title: Study of the Testicular Function After Iodine 131 Therapy in Patients With Papillary Carcinoma

acronym: SAPIRA

summary: Papillary cancer may affect patients of any age,with a good prognosis. Most of young patients may hence procreate as often as the general population.131iodine is an essential tool during treatment of thyroid cancer. According literature data, 131iodine given patients may experience exocrine testicular dysfunction with transient azoospermia, as a significant growing number of Desoxyribonucleic acid (DNA) damage may concern the patient or his offspring. The primary purpose will be to study a genomic instability within the germinal line, based on a significant mutation rate analysis in their minisatellites regions after 100 mCi 131 iodine irradiation compared to the baseline spermogram of each patient, thus being his own control case in a cross-over study.The inclusion of 50 patients treated by surgery prior to131iodine would result in statistically significant results.This multicentric cross-over study with a multidisciplinary approach will act for a direct benefit on testis function in patients aged 18-45 treated by 131iodine for thyroid cancer. Samples measurements timing will be: after surgery, 2 and 12 months after 131iodine administration.

ReferenceCitation: Bourcigaux N, Rubino C, Berthaud I, Toubert ME, Donadille B, Leenhardt L, Petrot-Keller I, Brailly-Tabard S, Fromigué J, de Vathaire F, Simon T, Siffroi JP, Schlumberger M, Bouchard P, Christin-Maitre S. Impact on testicular function of a single ablative activity of 3.7 GBq radioactive iodine for differentiated thyroid carcinoma. Hum Reprod. 2018 Aug 1;33(8):1408-1416. doi: 10.1093/humrep/dey222.

name: Department of Endocrinology, St Antoine Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France

family: Bourcigaux

full_name: N Bourcigaux

given: N

name: Radiation Epidemiology Group and Center for Research in Epidemiology and Population Health (CESP), Inserm, U1018, Institute Gustave Roussy, Villejuif, France

name: University of Paris-Sud, Villejuif, France

family: Rubino

full_name: C Rubino

given: C

name: Department of Reproduction Biology CECOS, Tenon Hospital, Assistance Publique Hôpitaux de Paris, Paris, France

family: Berthaud

full_name: I Berthaud

given: I

name: Department of Nuclear Medicine, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France

family: Toubert

full_name: M E Toubert

given: M E

family: Donadille

full_name: B Donadille

given: B

name: Department of Nuclear Medicine, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France

family: Leenhardt

full_name: L Leenhardt

given: L

name: Department of Nuclear Medicine, St Antoine Hospital, Assistance Publique Hôpitaux de Paris, France

family: Petrot-Keller

full_name: I Petrot-Keller

name: Department of Molecular Genetics, Pharmacogenetics and Hormonology, Kremlin-Bicêtre Hospital, Assistance Publique Hôpitaux de Paris, Inserm, U1185, Le Kremlin-Bicêtre, France

family: Brailly-Tabard

full_name: S Brailly-Tabard

given: S

family: Fromigué

full_name: J Fromigué

given: J

family: de Vathaire

full_name: F de Vathaire

given: F

name: Clinical Research Unit (GH HUEP), St Antoine Hospital, Assistance Publique-Hôpitaux de Paris, France

family: Simon

full_name: T Simon

given: T

name: Department of Medical Genetics, Pediatrics Hospital Armand Trousseau, Assistance Publique-Hôpitaux de Paris, France

family: Siffroi

full_name: J P Siffroi

given: J P

name: Department of Nuclear Medicine and Endocrine Oncology, Institute Gustave Roussy, University of Paris-Saclay, Villejuif, France

family: Schlumberger

full_name: M Schlumberger

given: M

name: Department of Gynecology, Hospital Foch, Suresnes, France

family: Bouchard

full_name: P Bouchard

given: P

family: Christin-Maitre

full_name: S Christin-Maitre

journal_name: Human Reproduction

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_facility: Saint Antoine Hospital, Endocrinology Unit


title: Genetic Epidemiology of Non-syndromic Dominant Deafness

acronym: SURDOM

summary: Hearing impairment is a common disorder that affects at least 7% of individuals in our countries. Even the causes of hearing impairment are numerous, genetic causes represent the main factor of sensorineural deafness. Among hereditary non-syndromic deafness autosomal-dominant inheritance is observed in about 10-20% of the cases. These forms of deafness are usually post-lingual and progressive. To date more than 41 chromosomal localisation and 21 genes associated to non syndromic dominant deafness have been described. It represents an extreme genetic heterogeneity making difficult the studies of these forms of hearing impairment. But, genetic diagnostic testing is crucial in these cases. Indeed, therapeutic research are in the way to prevent the progression of the disorder. The aim of this work is to establish the prevalence of the different genes involved in these forms of deafness.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Armand-Trousseau, Service d'ORL pédiatrique et de Chirurgie Maxillo Faciale

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Phase III Multicenter, Randomised and Double-blind Study Comparing an Oral Immunomodulatory Solution Versus a Placebo in Preventing Severe Acute Mucositis in Head and Neck Cancer Patients Treated Surgically and Concomitantly With Radiochemotherapy

acronym: IMPATOX

summary: This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Boisselier P, Kaminsky MC, Thézenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227.

name: Radiotherapy Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France

family: Boisselier

full_name: Pierre Boisselier

given: Pierre

sequence: first

name: Radiotherapy Department, Lorraine Cancer Institute, Vandœuvre-Lès-Nancy, France

family: Kaminsky

full_name: Marie-Christine Kaminsky

given: Marie-Christine

sequence: additional

name: Biometrics Unit, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France

family: Thézenas

full_name: Simon Thézenas

given: Simon

name: Radiotherapy Department, Clinique Pasteur, Toulouse, France

family: Gallocher

full_name: Olivier Gallocher

given: Olivier

name: Clinical Research Unit, Dupuytren University Hospital, Limoges, France

family: Lavau-Denes

full_name: Sandrine Lavau-Denes

given: Sandrine

name: Radiotherapy Department, Libourne Hospital Center, Libourne, France

family: Garcia-Ramirez

full_name: Muriel Garcia-Ramirez

given: Muriel

name: Radiotherapy Department, Sainte Catherine Institute, Avignon, France

family: Alfonsi

full_name: Marc Alfonsi

given: Marc

name: Oncology Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France

family: Cupissol

full_name: Didier Cupissol

given: Didier

name: Clinical Research and Innovation Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France

family: de Forges

full_name: Hélène de Forges

given: Hélène

family: Janiszewski

full_name: Chloé Janiszewski

given: Chloé

family: Geoffrois

full_name: Lionnel Geoffrois

given: Lionnel

name: Radiotherapy Department, Bretagne Sud Hospital, Lorient, France

family: Sire

full_name: Christian Sire

given: Christian

name: Clinical Nutrition and Gastroenterology Department, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France

name: IRCM, University of Montpellier, Inserm, and ICM, Montpellier, France

family: Senesse

full_name: Pierre Senesse

name: the Head and Neck Oncology and Radiotherapy Group (GORTEC)

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The American Journal of Clinical Nutrition

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

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


acronym: SEPSISPAM

summary: The ideal mean arterial pressure in patients with septic shock is unknown. The expert's recommandations have stated a target between 65 and 70 mm Hg. However the scientific basis are weak. Indead there are only few prospective studies which addressed this question without clear answer. Therefore we designed a RCT in order to assess the effect on mortality of two levels of mean arterial pressure in patients with septic shock.(800 patients, 30 centres)

primary_purpose: Treatment

ReferenceCitation: Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Hervé F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.

family: Asfar

full_name: Pierre Asfar

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Hamel

full_name: Jean-François Hamel

given: Jean-François

family: Grelon

full_name: Fabien Grelon

given: Fabien

family: Megarbane

full_name: Bruno Megarbane

given: Bruno

family: Anguel

full_name: Nadia Anguel

given: Nadia

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

family: Gergaud

full_name: Soizic Gergaud

given: Soizic

family: Weiss

full_name: Nicolas Weiss

given: Nicolas

family: Legay

full_name: François Legay

given: François

family: Le Tulzo

full_name: Yves Le Tulzo

given: Yves

family: Conrad

full_name: Marie Conrad

given: Marie

family: Robert

full_name: René Robert

given: René

family: Gonzalez

full_name: Frédéric Gonzalez

given: Frédéric

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Tamion

full_name: Fabienne Tamion

given: Fabienne

family: Tonnelier

full_name: Jean-Marie Tonnelier

given: Jean-Marie

family: Guezennec

full_name: Pierre Guezennec

family: Van Der Linden

full_name: Thierry Van Der Linden

given: Thierry

family: Vieillard-Baron

full_name: Antoine Vieillard-Baron

given: Antoine

family: Mariotte

full_name: Eric Mariotte

given: Eric

family: Pradel

full_name: Gaël Pradel

given: Gaël

title: High versus Low Blood-Pressure Target in Patients with Septic Shock


title: Accuracy of the 64 Slices Computed Tomography for the Diagnosis of Left Atrial Appendage Thrombus

acronym: THROMBI-SCAN

summary: Transoesophageal echocardiography (TEE) is considered as the gold standard method for detection of left atrial appendage (LAA) thrombus but is a semi-invasive investigation. The primary aim of the study is to evaluate the accuracy of the 64 slices CT using prospective gating for the diagnosis LAA thrombus. The secondary objective is to defined the optimal acquisition time offering the best diagnostic performance (early, late or both).

status: Terminated

primary_purpose: Diagnostic

intervention_type: Device

status_simplified: Unknown


title: Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR

acronym: CD lam

summary: Dendritic cells vaccinations are increasingly used in order to develop antitumoral immune response. This will be a Phase 2 trial using autologous dendritic cells pulsed with leukemic apoptotic corpse in acute myelogenous leukemia (AML) patients in first or second Complete remission (CR).

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ReferenceCitation: Chevallier P, Saiagh S, Dehame V, Guillaume T, Peterlin P, Bercegeay S, Le Bris Y, Bossard C, Gauvrit I, Dreno B, Juge-Morineau N, Béné MC, Gregoire M. A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients. Hum Vaccin Immunother. 2021 Oct 3;17(10):3511-3514. doi: 10.1080/21645515.2021.1943991. Epub 2021 Jun 21.

name: Hematology Department, Nantes University Hospital, Nantes, France

name: CRCINA, INSERM, CNRS, Nantes University, Nantes, France

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

name: UTCG, Nantes University Hospital & CIC 1413, CRCINA, Nantes University, Nantes, France

family: Saiagh

full_name: Soraya Saiagh

given: Soraya

family: Dehame

full_name: Virginie Dehame

given: Virginie

family: Guillaume

full_name: Thierry Guillaume

family: Peterlin

full_name: Pierre Peterlin

given: Pierre

family: Bercegeay

full_name: Sylvain Bercegeay

given: Sylvain

name: Hematology Biology Department, Nantes University Hospital, Nantes, France

family: Le Bris

full_name: Yannick Le Bris

given: Yannick

name: CHU Nantes, Service d’anatomie et Cytologie Pathologiques, INSERM, CRCINA, Université de Nantes, Nantes, France

family: Bossard

full_name: Céline Bossard

given: Céline

name: Etablissement Français du sang des Pays de Loire, EFS, Nantes, France

family: Gauvrit

full_name: Isabelle Gauvrit

given: Isabelle

family: Dreno

full_name: Brigitte Dreno

given: Brigitte

family: Juge-Morineau

full_name: Nadine Juge-Morineau

given: Nadine

family: Béné

full_name: Marie C. Béné

given: Marie C.

family: Gregoire

full_name: Marc Gregoire

given: Marc

journal_name: Human Vaccines & Immunotherapeutics

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Nantes University Hospital

location_facility: Cellule de Promotion de la recherche clinique

intervention_type: Other


title: Evaluation of the Sensorial Preference for Balance Control

acronym: PREFSENSOR

summary:
Among the components of postural control, sensorial integration is of crucial importance. The most important sensorial inputs for postural maintenance are the vestibular system which provides information regarding accelerations of the head in space (HORAK 1994), the somatosensory system which provides proprioceptive information that are used to determine changes in body position (INGLIS 1994) and the visual system which provides information for self motion in the environment. The receptors and the integration channel of each sensorial system have inner characteristics which lead to different performance of the different input in regards to the task and the environmental context (FITZGERALD 1994). Most of time, sensorial information are congruent but sometimes they are conflicted. This is the case when being in a stationary train, the train beside going on, giving the illusory sensation of movement even if the vestibular system is not activated. A sensory weighting process is then necessary for subjects to control balance. The Central Nervous System (CNS) is thought to adjust the relative contribution of sensory input to control stance depending on environmental conditions (CENCIANNI 2006) and the reliability of the sensory input (OIE 2002, KESHNER 2004) in order to maintain or achieve the desired orientation in space and to provide postural stability. Nevertheless the interconnection of the multiple sensorial feedback involved in the postural control is not yet completely understood (CHIARI 2000).

Today, there is no tool available to evaluate the individual use of the sensorial information to postural control. It seems interesting to have such a tool to better understand the sensorial preference of subjects. It would be of particular importance for patients with various pathologies in the aim to design individualized balance rehabilitation programs.

The aim of the study was to test a tool built to evaluate the sensorial preference of subjects by studying their postural reaction related to the 3 main sensorial perturbations. Normal subjects will be first tested to assess the repeatability of the protocol and to collect normal values. Then, patients with post stroke hemiplegia, vestibular disease, neuropathy and fallers will be studied in order to test the feasibility of the protocol and to have preliminary data of sensorial preference among these populations.

time_perspective: Prospective

enrollment_type: Anticipated

location_facility: Service de MPR - Hôpital Lariboisière - Fernand Widal


title: Evaluation of Safety and Efficacity of Indometacin and Two Potassium Sparing Diuretics in Adult Patients Affected by Gitelman Syndrome

acronym: GITAB

summary: Gitelman syndrome is a rare renal disease where the kidneys are unable to normally retain some salts (sodium, potassium and magnesium). Main consequences of these renal leaks of salts are a tendency toward low blood pressure, hypokalemia and hypomagnesemia both contributing to cardiac and muscles symptoms.

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10:CD007004. doi: 10.1002/14651858.CD007004.pub4.

name: Department of Medicine; Royal North Shore Hospital; Sydney Australia

family: Chung

full_name: Edmund YM Chung

given: Edmund YM

name: Sydney School of Public Health; The University of Sydney; Sydney Australia

name: Department of Emergency and Organ Transplantation; University of Bari; Bari Italy

family: Ruospo

full_name: Marinella Ruospo

given: Marinella

family: Natale

full_name: Patrizia Natale

given: Patrizia

name: Institute of Clinical Physiology; CNR - Italian National Council of Research; Reggio Calabria Italy

family: Bolignano

full_name: Davide Bolignano

given: Davide

name: Baylor College of Medicine; Houston Texas USA

family: Navaneethan

full_name: Sankar D Navaneethan

given: Sankar D

name: Department of Medicine; University of Otago Christchurch; Christchurch New Zealand

family: Palmer

full_name: Suetonia C Palmer

given: Suetonia C

name: Cochrane Kidney and Transplant, Centre for Kidney Research; The Children's Hospital at Westmead; Westmead Australia

family: Strippoli

full_name: Giovanni FM Strippoli

given: Giovanni FM

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

intervention_type: Drug


title: Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.

acronym: SENTIBRAS

summary: Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.

ReferenceType: background

ReferenceCitation: Nos C, Lesieur B, Clough KB, Lecuru F. Blue dye injection in the arm in order to conserve the lymphatic drainage of the arm in breast cancer patients requiring an axillary dissection. Ann Surg Oncol. 2007 Sep;14(9):2490-6. Epub 2007 Jun 5.

ReferenceCitation: Nos C, Kaufmann G, Clough KB, Collignon MA, Zerbib E, Cusumano P, Lecuru F. Combined axillary reverse mapping (ARM) technique for breast cancer patients requiring axillary dissection. Ann Surg Oncol. 2008 Sep;15(9):2550-5. doi: 10.1245/s10434-008-0030-z. Epub 2008 Jul 11.

intervention_type: Procedure


title: Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine

acronym: KEMO

summary: This is a randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine.


title: Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation

acronym: CLAAAF

summary: The purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter ablation of persistent Atrial fibrillation( pAF).

ReferenceCitation: Combes S, Jacob S, Combes N, Karam N, Chaumeil A, Guy-Moyat B, Treguer F, Deplagne A, Boveda S, Marijon E, Albenque JP. Predicting favourable outcomes in the setting of radiofrequency catheter ablation of long-standing persistent atrial fibrillation: a pilot study assessing the value of left atrial appendage peak flow velocity. Arch Cardiovasc Dis. 2013 Jan;106(1):36-43. doi: 10.1016/j.acvd.2012.09.002. Epub 2012 Dec 20.

family: Combes

full_name: Stéphane Combes

given: Stéphane

family: Jacob

full_name: Sophie Jacob

given: Sophie

full_name: Nicolas Combes

given: Nicolas

family: Karam

full_name: Nicole Karam

given: Nicole

family: Chaumeil

full_name: Arnaud Chaumeil

given: Arnaud

family: Guy-Moyat

full_name: Benoit Guy-Moyat

given: Benoit

family: Treguer

full_name: Frédéric Treguer

given: Frédéric

family: Deplagne

full_name: Antoine Deplagne

given: Antoine

family: Boveda

full_name: Serge Boveda

given: Serge

family: Marijon

full_name: Eloi Marijon

given: Eloi

family: Albenque

full_name: Jean-Paul Albenque

given: Jean-Paul

journal_name: Archives of Cardiovascular Diseases

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Predicting favourable outcomes in the setting of radiofrequency catheter ablation of long-standing persistent atrial fibrillation: A pilot study assessing the value of left atrial appendage peak flow velocity

lead_sponsor: Clinique Pasteur


summary:
The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium term effectiveness of staff education as a non-pharmacological intervention to manage apathy in older people with a diagnosis of dementia.

Primary efficacy criteria: Apathy Inventory clinician score changes
Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes

primary_purpose: Health Services Research

lead_sponsor: Centre Hospitalier Universitaire de Nice


summary: The aim of this study is to analyze the differential expression of the miR transcriptome in the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each biopsy and the miRNA profiles will be characterized using a dedicated miR array.

primary_purpose: Basic Science

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

intervention_type: Genetic


title: A Descriptive Study of Lymphocytic Phosphorylation of ERK1/2 in Patients With Parkinson's Disease With Dyskinesias and in Controls

acronym: BIODYS (1)

summary:
Levodopa-induced dyskinesia severely limits the use of levodopa in Parkinson's disease and constitutes a debilitating complication of dopaminergic treatment in late stage. Among several neurobiological mechanisms identified so far, the investigators have established in experimental models the key role of D1 receptor hypersensitivity and a"Ras-ERK" signalling pathway. As the very same dopamine receptor machinery and the Ras-ERK pathway are present in blood lymphocytes, the investigators wish to test the hypothesis that the level of ERK phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in Parkinson's Disease.

The study will be performed in dyskinetic levodopa-treated patients and non-Parkinson's Disease controls. Blood sampling "off" and "on" levodopa treatment (1 hour post-dose), as well as clinical data collection will be done during a scheduled pre-op work-up (deep brain stimulation). Subsequently, suspended lymphocytes from blood samples will be immunolabelled using an anti-pERK antibody and mean fluorescence intensity and percent of labelled lymphocytes will be assessed by flow cytometry. Additionally, plasma and urine samples will be collected "on" et "off" for dosage of dopamine. The motor effect of levodopa will be assessed through UPRSIII rating scale and eye movement (saccades) speed by non-invasive oculometric recordings.

lead_sponsor: University Hospital, Bordeaux


title: Feasibility of Home-based Measurement of Walking Capacity Using Global Positioning System in Patients With Peripheral Arterial Disease

acronym: POST-GPS

summary: The purpose of this study is to assess the feasibility of home-based measurement of walking capacity in peripheral arterial disease (PAD) patients, uing the Global Positioning System (GPS). This study should state if the GPS technique could be used in clinical routine in order to assess walking capacity in PAD patients. Patients will be assessed a first time (test 1) and six months later (test 2).

ReferenceCitation: Gernigon M, Le Faucheur A, Fradin D, Noury-Desvaux B, Landron C, Mahe G, Abraham P. Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease. Medicine (Baltimore). 2015 May;94(18):e838. doi: 10.1097/MD.0000000000000838.

family: Gernigon

full_name: Marie Gernigon

given: Marie

family: Le Faucheur

full_name: Alexis Le Faucheur

given: Alexis

family: Fradin

full_name: Dominique Fradin

given: Dominique

family: Noury-Desvaux

full_name: Bénédicte Noury-Desvaux

given: Bénédicte

family: Landron

full_name: Cédric Landron

given: Cédric

family: Mahe

full_name: Guillaume Mahe

given: Guillaume

family: Abraham

full_name: Pierre Abraham

given: Pierre

currency_apc_doaj: USD

journal_name: Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Global Positioning System Use in the Community to Evaluate Improvements in Walking After Revascularization

lead_sponsor: University Hospital, Angers


ReferenceCitation: Couturier R, Rubatti M, Credico C, Louvain-Quintard V, Anerkian V, Doubine S, Vasse M, Grassin-Delyle S. Continuous or discontinuous tranexamic acid effectively inhibits fibrinolysis in children undergoing cardiac surgery with cardiopulmonary bypass. Blood Coagul Fibrinolysis. 2014 Apr;25(3):259-65. doi: 10.1097/MBC.0000000000000051.

family: Couturier

full_name: Roland Couturier

given: Roland

family: Rubatti

full_name: Marina Rubatti

given: Marina

family: Credico

full_name: Carmen Credico

given: Carmen

family: Louvain-Quintard

full_name: Virginie Louvain-Quintard

given: Virginie

family: Anerkian

full_name: Vregina Anerkian

given: Vregina

family: Doubine

full_name: Sylvie Doubine

given: Sylvie

family: Vasse

full_name: Marc Vasse

given: Marc

family: Grassin-Delyle

full_name: Stanislas Grassin-Delyle

given: Stanislas

journal_name: Blood Coagulation & Fibrinolysis

lead_sponsor: Centre Chirurgical Marie Lannelongue

primary_purpose: Supportive Care

acronym: Exacyl

type: EudraCT Number

source: euctr

title: Tranexamic Acid (TXA) During Pediatric Cardiac Surgery: A Prospective Randomised Study Comparing Two Dosing Regimens

summary: The purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.


lead_sponsor: University Hospital, Clermont-Ferrand

acronym: SUF-REM-DDS

title: Comparison of Sufentanil and Remifentanil Infusion During General Anaesthesia for Removal of Wisdom Teeth in Ambulatory Surgery

summary:
Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.

The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses.


title: Effect of Dietary Supplement Limicol on LDL-cholesterol Levels in Moderate Hypercholesterolaemia

summary: The purpose of this study is to validate the effectiveness of food supplement Limicol on reducing LDL-cholesterol in moderate hypercholesterolemic volunteers.

lead_sponsor: Lescuyer Laboratory


title: Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Emergency Wards: a Multicenter Randomized Controlled Trial.

acronym: ATBREFEMERG

summary:
CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.

OBJECTIVES: To show using a randomized trial that patients hospitalized in emergency wards with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.

METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients admitted in emergency wards:

Control group: antibiotic prescriptions will be initiated and managed by the attending physicians Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.

STUDY PROCESS: The study will took place in the emergency wards of 4 university hospitals. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.

lead_sponsor: Henri Mondor University Hospital


title: Comparison of Light-emitting Diodes (LED) Phototherapy Versus Fluorescent Lamps Phototherapy for Treatment of Hyperbilirubinemia in Term Newborn

acronym: DELF

summary: Phototherapy is almost (beside exchange transfusion) the unique treatment for hyperbilirubinemia of the newborn. Its efficacy to decrease bilirubin level (because the light interacts with bilirubin at the skin level to transform it in water soluble products eliminated in urine and stools without liver metabolism) relies on the irradiance dispensed at the skin level by the device (in the 430-490nm range) and on the exposed surface of the baby. In the past years, technology of phototherapy devices moved from fluorescent lamps to LED, improving the amount of light energy emitted but on a smaller surface. The purpose of the study is to compare the efficacy of three ramps of phototherapy, one equipped with fluorescent tubes and two with LED (in a different technological settings) in the treatment of term (35 GW or more) healthy newborn suffering hyperbilirubinemia after 2days of life.

ReferenceCitation: American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. Erratum in: Pediatrics. 2004 Oct;114(4):1138.

ReferenceCitation: Bertini G, Dani C, Pezzati M, Rubaltelli FF. Prevention of bilirubin encephalopathy. Biol Neonate. 2001;79(3-4):219-23. Review.

ReferenceCitation: Bertini G, Perugi S, Elia S, Pratesi S, Dani C, Rubaltelli FF. Transepidermal water loss and cerebral hemodynamics in preterm infants: conventional versus LED phototherapy. Eur J Pediatr. 2008 Jan;167(1):37-42. Epub 2007 Feb 13.

ReferenceCitation: Bertini G, Dani C, Tronchin M, Rubaltelli FF. Is breastfeeding really favoring early neonatal jaundice? Pediatrics. 2001 Mar;107(3):E41.

ReferenceCitation: Bhutani VK, Johnson L, Sivieri EM. Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. Pediatrics. 1999 Jan;103(1):6-14.

ReferenceCitation: Bhutani VK, Johnson L. Prevention of severe neonatal hyperbilirubinemia in healthy infants of 35 or more weeks of gestation: implementation of a systems-based approach. J Pediatr (Rio J). 2007 Jul-Aug;83(4):289-93. doi: 10.2223/JPED.1673.

ReferenceCitation: Bhutani VK, Maisels MJ, Stark AR, Buonocore G; Expert Committee for Severe Neonatal Hyperbilirubinemia; European Society for Pediatric Research; American Academy of Pediatrics. Management of jaundice and prevention of severe neonatal hyperbilirubinemia in infants >or=35 weeks gestation. Neonatology. 2008;94(1):63-7. doi: 10.1159/000113463. Epub 2008 Jan 17.

ReferenceCitation: Bhutani VK, Johnson LH, Keren R. Diagnosis and management of hyperbilirubinemia in the term neonate: for a safer first week. Pediatr Clin North Am. 2004 Aug;51(4):843-61, vii. Review.

ReferenceCitation: Chang YS, Hwang JH, Kwon HN, Choi CW, Ko SY, Park WS, Shin SM, Lee M. In vitro and in vivo efficacy of new blue light emitting diode phototherapy compared to conventional halogen quartz phototherapy for neonatal jaundice. J Korean Med Sci. 2005 Feb;20(1):61-4.

ReferenceCitation: Cohen SM. Jaundice in the full-term newborn. Pediatr Nurs. 2006 May-Jun;32(3):202-8. Review.

ReferenceCitation: Grohmann K, Roser M, Rolinski B, Kadow I, Müller C, Goerlach-Graw A, Nauck M, Küster H. Bilirubin measurement for neonates: comparison of 9 frequently used methods. Pediatrics. 2006 Apr;117(4):1174-83.

ReferenceCitation: Hansen TW. Acute management of extreme neonatal jaundice--the potential benefits of intensified phototherapy and interruption of enterohepatic bilirubin circulation. Acta Paediatr. 1997 Aug;86(8):843-6.

ReferenceCitation: Lindgren C, Nilsson T. [Treatment of neonatal hyperbilirubinemia with BiliBed]. Tidsskr Nor Laegeforen. 1999 Nov 10;119(27):4027-9. Norwegian.

ReferenceCitation: Maisels MJ, Kring E. Transcutaneous bilirubin levels in the first 96 hours in a normal newborn population of > or = 35 weeks' gestation. Pediatrics. 2006 Apr;117(4):1169-73.

ReferenceCitation: Maisels MJ. What's in a name? Physiologic and pathologic jaundice: the conundrum of defining normal bilirubin levels in the newborn. Pediatrics. 2006 Aug;118(2):805-7.

ReferenceCitation: Maisels MJ, McDonagh AF. Phototherapy for neonatal jaundice. N Engl J Med. 2008 Feb 28;358(9):920-8. doi: 10.1056/NEJMct0708376. Review.

ReferenceCitation: Maisels MJ, Newman TB. Surveillance of severe neonatal hyperbilirubinemia: a view from south of the border. CMAJ. 2006 Sep 12;175(6):599.

ReferenceCitation: Newman TB, Liljestrand P, Jeremy RJ, Ferriero DM, Wu YW, Hudes ES, Escobar GJ; Jaundice and Infant Feeding Study Team. Outcomes among newborns with total serum bilirubin levels of 25 mg per deciliter or more. N Engl J Med. 2006 May 4;354(18):1889-900.

ReferenceCitation: Newman TB, Liljestrand P, Escobar GJ. Combining clinical risk factors with serum bilirubin levels to predict hyperbilirubinemia in newborns. Arch Pediatr Adolesc Med. 2005 Feb;159(2):113-9.

ReferenceCitation: Rubaltelli FF, Gourley GR, Loskamp N, Modi N, Roth-Kleiner M, Sender A, Vert P. Transcutaneous bilirubin measurement: a multicenter evaluation of a new device. Pediatrics. 2001 Jun;107(6):1264-71.

ReferenceCitation: Seidman DS, Moise J, Ergaz Z, Laor A, Vreman HJ, Stevenson DK, Gale R. A new blue light-emitting phototherapy device: a prospective randomized controlled study. J Pediatr. 2000 Jun;136(6):771-4.

ReferenceCitation: Seidman DS, Moise J, Ergaz Z, Laor A, Vreman HJ, Stevenson DK, Gale R. A prospective randomized controlled study of phototherapy using blue and blue-green light-emitting devices, and conventional halogen-quartz phototherapy. J Perinatol. 2003 Mar;23(2):123-7.

ReferenceCitation: Shapiro SM. Bilirubin toxicity in the developing nervous system. Pediatr Neurol. 2003 Nov;29(5):410-21. Review.

ReferenceCitation: Smitherman H, Stark AR, Bhutani VK. Early recognition of neonatal hyperbilirubinemia and its emergent management. Semin Fetal Neonatal Med. 2006 Jun;11(3):214-24. Review.

ReferenceCitation: Stokowski LA. Fundamentals of phototherapy for neonatal jaundice. Adv Neonatal Care. 2006 Dec;6(6):303-12. Review. Erratum in: Adv Neonatal Care. 2007 Apr;7(2):65.


ReferenceCitation: Herman JG, Latif F, Weng Y, Lerman MI, Zbar B, Liu S, Samid D, Duan DS, Gnarra JR, Linehan WM, et al. Silencing of the VHL tumor-suppressor gene by DNA methylation in renal carcinoma. Proc Natl Acad Sci U S A. 1994 Oct 11;91(21):9700-4.

ReferenceCitation: Szyf M. DNA methylation properties: consequences for pharmacology. Trends Pharmacol Sci. 1994 Jul;15(7):233-8. Review.

ReferenceCitation: Herman JG, Merlo A, Mao L, Lapidus RG, Issa JP, Davidson NE, Sidransky D, Baylin SB. Inactivation of the CDKN2/p16/MTS1 gene is frequently associated with aberrant DNA methylation in all common human cancers. Cancer Res. 1995 Oct 15;55(20):4525-30.

ReferenceCitation: Merlo A, Herman JG, Mao L, Lee DJ, Gabrielson E, Burger PC, Baylin SB, Sidransky D. 5' CpG island methylation is associated with transcriptional silencing of the tumour suppressor p16/CDKN2/MTS1 in human cancers. Nat Med. 1995 Jul;1(7):686-92.

ReferenceCitation: Herman JG, Jen J, Merlo A, Baylin SB. Hypermethylation-associated inactivation indicates a tumor suppressor role for p15INK4B. Cancer Res. 1996 Feb 15;56(4):722-7.

ReferenceCitation: Herman JG, Umar A, Polyak K, Graff JR, Ahuja N, Issa JP, Markowitz S, Willson JK, Hamilton SR, Kinzler KW, Kane MF, Kolodner RD, Vogelstein B, Kunkel TA, Baylin SB. Incidence and functional consequences of hMLH1 promoter hypermethylation in colorectal carcinoma. Proc Natl Acad Sci U S A. 1998 Jun 9;95(12):6870-5.

ReferenceCitation: Cameron EE, Baylin SB, Herman JG. p15(INK4B) CpG island methylation in primary acute leukemia is heterogeneous and suggests density as a critical factor for transcriptional silencing. Blood. 1999 Oct 1;94(7):2445-51.

ReferenceCitation: Gelmetti V, Zhang J, Fanelli M, Minucci S, Pelicci PG, Lazar MA. Aberrant recruitment of the nuclear receptor corepressor-histone deacetylase complex by the acute myeloid leukemia fusion partner ETO. Mol Cell Biol. 1998 Dec;18(12):7185-91.

ReferenceCitation: Grignani F, De Matteis S, Nervi C, Tomassoni L, Gelmetti V, Cioce M, Fanelli M, Ruthardt M, Ferrara FF, Zamir I, Seiser C, Grignani F, Lazar MA, Minucci S, Pelicci PG. Fusion proteins of the retinoic acid receptor-alpha recruit histone deacetylase in promyelocytic leukaemia. Nature. 1998 Feb 19;391(6669):815-8.

ReferenceCitation: Lin RJ, Nagy L, Inoue S, Shao W, Miller WH Jr, Evans RM. Role of the histone deacetylase complex in acute promyelocytic leukaemia. Nature. 1998 Feb 19;391(6669):811-4.

ReferenceCitation: Redner RL, Wang J, Liu JM. Chromatin remodeling and leukemia: new therapeutic paradigms. Blood. 1999 Jul 15;94(2):417-28. Review.

ReferenceCitation: Yoshida M, Nomura S, Beppu T. Effects of trichostatins on differentiation of murine erythroleukemia cells. Cancer Res. 1987 Jul 15;47(14):3688-91.

ReferenceCitation: Yoshida M, Beppu T. Reversible arrest of proliferation of rat 3Y1 fibroblasts in both the G1 and G2 phases by trichostatin A. Exp Cell Res. 1988 Jul;177(1):122-31.

ReferenceCitation: Itazaki H, Nagashima K, Sugita K, Yoshida H, Kawamura Y, Yasuda Y, Matsumoto K, Ishii K, Uotani N, Nakai H, et al. Isolation and structural elucidation of new cyclotetrapeptides, trapoxins A and B, having detransformation activities as antitumor agents. J Antibiot (Tokyo). 1990 Dec;43(12):1524-32.

ReferenceCitation: Sugita K, Koizumi K, Yoshida H. Morphological reversion of sis-transformed NIH3T3 cells by trichostatin A. Cancer Res. 1992 Jan 1;52(1):168-72.

ReferenceCitation: Hoshikawa Y, Kwon HJ, Yoshida M, Horinouchi S, Beppu T. Trichostatin A induces morphological changes and gelsolin expression by inhibiting histone deacetylase in human carcinoma cell lines. Exp Cell Res. 1994 Sep;214(1):189-97.

ReferenceCitation: Medina V, Edmonds B, Young GP, James R, Appleton S, Zalewski PD. Induction of caspase-3 protease activity and apoptosis by butyrate and trichostatin A (inhibitors of histone deacetylase): dependence on protein synthesis and synergy with a mitochondrial/cytochrome c-dependent pathway. Cancer Res. 1997 Sep 1;57(17):3697-707.

ReferenceCitation: Biggs JR, Kudlow JE, Kraft AS. The role of the transcription factor Sp1 in regulating the expression of the WAF1/CIP1 gene in U937 leukemic cells. J Biol Chem. 1996 Jan 12;271(2):901-6.

ReferenceCitation: Nakano K, Mizuno T, Sowa Y, Orita T, Yoshino T, Okuyama Y, Fujita T, Ohtani-Fujita N, Matsukawa Y, Tokino T, Yamagishi H, Oka T, Nomura H, Sakai T. Butyrate activates the WAF1/Cip1 gene promoter through Sp1 sites in a p53-negative human colon cancer cell line. J Biol Chem. 1997 Aug 29;272(35):22199-206.

ReferenceCitation: Sowa Y, Orita T, Minamikawa S, Nakano K, Mizuno T, Nomura H, Sakai T. Histone deacetylase inhibitor activates the WAF1/Cip1 gene promoter through the Sp1 sites. Biochem Biophys Res Commun. 1997 Dec 8;241(1):142-50.

ReferenceCitation: Sambucetti LC, Fischer DD, Zabludoff S, Kwon PO, Chamberlin H, Trogani N, Xu H, Cohen D. Histone deacetylase inhibition selectively alters the activity and expression of cell cycle proteins leading to specific chromatin acetylation and antiproliferative effects. J Biol Chem. 1999 Dec 3;274(49):34940-7.

ReferenceCitation: Yu X, Guo ZS, Marcu MG, Neckers L, Nguyen DM, Chen GA, Schrump DS. Modulation of p53, ErbB1, ErbB2, and Raf-1 expression in lung cancer cells by depsipeptide FR901228. J Natl Cancer Inst. 2002 Apr 3;94(7):504-13.

ReferenceCitation: Nimmanapalli R, Fuino L, Bali P, Gasparetto M, Glozak M, Tao J, Moscinski L, Smith C, Wu J, Jove R, Atadja P, Bhalla K. Histone deacetylase inhibitor LAQ824 both lowers expression and promotes proteasomal degradation of Bcr-Abl and induces apoptosis of imatinib mesylate-sensitive or -refractory chronic myelogenous leukemia-blast crisis cells. Cancer Res. 2003 Aug 15;63(16):5126-35.

ReferenceCitation: Whitesell L, Lindquist SL. HSP90 and the chaperoning of cancer. Nat Rev Cancer. 2005 Oct;5(10):761-72. Review.

ReferenceCitation: Blagosklonny MV, Trostel S, Kayastha G, Demidenko ZN, Vassilev LT, Romanova LY, Bates S, Fojo T. Depletion of mutant p53 and cytotoxicity of histone deacetylase inhibitors. Cancer Res. 2005 Aug 15;65(16):7386-92.

ReferenceCitation: Warrell RP Jr, He LZ, Richon V, Calleja E, Pandolfi PP. Therapeutic targeting of transcription in acute promyelocytic leukemia by use of an inhibitor of histone deacetylase. J Natl Cancer Inst. 1998 Nov 4;90(21):1621-5.

ReferenceCitation: O'Connor OA, Heaney ML, Schwartz L, Richardson S, Willim R, MacGregor-Cortelli B, Curly T, Moskowitz C, Portlock C, Horwitz S, Zelenetz AD, Frankel S, Richon V, Marks P, Kelly WK. Clinical experience with intravenous and oral formulations of the novel histone deacetylase inhibitor suberoylanilide hydroxamic acid in patients with advanced hematologic malignancies. J Clin Oncol. 2006 Jan 1;24(1):166-73. Epub 2005 Dec 5.

ReferenceCitation: Saito A, Yamashita T, Mariko Y, Nosaka Y, Tsuchiya K, Ando T, Suzuki T, Tsuruo T, Nakanishi O. A synthetic inhibitor of histone deacetylase, MS-27-275, with marked in vivo antitumor activity against human tumors. Proc Natl Acad Sci U S A. 1999 Apr 13;96(8):4592-7.

ReferenceCitation: Piekarz RL, Robey R, Sandor V, Bakke S, Wilson WH, Dahmoush L, Kingma DM, Turner ML, Altemus R, Bates SE. Inhibitor of histone deacetylation, depsipeptide (FR901228), in the treatment of peripheral and cutaneous T-cell lymphoma: a case report. Blood. 2001 Nov 1;98(9):2865-8.

ReferenceCitation: Parker C, Molife R, Karavasilis V, Reid A, Patterson SG, Riggs C et al. Romidepsin (FK228), a histone deacetylase inhibitor: Final results of a phase II study in metastatic hormone refractory prostate cancer (HRPC). J Clin Oncol (Meeting Abstracts) 2007;25:15507.

ReferenceCitation: Rathkopf, D. E., Wong, B. Y., Ross, R. W., George, D. J., Picus, J., Sawyers, C. L., Chen, Y., Tanaka, E., Yang, W., Culver, K. W., and Scher, H. I. A phase I dose escalation study of oral panobinostat (LBH589) alone and in combination with IV docetaxel (Doc) and oral prednisone in castration-resistant prostate cancer (CRPC). 2008 Genitourinary Cancer Sympsium , abst. 171. 2008.

ReferenceCitation: Clark MA, Fisher C, Judson I, Thomas JM. Soft-tissue sarcomas in adults. N Engl J Med. 2005 Aug 18;353(7):701-11. Review.

ReferenceCitation: Helman LJ, Meltzer P. Mechanisms of sarcoma development. Nat Rev Cancer. 2003 Sep;3(9):685-94. Review.

ReferenceCitation: Coindre JM, Terrier P, Bui NB, Bonichon F, Collin F, Le Doussal V, Mandard AM, Vilain MO, Jacquemier J, Duplay H, Sastre X, Barlier C, Henry-Amar M, Macé-Lesech J, Contesso G. Prognostic factors in adult patients with locally controlled soft tissue sarcoma. A study of 546 patients from the French Federation of Cancer Centers Sarcoma Group. J Clin Oncol. 1996 Mar;14(3):869-77.

ReferenceCitation: Guillou L, Coindre JM, Bonichon F, Nguyen BB, Terrier P, Collin F, Vilain MO, Mandard AM, Le Doussal V, Leroux A, Jacquemier J, Duplay H, Sastre-Garau X, Costa J. Comparative study of the National Cancer Institute and French Federation of Cancer Centers Sarcoma Group grading systems in a population of 410 adult patients with soft tissue sarcoma. J Clin Oncol. 1997 Jan;15(1):350-62.

ReferenceCitation: Coindre JM, Terrier P, Guillou L, Le Doussal V, Collin F, Ranchère D, Sastre X, Vilain MO, Bonichon F, N'Guyen Bui B. Predictive value of grade for metastasis development in the main histologic types of adult soft tissue sarcomas: a study of 1240 patients from the French Federation of Cancer Centers Sarcoma Group. Cancer. 2001 May 15;91(10):1914-26.

ReferenceCitation: Jebsen NL, Trovik CS, Bauer HC, Rydholm A, Monge OR, Hall KS, Alvegård T, Bruland OS. Radiotherapy to improve local control regardless of surgical margin and malignancy grade in extremity and trunk wall soft tissue sarcoma: a Scandinavian sarcoma group study. Int J Radiat Oncol Biol Phys. 2008 Jul 15;71(4):1196-203. doi: 10.1016/j.ijrobp.2007.11.023. Epub 2008 Jan 22.

ReferenceCitation: Adjuvant chemotherapy for localised resectable soft-tissue sarcoma of adults: meta-analysis of individual data. Sarcoma Meta-analysis Collaboration. Lancet. 1997 Dec 6;350(9092):1647-54.

ReferenceCitation: Woll PJ, Van GM, Hohenberger P, Le CA, Gronchi A, Hoekstra HJ et al. Adjuvant chemotherapy (CT) with doxorubicin and ifosfamide in resected soft tissue sarcoma (STS): Interim analysis of a randomised phase III trial. ASCO Meeting Abstracts 2007;25:10008.

ReferenceCitation: Edmonson JH, Ryan LM, Blum RH, Brooks JS, Shiraki M, Frytak S, Parkinson DR. Randomized comparison of doxorubicin alone versus ifosfamide plus doxorubicin or mitomycin, doxorubicin, and cisplatin against advanced soft tissue sarcomas. J Clin Oncol. 1993 Jul;11(7):1269-75.

ReferenceCitation: Santoro A, Tursz T, Mouridsen H, Verweij J, Steward W, Somers R, Buesa J, Casali P, Spooner D, Rankin E, et al. Doxorubicin versus CYVADIC versus doxorubicin plus ifosfamide in first-line treatment of advanced soft tissue sarcomas: a randomized study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 1995 Jul;13(7):1537-45.

ReferenceCitation: Prince HM, George DJ, Johnstone R, Williams-Truax R, Atadja P, Zhao C et al. LBH589, a novel histone deacetylase inhibitor (HDACi), treatment of patients with cutaneous T-cell lymphoma (CTCL). Changes in skin gene expression profiles related to clinical response following therapy. J Clin Oncol (Meeting Abstracts) 2006;24:7501.

ReferenceCitation: Beck J, Fischer T, George D, Huber C, Calvo E, Atadja P et al. Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of ORAL LBH589B: A novel histone deacetylase (HDAC) inhibitor. J Clin Oncol (Meeting Abstracts) 2005;23:3148.

ReferenceCitation: Beck J, Fischer T, Rowinsky E, Huber C, Mita M, Atadja P et al. Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of LBH589A: A novel histone deacetylase inhibitor. J Clin Oncol (Meeting Abstracts) 2004;22:3025.

ReferenceCitation: Le Cesne A, Judson I, Crowther D, Rodenhuis S, Keizer HJ, Van Hoesel Q, Blay JY, Frisch J, Van Glabbeke M, Hermans C, Van Oosterom A, Tursz T, Verweij J. Randomized phase III study comparing conventional-dose doxorubicin plus ifosfamide versus high-dose doxorubicin plus ifosfamide plus recombinant human granulocyte-macrophage colony-stimulating factor in advanced soft tissue sarcomas: A trial of the European Organization for Research and Treatment of Cancer/Soft Tissue and Bone Sarcoma Group. J Clin Oncol. 2000 Jul;18(14):2676-84.

ReferenceCitation: Garcia-Carbonero R, Supko JG, Manola J, Seiden MV, Harmon D, Ryan DP, Quigley MT, Merriam P, Canniff J, Goss G, Matulonis U, Maki RG, Lopez T, Puchalski TA, Sancho MA, Gomez J, Guzman C, Jimeno J, Demetri GD. Phase II and pharmacokinetic study of ecteinascidin 743 in patients with progressive sarcomas of soft tissues refractory to chemotherapy. J Clin Oncol. 2004 Apr 15;22(8):1480-90.

ReferenceCitation: Le Cesne A, Blay JY, Judson I, Van Oosterom A, Verweij J, Radford J, Lorigan P, Rodenhuis S, Ray-Coquard I, Bonvalot S, Collin F, Jimeno J, Di Paola E, Van Glabbeke M, Nielsen OS. Phase II study of ET-743 in advanced soft tissue sarcomas: a European Organisation for the Research and Treatment of Cancer (EORTC) soft tissue and bone sarcoma group trial. J Clin Oncol. 2005 Jan 20;23(3):576-84. Erratum in: J Clin Oncol. 2005 Aug 1;23(22):5276.

ReferenceCitation: Bay JO, Ray-Coquard I, Fayette J, Leyvraz S, Cherix S, Piperno-Neumann S, Chevreau C, Isambert N, Brain E, Emile G, Le Cesne A, Cioffi A, Kwiatkowski F, Coindre JM, Bui NB, Peyrade F, Penel N, Blay JY; Groupe Sarcome Français. Docetaxel and gemcitabine combination in 133 advanced soft-tissue sarcomas: a retrospective analysis. Int J Cancer. 2006 Aug 1;119(3):706-11. Erratum in: Int J Cancer. 2007 Jan 15;120(2):450. Penel, Nicolas [added].

ReferenceCitation: Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, Sabbatini P, Tong W, Barakat R, Spriggs DR. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol. 2002 Jun 15;20(12):2824-31.

ReferenceCitation: Bolden JE, Peart MJ, Johnstone RW. Anticancer activities of histone deacetylase inhibitors. Nat Rev Drug Discov. 2006 Sep;5(9):769-84. Review.

ReferenceCitation: Ito T, Ouchida M, Ito S, Jitsumori Y, Morimoto Y, Ozaki T, Kawai A, Inoue H, Shimizu K. SYT, a partner of SYT-SSX oncoprotein in synovial sarcomas, interacts with mSin3A, a component of histone deacetylase complex. Lab Invest. 2004 Nov;84(11):1484-90.

ReferenceCitation: Wunder JS, Nielsen TO, Maki RG, O'Sullivan B, Alman BA. Opportunities for improving the therapeutic ratio for patients with sarcoma. Lancet Oncol. 2007 Jun;8(6):513-24. Review. Erratum in: Lancet Oncol. 2007 Aug;8(8):670.

ReferenceCitation: Kutko MC, Glick RD, Butler LM, Coffey DC, Rifkind RA, Marks PA, Richon VM, LaQuaglia MP. Histone deacetylase inhibitors induce growth suppression and cell death in human rhabdomyosarcoma in vitro. Clin Cancer Res. 2003 Nov 15;9(15):5749-55.

ReferenceCitation: Sakimura R, Tanaka K, Nakatani F, Matsunobu T, Li X, Hanada M, Okada T, Nakamura T, Matsumoto Y, Iwamoto Y. Antitumor effects of histone deacetylase inhibitor on Ewing's family tumors. Int J Cancer. 2005 Sep 20;116(5):784-92.

ReferenceCitation: Prince HM, George D, Patnaik A, Mita M, Dugan M, Butterfoss D et al. Phase I study of oral LBH589, a novel deacetylase (DAC) inhibitor in advanced solid tumors and non-hodgkin's lymphoma. J Clin Oncol (Meeting Abstracts) 2007;25:3500. 66. A'Hern RP. Sample

ReferenceCitation: A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66.

ReferenceCitation: Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.

ReferenceCitation: Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.

ReferenceCitation: van Maldegem AM, Bovée JV, Gelderblom H. Panobinostat-A Potential Treatment for Metastasized Ewing Sarcoma? A Case Report. Pediatr Blood Cancer. 2016 Oct;63(10):1840-3. doi: 10.1002/pbc.26077. Epub 2016 Jun 1.

name: Department of Medical Oncology; Leiden University Medical Centre; Leiden The Netherlands

family: van Maldegem

full_name: Annemiek M. van Maldegem

given: Annemiek M.

name: Department of Pathology; Leiden University Medical Centre; Leiden The Netherlands

family: Bovée

full_name: Judith V. M. G. Bovée

given: Judith V. M. G.

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

journal_name: Pediatric Blood & Cancer

title: Panobinostat-A Potential Treatment for Metastasized Ewing Sarcoma? A Case Report

ReferenceCitation: Cassier PA, Lefranc A, Amela EY, Chevreau C, Bui BN, Lecesne A, Ray-Coquard I, Chabaud S, Penel N, Berge Y, Dômont J, Italiano A, Duffaud F, Cadore AC, Polivka V, Blay JY. A phase II trial of panobinostat in patients with advanced pretreated soft tissue sarcoma. A study from the French Sarcoma Group. Br J Cancer. 2013 Aug 20;109(4):909-14. doi: 10.1038/bjc.2013.442. Epub 2013 Aug 6.

family: Cassier

full_name: P A Cassier

given: P A

family: Lefranc

full_name: A Lefranc

given: A

family: Y Amela

full_name: E Y Amela

given: E

family: Chevreau

full_name: C Chevreau

given: C

family: Bui

full_name: B N Bui

given: B N

title: Efficacy and Safety Assessment of Oral LBH589 in Adult Patients With Advanced Soft Tissue Sarcoma After Pre-treatment Failure: an Open-label, Multicenter Phase II Study

summary: The purpose of this study is to assess efficacy and safety of LBH589 - Panobinostat®, a potent HDACi, in patients with advanced STS who experiment disease progression after or during first-line chemotherapy. The rational is based on the observation of activity of deacetylase inhibitor (DACi) in several pre-clinical models of STS including Synovial sarcoma and Ewing sarcoma.


acronym: Oberab

summary: This study aims to determine, in obese subjects, the antisecretory effect of a single dose of placebo, rabeprazole 20 mg and omeprazole 20 mg using 24h gastric pH monitoring, in a prospective, monocentre, randomized manner. Monitorings are separated between 6 and10 days. The main outcome criteria of analysis is the percentage of time with gastric pH above 3 during 24hours.

ReferenceCitation: Belhocine K, Vavasseur F, Volteau C, Flet L, Touchefeu Y, Bruley des Varannes S. Controlling on-demand gastric acidity in obese subjects: a randomized, controlled trial comparing a single dose of 20 mg rabeprazole and 20 mg omeprazole. BMC Gastroenterol. 2014 Jul 15;14:128. doi: 10.1186/1471-230X-14-128.

family: Belhocine

full_name: Kafia Belhocine

given: Kafia

family: Vavasseur

full_name: Fabienne Vavasseur

given: Fabienne

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Flet

full_name: Laurent Flet

given: Laurent

family: Touchefeu

full_name: Yann Touchefeu

given: Yann

family: Bruley des Varannes

full_name: Stanislas Bruley des Varannes

currency_apc_doaj: GBP

journal_name: BMC Gastroenterology

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer


title: Impact of Infectious Diseases Specialists on the Appropriateness of Antimicrobial Therapy in Surgical and Medical Wards: a Multicenter Randomized Controlled Trial.

acronym: ATBREFSURMED

summary:
CONTEXT: Antibiotics are frequently used in hospital but the appropriateness of prescriptions ranged between 25-50%. The intervention of infectious disease specialists (IDS) could improve the appropriateness of prescriptions and reduce their use. The impact of IDS has not been yet fully estimated using a randomized trial to compare the quality of care of patients who will benefit of the intervention.

OBJECTIVES: To show using a randomized trial that patients with IDS advice will receive more appropriate antimicrobial therapy but less exposure to antibiotics, as compared to patients who will not receive IDS advice.

METHODS: Prospective randomized trial comparing antibiotic exposure and appropriateness of prescriptions in two groups of patients:

Control group: antibiotic prescriptions will be initiated and managed by the attending physicians
Intervention group: antibiotic prescriptions will be systematically evaluated by the IDS and changed if judged necessary by the attending physicians, following IDS' advice.

STUDY PROCESS: The study will took place in 4 university hospitals. Two medical or surgical wards will participate by hospital. For each ward, the period of the study will be 2 x 4 weeks.Total duration of the study: 12 months.

ReferenceCitation: Lesprit P, de Pontfarcy A, Esposito-Farese M, Ferrand H, Mainardi JL, Lafaurie M, Parize P, Rioux C, Tubach F, Lucet JC. Postprescription review improves in-hospital antibiotic use: a multicenter randomized controlled trial. Clin Microbiol Infect. 2015 Feb;21(2):180.e1-7. doi: 10.1016/j.cmi.2014.08.015. Epub 2014 Oct 14.

family: Lesprit

full_name: P. Lesprit

given: P.

family: de Pontfarcy

full_name: A. de Pontfarcy

given: A.

family: Esposito-Farese

full_name: M. Esposito-Farese

given: M.

family: Ferrand

full_name: H. Ferrand

given: H.

family: Mainardi

full_name: J.L. Mainardi

family: Lafaurie

full_name: M. Lafaurie

family: Parize

full_name: P. Parize

family: Rioux

full_name: C. Rioux

given: C.

family: Tubach

full_name: F. Tubach

given: F.

family: Lucet

full_name: J.C. Lucet

journal_name: Clinical Microbiology and Infection

title: Postprescription review improves in-hospital antibiotic use: A multicenter randomized controlled trial


type: Registry Identifier

title: Cardiac MRI for the Detection of Cellular Rejection in Patients With Heart Transplantation

summary: To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection (EMB) and follow-up of cellular rejection in heart transplant in childhood.


ReferenceCitation: Malard F, Labopin M, Yakoub-Agha I, Chantepie S, Guillaume T, Blaise D, Tabrizi R, Magro L, Vanhove B, Blancho G, Moreau P, Gaugler B, Chevallier P, Mohty M. Rituximab-based first-line treatment of cGVHD after allogeneic SCT: results of a phase 2 study. Blood. 2017 Nov 16;130(20):2186-2195. doi: 10.1182/blood-2017-05-786137. Epub 2017 Sep 1.

name: Centre de Recherche en Transplantation et Immunologie Unité Mixte de Recherche 1064, INSERM, Université de Nantes, Nantes, France;

name: Sorbonne Universités, Université Pierre et Marie Curie Université Paris 06, INSERM, Centre de Recherche Saint-Antoine, Paris, France;

name: Service d'Hématologie Clinique et de Thérapie Cellulaire, Assistance Publique-Hôpitaux de Paris, Hôpital, Saint Antoine, Paris, France;

family: Malard

full_name: Florent Malard

given: Florent

family: Labopin

full_name: Myriam Labopin

given: Myriam

name: Service des Maladies du Sang, Centre Hospitalo-Universitaire de Lille, Lille, France;

name: Centre de Recherche sur L'inflammation de Lille, INSERM U995, Université Lille 2, Lille, France;

family: Yakoub-Agha

full_name: Ibrahim Yakoub-Agha

given: Ibrahim

name: Service d'Hématologie Clinique, Centre Hospitalo-Universitaire de Caen, Caen, France;

family: Chantepie

full_name: Sylvain Chantepie

given: Sylvain

name: Service d'Hématologie Clinique, Centre Hospitalo-Universitaire de Nantes, Nantes, France;

family: Guillaume

full_name: Thierry Guillaume

given: Thierry

name: Institut Paoli-Calmettes, Université d'Aix-Marseille, Centre National de la Recherche Scientifique, INSERM, Centre de Recherche en Cancérologie de Marseille, Marseille, France;

family: Blaise

full_name: Didier Blaise

given: Didier

name: Service d'Hématologie Clinique, Centre Hospitalo-Universitaire de Bordeaux, Bordeaux, France; and

family: Tabrizi

full_name: Reza Tabrizi

given: Reza

family: Magro

full_name: Leonardo Magro

given: Leonardo

name: Institut de Transplantation Urologie Néphrologie and

family: Vanhove

full_name: Bernard Vanhove

given: Bernard

family: Blancho

full_name: Gilles Blancho

given: Gilles

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Gaugler

full_name: Béatrice Gaugler

given: Béatrice

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

name: Centre d'Investigation Clinique en Cancérologie Centre Hospitalo-Universitaire de Nantes, Nantes, France

family: Mohty

full_name: Mohamad Mohty

given: Mohamad

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

acronym: R-GVHD

title: Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab

summary: The main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD) and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.


title: Role of the Cortico-basal Ganglia Loops in Visual Attention: Effects of Dopaminergic and Subthalamic Nucleus Stimulation in Parkinson's Disease

acronym: VSA-PD

summary:
Parkinson's disease (PD), which is generally considered to be a motor disorder, is now known to be accompanied in many instances by a variety of cognitive defects. This can be explained considering that PD is a neurodegenerative and progressive disorder of the basal ganglia system, which works modulating not only motor, but also cognitive and emotional behaviours.

Concerning this, some studies suggest that non-demented PD patients may suffer from a voluntary selective visual attention orienting deficit, showing a reduced skill in focusing upon one target, and may be easily distracted from irrelevant but salient stimuli, with a consequent negative impact on their physical health, social interactions and quality of life.

Up to now, the evidence of the role of the basal-ganglia system in modulating visual attention functions is poor and indirect and the effects of dopaminergic and subthalamic nucleus (STN) stimulation (two usual and effective treatments in PD) on attention performances are controversial.

The main objectives of the project are: 1) to assess the visual selective attention as well as the distractibility in PD patients; 2) to study the effects of patient's usual antiparkinsonian treatments, that is dopaminergic and STN stimulation, on visual attention performances.

Secondly, from a clinical and neurophysiologic point of view, the investigators want to study the respective role of the dopaminergic pathways and the sensorimotor and associative/limbic cortico-basal ganglia loops passing across the STN in the visual attention performances.

To precisely answer the objectives of the protocol, the investigators will record the performances of participants during the administration of 3 computerized tests, which are suitable to study visual attention, decision making and motor performances.

The investigators will compare the performances on the computerized tests of two groups of PD patients, one evaluated in different sets of electrical (without stimulation, or selective stimulation of the sensorimotor or associative/limbic part of the STN) stimulation, the other in different conditions of medication (with or without dopaminergic treatment) with those of a group of healthy subjects.

lead_sponsor: University Hospital, Grenoble

location_facility: Unité des Troubles du Mouvement, Clinique de Neurologie, Grenoble University Hospital


title: Assessment of Quality of Life in Disorders of the Pelvic Floor

acronym: U-GYN-QOL

summary: The purpose of this study is to compare the touch-screen version of the PFDI-20, PFIQ-7, PISQ 12 and SF-36 french questionnaires to their paper versions. The investigators hypothesize that the percentage of completely filled questionnaires will be higher in the touch-screen version.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes


lead_sponsor: Millennium Pharmaceuticals, Inc.

location_facility: Hôpital Edouard Herriot, 5, Place d'Arsonval, Pavillon V - Urologie et chirurgie de la transplantation

title: A Phase 1/2, Open Label Study in Men With Prostate Cancer to Assess the Safety. Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448, Administered as a 1-Month Depot, Including a Randomized Portion With a Group Administered Leuprorelin

summary: The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of 1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. The phase 2 portion of this study is an open-label, multicenter, randomized study in men with prostate cancer that will confirm the testosterone- and prostate specific antigen (PSA)- lowering potential of up to 2 dose levels of 1-month depot TAK-448.


title: A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) Parameters After the Administration of Ketamine, Two Doses of AZD6765 and Placebo

acronym: AZD6765 EEG

summary: This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.

ReferenceCitation: Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.

family: Sanacora

full_name: G Sanacora

given: G

family: Smith

full_name: M A Smith

given: M A

family: Pathak

full_name: S Pathak

given: S

family: Su

full_name: H-L Su

given: H-L

family: Boeijinga

full_name: P H Boeijinga

given: P H

family: McCarthy

full_name: D J McCarthy

given: D J

family: Quirk

full_name: M C Quirk

given: M C

journal_name: Molecular Psychiatry

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: AstraZeneca


title: Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)

acronym: ABOS

summary:
Type 2 diabetes and obesity are both multifactorial diseases resulting from gene-environment interactions. However, this interaction, as well as the specific effect of each polymorphism, remains poorly understood.

We now proposed a prospective cohort study to improve our understanding of the influence of phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid metabolism by collecting different biological samples.

study_start_date_type: Actual

status: Recruiting

ReferenceCitation: Margerie D, Lefebvre P, Raverdy V, Schwahn U, Ruetten H, Larsen P, Duhamel A, Labreuche J, Thuillier D, Derudas B, Gheeraert C, Dehondt H, Dhalluin Q, Alexandre J, Caiazzo R, Nesslany P, Verkindt H, Pattou F, Staels B. Hepatic transcriptomic signatures of statin treatment are associated with impaired glucose homeostasis in severely obese patients. BMC Med Genomics. 2019 Jun 3;12(1):80. doi: 10.1186/s12920-019-0536-1.

apc_source: openAPC

family: Margerie

full_name: Daniel Margerie

given: Daniel

family: Lefebvre

full_name: Philippe Lefebvre

family: Raverdy

full_name: Violeta Raverdy

given: Violeta

family: Schwahn

full_name: Uwe Schwahn

given: Uwe

family: Ruetten

full_name: Hartmut Ruetten

given: Hartmut

family: Larsen

full_name: Philip Larsen

given: Philip

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Thuillier

full_name: Dorothée Thuillier

given: Dorothée

family: Derudas

full_name: Bruno Derudas

given: Bruno

family: Gheeraert

full_name: Céline Gheeraert

given: Céline

family: Dehondt

full_name: Hélène Dehondt

given: Hélène

family: Dhalluin

full_name: Quentin Dhalluin

given: Quentin

family: Alexandre

full_name: Jérémy Alexandre

given: Jérémy

family: Caiazzo

full_name: Robert Caiazzo

given: Robert

family: Nesslany

full_name: Pamela Nesslany

given: Pamela

family: Verkindt

full_name: Helene Verkindt

given: Helene

family: Pattou

full_name: François Pattou

given: François

family: Staels

full_name: Bart Staels

given: Bart

journal_name: BMC Medical Genomics

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

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

ReferenceCitation: Lien F, Berthier A, Bouchaert E, Gheeraert C, Alexandre J, Porez G, Prawitt J, Dehondt H, Ploton M, Colin S, Lucas A, Patrice A, Pattou F, Diemer H, Van Dorsselaer A, Rachez C, Kamilic J, Groen AK, Staels B, Lefebvre P. Metformin interferes with bile acid homeostasis through AMPK-FXR crosstalk. J Clin Invest. 2014 Mar;124(3):1037-51. doi: 10.1172/JCI68815. Epub 2014 Feb 17.

publisher: American Society for Clinical Investigation


title: An Open-label, Two-treatment Crossover Pharmacokinetic Study of Clopidogrel Hydrogen Sulfate in Healthy Male and Female Subjects

summary:
The objectives of the study are to:

Assess the within-subject variability of the pharmacokinetic profiles of the clopidogrel and its active metabolite after a replicated single administration of 75 mg of clopidogrel in healthy male and female subjects
Assess the pharmacokinetic profiles of the clopidogrel and its active metabolite after single administration of 75 or 300 mg of clopidogrel

lead_sponsor: Sanofi


summary:
Beta amyloid immunoreactivity is probably due to a significant number of Ab catabolites corresponding to N-terminally truncated and Cterminally truncated or extended forms which display distinct propensity to aggregation. Very few things are known concerning the mechanisms and proteases by which they are generated. Furthermore, the link between truncation and toxicity has not been delineated.

Finally, little is known concerning Ab fragments in biological fluids and whether they could be seen as early biomarkers and thereby, as putative targets for AD diagnostic. The present project will allow to examine the human biological samples and to identify various cohorts after complete clinical evaluation.


ReferenceType: result

ReferenceCitation: Ureña-Torres P, Prié D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.

family: Ureña-Torres

full_name: Pablo Ureña-Torres

given: Pablo

family: Prié

full_name: Dominique Prié

given: Dominique

family: Keddad

full_name: Karim Keddad

given: Karim

family: Preston

full_name: Peter Preston

given: Peter

family: Wilde

full_name: Paul Wilde

given: Paul

family: Wan

full_name: Hong Wan

given: Hong

family: Copley

full_name: J Brian Copley

given: J Brian

journal_name: BMC Nephrology

lead_sponsor: Shire

title: A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo-controlled Study to Assess the Effect of Lanthanum Carbonate on Intact FGF23 in Normo-phosphataemic Subjects With Stage 3 Chronic Kidney Disease

summary: To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.


summary: Land military missions generally combine prolonged walking/moderate-pace-running and other physical actions such as creeping, jumping, shooting,… which are associated with the direct carrying of high to severe loads of equipment and supplies (20-30 to 50 kg) by soldiers. For an infantry section, "typical" intervention phases last about 20-24 h and combine variable intensity grades. Consequently, military mission characteristics are an interesting investigation field of human fatigue. Previous studies have investigated human neuromuscular alterations after prolonged "normal" locomotion exercises [Millet et al., 2004, 2009], thus the aim of this study is to characterize the neuromuscular determinants of fatigue induced by a 24-h Simulated Military Effort (SME) and a 4-h Military Road March (MM), both performed with high load carriage. Additionally, the consequences of fatigue on physiological and biomechanical parameters of locomotion will be investigated.

ReferenceCitation: Grenier JG, Millet GY, Peyrot N, Samozino P, Oullion R, Messonnier L, Morin JB. Effects of extreme-duration heavy load carriage on neuromuscular function and locomotion: a military-based study. PLoS One. 2012;7(8):e43586. doi: 10.1371/journal.pone.0043586. Epub 2012 Aug 22.

family: Grenier

full_name: Jordane G. Grenier

given: Jordane G.

family: Millet

full_name: Guillaume Y. Millet

given: Guillaume Y.

family: Peyrot

full_name: Nicolas Peyrot

given: Nicolas

family: Samozino

full_name: Pierre Samozino

given: Pierre

family: Oullion

full_name: Roger Oullion

given: Roger

family: Messonnier

full_name: Laurent Messonnier

given: Laurent

family: Morin

full_name: Jean-Benoît Morin

given: Jean-Benoît

bso_classification: Biology (fond.)

journal_name: PLoS ONE

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

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Effects of Extreme-Duration Heavy Load Carriage on Neuromuscular Function and Locomotion: A Military-Based Study

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration

acronym: ARIBA

summary:
Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is replaced by a full syringe, it is named "relay". This change may cause a flow interruption and hypotension.

In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4 years, new devices are also used to make the relays. It is "smart pumps" allowing to manage automated the drug delays. This new method allows to not interrupt the drug flow. It could reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will show that the use of automatic method is the most sure medical strategy.

Our study want to compare manual and automatic method watching the variations of medium arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP before the relay). Noradrenalin is the catecholamine most administrated so we choose to study only the relay for this drug.

ReferenceCitation: Greau E, Lascarrou JB, Le Thuaut A, Maquigneau N, Alcourt Y, Coutolleau A, Rousseau C, Erragne V, Reignier J. Automatic versus manual changeovers of norepinephrine infusion pumps in critically ill adults: a prospective controlled study. Ann Intensive Care. 2015 Dec;5(1):40. doi: 10.1186/s13613-015-0083-7. Epub 2015 Nov 14.

family: Greau

full_name: Emilie Greau

given: Emilie

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

family: Le Thuaut

full_name: Aurélie Le Thuaut

given: Aurélie

family: Maquigneau

full_name: Nathalie Maquigneau

given: Nathalie

family: Alcourt

full_name: Yolaine Alcourt

given: Yolaine

family: Coutolleau

full_name: Anne Coutolleau

given: Anne

family: Rousseau

full_name: Cécile Rousseau

given: Cécile

family: Erragne

full_name: Vanessa Erragne

given: Vanessa

family: Reignier

full_name: Jean Reignier

given: Jean

journal_name: Annals of Intensive Care

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

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Phase 1 Study of Hepatic Intra-Arterial Administration of 188RE-SSS Lipiodol to Treat HepatoCellular Carcinomas

acronym: LIP-RE-I

summary: This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.

ReferenceCitation: Garin E, Rakotonirina H, Lejeune F, Denizot B, Roux J, Noiret N, Mesbah H, Herry JY, Bourguet P, Lejeune JJ. Effect of a 188 Re-SSS lipiodol/131I-lipiodol mixture, 188 Re-SSS lipiodol alone or 131I-lipiodol alone on the survival of rats with hepatocellular carcinoma. Nucl Med Commun. 2006 Apr;27(4):363-9.

lead_sponsor: Center Eugene Marquis


lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assisatnce Publique Hopitaux de Marseille

title: Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation

summary: The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.


title: Secondary Adult's Hemophagocytic Lymphohistiocytosis and Innate Immunity

summary:
Hemophagocytic lymphohisticytosis (HLH) is a rare and severe disease of genetic origin in children (familial-HLH, F-HLH) or affecting adults secondary to infections, hematologic malignancies or auto-immune diseases (secondary_HLH, S-HLH). F-HLH are due to genetic mutations affecting the genes of perforin or proteins involved in its secretion, resulting in the complete loss of lymphocyte cytotoxicity without affecting lymphocyte number. In S-HLH, the investigators have observed a severe NK cell lymphopenia and a transient loss of cytotoxicity of unknown mechanism. In this study, the investigators will dissect macrophage activation mechanisms as well as NK cytotoxicity inability in adults patients suffering of S-HLH.

Macrophage activation could result from the loss of the retro-control normally exerted by NK cells, thus the investigators will analyze reciprocal interactions of macrophages and NK cells during the acute phase and after recovery of S-HLH.

location_facility: Assistance Publique Hopitaux de Marseille


title: Head to Head Comparison of Multidetector Coronary Tomography and Conventional Coronary Angiogram in the Setting of Systematic Screening of Coronary Vasculopathy After Orthotopic Heart Transplantation.

summary: Coronary vasculopathy remains the leading cause of decreased survival after the first year post-transplantation. It is mainly asymptomatic because of the denervation of the heart transplant. Currently, annual invasive coronary angiogram is performed to ensure the lack of coronary narrowing. But invasive coronary angiography caries risks of serious adverse events and some concern rise from its repetition in that population. Recent advance in coronary multidetector computed tomography (CT) may allow non invasive visualization of the coronary tree. But, it remains unknown if the encouraging data observed in native coronary artery analysis can be extrapolated to transplant heart recipients. Indeed, only very small sample size studies (20 patients) have been conducted in this particular setting. Thus, the investigators decide to assess the diagnostic accuracy of the 64-row CT and 256-row CT compared to the gold standard coronary angiogram in a larger sample size study. The practice aim of this study is to determine if the conventional invasive coronarography can be switched by the 64-row CT or the 256-row CT to assess coronary anatomy especially for the patient without any coronary artery disease (CAD) or those with CAD not suitable for percutaneous coronary intervention.

lead_sponsor: French Cardiology Society


title: Neutrophile Gelatinase Associated Lipocalin Evaluation in Septic Acute Kidney Injury

acronym: NESAKI

summary:
Acute kidney injury (AKI) is a major organ failure in septic shock. Current medical tests (serum creatinine and urea) cannot identify AKI until approximately 48 hours after it occurs. Neutrophil gelatinase-associated lipocalin (NGAL) may be able to predict ischemic AKI more effectively and faster than serum creatinine and urea levels.

The purpose of this study is to take a blood sample from patients at admission and then at 24 and 48 hours after to test their plasma for NGAL and compare the NGAL levels to their creatinine and urea levels. The investigators hypothesize that NGAL is an earlier marker to classify the kidney failure as acute tubular necrosis or pre-renal azotemia than creatinine and urea.

lead_sponsor: Université Victor Segalen Bordeaux 2

location_facility: Reanimation medicale, Hopital Saint-Andre, Bordeaux University Hospital


title: Comparative Efficacy and Safety of Combined Radiotherapy and Adjuvant Hormone Therapy (Leuprorelin SR 11.25 mg) and Hormone Therapy Alone (Leuprorelin SR 11.25 mg) in Locally Advanced Prostate Cancer (T3-T4 or pT3 on Biopsy, N0, M0)

summary: The purpose of this study is to compare the efficacy and safety of combined radiotherapy and hormone therapy and hormone therapy alone in the treatment of clinically locally advanced prostate cancer (T3-T4 or pT3 on biopsy, N0, M0).

ReferenceCitation: Sargos P, Mottet N, Bellera C, Richaud P. Long-term androgen deprivation, with or without radiotherapy, in locally advanced prostate cancer: updated results from a phase III randomised trial. BJU Int. 2020 Jun;125(6):810-816. doi: 10.1111/bju.14768. Epub 2020 Mar 2.

name: Department of Radiation Oncology; Institut Bergonié; Bordeaux France

family: Sargos

full_name: Paul Sargos

given: Paul

name: Department of Urology; University Hospital; Saint-Etienne France

family: Mottet

full_name: Nicolas Mottet

name: Clinical and Epidemiological Research Unit; Institut Bergonié; Bordeaux France

family: Bellera

full_name: Carine Bellera

given: Carine

family: Richaud

full_name: Pierre Richaud

journal_name: BJU International

lead_sponsor: Takeda

intervention_type: Radiation


title: Impact of Oral Magnesium on Neuropathic Pain

summary:
Use lay language.

The aim of this study is to evaluate on pain scores (neuropathic pain questionnaire and pain numeric scale) and on quality of life, the effect of oral magnesium intake on patients with neuropathic pain comparing with patients receiving placebo,. The study drug will be taken during 4 weeks.


title: Effectiveness and Tolerance of CoSeal in the Prevention of Hepatic Adherences of Novo Post Operational Within the Framework of a Hepatic Surgery of Resection in Two Times for Hepatic Metastases: Study of Phase II/III.

acronym: COLIBIS

summary: Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Physiopathology of Rapid Aspirin Desensitization in Patients With Coronary Artery Disease and a History of Hypersensitivity to Aspirin or NSAIDs

summary: Aspirin is very effective in protecting patients with coronary artery disease against adverse cardiac events, because it is a potent "antiplatelet agent". Some patients may develop a history of hypersensitivity to aspirin and treatment cannot usually be resumed in these patients. We have developed a rapid procedure to induce tolerance in these patients (SILBERMAN et al, Am J CARDIOL 2005;95:509-10) and wish to test whether aspirin is as effective as antiplatelet agent in patients with a history of allergy to aspirin and who undergo desensitization as it is in patients without history of hypersensitivity

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre hospitalier Bichat Claude Bernard


title: A Prospective, Multicenter, Randomized and Single Bind Trial. Influence of Laryngoscope Blade Material on Postoperative PHARYNGEAL AND LARYNGEAL Morbidity Following Scheduled OroTracheal Intubation

acronym: MPLIT

summary:
Orotracheal intubation following general anesthesia requires blades to be performed. The risk of patients contamination with infectious agents related to reusable metal blades leads to promote single-use blades. Some of these latter are plastic and this material may need more strength to lift the jaw and expose the larynx before orotracheal intubation. Sometimes, change of blade, from plastic to metal, during the procedure is necessary to increase the larynx exposure. This change of blade may increase the frequency of sore throat following orotracheal intubation.

Consequently, the study hypothesis is an increase of both sore throat intensity and frequency with the plastic blades compared with the metal blades.

The primary purpose of the present study is to compare the impact of these two types of blades, metal versus plastic, on sore throat intensity and frequency following scheduled orotracheal intubation for general anesthesia

ReferenceCitation: Amour J, Marmion F, Birenbaum A, Nicolas-Robin A, Coriat P, Riou B, Langeron O. Comparison of plastic single-use and metal reusable laryngoscope blades for orotracheal intubation during rapid sequence induction of anesthesia. Anesthesiology. 2006 Jan;104(1):60-4.

ReferenceCitation: Maktabi MA, Smith RB, Todd MM. Is routine endotracheal intubation as safe as we think or wish? Anesthesiology. 2003 Aug;99(2):247-8.

location_facility: hospital Center of Meaux, department of anesthesiology


title: Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

summary:
Assess the effect of cigarette smoking of tobacco with or without addition of resin cannabis on driving performance in healthy volunteers in simulated driving in Marseille and Toulouse, and in real world driving to Bordeaux.

Multicenter Study of phase 1, randomized, double-blind, cross plan, carried out in healthy male volunteers.


title: Pilot Study for the Treatment of Bone Metastases by High Intensity Focused Ultrasound Guided by MRI to Perform Pain Palliation

summary:
This study is to confirm the safety and technical of MRI guided High Intensity Focused Ultrasound (HIFU) for Palliation for Pain of Skeletal Metastases.

MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate tissue. The MRI system identifies the ultrasound path and monitors heat rise in the tissue. The goal of the study is to show treatment safety and effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria.

ReferenceCitation: Chow E, Wu JS, Hoskin P, Coia LR, Bentzen SM, Blitzer PH. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiother Oncol. 2002 Sep;64(3):275-80.

lead_sponsor: Philips Healthcare


title: Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants

summary: To assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to 29 weeks of gestation age.


lead_sponsor: University Hospital, Clermont-Ferrand

title: Effect of Paracetamol on the Status in Glutathione for the Aged Person

summary:
Paracetamol is one of the most widely used analgesics in the world especially for chronic pain in the elderly. The metabolism of paracetamol occurs in the liver and involves the use of glutamyl-cysteinyl-glycine (Glutathione (GSH)). Medications such as paracetamol, may reduce the reserves of GSH because it is used for detoxification and elimination. It is well known that the concentration of GSH decrease after administration of paracetamol in humans and animals.

Aging is associated with decreased concentration of GSH in cells and tissues. In the elderly, a decrease of GSH concentration in plasma or red blood cells is associated with decreased physical and mental health.

We wish here to determine, in subjects aged over 70 years, the blood concentration of glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.


title: Impact on the Proteolysis of Obesity in Dialysis

acronym: IPOD

summary: The objective of this study is to determine whether obesity has a protective effect on muscle proteolysis in hemodialysis patients submitted to a short starvation. This effect will be tested by comparing measuring muscle proteolysis, using regional infusion of a tracer amino acid (D5 phenylalanine) in two groups of obese and non-obese patients compared to obese and non-obese control subjects.


title: Etude Observationnelle Multicentrique Relative à la tolérance de ISENTRESS® + TRUVADA® Prescrite en Prophylaxie Post-exposition de Personnes récemment Soumises au Risque de Transmission d'Une Infection Par le VIH

summary: The objective are to assess the nature and incidence of drug intolerance observed with a new antiretroviral triple therapy, Truvada® [0-0-1] + Isentress® 400 mg tablets [1-0-1], prescribed in a setting of the treatment of individuals with recent exposure to a risk of transmission of HIV infection and to compare the results with those of previous studies conducted according to the same methodology, with other combinations of antiretrovirals.

lead_sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux


title: Prevention of Nosocomial Escherichia Coli Infections After Placement of an Indwelling Catheter During Pelvic Surgery: a Randomized, Prospective, Double Blind Study for the Evaluation of Cranberry (Vaccinium Macrocarpon) Gel Capsules

acronym: NosoPink

summary: Indwelling urinary catheters are a primary site for nosocomial infections. The purpose of this study is to evaluate the anti-adhesive properties of Cranberry type A pro anthocyanidine gel capsules in the prevention Escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. The investigators primary working hypothesis is that cranberry treatment decreases E. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour un Test de Marche Sur Tapis Roulant

acronym: WELCH

summary: Purpose is to test and validate a new questionnaire (the WELCH questionnaire) to estimate walking capacity in patients with claudication

ReferenceCitation: Fouasson-Chailloux A, Abraham P, Vielle B, Laporte I, Omarjee L, Ouedraogo N. The correlation of the "Walking Estimated-Limitation Calculated by History" (WELCH) questionnaire with treadmill maximal walking time is not impaired by age, in patients with claudication. Qual Life Res. 2015 Aug;24(8):1857-64. doi: 10.1007/s11136-015-0915-9. Epub 2015 Jan 13.

family: Fouasson-Chailloux

full_name: Alban Fouasson-Chailloux

given: Alban

family: Abraham

full_name: Pierre Abraham

family: Vielle

full_name: Bruno Vielle

given: Bruno

family: Laporte

full_name: Isabelle Laporte

given: Isabelle

family: Omarjee

full_name: Loukman Omarjee

given: Loukman

family: Ouedraogo

full_name: Nafi Ouedraogo

given: Nafi

journal_name: Quality of Life Research

title: The correlation of the “Walking Estimated-Limitation Calculated by History” (WELCH) questionnaire with treadmill maximal walking time is not impaired by age, in patients with claudication

ReferenceCitation: Abraham P, Godet R, Harbonnier M, Laneelle D, Leftheriotis G, Ouedraogo N. External validation of the "walking estimated limitation calculated by history" (WELCH) questionnaire in patients with claudication. Eur J Vasc Endovasc Surg. 2014 Mar;47(3):319-25. doi: 10.1016/j.ejvs.2013.11.010. Epub 2013 Dec 3.

full_name: P. Abraham

given: P.

family: Godet

full_name: R. Godet

given: R.

family: Harbonnier

full_name: M. Harbonnier

given: M.

family: Laneelle

full_name: D. Laneelle

given: D.

family: Leftheriotis

full_name: G. Leftheriotis

given: G.

full_name: N. Ouedraogo

given: N.

journal_name: European Journal of Vascular and Endovascular Surgery

title: External Validation of the “Walking Estimated Limitation Calculated by History” (WELCH) Questionnaire in Patients with Claudication

ReferenceCitation: Mahe G, Ouedraogo N, Marchand J, Vielle B, Picquet J, Leftheriotis G, Abraham P. Self-reported estimation of usual walking speed improves the performance of questionnaires estimating walking capacity in patients with vascular-type claudication. J Vasc Surg. 2011 Nov;54(5):1360-5. doi: 10.1016/j.jvs.2011.05.048.

family: Mahe

full_name: Guillaume Mahe

given: Guillaume

family: Marchand

full_name: Johann Marchand

given: Johann

family: Picquet

full_name: Jean Picquet

ReferenceCitation: Mahe G, Ouedraogo N, Vasseur M, Faligant C, Saidi K, Leftheriotis G, Abraham P. Limitations of self-reported estimates of functional capacity using the Walking Impairment Questionnaire. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):104-9. doi: 10.1016/j.ejvs.2010.10.002. Epub 2010 Nov 30.

title: Limitations of Self-reported Estimates of Functional Capacity Using the Walking Impairment Questionnaire


title: Randomized, Double-blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia

summary: The primary objective of the study is to evaluate the safety and tolerability of Neu-P11, following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching placebo) given nightly over 2 periods of 5 days to male and female subjects with primary insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11 after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated and have significant sleep promoting effects.

lead_sponsor: Neurim Pharmaceuticals Ltd.


title: Impact of the Inhibitors of Tyrosine Kinase on the Male Fertility

acronym: GLIFERTI

summary: Evaluate the possible deleterious effects of tyrosine kinase inhibitors on sperm concentration, after 6 months of therapy, which corresponds to 2 cycles of spermatogenesis and on the sperm nuclear integrity. The main comparison criterion will be the mean difference in sperm concentration before and after the 6 month treatment.

location_facility: Department of Biology of reproduction (TENON Hospital-APHP)