title: Adjusted Value of Thromboprophylaxis in Hospitalized Obese Patients: A Comparative Study of Two Regimens of Enoxaparin

acronym: ITOHENOX

summary: Venous thromboembolism (VTE), deep vein thrombosis (DVT) or pulmonary embolism (PE) is a common medical condition encountered during hospitalization in a medical environment. The use of thromboprophylaxis with Low Molecular Weight Heparin (LMWH) or fondaparinux has reduced more than 50% relative risk of thromboembolic complications.However, while obesity defined by a body mass index (BMI) greater than 30 kg/m2, is a major risk factor for venous thrombotic events, data on obese patients are limited. In fact, less than 20% of patients included in the three major studies of preventive medicine had a BMI ≥ 30 kg/m2 and most studies specific to the obese population comes from a series of bariatric surgery patients or orthopedic surgery. The main results of this series show regarding the obese population a decrease of the anti-Xa activity during the administration of a standard dose of enoxaparin (40 mg / d). However, no specific recommendation in this population has not been published to date and therefore,the dosages currently used are the same regardless of the patient's weight. In this context, the use in obese patients hospitalized in a medical environment a stronger dosage of enoxaparin (60 mg / d) compared to the standard dose of 40 mg / day, could get rates anti-Xa activity levels more consistent with the treatment required, and thus reduce the risk for thromboembolic complications in these patients

ReferenceCitation: Miranda S, Le Cam-Duchez V, Benichou J, Donnadieu N, Barbay V, Le Besnerais M, Delmas FX, Cuvelier A, Lévesque H, Benhamou Y, Armengol G. Adjusted value of thromboprophylaxis in hospitalized obese patients: A comparative study of two regimens of enoxaparin: The ITOHENOX study. Thromb Res. 2017 Jul;155:1-5. doi: 10.1016/j.thromres.2017.04.011. Epub 2017 Apr 12.

family: Miranda

full_name: Sébastien Miranda

given: Sébastien

family: Le Cam-Duchez

full_name: Véronique Le Cam-Duchez

given: Véronique

family: Benichou

full_name: Jacques Benichou

given: Jacques

family: Donnadieu

full_name: Nathalie Donnadieu

given: Nathalie

family: Barbay

full_name: Virginie Barbay

given: Virginie

family: Le Besnerais

full_name: Maelle Le Besnerais

given: Maelle

family: Delmas

full_name: François-Xavier Delmas

given: François-Xavier

family: Cuvelier

full_name: Antoine Cuvelier

given: Antoine

family: Lévesque

full_name: Hervé Lévesque

given: Hervé

family: Benhamou

full_name: Ygal Benhamou

given: Ygal

family: Armengol

full_name: Guillaume Armengol

given: Guillaume

journal_name: Thrombosis Research


title: Home Non-invasive Ventilation Versus Long-term Oxygen Therapy in COPD Survivors of Acute Hypercapnic Respiratory Failure. A Multicenter Randomized Controlled Trial

acronym: NIVOLD

summary: Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lamia B, Cuvelier A, Benichou J, Muir JF. [A multi-centre randomized controlled trial of domiciliary non-invasive ventilation vs long-term oxygen therapy in survivors of acute hypercapnic respiratory failure due to COPD. Non-invasive ventilation in obstructive lung disease (NIVOLD) study]. Rev Mal Respir. 2012 Nov;29(9):1141-8. doi: 10.1016/j.rmr.2012.09.006. Epub 2012 Oct 16. French.

family: Lamia

full_name: B. Lamia

given: B.

sequence: first

full_name: A. Cuvelier

given: A.

sequence: additional

full_name: J. Benichou

given: J.

family: Muir

full_name: J.-F. Muir

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Revue des Maladies Respiratoires

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Bénéfices de la ventilation non invasive à domicile au décours d’une insuffisance respiratoire aiguë hypercapnique chez les patients BPCO. Étude contrôlée randomisée multicentrique. Étude Non Invasive Ventilation in Obstructive Lung Disease (Nivold)

lead_sponsor: University Hospital, Rouen

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

acronym: FEE

summary: Visualize surgical needles inserted in the prostate, under the ultrasound modality.

lead_sponsor: AdministrateurCIC

location_facility: Urology, University hospital of Grenoble

lead_sponsor_type: industriel


title: Acquisition of Multidrug-resistant Bacteria After Travel in the Tropics : Prevalence, Determinants and Length of Carriage

acronym: VOYAG-R

summary: The purpose of this study is to Measure the fecal carriage of multidrug-resistant bacteria after a travel in the tropics.

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Armand-Lefèvre L, Rondinaud E, Desvillechabrol D, Mullaert J, Clermont O, Petitjean M, Ruppe E, Cokelaer T, Bouchier C, Tenaillon O, Ma L, Nooroya Y, Matheron S, The Voyag-R Study Group, Andremont A, Denamur E, Kennedy SP. Dynamics of extended-spectrum beta-lactamase-producing Enterobacterales colonization in long-term carriers following travel abroad. Microb Genom. 2021 Jul;7(7). doi: 10.1099/mgen.0.000576.

name: Université de Paris, IAME, INSERM UMR 1137, F-75018 Paris, France

name: Laboratoire de Bactériologie, Hôpital Bichat-Claude Bernard, AP-HP Nord-Université de Paris, F-75018 Paris, France

family: Armand-Lefèvre

full_name: Laurence Armand-Lefèvre

given: Laurence

family: Rondinaud

full_name: Emilie Rondinaud

given: Emilie

name: Plate-forme Technologique Biomics – Centre de Ressources et Recherches Technologiques (C2RT), Institut Pasteur, F-75015 Paris, France

family: Desvillechabrol

full_name: Dimitri Desvillechabrol

given: Dimitri

family: Mullaert

full_name: Jimmy Mullaert

given: Jimmy

family: Clermont

full_name: Olivier Clermont

given: Olivier

family: Petitjean

full_name: Marie Petitjean

given: Marie

family: Ruppe

full_name: Etienne Ruppe

given: Etienne

name: Hub de Bioinformatique et Biostatistique – Département Biologie Computationnelle, Institut Pasteur, USR 3756 CNRS, F-75015 Paris, France

family: Cokelaer

full_name: Thomas Cokelaer

given: Thomas

family: Bouchier

full_name: Christiane Bouchier

given: Christiane

family: Tenaillon

full_name: Olivier Tenaillon

family: Ma

full_name: Laurence Ma

family: Nooroya

full_name: Yasmine Nooroya

given: Yasmine

name: Service de Maladies Infectieuses et Tropicales, Hôpital Bichat-Claude Bernard, AP-HP Nord-Université de Paris, F-75018 Paris, France

family: Matheron

full_name: Sophie Matheron

given: Sophie

family: Andremont

full_name: Antoine Andremont

name: Laboratoire de Génétique Moléculaire, Hôpital Bichat-Claude Bernard, AP-HP Nord-Université de Paris, F-75018 Paris, France

family: Denamur

full_name: Erick Denamur

given: Erick

family: Kennedy

full_name: Sean P. Kennedy

given: Sean P.

bso_classification: Biology (fond.)

currency_apc_doaj: GBP

journal_name: Microbial Genomics

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Microbiology Society

publisher_dissemination: Microbiology Society

publisher_group: Microbiology Society

publisher_normalized: Microbiology Society

ReferenceCitation: Ruppé E, Armand-Lefèvre L, Estellat C, Consigny PH, El Mniai A, Boussadia Y, Goujon C, Ralaimazava P, Campa P, Girard PM, Wyplosz B, Vittecoq D, Bouchaud O, Le Loup G, Pialoux G, Perrier M, Wieder I, Moussa N, Esposito-Farèse M, Hoffmann I, Coignard B, Lucet JC, Andremont A, Matheron S. High Rate of Acquisition but Short Duration of Carriage of Multidrug-Resistant Enterobacteriaceae After Travel to the Tropics. Clin Infect Dis. 2015 Aug 15;61(4):593-600. doi: 10.1093/cid/civ333. Epub 2015 Apr 22.

family: Ruppé

full_name: Etienne Ruppé


title: Predictors of Survival for Complete Clinical Responders to Definite Chemoradiation or Radiation Therapy for Esophageal Cancer

acronym: CRCRT-EC

summary: The aim of this study is to identify prognostic factors for outcome in patients being complete clinical responders with chemoradiation or radiation for esophageal cancer

time_perspective: Retrospective

lead_sponsor: Centre Oscar Lambret

intervention_type: Radiation

status_simplified: Completed


title: Genetic & Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine

acronym: LabExMI

summary: The purpose of this study is to assess the determinants of immunologic variance within the general healthy population.

primary_purpose: Health Services Research

ReferenceCitation: Scepanovic P, Hodel F, Mondot S, Partula V, Byrd A, Hammer C, Alanio C, Bergstedt J, Patin E, Touvier M, Lantz O, Albert ML, Duffy D, Quintana-Murci L, Fellay J; Milieu Intérieur Consortium. A comprehensive assessment of demographic, environmental, and host genetic associations with gut microbiome diversity in healthy individuals. Microbiome. 2019 Sep 13;7(1):130. doi: 10.1186/s40168-019-0747-x.

family: Scepanovic

full_name: Petar Scepanovic

given: Petar

family: Hodel

full_name: Flavia Hodel

given: Flavia

family: Mondot

full_name: Stanislas Mondot

given: Stanislas

family: Partula

full_name: Valentin Partula

given: Valentin

family: Byrd

full_name: Allyson Byrd

given: Allyson

family: Hammer

full_name: Christian Hammer

given: Christian

family: Alanio

full_name: Cécile Alanio

given: Cécile

family: Bergstedt

full_name: Jacob Bergstedt

given: Jacob

family: Patin

full_name: Etienne Patin

family: Touvier

full_name: Mathilde Touvier

given: Mathilde

family: Lantz

full_name: Olivier Lantz

family: Albert

full_name: Matthew L. Albert

given: Matthew L.

