ReferenceCitation: Moustafa F, Nguyen G, Mathevon T, Baud O, Saint-Denis J, Dublanchet N, Pereira B, Shinjo C, Romaszko JP, Dopeux L, Dutheil F, Schmidt J. Evaluation of the efficacy and tolerance of a short 7 day third-generation cephalosporin treatment in the management of acute pyelonephritis in young women in the emergency department. J Antimicrob Chemother. 2016 Jun;71(6):1660-4. doi: 10.1093/jac/dkw021. Epub 2016 Feb 21.

family: Moustafa

full_name: F. Moustafa

given: F.

family: Nguyen

full_name: G. Nguyen

given: G.

family: Mathevon

full_name: T. Mathevon

given: T.

family: Baud

full_name: O. Baud

given: O.

family: Saint-Denis

full_name: J. Saint-Denis

given: J.

family: Dublanchet

full_name: N. Dublanchet

given: N.

family: Pereira

full_name: B. Pereira

given: B.

family: Shinjo

full_name: C. Shinjo

given: C.

family: Romaszko

full_name: J. P. Romaszko

given: J. P.

family: Dopeux

full_name: L. Dopeux

given: L.

family: Dutheil

full_name: F. Dutheil

family: Schmidt

full_name: J. Schmidt

journal_name: Journal of Antimicrobial Chemotherapy

oa_host_type: publisher

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University Hospital, Clermont-Ferrand

source: euctr

title: Efficacy and Safety Study of Short Term Antibiotic During Seven Days With Ceftriaxone Intravenous the First Day Then Cefixime the Second Day Till the Seventh Day of Acute Uncomplicated Pyelonephritis in Women Between 18 and 65 Years Old

summary:
Urinary tract community infections are one of very frequent reason consultation and prescription. Urinary tract represents the second site of bacterial community infection after the respiratory system. The management of the acute uncomplicated pyelonephritis was simply codified in the past recommendations of the French Agency for Safety Health Products (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.

The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally provides a simplified treatment for patients, a reduced use of fluoroquinolones and a probable decrease in correlation with the emergence of fluoroquinolones resistance, and finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.


type: Registry Identifier

title: Left Ventricular Dyssynchrony: Rest/Stress 3D Blood-Pool Gated D-SPECT Quantification With a High-Speed Dedicated Cardiac Camera Before CRT

summary:
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with advanced heart failure and left ventricular dyssynchrony (LVD). Too many patients do not clinically improve with CRT. New LVD markers other than QRS duration are needed.

Study objective : feasibility assessment of rest and real-time stress 3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel) to quantify LVD.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain

acronym: EPICORE

summary: Our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Procedure

status_simplified: Completed


title: Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)

summary: RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Angers


title: Remote Ischemic Preconditioning in Aortic Valve Surgery (RIP-Valve)

acronym: RIP-Valve

summary: RIP-VALVE is a randomized, single blinded study that will test the hypothesis that remote ischemic preconditioning initiated before surgery reduces post-operative myocardial damage in aortic valve surgery. Infarct size will be determined by 72 hours area under curve of troponin-I.

ReferenceType: derived

ReferenceCitation: Chao de la Barca JM, Bakhta O, Kalakech H, Simard G, Tamareille S, Catros V, Callebert J, Gadras C, Tessier L, Reynier P, Prunier F, Mirebeau-Prunier D. Metabolic Signature of Remote Ischemic Preconditioning Involving a Cocktail of Amino Acids and Biogenic Amines. J Am Heart Assoc. 2016 Sep 24;5(9). pii: e003891.


title: Validation of the French Version of the Back Belief Questionnaire

acronym: BBQ

summary: The goal of this study is to carry out a transcultural validation of the Back Belief Questionnaire in order to assess its appropriateness for French-speaking populations.

status: Terminated

study_type: Observational

time_perspective: Prospective

intervention_type: Other


title: Study of Non Major Microcirculation During Extracorporeal Circulation : Relation Between Endothelial Dysfunction and Digestive

summary:
Digestive tract is supposed to be the motor of multiple organ failure. In ICU patients, mesenteric ischemia appears even when macrocirculatory parameters are controlled especially in our experience in patients coming in ICU after a cardiac surgery. The investigators suppose that microcirculatory failure develops and results in suffering of non major organs like muscle, skin and digestive tracts. In this study the investigators monitor digestive tract with plasmatic IFABP dosage and microcirculatory circulation with NIRS during a VOT and plasma glycocalyx measurements. The population is composed by patients having coronary artery bypass during cardiopulmonary bypass.

The first aim of this study is to show that digestive tract is suffering with the use of extracorporeal circulation and will be assessed with Plasmatic Intestinal Fatty Acid Binding Protein when IFABP will more than 300 pg/ml ; and with citrullinemia when citrullinemia will be less than 20 micromol/L.

The second aim is to investigate link between endothelial dysfunction and digestive tract. Endothelial dysfunction is assessed with tissular oxygen saturation before, during and after a vascular occlusion test of 3 minutes (measurement of basal value, desaturation curve, resaturation curve and hyperemic response by measurement of area under curve). Endothelial glycocalyx and NO pathway will be investigate (see under)

Our objective is to enroll 100 patients. The same study will be done in a group of patients who benefit from coronary artery bypass without extracorporeal circulation to see the effects of extracorporeal circulation support.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Multicentre, Open Label, Phase II Trial to Evaluate the Efficacy and Safety of Treatment With Rituximab in Patients Suffering From Follicular Non-Hodgkin's Lymphoma (FNHL) With Residual Minimal Disease After Autologous Transplantation of hematopoïetic Stem Cell (Bone Marrow or Peripheral Blood)

summary: This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug

lead_sponsor_type: industriel


title: Impact of Donor and Recipient CYP3A5 Genetic Polymorphism on Tacrolimus Exposure in Patients With Hepatic Transplant

summary:
The choice of an immunosuppressant after hepatic transplant is now more difficult than before because of the increasing number of drugs available.

Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best treatment and the best dose for each patient. The genetic polymorphism of enzymes metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5 activity is a major determinant of the dose needed to reach target concentrations. This study is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic polymorphisms on tacrolimus exposure in patients with hepatic transplant.

lead_sponsor: Rennes University Hospital

location_facility: Service des Maladies du Foie - Hôpital de Pontchaillou


title: Comparison of Two Strategies of Hypoglycemia Correction in ICU

summary: Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG and measures of brain electrical activity noninvasively. It has already been shown that its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. It has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. The hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic variation, brain function and hormonal response.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes


title: Evaluation of the Efficacy of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis: Randomized Double-blind Placebo-controlled Trial

acronym: ADJUVITE

summary: The investigators propose to study the efficacy of adalimumab versus placebo (double-blind randomization on inclusion into 2 equal groups) on reduction of ocular inflammation quantified by laser flare photometry after two months of treatment in patients with active uveitis despite well conducted treatment with steroid eye drops and MTX. The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm. Will be considered as responding patients those in whom the evaluated eye, 2 months after inclusion, presents at least 30% reduction of inflammation on laser flare photometry and improvement or a stable appearance on slit lamp examination. After the second month, all patients wishing to continue the trial and presenting a satisfactory clinical state will be treated with adalimumab for a total of one year after inclusion to descriptively evaluate the efficacy and safety of treatment over 10 to 12 months.

ReferenceType: background

ReferenceCitation: Simonini G, Taddio A, Cattalini M, Caputo R, De Libero C, Naviglio S, Bresci C, Lorusso M, Lepore L, Cimaz R. Prevention of flare recurrences in childhood-refractory chronic uveitis: an open-label comparative study of adalimumab versus infliximab. Arthritis Care Res (Hoboken). 2011 Apr;63(4):612-8. doi: 10.1002/acr.20404.

ReferenceCitation: Callejas-Rubio JL, Sánchez-Cano D, Serrano JL, Ortego-Centeno N. Adalimumab therapy for refractory uveitis: a pilot study. J Ocul Pharmacol Ther. 2008 Dec;24(6):613-4; author reply 614. doi: 10.1089/jop.2008.0073.

ReferenceCitation: Tynjälä P, Kotaniemi K, Lindahl P, Latva K, Aalto K, Honkanen V, Lahdenne P. Adalimumab in juvenile idiopathic arthritis-associated chronic anterior uveitis. Rheumatology (Oxford). 2008 Mar;47(3):339-44. doi: 10.1093/rheumatology/kem356. Epub 2008 Jan 31.

ReferenceCitation: Biester S, Deuter C, Michels H, Haefner R, Kuemmerle-Deschner J, Doycheva D, Zierhut M. Adalimumab in the therapy of uveitis in childhood. Br J Ophthalmol. 2007 Mar;91(3):319-24. Epub 2006 Oct 11.

ReferenceCitation: Vazquez-Cobian LB, Flynn T, Lehman TJ. Adalimumab therapy for childhood uveitis. J Pediatr. 2006 Oct;149(4):572-5.

ReferenceCitation: Quartier P, Baptiste A, Despert V, Allain-Launay E, Koné-Paut I, Belot A, Kodjikian L, Monnet D, Weber M, Elie C, Bodaghi B; ADJUVITE Study Group. ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. Ann Rheum Dis. 2018 Jul;77(7):1003-1011. doi: 10.1136/annrheumdis-2017-212089. Epub 2017 Dec 23.

family: Quartier

full_name: Pierre Quartier

given: Pierre

sequence: first

family: Baptiste

full_name: Amandine Baptiste

given: Amandine

sequence: additional

family: Despert

full_name: Véronique Despert

given: Véronique

family: Allain-Launay

full_name: Emma Allain-Launay

given: Emma

family: Koné-Paut

full_name: Isabelle Koné-Paut

given: Isabelle

family: Belot

full_name: Alexandre Belot

given: Alexandre

family: Kodjikian

full_name: Laurent Kodjikian

given: Laurent

family: Monnet

full_name: Dominique Monnet

given: Dominique

family: Weber

full_name: Michel Weber

given: Michel

family: Elie

full_name: Caroline Elie

given: Caroline

family: Bodaghi

full_name: Bahram Bodaghi

given: Bahram

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: EudraCT Number

title: Investigation Drug-drug Interaction Between Dabigatran and Clarithromycin

acronym: IMAGINE

summary: Dabigatran (Pradaxa ®) is a new oral anticoagulant. It is used to prevent venous thromboembolism in orthopedic surgery and has recently demonstrated efficacy and safety at least as good as anticoagulants in the prevention of thromboembolism in atrial fibrillation and the treatment of venous thromboembolism. It is administered with fixed dose and does not require laboratory monitoring because of the low inter and intra individual pharmacokinetic (PK) and pharmacodynamics (PD) of dabigatran. However, the bioavailability of dabigatran is very low (6.5%) and is controlled by an efflux protein, P-GP. This molecule has a genetic polymorphism. The inhibition of this protein can cause a significant increase in intestinal absorption of dabigatran and expose patients to a risk of bleeding by overdose. Two major drug interactions have been identified : quinidine (cons-indication) and amiodarone (precautions). It is likely that other interactions exist and can be clinically significant in patients not selected such as testing. The development of tools to study the influence of P-GP on the PK and PD of dabigatran is therefore interesting. As the P-GP has a genetic polymorphism, the study of the latter is an important element in the detection of drug interactions. In this sense, clarithromycin, a potent inhibitor of P-GP is a good model to evaluate the primary mechanism of drug interaction of dabigatran and optimize the experimental design of studies to be conducted.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist

acronym: IDILIC

summary: This multicenter cluster-randomized trial will evaluate the impact of Crew Resource Management training on the occurrence of postoperative complications and the adherence to a surgical safety checklist, among a large sample of French surgical departments.

ReferenceCitation: Duclos A, Peix JL, Piriou V, Occelli P, Denis A, Bourdy S, Carty MJ, Gawande AA, Debouck F, Vacca C, Lifante JC, Colin C; IDILIC Study Group. Cluster randomized trial to evaluate the impact of team training on surgical outcomes. Br J Surg. 2016 Dec;103(13):1804-1814. doi: 10.1002/bjs.10295. Epub 2016 Sep 19.

name: Pôle Information Médicale Evaluation Recherche, Hospices Civils de Lyon, Lyon, France

name: Health Services and Performance Research Laboratory, Université Claude Bernard Lyon 1, EA, 7425, Lyon, France

name: Center for Surgery and Public Health, Brigham and Women's Hospital – Harvard Medical School, Boston, Massachusetts, USA

family: Duclos

full_name: A Duclos

given: A

name: Service de Chirurgie Générale et Endocrinienne, Pierre Bénite, France

family: Peix

full_name: J L Peix

given: J L

name: Service d'Anesthésie Réanimation Médicale et Chirurgicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Bénite, France

family: Piriou

full_name: V Piriou

given: V

family: Occelli

full_name: P Occelli

given: P

family: Denis

full_name: A Denis

family: Bourdy

full_name: S Bourdy

given: S

family: Carty

full_name: M J Carty

given: M J

name: Ariadne Labs and Harvard Chan School of Public Health, Boston, Massachusetts, USA

family: Gawande

full_name: A A Gawande

given: A A

name: Air France Consulting, AFM42, Chambourcy, France

family: Debouck

full_name: F Debouck

given: F

name: Coordination pour l'Evaluation des Pratiques Professionnelles en Santé en Rhône-Alpes, Lyon, France

family: Vacca

full_name: C Vacca

given: C

family: Lifante

full_name: J C Lifante

given: J C

family: Colin

full_name: C Colin

family: Aegerter

full_name: P Aegerter

family: Aouifi

full_name: A Aouifi

family: Arickx

full_name: D Arickx

given: D

family: Aubart

full_name: F Aubart

family: Baudrin

full_name: D Baudrin

family: Berry

full_name: W R Berry

given: W R

family: Beuvry

full_name: C Beuvry

family: Bonnet

full_name: F Bonnet

family: Bouveret

full_name: L Bouveret

given: L

family: Cabarrot

full_name: P Cabarrot

name: Centre Hospitalier Universitaire de Toulouse

family: Cames

full_name: E Cames

given: E

name: Brigham and Women's Hospital, Boston, Massachusetts, USA

name: Hôpital d'Instruction des Armées du Val de Grâce

name: Centre Hospitalier Régional Universitaire de Toulouse

name: Centre Hospitalier de Villefranche sur Saône

name: Centre Hospitalier Régional Universitaire de Lille

name: Hôpital d'Instruction des Armées Desgenettes de Lyon

name: Coordination pour l'Evaluation des Pratiques Professionnelles en Santé en Rhône-Alpes de Lyon


title: Ecological Assessment of Apathy in Alzheimer's Disease and in Control Subjects: Interest on Video Recognition and Actigraphy

summary:
Cognitive and memory disorders are characterized of Alzheimer disease. In addition, psychologic and behavioural symptoms, called speak neuropsychiatric symptoms, are frequents and play an important role in prognostic and intervention. These symptoms are noticed before the diagnostic of dementia, their prevalence and their intensity increase with the evolution of disease. Apathy, which is characterized by a decrease of motivation, is the most frequent of this behaviour disrupt. Clinically, a decrease, or a totally, lack of interest, initiative and blunting emotional are noticed. Fundamentally, apathy is considered as a decrease of cognition and behaviour to "go in goal". Assessment of psychological and behavioural symptoms is realised principally with neuropsychiatric scales. These contribute to obtain particular informations about health of patient allowing by patient and caregiver discussions and impressions of clinician. These scales are simples but loss of subjectivity. An alternative of this method is the use of gerontechnology as actigraphy (system out-patient which records locomotive activity with the help of piezo-electrical sensor fixed on a bracelet) and video recording which is associated to an informatic treatment of signal in order event recognition.

The aim of study is to realise an objective assessment of activities "go in goal" during experimental sequence which has well-characterized acts, using at the same time an actigraphic record of activity "motive" (system of assessment indirect of apathy fit) and a video records which uses an informatic event recognition system. The assessment will realise with participants controls (n=30) and Alzheimer disease patients with (n=20) or without (n=20) apathy, during well-characterized records. The final aim is to obtain a particular assessment of some disorders behaviours, as apathy, which is principally characterize by a decrease of behaviours "to go in goal".

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients

acronym: IBISD

summary: The purpose of this study is to identify potential biomarkers for the diagnosis, disease progression assessment and response to treatment in patients with Duchenne Muscular Dystrophy.

lead_sponsor: Genethon


title: Early Prediction of Chronic Allograft Nephropathy by Non Invasive Monitoring of Urinary Cell mRNAs

acronym: Prefigur

summary:
The investigators have shown that epithelial-to-mesenchymal transition (EMT) markers in early protocol biopsies of the renal allograft predicts the progression of fibrosis during the first year post-transplantation.

The investigators will develop a non-invasive approach for predicting fibrosis as a substitute for the invasive allograft biopsy procedure, by longitudinal assessment of the mRNA expression level of genes implicated in EMT/fibrogenesis and inflammation in urinary cells from kidney transplant recipients during the first year post-transplantation.

time_perspective: Other

intervention_type: Genetic


title: Biological Study of Feasibility Concerning the Research for Mutation of the Gene of EGFR and for K-Ras in Circulating Tumoral Cells(CTCs) of the Patients Carriers of Metastatic Non Small Cells Bronchial Carcinomas

acronym: CTC-Poumon

summary:
The knowledge concerning the biology of the human tumors do not stop widening, in particular concerning the molecular mechanisms at the origin of the process of carcinogenesis and its ability to become perpetual. The identification and the increasing knowledge of these abnormalities allowed during these last years the development of therapeutic strategies targeting specifically the molecular pathways involved in the carcinogenesis. It quickly lead to numerous therapeutic successes in association with conventional chemotherapy, allowing a better individualization of the treatment according to the biological characteristics of the tumor of the patient.

However such therapeutics are effective only if the patients carries specific genomic mutations making necessary the systematic research for one kind of mutation.

The problem is that currently the mutational status is frequently made on the tissue resulting from the initial tumor biopsy, and as it is not excluded that the evolution of the biology of the metastasis reports a different genomic status, the only theoretical solution is then to make biopsy systematically on metastasis, what is not always technically possible. The problem still complicates when the investigators know that the biology of the tumor may evolve in time, particularly under treatment, with appearance of chemotherapy resistant clones. The monitoring of the genomic status of the tumor thus appears to be a crucial stake in the next years in cancer research as far as the efficiency of numerous therapeutic targeted put at the disposal of the clinician, depends on it largely. The repeated access to tumor tissue, during the follow-up of the patient in treatment, seems from then on indispensable to guide prematurely the therapeutics, in particular by stopping a targeted therapeutics which the investigators know that it is not any more going to be effective, and so avoiding exposing the patient to useless toxicity of a treatment often extremely expensive, and of which usage should have to be reserved to patient who could respond to it.

The access to the circulating tumor cells in the blood of patients is a repeatable, not invasive technique (blood test) and henceforth accessible thanks to a technique using a magnetic sorting of the tumor cells selected by an antibody directed against the tumor antigen EpCAM. This new technology (CellSearch, Veridex system) totally standardized and automated, allows from a total sample of blood of the patient, to determine the quantity of circulating tumor cells (CTC).The number of CTC seems to constitute in recent studies, a powerful prognosis tool at the moment diagnosis, but also during treatment, according to its decrease or not under chemotherapy. In United States, the Food and Drug Administration (FDA) recently approved the use of this system for the quantification of the CTCs in the care of the patients affected by breast, colon, and prostate cancer. The CellSearch system will probably become in the future years an indispensable tool to help the clinicians to encircle better the prognosis of their patient. This technology already allows to realize besides a quantification, the isolation of viable CTCs, from which the genetic material can be extracted, amplified thus potentially analyzed. The investigators thus see all the interest which such a device can represent in the non invasive monitoring of the patients under treatment targeting molecular abnormality susceptible to evolve in time. The investigators thus propose to study thanks to the system CellSearch the feasibility of the research for the mutation of K-Ras and EGFR in the CTC of patients carriers of a metastatic non small cells bronchial carcinoma.

Secondly, the investigators research will be interested in the possible conflicts existing between the primitive tumor and the CTCs for the various popular mutations. In case of feasibility of the method, and the good initial concordance between the genomic status of the CTCs and that of the tumor, the investigators shall describe the genomic evolution under treatment monitoring the CTCs of the patients under targeted therapeutics. The investigators shall describe then if the premature observation of modification precedes the appearance of an effective resistance in treatments.

primary_purpose: Screening

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Biological


title: Pulmonary Hypertension: Impact of the Evolution of a Rare Disease on the Quality of Life and Role of Variables Psychosocial as Predictive of the Current and Later Quality of Life

acronym: HyPsy

summary:
The investigators aim to :

describe and analyse psychological characteristics, cognitive factors and representations in patients with Pulmonary Hypertension, a rare disease.
assess the psychological characteristics impact on quality of life, check the association between disease and QoL evolution, and the variability of QoL parameters over severity class changes and follow-up

ReferenceType: result

ReferenceCitation: Halimi L, Suehs CM, Marin G, Boissin C, Gamez AS, Vachier I, Molinari N, Bourdin A. Health-related quality of life and disease progression in pulmonary arterial hypertension patients: a 3-year study. ERJ Open Res. 2021 Aug 23;7(3). pii: 00617-2020. doi: 10.1183/23120541.00617-2020. eCollection 2021 Jul.

apc_source: doaj

family: Halimi

full_name: Laurence Halimi

given: Laurence

family: Suehs

full_name: Carey M. Suehs

given: Carey M.

family: Marin

full_name: Gregory Marin

given: Gregory

family: Boissin

full_name: Clement Boissin

given: Clement

family: Gamez

full_name: Anne-Sophie Gamez

given: Anne-Sophie

family: Vachier

full_name: Isabelle Vachier

given: Isabelle

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

currency_apc_doaj: EUR

journal_name: ERJ Open Research

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

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

repository_normalized: HAL

version: submittedVersion

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

repositories:
HAL
PubMed Central

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ReferenceCitation: Halimi L, Marin G, Molinari N, Gamez AS, Boissin C, Suehs CM, Vachier I, Bourdin A. Impact of psychological factors on the health-related quality of life of patients treated for pulmonary arterial hypertension. J Psychosom Res. 2018 Feb;105:45-51. doi: 10.1016/j.jpsychores.2017.12.003. Epub 2017 Dec 6.

full_name: Grégory Marin

given: Grégory

full_name: Clément Boissin

given: Clément


title: Identification of Multiple Sclerosis Biomarkers in Human CSF by Means of Cytokine Array

acronym: CYTOSEP

summary: Multiple Sclerosis (MS) is an inflammatory disease of the brain leading to disability. Brain MRI is very useful for MS diagnosis but prognostic biomarkers are still needed. New therapies are also expected to improve MS care. Cytokine arrays provide measure of many different inflammation-related molecules that could help understanding the disease. Moreover, individual prognosis could be linked with the level of such molecules in the CSF of MS patients. The investigators will analyze the cytokine profile of MS and control patients CSF to determine a specific profile of MS and look for prognosis implication in a cohort of patients with clinically isolated syndromes (first manifesatation of MS).

lead_sponsor: University Hospital, Montpellier


title: Early Detection and Diagnostic Performance of Bio-markers During Bacterial Sepsis: Multicentre Cohort Study in Intensive Care

acronym: Captain

summary:
Aim of the study : The primary aim of the investigators study is to highlight the presence of biomarkers (biological indicators of the presence of inflammation or infection) of infectious processes during the systemic inflammatory response (SIRS) allowing, first to discriminate non-infectious inflammation from infectious processes and secondary to determine the microbial pathogen responsive of the infection. For this purpose the investigators will conduct a combinatorial approach of several blood markers including usual markers of inflammation and other blood and cells markers. Expression of small pieces of RNA (miRNA) known to inhibit determined gene expression, will also be analysed in monocytes (a specific group of white blood cells involved in the fist line of defences against microbes.

Study design : For this purpose the investigators will include 300 patients admitted to the intensive care unit with suspicion of infection. Serial blood sample will be take for biological parameters analysis. Efficiency of each single parameters and of different combinations of different markers to determine the presence or absence of infection responsive of clinical inflammation will be studied.

ReferenceCitation: Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. Review.

ReferenceCitation: Gibot S, Cravoisy A, Levy B, Bene MC, Faure G, Bollaert PE. Soluble triggering receptor expressed on myeloid cells and the diagnosis of pneumonia. N Engl J Med. 2004 Jan 29;350(5):451-8.

ReferenceCitation: Adib-Conquy M, Monchi M, Goulenok C, Laurent I, Thuong M, Cavaillon JM, Adrie C. Increased plasma levels of soluble triggering receptor expressed on myeloid cells 1 and procalcitonin after cardiac surgery and cardiac arrest without infection. Shock. 2007 Oct;28(4):406-10.

ReferenceCitation: Cavaillon JM, Adib-Conquy M, Fitting C, Adrie C, Payen D. Cytokine cascade in sepsis. Scand J Infect Dis. 2003;35(9):535-44. Review.

ReferenceCitation: Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8.

ReferenceCitation: Monneret G, Lepape A, Voirin N, Bohé J, Venet F, Debard AL, Thizy H, Bienvenu J, Gueyffier F, Vanhems P. Persisting low monocyte human leukocyte antigen-DR expression predicts mortality in septic shock. Intensive Care Med. 2006 Aug;32(8):1175-83. Epub 2006 Jun 2.

ReferenceCitation: Munoz C, Carlet J, Fitting C, Misset B, Blériot JP, Cavaillon JM. Dysregulation of in vitro cytokine production by monocytes during sepsis. J Clin Invest. 1991 Nov;88(5):1747-54.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques

acronym: LCA IRM

summary: The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).


title: A Randomized Phase II Study of PEP02 or Irinotecan in Combination With Leucovorin and 5-Fluorouracil in Second Line Therapy of Metastatic Colorectal Cancer

acronym: PEPCOL

summary:
RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan hydrochloride PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving liposome-encapsulated irinotecan hydrochloride PEP02 together with leucovorin calcium and fluorouracil is more effective than giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.

PURPOSE: This randomized phase II trial is studying liposome-encapsulated irinotecan hydrochloride PEP02 given together with leucovorin calcium and fluorouracil to see how well it works compared with giving irinotecan hydrochloride together with leucovorin calcium and fluorouracil as second-line therapy in treating patients with metastatic colorectal cancer.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group


title: Screening Project for a Detection of Fabry Disease in Chronic Renal Failure Patients in Area PACA

summary:
Fabry disease is a rare genetic disease characterized by an enzyme deficiency, called alpha-galactosidase A, which normally breaks down a lipid, is missing or does not function properly. As a result, the lipid accumulates in the body, this leads to multisystem impairment, including progressive renal failure.

Several studies have focused on the detection of this disease in end-stage renal failure patients, transplant or hemodialysis.

This study aims to diagnose the Fabry patients earlier, among men aged 18-60 years with a glomerular filtration rate estimated by MDRD between 60 and 15 ml/min/1, 73m2, or between 90 and 60 ml/min/1, 73m2 in association with proteinuria greater than 0.3 g / g or creatinine level greater than 0,5 g/l.

This screening will be conducted by a blood test to measure the level of alpha-galactosidase A activity by micromethod from samples taken from blood spots on filter paper. If this assay was positive, confirmation of diagnosis of Fabry disease will done the standard method: macrodosage of leukocytic alpha-galactosidase A activity.

This multicenter prospective study, openly contacted in medical practice, with patient follow-up corresponding to the management of renal insufficiency, will be offered to all departments of nephrology and dialysis for adults in the Provence - Alpes - Côte d'Azur.

The objective of this study is to assess the prevalence of Fabry disease in the target population and to identify previously undiagnosed patients, enabling them to benefit from appropriate management of their disease, including whether need enzyme replacement therapy.

location_facility: Service de Néphrologie - Hôpital Pasteur


title: Phase I Study : Dose Escalation of Intravenous Weekly Paclitaxel in Association With Metronomic Administration of Cyclophosphamide

summary: The aim of the study is to determine the MTD of Paclitaxel in association with metronomic Cyclophosphamide.

ReferenceCitation: Pannier D, Adenis A, Bogart E, Dansin E, Clisant-Delaine S, Decoupigny E, Lesoin A, Amela E, Ducornet S, Meurant JP, Le Deley MC, Penel N. Once weekly paclitaxel associated with a fixed dose of oral metronomic cyclophosphamide: a dose-finding phase 1 trial. BMC Cancer. 2018 Jul 31;18(1):775. doi: 10.1186/s12885-018-4678-x.

family: Pannier

full_name: Diane Pannier

given: Diane

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Bogart

full_name: Emilie Bogart

given: Emilie

family: Dansin

full_name: Eric Dansin

given: Eric

family: Clisant-Delaine

full_name: Stéphanie Clisant-Delaine

given: Stéphanie

family: Decoupigny

full_name: Emilie Decoupigny

family: Lesoin

full_name: Anne Lesoin

given: Anne

family: Amela

full_name: Eric Amela

family: Ducornet

full_name: Sandrine Ducornet

given: Sandrine

family: Meurant

full_name: Jean-Pierre Meurant

given: Jean-Pierre

family: Le Deley

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

family: Penel

full_name: Nicolas Penel

currency_apc_doaj: GBP

journal_name: BMC Cancer

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

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


title: Impact of c242T Polymorphism of p22phox in the Development of Diabetic Nephropathy,in Caucasian Diabetic Type 1 Patient.

acronym: NEPHRODIANOX

summary:
The physiopathology of diabetic nephropathy (DN) is unclear. To investigate risk factor, the investigators choose to look about some oxidative stress genes. Today a one-gene explanation is not really possible. So the theory of some genetic predisposition to DN is more likely.

The aim of the study is to look about the association of the C282T polymorphism of P22phox, a sub unit of the nicotinamide adenine dinucleotide phosphate-oxidase (NADPH oxidase) in the occurrence of DN. To follow the oxidative stress pathway of the DN, the investigators also investigate three other polymorphisms: -429 T/C, -374 T/A polymorphism of advanced glycation end-products receptor (AGER) and the p.Arg261Gln polymorphism of the 12 lipoxygenase (ALOX 12). Discordant data suggest a link between the first 2 polymorphisms and DN. The last polymorphism is correlated to albuminuria in diabetic patients.

lead_sponsor: University Hospital, Grenoble


title: Study Searching for Hypoxemic Sleep Breathing Disorders in a Cohort of Patients With Idiopathic Pulmonary Arterial Hypertension (IPAH) and Chronic Post-embolic Pulmonary Hypertension (CPEPH)

summary: In the investigators study, and regarding results of small cohorts in the literature, the investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators will explore these patients with a one night polysomnography and transcutaneous capnography, searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.

