title: The Role of the GP in the Management of Ambulatory Heart Failure

acronym: GPsHF

summary: To describe the causes mentioned by general practitioners, explaining the under-treatment of the three main treatments for heart failure with impaired ejection fraction (ARS blockers of the type ACEinhibitor/ARA2/ARNi, ß- and/or anti-aldosterone).

lead_sponsor: Jean-Marc BOIVIN


title: Evaluation of the Hemodynamic Stability of Potassium Canrenoate in Brain-dead Organ Donors: Randomized Controlled Clinical Trial

acronym: CANREO-PMO

summary:
Given the current organ shortage, improving the quality/efficacy of harvested grafts from expanded criteria donors is essential to substantially increase the number of potential donors. Preclinical studies have shown that blocking the vascular mineralocorticoid receptor (MR) mitigates ischemia-reperfusion injury (I/R) and prevents renal dysfunction following acute kidney injury. Potassium canrenoate is an intravenous MR antagonist. Blocking the MR upstream from aortic cross clamping is likely the most effective strategy to limit I/R injury.

Yet, brain-dead donors are prone to severe hemodynamic instability and polyuria. Consequently, this study seeks to assess the hemodynamic tolerance of the use of potassium canrenoate in this context, as a first step to a large-scale clinical trial testing the impact of this therapeutic intervention on the survival of kidney grafts.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: Pr. Nicolas GIRERD

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Tracheobronchitis May Constitute the Main Sign of Respiratory Involvement on the Lung SPECT/CT Images of COVID-19 Patients

summary: Tracheobronchitis signs may be observed on ventilation lung scintigraphy during COVID-19 infection. This case report study aimed to analyze the rates and associated factors of such tracheobronchitis in COVID-19 patients referred to ventilation/perfusion lung scintigraphy with shortness of breath, suspected of pulmonary embolism.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Pierre Yves MARIE

status_simplified: Completed


title: Prognostic Value of Low Irradiation Cardiac Stress Perfusion Scans

acronym: PROSPERCARS

summary:
Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices.

Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments.

The implications are unknown in terms of the risk of death of the different parameters studied

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: No


title: OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

acronym: OBSTINATE

summary: This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Dufrost V, Risse J, Reshetnyak T, Satybaldyeva M, Du Y, Yan XX, Salta S, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018 Oct;17(10):1011-1021. doi: 10.1016/j.autrev.2018.04.009. Epub 2018 Aug 11. Review.

ReferenceCitation: Dufrost V, Risse J, Wahl D, Zuily S. Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Response to Comment. Curr Rheumatol Rep. 2017 Aug;19(8):52. doi: 10.1007/s11926-017-0676-2.

ipd_sharing: Undecided

lead_sponsor: Stéphane Zuily


type: Other Identifier

title: Early (4 Days) Versus Standard Drainage Removal of the Abdominal Cavity After Pancreaticoduodenectomy- - A Randomized Multicenter Study

summary:
Around two thousand pancreaticoduodenectomy (PD) are performed each year in France. This intervention is associated with a high rate of postoperative complications including:

pancreatic fistulas (PF);
surgical site infections (intra-abdominal abscess, wound infection);
delayed gastric emptying (gastroparesis);
and hemorrhage.

The incidence of SSI (superficial and deep) is about 35% and seems influenced by the prolonged intra-abdominal drainage. For several years, there has been a global trend to reduce the use of abdominal drainage after abdominal surgery. Several randomized clinical trials have shown that prophylactic drainage does not decrease the incidence of postoperative complications during elective hepatectomy, colectomy, and cholecystectomy and could increase the number of SSI. However, the role of prophylactic drainage after PD is so far unclear.

The aim of this prospective randomized multicenter study is to evaluate the influence of early (4 days) versus standard (10 to 15 days, depending on the staff clinical practice) drainage removal of the abdominal cavity after PD, on the rate of SSI.

Materials and Methods: The technique of PD is left at the discretion of the operator as well as the prescription of analogues of somatostatin. Drainage of the abdominal cavity is made of one or two round silicone close suction drains or open multichannel silicone drains placed in the vicinity of the pancreatic and biliary anastomosis. Shall be excluded patients operated on for chronic pancreatitis and patients who underwent preoperative radiotherapy. The 3rd postoperative day, a fistula is sought clinically, biologically and on CT-scanner images. In case of pancreatic fistula, the patient is excluded from randomization and drainage of the abdominal cavity is left in place depending on the different teams' practice. Patients without fistula are randomized to either drainage removal 4 days after surgery (D4) or standard drainage.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Régional Universitaire Claude Huriez

intervention_type: Procedure

lead_sponsor_type: academique


title: Prospective, Open-label, Single Arm Pilot Study Evaluating the Effect on Virological Response of the Switch From Tacrolimus to Cyclosporin Associated With a Peginterferon Alfa-2a / Ribavirin Bitherapy, in Non-responder or With Recurrent VHC+ Disease Liver Transplanted Patients.

summary: In France, 50% of hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation and recurrence causes chronic liver disease in 50 to 80% of cases. The aim of this study is to assess the efficacy of cyclosporin on C virological response. Patients included in the Transpeg 1 study and non-responder or with a recurrent disease will be switched from their tacrolimus therapy to cyclosporin, in association with a 1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Rennes University Hospital

location_facility: Service des Maladies du Foie - Hôpital Pontchaillou

location_facility: Service d'Hépato-gastro-entérologie - Hôpital de Rangueil

location_facility: Service d'Hépatologie et Gastroentérologie - CH Henri Mondor

location_facility: Service de Chirurgie Générale - Hôpital Edouard Herriot

location_facility: Service de Chirurgie Générale - Hôpital Cochin

location_facility: Centre Hépato-Biliaire - Hôpital Paul Brousse

location_facility: Chirurgie Viscérale et Digestive - Hôpital de l'Archet

location_facility: Service d'Hépatogastroentérologie - Hôpital Beaujon

location_facility: Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre

location_facility: Service d'Hépatologie - Hôpital Jean Minjoz

location_facility: Chirurgie Générale - Hôpital de la Conception

location_facility: Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez

location_facility: Service d'Hépato-gastro-entérologie - Hôpital Saint Eloi

status_simplified: Unknown


title: Quality of Life and Cancers in Nursing Homes

acronym: QUALICE

summary:
Quality of life (QOL) of nursing homes residents with cancer in France is not known. High prevalence of neurodegenerative diseases makes it difficult. It was found that oncological management is suboptimal among Poitevin territory residents. Publications report an inadequate management of symptoms of discomfort related to cancers.

The multicentric study will comparate quality of life in patients with and without Cancers in nursing homes, including residents with neurodegenerative disease, using validated questionnaires. These questionnaires, as well as pain evaluation, will be carried out by a geriatric consultations' nurse.

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Drageset J, Corbett A, Selbaek G, Husebo BS. Cancer-related pain and symptoms among nursing home residents: a systematic review. J Pain Symptom Manage. 2014 Oct;48(4):699-710.e1. doi: 10.1016/j.jpainsymman.2013.12.238. Epub 2014 Apr 3. Review.

family: Drageset

full_name: Jorunn Drageset

given: Jorunn

sequence: first

family: Corbett

full_name: Anne Corbett

given: Anne

sequence: additional

family: Selbaek

full_name: Geir Selbaek

given: Geir

family: Husebo

full_name: Bettina S. Husebo

given: Bettina S.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Pain and Symptom Management

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Cancer-Related Pain and Symptoms Among Nursing Home Residents: A Systematic Review

ReferenceCitation: Novella JL, Dhaussy G, Wolak A, Morrone I, Drame M, Blanchard F, Jolly D. [Quality of life in dementia: state of the knowledge]. Geriatr Psychol Neuropsychiatr Vieil. 2012 Dec;10(4):365-72. doi: 10.1684/pnv.2012.0375. Review. French.

family: Novella

full_name: Jean-Luc Novella

given: Jean-Luc

family: Dhaussy

full_name: Gaëlle Dhaussy

given: Gaëlle

family: Wolak

full_name: Aurore Wolak

given: Aurore

family: Morrone

full_name: Isabella Morrone

given: Isabella

family: Drame

full_name: Moustapha Drame

given: Moustapha

family: Blanchard

full_name: François Blanchard

given: François

family: Jolly

full_name: Damien Jolly

given: Damien

journal_name: Gériatrie et Psychologie Neuropsychiatrie du Viellissement

publisher: John Libbey Eurotext

publisher_dissemination: John Libbey Eurotext

publisher_group: John Libbey Eurotext

publisher_normalized: John Libbey Eurotext

ReferenceCitation: Leplège A, Perret-Guillaume C, Ecosse E, Hervy MP, Ankri J, von Steinbüchel N. [A new instrument to measure quality of life in older people: The French version of the WHOQOL-OLD]. Rev Med Interne. 2013 Feb;34(2):78-84. doi: 10.1016/j.revmed.2012.07.011. Epub 2012 Dec 23. French.

family: Leplège

full_name: A. Leplège

given: A.

family: Perret-Guillaume

full_name: C. Perret-Guillaume

given: C.

family: Ecosse

full_name: E. Ecosse

given: E.

family: Hervy

full_name: M.-P. Hervy

family: Ankri

full_name: J. Ankri

given: J.

family: von Steinbüchel

full_name: N. von Steinbüchel

given: N.

title: Un nouvel instrument destiné à mesurer la qualité de vie des personnes âgées : le WHOQOL-OLD version française

ReferenceCitation: Wheelwright S, Darlington AS, Fitzsimmons D, Fayers P, Arraras JI, Bonnetain F, Brain E, Bredart A, Chie WC, Giesinger J, Hammerlid E, O'Connor SJ, Oerlemans S, Pallis A, Reed M, Singhal N, Vassiliou V, Young T, Johnson C. International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer. 2013 Aug 20;109(4):852-8. doi: 10.1038/bjc.2013.407. Epub 2013 Jul 18.

name: on behalf of the EORTC Quality of Life Group

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repository_institution: Aberdeen University - Aberdeen University Research Archive

location_facility:
Fecamp HC
Rouen UH
Amiens UH
Pasteur HC
Saint Quentin HC
Caen UH


title: Effect of Lithium in Patients With Autism Spectrum Disorder and Phelan-McDermid Syndrome (SHANK3 Haploinsufficiency): Pilot Study.

acronym: Lisphem

summary: There is currently no treatment for the body symptoms of Autism Spectrum Disorders (ASD). However, basic research suggests that some forms of ASD may be alleviated, even in the adult stage. The genes involved in ASDs particularly impact synaptic homeostasis. Specific clinical trials in patients with synaptic mutations need to be carried out. In this spirit, patients with deleterious mutations in SHANK3 represent a paradigm. The induced pluripotent stem cells (iPSc) carrying SHANK3 mutations and derived in neurons, can be used for high-throughput screening of pharmacological substances and allow the identification of compounds that can restore the expression level of SHANK3. The objective of this proposed project is to test one of the compounds identified by research on these iPSc as a novel treatment for social communication deficit in patients with deleterious mutations in SHANK3. Its effect on the symptoms of the social deficit could represent a new perspective for other forms of idiopathic autism.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder

acronym: ULENAP

summary: The aim of this study is to evaluate different devices to quantify upper limb function (Motriplate) and strength (Myogrip, Myopinch) in non-ambulatory patients with neuromuscular disorder. Motriplate measures the ability of the patient to reproduce a repetitive movement of the wrist to push two 5cm*5cm targets during 30 seconds. One hundred patients aged 8-30 years and 60 controls will be evaluated during twelve months (M0, M6 and M12) with theses new tools, and results will be compared to other testing, such as wrist, grip and pinch strength, taping, MFM measurement, and self evaluation of hand ability.

primary_purpose: Other

ReferenceCitation: Mercuri E, Mayhew A, Muntoni F, Messina S, Straub V, Van Ommen GJ, Voit T, Bertini E, Bushby K; TREAT-NMD Neuromuscular Network. Towards harmonisation of outcome measures for DMD and SMA within TREAT-NMD; report of three expert workshops: TREAT-NMD/ENMC workshop on outcome measures, 12th--13th May 2007, Naarden, The Netherlands; TREAT-NMD workshop on outcome measures in experimental trials for DMD, 30th June--1st July 2007, Naarden, The Netherlands; conjoint Institute of Myology TREAT-NMD meeting on physical activity monitoring in neuromuscular disorders, 11th July 2007, Paris, France. Neuromuscul Disord. 2008 Nov;18(11):894-903. doi: 10.1016/j.nmd.2008.07.003. Epub 2008 Sep 24.

ReferenceType: derived

ReferenceCitation: Seferian AM, Moraux A, Canal A, Decostre V, Diebate O, Le Moing AG, Gidaro T, Deconinck N, Van Parys F, Vereecke W, Wittevrongel S, Annoussamy M, Mayer M, Maincent K, Cuisset JM, Tiffreau V, Denis S, Jousten V, Quijano-Roy S, Voit T, Hogrel JY, Servais L. Upper limb evaluation and one-year follow up of non-ambulant patients with spinal muscular atrophy: an observational multicenter trial. PLoS One. 2015 Apr 10;10(4):e0121799. doi: 10.1371/journal.pone.0121799. eCollection 2015.

family: Seferian

full_name: Andreea Mihaela Seferian

given: Andreea Mihaela

family: Moraux

full_name: Amélie Moraux

given: Amélie

family: Canal

full_name: Aurélie Canal

given: Aurélie

family: Decostre

full_name: Valérie Decostre

given: Valérie

family: Diebate

full_name: Oumar Diebate

given: Oumar

family: Le Moing

full_name: Anne Gaëlle Le Moing

given: Anne Gaëlle

family: Gidaro

full_name: Teresa Gidaro

given: Teresa

family: Deconinck

full_name: Nicolas Deconinck

given: Nicolas

family: Van Parys

full_name: Frauke Van Parys

given: Frauke

family: Vereecke

full_name: Wendy Vereecke

given: Wendy

family: Wittevrongel

full_name: Sylvia Wittevrongel

given: Sylvia

family: Annoussamy

full_name: Mélanie Annoussamy

given: Mélanie

family: Mayer

full_name: Michèle Mayer

given: Michèle

family: Maincent

full_name: Kim Maincent

given: Kim

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Tiffreau

full_name: Vincent Tiffreau

given: Vincent

family: Denis

full_name: Severine Denis

given: Severine

family: Jousten

full_name: Virginie Jousten

given: Virginie

family: Quijano-Roy

full_name: Susana Quijano-Roy

given: Susana

family: Voit

full_name: Thomas Voit

given: Thomas

family: Hogrel

full_name: Jean-Yves Hogrel

given: Jean-Yves

family: Servais

full_name: Laurent Servais

given: Laurent

currency_apc_doaj: USD

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

title: Upper Limb Evaluation and One-Year Follow Up of Non-Ambulant Patients with Spinal Muscular Atrophy: An Observational Multicenter Trial

ReferenceCitation: Seferian AM, Moraux A, Annoussamy M, Canal A, Decostre V, Diebate O, Le Moing AG, Gidaro T, Deconinck N, Van Parys F, Vereecke W, Wittevrongel S, Mayer M, Maincent K, Desguerre I, Thémar-Noël C, Cuisset JM, Tiffreau V, Denis S, Jousten V, Quijano-Roy S, Voit T, Hogrel JY, Servais L. Upper limb strength and function changes during a one-year follow-up in non-ambulant patients with Duchenne Muscular Dystrophy: an observational multicenter trial. PLoS One. 2015 Feb 2;10(2):e0113999. doi: 10.1371/journal.pone.0113999. eCollection 2015.

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

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

repository_institution: University of Illinois at Chicago - INDIGO

title: Upper Limb Strength and Function Changes during a One-Year Follow-Up in Non-Ambulant Patients with Duchenne Muscular Dystrophy: An Observational Multicenter Trial

location_facility:
Necker
Trousseau
Institut de Myologie
Hôpital Raymond Poincare


type: Registry Identifier

title: Glytactin EfficiEncy in Non or Insufficiently Treated Adult PHENylketonuria Patients

acronym: GLEEPHEN

summary: Phenylketonuria is the most common inherited metabolic disease in France and is screened for neonatal exposure. Management consists of a strict and restrictive hypoproteic diet and the intake of amino acid substitutes and dietary supplements free of phenylalanine.One of the major difficulties, which is the source of many treatment failures, is the inappetence of the amino acid supplements required during a strict hypoproteic diet. New formulations, Glycomacropeptides (GMP), have recently appeared and are considered more palatable than conventional amino acid mixtures.

lead_sponsor: University Hospital, Tours

location_facility: CHU de LILLE-Hôpital Claude HURIEZ-Service d'Endocrinologie

location_facility: CHU du Morvan-Département de Pédiatrie et génétique médicale,

location_facility: Hôpital Femme-Mère-Enfant-Centre de Référence des Maladies Héréditaires du Métabolisme de Lyon

location_facility: CHU-Service de Réanimation Pédiatrique / Néonatalogie, Consultation spécialisée en Maladies Héréditaires du Métabolisme

location_facility: CHRU-Hôpital Bretonneau - Service de Médecine Interne-Nutrition

location_facility: CHU-RENNES-Hôpital Sud-Service de Génétique-Clinique

intervention_type: Dietary Supplement


title: A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System

summary:
Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.

The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.

status: Active, not recruiting

lead_sponsor: Biosensors Europe SA

location_facility:
CHU Toulouse Rangeuil
Clinique Des Dômes
Clinique Saint Martin
at Hôpital Privé Claude Galien ICPS
Clinique de Fontaine
Centre Hospitalier General


title: INVIBO: Evaluation of the Feasibility and Tolerance of an Intubation Procedure Performed by Means of the Bonfils Fiberscope in Awake Patients With Predicted Difficult Intubation in the Context of ENT Cancer Surgery

acronym: INVIBO

summary:
The Bonfils intubation fiberscope (BF), a rigid medical device with a curved tip, is exclusively used in anesthesiology for orotracheal intubation (OTI). The objective of the study was to evaluate the feasibility and the tolerance of an intubation procedure realized by means of the BF (BFI) in awake adult patients with predicted difficult intubation (PDI), in the context of ENT cancer surgery.

The intubation is performed under local anesthesia (either nasal, oral, or intercricothyroidal) and sedation using Remifentanyl (AIVOC) with spontaneous ventilation. The primary endpoint is the rate of BFI meeting quality requirements: the procedure must be both successful (≤ 2 attempts and duration < 180 sec) and well tolerated (Fahey score < 2). The secondary endpoints include the difficulties met by the operator during the BFI and patient's perception of the intubation procedure, evaluated in the recovery room and 7 days after the intervention. Sample size is calculated using a one-stage Fleming design with p0=80%, p1=95%, alpha=5% and 80% power, for a total of 32 evaluable patients.

ReferenceCitation: Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. Review. Erratum in: Anesthesiology 1993 Jan;78(1):224.

ReferenceCitation: Arné J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Ariès J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6.

ReferenceCitation: Boisson-Bertrand D, Bourgain JL, Camboulives J, Crinquette V, Cros AM, Dubreuil M, Eurin B, Haberer JP, Pottecher T, Thorin D, Ravussin P, Riou B. [Difficult intubation. French Society of Anesthesia and Intensive Care. A collective expertise]. Ann Fr Anesth Reanim. 1996;15(2):207-14. French.

ReferenceCitation: Halligan M, Charters P. A clinical evaluation of the Bonfils Intubation Fibrescope. Anaesthesia. 2003 Nov;58(11):1087-91.

ReferenceCitation: Bein B, Worthmann F, Scholz J, Brinkmann F, Tonner PH, Steinfath M, Dörges V. A comparison of the intubating laryngeal mask airway and the Bonfils intubation fibrescope in patients with predicted difficult airways. Anaesthesia. 2004 Jul;59(7):668-74.

ReferenceCitation: Bein B, Yan M, Tonner PH, Scholz J, Steinfath M, Dörges V. Tracheal intubation using the Bonfils intubation fibrescope after failed direct laryngoscopy. Anaesthesia. 2004 Dec;59(12):1207-9.

ReferenceCitation: Fahey MR, Morris RB, Miller RD, Sohn YJ, Cronnelly R, Gencarelli P. Clinical pharmacology of ORG NC45 (NorcuronTM): a new nondepolarizing muscle relaxant. Anesthesiology. 1981 Jul;55(1):6-11.

ReferenceCitation: Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.

ReferenceCitation: Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.

ReferenceCitation: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9.

ReferenceCitation: Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34.

ReferenceCitation: Loh KS, Irish JC. Traumatic complications of intubation and other airway management procedures. Anesthesiol Clin North Am. 2002 Dec;20(4):953-69. Review.

ReferenceCitation: Mazères JE, Lefranc A, Cropet C, Steghens A, Bachmann P, Pérol O, Rosay H. Evaluation of the Bonfils intubating fibrescope for predicted difficult intubation in awake patients with ear, nose and throat cancer. Eur J Anaesthesiol. 2011 Sep;28(9):646-50. doi: 10.1097/EJA.0b013e3283495b85.

family: Mazères

full_name: Jean E. Mazères

given: Jean E.

family: Lefranc

full_name: Anne Lefranc

given: Anne

family: Cropet

full_name: Claire Cropet

given: Claire

family: Steghens

full_name: Aline Steghens

given: Aline

family: Bachmann

full_name: Patrick Bachmann

given: Patrick

family: Pérol

full_name: Olivia Pérol

given: Olivia

family: Rosay

full_name: Hervé Rosay

given: Hervé

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Centre Leon Berard

intervention_type: Device


title: Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)

acronym: EVACO

summary: Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.

primary_purpose: Diagnostic

lead_sponsor: Versailles Hospital

location_facility:
Hôpital Henri Mondor
Hôpital Louis Mourier
CHU de Clermont Ferrand
CHU de Strasbourg
CHRU de Montpellier
Centre Hospitalier de Versailles
Hôpital Sainte Marguerite
Centre Hospitalier Alpes Isère

intervention_type: Behavioral


title: Multicenter Protocol in Treating Patients With Childhood Acute Myeloid Leukemia. Randomized Study of Maintenance Treatment With Interleukin-2

summary: The purpose of this study is to evaluate the interest of maintenance treatment with interleukin-2 by randomizing the patients being not allogeneic transplanted in complete remission after induction and consolidation chemotherapy concerning the event free survival.

status: Unknown status

ReferenceCitation: Lie SO, Jonmundsson G, Mellander L, Siimes MA, Yssing M, Gustafsson G. A population-based study of 272 children with acute myeloid leukaemia treated on two consecutive protocols with different intensity: best outcome in girls, infants, and children with Down's syndrome. Nordic Society of Paediatric Haematology and Oncology (NOPHO). Br J Haematol. 1996 Jul;94(1):82-8.

ReferenceCitation: Wells RJ, Woods WG, Buckley JD, Odom LF, Benjamin D, Bernstein I, Betcher D, Feig S, Kim T, Ruymann F, et al. Treatment of newly diagnosed children and adolescents with acute myeloid leukemia: a Childrens Cancer Group study. J Clin Oncol. 1994 Nov;12(11):2367-77.

ReferenceCitation: Lipshultz SE, Colan SD, Gelber RD, Perez-Atayde AR, Sallan SE, Sanders SP. Late cardiac effects of doxorubicin therapy for acute lymphoblastic leukemia in childhood. N Engl J Med. 1991 Mar 21;324(12):808-15.

ReferenceCitation: Mertens AC, Wen W, Davies SM, Steinbuch M, Buckley JD, Potter JD, Robison LL. Congenital abnormalities in children with acute leukemia: a report from the Children's Cancer Group. J Pediatr. 1998 Nov;133(5):617-23.

ReferenceCitation: Krischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE. Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol. 1997 Apr;15(4):1544-52.

ReferenceCitation: Béhar C, Suciu S, Benoit Y, Robert A, Vilmer E, Boutard P, Bertrand Y, Lutz P, Ferster A, Tokaji E, Manel AM, Solbu G, Otten J. Mitoxantrone-containing regimen for treatment of childhood acute leukemia (AML) and analysis of prognostic factors: results of the EORTC Children Leukemia Cooperative Study 58872. Med Pediatr Oncol. 1996 Mar;26(3):173-9.

ReferenceCitation: Burnett AK, Goldstone AH, Stevens RM, Hann IM, Rees JK, Gray RG, Wheatley K. Randomised comparison of addition of autologous bone-marrow transplantation to intensive chemotherapy for acute myeloid leukaemia in first remission: results of MRC AML 10 trial. UK Medical Research Council Adult and Children's Leukaemia Working Parties. Lancet. 1998 Mar 7;351(9104):700-8.

ReferenceCitation: Byrd JC, Dodge RK, Carroll A, Baer MR, Edwards C, Stamberg J, Qumsiyeh M, Moore JO, Mayer RJ, Davey F, Schiffer CA, Bloomfield CD. Patients with t(8;21)(q22;q22) and acute myeloid leukemia have superior failure-free and overall survival when repetitive cycles of high-dose cytarabine are administered. J Clin Oncol. 1999 Dec;17(12):3767-75.

ReferenceCitation: Cortes JE, Kantarjian HM, O'Brien S, Giles F, Keating MJ, Freireich EJ, Estey EH. A pilot study of interleukin-2 for adult patients with acute myelogenous leukemia in first complete remission. Cancer. 1999 Apr 1;85(7):1506-13. Review.

ReferenceCitation: Creutzig U, Ritter J, Zimmermann M, Reinhardt D, Hermann J, Berthold F, Henze G, Jürgens H, Kabisch H, Havers W, Reiter A, Kluba U, Niggli F, Gadner H. Improved treatment results in high-risk pediatric acute myeloid leukemia patients after intensification with high-dose cytarabine and mitoxantrone: results of Study Acute Myeloid Leukemia-Berlin-Frankfurt-Münster 93. J Clin Oncol. 2001 May 15;19(10):2705-13.

ReferenceCitation: Foa R, Caretto P, Fierro MT, Bonferroni M, Cardona S, Guarini A, Lista P, Pegoraro L, Mandelli F, Forni G, et al. Interleukin 2 does not promote the in vitro and in vivo proliferation and growth of human acute leukaemia cells of myeloid and lymphoid origin. Br J Haematol. 1990 May;75(1):34-40.

ReferenceCitation: Leblanc T, Berger R. Molecular cytogenetics of childhood acute myelogenous leukaemias. Eur J Haematol. 1997 Jul;59(1):1-13. Review.

ReferenceCitation: Maraninchi D, Blaise D, Viens P, Brandely M, Olive D, Lopez M, Sainty D, Marit G, Stoppa AM, Reiffers J, et al. High-dose recombinant interleukin-2 and acute myeloid leukemias in relapse. Blood. 1991 Nov 1;78(9):2182-7.

ReferenceCitation: Meloni G, Foa R, Vignetti M, Guarini A, Fenu S, Tosti S, Tos AG, Mandelli F. Interleukin-2 may induce prolonged remissions in advanced acute myelogenous leukemia. Blood. 1994 Oct 1;84(7):2158-63.

ReferenceCitation: Michel G, Leverger G, Leblanc T, Nelken B, Baruchel A, Landman-Parker J, Thuret I, Bergeron C, Bordigoni P, Esperou-Bourdeau H, Perel Y, Vannier JP, Schaison G. Allogeneic bone marrow transplantation vs aggressive post-remission chemotherapy for children with acute myeloid leukemia in first complete remission. A prospective study from the French Society of Pediatric Hematology and Immunology (SHIP). Bone Marrow Transplant. 1996 Feb;17(2):191-6.

ReferenceCitation: Michel G, Baruchel A, Tabone MD, Nelken B, Leblanc T, Thuret I, Bordigoni P, Bergeron C, Esperou-Bourdeau H, Perel Y, Vannier JP, De Lumley L, Dommergues JP, Lamagnère JP, Couillaud G, Auvrignon A, Schaison G, Leverger G. Induction chemotherapy followed by allogeneic bone marrow transplantation or aggressive consolidation chemotherapy in childhood acute myeloblastic leukemia. A prospective study from the French Society of Pediatric Hematology and Immunology (SHIP). Hematol Cell Ther. 1996 Apr;38(2):169-76.

