title: Natural History and Disease Progression Biomarkers of Multiple System Atrophy

acronym: ASPIRE-MSA

summary:
Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disease characterised by a variable combination of parkinsonism, cerebellar impairment and autonomic dysfunction. The neuropathological hallmark is the accumulation of alpha-synuclein in oligodendrocytes. While some symptomatic treatments exist, neuroprotective treatments for MSA remain an urgent, unmet need. Moreover, at present there is not a single surrogate biomarker of MSA which could be used to inform clinical trials.

This study seeks to characterise the natural history of MSA on a panel of candidate biomarkers, pre-selected for being putative surrogates of the underlying neurodegenerative process

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital Pitié-Salpêtrière
Hôpital de Hautepierre
CHU de Nancy
Hôpital de La Timone
CHU de Bordeaux
Chu Clermont Ferrand
Hôpital Neurologique Pierre Wertheimer
CHU Lille
Clinique neurologique - Hôpital Laennec
CHU


title: Prospective Observational Clinical Study Conducted on Patient Operated With a Total Knee Prosthesis FHK ASYMETRIQUE to Confirm Security and Performance of the Device Over a Period of 10 Years

summary: This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: FH ORTHO

location_facility: Clinique Mutualiste de la Porte de l'Orient

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Comparative, Multicenter and Randomized Study Evaluating the Safety and Efficacy of RESPIMER® Netiflow® Versus Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy in the Treatment of Nasal Polyposis.

acronym: NETIFLOW

summary: The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: background

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ReferenceType: result

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ReferenceCitation: Bardou O, Trinh NT, Brochiero E. Molecular diversity and function of K+ channels in airway and alveolar epithelial cells. Am J Physiol Lung Cell Mol Physiol. 2009 Feb;296(2):L145-55. doi: 10.1152/ajplung.90525.2008. Epub 2008 Dec 5. Review.

family: Bardou

full_name: Olivier Bardou

given: Olivier

sequence: first

family: Trinh

full_name: Nguyen Thu Ngan Trinh

given: Nguyen Thu Ngan

sequence: additional

family: Brochiero

full_name: Emmanuelle Brochiero

given: Emmanuelle

bso_classification: Biology (fond.)

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Physiology-Lung Cellular and Molecular Physiology

publisher: American Physiological Society

publisher_dissemination: American Physiological Society

publisher_group: American Physiological Society

publisher_normalized: American Physiological Society

title: Molecular diversity and function of K+ channels in airway and alveolar epithelial cells

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family: Braiman

full_name: Alex Braiman

given: Alex

family: Priel

full_name: Zvi Priel

given: Zvi

bso_classification: Medical research

journal_name: Respiratory Physiology & Neurobiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Efficient mucociliary transport relies on efficient regulation of ciliary beating

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ReferenceCitation: Buchanan PJ, McNally P, Harvey BJ, Urbach V. Lipoxin A₄-mediated KATP potassium channel activation results in cystic fibrosis airway epithelial repair. Am J Physiol Lung Cell Mol Physiol. 2013 Jul 15;305(2):L193-201. doi: 10.1152/ajplung.00058.2013. Epub 2013 May 17.

name: National Children's Research Center, Our Lady's Children Hospital, Dublin;

family: Buchanan

full_name: Paul J. Buchanan

given: Paul J.

family: McNally

full_name: Paul McNally

given: Paul

name: Department of Molecular Medicine, Royal College of Surgeons in Ireland, Beaumont Hospital, Dublin, Ireland;

family: Harvey

full_name: Brian J. Harvey

given: Brian J.

name: INSERM U845, Faculté de Médecine Paris Descartes, Site Necker, Paris, France

family: Urbach

full_name: Valerie Urbach

given: Valerie

title: Lipoxin A4-mediated KATP potassium channel activation results in cystic fibrosis airway epithelial repair

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family: Campos

full_name: Janna Campos

given: Janna

family: Heppt

full_name: Werner Heppt

given: Werner

family: Weber

full_name: Rainer Weber

given: Rainer

journal_name: European Archives of Oto-Rhino-Laryngology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

title: Nasal douches for diseases of the nose and the paranasal sinuses—a comparative in vitro investigation

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name: Bioengineering, University of California at Merced, Merced;

name: Division of Respiratory Medicine, Department of Pediatrics, University of California at San Diego School of Medicine, Rady Children's Hospital, La Jolla; and

name: Division of Biomedical Sciences, University of California at Riverside, Riverside, California

title: A new role for bicarbonate in mucus formation

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title: A preliminary randomised controlled trial evaluating the efficacy of saline douching following endoscopic sinus surgery

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journal_name: International Forum of Allergy & Rhinology

title: Dead Sea salt irrigations vs saline irrigations with nasal steroids for symptomatic treatment of chronic rhinosinusitis: a randomized, prospective double-blind study

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name: Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC

name: Department of Otolaryngology-Head and Neck Surgery, Emory University, Atlanta, GA.

title: Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation

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title: Serotonin Increases Cilia-Driven Particle Transport via an Acetylcholine-Independent Pathway in the Mouse Trachea

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name: Department of Pathology and Laboratory Medicine, Division of Medical Genetics, University of Pennsylvania, Philadelphia, PA 19104

name: Department of Cell and Developmental Biology,

title: HCO3− Secretion by Murine Nasal Submucosal Gland Serous Acinar Cells during Ca2+-stimulated Fluid Secretion

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name: Department of Otolaryngology–Head and Neck Surgery, University of Toronto, St. Michael's Hospital, Toronto, Ontario, Canada

name: Department of Otolaryngology–Head and Neck Surgery, Stanford University, Stanford, California

name: Division of Rhinology, Department of Otorhinolaryngology–Head and Neck Surgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania

name: Department of Otolaryngology–Head and Neck Surgery, Loyola University Health System, Maywood, Illinois

title: Assessing the Risk of Irrigation Bottle and Fluid Contamination after Endoscopic Sinus Surgery

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name: Department of Bioengineering; University of California-Riverside; 900 University Avenue Riverside California 92521

name: Department of Biochemistry and Molecular Biology; University of California-Riverside; 900 University Avenue Riverside California 92521

name: Materials Science and Engineering Program; University of California-Riverside; 900 University Avenue Riverside California 92521

name: Department of Chemistry; University of California-Riverside; 900 University Avenue Riverside California 92521

journal_name: Journal of Biomedical Materials Research Part A

title: Degradation and antibacterial properties of magnesium alloys in artificial urine for potential resorbable ureteral stent applications

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title: Influence of intranasal sterile isotonic sea water applications on xylometazoline administration: An experimental study in pigs

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title: Early postoperative care following endoscopic sinus surgery: an evidence-based review with recommendations

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name: Academic unit of Clinical and Experimental Sciences; Department of Otorhinolaryngology - Head and Neck Surgery; University Hospital Southampton NHS Foundation Trust; Southampton; UK

name: Department of Otorhinolaryngology - Head and Neck Surgery; Royal Hampshire County Hospital; Winchester; UK

name: Department of Otorhinolaryngology - Head and Neck Surgery; Khoo Teck Puat Hospital; Singapore City; Singapore

name: Department of Otorhinolaryngology - Head and Neck Surgery; Auckland University Hospitals and Manukau SuperClinic; Auckland; New Zealand

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journal_name: International Journal of Pediatric Otorhinolaryngology

title: Efficacy of buffered hypertonic saline nasal irrigation in children with symptomatic allergic rhinitis: A randomized double-blind study

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title: Ciliary beat co-ordination by calcium

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title: Biodegradation of metallic magnesium elicits an inflammatory response in primary nasal epithelial cells

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journal_name: Archives of Otolaryngology–Head & Neck Surgery

title: Efficacy of Isotonic Nasal Wash (Seawater) in the Treatment and Prevention of Rhinitis in Children

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title: Effects of buffered 2.3%, buffered 0.9%, and non-buffered 0.9% irrigation solutions on nasal mucosa after septoplasty

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ReferenceCitation: Tesfaigzi Y. Roles of apoptosis in airway epithelia. Am J Respir Cell Mol Biol. 2006 May;34(5):537-47. Epub 2006 Jan 26. Review.

ReferenceCitation: Traissac L, Ohayon-Courtes C, Dufour P, Bordenave L. [Nasal washing with Physiomer ... 10 years later: 1988-1998]. Rev Laryngol Otol Rhinol (Bord). 1999;120(2):133-5. French.

ReferenceCitation: Trinh NT, Privé A, Kheir L, Bourret JC, Hijazi T, Amraei MG, Noël J, Brochiero E. Involvement of KATP and KvLQT1 K+ channels in EGF-stimulated alveolar epithelial cell repair processes. Am J Physiol Lung Cell Mol Physiol. 2007 Oct;293(4):L870-82. Epub 2007 Jul 13.

ReferenceCitation: Trinh NT, Privé A, Maillé E, Noël J, Brochiero E. EGF and K+ channel activity control normal and cystic fibrosis bronchial epithelia repair. Am J Physiol Lung Cell Mol Physiol. 2008 Nov;295(5):L866-80. doi: 10.1152/ajplung.90224.2008. Epub 2008 Aug 29.

title: EGF and K+ channel activity control normal and cystic fibrosis bronchial epithelia repair

ReferenceCitation: Unal M, Seymen HO. Effect of Ringer-Lactate and isotonic saline solutions on mucociliary clearance of tracheal epithelium: an experimental study in rats. J Laryngol Otol. 2002 Jul;116(7):536-8.

ReferenceCitation: van de Donk HJ, Zuidema J, Merkus FW. The influence of the pH and osmotic pressure upon tracheal ciliary beat frequency as determined with a new photo-electric registration device. Rhinology. 1980 Jun;18(2):93-104.

ReferenceCitation: Watelet JB, Demetter P, Claeys C, Cauwenberge P, Cuvelier C, Bachert C. Wound healing after paranasal sinus surgery: neutrophilic inflammation influences the outcome. Histopathology. 2006 Jan;48(2):174-81.

ReferenceCitation: Wei CC, Adappa ND, Cohen NA. Use of topical nasal therapies in the management of chronic rhinosinusitis. Laryngoscope. 2013 Oct;123(10):2347-59. doi: 10.1002/lary.24066. Epub 2013 Apr 1. Review.

name: Department of Otolaryngology-Head and Neck Surgery; St. Luke's-Roosevelt Hospital; New York; New York

name: Department of Otorhinolaryngology-Head and Neck Surgery; University of Pennsylvania School of Medicine; Hospital of the University of Pennsylvania; Philadelphia; Pennsylvania; U.S.A

title: Use of topical nasal therapies in the management of Chronic rhinosinusitis

ReferenceCitation: Wormald PJ, Cain T, Oates L, Hawke L, Wong I. A comparative study of three methods of nasal irrigation. Laryngoscope. 2004 Dec;114(12):2224-7.

ReferenceCitation: Yeh TH, Tsai CH, Chen YS, Hsu WC, Cheng CH, Hsu CJ, Lee SY. Increased communication among nasal epithelial cells in air-liquid interface culture. Laryngoscope. 2007 Aug;117(8):1439-44.

ReferenceCitation: Zahm JM, Kaplan H, Hérard AL, Doriot F, Pierrot D, Somelette P, Puchelle E. Cell migration and proliferation during the in vitro wound repair of the respiratory epithelium. Cell Motil Cytoskeleton. 1997;37(1):33-43.

ReferenceCitation: Zsembery A, Boyce AT, Liang L, Peti-Peterdi J, Bell PD, Schwiebert EM. Sustained calcium entry through P2X nucleotide receptor channels in human airway epithelial cells. J Biol Chem. 2003 Apr 11;278(15):13398-408. Epub 2003 Feb 3.

ReferenceCitation: Zsembery A, Fortenberry JA, Liang L, Bebok Z, Tucker TA, Boyce AT, Braunstein GM, Welty E, Bell PD, Sorscher EJ, Clancy JP, Schwiebert EM. Extracellular zinc and ATP restore chloride secretion across cystic fibrosis airway epithelia by triggering calcium entry. J Biol Chem. 2004 Mar 12;279(11):10720-9. Epub 2003 Dec 29.

location_facility: Service d'ORL et Chirurgie cervico faciale - CHRU Tours

location_facility: Service d'oto-rhino-laryngologie - CHU de Nantes

location_facility: Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpital Pellegrin

location_facility: ORL et Chirurgie Cervico-faciale - Pôle Voies Respiratoires - CHU Toulouse

location_facility: Service ORL et Chirurgie cervico-faciale - CHRU Lille

location_facility: ORL et Chirurgie Cervico-faciale - Centre Hospitalier Intercommunal (CHI) de Créteil

location_facility: Service d'Oto-rhino-laryngologie - Clinique Saint-Augustin

location_facility: Service ORL et Chirurgie Cervico-faciale - CHRU Nancy


type: Other Identifier

title: A Multicenter Pilot Study to Determine Criteria for Evaluating the Effectiveness of Two Comparative Monitoring Methods in the Management of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Receiving Home-based Treatment With IVIg (Privigen®)

acronym: HELIPAD 1

summary:
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating polyneuropathy of autoimmune origin with a progressive or relapsing course.

Diagnosis is based on clinical presentation and electrophysiological findings in accordance with the EFNS/PNS consensus guidelines. IVIg is the first line treatment witch has been shown to be effective in several placebo-controlled trials.

Once IVIg therapy produces a response and is well tolerated, some patients are able to continue their treatment in the home setting. The HOME LINK system offers an integrated, global solution based on telemonitoring technology providing continuous, remote monitoring of Privigen® infusions administered at home.

status: Terminated

lead_sponsor: CSL Behring

location_facility: Hôpital Nord - Saint Etienne University Hospital (CHU)

location_facility: Hôpital Pellegrin, Bordeaux University Hospital (CHU)

location_facility: Hôpital Pasteur 2 - Nice University Hospital (CHU)

location_facility: Hôpital Gui de Chauliac - Montpellier University Hospital (CHU)

status_simplified: Unknown


title: Etude Prospective Observationnelle Multicentrique Sur Volontaires Sains Des VALeurs de Pression Artérielle mesurées Sur Trois Sites alteRnAtIfS Des Membres inférieurs cOmparées au Site de référence

acronym: VALPARAISO

summary:
Non-invasive measurement of blood pressure is an instrument governed nursing routine care. The use of an automated oscillometric cuff is a common technique and validated if this is done on the arm with a suitable cuff, positioned opposite the brachial artery and up to the right atrium (the brachial site) . If cons-indication to use the brachial site, measurements are frequently performed at the ankle, calf or thigh. Among the blood pressure values measured on the 3 sites of the lower limb (thigh, calf or ankle), it may be a specific property of which the observed values are closest to the reference values (brachial).

The objective of this study is to measure the non-invasive blood pressure values at three sites of the lower limb, to compare the reference value to determine which alternative site should be preferred when the reference measurement is not feasible .

We want to determine the alternative site to obtain values as close as the measured values of the reference site. The three study sites are the thigh, calf and ankle. The reference site recommended for monitoring non-invasive blood pressureis the arm.

It is also assessing the impact of certain parameters on the primary endpoint:

Physiological parameters: gender, weight, height, age, systolic blood pressure reference, listed measures.
A parameter related to measurement: discomfort felt when the blood pressure outlet.
Exposure setting: smoking.

status: Available

study_type: Expanded Access

ReferenceCitation: Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.

family: Chatterjee

full_name: Arjun Chatterjee

given: Arjun

family: DePriest

full_name: Kirk DePriest

given: Kirk

family: Blair

full_name: Russell Blair

given: Russell

family: Bowton

full_name: David Bowton

given: David

family: Chin

full_name: Robert Chin

given: Robert

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Results of a survey of blood pressure monitoring by intensivists in critically ill patients: A preliminary study

ReferenceCitation: Block FE, Schulte GT. Ankle blood pressure measurement, an acceptable alternative to arm measurements. Int J Clin Monit Comput. 1996 Aug;13(3):167-71.

ReferenceCitation: Sanghera S, North A, Abernethy S, Wrench I. Arm and ankle blood pressure during caesarean section. Int J Obstet Anesth. 2006 Jan;15(1):24-7. Epub 2005 Oct 26.

ReferenceCitation: Moore C, Dobson A, Kinagi M, Dillon B. Comparison of blood pressure measured at the arm, ankle and calf. Anaesthesia. 2008 Dec;63(12):1327-31. doi: 10.1111/j.1365-2044.2008.05633.x.

family: Moore

full_name: C. Moore

given: C.

family: Dobson

full_name: A. Dobson

given: A.

family: Kinagi

full_name: M. Kinagi

given: M.

family: Dillon

full_name: B. Dillon

given: B.

journal_name: Anaesthesia

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Lakhal K, Macq C, Ehrmann S, Boulain T, Capdevila X. Noninvasive monitoring of blood pressure in the critically ill: reliability according to the cuff site (arm, thigh, or ankle). Crit Care Med. 2012 Apr;40(4):1207-13. doi: 10.1097/CCM.0b013e31823dae42.

family: Lakhal

full_name: Karim Lakhal

given: Karim

family: Macq

full_name: Christine Macq

given: Christine

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Capdevila

full_name: Xavier Capdevila

given: Xavier

lead_sponsor: Centre Hospitalier Sud Francilien

location_facility:
Nursing School Rambouillet
Sud Francilien Nursing School
Nursing School Foch
Perray-Vaucluse Nursing School
Nursing School of Longjumeau
Nursing Scool Barthelemy Durand
SSSM of Essonne SDIS91
Nursing School Tenon

intervention_type: Other

lead_sponsor_type: academique


title: Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?

acronym: TCAP

summary:
At the emergencies rooms, patients with head trauma meeting one of the NICE criteria, which include antiplatelet inhibitors treatment, are considered as patients with a risk of cerebral haemorrage and are taken systematically for a CT-scanner.

However, there are more and more antiplatelet inhibitor's patient with minor head injury traumas seen at the emergencies room and the efficiency of this NICE criteria is controversial on litterature.

This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

status: Recruiting

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility:
CH Bretagne Sud, Lorient
CH Le Mans
CHU de Nantes
CHU d'Angers
CH de Saint Malo
CHU de Poitiers
CH de Saint Brieuc
CH Bretagne Sud - Quimperlé
CH Chartres
CHU de Rennes

intervention_type: Radiation


title: Axonal Excitability Measured by QTRAC Technique in Patients With Anti-MAG Neuropathy

acronym: EXCIMAG

summary:
The QTRAC method is an electrophysiological technique that assesses peripheral nerve axonal excitability, using computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve.

Because of its high sensitivity to small changes in axonal excitability, QTRAC may help improve the follow-up of patients suffering from peripheral neuropathy caused by anti-myelin-associated-glycoprotein antibodies (anti-MAG neuropathy), as axonal excitability is early affected in this disease.

The main aim of the study is to compare QTRAC results in anti-MAG neuropathy patients, with QTRAC results in healthy persons (matched for sex and age).

A secondary aim is to determine whether or not the disease's clinical severity (measured by quantitative clinical scores) is correlated with the results of the QTRAC and could be predicted by a model based on the several parameters measured in the QTRAC exploration.

100 anti-MAG neuropathy patients will undergo a QTRAC exploration and a thorough neurological examination with clinical scoring. The results will be compared with data (matched by sex and age) from the reference database on healthy subjects, that is provided with the QTRAC software.

The investigators expect to prove that QTRAC results are modified in anti-MAG neuropathy patients, and that the clinical severity of the disease can be predicted by a combination of QTRAC-measured parameters.

primary_purpose: Diagnostic

location_facility: Service ENMG et pathologies Neuro Musculaires, Hôpital Neurologique Pierre Wertheimer

location_facility: Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Laboratoire des explorations fonctionnelles, Hôtel Dieu

location_facility: Service de Neurologie Hôpital Henry Mondor

location_facility: Département de Neurologie Hôpital Roger Salengro


title: Effects of a Long-term Exercise Program on Functional Ability in People With Dementia Living in Nursing Homes: a Cluster Randomised Controlled Trial. The LEDEN Study

acronym: LEDEN

summary: This is a cluster randomised controlled trial composed of two research arms: exercise training group (experimental group) and a social activity group (control group).

primary_purpose: Supportive Care

location_facility: Résidence d'Automne de Notre Dame de Sanhilac

status_simplified: Completed


type: EudraCT Number

title: Effect And Tolerance of Botulinum A Toxin Rectal Injections on Fecal Incontinence

summary:
Fecal incontinence is a frequent pathology which concerns 10% of the general population and severely alters patients quality of life. The cost of urinary and faecal incontinence has been estimated to be $16 billions a year. Several treatments exist depending on the aetiology of the faecal incontinence: medical treatments, biofeedback and sacral nerve stimulation. Nevertheless, these treatments are not always effective (50-70% of success) and are not without side effects, particularly the sacral nerve stimulation (pain, infection, electrode displacement..).

The intravesical injections of botulinum toxin have been used for several years for the treatment of urinary incontinence with overactive bladder. Several randomized trials have demonstrated the efficacy of these injections in patients with neurological disorders and overactive bladder, as well as in idiopathic overactive bladder. The toxin injections in the detrusor muscle increase the compliance and the bladder capacity and delay the initial appearance of detrusor uninhibited contraction. Furthermore, botulinum toxin decreases the urinary urgency. It maybe secondary to the reduction of the amplitude of the detrusor uninhibited contraction as well as to a direct effect of toxin on sensory pelvic nerve afferents.

The botulinum toxin should play a role on motor afferents as well as on the sensory function of efferent nerves.

The hypothesis is to demonstrate a decrease of active faecal incontinence and/or urgency episodes with improvement in quality of life, without any major side effects, in the patients included in this study. Nevertheless, the benefit of toxin injections are known to be temporary because of nerve re-growth. If we obtain similar results for fecal incontinence, it would be possible to schedule one to two injections a year because of the limited side-effects and invasiveness of the rectal injections.

status: Unknown status

primary_purpose: Treatment

lead_sponsor: University Hospital, Rouen

location_facility:
Hospices Civils de Lyon
Rennes University Hospital
Hôpital des Diaconesses
Rouen University Hospital
AP-HP Hôpital Tenon
AP-HM Hôpital Nord
Clinique des Cèdres
Bordeaux University Hospital

intervention_type: Procedure


title: Randomized Clinical Trial Comparing High Flow Oxygen Delivery System (Optiflow) With Oxygen Therapy Under High-concentration Mask on Oxygenation of Patients Who Receive Sequential Non-Invasive Ventilation (NIV) Sessions

acronym: VNI-HD

summary:
Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. In observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory failure. Oxygenation is better than under high-concentration mask and work of breathing is reduced.

The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session), during the first two NIV sessions

Study design : Prospective, randomized, controlled, multicentric, open clinical trial with two groups:

control group with conventional clinical management, oxygen therapy and sequential used of NIV
Optiflow group with high flow oxygen delivery system, conventional clinical management and sequential used of NIV for a period of 36 hours at least.

Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for hypoxemic respiratory failure.

lead_sponsor: University Hospital, Bordeaux

location_facility: Réanimation Polyvalente - CH de Mont de Marsan

location_facility: Service de Réanimation Polyvalente - CHU de Toulouse

location_facility: Service de Réanimation Polyvalente - CH de Libourne

location_facility: Service de Réanimation - CH de Perigueux

location_facility: Service de Réanimation Polyvalente - CH d'Agen

location_facility: Service de réanimation médicale - CHU de Bordeaux

location_facility: Service de réanimation - CH de la côte basque


title: Feasibility Clinical Trial of Intraoperative Radiotherapy (IORT) and Second Breast-conserving-surgery After Local Recurrence of Breast Carcinoma

summary: The investigators propose a prospective, multicenter, single arm Phase II design to evaluate the feasibility of repeated breast-conserving surgery combined with re- irradiation using IORT after local recurrence of breast carcinoma.

status: Active, not recruiting

ReferenceCitation: Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41.

ReferenceCitation: Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32.

ReferenceCitation: Brewster AM, Hortobagyi GN, Broglio KR, Kau SW, Santa-Maria CA, Arun B, Buzdar AU, Booser DJ, Valero V, Bondy M, Esteva FJ. Residual risk of breast cancer recurrence 5 years after adjuvant therapy. J Natl Cancer Inst. 2008 Aug 20;100(16):1179-83. doi: 10.1093/jnci/djn233. Epub 2008 Aug 11.

ReferenceCitation: Panet-Raymond V, Truong PT, Alexander C, Lesperance M, McDonald RE, Watson PH. Clinicopathologic factors of the recurrent tumor predict outcome in patients with ipsilateral breast tumor recurrence. Cancer. 2011 May 15;117(10):2035-43. doi: 10.1002/cncr.25767. Epub 2010 Nov 29.

ReferenceCitation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19. Review.

ReferenceCitation: Kurtz JM, Spitalier JM, Amalric R, Brandone H, Ayme Y, Jacquemier J, Hans D, Bressac C. The prognostic significance of late local recurrence after breast-conserving therapy. Int J Radiat Oncol Biol Phys. 1990 Jan;18(1):87-93.

ReferenceCitation: Hannoun-Levi JM, Resch A, Gal J, Kauer-Dorner D, Strnad V, Niehoff P, Loessl K, Kovács G, Van Limbergen E, Polgár C; GEC-ESTRO Breast Cancer Working Group. Accelerated partial breast irradiation with interstitial brachytherapy as second conservative treatment for ipsilateral breast tumour recurrence: multicentric study of the GEC-ESTRO Breast Cancer Working Group. Radiother Oncol. 2013 Aug;108(2):226-31. doi: 10.1016/j.radonc.2013.03.026. Epub 2013 May 3.

ReferenceCitation: Moran MS, Haffty BG. Local-regional breast cancer recurrence: prognostic groups based on patterns of failure. Breast J. 2002 Mar-Apr;8(2):81-7.

ReferenceCitation: Fourquet A, Campana F, Zafrani B, Mosseri V, Vielh P, Durand JC, Vilcoq JR. Prognostic factors of breast recurrence in the conservative management of early breast cancer: a 25-year follow-up. Int J Radiat Oncol Biol Phys. 1989 Oct;17(4):719-25.

ReferenceCitation: Fisher B, Anderson S, Fisher ER, Redmond C, Wickerham DL, Wolmark N, Mamounas EP, Deutsch M, Margolese R. Significance of ipsilateral breast tumour recurrence after lumpectomy. Lancet. 1991 Aug 10;338(8763):327-31.

ReferenceCitation: Veronesi U, Marubini E, Del Vecchio M, Manzari A, Andreola S, Greco M, Luini A, Merson M, Saccozzi R, Rilke F, et al. Local recurrences and distant metastases after conservative breast cancer treatments: partly independent events. J Natl Cancer Inst. 1995 Jan 4;87(1):19-27.

ReferenceCitation: Tanis E, van de Velde CJ, Bartelink H, van de Vijver MJ, Putter H, van der Hage JA. Locoregional recurrence after breast-conserving therapy remains an independent prognostic factor even after an event free interval of 10 years in early stage breast cancer. Eur J Cancer. 2012 Aug;48(12):1751-6. doi: 10.1016/j.ejca.2012.02.051. Epub 2012 Mar 23.

ReferenceCitation: Schmoor C, Sauerbrei W, Bastert G, Schumacher M. Role of isolated locoregional recurrence of breast cancer: results of four prospective studies. J Clin Oncol. 2000 Apr;18(8):1696-708.

ReferenceCitation: Anderson SJ, Wapnir I, Dignam JJ, Fisher B, Mamounas EP, Jeong JH, Geyer CE Jr, Wickerham DL, Costantino JP, Wolmark N. Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer. J Clin Oncol. 2009 May 20;27(15):2466-73. doi: 10.1200/JCO.2008.19.8424. Epub 2009 Apr 6.

ReferenceCitation: van der Sangen MJ, van de Poll-Franse LV, Roumen RM, Rutten HJ, Coebergh JW, Vreugdenhil G, Voogd AC. The prognosis of patients with local recurrence more than five years after breast conservation therapy for invasive breast carcinoma. Eur J Surg Oncol. 2006 Feb;32(1):34-8. Epub 2005 Nov 21.

ReferenceCitation: Galper S, Blood E, Gelman R, Abner A, Recht A, Kohli A, Wong JS, Smith D, Bellon J, Connolly J, Schnitt S, Winer E, Silver B, Harris JR. Prognosis after local recurrence after conservative surgery and radiation for early-stage breast cancer. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):348-57.

ReferenceCitation: Lê MG, Arriagada R, Spielmann M, Guinebretière JM, Rochard F. Prognostic factors for death after an isolated local recurrence in patients with early-stage breast carcinoma. Cancer. 2002 Jun 1;94(11):2813-20.

ReferenceCitation: Courdi A, Doyen J, Gal J, Chamorey E. Local recurrence after breast cancer affects specific survival differently according to patient age. Oncology. 2010;79(5-6):349-54. doi: 10.1159/000323483. Epub 2011 Mar 23.

ReferenceCitation: Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17.

ReferenceCitation: Sabatier R, Finetti P, Cervera N, Tallet A, Benchalal M, Houvenaeghel G, Jacquemier J, Birnbaum D, Bertucci F. Gene expression profiling and its utility in prediction of local relapse after breast-conserving therapy in early breast cancer. Cancer Genomics Proteomics. 2011 Jul-Aug;8(4):199-209.

ReferenceCitation: Kurtz JM, Jacquemier J, Amalric R, Brandone H, Ayme Y, Hans D, Bressac C, Spitalier JM. Is breast conservation after local recurrence feasible? Eur J Cancer. 1991;27(3):240-4.

ReferenceCitation: Salvadori B, Marubini E, Miceli R, Conti AR, Cusumano F, Andreola S, Zucali R, Veronesi U. Reoperation for locally recurrent breast cancer in patients previously treated with conservative surgery. Br J Surg. 1999 Jan;86(1):84-7.

ReferenceCitation: Alpert TE, Kuerer HM, Arthur DW, Lannin DR, Haffty BG. Ipsilateral breast tumor recurrence after breast conservation therapy: outcomes of salvage mastectomy vs. salvage breast-conserving surgery and prognostic factors for salvage breast preservation. Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):845-51.

ReferenceCitation: Gentilini O, Botteri E, Veronesi P, Sangalli C, Del Castillo A, Ballardini B, Galimberti V, Rietjens M, Colleoni M, Luini A, Veronesi U. Repeating conservative surgery after ipsilateral breast tumor reappearance: criteria for selecting the best candidates. Ann Surg Oncol. 2012 Nov;19(12):3771-6. doi: 10.1245/s10434-012-2404-5. Epub 2012 May 23.

ReferenceCitation: Deutsch M. Repeat high-dose external beam irradiation for in-breast tumor recurrence after previous lumpectomy and whole breast irradiation. Int J Radiat Oncol Biol Phys. 2002 Jul 1;53(3):687-91.

ReferenceCitation: Hannoun-Levi JM, Ihrai T, Courdi A. Local treatment options for ipsilateral breast tumour recurrence. Cancer Treat Rev. 2013 Nov;39(7):737-41. doi: 10.1016/j.ctrv.2013.02.003. Epub 2013 Mar 5. Review.

ReferenceCitation: Chadha M, Feldman S, Boolbol S, Wang L, Harrison LB. The feasibility of a second lumpectomy and breast brachytherapy for localized cancer in a breast previously treated with lumpectomy and radiation therapy for breast cancer. Brachytherapy. 2008 Jan-Mar;7(1):22-8. doi: 10.1016/j.brachy.2007.10.006.

ReferenceCitation: Trombetta M, Julian TB, Werts ED, Colonias A, Betler J, Kotinsley K, Kim Y, Parda D. Comparison of conservative management techniques in the re-treatment of ipsilateral breast tumor recurrence. Brachytherapy. 2011 Jan-Feb;10(1):74-80. doi: 10.1016/j.brachy.2010.01.005. Epub 2010 Aug 4.

ReferenceCitation: Wapnir IL, Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Mamounas EP, Wolmark N. Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a prospective randomized trial evaluating chemotherapy after local therapy for isolated locoregional recurrences of breast cancer. Ann Surg Oncol. 2008 Nov;15(11):3227-31. doi: 10.1245/s10434-008-0129-2. Epub 2008 Sep 11.

ReferenceCitation: Aebi S, Gelber S, Anderson SJ, Láng I, Robidoux A, Martín M, Nortier JW, Paterson AH, Rimawi MF, Cañada JM, Thürlimann B, Murray E, Mamounas EP, Geyer CE Jr, Price KN, Coates AS, Gelber RD, Rastogi P, Wolmark N, Wapnir IL; CALOR investigators. Chemotherapy for isolated locoregional recurrence of breast cancer (CALOR): a randomised trial. Lancet Oncol. 2014 Feb;15(2):156-63. doi: 10.1016/S1470-2045(13)70589-8. Epub 2014 Jan 16.

ReferenceCitation: Borner M, Bacchi M, Goldhirsch A, Greiner R, Harder F, Castiglione M, Jungi WF, Thürlimann B, Cavalli F, Obrecht JP, et al. First isolated locoregional recurrence following mastectomy for breast cancer: results of a phase III multicenter study comparing systemic treatment with observation after excision and radiation. Swiss Group for Clinical Cancer Research. J Clin Oncol. 1994 Oct;12(10):2071-7.

ReferenceCitation: Waeber M, Castiglione-Gertsch M, Dietrich D, Thürlimann B, Goldhirsch A, Brunner KW, Borner MM; Swiss Group for Clinical Cancer Research (SAKK). Adjuvant therapy after excision and radiation of isolated postmastectomy locoregional breast cancer recurrence: definitive results of a phase III randomized trial (SAKK 23/82) comparing tamoxifen with observation. Ann Oncol. 2003 Aug;14(8):1215-21.

ReferenceCitation: Doyle T, Schultz DJ, Peters C, Harris E, Solin LJ. Long-term results of local recurrence after breast conservation treatment for invasive breast cancer. Int J Radiat Oncol Biol Phys. 2001 Sep 1;51(1):74-80.

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ReferenceCitation: Kraus-Tiefenbacher U, Bauer L, Scheda A, Schoeber C, Schaefer J, Steil V, Wenz F. Intraoperative radiotherapy (IORT) is an option for patients with localized breast recurrences after previous external-beam radiotherapy. BMC Cancer. 2007 Sep 14;7:178.

ReferenceCitation: Kauer-Dorner D, Pötter R, Resch A, Handl-Zeller L, Kirchheiner K, Meyer-Schell K, Dörr W. Partial breast irradiation for locally recurrent breast cancer within a second breast conserving treatment: alternative to mastectomy? Results from a prospective trial. Radiother Oncol. 2012 Jan;102(1):96-101. doi: 10.1016/j.radonc.2011.07.020. Epub 2011 Sep 8.

ReferenceCitation: Guix B, Lejárcegui JA, Tello JI, Zanón G, Henríquez I, Finestres F, Martínez A, Fernandez-Ibiza J, Quinzaños L, Palombo P, Encinas X, Guix I. Exeresis and brachytherapy as salvage treatment for local recurrence after conservative treatment for breast cancer: results of a ten-year pilot study. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):804-10. doi: 10.1016/j.ijrobp.2009.08.009. Epub 2010 Jan 26.

ReferenceCitation: Nairz O, Deutschmann H, Kopp M, Wurstbauer K, Kametriser G, Fastner G, Merz F, Reitsamer R, Menzel C, Sedlmayer F. A dosimetric comparison of IORT techniques in limited-stage breast cancer. Strahlenther Onkol. 2006 Jun;182(6):342-8.

ReferenceCitation: Herskind C, Griebel J, Kraus-Tiefenbacher U, Wenz F. Sphere of equivalence--a novel target volume concept for intraoperative radiotherapy using low-energy X rays. Int J Radiat Oncol Biol Phys. 2008 Dec 1;72(5):1575-81. doi: 10.1016/j.ijrobp.2008.08.009.

ReferenceCitation: Liu Q, Schneider F, Ma L, Wenz F, Herskind C. Relative Biologic Effectiveness (RBE) of 50 kV X-rays measured in a phantom for intraoperative tumor-bed irradiation. Int J Radiat Oncol Biol Phys. 2013 Mar 15;85(4):1127-33. doi: 10.1016/j.ijrobp.2012.08.005. Epub 2012 Sep 14.

ReferenceCitation: Reitsamer R, Fastner G, Kopp M, Menzel C, Sedlmayer F. Intraoperative radiotherapy for early breast cancer. Lancet. 2010 Oct 2;376(9747):1141; author reply 1143-4. doi: 10.1016/S0140-6736(10)61529-2.

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ReferenceCitation: Reitsamer R, Sedlmayer F, Kopp M, Kametriser G, Menzel C, Deutschmann H, Nairz O, Hitzl W, Peintinger F. The Salzburg concept of intraoperative radiotherapy for breast cancer: results and considerations. Int J Cancer. 2006 Jun 1;118(11):2882-7.

ReferenceCitation: Dubois JB, Hay M, Gely S, Saint-Aubert B, Rouanet P, Pujol H. IORT in breast carcinomas. Front Radiat Ther Oncol. 1997;31:131-7.

ReferenceCitation: Fastner G, Sedlmayer F, Merz F, Deutschmann H, Reitsamer R, Menzel C, Stierle C, Farmini A, Fischer T, Ciabattoni A, Mirri A, Hager E, Reinartz G, Lemanski C, Orecchia R, Valentini V. IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: long term results of an ISIORT pooled analysis. Radiother Oncol. 2013 Aug;108(2):279-86. doi: 10.1016/j.radonc.2013.05.031. Epub 2013 Jul 2.

ReferenceCitation: Lemanski C, Azria D, Thezenas S, Gutowski M, Saint-Aubert B, Rouanet P, Fenoglietto P, Ailleres N, Dubois JB. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1410-5. Epub 2006 Jan 25.

ReferenceCitation: Lemanski C, Azria D, Gourgon-Bourgade S, Gutowski M, Rouanet P, Saint-Aubert B, Ailleres N, Fenoglietto P, Dubois JB. Intraoperative radiotherapy in early-stage breast cancer: results of the montpellier phase II trial. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.

ReferenceCitation: Welzel G, Boch A, Sperk E, Hofmann F, Kraus-Tiefenbacher U, Gerhardt A, Suetterlin M, Wenz F. Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. Radiat Oncol. 2013 Jan 7;8:9. doi: 10.1186/1748-717X-8-9.

ReferenceCitation: Sperk E, Welzel G, Keller A, Kraus-Tiefenbacher U, Gerhardt A, Sütterlin M, Wenz F. Late radiation toxicity after intraoperative radiotherapy (IORT) for breast cancer: results from the randomized phase III trial TARGIT A. Breast Cancer Res Treat. 2012 Aug;135(1):253-60. doi: 10.1007/s10549-012-2168-4. Epub 2012 Jul 29.

ReferenceCitation: Grobmyer SR, Lightsey JL, Bryant CM, Shaw C, Yeung A, Bhandare N, Hitchingham B, Copeland EM 3rd. Low-kilovoltage, single-dose intraoperative radiation therapy for breast cancer: results and impact on a multidisciplinary breast cancer program. J Am Coll Surg. 2013 Apr;216(4):617-23; discussion 623-4. doi: 10.1016/j.jamcollsurg.2012.12.038. Epub 2013 Feb 14.

ReferenceCitation: Keshtgar MR, Williams NR, Bulsara M, Saunders C, Flyger H, Cardoso JS, Corica T, Bentzon N, Michalopoulos NV, Joseph DJ. Objective assessment of cosmetic outcome after targeted intraoperative radiotherapy in breast cancer: results from a randomised controlled trial. Breast Cancer Res Treat. 2013 Aug;140(3):519-25. doi: 10.1007/s10549-013-2641-8. Epub 2013 Jul 23.

ReferenceCitation: Dubois JB, Gu SD, Hay MH, Gely S, Delard R, Joyeux H, Solassol C, Pujol H. Intra-operative radiation therapy (IORT) with 100 kV X photons. Experience on 170 patients. Pathol Biol (Paris). 1992 Nov;39(9):884-5.

ReferenceCitation: Lemanski C, Azria D, Gourgou-Bourgade S, Ailleres N, Pastant A, Rouanet P, Fenoglietto P, Dubois JB, Gutowski M. Electrons for intraoperative radiotherapy in selected breast-cancer patients: late results of the Montpellier phase II trial. Radiat Oncol. 2013 Aug 1;8:191. doi: 10.1186/1748-717X-8-191.

ReferenceCitation: Neumaier C, Elena S, Grit W, Yasser AM, Uta KT, Anke K, Axel G, Marc S, Frederik W. TARGIT-E(lderly)--prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer. BMC Cancer. 2012 May 8;12:171. doi: 10.1186/1471-2407-12-171.

ReferenceCitation: Azria D, Belkacemi Y, Romieu G, Gourgou S, Gutowski M, Zaman K, Moscardo CL, Lemanski C, Coelho M, Rosenstein B, Fenoglietto P, Crompton NE, Ozsahin M. Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. Lancet Oncol. 2010 Mar;11(3):258-65. doi: 10.1016/S1470-2045(10)70013-9. Epub 2010 Feb 6.

family: Azria

full_name: David Azria

family: Belkacemi

full_name: Yazid Belkacemi

given: Yazid

family: Romieu

full_name: Gilles Romieu

given: Gilles

family: Gourgou

full_name: Sophie Gourgou

given: Sophie

family: Gutowski

full_name: Marian Gutowski

given: Marian

family: Zaman

full_name: Khalil Zaman

given: Khalil

family: Moscardo

full_name: Carmen Llacer Moscardo

title: Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial

ReferenceCitation: Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33.

ReferenceCitation: Rothkamm K, Beinke C, Romm H, Badie C, Balagurunathan Y, Barnard S, Bernard N, Boulay-Greene H, Brengues M, De Amicis A, De Sanctis S, Greither R, Herodin F, Jones A, Kabacik S, Knie T, Kulka U, Lista F, Martigne P, Missel A, Moquet J, Oestreicher U, Peinnequin A, Poyot T, Roessler U, Scherthan H, Terbrueggen B, Thierens H, Valente M, Vral A, Zenhausern F, Meineke V, Braselmann H, Abend M. Comparison of established and emerging biodosimetry assays. Radiat Res. 2013 Aug;180(2):111-9. doi: 10.1667/RR3231.1. Epub 2013 Jul 17.

ReferenceCitation: Templin T, Paul S, Amundson SA, Young EF, Barker CA, Wolden SL, Smilenov LB. Radiation-induced micro-RNA expression changes in peripheral blood cells of radiotherapy patients. Int J Radiat Oncol Biol Phys. 2011 Jun 1;80(2):549-57. doi: 10.1016/j.ijrobp.2010.12.061. Epub 2011 Mar 21.

ReferenceCitation: Park SH, Kim MJ, Park BW, Moon HJ, Kwak JY, Kim EK. Impact of preoperative ultrasonography and fine-needle aspiration of axillary lymph nodes on surgical management of primary breast cancer. Ann Surg Oncol. 2011 Mar;18(3):738-44. doi: 10.1245/s10434-010-1347-y. Epub 2010 Oct 2.

ReferenceCitation: MacNeill M, Arnott I, Thomas J. Fine needle aspiration cytology is a valuable adjunct to axillary ultrasound in the preoperative staging of breast cancer. J Clin Pathol. 2011 Jan;64(1):42-6. doi: 10.1136/jcp.2010.083063. Epub 2010 Nov 19.

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

location_facility:
Centre Léon Bérard
Chu Brest
Institut de Cancérologie de l'Ouest
Centre George Francois Leclerc
CHU La TIMONE
Institut Paoli Calmette
Institut Bergonié
CRLC Val d'Aurelle


title: RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK1/2/3, ROS1 or ALK Gene Fusions.

acronym: RNASARC

summary: This trial is a multicenter, prospective cohort study aiming to describe molecular profiles of soft tissue sarcoma (STS) with complex genomic profiles in particular to assess the incidence of NTRK1/2/3, ROS1 or ALK gene fusions to direct such patients through an ongoing clinical trial with entrectinib when appropriate. An exploratory translational program is also correlated to this trial in order to analyse immune gene expression.

primary_purpose: Screening

ReferenceCitation: Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R Jr, Conti I, Cosaert J, Schwartz GK. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. Lancet. 2016 Jul 30;388(10043):488-97. doi: 10.1016/S0140-6736(16)30587-6. Epub 2016 Jun 9. Erratum in: Lancet. 2016 Jul 30;388(10043):464.

ReferenceCitation: Jain S, Xu R, Prieto VG, Lee P. Molecular classification of soft tissue sarcomas and its clinical applications. Int J Clin Exp Pathol. 2010 Apr 23;3(4):416-28. Review.

ReferenceCitation: Fleitas T, Ibarrola-Villava M, Ribas G, Cervantes A. MassARRAY determination of somatic oncogenic mutations in solid tumors: Moving forward to personalized medicine. Cancer Treat Rev. 2016 Sep;49:57-64. doi: 10.1016/j.ctrv.2016.07.007. Epub 2016 Jul 29. Review.

ReferenceCitation: Schmidt KT, Chau CH, Price DK, Figg WD. Precision Oncology Medicine: The Clinical Relevance of Patient-Specific Biomarkers Used to Optimize Cancer Treatment. J Clin Pharmacol. 2016 Dec;56(12):1484-1499. doi: 10.1002/jcph.765. Epub 2016 Jun 17. Review.

ReferenceCitation: Nakagawara A. Trk receptor tyrosine kinases: a bridge between cancer and neural development. Cancer Lett. 2001 Aug 28;169(2):107-14. Review.

ReferenceCitation: Pulciani S, Santos E, Lauver AV, Long LK, Aaronson SA, Barbacid M. Oncogenes in solid human tumours. Nature. 1982 Dec 9;300(5892):539-42.

ReferenceCitation: Martin-Zanca D, Hughes SH, Barbacid M. A human oncogene formed by the fusion of truncated tropomyosin and protein tyrosine kinase sequences. Nature. 1986 Feb 27-Mar 5;319(6056):743-8.

ReferenceCitation: Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. doi: 10.1056/NEJMoa1406766. Epub 2014 Sep 27.

ReferenceCitation: Shaw AT, Kim DW, Mehra R, Tan DS, Felip E, Chow LQ, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Lau YY, Goldwasser M, Boral AL, Engelman JA. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Mar 27;370(13):1189-97. doi: 10.1056/NEJMoa1311107.

ReferenceCitation: Vaishnavi A, Le AT, Doebele RC. TRKing down an old oncogene in a new era of targeted therapy. Cancer Discov. 2015 Jan;5(1):25-34. doi: 10.1158/2159-8290.CD-14-0765. Epub 2014 Dec 19. Review.

ReferenceCitation: Doebele RC, Davis LE, Vaishnavi A, Le AT, Estrada-Bernal A, Keysar S, Jimeno A, Varella-Garcia M, Aisner DL, Li Y, Stephens PJ, Morosini D, Tuch BB, Fernandes M, Nanda N, Low JA. An Oncogenic NTRK Fusion in a Patient with Soft-Tissue Sarcoma with Response to the Tropomyosin-Related Kinase Inhibitor LOXO-101. Cancer Discov. 2015 Oct;5(10):1049-57. doi: 10.1158/2159-8290.CD-15-0443. Epub 2015 Jul 27.

ReferenceCitation: Judson I, Verweij J, Gelderblom H, Hartmann JT, Schöffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litière S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.

family: Judson

full_name: Ian Judson

given: Ian

family: Verweij

full_name: Jaap Verweij

given: Jaap

family: Gelderblom

full_name: Hans Gelderblom

given: Hans

family: Hartmann

full_name: Jörg T Hartmann

given: Jörg T

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Kerst

full_name: J Martijn Kerst

given: J Martijn

family: Sufliarsky

full_name: Josef Sufliarsky

given: Josef

family: Whelan

full_name: Jeremy Whelan

given: Jeremy

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

family: Krarup-Hansen

full_name: Anders Krarup-Hansen

given: Anders

family: Alcindor

full_name: Thierry Alcindor

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: Litière

full_name: Saskia Litière

given: Saskia

family: Hermans

full_name: Catherine Hermans

given: Catherine

family: Fisher

full_name: Cyril Fisher

given: Cyril

family: Hogendoorn

full_name: Pancras C W Hogendoorn

given: Pancras C W

family: dei Tos

full_name: A Paolo dei Tos

given: A Paolo

family: van der Graaf

full_name: Winette T A van der Graaf

given: Winette T A

journal_name: The Lancet Oncology

ReferenceCitation: Ryan CW, Merimsky O, Agulnik M, Blay JY, Schuetze SM, Van Tine BA, Jones RL, Elias AD, Choy E, Alcindor T, Keedy VL, Reed DR, Taub RN, Italiano A, Garcia Del Muro X, Judson IR, Buck JY, Lebel F, Lewis JJ, Maki RG, Schöffski P. PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma. J Clin Oncol. 2016 Nov 10;34(32):3898-3905. doi: 10.1200/JCO.2016.67.6684. Epub 2016 Sep 30.

name: Christopher W. Ryan, Oregon Health & Science University, Portland, OR; Ofer Merimsky, Sackler School of Medicine, Tel-Aviv, Israel; Mark Agulnik, Northwestern University, Chicago, IL; Jean-Yves Blay, Centre Léon Bérard, Lyon; Antoine Italiano, Institut Bergonié, Bordeaux, France; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Robin L. Jones and Ian R. Judson, The Royal Marsden Hospital, London, United Kingdom; Anthony D. Elias...

publisher: American Society of Clinical Oncology (ASCO)

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth


title: Levetiracetam Efficacy and Safety as First-line Treatment of Neonatal Seizures Occuring in Hypoxic-ischemic Encephalopathy Context

summary: LEVNEONAT is a multicentre French clinical trials with the aim to develop new treatment strategies for the treatment of neonatal seizures using Levetiracetam. The purpose of this study is to determine the correct dosing, safety and efficacy for intravenous levetiracetam as first line treatment in term newborn babies with seizures in hypoxic-ischemic encephalopathy context. This new anticonvulsivant drug is a promising treatment for seizures in newborns.

ReferenceType: derived

ReferenceCitation: Favrais G, Ursino M, Mouchel C, Boivin E, Jullien V, Zohar S, Saliba E. Levetiracetam optimal dose-finding as first-line treatment for neonatal seizures occurring in the context of hypoxic-ischaemic encephalopathy (LEVNEONAT-1): study protocol of a phase II trial. BMJ Open. 2019 Jan 24;9(1):e022739. doi: 10.1136/bmjopen-2018-022739.

family: Favrais

full_name: Geraldine Favrais

given: Geraldine

family: Ursino

full_name: Moreno Ursino

given: Moreno

family: Mouchel

full_name: Catherine Mouchel

family: Boivin

full_name: Estelle Boivin

given: Estelle

family: Jullien

full_name: Vincent Jullien

given: Vincent

family: Zohar

full_name: Sarah Zohar

given: Sarah

family: Saliba

full_name: Elie Saliba

given: Elie

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Tours

location_facility: Service de réanimation et service néonatale

location_facility: Service de Pédiatrie néonatale et réanimation

location_facility: Service de réanimation néonatale et pédiatrique

intervention_type: Drug


title: Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector CT for Arthrography of the Wrist, Ankle, Elbow and Knee

acronym: ARCOBE

summary: ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the limbs distal joints. Our hypothesis is that the cone-beam scanner could detect and characterize chondral lesions the cartilage similarly to a multidetector CT (MDCT). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or knee will be enrolled The primary endpoint based on the ability of cone-beam scanner to detect cartilage lesions. Secondary endpoints will concern the depiction of the joint lesions, quality of the images, tolerability of the exams and inter- intra-operator reproducibility. After arthrography, patients will have a MDCT considered as the reference exam, and a CBCT on a randomized order. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of cartilage lesion type between the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the consistency of the depiction of the lesions. A Student t test will be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not apply).

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon- hôpital Edouard Herriot- service de radiologie pavillon B


title: The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2

acronym: NIRS

summary: We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Study of Inflammatory Mechanisms in Epidermolysis Bullosa Simplex- Dowling Meara

summary:
Introduction: Epidermolysis Bullosa Simplex-Dowling-Meara (DM-EBS) is a rare genodermatosis characterized by spontaneous or post traumatic large cutaneous blisters. No curative treatment is actually available. Some data suggest a role of inflammation in the occurrence of blisters. The aim of this study is to study the epidermis inflammatory mechanisms in DM-EBS.

Material and methods: A first retrospective immunohistochemical study will be led on remainder skin biopsies of DM-EBS patients took for the diagnosis. A second clinical multicentric prospective study will be led on 8 patients older than 1 year with severe DM-EBS. After informed written consent, they will answer to a standardized questionnaire. In case of flare of the disease, the liquid and the top of the blisters will be took. Samples will be analyzed in the Pr Nicolas 851 INSERM unit. After centrifugation of the liquid blisters, the repartition of inflammatory cells will be evaluated by Fluorescence Activated Cell Sorting on the pellet. Markers of inflammation will be evaluated on the surnageant with Luminex® technical with a multiplex targeting cytokines and chemokines. An immuno-histochemic analysis in association with a quantitative PCR will be made on the top of the blisters. If unknown, genotypic study will be made.

Perspectives: A better comprehension of physiopathological mechanisms in DM-EBS could offer new therapeutic ways.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®

summary: The primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.

lead_sponsor: University Hospital, Montpellier


title: A Prospective, Observational, Open Label Study to Assess the 24-hour IOP Fluctuation Pattern Recorded With SENSIMED Triggerfish® in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

summary:
Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients.

The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.

lead_sponsor: Sensimed AG

location_facility: Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts


title: A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy

summary:
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork through the Schlemm's canal towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy (DS) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular meshwork. DS was shown to achieve a good control on IOP over the long term.

The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with Triggerfish in patients with POAG before and after DS.

status: Withdrawn

location_facility: Centre Hospitalier National d'Opthalmology des Quinze-Vingts


title: Study the Signs of Ocular Degeneration in a Population Cohort (Dijon 3C Montrachet Cohort): Seek Correlations Between Signs of Neurological and Vascular Degeneration and Signs of Ocular Aging

summary:
The aim of the study proposed in Dijon is above all to focus on the possible relationship between age-related ocular pathologies (AMD and glaucoma) and et les degenerative neurological and cardiac pathologies.

The principal objective is to seek in subjects who have undergone cerebral MRI and echocardiography, associations between the thickness of postganglionic fibers measured by Optical Coherence Tomography at the 7th year (n=1500) and signs of cerebral impairment (psycho-cognitive tests, circulation time, MRI signs). This association will be studied after taking into account the principal environmental (particularly dietary) and genetic risk factors.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods

acronym: IMPREA

summary: Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

summary:
Interferential current has shown promising results for treating psoriasis with a good tolerance. Prospective randomized studies versus placebo are required to confirm the interest of such an approach.

The Main objective is to assess the efficacy of interferential current for treating palmoplantar psoriasis.

Secondary objectives is to assess the subjective efficacy by the patients, the efficacy on the nails, to study the potential side effects.

lead_sponsor: Pr PASSERON

location_facility: ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière


title: Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU).

summary: Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU).

lead_sponsor: Theraclion


title: Contrast-harmonic Endoscopic Ultrasound (CH-EUS) for the Diagnosis of Pancreatic Adenocarcinoma: Results of the First Multicenter Prospective Study With Intra- and Interobserver Concordances Evaluation

summary:
Ductal adenocarcinoma is the most frequent pancreatic solid lesion and the most common tumor of the pancreas. Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory. EUS is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors [1-3]. Nevertheless it remains difficult to differentiate, on morphological features, PA from other solid masses. For 15 years, endoscopic ultrasound fine needle aspiration (EUS-FNA) has demonstrated its efficiency for tissue sampling and cyto-histologic diagnosis of PA. However, the negative predictive value (NPV) for the diagnosis of pancreatic adenocarcinoma (PA) remains low (30-70%) in the published prospective series [4]. So, in case of negative result, the choice between surgery and follow-up remains difficult. Additional criteria to get the decision are then warranted.

The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in real time with imaging specific methods seems useful to improve their characterization [4-8] either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-enhanced harmonic EUS (CH-EUS).

The aims of this prospective multicenter study is:

to compare the NPV of contrast-enhanced endoscopic ultrasound (CH-EUS) and EUS-FNA for the diagnosis of PA;
to assess the intra- and inter-observer concordances of CH-EUS for the diagnosis of PA.

lead_sponsor: Société Française d'Endoscopie Digestive

location_facility: Société Française d'Endoscopie Digrestive


title: to Evaluate the Long-term Results of Endoscopic Papillectomy (EP)

summary:
Adenoma of the ampulla of Vater is rare but represents a large proportion of benign tumors occurring in the small intestine. The symptoms are usually non specific or due to pancreaticobiliary obstruction . The diagnosis can also be made in asymptomatic patients during an upper gastrointestinal endoscopy. Finally, the adenoma can be discovered during a screening procedure in patients with Familial Adenomatous Polyposis (FAP).

It has been demonstrated that ampullary adenomas have a malignant potential mimicking the "adenoma-adenocarcinoma" sequence already described in the colon. So, a complete removal is mandatory. The only exception is represented by subnormal ampulla with low grade dysplasia (LGD) adenoma discovered during screening follow-up of FAP patients. In these cases the situation can be stable during several years leading to simple, annual or biannual surveillance. Historically, the treatment was surgical, associated with a high mortality and morbidity rate for pancreaticoduodenectomy (PD) and a high recurrence rate for transduodenal resection (26 to 43%). Endoscopic papillectomy (EP) represents an alternative for patients with a benign or at least non-invasive ampullary tumor. Unlike thermal ablative methods by laser photoablation or argon plasma destruction, EP allows adequate histologic evaluation especially in case of en-bloc resection. This technique has been increasingly used in the last decade with very promising results. Nevertheless the long-term results have mainly been reported in retrospective monocentric series.

We intended to evaluate, in the first large multicenter prospective study, the long-term results of endoscopic papillectomy.

ReferenceCitation: Napoleon B, Gincul R, Ponchon T, Berthiller J, Escourrou J, Canard JM, Boyer J, Barthet M, Ponsot P, Laugier R, Helbert T, Coumaros D, Scoazec JY, Mion F, Saurin JC; Sociéte Française d'Endoscopie Digestive (SFED, French Society of Digestive Endoscopy). Endoscopic papillectomy for early ampullary tumors: long-term results from a large multicenter prospective study. Endoscopy. 2014 Feb;46(2):127-34. doi: 10.1055/s-0034-1364875. Epub 2014 Jan 29.

family: Napoleon

full_name: Bertrand Napoleon

given: Bertrand

name: Service d’hépatogastroentérologie, Hôpital Edouard Herriot, Lyon, France

family: Gincul

full_name: Rodica Gincul

given: Rodica

family: Ponchon

full_name: Thierry Ponchon

given: Thierry

name: Unité d’épidémiologie clinique, Pôle Information Médicale Evaluation Recherche, Hospices Civils de Lyon, France

family: Berthiller

full_name: Julien Berthiller

given: Julien

name: Service de gastroentérologie CHU Rangueil 1, Toulouse, France

family: Escourrou

full_name: Jean Escourrou

given: Jean

family: Canard

full_name: Jean-Marc Canard

given: Jean-Marc

name: Service de gastroentérologie CHU Angers 4, Angers, France

family: Boyer

full_name: Jean Boyer

name: Service de gastroentérologie Hôpital Nord, Marseille, France

family: Barthet

full_name: Marc Barthet

given: Marc

name: Service de gastroentérologie Hôpital Beaujon, Clichy, France

family: Ponsot

full_name: Philippe Ponsot

given: Philippe

name: Service de gastroentérologie Hôpital de la Timone, Marseille, France

family: Laugier

full_name: René Laugier

given: René

name: Service de gastroentérologie Hôpital Ambroise Paré, Marseille, France

family: Helbert

full_name: Thierry Helbert

name: Hôpital Civil de Strasbourg, Strasbourg, France

family: Coumaros

full_name: Dimitri Coumaros

given: Dimitri

name: Service d’anatomopathologie, Hôpital Edouard Herriot, Lyon, France

family: Scoazec

full_name: Jean-Yves Scoazec

given: Jean-Yves

family: Mion

full_name: François Mion

given: François

family: Saurin

full_name: Jean-Christophe Saurin

given: Jean-Christophe

name: the Sociéte Française d’Endoscopie Digestive (SFED, French Society of Digestive Endoscopy)

journal_name: Endoscopy

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme


title: Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)

acronym: IROCA

summary:
The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon that the intensivist must recognize early and treat promptly. Fluid challenge may have adverse side effects associated with fluid administration. The diffusion within the interstitial space may favor edema formation and cause cardiac dysfunction by volume overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial integrity, leading to enhanced alveolar edema and impaired gas exchange.

Currently, two types of fluids are frequently used, crystalloids and colloids. Among colloids and compared to crystalloids, albumin has the theoretical advantage of causing greater volume expansion.

We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary edema than a fluid resuscitation therapy with crystalloids.

The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema fluid resorption, in 2 groups of patients: those treated with albumin and those treated with crystalloid.


title: Prospective, Single-blind, Randomized, Non-inferiority, and Controlled Study of Clinical and Health Economic Impact of Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery: the Case of Gastric Bypass

summary:
The purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass).

This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. It will also provide information on direct and indirect costs of surgery.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne


title: Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients

acronym: DARK

summary:
Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides.

As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis.

However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually.

The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Est


title: Long-term Anatomical and Functional Outcomes of Idiopathic Macular Hole Surgery. The Yield of Spectral-domain OCT Combined With Microperimetry.

summary: To evaluate the correlations between anatomical and functional changes studied with microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of idiopathic macular hole (MH).

time_perspective: Retrospective

ReferenceCitation: Bonnabel A, Bron AM, Isaico R, Dugas B, Nicot F, Creuzot-Garcher C. Long-term anatomical and functional outcomes of idiopathic macular hole surgery. The yield of spectral-domain OCT combined with microperimetry. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2505-11. doi: 10.1007/s00417-013-2339-y. Epub 2013 Apr 26.

family: Bonnabel

full_name: Arnaud Bonnabel

given: Arnaud

family: Bron

full_name: Alain M. Bron

given: Alain M.

family: Isaico

full_name: Rodica Isaico

family: Dugas

full_name: Brice Dugas

given: Brice

family: Nicot

full_name: Frédéric Nicot

given: Frédéric

family: Creuzot-Garcher

full_name: Catherine Creuzot-Garcher

given: Catherine

journal_name: Graefe's Archive for Clinical and Experimental Ophthalmology

publisher_normalized: Springer