ReferenceCitation: Jilwan FN, Escourrou P, Garcia G, Jaïs X, Humbert M, Roisman G. High occurrence of hypoxemic sleep respiratory disorders in precapillary pulmonary hypertension and mechanisms. Chest. 2013 Jan;143(1):47-55. doi: 10.1378/chest.11-3124.

family: Jilwan

full_name: Fadia Nicolas Jilwan

given: Fadia Nicolas

family: Escourrou

full_name: Pierre Escourrou

given: Pierre

family: Garcia

full_name: Gilles Garcia

given: Gilles

family: Jaïs

full_name: Xavier Jaïs

given: Xavier

family: Humbert

full_name: Marc Humbert

given: Marc

family: Roisman

full_name: Gabriel Roisman

given: Gabriel

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: High Occurrence of Hypoxemic Sleep Respiratory Disorders in Precapillary Pulmonary Hypertension and Mechanisms

location_facility: Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital


title: Prospective Randomized Study of the Impact on the Autonomy of the Elderly of 75 Years of Age and Older by the Unit for Prevention, Monitoring and Analysis of Aging (UPSAV).

acronym: GEROPASS

summary:
Background :

The evolving concept of frailty was born in the United States under the term of " frail elderly ". It allows describing geriatrics situations, dominated by the weakness or the functional instability of aged person, illustrating situations at risk. It is about an effective concept, especially in the field of the prevention where it determines strategies of specific care. The ageing, changing according to individuals, is characterized by a decrease of the physiological reserves leading to a precarious balance and to a destabilization.

Epidemiological studies show a very uneven distribution of three categories of old persons according to their health status. Every year, approximately, 12 % of the independent population of 75 years of age and older and living at home, lose their autonomy for one of the activities of the daily life and turn into frailty.

Identifying frailty of old subjects is interesting in order to apply preventive and specific care strategies to reduce the risks of decompensation. The Global Geriatric Assessment (GGA) is the gold standard to detect frailty in this population. The beneficial effects of the GGA during the hospitalization have been recognized in international literature.

The ageing heterogeneousness complexity and the high time-consuming character of GGA led to a difficult approach for the nurses or family practioners in taking care of old persons at home.

To balance these difficulties and to optimize prevention of dependence in the elderly, an experimental unit of prevention was created : Unit for Prevention, Monitoring and Analysis of Aging (UPSAV) on January 4th, 2010 within the geriatric department of the Hospital University of Limoges. It is an innovative organizational structure because, for the first time, the geriatric expertise is proposed freely to the elderly at home. A multidisciplinary gerontological team consisting in a geriatrician, a nurse, a psychomotor therapist and an occupational therapist, can, on requiry, move at old persons' home to make a preventive GGA to detect the risks of loss of autonomy and to propose a coordination of preventive actions.

Purpose :

UPSAV's endpoints are to prevent frail elderly persons from the risk of autonomy loss. This action is led in partnership with all the professionals working around old persons.

The randomized study endpoint is to evaluate elderly from 75 years of age and older at home and to select two homogeneous groups: "reference" and " specific intervention ".

primary_purpose: Prevention

lead_sponsor: University Hospital, Limoges

location_facility: Pôle Personnes âgées et soins à domicile - Limoges UH


title: PLACEBO-CONTROLLED STUDY OF THE EFFECT OF TWO FOOD SUPPLEMENTS ON SKIN REACTIVITY

summary:
In recent decades, the incidence of subjects presenting reactive skin has considerably increased in industrialized countries. Probiotics are live microorganisms which, when ingested in sufficient amounts, have beneficial effects on human health. The mechanism underlying the effect of probiotics involves, in part, regulation of the composition and/or metabolic activity of the intestinal microbiota.. It is postulated that following interaction of probiotics with the intestinal epithelium, associated intestinal cells become activated and consequently mediators are released into the blood circulation. Mediators, activated intestinal epithelial cells and possibly bacterial fractions might reach the skin through the bloodstream where they potentially could exert effects.The objective of this study was to assess the effects of probiotics on reactive skin symptoms. The strain Lactobacillus paracasei NCC2461 was tested alone and in combination with the strain Bifidobacterium longum NCC3001 in a randomized, double-blind study. The two strains were selected for their immune-modulatory properties demonstrated in in vitro and other preclinical studies as well as in a pilot clinical trial.

Ninety-six women presenting reactive skin were randomized to 3 groups: placebo (n = 32), L. paracasei NCC2461 alone (n = 32) and L. paracasei NCC2461 + B. longum NCC3001 (n = 32). The supplements were administered by the oral route for 58 days (1010 CFU/day).

The objective of the clinical trial was to determine, in vivo, the effect of food supplements on reactive skin symptoms (as measured by skin sensitivity and the reconstruction of barrier function post-repeated tape stripping).

The secondary objectives were to determine the effect of the food supplements on leg skin dryness and facial skin roughness and the associated biochemical, immunological and microbiological factors.

Accordingly, the subjects' skin sensitivity was determined by the capsaicin test. The reconstruction of barrier function was determined by measuring the trans-epidermal water loss (TEWL) post-repeated stripping using a SERVOMED evaporimeter. A clinical score for skin dryness and roughness was assigned by a dermatologist. The subjects also assessed their leg and facial skin dryness themselves. Each analysis was conducted at the various time points.

In parallel, assessment of the skin moisturizing factors and serum inflammatory and immune-regulatory cytokines were performed. Finally, key components of the intestinal microbiota were analyzed.

lead_sponsor: L'Oreal

intervention_type: Dietary Supplement


title: A Single Center, Randomized, Double-blind, Parallel-design Study to Investigate the Safety and Tolerability of RO4995819 in Combination With Citalopram Following Oral Administration in Healthy Volunteers

summary: This randomized, double-blind, parallel-arm study will assess the safety and tolerability of RO4995819 in combination with citalopram in healthy volunteers. Subjects will receive citalopram orally on Days 1-9 and be randomized to receive either RO4995819 orally or placebo in combination with citalopram on Days 10-16. Safety follow-up will be up to Day 58.


title: A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE CARBAMAZEPINE ON SINGLE DOSE PHARMACOKINETICS OF RO4917838 IN HEALTHY MALE VOLUNTEERS

summary: This open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.


title: Impact of the Deliverance and Use of a Written Detailed Information Brochure on Anxiety Felt by the Family Members of Patients Admitted in Intensive Care Unit

acronym: FAMILLE

summary:
Anxiety and depression are symptoms frequently met in ICU patients and relatives. Risk factors are known: disease severity, age, gender. Another risk factor is lack of information from the medical staff and nurses.

Anxiety and depression can be measured by the Hospital Anxiety and Depression Scale (HADS). Other scales are used in the psychiatric field : the Impact Event Score - Revisited (IES-R) is relevant to detect Post-Traumatic Stress Disorder (PTSD), The Short Form Health Survey (SF-36) is an assessment of life quality.

In the following study, the investigators will evaluate the impact of a "brochure" as complement of oral information on Anxiety developed by relatives and family of ICU patients.

The medical and surgical ICU is composed by two different units (different medical and nurse team, different location in the same hospital) of 12 beds on one side, 14 beds on the other side.

During a year, in the first unit, the investigators will use the booklet as support and complement of oral information : "booklet arm". The information process will be as usual in the other unit : "control arm". During the second year, the booklet will be used in the second unit while the first unit will return to the usual oral information (cross-over).

For each included patient, one relative or family member is pointed to be the referring family member or "referent". This "referent" receives the HADS questionnaire at Day 3 after admission, at day of discharge if the patient is alive, at one month after discharge. The IES-R questionnaire is delivered at discharge of the living patient and at day 30. The SF-36 questionnaire is given to the "referent" and the living patient at day 30. The day 30 questionnaires are send by mail at the "referent" address.

ReferenceCitation: Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larché J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. Epub 2005 Jan 21.

ReferenceCitation: Jackson JC, Hart RP, Gordon SM, Shintani A, Truman B, May L, Ely EW. Six-month neuropsychological outcome of medical intensive care unit patients. Crit Care Med. 2003 Apr;31(4):1226-34.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere


title: Effects of an In-Patient Individualized Rehabilitation Program on Severity and Symptoms of Obstructive Sleep Apnea Syndrome (OSAS):Results of a Randomized Controlled Pilot Study

acronym: Rehsolvas

summary:
The obstructive sleep apnea/hypopnea syndrome (OSAS) is a common disease (2-4% of the general population) that generates intermittent hypoxemia and sleep fragmentation. OSAS is associated with various metabolic disorders such as metabolic syndrome, type 2 diabetes. OSAS is a risk factor for cardio-vascular diseases by increasing morbidity/mortality. OSAS patients suffer from excessive daytime sleepiness (EDS), a symptom also responsible for at least 30% of traffic accidents but also other cognitive disorders with significant impact on quality of life. OSAS generates oxidative stress, inflammation and resistance to insulin and other systemic metabolic dysregulation of many whose levels are correlated with the severity of the disease.

Treatment with Continuous Positive Airway Pressure (CPAP) has clearly demonstrated its effectiveness to eliminate apneas and improve EDS but it is sometimes difficult to accept and/or poorly tolerated, limiting its effectiveness.

Weight loss and regular physical activity are clearly recommended but rarely done in clinical practice. A few studies have applied to study the effects of rehabilitation training (REE) on the sleep apnea patients and have shown an improvement in sleep quality, reduction of awakenings and arousals from sleep and the Index of Apnea/Hypopnea (AHI), but their methodology was questionable, and the number of patients included was too low.

The investigators hypothesis is that an in-patient multidisciplinary rehabilitation program comprising educational activities, dietary management and individualized exercise training (IET) will decrease OSAS severity, improve sleep quality and symptoms (EDS, fatigue, QoL). This IET program (24 sessions during 4 weeks) could also help to improve many metabolic dysregulation, inflammation and oxidative stress (also markers of cardiovascular risk). Leptin, a hormone involved in regulating appetite, energy expenditure and ventilatory control is increased in OSA (mechanism of leptin resistance). The improved sensitivity to leptin may play a role in enabling a better control of ventilation in these patients.

ReferenceCitation: Desplan M, Mercier J, Sabaté M, Ninot G, Prefaut C, Dauvilliers Y. A comprehensive rehabilitation program improves disease severity in patients with obstructive sleep apnea syndrome: a pilot randomized controlled study. Sleep Med. 2014 Aug;15(8):906-12. doi: 10.1016/j.sleep.2013.09.023. Epub 2014 Apr 1.

family: Desplan

full_name: M. Desplan

given: M.

family: Mercier

full_name: J. Mercier

given: J.

family: Sabaté

full_name: M. Sabaté

family: Ninot

full_name: G. Ninot

given: G.

family: Prefaut

full_name: C. Prefaut

given: C.

family: Dauvilliers

full_name: Y. Dauvilliers

given: Y.

journal_name: Sleep Medicine

lead_sponsor: 5 Santé

intervention_type: Behavioral


title: Endoscopic Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia: a Randomised Controlled Trial vs Endoscopic Surveillance

acronym: RF-DBG

summary: Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

ReferenceCitation: Barret M, Pioche M, Terris B, Ponchon T, Cholet F, Zerbib F, Chabrun E, Le Rhun M, Coron E, Giovannini M, Caillol F, Laugier R, Jacques J, Legros R, Boustiere C, Rahmi G, Metivier-Cesbron E, Vanbiervliet G, Bauret P, Escourrou J, Branche J, Jilet L, Abdoul H, Kaddour N, Leblanc S, Bensoussan M, Prat F, Chaussade S. Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial. Gut. 2021 Jun;70(6):1014-1022. doi: 10.1136/gutjnl-2020-322082. Epub 2021 Mar 8.

family: Barret

full_name: Maximilien Barret

given: Maximilien

family: Pioche

full_name: Mathieu Pioche

given: Mathieu

family: Terris

full_name: Benoit Terris

given: Benoit

family: Ponchon

full_name: Thierry Ponchon

given: Thierry

family: Cholet

full_name: Franck Cholet

given: Franck

family: Zerbib

full_name: Frank Zerbib

given: Frank

family: Chabrun

full_name: Edouard Chabrun

given: Edouard

family: Le Rhun

full_name: Marc Le Rhun

family: Coron

full_name: Emmanuel Coron

given: Emmanuel

family: Giovannini

full_name: Marc Giovannini

family: Caillol

full_name: Fabrice Caillol

given: Fabrice

family: Laugier

full_name: René Laugier

given: René

family: Jacques

full_name: Jeremie Jacques

given: Jeremie

family: Legros

full_name: Romain Legros

given: Romain

family: Boustiere

full_name: Christian Boustiere

given: Christian

family: Rahmi

full_name: Gabriel Rahmi

family: Metivier-Cesbron

full_name: Elodie Metivier-Cesbron

given: Elodie

family: Vanbiervliet

full_name: Geoffroy Vanbiervliet

given: Geoffroy

family: Bauret

full_name: Paul Bauret

given: Paul

full_name: Jean Escourrou

given: Jean

family: Branche

full_name: Julien Branche

given: Julien

family: Jilet

full_name: Lea Jilet

given: Lea

family: Abdoul

full_name: Hendy Abdoul

given: Hendy

title: Endoscopic radiofrequency ablation or surveillance in patients with Barrett’s oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial

location_facility: Gastroenterology and Endoscopy department, Cochin Hospital


title: Evaluation of the Interests of a Therapeutic Hypothermia Procedure in Convulsive Status EPILEPTICUS in Adults in Intensive Care - HYBERNATUS Study

acronym: HYBERNATUS

summary: Status EPILEPTICUS (SE) is a major medical emergency. The incidence per 100,000 population has been estimated at 9.9 episodes in Europe and 41 episodes in the US. The overall morbidity and mortality associated with convulsive SE (CSE) is 60% at three months. The alteration of functional prognosis of these patients is more conventionally attributed to the cause than to CSE itself. Longer seizure duration, progression to refractory status EPILEPTICUS and presence of cerebral insult are strong factors independently associated with a poor functional outcome. These three factors offer may be amenable to improvement and hope for preventive strategies. Current guidelines recommend the use of anticonvulsant treatment whose goal is prompt cessation of clinical and electrical seizures. None of these treatments has demonstrated NEUROPROTECTICE property. Therapeutic moderate hypothermia (between 32 and 34 ° C) showed interest in neuroprotection of post anoxic coma patients after a cardiovascular arrest on ventricular fibrillation by reducing morbidity and mortality in about 20% without major side effects. This technique has been used successfully in various pathologies such as stroke or traumatic brain injury. Pathophysiological mechanisms involved in epileptogenesis and neurotoxicity induced by persistence of seizures can be blocked by therapeutic hypothermia. Recent work on experimental models of SE demonstrated neuroprotective and anticonvulsant interest of therapeutic hypothermia. Therapeutic hypothermia has also been successfully used in some cases of particularly refractory CSE. Its early use in patients with SE would have a double interest: neuroprotective and anticonvulsant. There is currently no published studies or ongoing to determine the interest of its early use in patients with CSE.

ReferenceCitation: Fontaine C, Lemiale V, Resche-Rigon M, Schenck M, Chelly J, Geeraerts T, Hamdi A, Guitton C, Meziani F, Lefrant JY, Megarbane B, Mentec H, Chaffaut C, Cariou A, Legriel S; HYBERNATUS Study Group. Association of systemic secondary brain insults and outcome in patients with convulsive status epilepticus: A post hoc study of a randomized controlled trial. Neurology. 2020 Nov 3;95(18):e2529-e2541. doi: 10.1212/WNL.0000000000010726. Epub 2020 Sep 10.

family: Fontaine

full_name: Candice Fontaine

given: Candice

family: Lemiale

full_name: Virginie Lemiale

given: Virginie

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

family: Schenck

full_name: Maleka Schenck

given: Maleka

family: Chelly

full_name: Jonathan Chelly

given: Jonathan

family: Geeraerts

full_name: Thomas Geeraerts

given: Thomas

family: Hamdi

full_name: Aicha Hamdi

given: Aicha

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Megarbane

full_name: Bruno Megarbane

given: Bruno

family: Mentec

full_name: Hervé Mentec

given: Hervé

family: Chaffaut

full_name: Cendrine Chaffaut

given: Cendrine

family: Cariou

full_name: Alain Cariou

given: Alain

family: Legriel

full_name: Stephane Legriel

given: Stephane

journal_name: Neurology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Legriel S, Lemiale V, Schenck M, Chelly J, Laurent V, Daviaud F, Srairi M, Hamdi A, Geri G, Rossignol T, Hilly-Ginoux J, Boisramé-Helms J, Louart B, Malissin I, Mongardon N, Planquette B, Thirion M, Merceron S, Canet E, Pico F, Tran-Dinh YR, Bedos JP, Azoulay E, Resche-Rigon M, Cariou A; HYBERNATUS Study Group. Hypothermia for Neuroprotection in Convulsive Status Epilepticus. N Engl J Med. 2016 Dec 22;375(25):2457-2467. doi: 10.1056/NEJMoa1608193.

family: Laurent

full_name: Virginie Laurent

family: Daviaud

full_name: Fabrice Daviaud

ReferenceCitation: Legriel S, Pico F, Tran-Dinh YR, Lemiale V, Bedos JP, Resche-Rigon M, Cariou A. Neuroprotective effect of therapeutic hypothermia versus standard care alone after convulsive status epilepticus: protocol of the multicentre randomised controlled trial HYBERNATUS. Ann Intensive Care. 2016 Dec;6(1):54. doi: 10.1186/s13613-016-0159-z. Epub 2016 Jun 21. Review.

location_facility: Hôpital André MIGNOT- Service de réanimation médico-chirurgical


title: Biological Markers in Patients Presenting Aneurism Coiling for Subarachnoid Hemorrhage

acronym: ABCSAH

summary:
The goal of this observational study is to develop and validate a predictive score of 1-year outcomes in subarachnoid hemorrhage (SAH) patients receiving aneurism coiling.

Using our database filled up prospectively, the investigators plan to collect clinical, biological and radiological admission characteristics of coiled SAH cases and their 1-year Rankin outcome score during 5 years (2003-2007). The investigators plan to confirm our score in a validation cohort (from 2008 to 2009).

time_perspective: Retrospective

ReferenceCitation: Degos V, Apfel CC, Sanchez P, Colonne C, Renuit I, Clarençon F, Nouet A, Boch AL, Pourmohamad T, Kim H, Gourraud PA, Young WL, Puybasset L. An admission bioclinical score to predict 1-year outcomes in patients undergoing aneurysm coiling. Stroke. 2012 May;43(5):1253-9. doi: 10.1161/STROKEAHA.111.638197. Epub 2012 Feb 23.

name: From the Departments of Anesthesiology and Critical Care (V.D., P.S., C.C., I.R., L.P.), Neuroradiology (F.C.), and Neurosurgery (A.N., A.L.B.), Groupe Hospitalier Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Université Pierre et Marie Curie, Paris France; and the Center for Cerebrovascular Research (V.D., T.P., H.K., W.L.Y.), Department of Anesthesia and Perioperative Care (V.D., C.C.A., H.K., T.P., W.L.Y.), and Departments of Epidemiology and Biostatistics (H.K.), Neurological Surgery...

family: Degos

full_name: Vincent Degos

given: Vincent

family: Apfel

full_name: Christian C. Apfel

given: Christian C.

family: Sanchez

full_name: Paola Sanchez

given: Paola

family: Colonne

full_name: Chantal Colonne

given: Chantal

family: Renuit

full_name: Isabelle Renuit

given: Isabelle

family: Clarençon

full_name: Frédéric Clarençon

given: Frédéric

family: Nouet

full_name: Aurélien Nouet

given: Aurélien

family: Boch

full_name: Anne Laure Boch

given: Anne Laure

family: Pourmohamad

full_name: Tony Pourmohamad

given: Tony

family: Kim

full_name: Helen Kim

given: Helen

family: Gourraud

full_name: Pierre Antoine Gourraud

given: Pierre Antoine

family: Young

full_name: William L. Young

given: William L.

family: Puybasset

full_name: Louis Puybasset

given: Louis

journal_name: Stroke

evidence: open (via free pdf)

title: An Admission Bioclinical Score to Predict 1-Year Outcomes in Patients Undergoing Aneurysm Coiling

location_facility: Neuro-réanimation Chirurgicale Babinski - Hopital Pitié Salpetriere


title: Efficacy of Premixed Nitrous Oxide and Oxygen in Patient With Out-of-hospital Moderate Acute Pain: a Randomized Double-blind Study

acronym: MEOPA

summary: Less than 10% of patients with a traumatic pain have been managed by a physician before to be admitted in an emergency service. 50 % of those patients have been carried by paramedics. Premixed nitrous oxide and oxygen is often used by paramedics, but no scientific studies have demonstrated its efficacy. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen in patients with out-of-hospital moderate acute pain.

ReferenceCitation: Ducassé JL, Siksik G, Durand-Béchu M, Couarraze S, Vallé B, Lecoules N, Marco P, Lacombe T, Bounes V. Nitrous oxide for early analgesia in the emergency setting: a randomized, double-blind multicenter prehospital trial. Acad Emerg Med. 2013 Feb;20(2):178-84. doi: 10.1111/acem.12072.

name: Service d'Aide Médicale Urgente de la Haute Garonne (SAMU 31); Hôpital Universitaire de Purpan; Toulouse; France

family: Ducassé

full_name: Jean-Louis Ducassé

given: Jean-Louis

name: The Service de Santé et de Secours Médical (SSSM) and the Service Départemental d'Incendie et de Secours de la Haute Garonne (SDIS 31); Colomiers; France

family: Siksik

full_name: Georges Siksik

given: Georges

family: Durand-Béchu

full_name: Manon Durand-Béchu

given: Manon

family: Couarraze

full_name: Sébastien Couarraze

given: Sébastien

family: Vallé

full_name: Baptiste Vallé

given: Baptiste

name: The Service d'Accueil des Urgences; Hôpital Universitaire de Purpan; Toulouse; France

family: Lecoules

full_name: Nathalie Lecoules

given: Nathalie

family: Marco

full_name: Patrice Marco

given: Patrice

family: Lacombe

full_name: Thierry Lacombe

given: Thierry

family: Bounes

full_name: Vincent Bounes

journal_name: Academic Emergency Medicine

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Nitrous Oxide for Early Analgesia in the Emergency Setting: A Randomized, Double-blind Multicenter Prehospital Trial

lead_sponsor: University Hospital, Toulouse


title: Determination of the 90% Effective Dose of a Sufentanil Bolus in Analgesia During Lateral Decubitus of Mechanically Ventilated Patients.

acronym: REANURSUF

summary:
Mechanically ventilated patients experiencing pain are frequent in intensive care units (ICU) however their treatment remains unclear. This prospective pharmacodynamic study relates to the analgesia of procedural pains. The primary objective was to determine the 90% effective dose (ED) of a sufentanil bolus to obtain a satisfactory analgesia (defined by a Behavioral Pain Scale (BPS) at 3 or 4) during lateral decubitus (LD) of mechanically ventilated patients.

Material and Method. Patients who, at rest before the 48th hour of mechanical ventilation, reach the objectives of BPS at 3 or 4 and Ramsay sedation score between 3 and 5, were included.

During a 72h evaluation phase, BPS was used to measure the efficiency of a bolus of sufentanil on the analgesia of the LD. The dose of this bolus was raised gradually every new LD until BPS was at 3 or 4.

ReferenceCitation: Chaveron D, Silva S, Sanchez-Verlaan P, Conil JM, Sommet A, Geeraerts T, Génestal M, Minville V, Fourcade O. The 90% effective dose of a sufentanil bolus for the management of painful positioning in intubated patients in the ICU. Eur J Anaesthesiol. 2012 Jun;29(6):280-5. doi: 10.1097/EJA.0b013e328352234d.

family: Chaveron

full_name: Damien Chaveron

given: Damien

family: Silva

full_name: Stein Silva

given: Stein

family: Sanchez-Verlaan

full_name: Pascale Sanchez-Verlaan

given: Pascale

family: Conil

full_name: Jean-Marie Conil

given: Jean-Marie

family: Sommet

full_name: Agnès Sommet

given: Agnès

family: Geeraerts

full_name: Thomas Geeraerts

given: Thomas

family: Génestal

full_name: Michèle Génestal

given: Michèle

family: Minville

full_name: Vincent Minville

given: Vincent

family: Fourcade

full_name: Olivier Fourcade

given: Olivier

journal_name: European Journal of Anaesthesiology

ipd_sharing: No


title: Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques

summary: The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.

primary_purpose: Supportive Care

lead_sponsor: Lescuyer Laboratory

location_facility: Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion


title: Evaluation of the Efficacy and Tolerance of Fractionated Radio-immunotherapy With 90Y-Epratuzumab (90Y-hLL2) for Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients

acronym: RIT 90YEpra

summary: The purpose of this study is to determine whether fractionated RIT with Epratuzumab and radiolabeled Epratuzumab are effective in the treatment of relapsing or refractory ALL.

ReferenceCitation: Chevallier P, Eugene T, Robillard N, Isnard F, Nicolini F, Escoffre-Barbe M, Huguet F, Hunault M, Marcais A, Gaschet J, Cherel M, Guillaume T, Delaunay J, Peterlin P, Eveillard M, Thomas X, Ifrah N, Lapusan S, Bodet-Milin C, Barbet J, Faivre-Chauvet A, Ferrer L, Bene MC, Le Houerou C, Goldenberg DM, Wegener WA, Kraeber-Bodéré F. (90)Y-labelled anti-CD22 epratuzumab tetraxetan in adults with refractory or relapsed CD22-positive B-cell acute lymphoblastic leukaemia: a phase 1 dose-escalation study. Lancet Haematol. 2015 Mar;2(3):e108-17. doi: 10.1016/S2352-3026(15)00020-4. Epub 2015 Feb 25.

family: Chevallier

full_name: Patrice Chevallier

family: Eugene

full_name: Thomas Eugene

family: Robillard

full_name: Nelly Robillard

given: Nelly

family: Isnard

full_name: Françoise Isnard

given: Françoise

family: Nicolini

full_name: Franck Nicolini

given: Franck

family: Escoffre-Barbe

full_name: Martine Escoffre-Barbe

given: Martine

family: Huguet

full_name: Françoise Huguet

family: Hunault

full_name: Mathilde Hunault

given: Mathilde

family: Marcais

full_name: Antoine Marcais

given: Antoine

family: Gaschet

full_name: Joelle Gaschet

given: Joelle

family: Cherel

full_name: Michel Cherel

given: Michel

family: Guillaume

full_name: Thierry Guillaume

family: Delaunay

full_name: Jacques Delaunay

given: Jacques

family: Peterlin

full_name: Pierre Peterlin

given: Pierre

family: Eveillard

full_name: Marion Eveillard

given: Marion

family: Thomas

full_name: Xavier Thomas

given: Xavier

family: Ifrah

full_name: Norbert Ifrah

given: Norbert

family: Lapusan

full_name: Simona Lapusan

given: Simona

family: Bodet-Milin

full_name: Caroline Bodet-Milin

given: Caroline

family: Barbet

full_name: Jacques Barbet

family: Faivre-Chauvet

full_name: Alain Faivre-Chauvet

given: Alain

family: Ferrer

full_name: Ludovic Ferrer

given: Ludovic

family: Bene

full_name: Marie C Bene

given: Marie C

title: 90 Y-labelled anti-CD22 epratuzumab tetraxetan in adults with refractory or relapsed CD22-positive B-cell acute lymphoblastic leukaemia: a phase 1 dose-escalation study


title: Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia

summary: The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.

ReferenceCitation: Barrat E, Zaïr Y, Sirvent P, Chauveau P, Maudet C, Housez B, Derbord E, Lescuyer JF, Bard JM, Cazaubiel M, Peltier SL. Effect on LDL-cholesterol of a large dose of a dietary supplement with plant extracts in subjects with untreated moderate hypercholesterolaemia: a randomised, double-blind, placebo-controlled study. Eur J Nutr. 2013 Dec;52(8):1843-52. doi: 10.1007/s00394-012-0486-2. Epub 2012 Dec 25.

family: Barrat

full_name: Emmanuel Barrat

given: Emmanuel

family: Zaïr

full_name: Yassine Zaïr

given: Yassine

family: Sirvent

full_name: Pascal Sirvent

given: Pascal

family: Chauveau

full_name: Patrice Chauveau

given: Patrice

family: Maudet

full_name: Corinne Maudet

given: Corinne

family: Housez

full_name: Béatrice Housez

given: Béatrice

family: Derbord

full_name: Elodie Derbord

given: Elodie

family: Lescuyer

full_name: Jean-François Lescuyer

given: Jean-François

family: Bard

full_name: Jean-Marie Bard

given: Jean-Marie

family: Cazaubiel

full_name: Murielle Cazaubiel

given: Murielle

family: Peltier

full_name: Sébastien L. Peltier

given: Sébastien L.

journal_name: European Journal of Nutrition

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer


title: Study of the Effects of Limicol (a Food Supplement) on LDL-cholesterol in Moderate Hypercholesterolemia Subjects

summary: The principal objective of this study is to investigate the effects of a novel food supplement (Limicol) on LDL-cholesterol levels in healthy subjects with moderate hypercholesterolemia.


title: Therapeutic Education in Very Young Children With Diabetes Mellitus. Evaluation of the Impact of a Specific Tool for Parents on Glycemic Control and Prevention of Acute Events (Hypoglycemia and Ketosis)

acronym: DIAB-EDUC

summary: DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management, over a period of 2 years. The investigators plan to include 300 type 1 diabetic children in 10 french hospitals.


title: Effects of Ingestion of Different Sports Drinks on Fatigue During Playing Tennis

summary: The main objective of this study is to investigate the effects of ingestion of different sports drinks (Nutrattente / Nutraperf / Nutrarecup) on fatigue induced by a tennis tournament simulation.

ReferenceCitation: Brink-Elfegoun T, Ratel S, Leprêtre PM, Metz L, Ennequin G, Doré E, Martin V, Bishop D, Aubineau N, Lescuyer JF, Duclos M, Sirvent P, Peltier SL. Effects of sports drinks on the maintenance of physical performance during 3 tennis matches: a randomized controlled study. J Int Soc Sports Nutr. 2014 Sep 2;11:46. doi: 10.1186/s12970-014-0046-7. eCollection 2014.

family: Brink-Elfegoun

full_name: Thibault Brink-Elfegoun

given: Thibault

family: Ratel

full_name: Sébastien Ratel

given: Sébastien

family: Leprétre

full_name: Pierre-Marie Leprétre

given: Pierre-Marie

family: Metz

full_name: Lore Metz

given: Lore

family: Ennequin

full_name: Gael Ennequin

given: Gael

family: Doré

full_name: Eric Doré

given: Eric

family: Martin

full_name: Vincent Martin

given: Vincent

family: Bishop

full_name: David Bishop

given: David

family: Aubineau

full_name: Nicolas Aubineau

given: Nicolas

full_name: Jean-Franéois Lescuyer

given: Jean-Franéois

family: Duclos

full_name: Martine Duclos

given: Martine

full_name: Sébastien L Peltier

given: Sébastien L

bso_classification: Biology (fond.)

journal_name: Journal of the International Society of Sports Nutrition

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

repository_institution: Victoria University - VU Research Repository

version: acceptedVersion

repositories:
HAL
PubMed Central
eprints.vu.edu.au


title: Dose-effect Relationship of Repeated Administration of Low-dose IL-2 Versus Placebo on the Kinetic of Regulatory T Cells in Patients With Type 1 Diabetes

summary: IL-2 is an inducer of regulatory T cells (Treg), a population of lymphocytes that fail to control the autoimmune destruction of beta-cells in patients with Type 1 Diabetes (T1D). The investigators recently showed that low dose IL-2 is well tolerated in patients with an autoimmune disease. The investigators aim to use IL-2 to induce/stimulate Treg in T1D patients. This study will investigate the dose effect relationship of low dose IL-2 for Treg induction such as to optimize the risk benefit ratio for this treatment in T1D. By Treg induction, the investigators aim to protect the remaining/regenerating β-cells from autoimmune destruction, thus improving or even curing T1D.

ReferenceCitation: Hartemann A, Bensimon G, Payan CA, Jacqueminet S, Bourron O, Nicolas N, Fonfrede M, Rosenzwajg M, Bernard C, Klatzmann D. Low-dose interleukin 2 in patients with type 1 diabetes: a phase 1/2 randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2013 Dec;1(4):295-305. doi: 10.1016/S2213-8587(13)70113-X. Epub 2013 Oct 8.

family: Hartemann

full_name: Agnès Hartemann

given: Agnès

family: Bensimon

full_name: Gilbert Bensimon

given: Gilbert

family: Payan

full_name: Christine A Payan

given: Christine A

family: Jacqueminet

full_name: Sophie Jacqueminet

given: Sophie

family: Bourron

full_name: Olivier Bourron

given: Olivier

family: Nicolas

full_name: Nathalie Nicolas

given: Nathalie

family: Fonfrede

full_name: Michèle Fonfrede

given: Michèle

family: Rosenzwajg

full_name: Michelle Rosenzwajg

given: Michelle

family: Bernard

full_name: Claude Bernard

given: Claude

family: Klatzmann

full_name: David Klatzmann

journal_name: The Lancet Diabetes & Endocrinology


title: Analysis of the Enteric Nervous System Using Colonic Biopsies: a Useful Biomarker for the Differential Diagnosis of Parkinsonian Syndromes?

acronym: ColoBioParker

summary: The aim of this project is to develop an original biomarker for Parkinson's disease (PD) and other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy) based upon the detection of pathological alpha-synuclein species in routine colonoscopic biopsies.

lead_sponsor: Nantes University Hospital


title: A Prospective Randomised Controlled Trial of Hyperfractionated Versus Conventionally Fractionated Radiotherapy in Standard Risk Medulloblastoma

summary: This is an international prospective randomised trial, which will compare two radiotherapy regimens in children and adolescents (aged 4 or 5 years to 21 years inclusive) with carefully staged 'standard risk' medulloblastoma.

status: Active, not recruiting

ReferenceCitation: Goschzik T, Schwalbe EC, Hicks D, Smith A, Zur Muehlen A, Figarella-Branger D, Doz F, Rutkowski S, Lannering B, Pietsch T, Clifford SC. Prognostic effect of whole chromosomal aberration signatures in standard-risk, non-WNT/non-SHH medulloblastoma: a retrospective, molecular analysis of the HIT-SIOP PNET 4 trial. Lancet Oncol. 2018 Dec;19(12):1602-1616. doi: 10.1016/S1470-2045(18)30532-1. Epub 2018 Nov 1.

apc_source: openAPC

family: Goschzik

full_name: Tobias Goschzik

given: Tobias

family: Schwalbe

full_name: Edward C Schwalbe

given: Edward C

family: Hicks

full_name: Debbie Hicks

given: Debbie

family: Smith

full_name: Amanda Smith

given: Amanda

family: zur Muehlen

full_name: Anja zur Muehlen

given: Anja

family: Figarella-Branger

full_name: Dominique Figarella-Branger

given: Dominique

family: Doz

full_name: François Doz

given: François

family: Rutkowski

full_name: Stefan Rutkowski

given: Stefan

family: Lannering

full_name: Birgitta Lannering

given: Birgitta

family: Pietsch

full_name: Torsten Pietsch

given: Torsten

family: Clifford

full_name: Steven C Clifford

given: Steven C

journal_name: The Lancet Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: Northumbria University - Northumbria Research Link

lead_sponsor: Institut Curie

intervention_type: Radiation

status_simplified: Ongoing


title: Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device

acronym: Nosten

summary: Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.

ReferenceCitation: Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50.

family: Jaillette

full_name: Emmanuelle Jaillette

given: Emmanuelle

family: Zerimech

full_name: Farid Zerimech

given: Farid

family: De Jonckheere

full_name: Julien De Jonckheere

given: Julien

family: Makris

full_name: Demosthenes Makris

given: Demosthenes

family: Balduyck

full_name: Malika Balduyck

given: Malika

family: Durocher

full_name: Alain Durocher

given: Alain

family: Duhamel

full_name: Alain Duhamel

family: Nseir

full_name: Saad Nseir

given: Saad

journal_name: BMC Anesthesiology

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

lead_sponsor: University Hospital, Lille


title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer

summary: Circulating tumor DNA detection and quantification in patients with ovarian cancer.

primary_purpose: Other


title: Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction

acronym: TETRADIA-UNI

summary: This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.

lead_sponsor: University Hospital, Rouen


title: Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing Whose Maturation Depends on the Protein HuR, Including Gene Encoding Insulin Receptor

acronym: METFORGENE

summary:
Main objective : Show that treatment with metformin in patients with type 2 diabetes has an effect on alternative splicing of the insulin receptor.

Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with discontinuation of treatment with metformin can be réversé by the resumption of metformin treatment.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète


title: Study Aiming to Collect Skin Samples of Diabetic Patients and Healthy Volunteers for Cellular Reprogramming, Within the Framework of New Therapeutic Strategies in Diabetes Treatment

summary: The main objective of this study is the Obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.


title: Scan Evaluation at 9 Years of the Bone Acetabular Supporting Cups Without Cement (Couple Metal/Metal in Diameter 28 mm)

acronym: ETOSA

summary: The couple of friction metal-polyethylene is regarded as the couple of reference in spite of the osteolysis induced by the wear of the polyethylene which remains the independent factor of long-term failure. This is all the more true as the patients are young, thus justifying the recourse to alternate couples of friction. The Metasul® couple was introduced on the French market under its current form in 1995 (year of its marking EC). The use of a couple of friction metal-metal (MM) is justified because it would be likely to improve longevity of the total arthroplasties of the active subjects by the reduction in osteolysis related to the wear of polyethylene. Various studies highlight evolutions different according to the types of fixing acetabular; favourable results of the not cemented cups contrasting with unsealings and the evolutionary edgings of the Metasul® cups cemented of or the cups "of cemented Weber type".

lead_sponsor: University Hospital, Clermont-Ferrand


lead_sponsor: Genethon

acronym: Gene therapy for WAS

title: Phase I/II Clinical Trial of Haematopoietic Stem Cell Gene Therapy for the Wiskott-Aldrich Syndrome

summary: This is a phase I/II study to evaluate the safety and efficacy of Hematopoietic Stem Cell genetherapy for the Wiskott-Aldrich Syndrome.


title: Neuromodulation in Post Stroke Dysphagia

summary: The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.


title: Phase I Clinical Study of AAV1-gamma-sarcoglycan Gene Therapy for Limb Girdle Muscular Dystrophy Type 2C

summary: The purpose of this trial is to study the evaluation of clinical safety and feasibility of gene therapy in patients with limb girdle muscular dystrophy type 2C (gamma-sarcoglycanopathy).


summary: The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine eye drops in the topical treatment of seasonal allergic conjunctivitis.

lead_sponsor: Laboratoires Thea


title: A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse After Immunosuppressive Therapy

acronym: APCORD

summary: This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an HLA identical donor;

ReferenceCitation: Peffault de Latour R, Chevret S, Jubert C, Sirvent A, Galambrun C, Ruggeri A, Gandemer V, Cornillon J, Rialland F, Dalle JH, Forcade E, Bruno B, Paillard C, Rorlich PS, Salmon A, Fürst S, Sicre de Fontbrune F, Rubio MT, Bay JO, Mohty M, Larghero J, Gluckman E, Socié G; Francophone Society of Bone Marrow Transplantation and Cellular Therapy. Unrelated cord blood transplantation in patients with idiopathic refractory severe aplastic anemia: a nationwide phase 2 study. Blood. 2018 Aug 16;132(7):750-754. doi: 10.1182/blood-2018-01-829630. Epub 2018 May 14.

name: Bone Marrow Transplantation (BMT) Unit, Saint Louis Hospital, Assistance Publique—Hôpitaux de Paris (AP-HP), Paris, France;

name: University Paris Diderot, Paris, France;

name: French Reference Center for Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria, Saint-Louis Hospital, Paris, France;

name: Severe Aplastic Anemia Working Party of the European Group for Blood and Marrow Transplantation, Leiden, The Netherlands;

family: Peffault de Latour

full_name: Regis Peffault de Latour

given: Regis

name: Biostatistic Unit, Saint Louis Hospital, AP-HP, Paris, France;

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

name: Pediatric BMT Unit, Bordeaux University Hospital, Bordeaux, France;

family: Jubert

full_name: Charlotte Jubert

given: Charlotte

name: Pediatric BMT Unit, Montpellier, France;

family: Sirvent

full_name: Anne Sirvent

given: Anne

family: Galambrun

full_name: Claire Galambrun

given: Claire

name: BMT Unit, Saint Antoine Hospital, AP-HP, Paris, France;

name: Department of Pediatric Hematology and Oncology, Istituto Di Ricovera e Cura a Carattere Scientifico (IRCCS) Bambino Gesù Pediatric Hospital, Rome, Italy;

family: Ruggeri

full_name: Annalisa Ruggeri

given: Annalisa

family: Gandemer

full_name: Virginie Gandemer

given: Virginie

name: BMT Unit, Lucien Neuwirth Oncology Institute, Saint-Priest-en-Jarez, France;

family: Cornillon

full_name: Jérôme Cornillon

given: Jérôme

family: Rialland

full_name: Fanny Rialland

given: Fanny

name: Pediatric BMT Unit, Robert-Debré, AP-HP, Paris, France;

family: Dalle

full_name: Jean-Hugues Dalle

given: Jean-Hugues

name: BMT and Cell Therapy Unit, Bordeaux, France;

family: Forcade

full_name: Edouard Forcade

given: Edouard

family: Bruno

full_name: Benedicte Bruno

given: Benedicte

family: Paillard

full_name: Catherine Paillard

given: Catherine

family: Rorlich

full_name: Pierre S. Rorlich

given: Pierre S.

family: Salmon

full_name: Alexandra Salmon

given: Alexandra

family: Fürst

full_name: Sabine Fürst

given: Sabine

family: Sicre de Fontbrune

full_name: Flore Sicre de Fontbrune

given: Flore

family: Rubio

full_name: Marie Therese Rubio

given: Marie Therese

family: Bay

full_name: Jacques-Olivier Bay

given: Jacques-Olivier

name: INSERM Unité Mixte de Recherche 938, Paris, France;

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

name: Cell Therapy Unit, Saint Louis Hospital, AP-HP, Paris, France;

name: INSERM Clinical Investigation Center–Biological Therapy (Centre d'investigation clinique en biothérapie; CBT501), Paris, France; and

family: Larghero

full_name: Jerome Larghero

given: Jerome

name: Eurocord, Saint Louis Hospital, AP-HP, Paris, France

family: Gluckman

full_name: Eliane Gluckman

given: Eliane

family: Socié

full_name: Gerard Socié

given: Gerard


title: Glycemic and Insulinemic Index Determination of 2 Products: Fructilight® and A Fruit Fructo-Oligosaccharides in Sweet Matrix

acronym: IGNUT

summary: The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups : FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.

lead_sponsor: CRITT Bio-Industries


summary: The purpose of this study is to evaluate the correlation between morphologic changes in the outer retina and visual function after successful repair of rhegmatogenous retinal detachment with macula off.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: INAPEN Protocol for Impact of Breakfast Improvement on the Nutritional Status of Hospitalized Patients (INcidence de l'Amélioration du Petit-déjeuner Sur l'Etat Nutritinonel Des Patients hospitalisés)

acronym: INAPEN

summary:
Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving patient nutritional status include improving the characteristics of the food provided to increase both protein and calorie intake in at-risk patients that do not require enteral or parenteral nutrition. Looking at the various daily meals, the investigators considered that breakfast following the night fast would be the easiest meal to improve .

Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care

ReferenceCitation: Rapport complet de l'ANAES :Evaluation diagnostique de la dénutrition protéino-énergétique des adultes hospitalises. September 2003; http://www.has-sante.fr

ReferenceCitation: Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6.

ReferenceCitation: Circulaire DHOS/E1 N°2002-186 29/03/2002 relative à l'alimentation et la nutrition dans les établissements de santé: J off de la République Française 18/04/2002

ReferenceCitation: Kudsk KA, Tolley EA, DeWitt RC, Janu PG, Blackwell AP, Yeary S, King BK. Preoperative albumin and surgical site identify surgical risk for major postoperative complications. JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):1-9.

ReferenceCitation: Edington J, Boorman J, Durrant ER, Perkins A, Giffin CV, James R, Thomson JM, Oldroyd JC, Smith JC, Torrance AD, Blackshaw V, Green S, Hill CJ, Berry C, McKenzie C, Vicca N, Ward JE, Coles SJ. Prevalence of malnutrition on admission to four hospitals in England. The Malnutrition Prevalence Group. Clin Nutr. 2000 Jun;19(3):191-5.

ReferenceCitation: Somanchi M, Tao X, Mullin GE. The facilitated early enteral and dietary management effectiveness trial in hospitalized patients with malnutrition. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):209-16. doi: 10.1177/0148607110392234.

lead_sponsor: Centre Hospitalier de Meaux


title: Randomized Phase II Trial Seeking the Most Promising Drug Association With Azacitidine- in Higher Risk Myelodysplastic Syndromes

acronym: AZA-PLUS

summary:
In order to improve the overall survival benefit observed with AZA in higher risk MDS, its combination with other active drugs in MDS must be tested.

Among drugs that have demonstrated to be active as a single agent in MDS and have preclinical potential additive or synergistic activity with AZA are Histone deacetylase (HDAC) inhibitors including Valproic acid, Lenalidomide and idarubicin. Phase I studies have already been conducted or are being conducted combining those agents to demethylating agents, showing a low toxicity profile and significant responses in high risk MDS. In this phase II randomized trial, we want to identify the most promising combination of Azacitidine and another drug (among 3 drugs: Valproic acid, Lenalidomide and Idarubicin) in higher risk MDS, by comparison to Azacitidine alone. Of note, based on efficacy and toxicity, one or several combinations may be stopped, and others, previously tested in phase I trials, included after protocol amendment.

ReferenceCitation: Jacob L, Uvarova M, Boulet S, Begaj I, Chevret S. Evaluation of a multi-arm multi-stage Bayesian design for phase II drug selection trials - an example in hemato-oncology. BMC Med Res Methodol. 2016 Jun 2;16:67. doi: 10.1186/s12874-016-0166-7.

family: Jacob

full_name: Louis Jacob

given: Louis

family: Uvarova

full_name: Maria Uvarova

given: Maria

family: Boulet

full_name: Sandrine Boulet

given: Sandrine

family: Begaj

full_name: Inva Begaj

given: Inva

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

journal_name: BMC Medical Research Methodology

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

title: Evaluation of a multi-arm multi-stage Bayesian design for phase II drug selection trials – an example in hemato-oncology

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson Disease

acronym: MIREILLE

summary: The purpose of this study is to evaluate the efficacy of repeated (monthly) injections of bee venom on motor symptoms of Parkinson's disease over a period of one year, also the potential effects of this treatment on disease progression compared to placebo (saline injections).

ReferenceCitation: Hartmann A, Müllner J, Meier N, Hesekamp H, van Meerbeeck P, Habert MO, Kas A, Tanguy ML, Mazmanian M, Oya H, Abuaf N, Gaouar H, Salhi S, Charbonnier-Beaupel F, Fievet MH, Galanaud D, Arguillere S, Roze E, Degos B, Grabli D, Lacomblez L, Hubsch C, Vidailhet M, Bonnet AM, Corvol JC, Schüpbach M. Bee Venom for the Treatment of Parkinson Disease - A Randomized Controlled Clinical Trial. PLoS One. 2016 Jul 12;11(7):e0158235. doi: 10.1371/journal.pone.0158235. eCollection 2016. Erratum in: PLoS One. 2016;11(9):e0162937.

family: Hartmann

full_name: Andreas Hartmann

given: Andreas

family: Müllner

full_name: Julia Müllner

given: Julia

family: Meier

full_name: Niklaus Meier

given: Niklaus

family: Hesekamp

full_name: Helke Hesekamp

given: Helke

family: van Meerbeeck

full_name: Priscilla van Meerbeeck

given: Priscilla

family: Habert

full_name: Marie-Odile Habert

given: Marie-Odile

family: Kas

full_name: Aurélie Kas

given: Aurélie

family: Tanguy

full_name: Marie-Laure Tanguy

given: Marie-Laure

family: Mazmanian

full_name: Merry Mazmanian

given: Merry

family: Oya

full_name: Hervé Oya

given: Hervé

family: Abuaf

full_name: Nissen Abuaf

given: Nissen

family: Gaouar

full_name: Hafida Gaouar

given: Hafida

family: Salhi

full_name: Sabrina Salhi

given: Sabrina

family: Charbonnier-Beaupel

full_name: Fanny Charbonnier-Beaupel

given: Fanny

family: Fievet

full_name: Marie-Hélène Fievet

given: Marie-Hélène

family: Galanaud

full_name: Damien Galanaud

given: Damien

family: Arguillere

full_name: Sophie Arguillere

given: Sophie

family: Roze

full_name: Emmanuel Roze

given: Emmanuel

family: Degos

full_name: Bertrand Degos

given: Bertrand

family: Grabli

full_name: David Grabli

given: David

family: Lacomblez

full_name: Lucette Lacomblez

given: Lucette

family: Hubsch

full_name: Cécile Hubsch

given: Cécile

family: Vidailhet

full_name: Marie Vidailhet

given: Marie

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

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

title: Bee Venom for the Treatment of Parkinson Disease – A Randomized Controlled Clinical Trial

ReferenceCitation: Maurice N, Deltheil T, Melon C, Degos B, Mourre C, Amalric M, Kerkerian-Le Goff L. Bee Venom Alleviates Motor Deficits and Modulates the Transfer of Cortical Information through the Basal Ganglia in Rat Models of Parkinson's Disease. PLoS One. 2015 Nov 16;10(11):e0142838. doi: 10.1371/journal.pone.0142838. eCollection 2015.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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

title: Bee Venom Alleviates Motor Deficits and Modulates the Transfer of Cortical Information through the Basal Ganglia in Rat Models of Parkinson’s Disease


title: Red Blood Cells (RBC) Transfusion Related to Central Venous O2 Saturation

summary:
The objective of this study is to estimate red blood cells (RBC) transfusion related to central venous O2 saturation (ScvO2) measurement. This prospective, randomized trial is performed in visceral, vascular and thoracic surgery units in the university hospital of Lille.

One hundred patients need to be included. Inclusion criteria are: age 18 to 99 year old, patient with central venous catheter in place and fulfilling the haemoglobin (Hb) threshold criteria for RBC transfusion according to the XXIIIth French Consensus Conference in critical care medicine recommendations.

After randomisation, patients will be eligible to receive RBC according to their level of Hb in the standard group and according to the Hb and ScvO2 in the optimization group. Patients without any disease are transfused if their Hb level is below 7g/dL; patients older than 60 years or having sepsis are transfused if their Hb level is 8g/dL or lower and cardiac patients are transfused if their Hb level is 9g/dL or lower. In the second group, transfusion is performed if and only if the ScvO2 level is les than 70% when Hb is under the same threshold levels.

The primary aim of the study is to compare the number of RBC units transfused by group (standard group or optimization group) over a period of 5 days counted from the first decision of transfusion taken post-operative. Considering the randomisation and considering the 50 % reduction of the decisions of transfusion in the group optimization, the absolute blood savings is estimated 25 % for the whole population. Secondary end points include the number of side effects associated with transfusion or when avoiding transfusion, length of hospital stay, and hospital mortality as well as major adverse events.