ReferenceCitation: Oshimi K, Oshimi Y, Akutsu M, Takei Y, Saito H, Okada M, Mizoguchi H. Cytotoxicity of interleukin 2-activated lymphocytes for leukemia and lymphoma cells. Blood. 1986 Oct;68(4):938-48.

ReferenceCitation: Perel Y, Auvrignon A, Leblanc T, Vannier JP, Michel G, Nelken B, Gandemer V, Schmitt C, Lamagnere JP, De Lumley L, Bader-Meunier B, Couillaud G, Schaison G, Landman-Parker J, Thuret I, Dalle JH, Baruchel A, Leverger G; Group LAME of the French Society of Pediatric Hematology and Immunology. Impact of addition of maintenance therapy to intensive induction and consolidation chemotherapy for childhood acute myeloblastic leukemia: results of a prospective randomized trial, LAME 89/91. Leucámie Aiqüe Myéloïde Enfant. J Clin Oncol. 2002 Jun 15;20(12):2774-82.

ReferenceCitation: Wells RJ, Woods WG, Lampkin BC, Nesbit ME, Lee JW, Buckley JD, Versteeg C, Hammond GD. Impact of high-dose cytarabine and asparaginase intensification on childhood acute myeloid leukemia: a report from the Childrens Cancer Group. J Clin Oncol. 1993 Mar;11(3):538-45.


title: Impact of an Adapted Physical Activity Program on Event-free Survival in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line

acronym: PHARAOM

summary:
Diffuse large B cell lymphoma is the most common histology of non-Hodgkin's malignant lymphomas (31% of lymphomas), with an incidence of between 15 and 20 new cases per year per 100,000 inhabitants in France. The median age is 65 and a third of patients are over 75 years old. 60% of patients are cured after a standard regimen of chemotherapy with RCHOP; 40% of patients will, however, relapse. No other regimen has shown improvement in overall survival, but poor prognosis factors have been identified. Beyond these factors, other prognostic factors can impact overall and progression-free survival: sarcopenia, nutritional status disorders Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it.

The positive impact of adapted physical activity has been shown in numerous publications on reducing the incidence and risk of relapse for certain cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on adapted physical activity . Adapted physical activity seems to provide a survival benefit in diffuse large cell B lymphoma however the number remains too low in this histology.

Sarcopenia is an often-underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.

Correcting sarcopenia through appropriate physical activity could reduce its negative prognostic impact.

The aim of the study is to increase the event-free survival of patients in the RCHOP and adapted physical activity arm by 15% compared to the standard arm.

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo / Centre Jean Bernard

intervention_type: Other


title: Economic Medical Evaluation of Treatment of the Neuropathic Pain Rebel by Cortical Stimulation

summary: All neuropathic chronicle pains are difficult to treat. Currently many patients are not relieved by electric stimulations of central nervous system, existing. Recently cortical stimulation had a development important and benefit effects are proven. In this study we evaluate medico-economic impact of this treatment.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Neurosurgery - Henri Mondor Hospital
Clermont-Ferrand UH


title: Evaluation of the Impact of Lung and Diaphragm Ultrasound Findings on Clinical Decisions for Chest Physiotherapy in Patients Hospitalized in Intensive Care Units

acronym: US-ADEPT

summary:
Introduction: Physiotherapist usually uses a clinical examination, including auscultation, an analysis of blood gasses and chest imaging to determine the indication for chest physiotherapy, to choose the treatment protocol and evaluate the efficacy of the management. Lung ultrasound (LUS) presents greater accuracy than chest X-ray in the diagnosis of lung deficiencies interesting the physiotherapist. So, it could allow the physiotherapist to determine the indication for chest physiotherapy and thus avoid unnecessary or inappropriate treatments. No study has evaluated the impact of LUS on clinical decisions in chest physiotherapy in ICU patients.

Objective: To evaluate the impact of using the results of lung and diaphragm US on clinical decisions in chest physiotherapy in hypoxemic patients hospitalized in ICU.

Method: The physiotherapist carries out a clinical examination and analyses the complementary tests (chest X-ray, chest CT-scan and blood gasses if available). Following the examination, he will put forward one or several hypotheses concerning the respiratory deficiency and will confirm or not the indication for chest physiotherapy. If respiratory physiotherapy is indicated, the physiotherapist will specify the protocol.

A lung and diaphragm US will be done following the evaluation of the clinical physiotherapist, and will make it possible to answer the question: are the results of the lung and diaphragm US compatible with the hypotheses put forward? The LUS report will be given to the clinical physiotherapist. He will specify the respiratory physiotherapy protocol according to the results of the US-scan.

The modification of the clinical decision will be assessed with the Net Reclassification Index (NRI).

Expected results: We expect that decisions for chest physiotherapy will be modified by LUS. The expected benefit for patients is therefore that they will be given a chest physiotherapy protocol that is better suited to the type of respiratory deficiency they are suffering from.

ReferenceCitation: Xirouchaki N, Georgopoulos D. Impact of lung ultrasound on clinical decision making in critically ill patients: response to O'Connor et al. Intensive Care Med. 2014 Jul;40(7):1063. doi: 10.1007/s00134-014-3316-6. Epub 2014 May 6.

family: Xirouchaki

full_name: N. Xirouchaki

given: N.

family: Georgopoulos

full_name: D. Georgopoulos

given: D.

journal_name: Intensive Care Medicine

evidence: open (via free pdf)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Impact of lung ultrasound on clinical decision making in critically ill patients: response to O’Connor et al.

ReferenceCitation: Le Neindre A, Mongodi S, Philippart F, Bouhemad B. Thoracic ultrasound: Potential new tool for physiotherapists in respiratory management. A narrative review. J Crit Care. 2016 Feb;31(1):101-9. doi: 10.1016/j.jcrc.2015.10.014. Epub 2015 Oct 26. Review.

family: Le Neindre

full_name: Aymeric Le Neindre

given: Aymeric

family: Mongodi

full_name: Silvia Mongodi

given: Silvia

family: Philippart

full_name: François Philippart

given: François

family: Bouhemad

full_name: Bélaïd Bouhemad

given: Bélaïd

journal_name: Journal of Critical Care

ReferenceCitation: Leech M, Bissett B, Kot M, Ntoumenopoulos G. Lung ultrasound for critical care physiotherapists: a narrative review. Physiother Res Int. 2015 Jun;20(2):69-76. doi: 10.1002/pri.1607. Epub 2014 Dec 29. Review.

name: Physiotherapy DepartmentCanberra Hospital Garran Australian Capital Territory Australia

family: Leech

full_name: Maja Leech

given: Maja

name: Discipline of PhysiotherapyUniversity of Canberra Bruce Australian Capital Territory Australia

family: Bissett

full_name: Bernie Bissett

given: Bernie

name: Intensive Care UnitCanberra Hospital Garran Australian Capital Territory Australia

family: Kot

full_name: Marta Kot

given: Marta

name: Australian Catholic University Sydney New South Wales Australia

family: Ntoumenopoulos

full_name: George Ntoumenopoulos

given: George

journal_name: Physiotherapy Research International

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Lung Ultrasound for Critical Care Physiotherapists: A Narrative Review

ipd_sharing: Yes

ipd_sharing_description: The data that support the findings of this study will be openly available in "figshare".

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_country: Australia France

location_facility:
Groupe Hospitalier Paris Saint Joseph
St Vincent's Hospital
Hôpital Forcilles
CHU de Dijon

intervention_type: Diagnostic Test


title: Recurrence of Arrhythmias After Pulmonary Veins Isolation Detected by ICM

acronym: RAPID XT

summary:
Post Marketing study, Interventional, Prospective, non randomised

Describe how the MD is using the information of the ICM in addition of standard FU(clinical exam and holter 24h)post AF ablation(1 year FU).

lead_sponsor: Dr Ange FERRACCI


title: Redefining the Phenotypic Spectrum of Heart Failure With Preserved Ejection Fraction (HFpEF) by Deep Phenotyping and Machine Learning Methods: The PACIFIC-PRESERVED Study (PhenomApping, ClassIFication, and Innovation for Cardiac Dysfunction - HF With PRESERVED LVEF Study)

summary: This is a prospective multicenter study to decipher phenotypic variability within patients with heart failure and preserved left ventricular ejection fraction (HFpEF). From a registry of heart failure patients (2500 anticipated) hospitalized in the participating centers in the last 3 years, 300 HFpEF patients, 100 patients with heart failure and reduced ejection fraction (HFrEF) and 100 matched subjects without heart failure will be enrolled for an extensive phenotyping with physical evaluation, biomarkers and omics, cardiac and vascular imaging and telemonitoring of cardiovascular parameters. Cluster analysis with machine learning methods will be performed to define phenogroups unique to the HFpEF patient population.

ReferenceCitation: Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.

ReferenceCitation: De Peretti, et al. Prévalence et statut fonctionnel des cardiopathies ischémiques et de l'insuffisance cardiaque dans la population adulte en France : apports des enquêtes déclaratives " Handicap-Santé " BEH 2014; (9-10):172-81

ReferenceCitation: Galinier M, et al. Parcours de Soins. Dossier insuffisance cardiaque, encore trop d'hospitalisations pourtant évitables. État des lieux en France en 2013. Le Concours Médical 2013; 135(6):443-7

ReferenceCitation: Lindenfeld J, Albert NM, Boehmer JP et coll. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail 2010 ; 16 (6): e1-e194. - Arnold JM, Liu P, Demers C et coll. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management. Can J Cardiol 2006 ; 22 (1) : 23-45

ReferenceCitation: Blanc - SVSE 1 - Physiologie, physiopathologie, santé publique (Blanc SVSE 1) 2013

ReferenceCitation: Vasan RS, Levy D. The role of hypertension in the pathogenesis of heart failure. A clinical mechanistic overview. Arch Intern Med. 1996 Sep 9;156(16):1789-96. Review.

ReferenceCitation: Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007 Aug 21;50(8):768-77. Epub 2007 Aug 6.

ReferenceCitation: CDC statistics 2016; AHA Heart disease and stoke statistics 2017; European CVD statistics 2017 ; Dunlay S et al 2017 Nat Rev Cardiol

ReferenceCitation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20.

ReferenceCitation: Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.

name: From the RHJ Department of Veterans Affairs Medical Center and Medical University of South Carolina, Charleston, SC (M.R.Z., C.F.B.); University of Maryland Medical Center, Baltimore, MD (J.S.G.); University of Wisconsin School of Medicine and Public Health, Madison, WI (S.J.H.); British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UK (J.J.M.); Université Paris 6; Pitié Salpêtrière Hospital, Paris, France (M.K.); Hamilton Health Sciences, McMaster...

family: Zile

full_name: Michael R. Zile

given: Michael R.

family: Gottdiener

full_name: John S. Gottdiener

given: John S.

family: Hetzel

full_name: Scott J. Hetzel

given: Scott J.

family: McMurray

full_name: John J. McMurray

given: John J.

family: Komajda

full_name: Michel Komajda

given: Michel

family: McKelvie

full_name: Robert McKelvie

given: Robert

family: Baicu

full_name: Catalin F. Baicu

given: Catalin F.

family: Massie

full_name: Barry M. Massie

given: Barry M.

family: Carson

full_name: Peter E. Carson

given: Peter E.

journal_name: Circulation

oa_colors: green hybrid

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: Australian Catholic University - Research Bank

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

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

title: Prevalence and Significance of Alterations in Cardiac Structure and Function in Patients With Heart Failure and a Preserved Ejection Fraction

ReferenceCitation: Katz DH, Beussink L, Sauer AJ, Freed BH, Burke MA, Shah SJ. Prevalence, clinical characteristics, and outcomes associated with eccentric versus concentric left ventricular hypertrophy in heart failure with preserved ejection fraction. Am J Cardiol. 2013 Oct 15;112(8):1158-64. doi: 10.1016/j.amjcard.2013.05.061. Epub 2013 Jun 28.

ReferenceCitation: Lam CS, Roger VL, Rodeheffer RJ, Bursi F, Borlaug BA, Ommen SR, Kass DA, Redfield MM. Cardiac structure and ventricular-vascular function in persons with heart failure and preserved ejection fraction from Olmsted County, Minnesota. Circulation. 2007 Apr 17;115(15):1982-90. Epub 2007 Apr 2. Erratum in: Circulation. 2007 May 22;115(20):e535.

ReferenceCitation: Persson H, Lonn E, Edner M, Baruch L, Lang CC, Morton JJ, Ostergren J, McKelvie RS; Investigators of the CHARM Echocardiographic Substudy-CHARMES. Diastolic dysfunction in heart failure with preserved systolic function: need for objective evidence:results from the CHARM Echocardiographic Substudy-CHARMES. J Am Coll Cardiol. 2007 Feb 13;49(6):687-94. Epub 2007 Jan 26.

ReferenceCitation: Shah AM, Claggett B, Kitzman D, Biering-Sørensen T, Jensen JS, Cheng S, Matsushita K, Konety S, Folsom AR, Mosley TH, Wright JD, Heiss G, Solomon SD. Contemporary Assessment of Left Ventricular Diastolic Function in Older Adults: The Atherosclerosis Risk in Communities Study. Circulation. 2017 Jan 31;135(5):426-439. doi: 10.1161/CIRCULATIONAHA.116.024825. Epub 2016 Dec 7.

ReferenceCitation: Borbély A, van der Velden J, Papp Z, Bronzwaer JG, Edes I, Stienen GJ, Paulus WJ. Cardiomyocyte stiffness in diastolic heart failure. Circulation. 2005 Feb 15;111(6):774-81. Epub 2005 Feb 7.

ReferenceCitation: van Heerebeek L, Borbély A, Niessen HW, Bronzwaer JG, van der Velden J, Stienen GJ, Linke WA, Laarman GJ, Paulus WJ. Myocardial structure and function differ in systolic and diastolic heart failure. Circulation. 2006 Apr 25;113(16):1966-73. Epub 2006 Apr 17.

ReferenceCitation: Zile MR, Baicu CF, Ikonomidis JS, Stroud RE, Nietert PJ, Bradshaw AD, Slater R, Palmer BM, Van Buren P, Meyer M, Redfield MM, Bull DA, Granzier HL, LeWinter MM. Myocardial stiffness in patients with heart failure and a preserved ejection fraction: contributions of collagen and titin. Circulation. 2015 Apr 7;131(14):1247-59. doi: 10.1161/CIRCULATIONAHA.114.013215. Epub 2015 Jan 30.

ReferenceCitation: Adeniran I, MacIver DH, Hancox JC, Zhang H. Abnormal calcium homeostasis in heart failure with preserved ejection fraction is related to both reduced contractile function and incomplete relaxation: an electromechanically detailed biophysical modeling study. Front Physiol. 2015 Mar 20;6:78. doi: 10.3389/fphys.2015.00078. eCollection 2015.

ReferenceCitation: van Heerebeek L, Hamdani N, Falcão-Pires I, Leite-Moreira AF, Begieneman MP, Bronzwaer JG, van der Velden J, Stienen GJ, Laarman GJ, Somsen A, Verheugt FW, Niessen HW, Paulus WJ. Low myocardial protein kinase G activity in heart failure with preserved ejection fraction. Circulation. 2012 Aug 14;126(7):830-9. doi: 10.1161/CIRCULATIONAHA.111.076075. Epub 2012 Jul 17.

ReferenceCitation: Rommel KP, von Roeder M, Latuscynski K, Oberueck C, Blazek S, Fengler K, Besler C, Sandri M, Lücke C, Gutberlet M, Linke A, Schuler G, Lurz P. Extracellular Volume Fraction for Characterization of Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2016 Apr 19;67(15):1815-1825. doi: 10.1016/j.jacc.2016.02.018.

ReferenceCitation: Mohammed SF, Hussain S, Mirzoyev SA, Edwards WD, Maleszewski JJ, Redfield MM. Coronary microvascular rarefaction and myocardial fibrosis in heart failure with preserved ejection fraction. Circulation. 2015 Feb 10;131(6):550-9. doi: 10.1161/CIRCULATIONAHA.114.009625. Epub 2014 Dec 31.

ReferenceCitation: Kjekshus J, Apetrei E, Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007;357:2248-61. / Weber T, Auer J, O'Rourke MF, et al. Prolonged mechanical systole and increased arterial wave reflections in diastolic dysfunction. Heart 2006;92:1616-22 / Desai AS, Mitchell GF, Fang JC, et al. Central aortic stiffness is increased in patients with heart failure and preserved ejection fraction. J Card Fail 2009;15:658-64.

ReferenceCitation: Lam CS, Roger VL, Rodeheffer RJ, Borlaug BA, Enders FT, Redfield MM. Pulmonary hypertension in heart failure with preserved ejection fraction: a community-based study. J Am Coll Cardiol. 2009 Mar 31;53(13):1119-26. doi: 10.1016/j.jacc.2008.11.051.

ReferenceCitation: Kenchaiah S, Evans JC, Levy D, et al. Obesity and the risk of heart failure. N Engl J Med 2002; 347:305-13 / Ebong IA, Goff DC Jr., Rodriguez CJ, et al. The relationship between measures of obesity and incident heart failure: the multi-ethnic study of atherosclerosis. Obesity (Silver Spring) 2013;21: 1915-22 / Sundström J, Bruze G, Ottosson J, et al. Weight loss and heart failure: a nationwide study of gastric bypass surgery versus intensive lifestyle treatment. Circulation 2017;135:1577-85.

ReferenceCitation: Lainscak M, Anker SD. Heart failure, chronic obstructive pulmonary disease, and asthma: numbers, facts, and challenges. ESC Heart Fail. 2015 Sep;2(3):103-107. Epub 2015 Jul 31.

ReferenceCitation: Ather S, Chan W, Bozkurt B, Aguilar D, Ramasubbu K, Zachariah AA, Wehrens XH, Deswal A. Impact of noncardiac comorbidities on morbidity and mortality in a predominantly male population with heart failure and preserved versus reduced ejection fraction. J Am Coll Cardiol. 2012 Mar 13;59(11):998-1005. doi: 10.1016/j.jacc.2011.11.040.

ReferenceCitation: Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.

ReferenceCitation: Villemain O, Correia M, Mousseaux E, Baranger J, Zarka S, Podetti I, Soulat G, Damy T, Hagège A, Tanter M, Pernot M, Messas E. Myocardial Stiffness Evaluation Using Noninvasive Shear Wave Imaging in Healthy and Hypertrophic Cardiomyopathic Adults. JACC Cardiovasc Imaging. 2019 Jul;12(7 Pt 1):1135-1145. doi: 10.1016/j.jcmg.2018.02.002. Epub 2018 Mar 14.

apc_source: openAPC

family: Villemain

full_name: Olivier Villemain

given: Olivier

ipd_sharing_description: Individual participant data used for publication could be shared through scientific collaboration with the sponsor or any collaborations implied.The sharing will respect the unital consortium agreement.

location_facility: AP - HP, Hôpital Européen Georges-Pompidou


title: Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer

summary: An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.

status: No longer available

study_type: Expanded Access

ReferenceCitation: Costa Neves M, Giakoustidis A, Stamp G, Gaya A, Mudan S. Extended Survival after Complete Pathological Response in Metastatic Pancreatic Ductal Adenocarcinoma Following Induction Chemotherapy, Chemoradiotherapy, and a Novel Immunotherapy Agent, IMM-101. Cureus. 2015 Dec 26;7(12):e435. doi: 10.7759/cureus.435.

ReferenceCitation: Dalgleish AG, Stebbing J, Adamson DJ, Arif SS, Bidoli P, Chang D, Cheeseman S, Diaz-Beveridge R, Fernandez-Martos C, Glynne-Jones R, Granetto C, Massuti B, McAdam K, McDermott R, Martín AJ, Papamichael D, Pazo-Cid R, Vieitez JM, Zaniboni A, Carroll KJ, Wagle S, Gaya A, Mudan SS. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer. Br J Cancer. 2016 Oct 25;115(9):e16. doi: 10.1038/bjc.2016.342. Epub 2016 Oct 11.

family: Dalgleish

full_name: Angus G Dalgleish

given: Angus G

family: Stebbing

full_name: Justin Stebbing

given: Justin

family: Adamson

full_name: Douglas J A Adamson

given: Douglas J A

family: Arif

full_name: Seema Safia Arif

given: Seema Safia

family: Bidoli

full_name: Paolo Bidoli

given: Paolo

family: Chang

full_name: David Chang

given: David

family: Cheeseman

full_name: Sue Cheeseman

given: Sue

family: Diaz-Beveridge

full_name: Robert Diaz-Beveridge

family: Fernandez-Martos

full_name: Carlos Fernandez-Martos

given: Carlos

family: Glynne-Jones

full_name: Rob Glynne-Jones

given: Rob

family: Granetto

full_name: Cristina Granetto

given: Cristina

family: Massuti

full_name: Bartomeu Massuti

given: Bartomeu

family: McAdam

full_name: Karen McAdam

given: Karen

family: McDermott

full_name: Raymond McDermott

given: Raymond

family: Martín

full_name: Andrés J Muñoz Martín

given: Andrés J Muñoz

family: Papamichael

full_name: Demetris Papamichael

given: Demetris

family: Pazo-Cid

full_name: Roberto Pazo-Cid

given: Roberto

family: Vieitez

full_name: Jose M Vieitez

given: Jose M

family: Zaniboni

full_name: Alberto Zaniboni

given: Alberto

family: Carroll

full_name: Kevin J Carroll

given: Kevin J

family: Wagle

full_name: Shama Wagle

given: Shama

family: Gaya

full_name: Andrew Gaya

given: Andrew

family: Mudan

full_name: Satvinder S Mudan

given: Satvinder S

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

title: Erratum: Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer


type: Other Grant/Funding Number

title: Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults

acronym: DisCoVeRy

summary:
DisCoVeRy is a randomized controlled trial among adults (≥18-year-old) hospitalized for COVID-19. This study is an adaptive, randomized, open or blinded, depending on the drug to be evaluated, clinical trial to evaluate the safety and efficacy of possible therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. The study will compare different investigational therapeutic agents to a control group managed with the SoC including corticosteroids and anticoagulants. There will be interim monitoring to allow early stopping for safety and to introduce new therapies as they become available. If one therapy proves to be superior to others in the trial, this treatment may become part of the SoC for comparison(s) with new experimental treatment(s).

In previous versions of the DisCoVeRy protocol, remdesivir, lopinavir/ritonavir with or without interferon ß-1a and hydroxychloroquine were evaluated as potential treatments for COVID-19. These treatments have been discontinued based on analyses review by both DSMC/DSMB, the Solidarity Executive Group and the DisCoVeRy steering committee.

This version of the protocol, therefore, describes a randomized blinded placebo-controlled trial among adults (≥18-year-old) hospitalized for COVID-19 that randomly allocates them (1:1 ratio) between 2 arms: SoC + placebo versus SoC + AZD7442.

Randomization will be stratified by region (according to the administrative definition in each country), antigenic status (positive or negative) obtained from the result of a rapid antigen test on nasopharyngeal swab performed at enrolment and vaccination initiation (yes or no).

The primary analyses will be conducted on patients with antigen-positive results. A positive antigenic test is evidence of high viral shedding consistent with a recently started or uncontrolled infection. Overall, the number of antigen-negative patients will be at most 30% of all included subjects. The number of patients with vaccination (partly or fully) will be limited to 20% of all participants, split evenly between antigen positive and antigen negative patients (i.e. vaccinated patients can make up at most 20% of antigene positive patients and 20% of antigene negative patients). Sensitivity analyses will be performed in all patients, stratified by antigenic status and vaccination initiation.

A global independent data and safety monitoring board (DSMB) monitors interim data to make recommendations about early study closure or changes to conduct, including adding or removing treatment arms. However, the current version of the protocol does not allow for efficacy or futility analysis, and the ability to add trial arms will be limited by the study being blinded and placebo-controlled during the investigation of AZD7442.

ReferenceCitation: Ader F; Discovery French Trial Management Team. Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults. BMJ Open. 2020 Sep 21;10(9):e041437. doi: 10.1136/bmjopen-2020-041437.

ReferenceCitation: Diallo A, Trøseid M, Simensen VC, Boston A, Demotes J, Olsen IC, Chung F, Paiva JA, Hites M, Ader F, Arribas Lopez JR, Barratt-Due A, Melien Ø, Tacconelli E, Staub T, Greil R, Tsiodras S, Briel M, Esperou H, Mentre F, Eustace J, Saillard J, Delmas C, Le Mestre S, Dumousseaux M, Costagliola D, Røttingen JA, Yazdanpanah Y. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group. Clin Microbiol Infect. 2021 Nov 8. pii: S1198-743X(21)00612-1. doi: 10.1016/j.cmi.2021.10.011. [Epub ahead of print]

ReferenceCitation: WHO Solidarity Trial Consortium, Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, Abdool Karim Q, Alejandria MM, Hernández García C, Kieny MP, Malekzadeh R, Murthy S, Reddy KS, Roses Periago M, Abi Hanna P, Ader F, Al-Bader AM, Alhasawi A, Allum E, Alotaibi A, Alvarez-Moreno CA, Appadoo S, Asiri A, Aukrust P, Barratt-Due A, Bellani S, Branca M, Cappel-Porter HBC, Cerrato N, Chow TS, Como N, Eustace J, García PJ, Godbole S, Gotuzzo E, Griskevicius L, Hamra R, Hassan M, Hassany M, Hutton D, Irmansyah I, Jancoriene L, Kirwan J, Kumar S, Lennon P, Lopardo G, Lydon P, Magrini N, Maguire T, Manevska S, Manuel O, McGinty S, Medina MT, Mesa Rubio ML, Miranda-Montoya MC, Nel J, Nunes EP, Perola M, Portolés A, Rasmin MR, Raza A, Rees H, Reges PPS, Rogers CA, Salami K, Salvadori MI, Sinani N, Sterne JAC, Stevanovikj M, Tacconelli E, Tikkinen KAO, Trelle S, Zaid H, Røttingen JA, Swaminathan S. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results. N Engl J Med. 2021 Feb 11;384(6):497-511. doi: 10.1056/NEJMoa2023184. Epub 2020 Dec 2.

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repository_institution: University of Turin - Institutional Research Information System University of Turin

repository_institution: University of Bristol - Bristol Research

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

version: submittedVersion

repositories_institution: University of Bristol - Bristol Research

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results

ReferenceCitation: Ader F, Peiffer-Smadja N, Poissy J, Bouscambert-Duchamp M, Belhadi D, Diallo A, Delmas C, Saillard J, Dechanet A, Mercier N, Dupont A, Alfaiate T, Lescure FX, Raffi F, Goehringer F, Kimmoun A, Jaureguiberry S, Reignier J, Nseir S, Danion F, Clere-Jehl R, Bouiller K, Navellou JC, Tolsma V, Cabié A, Dubost C, Courjon J, Leroy S, Mootien J, Gaci R, Mourvillier B, Faure E, Pourcher V, Gallien S, Launay O, Lacombe K, Lanoix JP, Makinson A, Martin-Blondel G, Bouadma L, Botelho-Nevers E, Gagneux-Brunon A, Epaulard O, Piroth L, Wallet F, Richard JC, Reuter J, Staub T, Lina B, Noret M, Andrejak C, Lê MP, Peytavin G, Hites M, Costagliola D, Yazdanpanah Y, Burdet C, Mentré F; DisCoVeRy study group. An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19. Clin Microbiol Infect. 2021 May 26. pii: S1198-743X(21)00259-7. doi: 10.1016/j.cmi.2021.05.020. [Epub ahead of print]

family: Ader

full_name: Florence Ader

given: Florence

family: Peiffer-Smadja

full_name: Nathan Peiffer-Smadja

given: Nathan

family: Poissy

full_name: Julien Poissy

given: Julien

family: Bouscambert-Duchamp

full_name: Maude Bouscambert-Duchamp

given: Maude

family: Belhadi

full_name: Drifa Belhadi

given: Drifa

family: Diallo

full_name: Alpha Diallo

given: Alpha

family: Delmas

full_name: Christelle Delmas

given: Christelle

family: Saillard

full_name: Juliette Saillard

given: Juliette

family: Dechanet

full_name: Aline Dechanet

given: Aline

family: Mercier

full_name: Noémie Mercier

given: Noémie

ReferenceCitation: Ader F, Bouscambert-Duchamp M, Hites M, Peiffer-Smadja N, Poissy J, Belhadi D, Diallo A, Lê MP, Peytavin G, Staub T, Greil R, Guedj J, Paiva JA, Costagliola D, Yazdanpanah Y, Burdet C, Mentré F; DisCoVeRy Study Group. Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial. Lancet Infect Dis. 2021 Sep 14. pii: S1473-3099(21)00485-0. doi: 10.1016/S1473-3099(21)00485-0. [Epub ahead of print]

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

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

name: Transfusion Research Unit, School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

name: Population Health Sciences, Bristol Medical School; University of Bristol; Bristol UK

name: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine; University Hospital Wuerzburg; Wuerzburg Germany

name: Laboratory of Experimental Immunology, Institute of Virology; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

name: Jon J van Rood Center for Clinical Transfusion Research; Sanquin/Leiden University Medical Center; Leiden Netherlands

name: Department of Nephrology; Technical University of Munich, School of Medicine, Klinikum rechts der Isar; Munich Germany

name: Erasmus Medical Centre; Rotterdam Netherlands

name: Systematic Review Initiative; NHS Blood and Transplant; Oxford UK

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

ReferenceCitation: Ansems K, Grundeis F, Dahms K, Mikolajewska A, Thieme V, Piechotta V, Metzendorf MI, Stegemann M, Benstoem C, Fichtner F. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Aug 5;8:CD014962. doi: 10.1002/14651858.CD014962.

name: Department of Intensive Care Medicine; Medical Faculty, RWTH Aachen University; Aachen Germany

name: Department of Anaesthesiology and Intensive Care; University of Leipzig Medical Center; Leipzig Germany

name: Department of Infectious Diseases and Respiratory Medicine; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin; Berlin Germany

name: Cochrane Metabolic and Endocrine Disorders Group; Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf; Düsseldorf Germany

title: Remdesivir for the treatment of COVID-19

ReferenceCitation: Taccone FS, Gorham J, Vincent JL. Hydroxychloroquine in the management of critically ill patients with COVID-19: the need for an evidence base. Lancet Respir Med. 2020 Jun;8(6):539-541. doi: 10.1016/S2213-2600(20)30172-7. Epub 2020 Apr 15.

ipd_sharing_description: Study protocol and statistical analysis plan will be available. Systematic individual patient data sharing is not intended, but all requests for the trial's data will be considered by the French DisCoVeRy Trial Management Team.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_country: Luxembourg Austria France Norway Belgium Portugal

location_facility: Centre Hospitalier Universitaire de Martinique

location_facility: Centre Hospitalier Régional et Universitaire de Nancy

location_facility: Groupe Hospitalier de la Région de Mulhouse Sud Alsace

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Centre Hospitalier Universitaire Amiens-Picardie

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalo-Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire Dijon-Bourgogne

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centro Hospitalar Universitário de São João, EPE

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Regional Metz-Thionville

location_facility: APHP - Hôpital Universitaire Pitié Salpêtrière

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Régional Universitaire de Strasbourg

location_facility: Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität

location_facility: Hôpital Erasme - Cliniques universitaires de Bruxelles

location_facility: Hôpital Paris Saint-Joseph et Marie Lannelongue


title: Pharmaco-economic Cost-effective Prospective Randomized Trial Evaluating the Open Interest Caphosol ® Mouthwashes in the Prevention and Treatment of Severe Oral Mucositis in Patients Receiving High-dose Chemotherapy in Hematology

acronym: Caphosol

summary: The purpose of the study is to determine whether the use of mouthwashes Caphosol ™ in addition to standard oral care (strategy A) is cost-effective in the prevention and treatment of severe mucositis in adult patients with auto or allograft packaging without ICT versus mouthwashes standard bicarbonates with an antiseptic (strategy B).

lead_sponsor: Nantes University Hospital


title: Tolerance of "on Line" Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients

acronym: on-line-HDF

summary: The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.

lead_sponsor: University Hospital, Montpellier


title: Frequency and Characteristics of Rehospitalizations During One Year After Percutaneous Coronary Intervention and Coronary Angiography - Results of the ACIRA Registry, Aquitaine Region

acronym: ACIRA-REHOSP

summary: Hospital readmission rate following percutaneous coronary interventions (PCI) or coronary angiographies (CAG) is a main indicator of quality of care and addresses economic issues. The aim of this study is to quantify the frequency and analyse the types of rehospitalizations and repeat revascularizations during one year after a PCI or a CAG. This information is needed to organize the health care pathway and to identify preventable rehospitalizations.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Clinique cardiologique d'Aressy
Hôpital privé St Martin
Clinique Esquirol St Hilaire
CH de Pau
CHU de Bordeaux
CH de Mont de Marsan
Clinique de St Augustin
CH de Libourne
Clinique de Caudéran les pins-francs
GCS Bayonne
CH de Perigueux


title: A Multi-center, Prospective, Randomized Crossover Study With the NightBalance SPT Compared to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA)

acronym: SOS

summary: Comparison of the NightBalance Sleep Position Trainer (SPT) to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA). Primary Objective: Efficacy and Adherence of the SPT over 3 months of use compared to PAP for the treatment of POSA. The study is run from centers in France, the UK and Germany.

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
Germany
United Kingdom
France

location_facility: Hôpital Universitaire Pitié - Salpêtrière (UPMC)

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: Guy's and St Thomas' NHS Foundation Trust (GSTT)


title: Protocol of Herceptin Adjuvant With Reduced Exposure, a Randomised Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin [PHARE]

summary:
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery.

ReferenceCitation: Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espié M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Venat-Bouvet L, Cany L, Catala S, Khayat D, Gambotti L, Pauporté I, Faure-Mercier C, Paget-Bailly S, Henriques J, Grouin JM; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, open-label, phase 3 randomised trial. Lancet. 2019 Jun 29;393(10191):2591-2598. doi: 10.1016/S0140-6736(19)30653-1. Epub 2019 Jun 6.

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Romieu

full_name: Gilles Romieu

given: Gilles

family: Debled

full_name: Marc Debled

given: Marc

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Kerbrat

full_name: Pierre Kerbrat

given: Pierre

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Lortholary

full_name: Alain Lortholary

given: Alain

family: Espié

full_name: Marc Espié

family: Fumoleau

full_name: Pierre Fumoleau

family: Serin

full_name: Daniel Serin

given: Daniel

family: Jacquin

full_name: Jean-Philippe Jacquin

given: Jean-Philippe

family: Jouannaud

full_name: Christelle Jouannaud

family: Rios

full_name: Maria Rios

given: Maria

family: Abadie-Lacourtoisie

full_name: Sophie Abadie-Lacourtoisie

given: Sophie

family: Venat-Bouvet

full_name: Laurence Venat-Bouvet

given: Laurence

family: Cany

full_name: Laurent Cany

given: Laurent

family: Catala

full_name: Stéphanie Catala

given: Stéphanie

family: Khayat

full_name: David Khayat

given: David

family: Gambotti

full_name: Laetitia Gambotti

given: Laetitia

family: Pauporté

full_name: Iris Pauporté

given: Iris

family: Faure-Mercier

full_name: Celine Faure-Mercier

given: Celine

family: Paget-Bailly

full_name: Sophie Paget-Bailly

family: Henriques

full_name: Julie Henriques

given: Julie

family: Grouin

full_name: Jean Marie Grouin

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

ReferenceCitation: Jacquinot Q, Paget-Bailly S, Fumoleau P, Romieu G, Pierga JY, Espié M, Lortholary A, Nabholtz JM, Mercier CF, Pauporté I, Henriques J, Pivot X. Fluctuation of the left ventricular ejection fraction in patients with HER2-positive early breast cancer treated by 12 months of adjuvant trastuzumab. Breast. 2018 Oct;41:1-7. doi: 10.1016/j.breast.2018.06.001. Epub 2018 Jun 15.

ReferenceCitation: Curtit E, Pivot X, Henriques J, Paget-Bailly S, Fumoleau P, Rios M, Bonnefoi H, Bachelot T, Soulié P, Jouannaud C, Bourgeois H, Petit T, Tennevet I, Assouline D, Mathieu MC, Jacquin JP, Lavau-Denes S, Darut-Jouve A, Ferrero JM, Tarpin C, Lévy C, Delecroix V, Trillet-Lenoir V, Cojocarasu O, Meunier J, Pierga JY, Kerbrat P, Faure-Mercier C, Blanché H, Sahbatou M, Boland A, Bacq D, Besse C, Thomas G, Deleuze JF, Pauporté I, Romieu G, Cox DG. Assessment of the prognostic role of a 94-single nucleotide polymorphisms risk score in early breast cancer in the SIGNAL/PHARE prospective cohort: no correlation with clinico-pathological characteristics and outcomes. Breast Cancer Res. 2017 Aug 22;19(1):98. doi: 10.1186/s13058-017-0888-4.

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

ReferenceCitation: Pivot X, Fumoleau P, Pierga JY, Delaloge S, Bonnefoi H, Bachelot T, Jouannaud C, Bourgeois H, Rios M, Soulié P, Jacquin JP, Lavau-Denes S, Kerbrat P, Cox D, Faure-Mercier C, Pauporte I, Gligorov J, Curtit E, Henriques J, Paget-Bailly S, Romieu G. Superimposable outcomes for sequential and concomitant administration of adjuvant trastuzumab in HER2-positive breast cancer: Results from the SIGNAL/PHARE prospective cohort. Eur J Cancer. 2017 Aug;81:151-160. doi: 10.1016/j.ejca.2017.05.020. Epub 2017 Jun 16.

ReferenceCitation: Pivot X, Suter T, Nabholtz JM, Pierga JY, Espie M, Lortholary A, Khayat D, Pauporte I, Romieu G, Kramar A, Fumoleau P. Cardiac toxicity events in the PHARE trial, an adjuvant trastuzumab randomised phase III study. Eur J Cancer. 2015 Sep;51(13):1660-6. doi: 10.1016/j.ejca.2015.05.028. Epub 2015 Jul 7.

ReferenceCitation: Kramar A, Bachelot T, Madrange N, Pierga JY, Kerbrat P, Espié M, Fumoleau P, Pauporté I, Khayat D, Romieu G, Pivot X. Trastuzumab duration effects within patient prognostic subgroups in the PHARE trial. Ann Oncol. 2014 Aug;25(8):1563-70. doi: 10.1093/annonc/mdu177. Epub 2014 May 14.

ReferenceCitation: Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espié M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Tubiana-Mathieu N, Cany L, Catala S, Khayat D, Pauporté I, Kramar A; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013 Jul;14(8):741-8. doi: 10.1016/S1470-2045(13)70225-0. Epub 2013 Jun 11.

location_facility: Centre Hospital General Robert Ballanger

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Centre de Radiologie et de Traitement des Tumeurs


title: Impact of the Arrival on the French Market of New First Line Oral Treatments on the Delay Between MS Onset and First Disease Modifying Treatment (DMTs) Administration

acronym: PREMISEP

summary:
The study design matches with a multicenter observational ambispective study. A first pilot study will be undertaken in Caen center and is expected to be extended to Rouen and Lille center. So patients from Normandy and North-West areas will be included.

In order to include patients in this observational study historical data about first line injectable treatments (interferons and glatiramer acetate) are used. As well as the data on patients treated with oral first line therapies (teriflunomide and dimethyl fumarate) began to be collected ahead of the study start (Retrospective phase). During the course of the study, new patients under teriflunomide or dimethyl fumarate will be included (Prospective phase).

time_perspective: Other

lead_sponsor: University Hospital, Caen

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille (HICL)


title: Randomized, Comparative Study to Assess the Effects of Cosmetic Lotion on Telogen Effluvium in Women Compared to a Control Group

summary:
Telogen effluvium (TE) is one of the most common causes of non-scarring diffuse hair loss, defined as global diminution of hair with no formation of areas completely bald.

Premature termination of anagen into catagen and telogen hair follicle is the main mechanism observed in TE. It results in increased, synchronized telogen shedding leading to a decrease in global hair density.

Acute telogen effluvium (ATE) has an abrupt onset and generalized scalp hair loss occurring 2-3 months after a triggering event, which could be unidentifiable in up to 33% cases.

The degree of effluvium depends on the severity, duration of exposure and the type of agent, that can be: emotional stress, hormonal changes in the postpartum period, high fever, surgery, surgical/accidental trauma, severe haemorrhage, chronic systemic illness, or immense psychological stress, changes in medication or crash-diets. A summer effect possibly ultraviolet (UV) light induced, manifesting itself in autumn can cause ATE. The incidence of TE is not known, although it is likely that most women will experience at least 1 episode of TE during a lifetime.

ATE can be diagnosed based on relevant medical and personal history and examination subjective complaints, clinical and physical exams or relevant investigations (hair pull test, phototrichogram, blood test…). ATE generates a lot of anxiety in the patient: significant impact on quality of life, self-esteem impairment, and stress increase. Thus, stress may act as a primary inducer; an aggravating factor or be a response to hair loss.

ATE usually remits within few months (3-4 to 6 months) in 95% of cases if the trigger is removed or treated. Complete recovery may take until 1 year. A resolving TE is characterized by the absence of hair shedding, a negative hair pull test and synchronized hair growth.

In this study, our aim is to assess the effects of the RV3466F lotion on hair growth, compared to a control group, with clinical and biometrological non- invasive methods on an adult female population with telogen effluvium.

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility:
INTERTEK
Centre de santé SABOURAUD C.E.P.C


title: Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication and Adherence in Emergency Ward

acronym: EDIFIP

summary: The purpose of this "before-after" prospective multicenter study is to assess the impact of six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and adherence scale for common acute illnesses in emergency ward.

ReferenceCitation: Sustersic M, Jeannet E, Cozon-Rein L, Maréchaux F, Genty C, Foote A, David-Tchouda S, Martinez L, Bosson JL. Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care. J Gen Intern Med. 2013 Jan;28(1):25-31. doi: 10.1007/s11606-012-2164-8. Epub 2012 Jul 25.

ReferenceCitation: Sustersic M, Meneau A, Drémont R, Paris A, Laborde L, Bosson JL. [Developing patient information sheets in general practice. Proposal for a methodology]. Rev Prat. 2008 Dec 15;58(19 Suppl):17-24. French.

ReferenceCitation: Little P, Moore M, Kelly J, Williamson I, Leydon G, McDermott L, Mullee M, Stuart B; PIPS Investigators. Delayed antibiotic prescribing strategies for respiratory tract infections in primary care: pragmatic, factorial, randomised controlled trial. BMJ. 2014 Mar 6;348:g1606. doi: 10.1136/bmj.g1606.

ReferenceCitation: Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706.

ReferenceCitation: Grime J, Blenkinsopp A, Raynor DK, Pollock K, Knapp P. The role and value of written information for patients about individual medicines: a systematic review. Health Expect. 2007 Sep;10(3):286-98. Review.

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ReferenceCitation: Sustersic M, Tissot M, Tyrant J, Gauchet A, Foote A, Vermorel C, Bosson JL. Impact of patient information leaflets on doctor-patient communication in the context of acute conditions: a prospective, controlled, before-after study in two French emergency departments. BMJ Open. 2019 Feb 20;9(2):e024184. doi: 10.1136/bmjopen-2018-024184.

family: Sustersic

full_name: Mélanie Sustersic

given: Mélanie

family: Tissot

full_name: Marisa Tissot

given: Marisa

family: Tyrant

full_name: Julie Tyrant

family: Gauchet

full_name: Aurelie Gauchet

given: Aurelie

family: Foote

full_name: Alison Foote

given: Alison

family: Vermorel

full_name: Céline Vermorel

given: Céline

family: Bosson

full_name: Jean Luc Bosson

given: Jean Luc

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Impact of patient information leaflets on doctor–patient communication in the context of acute conditions: a prospective, controlled, before–after study in two French emergency departments

lead_sponsor: Floralis

location_facility: Groupe Hospitalier Mutualiste, service des urgences


title: Effects of Mesenchymal Stem Cells Administration on Organ Failure During Septic Shock: Phase II Randomized Comparator-controlled Study

acronym: CHOCMSC

summary: The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.

lead_sponsor: Central Hospital, Nancy, France

location_facility: Service de Réanimation Médicale, Hôpital Central

location_facility: Service de Réanimation Médicale, Hôpital Bocage

location_facility: Hôpital Hautepierre, Service de réanimation médicale

intervention_type: Biological


title: A Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced Dyskinesias

acronym: Safinamide-LID

summary: Approximately twenty four (24) subjects will participate in this research trial. The research trial will be conducted in approximately twelve (12) medical centers in the following countries: Germany, France, South Africa, Austria and Canada. The research trial will last until December 2011.

lead_sponsor: Newron Pharmaceuticals SPA

location_country:
Austria
South Africa
Germany
France
Canada

location_facility: Quebec Memory and Motor Skills Disorders

location_facility: St. Josef Hospital, Klinik für Neurologie

location_facility: Medical University Graz, Klinische Abteilung für Spezielle Neurologie

location_facility: Medical University Innsbruck, Dept. of Neurology


title: Phase III Study Evaluating Two Strategies of Maintenance, One With Pemetrexed in Continuous Strategy and One According to the Response of Induction Chemotherapy, in Non Squamous Non Small Cell Lung Cancer of Advanced Stage

summary:
In France, lung cancer is responsible for more than 30000 each year. Progress was made in treatment of lung cancer in the last five years due to targeted therapies and to strategical evolutions consisting in a best adjustment of treatments. Maintenance strategies is one of this strategical evolution. It is based on maintaining continuous therapeutical pression in order to preserve the therapeutical benefit obtained by the first line (induction chemotherapy). Several clinical trials showed that maintenance strategies increase the duration of controlled disease.

There is two types of maintenance strategies:

Continuous maintenance : prolongation of the treatment initially associated with platin until progression
Switch maintenance : introduction of a new treatment after the end of induction chemotherapy

The aim of this study is to compare two maintenance strategies

A continuous maintenance by pemetrexed
A switch maintenance or a continuous maintenance according to the response of induction chemotherapy.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques