarche N, El Mahmoud R, Carrié D, Souteyrand G, Kerneis M, Hauguel-Moreau M, Zeitouni M, Guedeney P, Diallo A, Collet JP, Vicaut E, Montalescot G; ACTION Study Group. Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial. Am J Cardiovasc Drugs. 2021 Nov;21(6):681-691. doi: 10.1007/s40256-021-00468-8. Epub 2021 Jun 30.

journal_name: American Journal of Cardiovascular Drugs

ReferenceCitation: Cayla G, Cuisset T, Silvain J, Henry P, Leclercq F, Carrié D, Etienne CS, Belle L, Rangé G, Pouillot C, Varenne O, Van Belle E, Boueri Z, Motreff P, Elhadad S, Delarche N, El Mahmoud R, Vicaut E, Collet JP, Montalescot G; ANTARCTIC investigators. Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome: design of the randomized antarctic study. Am Heart J. 2014 Nov;168(5):674-81. doi: 10.1016/j.ahj.2014.07.026. Epub 2014 Aug 7.

title: Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome: Design of the randomized antarctic study

location_facility: CHU Caremeau à Nimes - Service de Cardiologie

location_facility: ACTION study group - Institut de Cardiologie- Hôpital la Pitié Salpêtrière


title: Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery

summary: The main objective is to demonstrate that postoperative analgesia by IV oxycodone (compared to morphine IV) reduces opioid-related adverse events (nausea, vomiting, pruritus, respiratory depression, urinary retention, allergies, hallucination) by 50% in adult patients operated on for prosthetic hip surgery.

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière


title: Randomized, Double-blind, Placebo-controlled Sequential Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SCYX-7158 After Single Oral Ascending Doses in Healthy Male Volunteers

summary: This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, SCYX-7158 shows highly promising efficacy.

lead_sponsor: Drugs for Neglected Diseases

location_facility:
SGS Aster
Optimed


title: Cognitive and Emotional Disorders in Amyotrophic Lateral Sclerosis : Neuropsychological, Imaging and Neuropathological Study

acronym: SLAMEM

summary: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that involves not only motor structures, as was previously thought, but also brain areas dealing with cognition as well as parts of the limbic system. Clinical, imaging and pathological evidence suggests that ALS and fronto-temporal dementia (FTD) have several features in common, and that these two diseases could be the two ends of a pathological continuum.

lead_sponsor: University Hospital, Caen


title: Etude de l'efficacité et de la sécurité d'Injections Intra-sphinctériennes de Myoblastes Autologues Chez Des Patients Atteints d'Incontinence Anale sévère Par Insuffisance sphinctérienne

acronym: MIAS

summary: This project aims to offer autologous muscle-derived progenitor cell injection as an efficient mini-invasive surgical therapy that would be simple for the patient and could be used in a majority of cases, including in young women in the post-partum. This approach may provide efficient tissue repair of the striated anal sphincter which is not permitted by existing therapies. This innovative therapy may ultimately be proposed after failure of the common treatments and before an high-risk invasive surgical intervention. Besides, injection of muscle-derived progenitor cells in animals has shown very encouraging results of the sphincter function assessed ex vivo. Hence, a high benefit may be expected with this approach.

ReferenceCitation: Bisson A, Le Corre S, Joly-Helas G, Chambon P, Demoulins L, Jean L, Adriouch S, Drouot L, Giverne C, Roussel F, Jacquot S, Doucet C, Michot F, Lamacz M, Frébourg T, Flaman JM, Boyer O. Chromosomal instability but lack of transformation in human myoblast preparations. Cell Transplant. 2014;23(12):1475-87. doi: 10.3727/096368913X670192.

name: Normandy University, IRIB, Rouen, France

family: Bisson

full_name: Aurélie Bisson

given: Aurélie

name: Rouen University Hospital, Laboratory of Biotherapy, Rouen, France

family: Le Corre

full_name: Stéphanie Le Corre

given: Stéphanie

name: Rouen University Hospital, Department of Cytogenetics, Rouen, France

family: Joly-Helas

full_name: Géraldine Joly-Helas

given: Géraldine

family: Chambon

full_name: Pascal Chambon

given: Pascal

family: Demoulins

full_name: Laetitia Demoulins

given: Laetitia

family: Jean

full_name: Laetitia Jean

family: Adriouch

full_name: Sahil Adriouch

given: Sahil

family: Drouot

full_name: Laurent Drouot

given: Laurent

family: Giverne

full_name: Camille Giverne

given: Camille

name: Rouen University Hospital, Department of Pathology, Rouen, France

family: Roussel

full_name: Francis Roussel

given: Francis

family: Jacquot

full_name: Serge Jacquot

given: Serge

family: Doucet

full_name: Christelle Doucet

given: Christelle

name: Rouen University Hospital, Department of Digestive Surgery, Rouen, France

family: Michot

full_name: Francis Michot

family: Lamacz

full_name: Marek Lamacz

given: Marek

name: Rouen University Hospital, Department of Genetics, Rouen, France

family: Frébourg

full_name: Thierry Frébourg

given: Thierry

family: Flaman

full_name: Jean-Michel Flaman

given: Jean-Michel

family: Boyer

full_name: Olivier Boyer

journal_name: Cell Transplantation

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Chromosomal Instability but Lack of Transformation in Human Myoblast Preparations

lead_sponsor: University Hospital, Rouen

location_facility:
Rouen University Hospital
MICHOT


title: Research of Predictive Clinical and Biological Parameters in Breast Cancer

acronym: BC-BIO

summary:
Research of predictive clinical and biological factors in breast cancer :

genomic, proteomic, mutation

ReferenceCitation: Gonçalves A, Bertucci F, Guille A, Garnier S, Adelaide J, Carbuccia N, Cabaud O, Finetti P, Brunelle S, Piana G, Tomassin-Piana J, Paciencia M, Lambaudie E, Popovici C, Sabatier R, Tarpin C, Provansal M, Extra JM, Eisinger F, Sobol H, Viens P, Lopez M, Ginestier C, Charafe-Jauffret E, Chaffanet M, Birnbaum D. Targeted NGS, array-CGH, and patient-derived tumor xenografts for precision medicine in advanced breast cancer: a single-center prospective study. Oncotarget. 2016 Nov 29;7(48):79428-79441. doi: 10.18632/oncotarget.12714.

name: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France

name: Aix Marseille Univ, CNRS U7258, INSERM U1068, Institut Paoli-Calmettes, CRCM, Marseille, France

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

name: Department of Molecular Oncology, Institut Paoli-Calmettes, Marseille, France

family: Bertucci

full_name: François Bertucci

given: François

family: Guille

full_name: Arnaud Guille

given: Arnaud

family: Garnier

full_name: Severine Garnier

given: Severine

family: Adelaide

full_name: José Adelaide

given: José

family: Carbuccia

full_name: Nadine Carbuccia

given: Nadine

family: Cabaud

full_name: Oliver Cabaud

given: Oliver

family: Finetti

full_name: Pascal Finetti

name: Department of Imaging, Institut Paoli-Calmettes, Marseille, France

family: Brunelle

full_name: Serge Brunelle

family: Piana

full_name: Gilles Piana

given: Gilles

name: Department of Biopathology, Institut Paoli-Calmettes, Marseille, France

family: Tomassin-Piana

full_name: Jeanne Tomassin-Piana

given: Jeanne

family: Paciencia

full_name: Maria Paciencia

given: Maria

name: Department of Surgical Oncology, Institut Paoli-Calmettes, Marseille, France

family: Lambaudie

full_name: Eric Lambaudie

given: Eric

name: Department of Oncogenetics, Institut Paoli-Calmettes, Marseille, France

family: Popovici

full_name: Cornel Popovici

given: Cornel

family: Sabatier

full_name: Renaud Sabatier

given: Renaud

family: Tarpin

full_name: Carole Tarpin

given: Carole

family: Provansal

full_name: Magali Provansal

given: Magali

family: Extra

full_name: Jean-Marc Extra

given: Jean-Marc

family: Eisinger

full_name: François Eisinger

family: Sobol

full_name: Hagay Sobol

given: Hagay

family: Viens

full_name: Patrice Viens

given: Patrice

family: Lopez

full_name: Marc Lopez

given: Marc

family: Ginestier

full_name: Christophe Ginestier

given: Christophe

family: Charafe-Jauffret

location_facility:
Hôpital Sainte-Musse
Institut Paoli Calmettes


title: Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).

acronym: ReSTIM

summary:
Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.

This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.

ReferenceCitation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11:CD009645. doi: 10.1002/14651858.CD009645.pub4.

name: Department of Public Health; Dresden Medical School, Technical University Dresden; Dresden Germany

name: Department of Physiotherapy; SRH Hochschule für Gesundheit Gera; 07548 Gera Germany

family: Elsner

full_name: Bernhard Elsner

given: Bernhard

name: Department of Public Health, Dresden Medical School; Technical University Dresden; Dresden Germany

family: Kugler

full_name: Joachim Kugler

given: Joachim

name: Neurological Rehabilitation; Helios Klinik Schloss Pulsnitz; Pulsnitz Germany

family: Pohl

full_name: Marcus Pohl

given: Marcus

family: Mehrholz

full_name: Jan Mehrholz

given: Jan

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon- Hôpital Henry Gabrielle-Service de Médecine Physique et Réadaptation

location_facility: Centre de Lay-Saint-Christophe-Institut Régional de Médecine Physique et de Réadaptation


title: An Open-label, Single Arm, Monocentric, Phase I/II Clinical Study of Intracerebral Administration of Adeno-associated Viral Vector Serotype 10 Carrying the Human SGSH and SUMF1 cDNAs for the Treatment of Sanfilippo Type A Syndrome.

summary:
The clinical trial P1-SAF-301 is an open-label, single arm, monocentric, phase I/II clinical study evaluating the tolerance and the safety of intracerebral administration of adeno-associated viral vector serotype 10 carrying the human SGSH and SUMF1 cDNAs for the treatment of Sanfilippo type A syndrome The treatment plan consists on a direct injection of the investigational medicinal product SAF-301 to both sides of the brain through 6 image-guided tracks, with 2 deposits per track, in a single neurosurgical session.

The primary objective is to assess the tolerance and the safety associated to the proposed treatment through a one-year follow up.

The secondary objective is to collect data to define exploratory tests that could become evaluation criteria for further clinical phase III efficacy studies.

Four patients will be included in the clinical trial and will be followed during one year.

The enrollment and the follow-up of the patients will take place at Bicêtre Hospital. The Neurosurgery will be performed at Necker-Enfants Malades Hospital.

Safety will be evaluating on clinical, radiological and biological parameters.

lead_sponsor: LYSOGENE

location_facility: Hôpital Necker, Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris

intervention_type: Genetic


title: Effects of 15-day Donepezil and Memantine on Cognitive Functions After a 24 Hours Sleep Deprivation Challenge in Healthy Volunteers: a Double-blind, Placebo-controlled, Randomised, Cross-over Study, With Modafinil as Positive Control

summary: The aim of this study is to assess the utility of sleep deprivation as a potential model for prediction of clinical efficacy using a combination of cognitive physiological endpoints.

lead_sponsor: Qualissima

location_facility: MEDES CIC


title: Assessment of Gastrointestinal Symptoms and Health-related Quality of Life in Healthy People and Patients With Irritable Bowel Syndrome

summary: The aim of this study performed in Irritable Bowel Syndrome (IBS) subjects and healthy patients is to demonstrate the ability of composite score of frequency of gastrointestinal symptoms to discriminate healthy subjects and IBS patients. The properties of this questionnaire of composite score of gastrointestinal symptoms frequency will be compared to other validated questionnaires (severity of IBS symptoms and HRQoL).

ReferenceCitation: Azpiroz F, Guyonnet D, Donazzolo Y, Gendre D, Tanguy J, Guarner F. Digestive Symptoms in Healthy People and Subjects With Irritable Bowel Syndrome: Validation of Symptom Frequency Questionnaire. J Clin Gastroenterol. 2015 Aug;49(7):e64-70. doi: 10.1097/MCG.0000000000000178.

family: Azpiroz

full_name: Fernando Azpiroz

given: Fernando

family: Guyonnet

full_name: Denis Guyonnet

given: Denis

family: Donazzolo

full_name: Yves Donazzolo

given: Yves

family: Gendre

full_name: David Gendre

given: David

family: Tanguy

full_name: Jérôme Tanguy

given: Jérôme

family: Guarner

full_name: Francisco Guarner

given: Francisco

journal_name: Journal of Clinical Gastroenterology

oa_host_type: repository

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

lead_sponsor: Danone Research

location_facility:
Eurofins Optimed
Biofortis


title: Pilot Study on Efficacy and Tolerance of Intravitreous Injection of Ranibizumab (Lucentis®) in Early-onset Central Retinal Vein Occlusion in Comparison to Hemodilution Using Erythrocytapheresis

summary: The purpose of this study is to compare ranibizumab injection to hemodilution at the early phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both treatments may have a synergic effect.

ReferenceCitation: Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faÿsse M, Coscas G, Soubrane G, Souied E. Hemodilution therapy using automated erythrocytapheresis in central retinal vein occlusion: results of a multicenter randomized controlled study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):505-12. doi: 10.1007/s00417-010-1532-5. Epub 2010 Oct 17.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Pitie-Salpetriere Hospital
Intercommunal Hospital


title: Study of the Response to a Neoadjuvant Chemotherapy Based on the Antitumor Immune Response in Localized Breast Cancer

acronym: BREAST IMMUN

summary:
This is a prospective, non-randomized study which aims to evaluate the response to a neoadjuvant chemotherapy according to the the antitumor immune response in localized breast cancer.

40 patients will be enrolled in the study. They will receive chemotherapy : 3 or 4 anthracycline cycles or 3 or 4 FEC-100 cycles followed by 3 or 4 taxane cycles.

Trastuzumab will be added to taxane for HER2+/Neu+ patients. Then, patients will be operated and receive an adjuvant treatment which will both depend on the investigator's appreciation.

Blood sample will be collected on the first day of the first chemotherapy cycle, on the first day of the third cycle, on surgery, 6 months after the surgery and in case of relapse.

Tumor sample will be collected on diagnosis as much as possible and on surgery.

Patients will be followed during 5 years.

status: Active, not recruiting

ReferenceCitation: Apetoh L, Ghiringhelli F, Tesniere A, Obeid M, Ortiz C, Criollo A, Mignot G, Maiuri MC, Ullrich E, Saulnier P, Yang H, Amigorena S, Ryffel B, Barrat FJ, Saftig P, Levi F, Lidereau R, Nogues C, Mira JP, Chompret A, Joulin V, Clavel-Chapelon F, Bourhis J, André F, Delaloge S, Tursz T, Kroemer G, Zitvogel L. Toll-like receptor 4-dependent contribution of the immune system to anticancer chemotherapy and radiotherapy. Nat Med. 2007 Sep;13(9):1050-9. Epub 2007 Aug 19.

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ReferenceCitation: Bates GJ, Fox SB, Han C, Leek RD, Garcia JF, Harris AL, Banham AH. Quantification of regulatory T cells enables the identification of high-risk breast cancer patients and those at risk of late relapse. J Clin Oncol. 2006 Dec 1;24(34):5373-80.

ReferenceCitation: Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. Epub 2006 Apr 10.

ReferenceCitation: Blay JY, Chauvin F, Le Cesne A, Anglaret B, Bouhour D, Lasset C, Freyer G, Philip T, Biron P. Early lymphopenia after cytotoxic chemotherapy as a risk factor for febrile neutropenia. J Clin Oncol. 1996 Feb;14(2):636-43.

ReferenceCitation: Borg C, Ray-Coquard I, Philip I, Clapisson G, Bendriss-Vermare N, Menetrier-Caux C, Sebban C, Biron P, Blay JY. CD4 lymphopenia as a risk factor for febrile neutropenia and early death after cytotoxic chemotherapy in adult patients with cancer. Cancer. 2004 Dec 1;101(11):2675-80.

ReferenceCitation: Chapman C, Murray A, Chakrabarti J, Thorpe A, Woolston C, Sahin U, Barnes A, Robertson J. Autoantibodies in breast cancer: their use as an aid to early diagnosis. Ann Oncol. 2007 May;18(5):868-73. Epub 2007 Mar 7.

ReferenceCitation: Disis ML, Knutson KL, Schiffman K, Rinn K, McNeel DG. Pre-existent immunity to the HER-2/neu oncogenic protein in patients with HER-2/neu overexpressing breast and ovarian cancer. Breast Cancer Res Treat. 2000 Aug;62(3):245-52.

ReferenceCitation: Domschke C, Schuetz F, Ge Y, Seibel T, Falk C, Brors B, Vlodavsky I, Sommerfeldt N, Sinn HP, Kühnle MC, Schneeweiss A, Scharf A, Sohn C, Schirrmacher V, Moldenhauer G, Momburg F, Beckhove P. Intratumoral cytokines and tumor cell biology determine spontaneous breast cancer-specific immune responses and their correlation to prognosis. Cancer Res. 2009 Nov 1;69(21):8420-8. doi: 10.1158/0008-5472.CAN-09-1627. Epub 2009 Oct 20.

ReferenceCitation: Fan C, Oh DS, Wessels L, Weigelt B, Nuyten DS, Nobel AB, van't Veer LJ, Perou CM. Concordance among gene-expression-based predictors for breast cancer. N Engl J Med. 2006 Aug 10;355(6):560-9.

ReferenceCitation: Gückel B, Rentzsch C, Nastke MD, Marmé A, Gruber I, Stevanović S, Kayser S, Wallwiener D. Pre-existing T-cell immunity against mucin-1 in breast cancer patients and healthy volunteers. J Cancer Res Clin Oncol. 2006 Apr;132(4):265-74. Epub 2005 Dec 22.

ReferenceCitation: Loprinzi CL, Thomé SD. Understanding the utility of adjuvant systemic therapy for primary breast cancer. J Clin Oncol. 2001 Feb 15;19(4):972-9.

ReferenceCitation: Ray-Coquard I, Ghesquière H, Bachelot T, Borg C, Biron P, Sebban C, LeCesne A, Chauvin F, Blay JY; ELYPSE Study Group. Identification of patients at risk for early death after conventional chemotherapy in solid tumours and lymphomas. Br J Cancer. 2001 Sep 14;85(6):816-22.

ReferenceCitation: Remontet L, Estève J, Bouvier AM, Grosclaude P, Launoy G, Menegoz F, Exbrayat C, Tretare B, Carli PM, Guizard AV, Troussard X, Bercelli P, Colonna M, Halna JM, Hedelin G, Macé-Lesec'h J, Peng J, Buemi A, Velten M, Jougla E, Arveux P, Le Bodic L, Michel E, Sauvage M, Schvartz C, Faivre J. Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):3-30.

ReferenceCitation: Rentzsch C, Kayser S, Stumm S, Watermann I, Walter S, Stevanoviç S, Wallwiener D, Gückel B. Evaluation of pre-existent immunity in patients with primary breast cancer: molecular and cellular assays to quantify antigen-specific T lymphocytes in peripheral blood mononuclear cells. Clin Cancer Res. 2003 Oct 1;9(12):4376-86.

ReferenceCitation: Rosenberg SA. Shedding light on immunotherapy for cancer. N Engl J Med. 2004 Apr 1;350(14):1461-3. Review.

ReferenceCitation: Sakaguchi S. Naturally arising CD4+ regulatory t cells for immunologic self-tolerance and negative control of immune responses. Annu Rev Immunol. 2004;22:531-62. Review.

ReferenceCitation: Thomachot MC, Bendriss-Vermare N, Massacrier C, Biota C, Treilleux I, Goddard S, Caux C, Bachelot T, Blay JY, Menetrier-Caux C. Breast carcinoma cells promote the differentiation of CD34+ progenitors towards 2 different subpopulations of dendritic cells with CD1a(high)CD86(-)Langerin- and CD1a(+)CD86(+)Langerin+ phenotypes. Int J Cancer. 2004 Jul 10;110(5):710-20.

ReferenceCitation: Treilleux I, Blay JY, Bendriss-Vermare N, Ray-Coquard I, Bachelot T, Guastalla JP, Bremond A, Goddard S, Pin JJ, Barthelemy-Dubois C, Lebecque S. Dendritic cell infiltration and prognosis of early stage breast cancer. Clin Cancer Res. 2004 Nov 15;10(22):7466-74.

ReferenceCitation: van 't Veer LJ, Dai H, van de Vijver MJ, He YD, Hart AA, Mao M, Peterse HL, van der Kooy K, Marton MJ, Witteveen AT, Schreiber GJ, Kerkhoven RM, Roberts C, Linsley PS, Bernards R, Friend SH. Gene expression profiling predicts clinical outcome of breast cancer. Nature. 2002 Jan 31;415(6871):530-6.

ReferenceCitation: van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009.

ReferenceCitation: Zitvogel L, Tesniere A, Kroemer G. Cancer despite immunosurveillance: immunoselection and immunosubversion. Nat Rev Immunol. 2006 Oct;6(10):715-27. Epub 2006 Sep 15. Review.

ReferenceCitation: Zou W. Immunosuppressive networks in the tumour environment and their therapeutic relevance. Nat Rev Cancer. 2005 Apr;5(4):263-74. Review.

ReferenceCitation: Obeid M, Tesniere A, Ghiringhelli F, Fimia GM, Apetoh L, Perfettini JL, Castedo M, Mignot G, Panaretakis T, Casares N, Métivier D, Larochette N, van Endert P, Ciccosanti F, Piacentini M, Zitvogel L, Kroemer G. Calreticulin exposure dictates the immunogenicity of cancer cell death. Nat Med. 2007 Jan;13(1):54-61. Epub 2006 Dec 24.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Leon Berard
Centre Georges François Leclerc


title: An Open-Label, Single Arm, Feasibility And Safety Phase I Study With NBTXR3 Intratumor Implantation (By Injection) And Activated By External Beam Radiation Therapy In Patients With Soft Tissue Sarcoma Of The Extremity And Trunk Wall

summary:
RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor.

PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.

lead_sponsor: Nanobiotix

location_facility:
Institut Gustave Roussy
Institut Bergonie


lead_sponsor: University Hospital, Limoges

acronym: PARATRON

location_facility:
Chirurgie Ped
Service Anesthésie

source: euctr

title: Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children

summary: The aim of this study is to demonstrate that the association paracetamol / ondansetron is not as effective as the association paracetamol / droperidol in the treatment of pain in children following tonsillectomy. The secondary objectives are to compare opioid consumption (morphine / codeine) and the cumulated incidence of nausea and vomiting between the two groups of patients in the first 24 hours after


title: Impact Sur le Saignement Per et Post opératoire de 2 stratégies d'ostéosynthèse Des Fractures du Massif trochantérien du Sujet > 65 Ans : Essai randomisé Comparant le système MISS et le système PHS

acronym: MISSvsPHS

summary:
Fractures of the trochanter in the elderly have a terrible prognosis both vital and functional. It is certainly possible to reduce the medical and economic impact of this disease by reducing surgical trauma, by means of minimally invasive osteosynthesis material adapted to this approach. This minimally invasive approach should, however, guarantee a result at least equal to the standard approach. The goal is to have a technique, easily to transmit, using a percutaneous approach, but which may be converted to conventional surgery in case of difficulty, and with implants appropriate for trochanteric fractures.

With this in mind, the dynamic hip screw MISS® (Minimally Invasive Screw System) was developed and has already demonstrated its effectiveness in terms of anatomical results. It is as effective than the PHS® hip screw design for standard approach. The two implants have the same plate and screw and differ only by the system for fixing the screw on the plate to allow minimal invasive approach.

lead_sponsor: University Hospital, Tours

location_facility:
CHU
UH Tours CHRU Trousseau


title: An Open-label, Multi-center Study to Compare the Relative Bioavailability of Tocilizumab in Healthy Subjects Following Single Dose Subcutaneous (SC) Administration Via Disposable Auto-Injector (DAI) Device vs Pre-filled Glass Syringe (PFS)

summary: This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.

lead_sponsor: Hoffmann-La Roche


title: A Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy Subjects

summary: This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.

ReferenceCitation: Derks M, Lennon-Chrimes S, Guenther A, Squassante L, Wandel C, Szczesny P, Paehler A, Kletzl H. Bioavailability and pharmacokinetic profile of balovaptan, a selective, brain-penetrant vasopressin 1a receptor antagonist, in healthy volunteers. Expert Opin Investig Drugs. 2021 Aug;30(8):893-901. doi: 10.1080/13543784.2021.1948009. Epub 2021 Jul 16.

name: Roche Pharma Research & Early Development, Roche Innovation Center Welwyn, Roche Products Ltd, Welwyn Garden City, UK

family: Derks

full_name: Michael Derks

given: Michael

family: Lennon-Chrimes

full_name: Sian Lennon-Chrimes

given: Sian

name: Roche Pharma Research & Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche AG, Basel, Switzerland

family: Guenther

full_name: Andreas Guenther

given: Andreas

family: Squassante

full_name: Lisa Squassante

given: Lisa

family: Wandel

full_name: Christoph Wandel

given: Christoph

family: Szczesny

full_name: Piotr Szczesny

given: Piotr

family: Paehler

full_name: Axel Paehler

given: Axel

family: Kletzl

full_name: Heidemarie Kletzl

given: Heidemarie

journal_name: Expert Opinion on Investigational Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa


title: Exploration of New Biologic Factors' Predictive Value , Especially Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab

acronym: AVECC

summary:
It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response.

Biological factors will be correlated to clinical outcome measures.

100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled.

Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity.

Bevacizumab will be administered according to investigators appreciation.

Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.

ReferenceCitation: Bouvier AM, Remontet L, Jougla E, Launoy G, Grosclaude P, Buémi A, Tretarre B, Velten M, Dancourt V, Menegoz F, Guizard AV, Macé Lesec'h J, Peng J, Bercelli P, Arveux P, Estève J, Faivre J. Incidence of gastrointestinal cancers in France. Gastroenterol Clin Biol. 2004 Oct;28(10 Pt 1):877-81.

ReferenceCitation: Weitz J, Koch M, Debus J, Höhler T, Galle PR, Büchler MW. Colorectal cancer. Lancet. 2005 Jan 8-14;365(9454):153-65. Review.

ReferenceCitation: Kozloff M, Yood MU, Berlin J, Flynn PJ, Kabbinavar FF, Purdie DM, Ashby MA, Dong W, Sugrue MM, Grothey A; Investigators of the BRiTE study. Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: the BRiTE observational cohort study. Oncologist. 2009 Sep;14(9):862-70. doi: 10.1634/theoncologist.2009-0071. Epub 2009 Sep 2.

ReferenceCitation: Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pintér T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Köhne

full_name: Claus-Henning Köhne

given: Claus-Henning

family: Hitre

full_name: Erika Hitre

given: Erika

family: Zaluski

full_name: Jerzy Zaluski

given: Jerzy

family: Chang Chien

full_name: Chung-Rong Chang Chien

given: Chung-Rong

family: Makhson

full_name: Anatoly Makhson

given: Anatoly

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Pintér

full_name: Tamás Pintér

given: Tamás

family: Lim

full_name: Robert Lim

given: Robert

family: Bodoky

full_name: György Bodoky

given: György

family: Roh

full_name: Jae Kyung Roh

given: Jae Kyung

family: Folprecht

full_name: Gunnar Folprecht

given: Gunnar

family: Ruff

full_name: Paul Ruff

given: Paul

family: Stroh

full_name: Christopher Stroh

given: Christopher

family: Tejpar

full_name: Sabine Tejpar

given: Sabine

family: Schlichting

full_name: Michael Schlichting

family: Nippgen

full_name: Johannes Nippgen

given: Johannes

family: Rougier

full_name: Philippe Rougier

given: Philippe

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer

ReferenceCitation: Gruenberger B, Tamandl D, Schueller J, Scheithauer W, Zielinski C, Herbst F, Gruenberger T. Bevacizumab, capecitabine, and oxaliplatin as neoadjuvant therapy for patients with potentially curable metastatic colorectal cancer. J Clin Oncol. 2008 Apr 10;26(11):1830-5. doi: 10.1200/JCO.2007.13.7679.

ReferenceCitation: Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005 Jun 1;23(16):3706-12. Epub 2005 May 2.

ReferenceCitation: Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42.

ReferenceCitation: Kabbinavar FF, Schulz J, McCleod M, Patel T, Hamm JT, Hecht JR, Mass R, Perrou B, Nelson B, Novotny WF. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: results of a randomized phase II trial. J Clin Oncol. 2005 Jun 1;23(16):3697-705. Epub 2005 Feb 28.

ReferenceCitation: Saltz LB, Clarke S, Díaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzén F, Cassidy J. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008 Apr 20;26(12):2013-9. doi: 10.1200/JCO.2007.14.9930. Erratum in: J Clin Oncol. 2008 Jun;26(18):3110. J Clin Oncol. 2009 Feb 1;27(4):653.

ReferenceCitation: Jain RK, Duda DG, Willett CG, Sahani DV, Zhu AX, Loeffler JS, Batchelor TT, Sorensen AG. Biomarkers of response and resistance to antiangiogenic therapy. Nat Rev Clin Oncol. 2009 Jun;6(6):327-38. doi: 10.1038/nrclinonc.2009.63. Review.

ReferenceCitation: Jubb AM, Hurwitz HI, Bai W, Holmgren EB, Tobin P, Guerrero AS, Kabbinavar F, Holden SN, Novotny WF, Frantz GD, Hillan KJ, Koeppen H. Impact of vascular endothelial growth factor-A expression, thrombospondin-2 expression, and microvessel density on the treatment effect of bevacizumab in metastatic colorectal cancer. J Clin Oncol. 2006 Jan 10;24(2):217-27. Epub 2005 Dec 19.

ReferenceCitation: Burstein HJ, Chen YH, Parker LM, Savoie J, Younger J, Kuter I, Ryan PD, Garber JE, Chen H, Campos SM, Shulman LN, Harris LN, Gelman R, Winer EP. VEGF as a marker for outcome among advanced breast cancer patients receiving anti-VEGF therapy with bevacizumab and vinorelbine chemotherapy. Clin Cancer Res. 2008 Dec 1;14(23):7871-7. doi: 10.1158/1078-0432.CCR-08-0593.

ReferenceCitation: Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD; ECOG 2100. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008 Oct 1;26(28):4672-8. doi: 10.1200/JCO.2008.16.1612. Erratum in: J Clin Oncol. 2009 Jun 20;27(18):3070.

ReferenceCitation: Willett CG, Boucher Y, di Tomaso E, Duda DG, Munn LL, Tong RT, Chung DC, Sahani DV, Kalva SP, Kozin SV, Mino M, Cohen KS, Scadden DT, Hartford AC, Fischman AJ, Clark JW, Ryan DP, Zhu AX, Blaszkowsky LS, Chen HX, Shellito PC, Lauwers GY, Jain RK. Direct evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat Med. 2004 Feb;10(2):145-7. Epub 2004 Jan 25. Erratum in: Nat Med. 2004 Jun;10(6):649.

ReferenceCitation: Corada M, Zanetta L, Orsenigo F, Breviario F, Lampugnani MG, Bernasconi S, Liao F, Hicklin DJ, Bohlen P, Dejana E. A monoclonal antibody to vascular endothelial-cadherin inhibits tumor angiogenesis without side effects on endothelial permeability. Blood. 2002 Aug 1;100(3):905-11.

ReferenceCitation: Gory-Fauré S, Prandini MH, Pointu H, Roullot V, Pignot-Paintrand I, Vernet M, Huber P. Role of vascular endothelial-cadherin in vascular morphogenesis. Development. 1999 May;126(10):2093-102.

ReferenceCitation: Wallez Y, Vilgrain I, Huber P. Angiogenesis: the VE-cadherin switch. Trends Cardiovasc Med. 2006 Feb;16(2):55-9. Review.

ReferenceCitation: Wallez Y, Cand F, Cruzalegui F, Wernstedt C, Souchelnytskyi S, Vilgrain I, Huber P. Src kinase phosphorylates vascular endothelial-cadherin in response to vascular endothelial growth factor: identification of tyrosine 685 as the unique target site. Oncogene. 2007 Feb 15;26(7):1067-77. Epub 2006 Aug 14.

location_facility:
Centre Léon Bérard
Hôpital Privé Jean Mermoz


title: Assessment of the Evolution of Macular Pigment Density in Two Distinct Populations, Before and After Supplementation With Nutrof Total Versus Dietary Supplement Without Lutein and Zeaxanthin, Using the Macular Pigment Module of Visucam 200 or Visucam 500 (Zeiss).

summary:
•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An increase in macular pigment following dietary supplementation with lutein and zeaxanthin could allow early treatment with such supplements in subjects with a high risk of AMD, and encourage them to change their eating habits.

•Primary outcome:

Comparative analysis of the density and evolution of the density of macular pigment:

In patients without any retinal pathology who underwent cataract surgery 1 month previously

In the non-exudative eye of patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye

Secondary outcomes:

Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator):

Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements)

Time taken to return to the baseline macular pigment density after cessation of supplementation

Study design :

Pilot study -Prospective, randomised, double-masked, comparative, multicenter.

ReferenceCitation: Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

ReferenceCitation: Delcourt C. Epidémiologie de la DMLA dans la population française. In: Soubrane G, Coscas G, Souied EH, editors. Les DMLAs (9ème édition). Rapport de la Société Française d'Ophtalmologie. Paris: Masson; 2007. p. 108-110.

ReferenceCitation: Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008 Jun 12;358(24):2606-17. doi: 10.1056/NEJMra0801537. Review. Erratum in: N Engl J Med. 2008 Oct 16;359(16): 1736.

ReferenceCitation: Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001 Oct;119(10):1417-36. Erratum in: Arch Ophthalmol. 2008 Sep;126(9):1251.

ReferenceCitation: Whitehead AJ, Mares JA, Danis RP. Macular pigment: a review of current knowledge. Arch Ophthalmol. 2006 Jul;124(7):1038-45. Review.

ReferenceCitation: Antioxidant status and neovascular age-related macular degeneration. Eye Disease Case-Control Study Group. Arch Ophthalmol. 1993 Jan;111(1):104-9. Erratum in: Arch Ophthalmol 1993 Nov;111(11):1499. Arch Ophthalmol 1993 Sep;111(9):1228, 1993 Oct;111(10):1366.

ReferenceCitation: Gale CR, Hall NF, Phillips DI, Martyn CN. Lutein and zeaxanthin status and risk of age-related macular degeneration. Invest Ophthalmol Vis Sci. 2003 Jun;44(6):2461-5.

ReferenceCitation: Delcourt C, Carrière I, Delage M, Barberger-Gateau P, Schalch W; POLA Study Group. Plasma lutein and zeaxanthin and other carotenoids as modifiable risk factors for age-related maculopathy and cataract: the POLA Study. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2329-35.

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

ReferenceCitation: Cho E, Hankinson SE, Rosner B, Willett WC, Colditz GA. Prospective study of lutein/zeaxanthin intake and risk of age-related macular degeneration. Am J Clin Nutr. 2008 Jun;87(6):1837-43.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

lead_sponsor: Affordance

location_facility:
Centre ophtalmologique Rabelais
Docteur Jean-Jacques Masella

intervention_type: Dietary Supplement


title: Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure : a Prospective, Randomized, Double-blind, Cross-over Study

acronym: CITRUGRELE 2

summary: The specific aim of this study is to determine whether oral citrulline administration enhances whole body protein synthesis in patients with intestinal failure. Protein metabolism will be assessed using an intravenous infusion of stable isotope labeled leucine. The investigators hypothesize that citrulline supplementation will decrease leucine oxidation without altering proteolysis, and consequently stimulate protein synthesis.

ReferenceCitation: Jirka A, Layec S, Picot D, Bernon-Ferreira S, Grasset N, Flet L, Thibault R, Darmaun D. Effect of oral citrulline supplementation on whole body protein metabolism in adult patients with short bowel syndrome: A pilot, randomized, double-blind, cross-over study. Clin Nutr. 2019 Dec;38(6):2599-2606. doi: 10.1016/j.clnu.2018.12.030. Epub 2019 Jan 2.

family: Jirka

full_name: Adam Jirka

given: Adam

family: Layec

full_name: Sabrina Layec

given: Sabrina

family: Picot

full_name: Denis Picot

given: Denis

family: Bernon-Ferreira

full_name: Silvia Bernon-Ferreira

given: Silvia

family: Grasset

full_name: Nadège Grasset

given: Nadège

family: Flet

full_name: Laurent Flet

given: Laurent

family: Thibault

full_name: Ronan Thibault

given: Ronan

family: Darmaun

full_name: Dominique Darmaun

given: Dominique

journal_name: Clinical Nutrition

version: submittedVersion

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

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

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
Clinique Saint Yves


title: Phase II Multicentric, Randomized Trial, Exploring Intensified Rituximab Prephase Monotherapy Before Standard Fludarabine-Cyclophosphamide-Rituximab Regimen in Previously Untreated Symptomatic B-cell Chronic Lymphocytic Leukemia

summary:
Phase II, multicenter, randomized trial, exploring intensified Rituximab prephase monotherapy before standard Fludarabine-Cyclophosphamide-Rituximab FC-R regimen in previously untreated symptomatic B-cell chronic lymphocytic leukemia CLL.

A Study from the Goelams GCFLLCMW intergroup

ReferenceCitation: Gagez AL, Duroux-Richard I, Leprêtre S, Orsini-Piocelle F, Letestu R, De Guibert S, Tuaillon E, Leblond V, Khalifa O, Gouilleux-Gruart V, Banos A, Tournilhac O, Dupuis J, Jorgensen C, Cartron G, Apparailly F. miR-125b and miR-532-3p predict the efficiency of rituximab-mediated lymphodepletion in chronic lymphocytic leukemia patients. A French Innovative Leukemia Organization study. Haematologica. 2017 Apr;102(4):746-754. doi: 10.3324/haematol.2016.153189. Epub 2017 Jan 25.

family: Gagez

full_name: Anne-Laure Gagez

given: Anne-Laure

family: Duroux-Richard

full_name: Isabelle Duroux-Richard

given: Isabelle

family: Leprêtre

full_name: Stéphane Leprêtre

given: Stéphane

family: Orsini-Piocelle

full_name: Frédérique Orsini-Piocelle

given: Frédérique

family: Letestu

full_name: Rémi Letestu

given: Rémi

family: De Guibert

full_name: Sophie De Guibert

given: Sophie

family: Tuaillon

full_name: Edouard Tuaillon

given: Edouard

family: Leblond

full_name: Véronique Leblond

given: Véronique

family: Khalifa

full_name: Olfa Khalifa

given: Olfa

family: Gouilleux-Gruart

full_name: Valérie Gouilleux-Gruart

given: Valérie

family: Banos

full_name: Anne Banos

given: Anne

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

family: Dupuis

full_name: Jehan Dupuis

given: Jehan

family: Jorgensen

full_name: Christian Jorgensen

given: Christian

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

family: Apparailly

full_name: Florence Apparailly

given: Florence

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Tout M, Gagez AL, Leprêtre S, Gouilleux-Gruart V, Azzopardi N, Delmer A, Mercier M, Ysebaert L, Laribi K, Gonzalez H, Paintaud G, Cartron G, Ternant D. Influence of FCGR3A-158V/F Genotype and Baseline CD20 Antigen Count on Target-Mediated Elimination of Rituximab in Patients with Chronic Lymphocytic Leukemia: A Study of FILO Group. Clin Pharmacokinet. 2017 Jun;56(6):635-647. doi: 10.1007/s40262-016-0470-8.


title: Study of the Effects in Carbohydrate Metabolism and Renal Function of "in UTERO" Exposure to Glucocorticoids in Adult Offsprings (GLUCODEX)

acronym: GLUCODEX

summary: The main objective of this study is to show that the fetal exposure to excess of glucocorticoids is associated with a deficiency of the function beta insulin in the offspring adult.

ReferenceCitation: Riveline JP, Baz B, Nguewa JL, Vidal-Trecan T, Ibrahim F, Boudou P, Vicaut E, Brac de la Perrière A, Fetita S, Bréant B, Blondeau B, Tardy-Guidollet V, Morel Y, Gautier JF. Exposure to Glucocorticoids in the First Part of Fetal Life is Associated with Insulin Secretory Defect in Adult Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3). pii: dgz145. doi: 10.1210/clinem/dgz145.

name: Department of Diabetes and Endocrinology, Lariboisière Hospital, APHP, Paris, France

name: Paris Diderot- Paris VII University, Paris, France

name: Institut National de la Santé et de la Recherche Médicale (INSERM) UMRS 1138, Université Paris Diderot-Paris VII, Sorbonne Paris Cité, Paris, France

family: Riveline

full_name: Jean-Pierre Riveline

given: Jean-Pierre

family: Baz

full_name: Baz Baz

given: Baz

family: Nguewa

full_name: Jean-Louis Nguewa

given: Jean-Louis

family: Vidal-Trecan

full_name: Tiphaine Vidal-Trecan

given: Tiphaine

name: Unit of Hormonal Biology, Department of Biochemistry, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris (APHP), Paris, France

family: Ibrahim

full_name: Fidaa Ibrahim

given: Fidaa

family: Boudou

full_name: Philippe Boudou

given: Philippe

name: Assistance Publique-Hôpitaux de Paris, Clinical Research Unit, Fernand Widal Hospital, Sorbonne Paris Cité, Paris Diderot University, Paris, France

family: Vicaut

full_name: Eric Vicaut

given: Eric

name: Fédération d’endocrinologie Hopital Louis Pradel Groupement Hospitalier Est 28 av Doyen Lepine BRON

family: Brac de la Perrière

full_name: Aude Brac de la Perrière

given: Aude

family: Fetita

full_name: Sabrina Fetita

given: Sabrina

family: Bréant

full_name: Bernadette Bréant

given: Bernadette

family: Blondeau

full_name: Bertrand Blondeau

given: Bertrand

name: Department of Biochemistry and Molecular Biology, Groupement Hospitalier Est 59 Boulevard Pinel Bron, France

family: Tardy-Guidollet

full_name: Véronique Tardy-Guidollet

family: Morel

full_name: Yves Morel

given: Yves

family: Gautier

full_name: Jean-François Gautier

given: Jean-François

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Professor GAUTIER
Hôpital saint Louis