title: Evaluation of the Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

acronym: ALLOZITHRO

summary:
The occurrence of bronchiolitis obliterans syndrome (SBO) after allogeneic hematopoietic stem cell transplantation (HSCT) is considered to be a chronic pulmonary graft versus host disease (GVHD) that is associated with significant mortality and morbidity. The reported incidence of SBO varies from 6 to 26% of allogeneic HSC recipients and is usually diagnosed within 2 years after transplantation. The diagnosis of SBO relies on the occurrence of a new airflow obstruction identified during pulmonary function testing, and the definition differs between studies. Currently, no curative immunosuppressive treatment is available, and recent data suggest that the use of these treatments, especially corticosteroids, should be limited because of their toxicity. The impairment of lung function parameters is likely caused by fibrous small airway lesions. Few data on the pathogenesis of SBO after allogeneic HSCT are available. Several hypotheses are based on the occurrence of SBO during chronic graft rejection after lung transplantation, which shares many clinical and histopathological similarities with SBO after allogeneic HSCT. One hypothesis is that the first step leading to SBO is lung epithelium injury. SBO is then identified as an alloimmune reaction with only one clearly identified risk factor: extrathoracic chronic GVHD. Due to their anti-inflammatory and immunomodulatory properties, recent data suggest that low-dose macrolides may be effective at preventing SBO after lung transplants. This well-tolerated treatment may be useful for preventing SBO after allogeneic HSCT.

The objective of this Phase 3 multicentre randomized, double-blinded, clinical trial is to evaluate the efficacy of azithromycin in preventing BO syndrome after allogeneic HSCT in patients with malignant hematological diseases.

status: Active, not recruiting

ReferenceType: result

ReferenceCitation: Bergeron A, Chevret S, Chagnon K, Godet C, Bergot E, Peffault de Latour R, Dominique S, de Revel T, Juvin K, Maillard N, Reman O, Contentin N, Robin M, Buzyn A, Socié G, Tazi A. Budesonide/Formoterol for bronchiolitis obliterans after hematopoietic stem cell transplantation. Am J Respir Crit Care Med. 2015 Jun 1;191(11):1242-9. doi: 10.1164/rccm.201410-1818OC.

family: Bergeron

full_name: Anne Bergeron

given: Anne

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Chagnon

full_name: Karine Chagnon

given: Karine

family: Godet

full_name: Cendrine Godet

given: Cendrine

family: Bergot

full_name: Emmanuel Bergot

family: Dominique

full_name: Stéphane Dominique

family: de Revel

full_name: Thierry de Revel

given: Thierry

family: Juvin

full_name: Karine Juvin

family: Maillard

full_name: Natacha Maillard

given: Natacha

family: Reman

full_name: Oumedaly Reman

given: Oumedaly

family: Contentin

full_name: Nathalie Contentin

given: Nathalie

family: Robin

full_name: Marie Robin

given: Marie

family: Buzyn

full_name: Agnès Buzyn

given: Agnès

family: Socié

full_name: Gérard Socié

given: Gérard

family: Tazi

full_name: Abdellatif Tazi

given: Abdellatif

title: Budesonide/Formoterol for Bronchiolitis Obliterans after Hematopoietic Stem Cell Transplantation

ReferenceCitation: Bergeron A, Chevret S, Granata A, Chevallier P, Vincent L, Huynh A, Tabrizi R, Labussiere-Wallet H, Bernard M, Chantepie S, Bay JO, Thiebaut-Bertrand A, Thepot S, Contentin N, Fornecker LM, Maillard N, Risso K, Berceanu A, Blaise D, Peffault de La Tour R, Chien JW, Coiteux V, Socié G; ALLOZITHRO Study Investigators. Effect of Azithromycin on Airflow Decline-Free Survival After Allogeneic Hematopoietic Stem Cell Transplant: The ALLOZITHRO Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):557-566. doi: 10.1001/jama.2017.9938.

name: AP-HP, Hôpital Saint-Louis, Service de Pneumologie, Paris, France2Université Paris Diderot, Sorbonne Paris Cité, UMR 1153 CRESS, Biostatistics and Clinical Epidemiology Research Team, Paris, France

name: Université Paris Diderot, Sorbonne Paris Cité, UMR 1153 CRESS, Biostatistics and Clinical Epidemiology Research Team, Paris, France3AP-HP, Hôpital Saint-Louis, Service de Biostatistique et Information médicale, Paris, France

name: Institut Paoli-Calmettes, Marseille, France

family: Granata

full_name: Angela Granata

given: Angela

name: Service d’Hématologie, CHU Nantes, Nantes, France

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

name: Département d’hématologie clinique, CHU de Montpellier, Montpellier, France

family: Vincent

full_name: Laure Vincent

given: Laure

name: Secteur de Greffe, CHU-Oncopole, Toulouse, France

name: CHU Bordeaux, Service d'Hématologie et Thérapie Cellulaire, Bordeaux, France

name: Département d’Hématologie, Lyon-Sud Hospital, Hospices Civils de Lyon, Pierre Bénite, Lyon, France

name: Hématologie Clinique, CHU Pontchaillou, Rennes, France

name: Institut d’Hématologie de Basse-Normandie, CHU Caen, Avenue Côte de Nacre Caen, France

name: Service de Thérapie Cellulaire et d'Hématologie Clinique Adulte, Université d'Auvergne, CIC-501, CHU Clermont-Ferrand Hôpital Estaing, Clermont-Ferrand, France

name: Clinique Universitaire d’Hématologie, CHU Grenoble Alpes, Université Grenoble Alpes, CS 10217, Grenoble, France

name: Service d’Hématologie–Maladies du Sang, CHU d’Angers, Angers, France15Université d'Angers, Inserm, Unité 1232, LabEx IGO, Angers, France

name: Service Hématologie, Centre Henri Becquerel, Rouen, France

name: Service d’Hématologie, CHU Strasbourg, France

name: Service d’Hématologie, CHU Poitiers, France

name: Centre Hospitalier Universitaire de Nice, Service d’Hématologie, Nice, France

name: CHRU Besançon, Hématologie, Besançon, France

name: Institut Paoli-Calmettes, Aix Marseille Université, CNRS, INSERM, CRCM, Marseille, France

name: On behalf of the Société Française de Greffe de Moelle-Thérapie Cellulaire (SFGM-TC), France

name: Gilead Sciences Inc, Foster City, California

name: CHRU Lille, Service des Maladies du Sang, Secteur Allogreffe de Cellules Souches Hématopoïétiques, Lille, France

name: APHP, Hématologie-Transplantation Hôpital St Louis, Université Denis Diderot and INSERM UMR 1160, Paris, France

title: Effect of Azithromycin on Airflow Decline–Free Survival After Allogeneic Hematopoietic Stem Cell Transplant


title: Single Port Colic Laparoscopic Surgery - THE TRUE TRIAL

acronym: TRUE

summary: This study aims to compare the results of colonic surgery performed by single and multiport laparoscopy.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Maggiori L, Tuech JJ, Cotte E, Lelong B, Denost Q, Karoui M, Vicaut E, Panis Y. Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836.

family: Maggiori

full_name: Léon Maggiori

given: Léon

sequence: first

family: Tuech

full_name: Jean Jacques Tuech

given: Jean Jacques

sequence: additional

family: Cotte

full_name: Eddy Cotte

given: Eddy

family: Lelong

full_name: Bernard Lelong

given: Bernard

family: Denost

full_name: Quentin Denost

given: Quentin

family: Karoui

full_name: Mehdi Karoui

given: Mehdi

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Panis

full_name: Yves Panis

given: Yves

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Individualisation du Drainage Lymphatique Des Membres inférieurs Lors du Curage Pelvien Pour Cancer gynécologique

acronym: SENTIJAMBE

summary: The purpose of this study is to evaluate the feasibility of an isotopic technique to identify, and to map the lower-limb drainage nodes during pelvic lymphadenectomy for gynaecological cancers. The diagnostic value of our mapping method will be assessed, and we will determine the incidence of lymhedema.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

status_simplified: Unknown


title: OPtimized Stenting Using IVUS in Long lEsion: Rationale for Simplified criteriA

acronym: OPERA

summary:
Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization (AVIO) study was performed with (medical device's type )Promus stent, results are promising, but the study was not designed for clinical endpoint.

There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely used in the early 2000, but have limitations for complex long lesions. The AVIO criteria were recently proposed for complex lesions, but these criteria also have some issues and the complexity make their routine use challenging.

We performed a pilot study for long complex lesion analysis using IVUS, in order to define easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The new criteria (OPERA) are an adaptation of the MUSIC criteria.

OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the study.

Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS element stent deployment?

Study design This study will consist to prospectively include consecutive patients with>28mm taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives to reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients from the OTELLO study, with the same inclusion criteria, will composed the control group . Population will be matched using the propensity score.

20 to 30 French centers involved in OTELLO study will be contacted for participating in OPERA.

Hypothesis:

Long lesion percutaneous coronary intervention(PCI) have specific characteristics like Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA criteria have better outcomes than without IVUS

Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm implantation

Secondary endpoint

MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria
Safety: procedural Stroke, Urgent cardiac surgery, procedural MI
Comparison of IVUS criteria: OPERA, MUSIC, AVIO

Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria

Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric study propensity score matched analysis matched for comparison to OTELLO study. (Same inclusion criteria as OTELLO)

Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected in the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73 Number of patients analysable in the OPERA study needed =250 patients i.e 300 pts inclusions.

Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts

Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months telephone contact

Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization (TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery, According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours

ReferenceCitation: Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum in: N Engl J Med. 2013 Feb 7;368(6):584.

family: Serruys

full_name: Patrick W. Serruys

given: Patrick W.

family: Morice

full_name: Marie-Claude Morice

given: Marie-Claude

family: Kappetein

full_name: A. Pieter Kappetein

given: A. Pieter

family: Colombo

full_name: Antonio Colombo

given: Antonio

family: Holmes

full_name: David R. Holmes

given: David R.

family: Mack

full_name: Michael J. Mack

given: Michael J.

family: Ståhle

full_name: Elisabeth Ståhle

given: Elisabeth

family: Feldman

full_name: Ted E. Feldman

given: Ted E.

family: van den Brand

full_name: Marcel van den Brand

given: Marcel

family: Bass

full_name: Eric J. Bass

given: Eric J.

family: Van Dyck

full_name: Nic Van Dyck

given: Nic

family: Leadley

full_name: Katrin Leadley

given: Katrin

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

family: Mohr

full_name: Friedrich W. Mohr

given: Friedrich W.

journal_name: New England Journal of Medicine

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

version: publishedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Percutaneous Coronary Intervention versus Coronary-Artery Bypass Grafting for Severe Coronary Artery Disease

ReferenceCitation: Fujii K, Mintz GS, Kobayashi Y, Carlier SG, Takebayashi H, Yasuda T, Moussa I, Dangas G, Mehran R, Lansky AJ, Reyes A, Kreps E, Collins M, Colombo A, Stone GW, Teirstein PS, Leon MB, Moses JW. Contribution of stent underexpansion to recurrence after sirolimus-eluting stent implantation for in-stent restenosis. Circulation. 2004 Mar 9;109(9):1085-8. Epub 2004 Mar 1.

ReferenceCitation: Sonoda S, Morino Y, Ako J, Terashima M, Hassan AH, Bonneau HN, Leon MB, Moses JW, Yock PG, Honda Y, Kuntz RE, Fitzgerald PJ; SIRIUS Investigators. Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantation: serial intravascular ultrasound analysis from the sirius trial. J Am Coll Cardiol. 2004 Jun 2;43(11):1959-63.

lead_sponsor: Centre Chirurgical Marie Lannelongue

intervention_type: Device

lead_sponsor_type: industriel


title: Neurological Complications - Pulmonary Transplant

summary: A monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant.

status: Terminated

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Hopital Foch


acronym: OSCILLOPOUMON

summary: A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).

intervention_type: Other


type: Other Identifier

title: Extreme Weights and Antiretroviral Therapy Individual Concentrations

acronym: EXTATIC

summary:
The concentration of the third agent in antiretroviral therapy [Non Nucleoside Reverse Transcriptase Inhibitor (NNRTI), or boosted Protease inhibitor (PI) ] is different according to the body weight or body composition and therapeutic monitoring may be necessary in overweight HIV patients.

The investigators aim at measuring the individual trough concentrations of interest [at steady state for NNRTI and boosted PI] in overweight and normal weight HIV+ patients.

lead_sponsor: Hopital Lariboisière


title: A Multicentre Phase III Trial to Determine the Efficacy of RAD 001 (Everolimus, Afinitor) as Second Line Therapy in Patients With Transitional Cell Carcinoma TCC of the Urothelium Which Failed or Progressed After First Line Chemotherapy

acronym: AFINIVEST

summary: A study to determine the efficacy of Everolimus(Afinitor®) as third line therapy in patients with transitional cell carcinoma of the urothelium which failed or progressed after two lines of chemotherapy

primary_purpose: Treatment

intervention_type: Drug


title: Multicenter Randomised, Controlled Trial of a Intensive Care Follow -up Programme in Improving Long-term Outcomes of ICU Survivors

acronym: SUIVI-REA

summary:
Study Hypothesis:

Critical illness is associated with long-term medical and psychological sequelae that can impact the professional and private life. The purpose of the present multicenter randomized controlled trial is to assess whether or not a medical, psychological and social follow-up improves quality of life of critically ill patients at one year after their discharge from intensive care unit (ICU).

Primary Purpose:

Death or severe alteration of quality of life assessed with help of EQ5D questionnaire at one year after ICU discharge.

primary_purpose: Prevention


title: Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.

acronym: RHUM-TP

summary: Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.

intervention_type: Biological


type: EudraCT Number

title: Randomized Placebo Controlled Trial Assessing the Efficacy and Safety of BP1.4979 in Smoking Cessation

summary: Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent < 10 ppm).

lead_sponsor: Bioprojet


title: Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.

acronym: Trama-Code

summary:
Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit.

The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).


title: Correlations' Study Between Variability of Expression in FBN1 Gene and Clinical Features in Marfan Patients.

acronym: Variarfan

summary:
Marfan syndrome is an autosomal dominant connective tissue disorder caused by mutations in the fibrillin-1 gene (FBN1). Penetrance of FBN1 mutations is complete but intra and inter familial clinical expressivity is extremely variable. The underlying mechanisms for variability are not understood. An interesting mechanism is that the expression level of the wild type and/or mutated allele may play a role in the determination of variability.

Principal objective: To evaluate in Marfan patients, if FBN1 expression level (non-mutated or mutated allele) modulates the clinical expression of the disease.

Judgment criteria : Correlation allelic expression level-phenotype Perspectives : To search the predictive factors of severity in order to ameliorate precocity of taking care.

design_allocation: Non-Randomized

primary_purpose: Basic Science

location_facility: Centre de Reference Maladie de Marfan Et Apparente


title: Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.

acronym: SOS AOH

summary: This clinical trial aims to compare morbidity and cost associated with acute attacks of hereditary angioedema in patients with an intervention based on a support after a phone call to the call center (SOS HAE) from a group of patients does not change their practice.

ReferenceCitation: Javaud N, Altar A, Fain O, Reuter PG, Desmaizieres M, Petrovic T, Ghazali A, Durand-Zaleski I, Bouillet L, Vicaut E, Launay D, Martin L, Floccard B, Gompel A, Sobel A, Boccon-Gibod I, Kanny G, Lapostolle F, Adnet F. Hereditary angioedema, emergency management of attacks by a call center. Eur J Intern Med. 2019 Sep;67:42-46. doi: 10.1016/j.ejim.2019.05.007. Epub 2019 May 18.

family: Javaud

full_name: Nicolas Javaud

given: Nicolas

family: Altar

full_name: Adrien Altar

given: Adrien

family: Fain

full_name: Olivier Fain

given: Olivier

family: Reuter

full_name: Paul-Georges Reuter

given: Paul-Georges

family: Desmaizieres

full_name: Michel Desmaizieres

given: Michel

family: Petrovic

full_name: Tomislav Petrovic

given: Tomislav

family: Ghazali

full_name: Aiham Ghazali

given: Aiham

family: Durand-zaleski

full_name: Isabelle Durand-zaleski

given: Isabelle

family: Bouillet

full_name: Laurence Bouillet

given: Laurence

family: Launay

full_name: David Launay

given: David

family: Martin

full_name: Ludovic Martin

given: Ludovic

family: Floccard

full_name: Bernard Floccard

given: Bernard

family: Gompel

full_name: Anne Gompel

given: Anne

family: Sobel

full_name: Alain Sobel

given: Alain

family: Boccon-Gibod

full_name: Isabelle Boccon-Gibod

family: Kanny

full_name: Gisele Kanny

given: Gisele

family: Lapostolle

full_name: Frederic Lapostolle

given: Frederic

family: Adnet

full_name: Frederic Adnet

journal_name: European Journal of Internal Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Javaud N, Fain O, Durand-Zaleski I, Launay D, Bouillet L, Gompel A, Sobel A, Woimant M, Rabetrano H, Petrovic T, Lapostolle F, Boccon-Gibod I, Reuter PG, Bertrand P, Mezaour M, Coppere B, Floccard B, Kanny G, Baker E, Martin L, Vicaut E, Adnet F. Specialist Advice Support for Management of Severe Hereditary Angioedema Attacks: A Multicenter Cluster-Randomized Controlled Trial. Ann Emerg Med. 2018 Aug;72(2):194-203.e1. doi: 10.1016/j.annemergmed.2018.01.053. Epub 2018 Mar 2.

ReferenceCitation: Javaud N, Fain O, Durand-Zaleski I, Launay D, Bouillet L, Gompel A, Sobel A, Woimant M, Rabetrano H, Petrovic T, Lapostolle F, Boccon-Gibod I, Reuter PG, Bertrand P, Coppere B, Floccard B, Kanny G, Martin L, Vicaut E, Adnet F. Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial. Trials. 2016 Apr 30;17(1):225. doi: 10.1186/s13063-016-1350-0.


title: Comparison of the Diagnostic Performances of 82Rubidium Positron Emission Tomography and Conventional Scintigraphy With CZT Cameras for Detection of Myocardial Ischemia in a Population of Overweighed Patients and Women

acronym: RUBIS

summary: The main objective of this study will be to compare the diagnostic performances of 82Rubidium-PET associated to pharmacologic stress (Persantine) to 99mTc-Sestamibi-SPECT with CZT cameras associated to a stress test (exercise, pharmacological, mixed) for detection of myocardial ischemia in a population of overweighed patients on one hand, and women on the other hand, in a population with an intermediate prevalence of coronary artery disease (≥ 3 cardiovascular risk factors in asymptomatic patients or prevalence of CAD ≥ 30 % using the DIAMOND-FORRESTER score in symptomatic patients).

ipd_sharing: Undecided

location_facility: Groupe Hospitalier Bichat - Claude Bernard

intervention_type: Radiation


title: Perfusion Analysis Using Rubidium in Cardiac Sarcoidosis

acronym: PARCS

summary: The study aims at assessing diagnostic and therapeutic impact of Rubidium-82 PET in cardiac sarcoidosis.

location_facility: Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard


title: New Prognostic Classification of Acute Pyelonephritis With Adaptation of the Therapeutic. Prospective Randomized Study in the Emergency

acronym: PROPA

summary: The prevalence of acute pyelonephritis (PNA) is 60-75 000/year. They are traditionally classified as uncomplicated (60-65%) and complicated. If it is assumed that the uncomplicated PNA can be treated as outpatients with a cure rate of over 80%, the second group is very heterogeneous. Some patients are severely infected. But others, despite an older age, structural urologic abnormalities or a controlled history, have no risk factors and can be simply managed. The investigators propose to reclassify the PNA into 3 categories: uncomplicated PNA (PNA-1), the PNA of moderate severity (PNA-2), the major PNA (PNA-3) to test whether the PNA-2 can benefit from the same outpatient care that the PNA-1. The existence of biological markers of the severity of bacterial infections would further support a tailored approach. The pro-adrenomedullin (pro-ADM), successfully tested to identify severe community acquired pneumonia, is a an interesting candidate.


title: Systemic Treatment for Psoriasis Patients: A Prospective Multicentric Observational Cohort Study

acronym: PSOBIOTEQ

summary:
PSOBIOTEQ is a national multicentric prospective cohort of cutaneous psoriasis patients receiving systemic treatment (biotherapy or DMARDs) for moderate to severe cutaneous psoriasis. It is resulting from the merging of two studies that share the same study population but address different objectives: PSOBIO, developed by academic dermatologists and epidemiologists and supported by the National Drug Agency (AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE,ANSM) and the ministry of health (PHRC 2009) focusing on safety issues, and Pso-TEQ, developed by industrials at the request of the French Transparency Commission (HAUTE AUTORITE DE SANTE) focusing on utilisation issues.

The overall general objective of PSOBIO is to assess "in real life" the safety and efficacy of biotherapies in the treatment of cutaneous psoriasis in comparison with major conventional systemic therapy while Pso-TEQ has a descriptive objective concerning the modalities of use of biological therapies "in real life" and long-term benefit.


title: Interventional Rigid Bronchoscopy Under General Anesthesia: Influence of the Muscle Relaxant, Succinylcholine or Rocuronium, on the Quality of the Surgical Procedure

acronym: Broncho-SR

summary: Myorelaxation is generally used as a part of general anesthesia for interventional rigid bronchoscopy. Succinylcholine is most often used because its short duration of action but rocuronium can be used since sugammadex permits a rapid and complete reversal of the neuromuscular block. The aim of ths study is to compare both agents.


title: Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)

summary: Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.


title: COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence

acronym: COM-ON

summary: The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample of opiate-users without any lifetime opiate dependence.

time_perspective: Cross-Sectional

location_facility: Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP)

intervention_type: Genetic


title: Observational Study Evaluating the Quality of Laser Enucleation of the Prostate Using a LUMENIS Laser Device

acronym: QUAPELLA

summary: This observational study aims at describing the learning curve of the Holmium Enucleation of the Prostate (HoLEP) technique using a LUMENIS laser device by senior attending urologists.


title: Approach Your Neck Fracture

acronym: AYNF

summary:
Hueter anterior approach as described by Siguier allows an anatomical approach without muscle or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation.

The investigators hypothesis was Hueter anterior approach allows quicker functional recovery after partial hip replacement.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility: Ambroise Paré Hospital. Orthopaedic surgery department


title: Effect of Epidural Analgesia on the Parameter ANI During Childbirth

acronym: APD-ANI

summary:
There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious patients with a comparison of ANI with the measurement of pain by a visual analog scale (VAS).

Evaluation of ANI is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.


title: Early Nutrition and Neurological Development of Very Preterm Infants

acronym: EPINUTRI

summary:
The main goal of this study is to determine the association between:

the quantity of mother's milk and duration of breastfeeding
the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks.

lead_sponsor: Lapillonne, Alexandre, M.D.


title: Evaluation of the Impact of Bariatric Surgery by Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients

acronym: FORBES

summary:
Subject: Evaluation of the impact of obesity surgery by sleeve gastrectomy on intestinal iron absorption of morbid obese subjects.

Control of intestinal absorption of iron is mediated by hepcidin, which is expressed in adipose tissue and that its expression is increased in morbidly obese subjects. The working hypothesis is that this increase could explain the high prevalence of systemic iron depletion observed in obese patients.

Main objective: Assess the impact of the decrease in fat mass induced by surgery in obese patients on the intestinal absorption of iron (evaluated by measuring the expression of iron transporters in the duodenum)


title: Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.

acronym: OPTIFLOW

summary: The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the use, in the immediate postoperative period, should lead to define the role of each technique and lead to a optimal rationalization of patients management with acute respiratory failure after surgery.

ReferenceCitation: Stéphan F, Barrucand B, Petit P, Rézaiguia-Delclaux S, Médard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Bérard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.

name: Service de Réanimation Adulte, Centre Chirurgical Marie Lannelongue, Le Plessis Robinson, France

family: Stéphan

full_name: François Stéphan

given: François

name: Département d'Anesthésie-Réanimation, Centre Hospitalier Universitaire, Besançon, France

family: Barrucand

full_name: Benoit Barrucand

given: Benoit

family: Petit

full_name: Pascal Petit

given: Pascal

family: Rézaiguia-Delclaux

full_name: Saida Rézaiguia-Delclaux

given: Saida

name: Département d'Anesthésie-Réanimation, Centre Hospitalier Universitaire, Clermont Ferrand, France

family: Médard

full_name: Anne Médard

name: Département d'Anesthésie-Réanimation Centre Hospitalier Universitaire, Lyon, France

family: Delannoy

full_name: Bertrand Delannoy

given: Bertrand

family: Cosserant

full_name: Bernard Cosserant

family: Flicoteaux

full_name: Guillaume Flicoteaux

given: Guillaume

family: Imbert

full_name: Audrey Imbert

given: Audrey

family: Pilorge

full_name: Catherine Pilorge

given: Catherine

name: Hôpital St Antoine, Plateforme de recherche Clinique de l’Est Parisien, Paris, France

family: Bérard

full_name: Laurence Bérard

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association


title: Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate

summary: The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. The "biofilm" forms very early after the bacterial contamination of the prosthesis and poses a number of clinical challenges due to his resistance to immune defence mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also proved his biocompatibility and osseous-integration.

status: Withdrawn

lead_sponsor: Laboratoire Ceraver-Osteal


title: Pain Evaluation After ACL Ligamentoplasty: "All-inside" Versus Classical Technique. A Prospective Randomised Comparative Study

summary:
The "All-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called "classical" method, the fixation is achieved with interference screws.

The hypothesis of this study was that the "All-inside" technique causes less pain than the conventional technique. The main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.

ReferenceCitation: Benea H, d'Astorg H, Klouche S, Bauer T, Tomoaia G, Hardy P. Pain evaluation after all-inside anterior cruciate ligament reconstruction and short term functional results of a prospective randomized study. Knee. 2014 Jan;21(1):102-6. doi: 10.1016/j.knee.2013.09.006. Epub 2013 Oct 5. Erratum in: Knee. 2017 Jan;24(1):166.

family: Benea

full_name: Horea Benea

given: Horea

family: d’Astorg

full_name: Henri d’Astorg

given: Henri

family: Klouche

full_name: Shahnaz Klouche

given: Shahnaz

family: Bauer

full_name: Thomas Bauer

given: Thomas

family: Tomoaia

full_name: Gheorghe Tomoaia

given: Gheorghe

family: Hardy

full_name: Philippe Hardy

given: Philippe

journal_name: The Knee


title: Characterisation of T Lymphocytes, NK Cells and Macrophages in Melanoma Patients: Impact on Immunity Versus Immunosuppression

acronym: IMMUMELA

summary: Melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with an anti-tumoral specificity. The aim of the study is to analyse at different stages of the disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular T lymphocytes, NK cells and macrophages), the role of inhibitor receptors on in situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.


title: Study of the Efficiency of the Ketamine With Low Analgesic Doses, in Association With High Opioids, in the Treatment of the Rebels Pains, in Palliative Phase of the Cancerous Disease

acronym: KEPAL

summary: Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain.

ReferenceType: background

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ReferenceCitation: Fine PG. Low-dose ketamine in the management of opioid nonresponsive terminal cancer pain. J Pain Symptom Manage. 1999 Apr;17(4):296-300.

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location_facility: Center of Evaluation and Treatment of the pain - Saint-Antoine Hospital


title: A Phase II, Open Label Clinical Trial Exploring the Safety and the Efficacy of Oral Deferasirox in Patients Newly Diagnosed With Porphyria Cutanea Tarda (PCT) and Non-transfusion Iron Overload

summary: While clinical phlebotomy is current standard practice for alleviating non-transfusion iron overload in patients with PCT, it may not be suitable for all patients. For example, some patients are unwilling to be adequately phlebotomized because of inconvenience, as phlebotomy can be cumbersome, especially during the induction treatment phase requiring frequent clinic visits (twice a month, for at least 6 months) or because of venous access difficulties. Other patients are unable to undergo phlebotomy due to medical reasons such as anemia or cardiopulmonary disorders. It is postulated such patients with PCT who have non-transfusion iron overload could benefit from treatment with deferasirox (Exjade®), a once daily oral iron chelator licensed in several countries, including the EU, for treating transfusion iron overload in adult and pediatric patients. Although there is some data on the efficacy and safety of deferasirox in patients with HH, who, like those with PCT, have non-transfusional iron overload, there is a need to evaluate the safety and efficacy of deferasirox treatment of non-transfusion iron overload in patients with PCT.

family: Puy

full_name: Hervé Puy

given: Hervé

family: Gouya

full_name: Laurent Gouya

given: Laurent

family: Deybach

full_name: Jean-Charles Deybach

given: Jean-Charles

journal_name: The Lancet

title: Porphyrias


title: Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.

summary: The propose of this study is to assess the effect of general practitioner's involvement in the stimulus invitation letter in colorectal cancer screening compared to sending the patient home test (stimulus 2 of reference as contained in the specifications).

primary_purpose: Screening

lead_sponsor: University of Paris 5 - Rene Descartes


summary: The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).


title: Evaluation of Recent Techniques for Diagnosing Central Venous Catheter-related Bloodstream Infections in Critically Ill Children

acronym: Incat

summary: Removal of a central venous catheter (CVC) is often useful to prove its responsibility in a bloodstream infection. To avoid unnecessary removal of CVC, some catheter-spearing diagnostic methods have been recently developed. The aim of the study is to evaluate three catheter-spearing diagnostic methods in critically ill children: 1) the measurement of the differential time to positivity between a blood culture drawn from a peripherical vein and another one drawn through the CVC; 2) the exam of a blood sample drawn for the CVC and stained by acridine orange leucocyte cytospin test; 3) the semi-quantitative skin culture of the area around the insertion site of the CVC.


title: Structural Spinal Cord Integrity in Patients With Cervical Spondylosis in Relation to Clinical Status

acronym: Tractocervical

summary: This study aims at evaluating spinal cord structure using diffusion tensor imaging in patients with cervical spondylosis.


title: Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma?

acronym: NOnourisson

summary:
Background:

It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke

Objective: the investigators objective is to bring to light that the rise of the eNO, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. After allergic exploration (skin tests and assay of serum total and specific IgE, complete blood count), the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer. Annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. After a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eNO and the various clinical, biological and environmental parameters known to influence the variations of this marker. Then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.

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ReferenceCitation: Franklin PJ, Taplin R, Stick SM. A community study of exhaled nitric oxide in healthy children. Am J Respir Crit Care Med. 1999 Jan;159(1):69-73.

ReferenceCitation: Gratziou C, Lignos M, Dassiou M, Roussos C. Influence of atopy on exhaled nitric oxide in patients with stable asthma and rhinitis. Eur Respir J. 1999 Oct;14(4):897-901.

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ReferenceCitation: Lanz MJ, Leung DY, McCormick DR, Harbeck R, Szefler SJ, White CW. Comparison of exhaled nitric oxide, serum eosinophilic cationic protein, and soluble interleukin-2 receptor in exacerbations of pediatric asthma. Pediatr Pulmonol. 1997 Nov;24(5):305-11.

ReferenceCitation: Mahut B, Delclaux C, Tillie-Leblond I, Gosset P, Delacourt C, Zerah-Lancner F, Harf A, de Blic J. Both inflammation and remodeling influence nitric oxide output in children with refractory asthma. J Allergy Clin Immunol. 2004 Feb;113(2):252-6.

ReferenceCitation: Silvestri M, Sabatini F, Spallarossa D, Fregonese L, Battistini E, Biraghi MG, Rossi GA. Exhaled nitric oxide levels in non-allergic and allergic mono- or polysensitised children with asthma. Thorax. 2001 Nov;56(11):857-62.

ReferenceCitation: Silvestri M, Sabatini F, Sale R, Defilippi AC, Fregonese L, Battistini E, Biraghi MG, Rossi GA. Correlations between exhaled nitric oxide levels, blood eosinophilia, and airway obstruction reversibility in childhood asthma are detectable only in atopic individuals. Pediatr Pulmonol. 2003 May;35(5):358-63.

ReferenceCitation: Jouaville LF, Annesi-Maesano I, Nguyen LT, Bocage AS, Bedu M, Caillaud D. Interrelationships among asthma, atopy, rhinitis and exhaled nitric oxide in a population-based sample of children. Clin Exp Allergy. 2003 Nov;33(11):1506-11.

ReferenceCitation: Barreto M, Villa MP, Martella S, Ronchetti F, Darder MT, Falasca C, Pagani J, Massa F, Ronchetti R. Exhaled nitric oxide in asthmatic and non-asthmatic children: influence of type of allergen sensitization and exposure to tobacco smoke. Pediatr Allergy Immunol. 2001 Oct;12(5):247-56.

ReferenceCitation: Warke TJ, Fitch PS, Brown V, Taylor R, Lyons JD, Ennis M, Shields MD. Exhaled nitric oxide correlates with airway eosinophils in childhood asthma. Thorax. 2002 May;57(5):383-7.

ReferenceCitation: Bratton DL, Lanz MJ, Miyazawa N, White CW, Silkoff PE. Exhaled nitric oxide before and after montelukast sodium therapy in school-age children with chronic asthma: a preliminary study. Pediatr Pulmonol. 1999 Dec;28(6):402-7.

ReferenceCitation: Di Rosa M, Radomski M, Carnuccio R, Moncada S. Glucocorticoids inhibit the induction of nitric oxide synthase in macrophages. Biochem Biophys Res Commun. 1990 Nov 15;172(3):1246-52.

ReferenceCitation: Malmberg LP, Pelkonen AS, Haahtela T, Turpeinen M. Exhaled nitric oxide rather than lung function distinguishes preschool children with probable asthma. Thorax. 2003 Jun;58(6):494-9.

ReferenceCitation: Nathan C, Xie QW. Nitric oxide synthases: roles, tolls, and controls. Cell. 1994 Sep 23;78(6):915-8. Review.

ReferenceCitation: Thomas NS, Wilkinson J, Holgate ST. The candidate region approach to the genetics of asthma and allergy. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 2):S144-51.

ReferenceCitation: Grasemann H, Yandava CN, Drazen JM. Neuronal NO synthase (NOS1) is a major candidate gene for asthma. Clin Exp Allergy. 1999 Dec;29 Suppl 4:39-41.

ReferenceCitation: Grasemann H, Yandava CN, Storm van's Gravesande K, Deykin A, Pillari A, Ma J, Sonna LA, Lilly C, Stampfer MJ, Israel E, Silverman EK, Drazen JM. A neuronal NO synthase (NOS1) gene polymorphism is associated with asthma. Biochem Biophys Res Commun. 2000 Jun 7;272(2):391-4.

ReferenceCitation: Wechsler ME, Grasemann H, Deykin A, Silverman EK, Yandava CN, Israel E, Wand M, Drazen JM. Exhaled nitric oxide in patients with asthma: association with NOS1 genotype. Am J Respir Crit Care Med. 2000 Dec;162(6):2043-7.

ReferenceCitation: Hollá LI, Schüller M, Bucková D, Vácha J. Neuronal nitric oxide synthase gene polymorphism and IgE-mediated allergy in the Central European population. Allergy. 2004 May;59(5):548-52.

ReferenceCitation: Leung TF, Liu EK, Tang NL, Ko FW, Li CY, Lam CW, Wong GW. Nitric oxide synthase polymorphisms and asthma phenotypes in Chinese children. Clin Exp Allergy. 2005 Oct;35(10):1288-94.

ReferenceCitation: Lee YC, Cheon KT, Lee HB, Kim W, Rhee YK, Kim DS. Gene polymorphisms of endothelial nitric oxide synthase and angiotensin-converting enzyme in patients with asthma. Allergy. 2000 Oct;55(10):959-63.

ReferenceCitation: Hollá LI, Bucková D, Kuhrová V, Stejskalová A, Francová H, Znojil V, Vácha J. Prevalence of endothelial nitric oxide synthase gene polymorphisms in patients with atopic asthma. Clin Exp Allergy. 2002 Aug;32(8):1193-8.

ReferenceCitation: Dizier MH, Besse-Schmittler C, Guilloud-Bataille M, Annesi-Maesano I, Boussaha M, Bousquet J, Charpin D, Degioanni A, Gormand F, Grimfeld A, Hochez J, Hyne G, Lockhart A, Luillier-Lacombe M, Matran R, Meunier F, Neukirch F, Pacheco Y, Parent V, Paty E, Pin I, Pison C, Scheinmann P, Thobie N, Vervloet D, Kauffmann F, Feingold J, Lathrop M, Demenais F. Genome screen for asthma and related phenotypes in the French EGEA study. Am J Respir Crit Care Med. 2000 Nov;162(5):1812-8.

ReferenceCitation: Xu W, Liu L, Emson PC, Harrington CR, Charles IG. Evolution of a homopurine-homopyrimidine pentanucleotide repeat sequence upstream of the human inducible nitric oxide synthase gene. Gene. 1997 Dec 19;204(1-2):165-70.

ReferenceCitation: Warpeha KM, Xu W, Liu L, Charles IG, Patterson CC, Ah-Fat F, Harding S, Hart PM, Chakravarthy U, Hughes AE. Genotyping and functional analysis of a polymorphic (CCTTT)(n) repeat of NOS2A in diabetic retinopathy. FASEB J. 1999 Oct;13(13):1825-32.

ReferenceCitation: Wildhaber JH, Hall GL, Stick SM. Measurements of exhaled nitric oxide with the single-breath technique and positive expiratory pressure in infants. Am J Respir Crit Care Med. 1999 Jan;159(1):74-8.

ReferenceCitation: Lundberg JO, Weitzberg E, Lundberg JM, Alving K. Nitric oxide in exhaled air. Eur Respir J. 1996 Dec;9(12):2671-80. Review.

ReferenceCitation: George SC, Hogman M, Permutt S, Silkoff PE. Modeling pulmonary nitric oxide exchange. J Appl Physiol (1985). 2004 Mar;96(3):831-9. Review.

ReferenceCitation: Hamouda S, Chevalier-Bidaud B, Aboutaam R, Le Bourgeois M, Scheinmann P, Delclaux C, Mahut B. [Off-line exhaled nitric oxide measurement in children]. Rev Mal Respir. 2006 Nov;23(5 Pt 1):421-5. French.

ReferenceCitation: Mahut B, Louis B, Delclaux C. [Measurement of exhaled nitric oxide: methodology]. Rev Mal Respir. 2006 Jun;23(3 Suppl):6S29-6S36. Review. French.

ReferenceCitation: Paredi P, Loukides S, Ward S, Cramer D, Spicer M, Kharitonov SA, Barnes PJ. Exhalation flow and pressure-controlled reservoir collection of exhaled nitric oxide for remote and delayed analysis. Thorax. 1998 Sep;53(9):775-9.

ReferenceCitation: Jöbsis Q, Raatgeep HC, Hop WC, de Jongste JC. Controlled low flow off line sampling of exhaled nitric oxide in children. Thorax. 2001 Apr;56(4):285-9.

ReferenceCitation: Hall GL, Reinmann B, Wildhaber JH, Frey U. Tidal exhaled nitric oxide in healthy, unsedated newborn infants with prenatal tobacco exposure. J Appl Physiol (1985). 2002 Jan;92(1):59-66.

ReferenceCitation: Gabriele C, van der Wiel EC, Nieuwhof EM, Moll HA, Merkus PJ, de Jongste JC. Methodological aspects of exhaled nitric oxide measurements in infants. Pediatr Allergy Immunol. 2007 Feb;18(1):36-41.

ReferenceCitation: Tabachnik E, Levison H. Postgraduate course presentation. Infantile bronchial asthma. J Allergy Clin Immunol. 1981 May;67(5):339-47. Review.

ReferenceCitation: Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.

ReferenceCitation: Kauffmann F, Annesi-Maesano I, Liard R, Paty E, Faraldo B, Neukirch F, Dizier MH. [Construction and validation of a respiratory epidemiological questionnaire]. Rev Mal Respir. 2002 Jun;19(3):323-33. French.

ReferenceCitation: Annesi-Maesano I, Didier A, Klossek M, Chanal I, Moreau D, Bousquet J. The score for allergic rhinitis (SFAR): a simple and valid assessment method in population studies. Allergy. 2002 Feb;57(2):107-14.

ReferenceCitation: Azevedo I, de Blic J, Scheinmann P, Vargaftig BB, Bachelet M. Enhanced arachidonic acid metabolism in alveolar macrophages from wheezy infants. Modulation by dexamethasone. Am J Respir Crit Care Med. 1995 Oct;152(4 Pt 1):1208-14.

location_facility: Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)


title: Identification and Characterization of the Methylation Abnormalities on Whole Genome Among Infertile Men

acronym: METHYLHOMME

summary: This study will analyse the sperm global methylation status of 62 infertile men before assisted reproductive techniques. Some of these patients (20%) present hypomethylation of H19 locus. A global methylation analysis may reveal others imprinting defects.

ReferenceCitation: Adami HO, Bergström R, Möhner M, Zatoński W, Storm H, Ekbom A, Tretli S, Teppo L, Ziegler H, Rahu M, et al. Testicular cancer in nine northern European countries. Int J Cancer. 1994 Oct 1;59(1):33-8.

ReferenceCitation: Anway MD, Cupp AS, Uzumcu M, Skinner MK. Epigenetic transgenerational actions of endocrine disruptors and male fertility. Science. 2005 Jun 3;308(5727):1466-9. Erratum in: Science. 2010 May 7;328(5979):690.

ReferenceCitation: Auger J, Kunstmann JM, Czyglik F, Jouannet P. Decline in semen quality among fertile men in Paris during the past 20 years. N Engl J Med. 1995 Feb 2;332(5):281-5.

ReferenceCitation: Carlsen E, Giwercman A, Keiding N, Skakkebaek NE. Evidence for decreasing quality of semen during past 50 years. BMJ. 1992 Sep 12;305(6854):609-13. Review.

ReferenceCitation: Davis TL, Yang GJ, McCarrey JR, Bartolomei MS. The H19 methylation imprint is erased and re-established differentially on the parental alleles during male germ cell development. Hum Mol Genet. 2000 Nov 22;9(19):2885-94.

ReferenceCitation: Gicquel C, Gaston V, Mandelbaum J, Siffroi JP, Flahault A, Le Bouc Y. In vitro fertilization may increase the risk of Beckwith-Wiedemann syndrome related to the abnormal imprinting of the KCN1OT gene. Am J Hum Genet. 2003 May;72(5):1338-41.

ReferenceCitation: Hartmann S, Bergmann M, Bohle RM, Weidner W, Steger K. Genetic imprinting during impaired spermatogenesis. Mol Hum Reprod. 2006 Jun;12(6):407-11. Epub 2006 Apr 11.

ReferenceCitation: Kaiser J. Developmental biology. Endocrine disrupters trigger fertility problems in multiple generations. Science. 2005 Jun 3;308(5727):1391-2.

ReferenceCitation: Kobayashi H, Sato A, Otsu E, Hiura H, Tomatsu C, Utsunomiya T, Sasaki H, Yaegashi N, Arima T. Aberrant DNA methylation of imprinted loci in sperm from oligospermic patients. Hum Mol Genet. 2007 Nov 1;16(21):2542-51. Epub 2007 Jul 17.

ReferenceCitation: Paulozzi LJ, Erickson JD, Jackson RJ. Hypospadias trends in two US surveillance systems. Pediatrics. 1997 Nov;100(5):831-4.

ReferenceCitation: Preiksa RT, Zilaitiene B, Matulevicius V, Skakkebaek NE, Petersen JH, Jørgensen N, Toppari J. Higher than expected prevalence of congenital cryptorchidism in Lithuania: a study of 1204 boys at birth and 1 year follow-up. Hum Reprod. 2005 Jul;20(7):1928-32. Epub 2005 Apr 28.

ReferenceCitation: Skakkebaek NE, Rajpert-De Meyts E, Main KM. Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects. Hum Reprod. 2001 May;16(5):972-8. Review.

ReferenceCitation: Toppari J, Larsen JC, Christiansen P, Giwercman A, Grandjean P, Guillette LJ Jr, Jégou B, Jensen TK, Jouannet P, Keiding N, Leffers H, McLachlan JA, Meyer O, Müller J, Rajpert-De Meyts E, Scheike T, Sharpe R, Sumpter J, Skakkebaek NE. Male reproductive health and environmental xenoestrogens. Environ Health Perspect. 1996 Aug;104 Suppl 4:741-803. Review.

location_facility: Department of Biology of reproduction (TENON Hospital)


title: Reliving the Traumatic Event in Posttraumatic Stress Disorder: An Emotional Memory Reactivation Pathology? An fMRI Study

acronym: VIVITRAU

summary:
Converging lines of evidence have implicated the amygdala in the pathophysiology of posttraumatic stress disorder.

The primary purpose of our study is to assess the effect of propanolol, a beta adrenergic antagonism, on amygdala activation during a symptom provocation state in traumatized subjects with and without posttraumatic stress disorder.

ReferenceCitation: Adler SA, Wilk A, Rovee-Collier C. Reinstatement versus reactivation effects on active memory in infants. J Exp Child Psychol. 2000 Feb;75(2):93-115.

ReferenceCitation: Blanchard EB, Hickling EJ, Taylor AE, Forneris CA, Loos W, Jaccard J. Effects of varying scoring rules of the Clinician-Administered PTSD Scale (CAPS) for the diagnosis of post-traumatic stress disorder in motor vehicle accident victims. Behav Res Ther. 1995 May;33(4):471-5.

ReferenceCitation: Botreau F, El Massioui N, Chéruel F, Gisquet-Verrier P. Effects of medial prefrontal cortex and dorsal striatum lesions on retrieval processes in rats. Neuroscience. 2004;129(3):539-53.

ReferenceCitation: Boujabit M, Bontempi B, Destrade C, Gisquet-Verrier P. Exposure to a retrieval cue in rats induces changes in regional brain glucose metabolism in the amygdala and other related brain structures. Neurobiol Learn Mem. 2003 Jan;79(1):57-71.

ReferenceCitation: Brunet A, Orr SP, Tremblay J, Robertson K, Nader K, Pitman RK. Effect of post-retrieval propranolol on psychophysiologic responding during subsequent script-driven traumatic imagery in post-traumatic stress disorder. J Psychiatr Res. 2008 May;42(6):503-6. Epub 2007 Jun 22.

ReferenceCitation: Dirikx T, Hermans D, Vansteenwegen D, Baeyens F, Eelen P. Reinstatement of extinguished conditioned responses and negative stimulus valence as a pathway to return of fear in humans. Learn Mem. 2004 Sep-Oct;11(5):549-54.

ReferenceCitation: Ferry B, McGaugh JL. Clenbuterol administration into the basolateral amygdala post-training enhances retention in an inhibitory avoidance task. Neurobiol Learn Mem. 1999 Jul;72(1):8-12.

ReferenceCitation: Giles J. Beta-blockers tackle memories of horror. Nature. 2005 Jul 28;436(7050):448-9.

ReferenceCitation: Gisquet-Verrier P, Botreau F, Venero C, Sandi C. Exposure to retrieval cues improves retention performance and induces changes in ACTH and corticosterone release. Psychoneuroendocrinology. 2004 May;29(4):529-56.

ReferenceCitation: Herz RS. Are odors the best cues to memory? A cross-modal comparison of associative memory stimuli. Ann N Y Acad Sci. 1998 Nov 30;855:670-4.

ReferenceCitation: Maheu FS, Joober R, Beaulieu S, Lupien SJ. Differential effects of adrenergic and corticosteroid hormonal systems on human short- and long-term declarative memory for emotionally arousing material. Behav Neurosci. 2004 Apr;118(2):420-8.

ReferenceCitation: Przybyslawski J, Roullet P, Sara SJ. Attenuation of emotional and nonemotional memories after their reactivation: role of beta adrenergic receptors. J Neurosci. 1999 Aug 1;19(15):6623-8.

ReferenceCitation: Quirarte GL, Roozendaal B, McGaugh JL. Glucocorticoid enhancement of memory storage involves noradrenergic activation in the basolateral amygdala. Proc Natl Acad Sci U S A. 1997 Dec 9;94(25):14048-53.

ReferenceCitation: Sara SJ. Retrieval and reconsolidation: toward a neurobiology of remembering. Learn Mem. 2000 Mar-Apr;7(2):73-84. Review.

ReferenceCitation: Simson PE, Naylor JC, Gibson B, Schneider AM, Levin D. Dose-sensitive excitation and inhibition of spontaneous amygdala activity by propranolol. Pharmacol Biochem Behav. 2001 May-Jun;69(1-2):85-92.

ReferenceCitation: Strange BA, Dolan RJ. Beta-adrenergic modulation of emotional memory-evoked human amygdala and hippocampal responses. Proc Natl Acad Sci U S A. 2004 Aug 3;101(31):11454-8. Epub 2004 Jul 21.

ReferenceCitation: Taylor F, Cahill L. Propranolol for reemergent posttraumatic stress disorder following an event of retraumatization: a case study. J Trauma Stress. 2002 Oct;15(5):433-7.

ReferenceCitation: Vaiva G, Ducrocq F, Jezequel K, Averland B, Lestavel P, Brunet A, Marmar CR. Immediate treatment with propranolol decreases posttraumatic stress disorder two months after trauma. Biol Psychiatry. 2003 Nov 1;54(9):947-9. Erratum in: Biol Psychiatry. 2003 Dec 15;54(12):1471.

ReferenceCitation: van Stegeren AH, Everaerd W, Cahill L, McGaugh JL, Gooren LJ. Memory for emotional events: differential effects of centrally versus peripherally acting beta-blocking agents. Psychopharmacology (Berl). 1998 Aug;138(3-4):305-10.

ReferenceCitation: van Stegeren AH, Goekoop R, Everaerd W, Scheltens P, Barkhof F, Kuijer JP, Rombouts SA. Noradrenaline mediates amygdala activation in men and women during encoding of emotional material. Neuroimage. 2005 Feb 1;24(3):898-909.

location_facility: Saint-Antoine Hospital, Psychiatriy unit


title: Can we Better Select Patients With Heart Failure for a Primary Prevention Indication of Implantable Cardioverter Defibrillator (ICD)? Evaluation of the Diagnostic Value of 123I Meta-iodobenzylguanidine (MIBG)

acronym: MISTIC

summary: The aim of the study is to assess the cardiac innervation in patients with heart failure to better select candidates for an implantable cardioverter defibrillator. Cardiac innervation will be assessed using an imaging agent administered intravenously.


title: Evaluating the Necessity of TOT Implantation in Women With Pelvic Organ Prolapse and Occult Stress Urinary Incontinence

acronym: ATHENA

summary: Nowadays the clinical significance of an occult stress urinary incontinence and its optimal treatment is not known.Regarding treatment, there are 2 main approaches : either the systematic preventive treatment of the occult stress urinary incontinence by means of a tension free vaginal tape (TOT) together with the treatment of prolapse or the treatment of prolapse in the first place and treatment of stress incontinence in a second time when and if it appears.This study is expected to provide objective evidence concerning the efficacy and security of TOT implantation for the prevention treatment of occult stress urinary incontinence in women with pelvic organ prolapse and occult urinary incontinence.The perspective is to improve the management of these patients by providing evidence based recommendation for their treatment.

ReferenceCitation: Cortesse A, Jacquetin B, Grise P, Le Normand L, Richard F, Haab F. Prospective multicenter clinical trial of Uretex Sup for surgical treatment of stress urinary incontinence. Int J Urol. 2007 Jul;14(7):611-5.


title: Safety and Long-term Effectiveness of High Frequency Repetitive Transcranial Magnetic Stimulation at the Subacute Phase of Ischaemic Stroke

acronym: RAICup

summary: The aim of the study is to determine if 2-week repetitive transcranial magnetic stimulation at the subacute phase of stroke (between day 7 and day 14) improves significantly arm motility at 3 months with remaining effect at one year, without significant adverse effect.

location_facility: Physiology Department, Hôpital Lariboisière, Université Paris 7


title: Double Blind Randomized Controlled Trial of Recombinant Human Platelet Derived Growth Factor-BB Gel (Regranex Gel®) Versus Hydrogel (Duoderm Hydrogel®) for Healing of MARTORELL's Hypertensive Leg Ulcers. ERAN Trial.

acronym: ERAN

summary:
Background: No medical treatment has proved its efficacy for the treatment of hypertensive leg ulcers in a well designed trial.

Primary aim of the study: to compare the rate of healing in hypertensive leg ulcers treated with becaplermin gel (Regranex Gel®) daily application versus the application of the same quantity of an hydrogel (Duoderm Hydrogel™), corresponding to the excipient of becaplermin gel.

Method: Ambulatory or hospitalized patients presenting with an hypertensive leg ulcer, were randomized to receive either a daily application of becaplermin gel or hydrogel during 8 weeks. At week 8, a pinch graft was proposed to patients whom the ulcer has not healed.

Primary aim of the study: Complete closure at week 8

Secondary aims: percentage of wound area reduction at week 8, complete closure at week 12, pain and quality of life during treatment

Study hypothesis: becaplermin gel may promote the healing of hypertensive leg ulcers and be an alternative medical treatment to the skin graft usually proposed

ReferenceCitation: Senet P, Vicaut E, Beneton N, Debure C, Lok C, Chosidow O. Topical treatment of hypertensive leg ulcers with platelet-derived growth factor-BB: a randomized controlled trial. Arch Dermatol. 2011 Aug;147(8):926-30. doi: 10.1001/archdermatol.2011.84. Epub 2011 Apr 11.

family: Senet

full_name: Patricia Senet

given: Patricia

journal_name: Archives of Dermatology

title: Topical Treatment of Hypertensive Leg Ulcers With Platelet-Derived Growth Factor-BB


title: MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study

acronym: KALOVAL

summary: The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.

ReferenceCitation: Bauer C, Lahjibi-Paulet H, Somme D, Onody P, Saint Jean O, Gisselbrecht M. Tolerability of an equimolar mix of nitrous oxide and oxygen during painful procedures in very elderly patients. Drugs Aging. 2007;24(6):501-7.

location_facility: Hôpital Jean Verdier, service de la médecine de la reproduction, avenue du 14 juillet


title: A Double Blind Randomized Controlled Trial of Greater Occipital Nerve Infiltration in Cluster Headache

acronym: CHCI

summary: the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of the greater occipital nerve to diminish the frequency of cluster headache (episodic or chronic) attacks during an active period. Injections will be used in adjunct with oral verapamil.

ReferenceCitation: Leroux E, Valade D, Taifas I, Vicaut E, Chagnon M, Roos C, Ducros A. Suboccipital steroid injections for transitional treatment of patients with more than two cluster headache attacks per day: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2011 Oct;10(10):891-7. doi: 10.1016/S1474-4422(11)70186-7. Epub 2011 Sep 6.

family: Leroux

full_name: Elizabeth Leroux

given: Elizabeth

family: Valade

full_name: Dominique Valade

given: Dominique

family: Taifas

full_name: Irina Taifas

given: Irina

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Chagnon

full_name: Miguel Chagnon

given: Miguel

family: Roos

full_name: Caroline Roos

given: Caroline

family: Ducros

full_name: Anne Ducros

given: Anne

journal_name: The Lancet Neurology

location_facility: CHU Lariboisière, AP-HP, Centre des Urgences Céphalées (Emergency Headacha Center)


title: Implant System for Fixation of Cranial Bone Flaps After Craniotomy for Brain Surgery

acronym: CRANIOSG

summary: Bone flaps after craniotomy are typically fixed with suture material, mini plates and others devices. In some cases, fixation with suture material is not secure as it may result in shifting of the bone flap with its dislocation. We will test the safety and efficacy of SKULL GRIP a new device for fixation of the bone flap during cranial procedure comparing to traditional suture materials.

ReferenceCitation: Chibbaro S, Makiese O, Bresson D, Hamdi S, Cornelius JF, Guichard JP, Reiss A, Bouazza S, Vicaut E, Ricci A, Galzio R, Poczos P, George B, Marsella M, Di Emidio P. Skull bone flap fixation - reliability and efficacy of a new grip-like titanium device (Skull Grip) versus traditional sutures: a clinical randomized trial. Minim Invasive Neurosurg. 2011 Oct;54(5-6):282-5. doi: 10.1055/s-0031-1297246. Epub 2012 Jan 25.

family: Chibbaro

full_name: S. Chibbaro

given: S.

family: Makiese

full_name: O. Makiese

given: O.

family: Bresson

full_name: D. Bresson

given: D.

family: Hamdi

full_name: S. Hamdi

family: Cornelius

full_name: J. Cornelius

given: J.

family: Guichard

full_name: J. Guichard

family: Reiss

full_name: A. Reiss

given: A.

family: Bouazza

full_name: S. Bouazza

full_name: E. Vicaut

given: E.

name: Department of Neurosurgery University Hospital of Aquila

family: Ricci

full_name: A. Ricci

family: Galzio

full_name: R. Galzio

given: R.

family: Poczos

full_name: P. Poczos

given: P.

family: George

full_name: B. George

given: B.

family: Marsella

full_name: M. Marsella

given: M.

family: Di Emidio

full_name: P. Di Emidio

journal_name: min - Minimally Invasive Neurosurgery

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

title: Skull Bone Flap Fixation – Reliability and Efficacy of a New Grip-Like Titanium Device (Skull Grip) versus Traditional Sutures: A Clinical Randomized Trial


title: Cost-effectiveness of Quantiferon Gold in VITRO Test of T-lymphocytic Response for Detection of Latent Tuberculosis in At-risk Healthcare Workers

acronym: QUANTIPS

summary: The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. We aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine to detect latent tuberculosis in exposed healthcare workers (HCWs)

ReferenceCitation: Lucet JC, Abiteboul D, Estellat C, Roy C, Chollet-Martin S, Tubach F, Carcelain G; QUANTIPS Study Group. Interferon-γ release assay vs. tuberculin skin test for tuberculosis screening in exposed healthcare workers: a longitudinal multicenter comparative study. Infect Control Hosp Epidemiol. 2015 May;36(5):569-74. doi: 10.1017/ice.2015.19. Epub 2015 Feb 16.

family: Lucet

full_name: Jean-Christophe Lucet

given: Jean-Christophe

family: Abiteboul

full_name: Dominique Abiteboul

family: Estellat

full_name: Candice Estellat

given: Candice

family: Roy

full_name: Carine Roy

given: Carine

family: Chollet-Martin

full_name: Sylvie Chollet-Martin

given: Sylvie

family: Tubach

full_name: Florence Tubach

given: Florence

family: Carcelain

full_name: Guislaine Carcelain

given: Guislaine

journal_name: Infection Control & Hospital Epidemiology

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

title: Interferon-γ Release Assay vs. Tuberculin Skin Test for Tuberculosis Screening in Exposed Healthcare Workers: A Longitudinal Multicenter Comparative Study


title: Assessment of the Diagnostic Capacity of a New Sampling Technique for Lower Respiratory Tract Culture for Patients With Acute Infectious Pneumonia Admitted in Intensive Care Unit and Non Intubated.

acronym: Mini-LBA

summary: The aim of this study is to develop a safe and effective technique to take sample for lower respiratory tract cultures easy to perform in conditions of acute respiratory failure and spontaneous ventilation for patients admitted in intensive care unit for acute infectious pneumonia and non intubated. The investigators perform sample collection with a mini bronchoalveolar lavage catheter introduced by nasotracheal way through a suction catheter. The purpose of the study is to assess the microbiological diagnostic capacity of this new technique.

ReferenceCitation: Meyer P, Rousseau H, Maillet JM, Thierry S, Sy O, Vicaut E, Thiolliere F, Choukroun G, Chergui K, Chevrel G, Maury E. Evaluation of blind nasotracheal suctioning and non-bronchoscopic mini-bronchoalveolar lavage in critically ill patients with infectious pneumonia: a preliminary study. Respir Care. 2014 Mar;59(3):345-52. doi: 10.4187/respcare.02356. Epub 2013 Jul 23.

family: Meyer

full_name: P. Meyer

family: Rousseau

full_name: H. Rousseau

given: H.

family: Maillet

full_name: J.-M. Maillet

family: Thierry

full_name: S. Thierry

family: Sy

full_name: O. Sy

family: Vicaut

family: Thiolliere

full_name: F. Thiolliere

given: F.

family: Choukroun

full_name: G. Choukroun

given: G.

family: Chergui

full_name: K. Chergui

given: K.

family: Chevrel

full_name: G. Chevrel

family: Maury

full_name: E. Maury

journal_name: Respiratory Care

oa_colors: green other

oa_host_type: publisher;repository

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

publisher_normalized: Daedalus Enterprises

title: Evaluation of Blind Nasotracheal Suctioning and Non-bronchoscopic Mini-Bronchoalveolar Lavage in Critically Ill Patients with Infectious Pneumonia: A Preliminary Study


title: Genetic Study of Families Affected by Paget's Disease of Bone

acronym: PAGET

summary:
Paget's disease of bone is a frequent bone disorder which usually starts after the age of 40 and which is characterized by bone pain and deformities. Although often without any symptoms, this disease may have severe complications such as fissures, fractures, neurological compression, or deafness. In some cases, it is a genetic disorder transmitted with a dominant autosomal pattern of inheritance: one of the two parents carrying the disease transmits it to his offspring with a risk of 50% for each child. Since 2002, the first gene involved in Paget's disease of bone is known and 14 mutations of this gene have been published. A study confirmed that the presence of those mutations was associated with younger age of onset and more extensive disease. Thus, the knowledge of those genetic factors in the relatives of an affected individual allows the screening of the patients with a higher risk for complications, who may benefit from a medical follow up and earlier treatment, in order to avoid complications. Indeed, Paget's disease of bone may be treated efficiently by bisphosphonates.

This project aims at identifying and collecting over one year, 15 affected individuals affected by Paget's disease of bone and the relatives up to the second degree of relativeness (a total of 100 individuals is expected). The blood samples may be analysed in order to search for mutations of the previously known gene and/or to search for new mutations on new genes.

time_perspective: Retrospective

ReferenceCitation: Collet C, Michou L, Audran M, Chasseigneaux S, Hilliquin P, Bardin T, Lemaire I, Cornélis F, Launay JM, Orcel P, Laplanche JL. Paget's disease of bone in the French population: novel SQSTM1 mutations, functional analysis, and genotype-phenotype correlations. J Bone Miner Res. 2007 Feb;22(2):310-7.

ReferenceCitation: Morissette J, Laurin N, Brown JP. Sequestosome 1: mutation frequencies, haplotypes, and phenotypes in familial Paget's disease of bone. J Bone Miner Res. 2006 Dec;21 Suppl 2:P38-44.


title: Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS

summary: Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

ReferenceCitation: Camilleri M, Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008 Dec;135(6):1877-91. doi: 10.1053/j.gastro.2008.09.005. Epub 2008 Oct 9. Review.

intervention_type: Dietary Supplement


title: Treatment by Anti GP IIb/IIIa in the Setting of a Strategy of Early Coronarography to Patients With an Acute Coronary Syndrome Without ST Elevation

acronym: SISCA

summary:
The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.

Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.

Design Multicentric, prospective, randomized study.

lead_sponsor: Hospital Avicenne


summary: A randomized trial comparing radiotherapy with supportive care in patients aged 70 years or older with newly diagnosed, histologically confirmed anaplastic astrocytoma or glioblastoma, and a Karnofsky performance status > 70.

ReferenceCitation: Keime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Meneï P, Loiseau H, Bernier V, Honnorat J, Barrié M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35.


title: MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine

summary: Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine

location_facility: Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie


summary: To assess the potential benefits on mechanical ventilation plateau pressure of pressure controlled mode versus volume controlled mode for laparoscopic bariatric surgery in obese patients (BMI > 35). High plateau pressures encountered in obese patients due to their reduced pulmonary compliance could be lowered using pressure controlled mechanical ventilation.

ReferenceCitation: Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.


title: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Syndrome: Assessment of Coloscopy With Chromoscopy Benefit

summary: The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.

ReferenceCitation: Mention JJ, Ben Ahmed M, Bègue B, Barbe U, Verkarre V, Asnafi V, Colombel JF, Cugnenc PH, Ruemmele FM, McIntyre E, Brousse N, Cellier C, Cerf-Bensussan N. Interleukin 15: a key to disrupted intraepithelial lymphocyte homeostasis and lymphomagenesis in celiac disease. Gastroenterology. 2003 Sep;125(3):730-45.


title: Management of Resistant Hypertension -Pharmacokinetic Assessment of Different Antihypertensive Regimen -Comparison of Two Treatment Strategies: Increase Sodium Depletion or Combined Blockage of Renin-angiotensin System (RAS)

summary: The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.

ReferenceCitation: Mendes M, Dubourg J, Blanchard A, Bergerot D, Courand PY, Forni V, Frank M, Bobrie G, Menard J, Azizi M. Copeptin is increased in resistant hypertension. J Hypertens. 2016 Dec;34(12):2458-2464.

ReferenceCitation: Frank M, Peyrard S, Bobrie G, Azizi M. Method of mean value calculation as an additional source of variability in ambulatory blood pressure measurement. Am J Hypertens. 2010 Jul;23(7):725-31. doi: 10.1038/ajh.2010.47. Epub 2010 Mar 25.

family: Frank

full_name: M. Frank

family: Peyrard

full_name: S. Peyrard

given: S.

family: Bobrie

full_name: G. Bobrie

family: Azizi

full_name: M. Azizi

journal_name: American Journal of Hypertension

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Method of Mean Value Calculation as an Additional Source of Variability in Ambulatory Blood Pressure Measurement

location_facility: Investigation Clinical Center European Georges Pompidou Hospital


title: The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"

summary: Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are difficult to early diagnose, and are life-threatening. Historical trials have shown a small benefit of survival when this strategy is used. According to the drug usde for this strategy, safety and costs may be concerns. However, since this routine practice has been implemented in hematology, new non-invasive biological diagnostic methods are available to early diagnose fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study is to show that limiting the administration of antifungals in this setting to patients with clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of patients treated with chemotherapy for hematologic malignancies.

ReferenceCitation: Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. Epub 2002 Feb 13.