family: Duffy

full_name: Darragh Duffy

given: Darragh

family: Quintana-Murci

full_name: Lluis Quintana-Murci

given: Lluis

family: Fellay

full_name: Jacques Fellay

given: Jacques

journal_name: Microbiome

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

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

ReferenceCitation: Partula V, Mondot S, Torres MJ, Kesse-Guyot E, Deschasaux M, Assmann K, Latino-Martel P, Buscail C, Julia C, Galan P, Hercberg S, Rouilly V, Thomas S, Quintana-Murci L, Albert ML, Duffy D, Lantz O, Touvier M; Milieu Intérieur Consortium. Associations between usual diet and gut microbiota composition: results from the Milieu Intérieur cross-sectional study. Am J Clin Nutr. 2019 May 1;109(5):1472-1483. doi: 10.1093/ajcn/nqz029.

name: Sorbonne-Paris-Cité Research Center for Epidemiology and Statistics (CRESS), Nutritional Epidemiology Research Team (EREN) (INSERM U1153/INRA U1125/CNAM/Université Paris-XIII Nord), Bobigny, France

name: University of Paris-VII Denis Diderot, Sorbonne-Paris-Cité University, Department of Life Sciences (SdV), Paris, France

name: MICALIS Institute (INRA/AgroParisTech), Jouy-en-Josas, France

name: Nutritional Epidemiology Surveillance Team (ESEN) (Santé Publique France/Université Paris-XIII Nord/CRESS), Bobigny, France

name: Department of Public Health, Hôpital Avicenne (Hôpitaux Universitaires 93/AP-HP), Bobigny, France

name: Center of Bioinformatics, Biostatistics and Integrative Biology, Institut Pasteur, Paris, France

name: Center for Translation Research, Institut Pasteur, Paris, France

name: Immunobiology of Dendritic Cells laboratory (INSERM U1223/Institut Pasteur), Paris, France

name: Human Evolutionary Genetics laboratory (CNRS URA3012/Institut Pasteur), Paris, France

name: Department of Cancer Immunology, Genentech Inc., San Francisco, CA, USA

name: Curie Institute, PSL University, INSERM U932, Paris, France

name: Clinical Investigation Center CIC-BT1428 (Institut Gustave Roussy/Institut Curie), INSERM, Paris, France

journal_name: The American Journal of Clinical Nutrition

ReferenceCitation: Scepanovic P, Alanio C, Hammer C, Hodel F, Bergstedt J, Patin E, Thorball CW, Chaturvedi N, Charbit B, Abel L, Quintana-Murci L, Duffy D, Albert ML, Fellay J; Milieu Intérieur Consortium. Human genetic variants and age are the strongest predictors of humoral immune responses to common pathogens and vaccines. Genome Med. 2018 Jul 27;10(1):59. doi: 10.1186/s13073-018-0568-8.

repository_institution: Ecole Polytechnique Fédérale de Lausanne - Infoscience

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON


title: Multicentric Cohort of HIV Patient With Extrem Profil

acronym: CODEX

summary:
A consortium of research teams has studied the immunovirological characteristics of these patients:

The ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

lead_sponsor: ANRS, Emerging Infectious Diseases

intervention_type: Biological

status_simplified: Ongoing


title: Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method

summary: This study will examine the use of a variation of standard magnetic resonance imaging (MRI) called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is to find if a correlation exists between GA (generalized anisotropy) and the infiltration percentage of stereotactic peritumoral biopsies.

primary_purpose: Screening

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other


title: Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?

summary: To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis.

status: Unknown status

intervention_type: Dietary Supplement


title: Effect of the Consumption of a Probiotic Strain on the Prevention of Post-operative Recurrence in Crohn's Disease

summary: A double-blind, multicentre, stratified by centre, randomised, parallel study with two groups of adult patients operated on for Crohn's disease, to determine if oral ingestion of probiotics could prevent the appearance of Crohn's disease recurrent endoscopic ileo-colonic lesions 12 months after surgery. Patients will consume 900 mg/day of active product (N=56) or control product (N=56) during one year.

lead_sponsor: Danone Research

location_facility: Hôpital Huriez - Service des maladies de l'appareil digestif et de la nutrition


title: A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects

summary: The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.

lead_sponsor: Bial - Portela C S.A.

intervention_type: Drug


type: Other Identifier

title: Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis

summary:
The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The aim of the treatment of symptomatic osteoarthritis consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients.

The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular injections are proposed.

Intra articular injections of hyaluronic acid are recommended by the American College of Rheumatology and the European League against Rheumatism for the treatment of knee osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the duration of clinical improvement which does not exceed 6 months.

The articular cartilage has a limited capacity for self-repair due to the low mitotic activity of chondrocytes and its avascularity.

Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and the cytokines, liberated by platelet degranulation. The influence of these growth factors in the cartilage repair is being widely investigated in vivo and in vitro. These factors could stimulate the chondral reparation via a neovascularization, a collagen synthesis and an activation of the chondrocytes.

The hypothesis is that the intra articular injection of PRP, with its capacity to enhance articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the treatment of knee osteoarthritis resisting the oral drugs.

Material and methods: We intend to conduct a comparative, monocentric prospective randomized, double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


type: EudraCT Number

title: Phase II Study, Randomized, Monocentric, Single-blind, Comparing the Efficacy of Xenon and Desflurane, in Association With a Thoracic Epidural Analgesia in the Maintenance Phase of a Colorectal Oncologic Surgery

summary: This is a monocentric study in 2 steps: A safety part to assess the feasibility of using Xenon in association with a thoracic epidural analgesia (TEA) with a sequential recruitment of 3, 6 or 9 patients according to predefined safety rules. The second part will randomly allocated patients (1:1) to receive TEA+Xenon or TEA+Desflurane. 28 patients will be enrolled and followed over 45 days.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Nakata Y, Goto T, Ishiguro Y, Terui K, Kawakami H, Santo M, Niimi Y, Morita S. Minimum alveolar concentration (MAC) of xenon with sevoflurane in humans. Anesthesiology. 2001 Apr;94(4):611-4.

ReferenceCitation: Rasmussen LS, Schmehl W, Jakobsson J. Comparison of xenon with propofol for supplementary general anaesthesia for knee replacement: a randomized study. Br J Anaesth. 2006 Aug;97(2):154-9. Epub 2006 Jun 17.

ReferenceCitation: Salmi E, Laitio RM, Aalto S, Maksimow AT, Långsjö JW, Kaisti KK, Aantaa R, Oikonen V, Metsähonkala L, Någren K, Korpi ER, Scheinin H. Xenon does not affect gamma-aminobutyric acid type A receptor binding in humans. Anesth Analg. 2008 Jan;106(1):129-34, table of contents. doi: 10.1213/01.ane.0000287658.14763.13.

ReferenceCitation: CULLEN SC, GROSS EG. The anesthetic properties of xenon in animals and human beings, with additional observations on krypton. Science. 1951 May 18;113(2942):580-2.

ReferenceCitation: Wappler F, Rossaint R, Baumert J, Scholz J, Tonner PH, van Aken H, Berendes E, Klein J, Gommers D, Hammerle A, Franke A, Hofmann T, Schulte Esch J; Xenon Multicenter Study Research Group. Multicenter randomized comparison of xenon and isoflurane on left ventricular function in patients undergoing elective surgery. Anesthesiology. 2007 Mar;106(3):463-71.

ReferenceCitation: Baumert JH, Hein M, Hecker KE, Satlow S, Schnoor J, Rossaint R. Autonomic cardiac control with xenon anaesthesia in patients at cardiovascular risk. Br J Anaesth. 2007 Jun;98(6):722-7. Epub 2007 Apr 27.

ReferenceCitation: Luttropp HH, Thomasson R, Dahm S, Persson J, Werner O. Clinical experience with minimal flow xenon anesthesia. Acta Anaesthesiol Scand. 1994 Feb;38(2):121-5.

ReferenceCitation: Rossaint R, Reyle-Hahn M, Schulte Am Esch J, Scholz J, Scherpereel P, Vallet B, Giunta F, Del Turco M, Erdmann W, Tenbrinck R, Hammerle AF, Nagele P; Xenon Study Group. Multicenter randomized comparison of the efficacy and safety of xenon and isoflurane in patients undergoing elective surgery. Anesthesiology. 2003 Jan;98(1):6-13.

ReferenceCitation: Dupont J, Tavernier B, Ghosez Y, Durinck L, Thevenot A, Moktadir-Chalons N, Ruyffelaere-Moises L, Declerck N, Scherpereel P. Recovery after anaesthesia for pulmonary surgery: desflurane, sevoflurane and isoflurane. Br J Anaesth. 1999 Mar;82(3):355-9.

ReferenceCitation: Stuttmann R, Jakubetz J, Schultz K, Schäfer C, Langer S, Ullmann U, Hilbert P. Recovery index, attentiveness and state of memory after xenon or isoflurane anaesthesia: a randomized controlled trial. BMC Anesthesiol. 2010 May 7;10:5. doi: 10.1186/1471-2253-10-5.

ReferenceCitation: Diemunsch P; Société française d'anesthésie et de réanimation. [Conference of experts--short text. Management of postoperative nausea and vomiting. French Society of Anesthesia and Resuscitation]. Ann Fr Anesth Reanim. 2008 Oct;27(10):866-78. doi: 10.1016/j.annfar.2008.09.004. Epub 2008 Oct 25. French.

lead_sponsor: Centre Leon Berard


title: Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.

acronym: MODISC

summary: The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.

lead_sponsor: University Hospital, Montpellier


title: Sepsis in Neutropenic Patients: Autologous Stem Cell Transplantation as Model: a Transcriptomic Approach.

summary:
Treatment of cancer, and more particularly of haematological malignancies, partly relies on chemotherapy. Most therapeutic regimens display various toxicities, one of the most common being haematological toxicity, affecting the three lineages. While anaemia and thrombopenia can be overcome by haematological growth factors and transfusion, one of the most severe life-threatening toxicity is sepsis that develops during neutropenia. Neutropenia, despite the use of granulocyte colony-stimulating factors (G-CSF) and antibiotics, is still a major limitation in chemotherapy which is responsible for the majority of treatment-related morbidity and mortality and for prolonged hospitalisation.

In neutropenic patients, sepsis is more frequent and more severe than in non-neutropenic patients. While the occurence of neutropenia and sepsis is often unpredictable and thus difficult to study in a prospective way, stem cell transplantation represents a quite convenient model to study such a question. Autologous stem cell transplantation indications in haematology are mainly multiple myeloma and relapsed lymphoma or Hodgkin disease. Briefly, after a mobilization procedure, a graft of patient's hematopoietic stem cells is collected by cytapheresis and frozen. When the patient has reached complete remission by conventional chemotherapy, he benefits from a very high dose myeloablative chemotherapy (called "conditioning regimen"). The "conditioning regimen" targeted to have high antitumoral activity leads to a "cytokine storm" resulting in a "programmed inflammation". 36 hours after the lasting of the conditioning regimen, the CD34+ cells are thawed and infused to the patient. Thus neutropenia usually begins at D4 post transplantation and lasts for 10 days, until graft becomes "functional". Thus, the timing and duration of neutropenia are very homogeneous. During neutropenia, fever and sepsis are very frequent (>80% patients), thus, most patient will be informative regarding sepsis, and there is an easy possibility of biological sampling before" programmed inflammation" (due to conditioning regimen), after inflammation before sepsis, then during and after the sepsis. Since the patient is hospitalized, the kinetic monitoring is quite easy

primary_purpose: Diagnostic


title: Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease

summary: The purpose of this study is to determine the average risk for thyroid irradiation for any type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv, adjusted to the measured thyroid volume and to the patient's age.

primary_purpose: Prevention


title: Research for Prognostic and Predictive Biomarkers of Therapeutic Response in Pancreatic Tumors - PACAomics / IPC 2011-004

acronym: PACAomics

summary:
Pancreatic cancer is among the most serious human neoplasia and the most difficult to treat.

Most patients present at diagnosis a non resectable, locally advanced or metastatic disease, with a median survival of 12 month.

The aim of this study is the identification of diagnosis biomarkers, predictive of the therapeutic response.

This project investigate the use of molecular analyses applied to pancreatic tumor cells collected by microbiopsy under ultrasound-endoscopy, and blood cells.

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Procedure


title: Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease

acronym: FIBROCHIR

summary:
Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD) and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.

The main objective of the study is to analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD compared to control subjects.

lead_sponsor: University Hospital, Bordeaux

location_facility: University hospital of Bordeaux, Hôpital du Haut Lévêque


title: Spa Therapy in the Treatment of Chronic Shoulder Pain Due to Rotator Cuff Tendinopathy: ROTATHERM, a Large Randomized Multicentre Trial

acronym: ROTATHERM

summary: To determine whether spa therapy has a beneficial effect on pain and disability in the management of shoulder pain due to chronic rotator cuff lesions, this multicentre randomized prospective clinical trial includes patients with shoulder pain due to chronic degenerative rotator cuff tendinopathy who attend French spa resorts as outpatients. Subjects are randomized into two groups: immediate spa therapy (18 days of standardized treatment) and control (spa therapy delayed for 6 months). All patients continue usual treatments during the 6-month follow-up period. The main endpoint is the mean change in the DASH score at 6 months. Secondary endpoints are the mean change in SF-36 components, treatments used, and tolerance. The effect size of spa therapy is calculated and the proportion of patients reaching minimal clinically important improvement (MCII) is compared between groups.

ReferenceType: result

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

family: Forestier

full_name: R. Forestier

given: R.

family: Desfour

full_name: H. Desfour

given: H.

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

given: A.

family: Foote

full_name: A. M. Foote

given: A. M.

family: Genty

full_name: C. Genty

given: C.

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

evidence: open (via free pdf)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Association Francaise pour la Recherche Thermale


title: Preliminary Study of the Substitution of Sensory Deficits of the Hand by a Medical Device Embedded : a Functional Assessment of Vibration Feedback on the Gripping Pressure in the Territory of the Median Nerve.

acronym: TEXIGLOVE

summary: The objective of this study is to investigate the effect of vibration feedback on the gripping pressure in the territory of the median nerve.

lead_sponsor: University Hospital, Grenoble

location_facility: Department of Plastic Surgery of the Hand and Burned - University Hospital Grenoble


title: Alzheimer Disease : Rehabilitation's Intervention at Home. A Preliminary Pilot Study.

acronym: pré MATAPA

summary:
Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its prevalence and its medical and social consequences, AD represents a dual challenge to public health and society. The elderly want to stay in their homes even when their lives are altered by a chronic progressive disease. Their caregivers claim in turn a support at home. But this desire is questioned because of the characteristics of the disease, e.g. the altered relational function by the cognitive impairment and the behavioural disorders associated.

Outpatients non-drug therapies represent a potential support that adapts to patient with an AD or mixed dementia, especially in their milder forms.

The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention at home and its acceptability by both the patient and the caregiver.

The study of its efficiency in terms of autonomy will be the next step.

lead_sponsor: Nantes University Hospital

intervention_type: Behavioral


title: Strategy to Improve Antiplatelet Therapy Adherence After Coronary Stent Implantation

summary: The purpose of this study is to assess the effectiveness of an adherence protocol intervention among stented patients to improve adherence to antiplatelet therapy (primary endpoint). Secondary endpoints will assess whether the intervention reduces cardiovascular events (ACS, stent thrombosis, re- hospitalization and coronary angiography, revascularization, all-cause mortality) and its cost-effectiveness.

lead_sponsor: Hôpital de la Timone

location_facility: CHU Timone hospital . Sc CARDIOLOGIE. Rue saint Pierre.


title: Comparative Study of Subcutaneous and Visceral Adipose Tissue in Patients Affected by Cushing Syndrome Versus 2 Controls Population

acronym: LIPOCUSH

summary:
The purpose of this trial is to investigate the impact of cortisol on adipose tissue functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to visceral obesity and features of the metabolic syndrome. The aims of this study will be

to compare the pattern of gene expression between visceral and subcutaneous adipose tissue in Cushing patients requiring an adrenalectomy as cortisol adenoma treatment;
to compare these patterns of gene expression with those of two control populations:1/ healthy metabolic subjects having a partial nephrectomy, 2/obese patients with similar degree of insulin resistance.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Saint-Antoine, service d'Endocrinologie


title: Social Cognition and Turner Syndrome

acronym: COGNITUR

summary:
Monocentric multidisciplinary study (psychologists, endocrinologists, psychiatrists, and molecular biologists) to characterize social cognition in adolescents with Turner syndrome (TS).

Inclusion criteria:

Turner syndrome with homogeneous 45,X karyotype.
Age between 8 and 18 years.
Somatic state compatible with the evaluation.
Functional language and IQ ≥ 80 for the transfer tests
Informed consent signed by the holders of parental authority, the patient and the mother for her own participation (DNA collection).
Affiliation to Social Security (beneficiary or assignee).

The primary endpoint will be the overall score to the AQ (Autism Quotient) questionnaire and to the SRS (Social Reciprocity Scale), in comparison to the expected scores for the general population. For patients with scores above the threshold for SRS or QA validation of a possible diagnosis of autism spectrum disorders will be performed with commonly used diagnostic tools (ADIR (Lord et al, 1994), ADOS-G (Lord et al, 1999) and diagnostic criteria of DSM IV-TR).

Secondary criteria will include the results of standardized tests to assess autistic features (AQ, ADI-R, ADOS, DSM IV-TR criteria), intellectual efficiency (Wechsler scales), psychiatric comorbidities (Kiddie-SADS) and sociocognitive profile (SpeX test, Social cognition, Perception, eXecutive functions).

A DNA sample will be collected from the patient and her mother. The observation period is 2 days for the patient and about 1 hour for the mother. The total duration of the study is 3 years.


title: Determination of the Efficacy and Safety of the Seasonal Influenza Vaccine Among Patients Suffering From Sarcoidosis.

acronym: SARCOVAC

summary: Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs, especially the lungs and mediastinum. Some location of sarcoidosis may require treatment with corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis patients than in the general population. Similarly, it is unclear whether the vaccine response is modified by the severity of the disease and treatment with corticosteroids and immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which are both inflammatory and autoimmune diseases, the investigators expect at best a 50% vaccine response in patients with sarcoidosis and a 85% vaccination response in healthy controls. The demonstration of a vaccine response could allow reconsidering new vaccine approaches in sarcoidosis.

ReferenceCitation: Mert A, Bilir M, Ozaras R, Tabak F, Karayel T, Senturk H. Results of hepatitis B vaccination in sarcoidosis. Respiration. 2000;67(5):543-5.

ReferenceCitation: Recommendation for the composition of influenza virus vaccines for use in 1999. Wkly Epidemiol Rec. 1998 Oct 2;73(40):305-8. English, French.

ReferenceCitation: Statement on sarcoidosis. Joint Statement of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) adopted by the ATS Board of Directors and by the ERS Executive Committee, February 1999. Am J Respir Crit Care Med. 1999 Aug;160(2):736-55. Review.

ReferenceCitation: Bouvry D, Naccache JM, Valeyre D. [Interstitial lung diseases in sarcoidosis]. Rev Prat. 2007 Dec 31;57(20):2258-65. Review. French.

ReferenceCitation: Valeyre D, Duperron F. [Sarcoidosis: diagnosis and management of extra-pulmonary forms]. Rev Mal Respir. 2006 Dec;23(6):757-8. French.

ReferenceCitation: Löfgren S. The concept of erythema nodosum revised. Scand J Respir Dis. 1967;48(3):348-53.

ReferenceCitation: James DG. Lupus pernio. Lupus. 1992 May;1(3):129-31. Review.

ReferenceCitation: Asukata Y, Ishihara M, Hasumi Y, Nakamura S, Hayashi K, Ohno S, Mizuki N. Guidelines for the diagnosis of ocular sarcoidosis. Ocul Immunol Inflamm. 2008 May-Jun;16(3):77-81. doi: 10.1080/09273940802051100.


title: Microparticles, Vector of Genetic Information During HIV Infection ?

summary: The aim of the investigators study is to demonstrate in healthy subjects and a cohort of patients infected with HIV, the presence of miRNAs in circulating peripheral blood microparticles (MPs).


title: Can Branched Chain Amino Acids Supplementation Reduce Muscle Damage Induced by Neuromuscular Electrical Stimulation ? A Combined Functional and Metabolic Non-invasive Investigation in Healthy Humans.

summary:
Neuromuscular electrical stimulation (NMES) is commonly used in rehabilitation contexts in order to increase or restore muscle capacities of hypoactive patients or patients with articular trauma. Although this technique seems to be particularly adapted to muscle rehabilitation, growing evidence is emerging regarding potential damaging effects of electrically- induced isometric contractions in healthy humans. Recent studies have reported a 10 to 30-fold increase in creatine kinase (CK) activity coupled to significantly increased muscle soreness and impaired force production as a result of NMESs. On that basis, further studies should be conducted on these deleterious effects which might limit the clinical application of NMES.

Over the last decade, many studies paid attention to branched-chain amino acids (BCAA) supplementation as a potential prophylactic/therapeutic approach. The rationale of this approach is that BCAA might increase protein synthesis and reduce protein breakdown through physiological mechanisms involving mTOR regulation pathway (mammalian Target of Rapamycin). Additionally, BCAA could also be used as energetic substrate during exercise when glycogen stores are depleted. Overall, previous results have supported the efficacy of BCAA supplementation in attenuating muscle damage. Nevertheless, comprehensive studies investigating the effect of amino acid supplementation on markers of muscle damage are still scarce.

Magnetic resonance imaging (IRM) and phosphorus 31 magnetic resonance spectroscopy (31P-MRS) are powerful non invasive tools allowing the exploration of skeletal muscle structure and energy metabolism.

This ambitious project is devoted to the anatomical, functional and metabolic characterization of BCAA supplementation after NMES using MRI and 31P-MRS. Various markers of muscle damage, including maximal voluntary force production, T2 values and apparent diffusion coefficient (obtained by MRI) and energy metabolism assessed at rest and during exercise (using 31P-MRS), will be obtained before and after NMES. This project is of utmost importance for improving our knowledge of anatomic, metabolic and functional events related to BCAA supplementation in the context of exercise-induced muscle damage


title: Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

summary:
Prospective, monocentric, open-label study conducted in women requiring mastectomy and eligible for tumescent infiltrative anaesthesia.

Blood samples will be collected during 48h after start of infiltration. Total and free lidocaine concentrations measurements will be determined by gas chromatography. Visual analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs and adverse effects will be collected.

Population pharmacokinetic parameters will be estimated using NONMEM software and covariates influence on parameters variability will be tested.

Primary outcome value: Population pharmacokinetic parameters with possible covariates influence on variability.

Patients and period of study: n=30 patients enrolled during 24 months, total study duration: 30 months.


title: Epidural Analgesia and Troubles of Fetal Cardiaq Rythm : Effect of the Systemic Transfer of Ropivacaine and Sufentanil

acronym: epidarc

summary: The aim of the investigators study is to demonstrate the association between fetal cardiac rhythm abnormalies after epidural analgesia and the maternal systemic transfer of ropivacaine and/or sufentanil.

lead_sponsor: University Hospital, Rouen

location_facility: centre hospitalier universitaire de Rouen, Hopital Charles Nicolle


title: Does the Measurement of Pupillary Reactivity to Painful Stimulation by an Automated Pupillometer Determine the Effectiveness of Local Anesthesia When Undergoing General Anesthesia?

acronym: ALGISCAN

summary:
The pupillary pain-meter AlgiScan ® with integrated nociceptive stimulator is a portable, battery-operated device which automatically measures, by means of an infrared camera, pupil diameter. This is measured in response to noxious stimulation produced by a tetanus at a frequency of 100 Hz for 5 seconds. Its intensity varies from 10 to 60 mA. The recording is performed for a period of 13 seconds (3 seconds prior to stimulation, stimulation for 5 seconds, 5 seconds after the stimulation). An interval of 3 minutes is allowed between the two measurements (right and left), which is significantly higher than the time necessary to return to normal (about 20seconds).

The pupillary pain index (PPI) ranges from 0 to 10 and is a composite measure of the pupillary diameter reflex to the tetanus stimuli delivered by the AlgiScan device. Smaller scores indicate increased analgesia.

The main objective of this study is to determine whether PPI index variation can determine a prognostic threshold of analgesic efficacy of unilateral lower limb sensory nerve block before incision. The measurements are performed after bilateral nociceptive stimulation (blocked side versus non-blocked side) in patients under general anesthesia for major knee surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Intra Peritoneal Chemo Hyperthermia (IPCH) : Cellular and Metabolic Consequences

acronym: CHIP

summary:
Intra Peritoneal Chemo Hyperthermia (IPCH) is a recently validated option for the treatment of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program demonstrated a significant improvement of the late stages (i.e. carcinomatosis) of the disease. From a clinical point of view, within the first 24 hours after IPCH, patients undergo a systemic inflammatory response syndrome, and therefore require to be monitored in an intensive care unit. From a metabolic perspective, preliminary data have been shown a significant "anaerobic style" disturbance of energetic metabolism, suggesting a deep cellular energetic deficit throughout IPCH process.

Putative contradictory effects of IPCH, like the increase of chemotherapy-related cellular toxicity due to heat and on the other hand the initiation of a stress protein response (heat shock response) which helps to reduce the cell injuries, leads to conduct a research project on the underlying mechanisms: consequences, in terms of patient's care and follow-up, are of high relevance.

The primary goal is a multimodal assessment of the IPCH-related cell modifications: signaling pathways, apoptosis and antitumoral immune response.

The assessment criteria include Heat shock protein expression (blood/cell ratio) compared to baseline values, apoptosis and immune response before/after IPCH.

The scheduled sample size is 30 patients having an IPCH and 30 patients contraindicated per surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Département d'Anesthésie Réanimation, CHU de Nice


title: Validation of a New Non Invasive Method for Intracranial Pressure Monitoring

acronym: MINIPIC REA

summary:
In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing and treating several conditions. Physicians having to manage cases of head trauma, stroke and hydrocephalus need to assess the time course of ICP, yet they are often unwilling to implement invasive monitoring beyond the acute stage, on account of high septic risks. Standard techniques include direct ventricular manometry or measurement in the parenchyma with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical methods for gaining access to pressure changes is an important challenge. Fluctuations of ICP are transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the intra-labyrinthic pressure modify the functional activities of the outer hair cells in the cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure, which is detected as modifications in cochlear activities. Cochlear activities' recording are non-invasive and technically simple. A probe is gently inserted into the outer portion of the external ear canal.

The objective of this study is to assess prospectively the accuracy and the precision of a new method for ICP monitoring (using cochlear activities) compared with invasive gold standard CSF pressure monitoring.

ReferenceCitation: Giraudet F, Longeras F, Mulliez A, Thalamy A, Pereira B, Avan P, Sakka L. Noninvasive detection of alarming intracranial pressure changes by auditory monitoring in early management of brain injury: a prospective invasive versus noninvasive study. Crit Care. 2017 Feb 21;21(1):35. doi: 10.1186/s13054-017-1616-2.

family: Giraudet

full_name: Fabrice Giraudet

given: Fabrice

family: Longeras

full_name: François Longeras

given: François

family: Mulliez

full_name: Aurélien Mulliez

given: Aurélien

family: Thalamy

full_name: Aurélie Thalamy

given: Aurélie

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Avan

full_name: Paul Avan

given: Paul

family: Sakka

full_name: Laurent Sakka

given: Laurent

journal_name: Critical Care

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Validation of a New Non Invasive Method of Indirect Measurement of the Intracranial Pressure Variations

acronym: MINIPIC

summary:
The intracranial pressure (ICP), defined by the hydrostatic pressure of the cerebrospinal fluid (CSF), is a key parameter for diagnosing and treating several neurosurgical diseases. Continuous ICP monitoring has an important place in neuro-intensive care for patients with severe head trauma and severe meningeal hemorrhage.

Until now the assessment of ICP requires invasive methods, with a pressure transducer either within the ventricular CSF or within the brain parenchyma. The pressure sensor placement is performed in a neurosurgery department. These invasive methods have also disadvantages: highest risk of infections, catheter misplaced, and risk of bleeding. All these justify the development of a non invasive method. The Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the intra-labyrinthic pressure (ILP) modify the functional activities of the outer hair cells in the cochlea.

Cochlear activities' recording is non-invasive and technically simple. A probe is gently inserted into the outer portion of the external ear canal.

Anatomical studies showed communication between the subarachnoid spaces and the perilymphatic compartment by the cochlear aqueduct. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure, which is detected as modifications in cochlear activities.

CSF dynamic tests, as constant flow infusion test, are conducted in patients in the diagnosis of the idiopathic adult hydrocephalus syndrome. Artificial CSF is infused through a lumbar needle, into the CSF space at a constant rate, and the corresponding rise in ICP is registered and analyzed.

The objective of this study is to assess prospectively the accuracy and the precision of a new method for non invasive ICP measurement (using cochlear activities) compared with invasive gold standard CSF pressure measurement during CSF dynamic tests.


title: Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up : the "INCARD" Study

acronym: INCARD

summary: Treatment of chronic heart failure requires multidisciplinary approaches with a recognized role for cardiac rehabilitation. Rehabilitation helps to improve patient's functional, decrease morbidity and mortality, decrease rehospitalization rate, thereby reducing costs of this disease. After recovery from the acute phase of cardiac infarction, patients admitted to the rehabilitation center will follow the usual rehabilitation program during the hospitalization period. This step precludes outpatient follow-up period in our day hospital, in accordance with their physicians and cardiologists who manage the monitoring. The study INCARD (Insuffisance Cardiaque en Readaptation Durable) will be developed to evaluate the benefits of a sustainable rehabilitation heart failure on patients treated optimally and educated during a follow-up period of 24 months. The main objective of the study will be to compare the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients for each evaluation time point, periodically recorded

ReferenceCitation: Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Strömberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. Review. Erratum in: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text.

ReferenceCitation: Koukoui F, Desmoulin F, Lairy G, Bleinc D, Boursiquot L, Galinier M, Smih F, Rouet P. Benefits of cardiac rehabilitation in heart failure patients according to etiology: INCARD French study. Medicine (Baltimore). 2015 Feb;94(7):e544. doi: 10.1097/MD.0000000000000544.

family: Koukoui

full_name: François Koukoui

family: Desmoulin

full_name: Franck Desmoulin

given: Franck

family: Lairy

full_name: Gérard Lairy

given: Gérard

family: Bleinc

full_name: Dominique Bleinc

given: Dominique

family: Boursiquot

full_name: Ludovic Boursiquot

given: Ludovic

family: Galinier

full_name: Michel Galinier

given: Michel

family: Smih

full_name: Fatima Smih

given: Fatima

family: Rouet

full_name: Philippe Rouet

given: Philippe

currency_apc_doaj: USD

journal_name: Medicine

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Benefits of Cardiac Rehabilitation in Heart Failure Patients According to Etiology

lead_sponsor: Centre Hospitalier Sud Francilien


title: Multicentric Observational NAtional Study on LISteriosis and ListeriA

acronym: MONALISA

summary:
Listeriosis is a foodborne infection responsible for severe disease. Three main forms are described: septicaemia, central nervous system infections and maternal-fetal infections. Available data on the disease, are mostly retrospective and do not provide an accurate picture of the clinical / biological / genetic risk factors for the disease, nor identify any element to determine which patients are at higher risk of death, severe neurological impairment or fetal loss.

The primary purpose of the study is to identify clinical, biological and genetic risk factors for systemic listeriosis and the determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study.

ReferenceCitation: Mylonakis E, Hohmann EL, Calderwood SB. Central nervous system infection with Listeria monocytogenes. 33 years' experience at a general hospital and review of 776 episodes from the literature. Medicine (Baltimore). 1998 Sep;77(5):313-36. Review.

ReferenceCitation: Mylonakis E, Paliou M, Hohmann EL, Calderwood SB, Wing EJ. Listeriosis during pregnancy: a case series and review of 222 cases. Medicine (Baltimore). 2002 Jul;81(4):260-9. Review.

ReferenceCitation: Lecuit M, Vandormael-Pournin S, Lefort J, Huerre M, Gounon P, Dupuy C, Babinet C, Cossart P. A transgenic model for listeriosis: role of internalin in crossing the intestinal barrier. Science. 2001 Jun 1;292(5522):1722-5.

ReferenceCitation: Disson O, Grayo S, Huillet E, Nikitas G, Langa-Vives F, Dussurget O, Ragon M, Le Monnier A, Babinet C, Cossart P, Lecuit M. Conjugated action of two species-specific invasion proteins for fetoplacental listeriosis. Nature. 2008 Oct 23;455(7216):1114-8. doi: 10.1038/nature07303. Epub 2008 Sep 17.

ReferenceCitation: Charlier C, Leclercq A, Cazenave B, Desplaces N, Travier L, Cantinelli T, Lortholary O, Goulet V, Le Monnier A, Lecuit M; L monocytogenes Joint and Bone Infections Study Group. Listeria monocytogenes-associated joint and bone infections: a study of 43 consecutive cases. Clin Infect Dis. 2012 Jan 15;54(2):240-8. doi: 10.1093/cid/cir803. Epub 2011 Nov 18.

ReferenceCitation: Charlier C, Kermorvant-Duchemin E, Perrodeau E, Moura A, Maury MM, Bracq-Dieye H, Thouvenot P, Valès G, Leclercq A, Ravaud P, Lecuit M; neonatal MONALISA study group. Neonatal listeriosis presentation and outcome: a prospective study of 189 cases. Clin Infect Dis. 2021 Apr 20. pii: ciab337. doi: 10.1093/cid/ciab337. [Epub ahead of print]

name: Institut Pasteur, Biology of Infection Unit, Paris, France

name: Institut Pasteur, French National Reference Center and WHO Collaborating Center Listeria, Paris, France

name: Necker-Enfants Malades University Hospital, Department of Infectious Diseases and Tropical Medicine, Institut Imagine, AP-HP, Paris, France

family: Charlier

full_name: Caroline Charlier

given: Caroline

name: Necker-Enfants Malades University Hospital, Department of Neonatology, AP-HP, Paris, France

family: Kermorvant-Duchemin

full_name: Elsa Kermorvant-Duchemin

given: Elsa

name: Centre of Research in Epidemiology and Statistics Sorbonne Paris Cité, METHODS Team, UMR 1153, Inserm, Université de Paris, Paris, France

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

family: Moura

full_name: Alexandra Moura

given: Alexandra

family: Maury

full_name: Mylène M Maury

given: Mylène M

family: Bracq-Dieye

full_name: Hélène Bracq-Dieye

given: Hélène

family: Thouvenot

full_name: Pierre Thouvenot

given: Pierre

family: Valès

full_name: Guillaume Valès

given: Guillaume

family: Leclercq

full_name: Alexandre Leclercq

given: Alexandre

family: Ravaud

full_name: Philippe Ravaud

family: Lecuit

full_name: Marc Lecuit

given: Marc

journal_name: Clinical Infectious Diseases

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Charlier C, Poirée S, Delavaud C, Khoury G, Richaud C, Leclercq A, Hélénon O, Lecuit M; MONALISA Study Group. Imaging of Human Neurolisteriosis: A Prospective Study of 71 Cases. Clin Infect Dis. 2018 Oct 15;67(9):1419-1426. doi: 10.1093/cid/ciy449.

name: Institut national de la santé et de la recherche médicale (INSERM) U1117

name: National Reference Centre and World Health Organization (WHO) Collaborating Centre for Listeria

name: Division of Infectious Diseases and Tropical Medicine, Institut Imagine

name: Department of Adult Radiology, Necker-Enfants Malades University Hospital, Paris Descartes University, Sorbonne Paris Cité, Assistance Publique–Hôpitaux de Paris, France

family: Poirée

full_name: Sylvain Poirée

given: Sylvain

family: Delavaud

full_name: Christophe Delavaud

given: Christophe

family: Khoury

full_name: Gaby Khoury

given: Gaby

family: Richaud

full_name: Clémence Richaud

given: Clémence

family: Hélénon

full_name: Olivier Hélénon

given: Olivier

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

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

ReferenceCitation: Charlier C, Perrodeau É, Leclercq A, Cazenave B, Pilmis B, Henry B, Lopes A, Maury MM, Moura A, Goffinet F, Dieye HB, Thouvenot P, Ungeheuer MN, Tourdjman M, Goulet V, de Valk H, Lortholary O, Ravaud P, Lecuit M; MONALISA study group. Clinical features and prognostic factors of listeriosis: the MONALISA national prospective cohort study. Lancet Infect Dis. 2017 May;17(5):510-519. doi: 10.1016/S1473-3099(16)30521-7. Epub 2017 Jan 28. Erratum in: Lancet Infect Dis. 2017 Sep;17(9):897.

full_name: Vincent Cailleaux Pierre-Etienne Cailleux

full_name: Christine Chandesris Joséphine Chapalain-Cagnon

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

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

location_facility: Centre National de Reference et Centre Collaborateur OMS Listeria, Institut Pasteur


title: Randomized Control Trial Comparing the Impact of a Lengthening of the Interval Between the Radiochemotherapy and Surgery (7 Weeks vs. 11 Weeks) on Complete Pathological Response in Rectal Cancer

summary: At the end of the neoadjuvant radiochemotherapy, patients are seen by their surgeon to planify the surgery. During this visit, the study will be explained them and their consent obtained. They will then be randomized between the two groups 7 weeks vs. 11 weeks. Patients were reviewed 15 days before surgery and at 1 and 3 months after surgery. Participation in this study does not change treatment, investigations and consultations usually necessary for management of rectal cancer. The objective is to improve the pathological complete response rate of the rectal cancer.

ReferenceCitation: Lefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, Lupinacci R, Goasgen N, Parc Y, Simon T, Tiret E. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). J Clin Oncol. 2016 Nov 1;34(31):3773-3780. doi: 10.1200/JCO.2016.67.6049.

name: Jérémie H. Lefevre, Salma Kotti, Yann Parc, Tabassome Simon, and Emmanuel Tiret, Hôpital Saint-Antoine, Assistance Publique Hôpitaux de Paris, Sorbonne Universités; Mehdi Karoui, Centre Hospitalier Universitaire (CHU) Pitié-Salpétrière; Anne Berger, CHU Hôpital Européen Georges-Pompidou; Jérome Loriau, Hôpital Saint-Joseph; Renato Lupinacci, Hôpital Croix Saint-Simon; Nicolas Goasgen, Hôpital des Diaconesses-Croix Saint-Simon, Paris; Laurent Mineur, Sainte-Camille Institut, Avignon; Eric Rullier, CHU...

family: Lefevre

full_name: Jérémie H. Lefevre

given: Jérémie H.

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: Kotti

full_name: Salma Kotti

given: Salma

family: Rullier

full_name: Eric Rullier

given: Eric

family: Rouanet

full_name: Philippe Rouanet

family: de Chaisemartin

full_name: Cécile de Chaisemartin

given: Cécile

family: Meunier

full_name: Bernard Meunier

given: Bernard

family: Mehrdad

full_name: Jafari Mehrdad

given: Jafari

family: Cotte

full_name: Eddy Cotte

given: Eddy

family: Desrame

full_name: Jérome Desrame

given: Jérome

family: Karoui

full_name: Mehdi Karoui

given: Mehdi

family: Benoist

full_name: Stéphane Benoist

given: Stéphane

family: Kirzin

full_name: Sylvain Kirzin

family: Berger

full_name: Anne Berger

given: Anne

family: Panis

full_name: Yves Panis

given: Yves

family: Piessen

full_name: Guillaume Piessen

family: Saudemont

full_name: Alain Saudemont

given: Alain

family: Prudhomme

full_name: Michel Prudhomme

given: Michel

family: Peschaud

full_name: Frédérique Peschaud

given: Frédérique

family: Dubois

full_name: Anne Dubois

family: Loriau

full_name: Jérome Loriau

family: Tuech

full_name: Jean-Jacques Tuech

given: Jean-Jacques

family: Meurette

full_name: Guillaume Meurette

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Lefevre JH, Rousseau A, Svrcek M, Parc Y, Simon T, Tiret E; French Research Group of Rectal Cancer Surgery (GRECCAR). A multicentric randomized controlled trial on the impact of lengthening the interval between neoadjuvant radiochemotherapy and surgery on complete pathological response in rectal cancer (GRECCAR-6 trial): rationale and design. BMC Cancer. 2013 Sep 12;13:417. doi: 10.1186/1471-2407-13-417.

name: The French Research Group of Rectal Cancer Surgery (GRECCAR)

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

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

location_facility: Saint-Antoine Hospital - AP-HP, Department of general and digestive surgery


title: Consequences of Circulating Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn

acronym: ANGIODYS

summary: Preeclampsia complicates about 2-7% of pregnancies and is a major contributor to maternal and neonatal morbidity and mortality worldwide. Imbalance between circulating angiogenic and antiangiogenic factors has emerged as a potential key pathway in the pathophysiology of preeclampsia. Patients with preeclampsia have a higher circulating concentration of antiangiogenic factors (ie, soluble vascular endothelial growth factor receptor-1 [sVEGFR- 1], also called soluble fms-like tyrosine kinase 1 [sFlt1]) and soluble endoglin (sEng)] and a lower maternal circulating concentration of free angiogenic factors (ie, vascular endothelial growth factor [VEGF] and placental growth factor [PlGF]) than patients with a normal pregnancy. Bronchopulmonary dysplasia is the main respiratory sequelae of preterm birth. Its rate increased in preterm infants born from mother with preeclampsia. Recent studies showed that bronchopulmonary dysplasia is consistently accompanied by a reduction in the number of small arteries and on abnormal distribution of vessels within the distal lungs. This is associated with reduced lung VEGF expression. The main objective of this population-based study, ie in intra uterine growth restricted preterm babies born before 30 weeks of gestational age, was to examine whether levels of sFlt1 at birth in maternal and umbilical cord blood and in the amniotic fluid is associated with an increased risk of BPD.

ipd_sharing: No


title: Breathing-swallowing Interaction in Chronic Obstructive Pulmonary Disease (COPD) Patients Hospitalized in Intensive Care Unit for an Acute Exacerbation: Impact of Non Invasive Ventilation. Physiological Evaluation

summary:
In the investigators' knowledge there are no data about the impact of non invasive mechanical ventilation on the breathing-swallowing interaction.

Our main objective is to evaluate breathing-swallowing interaction in Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized in intensive care unit for an acute exacerbation, and evaluate the impact of using non invasive mechanical ventilation (NIV)

lead_sponsor: University Hospital, Caen


type: Other Grant/Funding Number

title: Interaction Between Genetic Factors and Maternal Stressors During Pregnancy in the Risk of Postpartum Depression

acronym: IGEDEPP

summary:
"The prevalence of postpartum depression (PPD) is approximately 13%. PPD is associated with a higher maternal morbidity and mortality, and also with pervasive effects on the emotional, cognitive and behavioral development of the infant.

Stressful life events, socio-demographic and obstetrical risk factors have been associated with the risk of PPD. Genetics risk factors of PPD have also been identified. We are presently studying for the first time how maternal stressors may interact with genetic factors to increase the risk of PPD (Gene x Environment interaction)".

ReferenceCitation: Tebeka S, Le Strat Y, Etain B, Ray M, Mullaert J, Dubertret C; IGEDEPP Study Group. Childhood Trauma and Perinatal Depression: Data From the IGEDEPP Cohort. J Clin Psychiatry. 2021 Sep 7;82(5). pii: 20m13664. doi: 10.4088/JCP.20m13664.

family: Tebeka

full_name: Sarah Tebeka

given: Sarah

family: Le Strat

full_name: Yann Le Strat

given: Yann

family: Etain

full_name: Bruno Etain

given: Bruno

family: Ray

full_name: Margaux Ray

given: Margaux

family: Mullaert

full_name: Jimmy Mullaert

given: Jimmy

family: Dubertret

full_name: Caroline Dubertret

given: Caroline

family: Group

full_name: IGEDEPP Study Group

given: IGEDEPP Study

bso_classification: Social sciences

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

ipd_sharing: Undecided


title: Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon (PEG-IFN) and Ribavirin (RBV) Included in the French Early Access Program for the Use of Protease Inhibitors in Genotype 1 Patients Who Failed to Eradicate HCV With a Previous Standard PEG-IFN and RBV Combination.

acronym: CUPIC

summary: The purpose fo the study is to evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs through the the marketing authorization.

time_perspective: Other

ReferenceCitation: Sultanik P, Mallet V, Lagaye S, Casrouge A, Dorival C, Barthe Y, Fontaine H, Hézode C, Mottez E, Bronowicki JP, Carrat F, Theodorou I, Abel L, Gayat E, Fontanet A, Pol S, Albert ML; ANRS CO20-CUPIC. Plasma apolipoprotein H limits HCV replication and associates with response to NS3 protease inhibitors-based therapy. Liver Int. 2015 Jul;35(7):1833-44. doi: 10.1111/liv.12759. Epub 2015 Jan 23.

name: Department of Hepatology, Hôpital Cochin; AP-HP; Paris France

name: INSERM U 1016, CNRS UMR 8104; Université Paris Descartes UMR-S 1016; Paris France

family: Sultanik

full_name: Philippe Sultanik

given: Philippe

family: Mallet

full_name: Vincent Mallet

given: Vincent

family: Lagaye

full_name: Sylvie Lagaye

given: Sylvie

name: The laboratory of Dendritic Cell Biology; Departement of Immunology; Institut Pasteur; INSERM U818; Paris France

family: Casrouge

full_name: Armanda Casrouge

given: Armanda

name: UMR-S 707; Université Pierre et Marie Curie-Paris 6 & INSERM; Paris France

family: Dorival

full_name: Céline Dorival

given: Céline

family: Barthe

full_name: Yoann Barthe

given: Yoann

family: Fontaine

full_name: Hélène Fontaine

given: Hélène

name: Department of Hepatology and Gastroenterology; Hôpital Henri Mondor; AP-HP; Université Paris-Est; Créteil France

family: Hézode

full_name: Christophe Hézode

given: Christophe

name: Centre for Human Immunology; Departement of Immunology; Institut Pasteur; INSERM S20; Paris France

family: Mottez

full_name: Estelle Mottez

given: Estelle

name: Centre Hospitalier Universitaire de Nancy; Université de Lorraine; INSERM U954; Vandoeuvre-les-Nancy France

family: Bronowicki

full_name: Jean-Pierre Bronowicki

given: Jean-Pierre

name: Department of Public Health; Hôpital Saint-Antoine; AP-HP; Paris France

family: Carrat

full_name: Fabrice Carrat

given: Fabrice

name: Laboratory of Immunity and Infection; Groupe Hospitalier Pitié-Salpêtrière AP-HP; INSERM UMR-S 945; UPMC Université Paris 6; Paris France

family: Theodorou

full_name: Ioannis Theodorou

given: Ioannis

name: Laboratory of Human Genetics of Infectious Diseases; Necker branch; INSERM U1163; Paris France

name: University Paris Descartes; Sorbonne Paris Cité; Imagine Institute; Paris France

name: Laboratory of Human Genetics of Infectious Diseases; Rockefeller branch; The Rockefeller University; New-York USA

family: Abel

full_name: Laurent Abel

given: Laurent

name: Department of Anesthesiology and Critical Care Medicine - Mobile Care Unit; Hôpital Lariboisière; AP-HP; Paris France

name: Biomarkers and cardiac diseases; Hôpital Lariboisière; INSERM U942; Paris France

family: Gayat

full_name: Etienne Gayat

given: Etienne

name: Departement of Epidemiology of Infectious Disease; Institut Pasteur; Paris France

family: Fontanet

full_name: Arnaud Fontanet

given: Arnaud

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Albert

full_name: Matthew L. Albert

given: Matthew L.

journal_name: Liver International

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Hézode C, Fontaine H, Dorival C, Zoulim F, Larrey D, Canva V, De Ledinghen V, Poynard T, Samuel D, Bourliere M, Alric L, Raabe JJ, Zarski JP, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Chazouilleres O, Abergel A, Guyader D, Metivier S, Tran A, Di Martino V, Causse X, Dao T, Lucidarme D, Portal I, Cacoub P, Gournay J, Grando-Lemaire V, Hillon P, Attali P, Fontanges T, Rosa I, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis. Gastroenterology. 2014 Jul;147(1):132-142.e4. doi: 10.1053/j.gastro.2014.03.051. Epub 2014 Apr 3.

full_name: Helene Fontaine

given: Helene

full_name: Celine Dorival

given: Celine

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

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

title: Effectiveness of Telaprevir or Boceprevir in Treatment-Experienced Patients With HCV Genotype 1 Infection and Cirrhosis

ReferenceCitation: Hézode C, Fontaine H, Dorival C, Larrey D, Zoulim F, Canva V, de Ledinghen V, Poynard T, Samuel D, Bourlière M, Zarski JP, Raabe JJ, Alric L, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Métivier S, Tran A, Serfaty L, Abergel A, Causse X, Di Martino V, Guyader D, Lucidarme D, Grando-Lemaire V, Hillon P, Feray C, Dao T, Cacoub P, Rosa I, Attali P, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) - NCT01514890. J Hepatol. 2013 Sep;59(3):434-41. doi: 10.1016/j.jhep.2013.04.035. Epub 2013 May 10.

title: Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) – NCT01514890


title: Influence of Hypnosis on the Propofol Requirement to Induce General Anesthesia

acronym: LoopHypnosis

summary:
Hypnosis may reduce patient anxiety. The main goal of this study is to determine in what extent, hypnosis decreases propofol requirement to induce induction of general anesthesia.

A particular aspect of this study is that induction is provided by a closed-loop system which delivers propofol according to bispectral index.

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

lead_sponsor: Hopital Foch


title: A Double Blind, Randomized, Two Period Crossover Study To Determine The Effect of Multiple Doses of 120 MG Modified Release Formulation of YM150 on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects

summary: This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in healthy subjects.

ReferenceCitation: Kadokura T, Groenendaal D, Heeringa M, Mol R, Verheggen F, Garcia-Hernandez A, Onkels H. Darexaban (YM150), an oral direct factor Xa inhibitor, has no effect on the pharmacokinetics of digoxin. Eur J Drug Metab Pharmacokinet. 2014 Mar;39(1):1-9. doi: 10.1007/s13318-013-0141-1. Epub 2013 Jun 11.

family: Kadokura

full_name: Takeshi Kadokura

given: Takeshi

family: Groenendaal

full_name: Dorien Groenendaal

given: Dorien

family: Heeringa

full_name: Marten Heeringa

given: Marten

family: Mol

full_name: Roelof Mol

given: Roelof

family: Verheggen

full_name: Frank Verheggen

given: Frank

family: Garcia-Hernandez

full_name: Alberto Garcia-Hernandez

given: Alberto

family: Onkels

full_name: Hartmut Onkels

given: Hartmut

journal_name: European Journal of Drug Metabolism and Pharmacokinetics

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Astellas Pharma Inc


title: Bone Healing After Dental Extraction in Postmenopausal Osteoporotic Women Treated With Alendronate Per os (70 mg Weekly)

acronym: BOCOMEDEN

summary: The purpose of this study is to determine whether the oral alendronate treatment of post-menopausal osteoporosis could be a risk factor for jaw bone healing after dental extraction.


title: TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function

summary:
The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient. This progress led to a more and more complex programming for the physicians. To help them set optimally the pacing parameters, physicians refer to the existing recommendations of learned societies as well as to his expertise. Manufacturers developed also algorithms integrated into pacemakers with the aim of assisting physicians in their programming.

TherapyGuide is a function which proposes a programming adapted to the psychopathological state of the patient, with a justification based on experts' consensus, clinical studies as well as on published articles.

Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When rejected, there is no means to analyze the modifications brought to the proposed set of parameters. The nature, the frequency and the reasons of these modifications are not thus known.

The purpose of this study is to assess the acceptance of the TherapyGuide proposals by physicians and to identify the most frequent type of programming changes they make and their rationale.

lead_sponsor: Medtronic Bakken Research Center


title: Research of Predictive Factors to Immune Thrombopenic Purpura in Front of a Thrombopenia in Appearance Isolated in the Elderly

acronym: PREDI-PTI

summary: It is about a multicentric study prospective of more than patients' 60 years with a thrombopenia isolated of less than 100 G/L blood platelet without cause found to estimate so certain examinations realized in the diagnosis (medullary cytogenetics, dosage of the TPO, the Anti-platelet antibodies, isotopic lifetime of platelet) are in favour of the diagnosis of PTI.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: A 2-years Extension Study of MAPT Trial : Evaluation of the Long Term Effects of Interventional Strategies to Prevent the Decline in Cognitive Functioning in Frail Older Adults

acronym: MAPT-PLUS

summary: The MAPT PLUS study is a two-year extension of follow-up of the patients included in the MAPT preventive study, after completion of the interventions. Subjects in the four groups of the MAPT study will be prospectively followed. MAPT is a multicentre, randomised, placebo-controlled study, using a 4-group design with 3 treatment groups (omega 3 alone, multi-domain intervention alone, omega 3 plus multi-domain intervention, n=420 each) and a placebo group (n=420). The MAPT PLUS study will be an extension of the MAPT study and includes an annual follow-up for two years.

ReferenceCitation: Takano E, Maltais M, Kondo I, Rolland Y; MAPT/DSA group. Bidirectional relationship between depressive symptoms and physical performance in community-dwelling older people with subjective memory complaints. Eur Geriatr Med. 2021 Oct;12(5):973-980. doi: 10.1007/s41999-021-00473-9. Epub 2021 Mar 5.

family: Takano

full_name: Eiko Takano

given: Eiko

family: Maltais

full_name: Mathieu Maltais

given: Mathieu

family: Kondo

full_name: Izumi Kondo

given: Izumi

family: Rolland

full_name: Yves Rolland

given: Yves

journal_name: European Geriatric Medicine

ReferenceCitation: Delrieu J, Voisin T, Saint-Aubert L, Carrie I, Cantet C, Vellas B, Payoux P, Andrieu S. The impact of a multi-domain intervention on cerebral glucose metabolism: analysis from the randomized ancillary FDG PET MAPT trial. Alzheimers Res Ther. 2020 Oct 19;12(1):134. doi: 10.1186/s13195-020-00683-6.

family: Delrieu

full_name: Julien Delrieu

given: Julien

family: Voisin

full_name: Thierry Voisin

given: Thierry

family: Saint-Aubert

full_name: Laure Saint-Aubert

given: Laure

family: Carrie

full_name: Isabelle Carrie

given: Isabelle

family: Cantet

full_name: Christelle Cantet

given: Christelle

family: Vellas

full_name: Bruno Vellas

given: Bruno

family: Payoux

full_name: Pierre Payoux

given: Pierre

family: Andrieu

full_name: Sandrine Andrieu

given: Sandrine

journal_name: Alzheimer's Research & Therapy

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
PubMed Central
Research Square

ReferenceCitation: Delrieu J, Payoux P, Carrié I, Cantet C, Weiner M, Vellas B, Andrieu S. Multidomain intervention and/or omega-3 in nondemented elderly subjects according to amyloid status. Alzheimers Dement. 2019 Nov;15(11):1392-1401. doi: 10.1016/j.jalz.2019.07.008. Epub 2019 Sep 23.

name: University of Toulouse III; Toulouse France

name: Gérontopôle, Department of Geriatrics; Toulouse (University Hospital) CHU, Purpan University Hospital; Toulouse France

name: Department of Nuclear Medicine; Toulouse CHU, Purpan University Hospital; Toulouse France

name: Toulouse NeuroImaging Center, University of Toulouse, INSERM, UPS; Toulouse France

name: Gérontopôle, Department of Geriatrics; Toulouse CHU, Purpan University Hospital; Toulouse France

name: Department of radiology and biomedical imaging; University of California, San Francisco; San Francisco CA USA

name: Department of Epidemiology and Public Health; Toulouse CHU; Toulouse France

ReferenceCitation: Pothier K, de Souto Barreto P, Maltais M, Rolland Y, Vellas B. Shifting from Declines to Improvements: Associations between a Meaningful Walking Speed Change and Cognitive Evolution over Three Years in Older Adults. J Nutr Health Aging. 2018;22(10):1183-1188. doi: 10.1007/s12603-018-1059-8.

journal_name: The journal of nutrition, health & aging

ReferenceCitation: Lilamand M, Cesari M, Cantet C, Payoux P, Andrieu S, Vellas B; the MAPT/DSA study group. Relationship Between Brain Amyloid Deposition and Instrumental Activities of Daily Living in Older Adults: A Longitudinal Study from the Multidomain Alzheimer Prevention Trial. J Am Geriatr Soc. 2018 Oct;66(10):1940-1947. doi: 10.1111/jgs.15497. Epub 2018 Sep 12.

name: Department of Internal Medicine and Geriatrics, Gérontopôle University of Toulouse  Toulouse France

name: Department of Geriatrics, Bichat Hospital Assistance Publique – Hôpitaux de Paris  Paris France

name: Institut National de la Santé et de la Recherche Médicale UMR 1027 University of Toulouse III  Toulouse France

name: Doctoral School of Public Health—ED560 Paris‐Sud University  Paris France

name: Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda‐Ospedale Maggiore Policlinico Università di Milano  Milan Italy

name: Department of Nuclear Medicine Hôpital Purpan—Centre Hospitalier Universitaire de Toulouse  Toulouse France

name: Department of Public Health Centre Hospitalier Universitaire de Toulouse  Toulouse France

journal_name: Journal of the American Geriatrics Society


title: Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study

acronym: GASTRAMBU

summary: The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.

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

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

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

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

ReferenceCitation: Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12.

ReferenceCitation: Badaoui R, Alami Chentoufi Y, Hchikat A, Rebibo L, Popov I, Dhahri A, Antoun G, Regimbeau JM, Lorne E, Dupont H. Outpatient laparoscopic sleeve gastrectomy: first 100 cases. J Clin Anesth. 2016 Nov;34:85-90. doi: 10.1016/j.jclinane.2016.03.026. Epub 2016 May 3.

family: Badaoui

full_name: Rachid Badaoui

given: Rachid

family: Alami Chentoufi

full_name: Youssef Alami Chentoufi

given: Youssef

family: Hchikat

full_name: Abdelhakim Hchikat

given: Abdelhakim

family: Rebibo

full_name: Lionel Rebibo

given: Lionel

family: Popov

full_name: Ivan Popov

given: Ivan

family: Dhahri

full_name: Abdennaceur Dhahri

given: Abdennaceur

family: Antoun

full_name: Ghada Antoun

given: Ghada

family: Regimbeau

full_name: Jean-Marc Regimbeau

given: Jean-Marc

family: Lorne

full_name: Emmanuel Lorne

given: Emmanuel

family: Dupont

full_name: Hervé Dupont

given: Hervé

journal_name: Journal of Clinical Anesthesia


title: Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps

acronym: IFOPI

summary: Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.

lead_sponsor: University Hospital, Montpellier


title: Long Term Follow-up of Moderate and Severe Traumatic Bain Injury and Assessment of Involvement of Hormonal Deficiency in the Quality of Life

acronym: INSPIRE-TC

summary: The primary objective is to assess the long-term impact of hormonal deficiency on Quality of Life (QoL) in a large group of moderate and severe Traumatic Brain Injury (TBI) patients.

lead_sponsor: Hospices Civils de Lyon


acronym: Viticell

summary:
Vitiligo is a depigmenting skin disease common. Vitiligo is caused by the disappearance of melanocytes in the epidermis. Vitiligo is the cause of disfigurement, psychological and social, that sounds a lot about the quality of life. Currently the standard treatment for vitiligo is ultraviolet ray (UV), but it only allows a 50% repigmentation of lesions in half of patients. The applications of autologous epidermal cells in the liquid phase is a promising new therapeutic approach of vitiligo.

The main goal of this study is to compare prospectively the repigmentation of vitiligo lesions induced by application of autologous epidermal cells in liquid phase associated with light therapy and light therapy alone.

Study's secondary goals: compare the applications of epidermal cells to phototherapy alone and phototherapy, in respect of:

Obtain a repigmentation> 70% (threshold considered aesthetically relevant)
The occurrence of adverse events
Patient satisfaction regarding the efficacy and safety of treatment

location_facility: service de Dermatologie - Hôpital l'Archet


title: Prospective Evaluation of the Reliability of the Combined Use of Two Models to Predict Non-sentinel Lymph Node Status in Breast Cancer Patients With Metastatic Sentinel Lymph Nodes: the MSKCC Nomogram and the Tenon Score.

acronym: NOTEGS

summary: The purpose of this study is to prospectively evaluate the combined use of the MSKCC nomogram (Memorial Sloan-Kettering Cancer Center) and Tenon score to select, in patients with metastatic sentinel lymph node (SN), those at low risk of metastatic non-SN in whom additional axillary lymph node dissection (ALND) could be avoided.

location_facility: Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital Tenon, 4 rue de la Chine


summary:
INTRODUCTION: Hip Fracture is a public health problem because of its constantly increasing frequency and its high morbidity and mortality. The leading cause of death is cardiovascular decompensation, caused by painful phenomena associated with fracture and orthopedic surgery.With hip fracture, epidural local analgesia techniques have proven their benefit in mortality but are associated with numerous side effects that prevent routine use. Peripheral analgesic techniques locoregional the lumbar plexus, much safer, cause a decrease in postoperative pain after surgery for hip fracture and a decrease in mortality at 6 months. Elderly patients suffering from a hip fracture, no study has investigated the effect of local analgesia continuous femoral perineural catheter on the incidence of cardiovascular events in the perioperative period.

OBJECTIVE: The main objective of this work is to show that perineural analgesia block continuous local anesthetic reduces the incidence of cardiovascular complications in the preoperative period of a patient with a hip fracture and fact, show that this technique decreases the incidence of mortality at one year of patients with a hip fracture (secondary objective).

MATERIAL AND METHODS: This is a prospective, multicenter, randomized, descriptive type. It compares two populations of patients: one has a perineural analgesia by continuous infusion via a catheter of ropivacaine (n = 157) associated with a systemic analgesia and the other only systemic analgesia without development of a catheter perineural (n = 157). The duration of patient participation will be 12 months. In the first 24 hours after a hip fracture after randomization, study participants will benefit from the installation under strict asepsis, a continuous block by catheter, placed by an anesthesiologist experienced control room post-interventional. The local analgesia will be provided by continuous administration via the perineural catheter, ropivacaine for 5 days for the treated group. Except the local analgesia protocol, the protocols pre-and postoperative systemic analgesia and general anesthesia will be identical for all participants of the 2 groups, similar to techniques proposed in the context of everyday clinical practice, ensuring analgesia optimal for all patients in the study. The main features will be found three bioassays Troponin IC and 3 electrocardiograms at the entrance to the hospital, J3 and J5 after inclusion. In addition, cardiovascular clinical monitoring and quantification of pain ( will be performed daily for 8 days after inclusion. Finally, an assessment of higher functions by ladder MMS will be conducted at the entrance, J3, J5 and J8. Moreover, a survey of survival at 1 month, 3 months and 1 year will be realized.

ReferenceCitation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11:CD001159. doi: 10.1002/14651858.CD001159.pub3.

name: Teaching and Research Unit, Health Sciences; University of Quebec in Abitibi-Temiscamingue; Rouyn-Noranda Canada

name: Department of Anesthesiology and Critical Care, Faculty of Medicine; Laval University; Quebec City Canada

name: Department of Anesthesiology and Critical Care; Faculty of Medicine, Laval University; Quebec City Canada

family: Guay

full_name: Joanne Guay

given: Joanne

name: Department of Anesthesiology and Perioperative Medicine; Mayo Clinic College of Medicine; Rochester MN USA

family: Kopp

full_name: Sandra Kopp

given: Sandra

journal_name: Cochrane Database of Systematic Reviews


title: Role of Neutrophil Activation in Anaphylaxis to Neuro-Muscular Blocking Agents

acronym: NASA

summary:
In about 10% of preoperative anaphylactic reactions to Neuro-Muscular Blocking Agents (NMBA) (114 patients analyzed at the BICHAT Hospital), a classical mechanism (mast cell- and IgE-dependent) is not identified. The mechanisms underlying these atypical anaphylactic reactions are unknown. The investigators have developed at the Pasteur Institute a murine model of anaphylaxis in which neutrophils, IgG and Platelet Activating Factor (PAF) play predominant roles. In addition, preliminary results obtained at the BICHAT Hospital suggest the presence of specific IgG anti-quaternary ammonium in the sera of patients that had developed a shock to NMBA anesthesia, but not in controls exposed to NMBA anesthesia or in normal blood donors. Finally, the release of neutrophil extracellular traps (NETs), extracellular filaments made of DNA and histones, may contribute to respiratory symptoms HYPOTHESIS: Neutrophils are implicated in NMBA -induced anaphylactic reactions in humans. Activated by IgG-NMBA complexes, which aggregate IgG receptors, neutrophils release PAF and NETs that are implicated in the cardiac and respiratory distress during anaphylaxis. It is possible that the activation of neutrophils: 1) explains the clinical features of atypical anaphylactic reactions (non-IgE mediated), 2) participates also in part to classical anaphylactic reactions GENERAL OBJECTIVE: Compare the percentage of circulating activated neutrophils in a group of patients immediately following a NMBA -induced shock (case) to that of a group of patients exposed to NMBA during anesthesia without developing a shock (control).

SECONDARY OBJECTIVES:

A) the day of the shock, quantify and compare between case and controls, 1) the level of circulating anti-quaternary ammonium IgG by immuno fluorometry, 2) the expression of IgG receptors (FcR) on the surface of neutrophils by cytometry, 3) the levels of circulating PAF by mass spectrometry, 4) the amount of NETs by immunofluorescence.

B) 6 to 10 weeks after the shock perform, 1) cutaneous tests to NMBA, 2) a study of the capacity of stimulation of ex vivo neutrophils by IgG- NMBA complexes

ReferenceCitation: Gouel-Chéron A, de Chaisemartin L, Jönsson F, Nicaise-Roland P, Granger V, Sabahov A, Guinnepain MT, Chollet-Martin S, Bruhns P, Neukirch C, Longrois D; NASA study group. Low end-tidal CO2 as a real-time severity marker of intra-anaesthetic acute hypersensitivity reactions. Br J Anaesth. 2017 Nov 1;119(5):908-917. doi: 10.1093/bja/aex260.

family: Gouel-Chéron

full_name: A. Gouel-Chéron

given: A.

family: de Chaisemartin

full_name: L. de Chaisemartin

given: L.

family: Jönsson

full_name: F. Jönsson

given: F.

family: Nicaise-Roland

full_name: P. Nicaise-Roland

given: P.

family: Granger

full_name: V. Granger

given: V.

family: Sabahov

full_name: A. Sabahov

family: Guinnepain

full_name: M-T Guinnepain

given: M-T

family: Chollet-Martin

full_name: S. Chollet-Martin

given: S.

family: Bruhns

full_name: P. Bruhns

family: Neukirch

full_name: C. Neukirch

given: C.

family: Longrois

full_name: D. Longrois

given: D.

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific