title: Implementation of Innovative Techniques in Routine Diagnosis of Childhood Acute Leukemia: Analysis of Genome and Transcriptome by Micro-array

summary:
Acute leukemias are a heterogeneous group of malignancies characterized by the abnormal proliferation of a cell clone in the bone marrow, having as origin lymphocytic or myeloid lineage. The repertoire of mutations that determine the leukemic transformation, complex and variable depending on the tumor type and progression of the disease, combined in the same cell of balanced and unbalanced chromosomal aberrations, point mutations and epigenetic abnormalities.

The project presented here is part of a comprehensive approach to diagnosis of hematologic malignancies of children. Using comparative genomic hybridization on microarray (or array- CGH) and transcriptome analysis by microarray, two innovative techniques for a comprehensive analysis of the genome and transcriptome , offer new perspectives identifying molecular defects . These techniques provide new elements in the identification of acute leukemia at diagnosis may identify new prognostic factors to optimize the care of patients.

This project involves both the Department of Medical Genetics (Prof. N. LEVY ) regarding the identification of genomic abnormalities associated with childhood leukemia , the Laboratory of Hematology of the Hospital de la Timone ( Prof. Pierre Morange ) in terms of the phenotypic characterization of tumor cells, and the Onco - Hematology Pediatric Department (Prof. Michel Gerard ) which provides diagnosis, treatment , monitoring and the bone marrow of children with hematologic malignancies . The following project is mainly focused on the identification of genomic abnormalities (deletions and duplications) and abnormalities in gene expression to identify a genetic profile ensuring a better classification within the different groups risk .

The project we propose is centered on the identification of genomic abnormalities , changing the number of copies of certain regions of the genome or determining loss of heterozygosity , and the identification of changes in the level of gene expression by using two analytical techniques, comparative genomic hybridization on microarray (or array- CGH) and expression studies with microarrays . The data generated will , for the identification of " molecular signatures " , the classification of patients according to prognosis , variations in treatment response and survival.

The originality of this project lies in the use of these new tools in the diagnosis of hematological malignancies in children. This pilot study will be conducted with commercial Affymetrix , will develop the chips ' processing' , dedicated , enriched probes corresponding to genes involved in leukemogenesis , with high discriminatory power in identifying these signatures.

The data published in the specialized literature from the study of large series of patients show that microarrays provide important information for the diagnosis and therapeutic management of patients. It is for this reason that in the end we hope to integrate these analyzes in routine diagnosis to complement other analyzes ( phenotyping , identification of fusion genes and sequencing) in order to further characterize the abnormal cells leukemia and establish an " identity card of leukemia .

location_facility: Assistance Publique Hôpitaux de Marseille


title: Persistent Platelet Reactivity in Acute Coronary Syndrome

summary: Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Hopital Lariboisière

location_facility: Department of Cardiology - Lariboisiere Hospital

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Randomized Study Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring

acronym: Cognides

summary:
The recovery of cognitive and psychomotor functions is best performed under anesthesia after desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing SSPI.

The principal objective is to compare the cognitive and psychomotor status of patients recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane) using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory (visual verbal learning test) made SSPI.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug

status_simplified: Completed


title: Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx

summary: The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Chabrillac E, Espinasse G, Lepage B, Uro-Coste E, Dupret-Bories A, De Bonnecaze G, Vergez S. Contribution of narrow band imaging in delineation of laryngopharyngeal superficial cancer spread: a prospective study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1491-1497. doi: 10.1007/s00405-020-06499-2. Epub 2021 Jan 5.

family: Chabrillac

full_name: Emilien Chabrillac

given: Emilien

sequence: first

family: Espinasse

full_name: Gaël Espinasse

given: Gaël

sequence: additional

family: Lepage

full_name: Benoît Lepage

given: Benoît

family: Uro-Coste

full_name: Emmanuelle Uro-Coste

given: Emmanuelle

family: Dupret-Bories

full_name: Agnès Dupret-Bories

given: Agnès

family: De Bonnecaze

full_name: Guillaume De Bonnecaze

given: Guillaume

family: Vergez

full_name: Sébastien Vergez

given: Sébastien

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Archives of Oto-Rhino-Laryngology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

intervention_type: Procedure


title: Effect of Apelin on Insulin Sensitivity: Proof of Concept in Healthy Volunteers

acronym: APELINS

summary:
The (PYR1)-apelin-13 is an endogenous peptide discovered relatively recently (1998). The apelin and its receptor, which is named apj, are expressed in many tissues including sensitive to the action of insulin, such as skeletal muscle, adipose tissue and heart tissue.

Recent work by the team of Prof. P.Valet (INSERM U1048, Toulouse) opened a new field of investigation, demonstrating for the first time in mouse models that apelin exerts a glucose-regulating in vivo action. The investigators propose a translational clinical research project whose goal is to provide the proof of concept of the favorable influence of apelin on insulin sensitivity in humans.

primary_purpose: Basic Science

ReferenceType: result

ReferenceCitation: Gourdy P, Cazals L, Thalamas C, Sommet A, Calvas F, Galitzky M, Vinel C, Dray C, Hanaire H, Castan-Laurell I, Valet P. Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic-euglycaemic clamp. Diabetes Obes Metab. 2018 Jan;20(1):157-164. doi: 10.1111/dom.13055. Epub 2017 Aug 10.

name: Service de Diabétologie, Maladies Métaboliques et Nutrition, Institut CardiometCHU de Toulouse Toulouse France

name: Institut des Maladies Métaboliques et Cardiovasculaires, INSERM U1048Université de Toulouse, UPS Toulouse France

family: Gourdy

full_name: Pierre Gourdy

given: Pierre

family: Cazals

full_name: Laurent Cazals

given: Laurent

name: Centre d'Investigation Clinique (CIC)CHU de Toulouse Toulouse France

family: Thalamas

full_name: Claire Thalamas

given: Claire

name: Unité de Soutien Méthodologique à la Recherche Clinique (USMR)CHU de Toulouse Toulouse France

family: Sommet

full_name: Agnès Sommet

family: Calvas

full_name: Fabienne Calvas

given: Fabienne

family: Galitzky

full_name: Monique Galitzky

given: Monique

family: Vinel

full_name: Claire Vinel

family: Dray

full_name: Cédric Dray

given: Cédric

family: Hanaire

full_name: Hélène Hanaire

given: Hélène

family: Castan‐Laurell

full_name: Isabelle Castan‐Laurell

given: Isabelle

family: Valet

full_name: Philippe Valet

given: Philippe

journal_name: Diabetes, Obesity and Metabolism

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Apelin administration improves insulin sensitivity in overweight men during hyperinsulinaemic‐euglycaemic clamp


title: Neurological and Psychiatric Comorbidities Patients With FSHD 1 and 2

summary: The investigators propose to conduct a comparative pilot cognitive and psychiatric profiles of 10 patients Facio-Scapulo-Humeral Dystrophy (= FHSD) type 1 and 10 patients with type 2 FSHD study. For this, the investigators relied on observational components: FSHD2 patients appear more often present with psychiatric comorbidities and seem to have lower cognitive performance compared to FSHD1 patients. This was confirmed by a preliminary study on a small sample population of patients. It seems to exist mainly executive dysfunction associated with attention disorders in patients FSHD2. Moreover, their performance in IQ tests would be low in relation to their socio-educational and compared with patients FSHD1 level.

study_start_date_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Behavioral


title: Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

acronym: RESPPEDHEM

summary: Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

primary_purpose: Screening

intervention_type: Other


acronym: SEDULC

summary: The purpose of this study is to determine whether consumption of carbonated drinks containing sweeteners affect insulin sensitivity.

primary_purpose: Other

ReferenceCitation: Bonnet F, Tavenard A, Esvan M, Laviolle B, Viltard M, Lepicard EM, Lainé F. Consumption of a Carbonated Beverage with High-Intensity Sweeteners Has No Effect on Insulin Sensitivity and Secretion in Nondiabetic Adults. J Nutr. 2018 Aug 1;148(8):1293-1299. doi: 10.1093/jn/nxy100.

name: Centre Hospitalo-Universitaire (CHU) Rennes, Rennes, France

name: Clinical Investigation Center of Rennes, National Institute of Health and Scientific Research (CIC-INSERM 0203), Rennes, France

family: Bonnet

full_name: Fabrice Bonnet

given: Fabrice

family: Tavenard

full_name: Aude Tavenard

given: Aude

family: Esvan

full_name: Maxime Esvan

given: Maxime

family: Laviolle

full_name: Bruno Laviolle

given: Bruno

name: Institute for European Expertise in Physiology, Paris, France

family: Viltard

full_name: Mélanie Viltard

given: Mélanie

family: Lepicard

full_name: Eve M Lepicard

given: Eve M

family: Lainé

full_name: Fabrice Lainé

bso_classification: Biology (fond.)

journal_name: The Journal of Nutrition

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Institute For European Expertise in Physiology

location_facility: Unit of Clinical Investigation,Centre Hospitalo-Universitaire de Rennes

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


title: Determination of the Effective Individual Dose of Etanercept in Patients Treated for Juvenile Idiopathic Arthritis

acronym: Etaplus

summary: The purpose of this study is to determine the optimal dosage of etanercept in patients treated for idiopathic juvenile arthritis

intervention_type: Genetic


title: Effect of Three Therapeutic Strategies on the Restriction of the Participation of Patients With a Chronic Back Pain : Multidisciplinary is it the Key Component ?

acronym: PLURICLEF

summary: Effect of three therapeutics strategies on the restriction of the participation of patients with a chronic back pain : multidisciplinary is it the key component ?

ReferenceType: background

ReferenceCitation: Bontoux L, Roquelaure Y, Billabert C, Dubus V, Sancho PO, Colin D, Brami L, Moisan S, Fanello S, Penneau-Fontbonne D, Richard I. [Prospective study of the outcome at one year of patients with chronic low back pain in a program of intensive functional restoration and ergonomic intervention. Factors predicting their return to work]. Ann Readapt Med Phys. 2004 Oct;47(8):563-72. French.

ReferenceCitation: Leclerc A, Chastang JF, Ozguler A, Ravaud JF. Chronic back problems among persons 30 to 64 years old in France. Spine (Phila Pa 1976). 2006 Feb 15;31(4):479-84.

ReferenceCitation: Leggett S, Mooney V, Matheson LN, Nelson B, Dreisinger T, Van Zytveld J, Vie L. Restorative exercise for clinical low back pain. A prospective two-center study with 1-year follow-up. Spine (Phila Pa 1976). 1999 May 1;24(9):889-98.

ReferenceCitation: Jousset N, Fanello S, Bontoux L, Dubus V, Billabert C, Vielle B, Roquelaure Y, Penneau-Fontbonne D, Richard I. Effects of functional restoration versus 3 hours per week physical therapy: a randomized controlled study. Spine (Phila Pa 1976). 2004 Mar 1;29(5):487-93; discussion 494.

ReferenceCitation: Biering-Sørensen F. Physical measurements as risk indicators for low-back trouble over a one-year period. Spine (Phila Pa 1976). 1984 Mar;9(2):106-19.

ReferenceCitation: Ronzi Y, Roche-Leboucher G, Bègue C, Dubus V, Bontoux L, Roquelaure Y, Richard I, Petit A. Efficiency of three treatment strategies on occupational and quality of life impairments for chronic low back pain patients: is the multidisciplinary approach the key feature to success? Clin Rehabil. 2017 Oct;31(10):1364-1373. doi: 10.1177/0269215517691086. Epub 2017 Feb 13.

name: Department of Physical Medicine and Rehabilitation, University Hospital of Angers, Angers, France

family: Ronzi

full_name: Yoann Ronzi

given: Yoann

family: Roche-Leboucher

full_name: Ghislaine Roche-Leboucher

given: Ghislaine

name: Department of General Practice, University of Angers, Angers, France

family: Bègue

full_name: Cyril Bègue

given: Cyril

family: Dubus

full_name: Valerie Dubus

given: Valerie

family: Bontoux

full_name: Luc Bontoux

given: Luc

name: Occupational Health Department, University Hospital of Angers, Angers, France

name: LUNAM University, University of Angers, Angers, France

family: Roquelaure

full_name: Yves Roquelaure

given: Yves

family: Richard

full_name: Isabelle Richard

family: Petit

full_name: Audrey Petit

given: Audrey

journal_name: Clinical Rehabilitation

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Petit A, Roche-Leboucher G, Bontoux L, Dubus V, Ronzi Y, Roquelaure Y, Richard I. Effectiveness of three treatment strategies on occupational limitations and quality of life for patients with non-specific chronic low back pain: Is a multidisciplinary approach the key feature to success: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 16;15:131. doi: 10.1186/1471-2474-15-131.

full_name: Valérie Dubus

given: Valérie

full_name: Yohann Ronzi

given: Yohann

currency_apc_doaj: GBP

journal_name: BMC Musculoskeletal Disorders

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

location_facility: University Hospital of Angers, laboratory epidemiology, ergonomics and occupational health


title: Evaluation de l'intérêt de l'électrostimulation Intra-vaginale à Domicile Par Rapport à Une Prise en Charge Habituelle Dans la Prise en Charge de Patientes Incontinentes Ayant bénéficié d'Une rééducation périnéale

summary: The aim of this study is to assess the benefit of GYNEFFIK®, a perineal electro-stimulator, during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI), that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK® electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained.

design_allocation: Non-Randomized

lead_sponsor: Effik


title: Search for Biological Markers of Orosensory Perception of Fatty Acids in Healthy Subjects and Possible Modifications in Patients With Type 2 Diabetes and in Obese Non-diabetic Patients.

summary:
Animal studies have shown that stimulation of the lingual lipid-receptor, CD 36, is accompanied by the rapid secretion of hormones in the digestive tract (incretines). We aim to determine in healthy humans whether the orosensory perception of fatty acids is followed by a modification in plasma levels of digestive tract hormones (cholecystokinin, GIP, GLP-1, secretin, pancreatic peptide, peptide YY, insulin) and metabolic markers from adipose tissue (leptin, ghrelin, adiponectin).

We also aim to determine whether the hormonal response induced by orosensory stimulation by lipids is modified:

in patients with type 2 diabetes
in obese non-diabetic patients We expect to show an increase in biological markers biological, and more particularly in certain digestive hormones such as Pancreatic polypeptide, GIP, GLP-1…after stimulation of the lingual lipid receptor, CD36. We will also determine whether or not this response is modified in patients with type 2 diabetes and in obese non-diabetic patients.

We also wish to measure the subjects' gustatory detection threshold for a fatty acid (linoleic acid), and to determine whether there is a relationship between the orosensory perception threshold for linoleic acid and the physiological status of the subjects. In order to achieve this, the thresholds for healthy subjects will be compared with thresholds for obese and diabetic subjects. Expected results: the threshold of detection for linoleic acid in healthy subjects will be lower than that in obese or diabetic patients.

ReferenceCitation: Besnard P, Christensen JE, Bernard A, Simoneau-Robin I, Collet X, Verges B, Burcelin R. Identification of an oral microbiota signature associated with an impaired orosensory perception of lipids in insulin-resistant patients. Acta Diabetol. 2020 Dec;57(12):1445-1451. doi: 10.1007/s00592-020-01567-9. Epub 2020 Jul 16.

apc_source: openAPC

family: Besnard

full_name: Philippe Besnard

family: Christensen

full_name: Jeffrey E. Christensen

given: Jeffrey E.

family: Bernard

full_name: Arnaud Bernard

given: Arnaud

family: Simoneau-Robin

full_name: Isabelle Simoneau-Robin

given: Isabelle

family: Collet

full_name: Xavier Collet

given: Xavier

family: Verges

full_name: Bruno Verges

family: Burcelin

full_name: Rémy Burcelin

given: Rémy

journal_name: Acta Diabetologica

oa_colors: green hybrid

evidence: open (via crossref license)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

ReferenceCitation: Chevrot M, Passilly-Degrace P, Ancel D, Bernard A, Enderli G, Gomes M, Robin I, Issanchou S, Vergès B, Nicklaus S, Besnard P. Obesity interferes with the orosensory detection of long-chain fatty acids in humans. Am J Clin Nutr. 2014 May;99(5):975-83. doi: 10.3945/ajcn.113.077198. Epub 2014 Feb 12.

family: Chevrot

full_name: Michael Chevrot

given: Michael

family: Passilly-Degrace

full_name: Patricia Passilly-Degrace

given: Patricia

family: Ancel

full_name: Déborah Ancel

given: Déborah

family: Enderli

full_name: Géraldine Enderli

given: Géraldine

family: Gomes

full_name: Marlène Gomes

given: Marlène

family: Robin

full_name: Isabelle Robin

family: Issanchou

full_name: Sylvie Issanchou

given: Sylvie

family: Vergès

full_name: Bruno Vergès

family: Nicklaus

full_name: Sophie Nicklaus

given: Sophie

journal_name: The American Journal of Clinical Nutrition


title: LIDA-B: Treatment of Cirrhosis-related Hepatocellular Carcinoma With the Intrahepatic Arterial Injection of an Emulsion of Lipiodol and Idarubicin (Zavedos®): Phase I Study

summary:
Unresectable, non-metastatic cirrhosis-related hepatocellular carcinoma (HCC) has a poor prognosis as there are no recommended curative treatments. Chemoembolisation is the most widely used treatment in these patients, but this technique can prove to be toxic. intrahepatic arterial chemotherapy with lipiodol and idarubicin could be an effective therapeutic approach, without deteriorating liver function.

The rationale for this treatment can be resumed as follows:

HCC are vascularised via the hepatic artery system
The IHA perfusion of anthracyclines leads to high elimination via the liver with low systemic concentrations
The absence of embolisation reduces toxicity
the toxiciity profile of idarubicin is well known and the drug is widely used for the IV treatment of leukemia
idarubicin is the most cytotoxic drug for tumor cell lines.
The in vitro cytotoxicity of idarubicin is 100% at low concentrations
Lipiodol can stay in contact with tumor tissue for several weeks after injection and act as a vector for the drug
The idarubicin-lipiodol is more stable than lipidol emulsions usually given by intraarterial injection
The emulsion is more stable with idarubicin than with other anticancer molecules
Sequential inclusion in accordance with the "continual reassessment method" makes it possible to increase inclusions at a target toxicity level while reducing inclusions at doses that are too low or too toxic The aim of the treatment is to improve survival.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of the Impact of the Regular Consumption of Polyphenol-rich Grape Juice on the Biological Parameters of Oxidative Stress and on Endothelial Function in Healthy Subjects: a Prospective Randomised Double-blind Study

acronym: Fijus Raisol

summary:
Many epidemiological and clinical studies have suggested the negative effect of oxidative stress ( = attack of cell components by free radicals) on the cardiovascular risk, notably in patients with metabolic syndrome, insulin resistance, diabetes or obesity and smokers.

Polyphenols, notably those present in red grapes, have a certain antioxidant effect. Dietary supplementation with polyphenols in high-risk patients could diminish the harmful consequences of oxidative stress.

The aim of this study is to show that the daily consumption of grape juice rich in polyphenols " R@isol ", has a positive impact on the oxidation/antioxidation balance in healthy volunteers.


title: Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion

acronym: EMPHILINE

summary: The main objective is to compare the physiological reactivity (heart and respiratory rates, galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion between depressive subjects, subjects remitted from depression and control subjects.

lead_sponsor: University Hospital, Tours

intervention_type: Device


title: Phase I / II Study of Sequential High-dose Chemotherapy With Stem Cell Support in Children Younger Than 5 Years of Age With High-risk Medulloblastoma

acronym: HR MB-5

summary:
The trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a phase II trial, and ii) a dose-finding part.

The Phase II trial is an open label, non-randomized, multicentre trial without control group. A Bayesian approach will be used to analyse the EFS, assuming a cure model. We will use three prior distributions of the EFS; (1) an enthusiastic prior distribution, (2) a pessimistic prior distribution, and (3) a non-informative prior distribution. As the patient outcomes in the trial will be recorded, the subsequent distribution of the outcome probability under experimental treatment will be computed by applying Bayes' theorem, which yields an estimated EFS probability with a 95% credibility interval (measure of Bayesian precision). Two interim analyses are planned to monitor the efficacy data (early stopping rules for futility or inefficacy).

The final analysis of efficacy will be made on an intention to treat basis, including all recruited patients, 3 years after recruitment of the last patient.

Due to the uncertainty on the dose of cyclophosphamide that can be given in combination with Busilvex for the last chemotherapy course in patients in complete response after intensification chemotherapy treatment, a dose-finding subtrial will be performed to address this issue (Phase I part). The dose escalation of cyclophosphamide will be performed using the Continual Reassessment Method in a Bayesian framework.

status: Active, not recruiting

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

status_simplified: Ongoing


type: Registry Identifier

title: Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

summary: Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

lead_sponsor: Laboratoires Thea


title: Prospective Study on Oncologic Cerebral Imagery Contribution by 18F-FDOPA Position Emission Tomography (PET) in a Multidisciplinary Meeting Therapeutic Proposal When Caring for Patients Diagnosed Primary or Secondary Cerebral Tumors

acronym: IMOTEP

summary:
In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral tumor, there is currently complex clinical situations in which the clinic and Magnetic Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive diagnosis. The therapeutic proposition requires then a delay in additional follow-up of at least 3 months in order to clarify the situation, with a potential delay in diagnosis and therefore therapeutic care. The contribution of cerebral molecular imagery could allow for new additional information to be brought in or to increase the confidence index in the diagnosis in order to comfort the therapeutic collective attitude proposed in the multidisciplinary meeting (MM).

3.4-dihydroxy-6-18F-fluoro-L-phenylalanine (18F-FD0PA), dopamine precursor amino-acid, Position Emission Tomography (PET), allows for the studying in vivo of the proteic transmembrane transport in gliomatous tissue; active transport happens through a sodic-independent canal, increased in malicious transformations, and in which kinetics can give an indication regarding the development of the primary tumor.

In MRIs, tumor tissue growth after injecting the contrast product translates to a rupture in the Blood-Brain Barrier (BBB), while tumor extraction from the radiopharmaceutical is independent of the state of integrity of the BBB and whose only function is metabolic tissue activity. This method of imagery thus appears as a promising contribution to conventional imagery.

Furthermore, different to 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose), similar to the largely used glucose in oncologic molecular imagery, exploration of harmful glioma in 18F-FDOPA, is not compromised by background noise activity, and is almost useless in a healthy cerebral cortex, with the exception of striatal physiological fixation used as a level of reference. The best performances in terms of positive and negative predictive value were defined in the literature with a tumor/striatum threshold of 1.

According to the latest and current European recommendations, turning to PET when caring for high-level gliomas patients can be proposed in the evaluation of therapeutic responses. However, very few studies have evaluated the in-practice current clinical contributions of PET and put it into perspective with classic clinical radiological data.

lead_sponsor: Centre Antoine Lacassagne


title: Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases

acronym: CVassist

summary: Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital capacity (VC) according to pathology and severity of pulmonary damage of patients with neuromuscular diseases. The methodology consists in realize VC by support of inspiratory/expiratory pressures, while the patient is passive and realizing a maximal inspiratory/expiratory effort simultaneously, with the aid of mechanical insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes and the non-inclusion criteria are those for an insufflation. The study hypothesis is that long term insufflation/exsufflation device use could improve thoracopulmonary mobility.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Prospective Monocentric Study on the Efficacy of Lidocain Spray for Patient Comfort During Nasogastric Tube Insertion in Enteral Nutrition: the Xylonut Trial

acronym: Xylonut

summary:
Enteral nutrition is the treatment of choice for malnourish patient. Nasogastric tube (NGT) is although a common act. Unfortunately, this procedure can be painful. Also, many patients will need many NGT re-insertion. Therefore, the investigators need to increase the acceptability of this procedure by increasing comfort during NGT passage. Professionals guidelines of HAS (recommendations professionnelles de bonne pratiques de soins) and SFNEP (Société Française de Nutrition Clinique et Métabolisme) talk about the possibility of using local anesthesic without ordering their use. However, NGT tube insertion is often put without pre-medication in the face of an accumulating body of evidence indicating that local anesthetic prior NGT insertion decrease discomfort of the procedure. On the other hand, these studies have been done in the emergency room with NGT of a bigger gauge and for many reasons except enteral nutrition.

The investigators primary objective of this prospective monocentric study is to evaluate the efficacy (patient comfort) of lidocaine 5 % spray versus placebo (physiologic serum) before NGT insertion in patient needing enteral nutrition, using visual analogue scale. Secondary objectives are to evaluate nurse and patient satisfaction using questionnaires, facility of NGT insertion using Likert scale, numbers of try, time of procedure, complications like tracheal insertion and success of the insertion using thorax x-ray.

The study will be held in CHU Nice at nutrition unit support. After signed consentment, patients will be separate in two groups : group A (lidocaïne spray 5 %) and group B (physiologic serum). There will be 2 spray in nostril and 2 in orophagyngeal cavity 2 minutes before NGT insertion, which will be done by a competent nurse. Vital signs will be noted at the beginning of the procedure and 10 minutes after. At the end, the nurse and the patient will have to answer a questionnaire. Pain will be grade using visual analogue scale immediately after the procedure. Demographic data and complications will be note by the investigator. Finally, thorax X-ray will be done at the end of the procedure. There will be 34 patients by group. If the investigators find a benefit, this can change their practice and guidelines.


title: The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery

acronym: ElastoMAP

summary: The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.

acronym: Splash

summary: The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of splenectomy

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ReferenceCitation: Barquist ES, Pizano LR, Feuer W, Pappas PA, McKenney KA, LeBlang SD, Henry RP, Rivas LA, Cohn SM. Inter- and intrarater reliability in computed axial tomographic grading of splenic injury: why so many grading scales? J Trauma. 2004 Feb;56(2):334-8.

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ReferenceCitation: Fingerhut A, Oberlin P, Cotte JL, Aziz L, Etienne JC, Vinson-Bonnet B, Aubert JD, Rea S. Splenic salvage using an absorbable mesh: feasibility, reliability and safety. Br J Surg. 1992 Apr;79(4):325-7.

ReferenceCitation: Madoff DC, Denys A, Wallace MJ, Murthy R, Gupta S, Pillsbury EP, Ahrar K, Bessoud B, Hicks ME. Splenic arterial interventions: anatomy, indications, technical considerations, and potential complications. Radiographics. 2005 Oct;25 Suppl 1:S191-211. Review.

ReferenceCitation: Caceres M, Buechter KJ, Tillou A, Shih JA, Liu D, Steeb G. Thoracic packing for uncontrolled bleeding in penetrating thoracic injuries. South Med J. 2004 Jul;97(7):637-41.

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ReferenceCitation: Hiraide A, Yamamoto H, Yahata K, Yoshioka T, Sugimoto T. Delayed rupture of the spleen caused by an intrasplenic pseudoaneurysm following blunt trauma: case report. J Trauma. 1994 May;36(5):743-4.

ReferenceCitation: Dror S, Dani BZ, Ur M, Yoram K. Spontaneous thrombosis of a splenic pseudoaneurysm after blunt abdominal trauma. J Trauma. 2002 Aug;53(2):383-5.

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ReferenceCitation: Paya K, Wurm J, Graf M, Pichler P, Oertl M, Mayerhoffer W, Engels M. Intrasplenic posttraumatic pseudoaneurysm secondary to spleen-salvaging surgery. J Trauma. 2002 Apr;52(4):783-5; discussion 785.

ReferenceCitation: Oguz B, Cil B, Ekinci S, Karnak I, Akata D, Haliloglu M. Posttraumatic splenic pseudoaneurysm and arteriovenous fistula: diagnosis by computed tomography angiography and treatment by transcatheter embolization. J Pediatr Surg. 2005 Dec;40(12):e43-6.

ReferenceCitation: Schwartz PE, Sterioff S, Mucha P, Melton LJ 3rd, Offord KP. Postsplenectomy sepsis and mortality in adults. JAMA. 1982 Nov 12;248(18):2279-83.

ReferenceCitation: Waghorn DJ, Mayon-White RT. A study of 42 episodes of overwhelming post-splenectomy infection: is current guidance for asplenic individuals being followed? J Infect. 1997 Nov;35(3):289-94.

ReferenceCitation: Holdsworth RJ, Irving AD, Cuschieri A. Postsplenectomy sepsis and its mortality rate: actual versus perceived risks. Br J Surg. 1991 Sep;78(9):1031-8. Review.

ReferenceCitation: Read RC, Finch RG. Prophylaxis after splenectomy. J Antimicrob Chemother. 1994 Jan;33(1):4-6. Review.

ReferenceCitation: Cullingford GL, Watkins DN, Watts AD, Mallon DF. Severe late postsplenectomy infection. Br J Surg. 1991 Jun;78(6):716-21.

ReferenceCitation: Waghorn DJ. Overwhelming infection in asplenic patients: current best practice preventive measures are not being followed. J Clin Pathol. 2001 Mar;54(3):214-8.

ReferenceCitation: Shih HC, Wang CY, Wen YS, Wu JK, Huang MS, Huang CI, Lee CH. Spleen artery embolization aggravates endotoxin hyporesponse of peripheral blood mononuclear cells in patients with spleen injury. J Trauma. 2010 Mar;68(3):532-7. doi: 10.1097/TA.0b013e3181a7bfaa.

ReferenceCitation: Tominaga GT, Simon FJ Jr, Dandan IS, Schaffer KB, Kraus JF, Kan M, Carlson SR, Moreland S 3rd, Nelson T, Schultz P, Eastman AB. Immunologic function after splenic embolization, is there a difference? J Trauma. 2009 Aug;67(2):289-95. doi: 10.1097/TA.0b013e3181a5e7e2.

ReferenceCitation: Arvieux C, Frandon J, Tidadini F, Monnin-Bares V, Foote A, Dubuisson V, Lermite E, David JS, Douane F, Tresallet C, Lemoine MC, Rodiere M, Bouzat P, Bosson JL, Vilotitch A, Barbois S, Thony F; Splenic Arterial Embolization to Avoid Splenectomy (SPLASH) Study Group. Effect of Prophylactic Embolization on Patients With Blunt Trauma at High Risk of Splenectomy: A Randomized Clinical Trial. JAMA Surg. 2020 Dec 1;155(12):1102-1111. doi: 10.1001/jamasurg.2020.3672.

name: Department of General and Digestive Surgery, Grenoble-Alpes University Hospital (CHU), Grenoble, France

family: Arvieux

full_name: Catherine Arvieux

given: Catherine

name: Department of Imaging and Interventional Radiology, Nîmes University Hospital (CHU), Nîmes, France

family: Frandon

full_name: Julien Frandon

given: Julien

family: Tidadini

full_name: Fatah Tidadini

given: Fatah

name: Department of Imaging and Interventional Radiology, Montpellier University Hospital (CHU), Montpellier, France

family: Monnin-Bares

full_name: Valérie Monnin-Bares

family: Foote

full_name: Alison Foote

given: Alison

name: Department of Vascular and General Surgery, Bordeaux University Hospital (CHU), Bordeaux, France

family: Dubuisson

full_name: Vincent Dubuisson

given: Vincent

name: Department of Visceral Surgery, Angers University Hospital (CHU), Angers, France

family: Lermite

full_name: Emilie Lermite

given: Emilie

name: Department of Anesthesia and Intensive Care, Lyon-Sud University Hospital (CHU), Pierre Bénite, France

family: David

full_name: Jean-Stéphane David

given: Jean-Stéphane

name: Department of Imaging and Interventional Radiology, Nantes University Hospital (CHU), Nantes, France

family: Douane

full_name: Frederic Douane

given: Frederic

name: Department of General, Digestive, Oncologic, Bariatric, and Metabolic Surgery, Avicenne University Hospital (CHU), Bobigny, France

family: Tresallet

full_name: Christophe Tresallet

given: Christophe

name: Department of General and Oncologic Surgery, Nîmes University Hospital (CHU), Nîmes, France

family: Lemoine

full_name: Marie-Christine Lemoine

given: Marie-Christine

name: Department of Imaging and Interventional Radiology, Grenoble-Alpes University Hospital (CHU), Grenoble, France

family: Rodiere

full_name: Mathieu Rodiere

name: Department of Anesthesia and Intensive Care, Grenoble-Alpes University Hospital (CHU), Grenoble, France

name: Department of Medical Information, Grenoble-Alpes University Hospital (CHU), Grenoble, France


title: Circulating Endotoxemia After Liver Resection for Hepatocellular Carcinoma in Liver Disease - Influence of Preoperative Administration of Probiotics

acronym: LIPROCES

summary:
Surgical resection is one of the curative treatment modalities for HCC. Limits are postoperative septic and liver functional complications related to an increase in bacterial translocation and systemic endotoxemia. Bacterial translocation is a passage of bacteria and bacterial degradation products from the intestine to the portal circulation. The endotoxemia secondary to bacterial translocation, stimulates endothelial production of nitric oxide (NO). NO is also a potent inducer of membrane instability, responsible for an increase in the permeability of the vascular endothelium and intestinal mucosa, possibly contributing to a worsening of bacterial translocation.

Probiotics are live microorganisms which when administered in adequate amounts, provide a health benefit on the host ((Health and Nutritional Properties of Probiotics in Food Including Powder Milk with Live Lactic Acid Bacteria - Cordoba Argentina October 2001). Data from experimental and clinical literature show a significant effect of probiotics on the improvement of liver function and a decrease in infectious complications in patients with chronic liver disease. The proposed study would evaluate the effect preventive and therapeutic in a population of surgical patients, in whom the intestinal portal and hepatic inflammation promotes postoperative complications.

ReferenceCitation: Edouard R, Carole BL, Jean-Jacques T, Helène M, Eloise P, Pauline T, Soumeya B, Lilian S. Influence of Probiotics Administration Before Liver Resection in Patients with Liver Disease: A Randomized Controlled Trial. World J Surg. 2021 Nov 26. doi: 10.1007/s00268-021-06388-7. [Epub ahead of print]

family: Edouard

full_name: Roussel Edouard

given: Roussel

family: Carole

full_name: Brasse-Lagnel Carole

given: Brasse-Lagnel

family: Jean-Jacques

full_name: Tuech Jean-Jacques

given: Tuech

family: Helène

full_name: Montialoux Helène

given: Montialoux

family: Eloise

full_name: Papet Eloise

given: Papet

family: Pauline

full_name: Tortajada Pauline

given: Tortajada

family: Soumeya

full_name: Bekri Soumeya

given: Bekri

family: Lilian

full_name: Schwarz Lilian

given: Schwarz

journal_name: World Journal of Surgery

lead_sponsor: University Hospital, Rouen


title: Effects of Chair Sitting Exercise Intervention on Weaning From Mechanical Ventilation and Mortality of Critically Ill Patients With Acute Respiratory Failure: a Randomised Controlled Trial.

acronym: RehabVent

summary:
The occurrence of an acute respiratory failure necessitates mostly admission to ICU and mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for the majority of patients. Many reasons may contribute to weaning, extubation failure and prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged MV, may represent a main factor and early rehabilitation may reverse these conditions and improve the success of weaning from MV.The objective of this study is to evaluate the effect of an early chair sitting (while the patient is awake but still mechanically ventilated) on weaning from mechanical ventilation and ICU mortality.

Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule: the studied group (20 patients): chair-sitting group will be transferred from bed to arm chair for at least 1 hour and once a day; the control group will stay in bed until extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality, ICU length of stay are assessed and compared between groups. Expected results: Early chair sitting would decrease MV duration, number of extubation failure, nosocomial infections and ICU mortality. Feasibility and safety of this intervention will also be evaluated and also the related work load.

ReferenceCitation: Canaud B, Formet C, Raynal N, Amigues L, Klouche K, Leray-Moragues H, Béraud JJ. Vascular access for extracorporeal renal replacement therapy in the intensive care unit. Contrib Nephrol. 2004;144:291-307. Review.

lead_sponsor: University Hospital, Montpellier

location_facility: Lapeyronie University Hospital, Intensive Care Department


title: Efficacy and Safety of Rebel Reliever Brace in Medial Femorotibial Knee Osteoarthritis. Phase 3, Multicenters, Randomised and Controlled Study With 2 Parallel Groups.

acronym: ROTOR

summary: The purpose of the study is to evaluate the superiority of Rebel Reliever® knee brace + standard treatment versus standard treatment alone in terms of last 24-hour pain relief after 6 weeks. in patients with medial knee osteoarthritis.

lead_sponsor: Thuasne


title: Study of Placental Transfer of Tenofovir and Its Factors of Variability Using the Human Placental Perfusion Model

acronym: TDF-PTP

summary: The purposes of this study are to determine whether transporters expression levels and drug interaction between TDF and FTC could contribute to modulate the placental transfer of this drug or. To test this hypothesis, an ex vivo model known as "the perfused ex vivo cotyledon model" allows to reproduce the conditions of the third trimester of pregnancy

ReferenceCitation: Hirt D, Urien S, Ekouévi DK, Rey E, Arrivé E, Blanche S, Amani-Bosse C, Nerrienet E, Gray G, Kone M, Leang SK, McIntyre J, Dabis F, Tréluyer JM; ANRS 12109. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109). Clin Pharmacol Ther. 2009 Feb;85(2):182-9. doi: 10.1038/clpt.2008.201. Epub 2008 Nov 5.

ReferenceCitation: Vinot C, Gavard L, Tréluyer JM, Manceau S, Courbon E, Scherrmann JM, Declèves X, Duro D, Peytavin G, Mandelbrot L, Giraud C. Placental transfer of maraviroc in an ex vivo human cotyledon perfusion model and influence of ABC transporter expression. Antimicrob Agents Chemother. 2013 Mar;57(3):1415-20. doi: 10.1128/AAC.01821-12. Epub 2013 Jan 7.


acronym: DEBITC

summary: Severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. It is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.

lead_sponsor: University Hospital, Grenoble


title: A Phase Ib, Open-label, Dose Escalation Study of the Safety, Tolerability and Efficacy of LY2780301 (a p70/AKT Inhibitor) in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer

acronym: INPAKT

summary: In the First-in-Human, JWAA trial, the LY2780301 displayed a favourable safety profile, a high pharmacokinetic exposure and the ability to decrease pS6. LY2780301 has shown synergistic activity in combination with targeted agents or chemotherapy including gemcitabine. We propose herein to combine LY2780301 with gemcitabine and to treat different tumor types with molecular alterations. This may validate the anti-tumor activity of the LY2780301 and it will increase our knowledge regarding molecular predictors of its efficacy.

ReferenceCitation: Angevin E, Cassier PA, Italiano A, Gonçalves A, Gazzah A, Terret C, Toulmonde M, Gravis G, Varga A, Parlavecchio C, Paci A, Poinsignon V, Soria JC, Drubay D, Hollebecque A. Safety, tolerability and antitumour activity of LY2780301 (p70S6K/AKT inhibitor) in combination with gemcitabine in molecularly selected patients with advanced or metastatic cancer: a phase IB dose escalation study. Eur J Cancer. 2017 Sep;83:194-202. doi: 10.1016/j.ejca.2017.06.036. Epub 2017 Jul 24.

family: Angevin

full_name: Eric Angevin

given: Eric

family: Cassier

full_name: Philippe A. Cassier

given: Philippe A.

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

family: Gazzah

full_name: Anas Gazzah

given: Anas

family: Terret

full_name: Catherine Terret

given: Catherine

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Gravis

full_name: Gwenaëlle Gravis

given: Gwenaëlle

family: Varga

full_name: Andrea Varga

given: Andrea

family: Parlavecchio

full_name: Cédric Parlavecchio

given: Cédric

family: Paci

full_name: Angelo Paci

given: Angelo

family: Poinsignon

full_name: Vianney Poinsignon

given: Vianney

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

family: Drubay

full_name: Damien Drubay

given: Damien

family: Hollebecque

full_name: Antoine Hollebecque

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.

summary:
Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the stress of exercise may offer early diagnostic indicators in patients suffering from valvular disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining importance in providing prognosis among those patients. However, decreased signal to noise ratio in the images and increased motion-related artifacts during exercise stress echocardiography have been reported, with a lack of reproducibility of results and a the limitation of its availability only in reference centers. In our laboratory, we are able to perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end of the patient table, previously described in healthy volunteers.

The first aim of our study is to demonstrate the safety and the feasibility of our MRI protocol in selected patients with asymptomatic severe organic mitral regurgitation, to assess left ventricular volumes and function, and regurgitant volume in comparison to exercise cardiac echography.

Besides, few recent studies sustain the relevance of novel markers of central aortic function (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic stiffness would be useful for risk assessment and preventive follow-up strategies in young asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore, this technique should be able to evaluate the effect of drugs on aortic stiffness change in trials, before and after drug therapy, more relevant than the classic change in aortic diameter measurement.

The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate local and regional heterogeneity in aortic functional parameters (distensibility, compliance and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave velocity estimation by applanation tonometry.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


summary: The aim of this study is to demonstrate and quantify the micro architecture and micro vascular changes within skeletal muscles after marathon using 3T MRI (diffusion tensor and arterial spin labeling). Apparent diffusion coefficient, fractional anisotropy and flow parameters will be registered before and after the long-distance run on the lower leg. Axial T1 and axial SPAIR sequences will also be applied at the same time.Stress ox and inflammatory markers will be collected in blood and urine samples and compare with both MRI and Near-infrared spectroscopy (NIRS).


title: Positioning of the Tibial Cut in Unicompartmental Medial Knee Replacement by Using Patient Specific Cutting Guides.

acronym: PSI-PUC

summary:
Unicompartmental knee replacements are performed to treat osteoarthritis or osteonecrosis of the knee especially when it affects only the medial femoro-tibial compartment. To place the prosthesis, bone removal is necessary. The orientations of the bony cuts directly influence the position of the different elements of the prosthesis and the limb alignment. It is known that good positioning of the prosthesis is the key of a good survival of the implants. To guide the blade of the saw, cutting guides are used. The position of these guides gives the final position of the cuts. At present, two main techniques are used to position the guides: the conventional one, not very costly but not very accurate, and the navigated procedure, which is more accurate but also more expensive and more invasive. Since few years, patient specific cutting guides are used in total knee replacement with encouraging results and more recently in uni compartmental knee replacement with no scientific proof of efficiency.

This study aims to validate the procedure of patient specific cutting guides.

lead_sponsor: Rennes University Hospital


acronym: ZOMAXEPT

summary: The study is performed to collect long-term data on the treatment adherence and patient's acceptability when Zomacton®10 mg is administered with the Zomajet® Vision X device in patients with a growth hormone deficiency or Turner's syndrome.

lead_sponsor: Ferring Pharmaceuticals


title: Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.

acronym: LEVO-PHARM

summary: The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory Concentration (MIC) ratio > 5 and Area Under Curve (AUC) /Minimum Inhibitory Concentration(MIC) ratio > 125. No therapeutic drug monitoring will be performed in this study.

lead_sponsor: University Hospital, Toulouse


title: A Phase 1, Randomized, Observer Blinded, Placebo Controlled, Single Center, Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine (1790GAHB) Administered Intramuscularly in Healthy Adults.

summary:
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route in healthy adults (18 to 45 years of age at enrollment). The safety profile of the 1790GAHB vaccine is evaluated in comparison to that of placebo (GAHB-Placebo), constituted by an aluminum hydroxide suspension having the same concentration as study vaccine formulations. A total of 50 eligible subjects will be assigned to one of five sequential cohorts of 10 subjects each.

Within each cohort, in an observer-blind fashion, subjects will be randomized to receive three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen concentrations) or GAHB placebo. A Data Safety Monitoring Board will be in place to receive a summary of all safety data obtained during one week follow-up post-first vaccination with the lower dose. Based on evaluation of the safety data, the Data Safety Monitoring Board will make a recommendation, as to whether the next cohort should be vaccinated with higher antigen concentration or not.

Expected duration of the study for an individual subject is 9 months. Each subject will be followed-up for 6 months after the 3rd vaccination.

primary_purpose: Prevention

ReferenceCitation: Micoli F, Rossi O, Conti V, Launay O, Sciré AS, Aruta MG, Nakakana UN, Marchetti E, Rappuoli R, Saul A, Martin LB, Necchi F, Podda A. Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension. Front Immunol. 2021 May 4;12:671325. doi: 10.3389/fimmu.2021.671325. eCollection 2021.

family: Micoli

full_name: Francesca Micoli

given: Francesca

family: Rossi

full_name: Omar Rossi

given: Omar

family: Conti

full_name: Valentino Conti

given: Valentino

family: Launay

full_name: Odile Launay

given: Odile

family: Sciré

full_name: Antonella Silvia Sciré

given: Antonella Silvia

family: Aruta

full_name: Maria Grazia Aruta

given: Maria Grazia

family: Nakakana

full_name: Usman Nasir Nakakana

given: Usman Nasir

family: Marchetti

full_name: Elisa Marchetti

given: Elisa

family: Rappuoli

full_name: Rino Rappuoli

given: Rino

family: Saul

full_name: Allan Saul

given: Allan

family: Martin

full_name: Laura B. Martin

given: Laura B.

family: Necchi

full_name: Francesca Necchi

family: Podda

full_name: Audino Podda

given: Audino

currency_apc_doaj: USD

journal_name: Frontiers in Immunology

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Launay O, Lewis DJM, Anemona A, Loulergue P, Leahy J, Sciré AS, Maugard A, Marchetti E, Zancan S, Huo Z, Rondini S, Marhaba R, Finco O, Martin LB, Auerbach J, Cohen D, Saul A, Gerke C, Podda A. Safety Profile and Immunologic Responses of a Novel Vaccine Against Shigella sonnei Administered Intramuscularly, Intradermally and Intranasally: Results From Two Parallel Randomized Phase 1 Clinical Studies in Healthy Adult Volunteers in Europe. EBioMedicine. 2017 Aug;22:164-172. doi: 10.1016/j.ebiom.2017.07.013. Epub 2017 Jul 15.

family: Lewis

full_name: David J.M. Lewis

given: David J.M.

family: Anemona

full_name: Alessandra Anemona

given: Alessandra

family: Loulergue

full_name: Pierre Loulergue

given: Pierre

family: Leahy

full_name: Jo Leahy

ReferenceCitation: Muturi-Kioi V, Lewis D, Launay O, Leroux-Roels G, Anemona A, Loulergue P, Bodinham CL, Aerssens A, Groth N, Saul A, Podda A. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. 2016 Aug 4;11(8):e0157385. doi: 10.1371/journal.pone.0157385. eCollection 2016. Review.

repository_institution: Ghent University - Ghent University Academic Bibliography

lead_sponsor: GSK Vaccines Institute For Global Health S.r.l.

location_facility: Centre d'Investigation Clinique en Vaccinologie Cochin-Pasteur (CIC1417)


type: EudraCT Number

source: euctr

title: Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance

summary:
Primary objective:

The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84.

The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).


title: REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL

acronym: CACICOL

summary: The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It is a double blinded comparison of epithelial defect in two groups of patients randomized between CACICOL20 and physiological salt solution.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

acronym: TURANDOT

summary: Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset. Efficacy of this therapy is limited in the setting of large artery occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90% with last generation devices. A recent meta-analysis has shown that the best candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is increased in association with antiplatelets such as abciximab. The aim of the study was to assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical trial versus the gold standard for acute ischemic stroke revascularization strategies using IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms onset.

lead_sponsor: SOS Attaque Cérébrale


title: Cerebrospinal Fluid Proteome in Hydrocephalus

acronym: PROLIPHYC

summary: PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of 100 patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.

ReferenceCitation: Bech-Azeddine R, Høgh P, Juhler M, Gjerris F, Waldemar G. Idiopathic normal-pressure hydrocephalus: clinical comorbidity correlated with cerebral biopsy findings and outcome of cerebrospinal fluid shunting. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):157-61. Epub 2006 Sep 29.

ipd_sharing: Undecided

intervention_type: Biological


title: Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor in Patients With or Without Epidural Anesthesia

acronym: Pain Drain

summary:
Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance.

Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.

lead_sponsor: Hopital Foch


title: Evaluation of Accuvein in Obese Patients

acronym: AVO

summary: The objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.


title: Evaluation du Niveau d'activité Physique Quotidien, Chez Des Patientes Porteuses d'un Cancer du Sein en période Post thérapeutique

acronym: APQ

summary:
Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in different cancer types.

It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it to the overall calculation of physical activity in clinical practice.

To assess the AP, two types of methods are validated : the subjective method using a questionnaries and objective method using a pedometer , accelerometer or measures calorimetry .

Subjective method shows , good acceptability by patients and low cost but can sometimes lead to poor estimation of the level of activity.

Objective methods obviously increase the accuracy of assessments but are more difficult to use for epidemiological studies , less accepted by the patient and more expensive.

In this study the investigators will measure the spontaneous Daily Physical Activity by both methods andd evaluate the correclation.

lead_sponsor: University Hospital, Limoges


title: A Cohort of Patients With Cystinosis : Compliance to Cysteamine and Neurological Complications

acronym: Crystobs

summary:
Preventing late onset of Cystinosis such as neurological complications and improving compliance to cysteamine treatment remain major challenges in management of subjects with cystinosis.

This study is designed to describe the relationship between compliance of patients with cystinosis treated with cysteamine and treatment efficacy and to understand the pathophysiologic mechanism of neurological disorders. Is cysteamine crossing the blood brain barrier? What is the impact of cystine accumulation in Cerebro Spinal Fluid and Central Nervous System? Our Primary objective is to study the relationship between compliance of patients treated with cysteamine and the WBC cystine level.

Secondary, the study will assess relationship between compliance to cysteamine and its neurological consequences.

The expected duration of the study is 48 months. The enrolment period is 24 months and the study participation of each subject is 24 months. Eligible participants are male and female (age > 4 years) with confirmed diagnosis of cystinosis and receiving any oral cysteamine treatment: Cystagon or RP103.

The compliance under cysteamine is measured using electronic devices, accountability of study treatment, and information in patients' diary. Specific memory and visuoperceptual tests are performed at the beginning and at the end of patients'participation. Nuclear Magnetic Resonance spectroscopy is used to detect possible sites of cystine accumulation in the CNS and their relationship with compliance to cysteamine treatment. NMRS is also used to establish a relationship with the neuropsychological status of the subject.

To describe absorption, distribution and elimination of cysteamine, and its metabolic pathways, and to determine the concentration effect and dose effect relationship, blood samples are performed at each study visit. A lumbar puncture is also proposed to participants to verify if cysteamine is crossing the blood brain barrier. New tools are used to compare metabonomic networks in patients with cystinosis and their controls.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of the Internal Rotation Deficit of the Glenohumeral Joint in Advanced-level Handball Players Occurring Over One Training Season

acronym: GIRDH

summary: The main objective of this study is to estimate the incidence and prevalence of Internal Rotation Deficit (IRD) defined by a measure of IRD 2 (Internal Rotation Deficit in position 2) strictly greater than 20 ° in a population of advanced-level handball players over a training season.


title: Evaluation of Therapeutic Management in ESBL-infected Patients or Carriers by Providing and Sharing a Free Tool - the "ESBL toolKIT" and Interventional Study of a Prospective Cohort of HIV+ Patients Searching for Possible Sexual Transmission Factors in ESBL (Extended-spectrum ß-lacatamase-producing Bacteria) Carriers

acronym: Calires

summary:
Bacterial resistance to antibiotics is a major public health problem. The epidemiology of enteric bacteria including E. coli is changing rapidly with the global spread of a resistance mechanism type beta-lactamase extended spectrum (ESBL), responsible for resistance to almost all penicillins and cephalosporins. The resistance is up to 75% for Quinolones, 67% for Cotrimoxazole and 30-50% for Aminoglycosides.

The main phenomena causing this problem are:

The selection pressure by antibiotics, in their use in humans or animals
The hand transmission via the digestive reservoir (faeces)
Easy spread of resistance mechanism in Enterobacteriaceae due to transferable genetic support (plasmid)

In this context, we decided to implement a cross-border study to improve and accelerate the management, diagnosis and treatment of patients with ESBL in close collaboration between medical and paramedical staff in hospitals, laboratories and private medical offices.

The objective of this study is to standardize diagnostic and therapeutic measures allowing a better and rapid treatment of patients and thus prevent the appearence of ESBL bacteria in the PACA region and Liguria by providing a tool : The "Kit ESBL".

The " ESBL ToolKIT" (also translated into Italian) includes:

Information on epidemiological data
A checklist edited for extra-hospital use (private practitioners, health care units other than hospitals)
A checklist edited for hospital use
A leaflet BMR for the patient explaining the problematic as well as hygiene measures
Therapeutical protocols for hospital use and extra hospital use
An sample letter for the attending physician

The objective of this prospective multicenter cohort study is to evaluate the use of this kit, and to measure its impact on:

The prescription of appropriate antibiotics
The measures taken to prevent man to man transmission
The quality of information provided to the patient

In this context we are also performing a multicentre prospective interventional cohort of HIV+ patients searching for possible sexual transmission factors in ESBL (extended-spectrum ß-lacatamase-producing bacteria) carriers.

We will also try to determine if other sexually transmitted infections associated (syphilis, gonorrhea and chlamydia) are contributing factors to ESBL carriage.

So far there is no data documented on ESBL-carriage in a population of HIV-positive patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Transient Global Amnesia (TGA) Exploratory Study of the Default Mode Network in Resting State Functional MRI (fMRI) During the Acute Phase

acronym: ICTUS

summary:
The transient global amnesia, in which the memory disorder is massive, transient and pure, offers a unique model for exploring episodic memory. Topographic MRI can reveal a focal and selective lesion located on the CA1 region of the hippocampus better visible between 48h and 72h after onset of the episode.

There is therefore a real dissociation between structural lesions witch are minimal or non-existent and the massive memory disorder. This suggests that functional impairment goes far beyond the structural damage in this condition. To our knowledge, no study has been performed to identify this functional impairment using resting state fMRI.

Thus, investigators wish to study the neural networks involved in memory impairment during the acute phase of transient global amnesia using resting state imaging. This technique appears to be modern and adapted to these patients population. Investigators hypothesize that despite limited structural lesions, a large functional network is impaired compared to that observed in a group of healthy subjects. investigators believe that the alteration of the functional network will explain the depth of memory impairment observed.

The main aim of this study will be to identify functional impairment in the patient group vs. control group during the acute phase of transient global amnesia (TGA) using resting state imaging.

Patients potentially eligible will be informed during their arrival to the emergency unit. If the patient is eligible and would like to participate, information will be given. For the patients willing to participate, inclusion and exclusion criteria will be verified. Two imaging exams (topographic MRI and resting state fMRI) and neuropsychological assessment will be performed during three visits.


title: Evaluation of a Clinico-biological Predictive Score of Enterocolitis and Enteropathy of the Preterm Neonates. Usefulness of the Rapid Assay of the Faecal Calprotectin.

acronym: CALPROPREMA

summary: This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.

ReferenceCitation: Campeotto F, Elie C, Rousseau C, Giuseppi A, Hachem T, Gobalakichenane P, Le Touzey M, de Stefano M, Butel MJ, Kapel N. Faecal calprotectin and gut microbiota do not predict enteropathy in very preterm infants. Acta Paediatr. 2021 Jan;110(1):109-116. doi: 10.1111/apa.15354. Epub 2020 Sep 1.

name: Department of Pediatric Gastroenterology Necker‐Enfants Malades HospitalAP‐HP Paris France

name: Faculty of Pharmacy INSERMU1139 Paris France

name: UMR‐S U1139 Hospital‐University Department Risks In PregnancyParis Descartes UniversityParis University Paris France

family: Campeotto

full_name: Florence Campeotto

given: Florence

name: Clinical Research Unit Clinical Investigation Center Necker‐Enfants Malades HospitalAP‐HP Paris France

family: Elie

full_name: Caroline Elie

given: Caroline

name: Microbiology Department St‐Louis HospitalAPHP Paris France

family: Rousseau

full_name: Clotilde Rousseau

given: Clotilde

name: Neonatology Department Necker‐Enfants Malades HospitalAP‐HP Paris France

family: Giuseppi

full_name: Agnès Giuseppi

given: Agnès

family: Hachem

full_name: Taymme Hachem

given: Taymme

name: Neonatology Department Armand Trousseau HospitalAP‐HP Paris France

family: Gobalakichenane

full_name: Ponny Gobalakichenane

given: Ponny

name: Neonatology Department Poissy‐Saint Germain Intercommunal Hospital Center Poissy France

family: Le Touzey

full_name: Mathilde Le Touzey

given: Mathilde

family: Stefano

full_name: Marie Stefano

given: Marie

family: Butel

full_name: Marie‐José Butel

given: Marie‐José

name: Coprology Department Pitié‐Salpétrière HospitalAPHP Paris France

family: Kapel

full_name: Nathalie Kapel

given: Nathalie

journal_name: Acta Paediatrica

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Randomized Short-term Pre-surgical Study to Assess the Effects of PD 0332991 in Early Breast Cancer Patients

acronym: POP

summary: This is a Phase II study trying to identify whether short term treatment with PD0332991 yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at surgery- or induces senescence as determined by SABG expression (IHC) in tumors from patients with early breast cancer non-candidates for neoadjuvant hormonotherapy or chemotherapy, as compared to no treatment.

ReferenceCitation: Turner NC, Liu Y, Zhu Z, Loi S, Colleoni M, Loibl S, DeMichele A, Harbeck N, André F, Bayar MA, Michiels S, Zhang Z, Giorgetti C, Arnedos M, Huang Bartlett C, Cristofanilli M. Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor-Positive Metastatic Breast Cancer. J Clin Oncol. 2019 May 10;37(14):1169-1178. doi: 10.1200/JCO.18.00925. Epub 2019 Feb 26. Erratum in: J Clin Oncol. 2019 Nov 1;37(31):2956.

name: Royal Marsden Hospital and Institute of Cancer Research, London, United Kingdom

family: Turner

full_name: Nicholas C. Turner

given: Nicholas C.

family: Liu

full_name: Yuan Liu

given: Yuan

family: Zhu

full_name: Zhou Zhu

given: Zhou

name: Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia

family: Loi

full_name: Sherene Loi

given: Sherene

name: Division of Medical Senology, IEO, European Institute of Oncology, IRCCS, Milan, Italy

family: Colleoni

full_name: Marco Colleoni

given: Marco

name: German Breast Group, Neu-Isenburg, Germany

family: Loibl

full_name: Sibylle Loibl

given: Sibylle

name: University of Pennsylvania, Philadelphia, PA

family: DeMichele

full_name: Angela DeMichele

given: Angela

name: Ludwig Maximilian University of Munich, Munich, Germany

family: Harbeck

full_name: Nadia Harbeck

given: Nadia

name: Institut Gustave Roussy, Villejuif, France

family: André

full_name: Fabrice André

given: Fabrice

family: Bayar

full_name: Mohamed Amine Bayar

given: Mohamed Amine

family: Michiels

full_name: Stefan Michiels

given: Stefan

family: Zhang

full_name: Zhe Zhang

given: Zhe

family: Giorgetti

full_name: Carla Giorgetti

given: Carla

family: Arnedos

full_name: Monica Arnedos

given: Monica

family: Huang Bartlett

full_name: Cynthia Huang Bartlett

given: Cynthia

name: Robert H Lurie Comprehensive Cancer Center, Chicago, IL

family: Cristofanilli

full_name: Massimo Cristofanilli

given: Massimo

journal_name: Journal of Clinical Oncology

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Melbourne - Minerva Access

publisher: American Society of Clinical Oncology (ASCO)

title: Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor–Positive Metastatic Breast Cancer

ReferenceCitation: Arnedos M, Bayar MA, Cheaib B, Scott V, Bouakka I, Valent A, Adam J, Leroux-Kozal V, Marty V, Rapinat A, Mazouni C, Sarfati B, Bieche I, Balleyguier C, Gentien D, Delaloge S, Lacroix-Triki M, Michiels S, Andre F. Modulation of Rb phosphorylation and antiproliferative response to palbociclib: the preoperative-palbociclib (POP) randomized clinical trial. Ann Oncol. 2018 Aug 1;29(8):1755-1762. doi: 10.1093/annonc/mdy202.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases

summary:
The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.


title: Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

acronym: MINIRAD

summary:
Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity.

The manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization).

Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures.

The investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Prospective Randomized Comparative Study of the Effectiveness of Suprascapular Nerve Block in Arthroscopic Shoulder Surgery

summary: Most arthroscopic surgeries of the shoulder are currently performed as an outpatient. The postoperative analgesia should be optimal. General anesthesia allows for any arthroscopic surgery but does not provide a satisfactory postoperative analgesia . The locoregional anesthesia is recommended and includes several techniques: the interscalene nerve block, the suprascapular nerve block, intra-articular injection of local anesthetic and subacromial infiltration. The interscalene nerve block is currently the gold standard for anesthesia and postoperative analgesia for arthroscopic shoulder surgery with a success rate above 80% . However it must be carried out by teams experienced in the locoregional anesthesia because it is operator -dependent. The suprascapular nerve block is a simple technique that can be performed by the surgeon after surgery , effective in arthroscopic shoulder surgery , less invasive than the interscalene nerve block and exposing the patient to fewer complications. However, his interest was not assessed in the repair of tendons of the rotator cuff. The main hypothesis of this study is that the suprascapular nerve block is as effective as the interscalene nerve block in the prevention of early postoperative pain after arthroscopic repair of the infra and / or the supraspinatus rotator cuff tendons, without increasing the analgesic consumption while reducing the risk of complications related to regional anesthesia.

lead_sponsor: Hospital Ambroise Paré Paris


title: Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.

acronym: NUTREND

summary: The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.


title: Phase 3 : Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis on Adult Face

acronym: Disease

summary: Seborrheic dermatitis is a chronic inflammatory dermatological disease, evolving by relapses, affecting mainly the face and scalp. It would be important to have a maintenance treatment for severe forms of seborrheic dermatitis witch is both effective and relatively well tolerated to reduce the frequency of relapses, prolong remissions obtained after attack treatment and reduce the use of topical steroids.

lead_sponsor: University Hospital, Rouen


title: Génomique de la résistance à la Prise de Poids Dans la Maigreur Constitutionnelle

summary: The purpose of this study is to evaluate the molecular differences between a group of Constitutionally Thin (CT) subjects and a group of controls.

ReferenceCitation: Bailly M, Germain N, Féasson L, Costes F, Estour B, Hourdé C, N Merlet A, Thomas T, Hager J, Pereira B, Thivel D, Courteix D, Galusca B, Verney J. Skeletal muscle of females and males with constitutional thinness: a low intramuscular lipid content and oxidative profile. Appl Physiol Nutr Metab. 2020 Nov;45(11):1287-1298. doi: 10.1139/apnm-2020-0068. Epub 2020 Jun 1.

name: Université Clermont Auvergne, CRNH, AME2P, Clermont-Ferrand 63000, France.

name: Eating Disorders, Addictions and Extreme Bodyweight Research Group (TAPE) EA 7423, Jean Monnet University, Saint-Étienne 42000, France.

family: Bailly

full_name: Mélina Bailly

given: Mélina

name: Division of Endocrinology, Diabetes, Metabolism and Eating Disorders, CHU Saint-Étienne 42000, France.

family: Germain

full_name: Natacha Germain

given: Natacha

name: Inter-University Laboratory of Human Movement Biology (LIBM) EA 7424, Jean Monnet University, Saint-Étienne 42000, France.

family: Féasson

full_name: Léonard Féasson

given: Léonard

name: Department of Sport Medicine and Functional Explorations, CHU Clermont-Ferrand 63000 France.

family: Costes

full_name: Frédéric Costes

given: Frédéric

family: Estour

full_name: Bruno Estour

given: Bruno

name: Inter-University Laboratory of Human Movement Biology (LIBM) EA 7424, Savoie Mont Blanc University, Chambéry 73000, France.

family: Hourdé

full_name: Christophe Hourdé

given: Christophe

family: N. Merlet

full_name: Angèle N. Merlet

given: Angèle

name: Department of Rheumatology, Hôpital Nord, CHU Saint-Etienne, France.

name: INSERM U1059, University of Lyon-Jean Monnet University, Saint-Étienne 42000, France.

family: Thomas

full_name: Thierry Thomas

given: Thierry

name: Metabolic Health, Nestlé Research, EPFL Innovation Park, Lausanne 1015, Switzerland.

family: Hager

full_name: Jorg Hager

given: Jorg

name: Biostatistics Unit, Délégation à la Recherche Clinique et à l’Innovation (DRCI), Clermont-Ferrand 63000, France.

family: Pereira

full_name: Bruno Pereira

family: Thivel

full_name: David Thivel

given: David

family: Courteix

full_name: Daniel Courteix

given: Daniel

family: Galusca

full_name: Bogdan Galusca

given: Bogdan

family: Verney

full_name: Julien Verney

given: Julien

journal_name: Applied Physiology, Nutrition, and Metabolism

oa_host_type: repository

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

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

publisher: Canadian Science Publishing

publisher_dissemination: Canadian Science Publishing

publisher_group: Canadian Science Publishing

publisher_normalized: Canadian Science Publishing

ReferenceCitation: Ling Y, Galusca B, Martin FP, Bartova S, Carayol J, Moco S, Epelbaum J, Grouselle D, Boirie Y, Montaurier C, Cuenco J, Minnion JS, Thomas T, Mure S, Hager J, Estour B, Gheldof N, Germain N. Resistance to lean mass gain in constitutional thinness in free-living conditions is not overpassed by overfeeding. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1187-1199. doi: 10.1002/jcsm.12572. Epub 2020 Apr 10.

name: Division of Endocrinology CHU Saint‐Etienne  Saint‐Etienne France

name: Eating Disorders, Addictions & Extreme Bodyweight Research Group  Jean Monnet University, Saint‐Etienne France

family: Ling

full_name: Yiin Ling

given: Yiin

name: Metabolic Health, Nestlé Research EPFL Innovation Park  Lausanne Switzerland

family: Martin

full_name: François‐Pierre Martin

given: François‐Pierre

family: Bartova

full_name: Simona Bartova

given: Simona

family: Carayol

full_name: Jérôme Carayol

name: Psychiatry and Neurosciences Center Paris Descartes University, INSERM UMR 894  Paris France

name: Human Nutrition Unit INRA, Research Center, UMR 1019  Clermont‐Ferrand France

name: Division of Diabetes, Endocrinology and Metabolism Imperial College  London UK

name: Rheumatology Department CHU Saint‐Etienne  Saint‐Etienne France

journal_name: Journal of Cachexia, Sarcopenia and Muscle

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

title: Resistance to lean mass gain in constitutional thinness in free‐living conditions is not overpassed by overfeeding

ReferenceCitation: Ling Y, Carayol J, Galusca B, Canto C, Montaurier C, Matone A, Vassallo I, Minehira K, Alexandre V, Cominetti O, Núñez Galindo A, Corthésy J, Dayon L, Charpagne A, Métairon S, Raymond F, Descombes P, Casteillo F, Peoc'h M, Palaghiu R, Féasson L, Boirie Y, Estour B, Hager J, Germain N, Gheldof N. Persistent low body weight in humans is associated with higher mitochondrial activity in white adipose tissue. Am J Clin Nutr. 2019 Sep 1;110(3):605-616. doi: 10.1093/ajcn/nqz144.

name: Division of Endocrinology, Diabetes, Metabolism, and Eating Disorders, CHU St-Etienne, France

name: Eating Disorders, Addictions, and Extreme Bodyweight Research Group (TAPE) EA 7423, Jean Monnet University, St-Etienne, France

name: Metabolic Health, Nestlé Research, EPFL Innovation Park, Lausanne, Switzerland

name: Clermont Auvergne University, INRA, Human Nutrition Unit, CHU Clermont-Ferrand, Service de Nutrition Clinique, CRNH Auvergne, Clermont-Ferrand, France

name: The Microsoft Research, University of Trento Centre for Computational Systems Biology (COSBI), Rovereto, Italy

name: Precision Medicine Group, Quartz Bio SA, Geneva, Switzerland

name: Proteomics, Nestlé Research, EPFL Innovation Park, Lausanne, Switzerland

name: Genomics, Nestlé Research, EPFL Innovation Park, Lausanne, Switzerland

name: Pathology Department, CHU St-Etienne, France

name: Surgery Department, CHU St-Etienne, France

name: Interuniversity Laboratory of Motricity and Biology (LIBM) EA 7424, Jean Monnet University, St-Etienne, France


title: Interest of Dynamic Measures of the Pupil in Optic Neuritis

acronym: PCT-NORB

summary: The investigators' hypothesis is that measuring the PCTdynamics would be an easy and reliable symptom to evaluate in pathologies affecting the optic nerve

time_perspective: Cross-Sectional

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.

acronym: CURARES

summary:
Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction.

Primary End Point: proportion of patients with a score of motion = 0


title: Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma

acronym: ICY

summary: For patients who are suffering from hepatocellular carcinoma and are treated with radioembolization, the purpose of this study is to analyse parameters of functional MRIs that are modified early and to detect parameters that vary significantly after treatment.

lead_sponsor: Center Eugene Marquis


title: Strain and Blood Inflammatory Markers as Prognostic Tools for ARDS AMIS (ARDS - Markers of Inflammation - Strain)

acronym: AMIS

summary: The objective is determine the strain measured at the bedside could be a dynamic prognostic marker of during Acute respiratory Distress Syndrome (ARDS).

location_facility: Réanimation Médicale CHU de Nice - Hôpital de l'Archet


title: Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

acronym: IBIS-VIRUS

summary: Morbidity and mortality of ICU patients is increased by the development of a "immunosuppression" systemic (IS). This IS develops in the early hours of hospitalization and is responsible for severe infections, including viral reactivations (Cytomegalovirus or Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and mortality in intensive care units. In clinical practice, they are searched at the onset of organ failure or unexplained fever. The investigators wish to conduct this research in the stroke patients to assess the predictive power of these viral reactivations on the duration of mechanical ventilation.

lead_sponsor: Nantes University Hospital


acronym: HYPNOART

summary: The purpose of this study is to compare the clinical benefits that can be expected by the Embryo transfert procedure with hypnosis to the usual embryo transfer procedure

lead_sponsor: University Hospital, Angers


title: Chronic Pain and Vitamin D: a Randomized Pilot Study in General Practice

acronym: DOVID

summary: Non-systematized chronic musculoskeletal pains are a frequent reason for consulting in general practice. The possible causes are numerous and sometimes nonspecific. In some cases, the etiologic investigation of patients with non-systematized and chronic musculoskeletal pain can not highlight any organic cause. Several studies have shown a link between these symptoms and vitamin D deficiency, characterized by a blood level of 25 (OH) vitamin D < 20.8ng/ml. This deficit is easy to identify and to correct through proper vitamin D supplementation with few side effects. Nevertheless, it remains unknown and vitamin D deficiency is rarely considered as a possible etiology in patients with chronic pain. We hypothesize that vitamin D supplementation in patients with non-systematized musculoskeletal pain and deficient in vitamin D could improve painful symptoms. We aim to perform a double-blind randomized controlled trial, vitamin D versus placebo, to assess the pain improvement after vitamin D supplementation.

location_facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon