title: Short and Long Term Fampridine Treatment in Persons With Multiple Sclerosis: Cognitive and Motor Performances

acronym: FAMPISEP

summary:
This prospective monocentric open label trial was realized in the Laboratory of Clinical Functional Exploration of Movement at the University Hospital of Besancon. Cognitive evaluations: 7 days before fampridine treatment initiation (Pre 1), on the day of fampridine treatment initiation (Pre 2), 14 and 21 days after fampridine treatment initiation, respectively Post 1 and Post 2. Gait evaluations were assessed at Pre 1, Pre 2 and Post 1.

Fampridine was prescribed according to guidelines issued by the French Health Products Safety Agency at the dose of 10 mg twice daily. Fampridine is indicated for the improvement of walking in MS patients with a walking disability (EDSS 4-6.5). A walking test is recommended to evaluate improvement after 2 weeks of treatment. According to the practitioner evaluation between Pre 2 and Post 1 (i.e. before and after fampridine treatment), patients were classified into 2 groups: responders whose clinical status was improved and non-responders whose clinical status was not improved.

ReferenceCitation: Allart E, Benoit A, Blanchard-Dauphin A, Tiffreau V, Thevenon A, Zephir H, Outteryck O, Lacour A, Vermersch P. Sustained-released fampridine in multiple sclerosis: effects on gait parameters, arm function, fatigue, and quality of life. J Neurol. 2015 Aug;262(8):1936-45. doi: 10.1007/s00415-015-7797-1. Epub 2015 Jun 5.

family: Allart

full_name: Etienne Allart

given: Etienne

family: Benoit

full_name: Anne Benoit

given: Anne

family: Blanchard-Dauphin

full_name: Anne Blanchard-Dauphin

family: Tiffreau

full_name: Vincent Tiffreau

given: Vincent

family: Thevenon

full_name: André Thevenon

given: André

family: Zephir

full_name: Hélène Zephir

given: Hélène

family: Outteryck

full_name: Olivier Outteryck

family: Lacour

full_name: Arnaud Lacour

given: Arnaud

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

journal_name: Journal of Neurology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Almarwani M, Perera S, VanSwearingen JM, Sparto PJ, Brach JS. The test-retest reliability and minimal detectable change of spatial and temporal gait variability during usual over-ground walking for younger and older adults. Gait Posture. 2016 Feb;44:94-9. doi: 10.1016/j.gaitpost.2015.11.014. Epub 2015 Nov 30.

family: Almarwani

full_name: Maha Almarwani

given: Maha

family: Perera

full_name: Subashan Perera

given: Subashan

family: VanSwearingen

full_name: Jessie M. VanSwearingen

given: Jessie M.

family: Sparto

full_name: Patrick J. Sparto

given: Patrick J.

family: Brach

full_name: Jennifer S. Brach

given: Jennifer S.

journal_name: Gait & Posture

oa_host_type: repository

version: acceptedVersion

title: The test–retest reliability and minimal detectable change of spatial and temporal gait variability during usual over-ground walking for younger and older adults

ReferenceCitation: Baert I, Freeman J, Smedal T, Dalgas U, Romberg A, Kalron A, Conyers H, Elorriaga I, Gebara B, Gumse J, Heric A, Jensen E, Jones K, Knuts K, Maertens de Noordhout B, Martic A, Normann B, Eijnde BO, Rasova K, Santoyo Medina C, Truyens V, Wens I, Feys P. Responsiveness and clinically meaningful improvement, according to disability level, of five walking measures after rehabilitation in multiple sclerosis: a European multicenter study. Neurorehabil Neural Repair. 2014 Sep;28(7):621-31. doi: 10.1177/1545968314521010. Epub 2014 Feb 6.

family: Baert

full_name: Ilse Baert

given: Ilse

name: Haukeland University Hospital, Bergen, Norway

name: Masku Neurological Rehabilitation Center, Masku, Finland

name: Sheba Medical Center, Tel-Hashomer, Israel

name: Poole Hospital, NHS Foundation Trust, Dorset, UK

name: Eugenia Epalza Rehabilitation Center, Bilbao, Spain

name: National Multiple Sclerosis Center, Melsbroek, Belgium

name: Multiple Sclerosis Center, Hakadal AS, Norway

name: Multiple Sclerosis Hospital, Haslev, Denmark

name: Multiple Sclerosis Hospital, Ry, Denmark

name: Rehabilitation and Multiple Sclerosis Center, Overpelt, Belgium

name: Centre Neurologique et de Réadaptation Fonctionelle, Fraiture-en-Condroz, Belgium

name: University Medical Center, Ljubljana, Slovenia

name: Kongsgaarden Physiotherapy AS/Nordland Hospital Trust, Bodø, Norway

name: Charles University, Prague, Czech Republic

name: Hospital de Dia de Barcelona, CEMCat, Barcelona, Spain

title: Responsiveness and Clinically Meaningful Improvement, According to Disability Level, of Five Walking Measures After Rehabilitation in Multiple Sclerosis

ReferenceCitation: Baroin A, Chopard G, Siliman G, Michoudet C, Vivot A, Vidal C, Mokadym H, Lavier A, Berger E, Rumbach L, Rude N. Validation of a new quality of life scale related to multiple sclerosis and relapses. Qual Life Res. 2013 Oct;22(8):1943-54. doi: 10.1007/s11136-012-0334-0. Epub 2012 Dec 18.

ReferenceCitation: Bland JM, Altman DG. Measurement error. BMJ. 1996 Jun 29;312(7047):1654. Corrected and republished in: BMJ. 1996 Sep 21;313(7059):744.

ReferenceCitation: Brochet B, Deloire MS, Bonnet M, Salort-Campana E, Ouallet JC, Petry KG, Dousset V. Should SDMT substitute for PASAT in MSFC? A 5-year longitudinal study. Mult Scler. 2008 Nov;14(9):1242-9. doi: 10.1177/1352458508094398. Epub 2008 Jul 24.

name: EA 2966, Université de Bordeaux, and Services de Neurologie et Neuroradiologie, CHU de Bordeaux, Bordeaux, France

name: Service de Neurologie et des maladies neuromusculaires, APHM, CHU de Marseille, Marseille, France

ReferenceCitation: Confavreux C, Vukusic S. The clinical epidemiology of multiple sclerosis. Neuroimaging Clin N Am. 2008 Nov;18(4):589-622, ix-x. doi: 10.1016/j.nic.2008.09.002. Review.

title: The Clinical Epidemiology of Multiple Sclerosis

ReferenceCitation: Debouverie M, Pittion-Vouyovitch S, Louis S, Guillemin F. Validity of a French version of the fatigue impact scale in multiple sclerosis. Mult Scler. 2007 Sep;13(8):1026-32.

ReferenceCitation: de Vet HC, Terwee CB, Knol DL, Bouter LM. When to use agreement versus reliability measures. J Clin Epidemiol. 2006 Oct;59(10):1033-9. Epub 2006 Aug 10.

ReferenceCitation: Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis. 1994 Jan;18 Suppl 1:S79-83.

ReferenceCitation: Givon U, Zeilig G, Achiron A. Gait analysis in multiple sclerosis: characterization of temporal-spatial parameters using GAITRite functional ambulation system. Gait Posture. 2009 Jan;29(1):138-42. doi: 10.1016/j.gaitpost.2008.07.011. Epub 2008 Oct 31.

title: Gait analysis in multiple sclerosis: Characterization of temporal–spatial parameters using GAITRite functional ambulation system

ReferenceCitation: Goldman MD, Marrie RA, Cohen JA. Evaluation of the six-minute walk in multiple sclerosis subjects and healthy controls. Mult Scler. 2008 Apr;14(3):383-90. Epub 2007 Oct 17.

ReferenceCitation: Goodkin DE. EDSS reliability. Neurology. 1991 Feb;41(2 ( Pt 1)):332.

ReferenceCitation: Goodman AD, Bethoux F, Brown TR, Schapiro RT, Cohen R, Marinucci LN, Henney HR 3rd, Blight AR; MS-F203, MS-F204, and Extension Study Investigators. Long-term safety and efficacy of dalfampridine for walking impairment in patients with multiple sclerosis: Results of open-label extensions of two Phase 3 clinical trials. Mult Scler. 2015 Sep;21(10):1322-31. doi: 10.1177/1352458514563591. Epub 2015 Jan 12.

name: University of Rochester Medical Center, Rochester, NY, USA

name: Evergreen Neuroscience Institute and Medical Center, Kirkland, WA, USA

name: The Schapiro Multiple Sclerosis Advisory Group, Eagle, CO, USA

name: on behalf of the MS-F203, MS-F204, and Extension Study Investigators

ReferenceCitation: Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.

ReferenceCitation: Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6.

ReferenceCitation: Hobart J, Blight AR, Goodman A, Lynn F, Putzki N. Timed 25-foot walk: direct evidence that improving 20% or greater is clinically meaningful in MS. Neurology. 2013 Apr 16;80(16):1509-17. doi: 10.1212/WNL.0b013e31828cf7f3. Epub 2013 Mar 27. Review.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Timed 25-Foot Walk: Direct evidence that improving 20% or greater is clinically meaningful in MS

ReferenceCitation: Kalron A, Dvir Z, Achiron A. Walking while talking--difficulties incurred during the initial stages of multiple sclerosis disease process. Gait Posture. 2010 Jul;32(3):332-5. doi: 10.1016/j.gaitpost.2010.06.002. Epub 2010 Jul 1.

title: Walking while talking—Difficulties incurred during the initial stages of multiple sclerosis disease process

ReferenceCitation: Kalron A. Gait variability across the disability spectrum in people with multiple sclerosis. J Neurol Sci. 2016 Feb 15;361:1-6. doi: 10.1016/j.jns.2015.12.012. Epub 2015 Dec 10.

ReferenceCitation: Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.

ReferenceCitation: Learmonth YC, Paul L, McFadyen AK, Mattison P, Miller L. Reliability and clinical significance of mobility and balance assessments in multiple sclerosis. Int J Rehabil Res. 2012 Mar;35(1):69-74. doi: 10.1097/MRR.0b013e328350b65f.

journal_name: International Journal of Rehabilitation Research

ReferenceCitation: Moon Y, Wajda DA, Motl RW, Sosnoff JJ. Stride-Time Variability and Fall Risk in Persons with Multiple Sclerosis. Mult Scler Int. 2015;2015:964790. doi: 10.1155/2015/964790. Epub 2015 Dec 30.

name: Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, 906 S. Goodwin Avenue, Urbana, IL 61801, USA

ReferenceCitation: Motl RW, Dlugonski D, Suh Y, Weikert M, Fernhall B, Goldman M. Accelerometry and its association with objective markers of walking limitations in ambulatory adults with multiple sclerosis. Arch Phys Med Rehabil. 2010 Dec;91(12):1942-7. doi: 10.1016/j.apmr.2010.08.011.

journal_name: Archives of Physical Medicine and Rehabilitation

title: Accelerometry and Its Association With Objective Markers of Walking Limitations in Ambulatory Adults With Multiple Sclerosis

ReferenceCitation: Motl RW, Sosnoff JJ, Dlugonski D, Pilutti LA, Klaren R, Sandroff BM. Walking and cognition, but not symptoms, correlate with dual task cost of walking in multiple sclerosis. Gait Posture. 2014 Mar;39(3):870-4. doi: 10.1016/j.gaitpost.2013.11.023. Epub 2013 Dec 14.

ReferenceCitation: Pilutti LA, Dlugonski D, Sandroff BM, Suh Y, Pula JH, Sosnoff JJ, Motl RW. Gait and six-minute walk performance in persons with multiple sclerosis. J Neurol Sci. 2013 Nov 15;334(1-2):72-6. doi: 10.1016/j.jns.2013.07.2511. Epub 2013 Jul 30.

ReferenceCitation: Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O'Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2005 revisions to the "McDonald Criteria". Ann Neurol. 2005 Dec;58(6):840-6. Review.

ReferenceCitation: Sandroff BM, Pilutti LA, Motl RW. Does the six-minute walk test measure walking performance or physical fitness in persons with multiple sclerosis? NeuroRehabilitation. 2015;37(1):149-55. doi: 10.3233/NRE-151247.

ReferenceCitation: van Uden CJ, Besser MP. Test-retest reliability of temporal and spatial gait characteristics measured with an instrumented walkway system (GAITRite). BMC Musculoskelet Disord. 2004 May 17;5:13.

ReferenceCitation: Vlaar AM, Wade DT. Verbal fluency assessment of patients with multiple sclerosis: test-retest and inter-observer reliability. Clin Rehabil. 2003 Nov;17(7):756-64.

ReferenceCitation: Wajda DA, Motl RW, Sosnoff JJ. Dual task cost of walking is related to fall risk in persons with multiple sclerosis. J Neurol Sci. 2013 Dec 15;335(1-2):160-3. doi: 10.1016/j.jns.2013.09.021. Epub 2013 Sep 20.

ReferenceCitation: Magnin E, Sagawa Y, Moulin T, Decavel P. What Are the Minimal Detectable Changes in SDMT and Verbal Fluency Tests for Assessing Changes in Cognitive Performance in Persons with Multiple Sclerosis and Non-Multiple Sclerosis Controls? Eur Neurol. 2020;83(3):263-270. doi: 10.1159/000508607. Epub 2020 Jul 7.


title: Future of the Older Patients After Intensive Care Unit

acronym: DAAR

summary: Estimate the future six months after the admission in an intensive care unit of the patients of 85 and more years old in terms of autonomy.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Khouli H, Astua A, Dombrowski W, Ahmad F, Homel P, Shapiro J, Singh J, Nallamothu R, Mahbub H, Eden E, Delfiner J. Changes in health-related quality of life and factors predicting long-term outcomes in older adults admitted to intensive care units. Crit Care Med. 2011 Apr;39(4):731-7. doi: 10.1097/CCM.0b013e318208edf8.

ReferenceCitation: Lewis-Newby M, Curtis JR, Martin DP, Engelberg RA. Measuring family satisfaction with care and quality of dying in the intensive care unit: does patient age matter? J Palliat Med. 2011 Dec;14(12):1284-90. doi: 10.1089/jpm.2011.0138. Epub 2011 Nov 22.

ReferenceCitation: Biston P, Aldecoa C, Devriendt J, Madl C, Chochrad D, Vincent JL, De Backer D. Outcome of elderly patients with circulatory failure. Intensive Care Med. 2014 Jan;40(1):50-6. doi: 10.1007/s00134-013-3121-7. Epub 2013 Oct 17.

ipd_sharing: No

lead_sponsor: Centre Hospitalier René Dubos

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: EudraCT Number

title: Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study

summary: Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast surgery.

study_start_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Lille

intervention_type: Drug


title: Study to Evaluation Interest of the Circulating Tumor DNA Dosage in Patient With Hepatic Metastatic Uveal Melanoma Candidate to Complete Resection (R0)

summary: Prospective, open labelled, monocentric trial to evaluation of the circulating tumor DNA rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (HMUM) and during post-surgery follow-up

primary_purpose: Other

ipd_sharing: Yes

lead_sponsor: Institut Curie

intervention_type: Biological


title: Re-training to Effort (RE) According to the Severity of Multiple Sclerosis: Preliminary Assessments Based on Fatigue and Quality of Life

acronym: RE-SEP

summary:
Regular physical activity promotes physical and mental well-being in the general population. Patients with multiple sclerosis (MS patients) tend them, to limit their physical activity or because of deficiencies related to the disease, or even on the advice of their caregivers in order to save their functional abilities. Time for leisure activity could be almost 20% lower in MS patients compared to healthy controls, and this situation is likely to aggravate the functional symptoms of multiple sclerosis.

The literature described the benefit of physical activity for MS patients according to protocols and varied assessments. Evaluations were indeed concern very analytical elements of metabolic functioning, nervous, muscular, cardiopulmonary etc ... or take into account the performance of components or fatigue and quality of life. Due to the multiplicity of RE protocols, sometimes on the verge of pragmatic goals of functional rehabilitation, the double issue was the profit earned by an RE program and of this benefit by level of severity of MS. The main objective of our study was an evaluation of the effects on fatigue and quality of life of a retraining program to effort suitable for levels of impairment and patients with MS activity limitations. The secondary objective was checking a performance improvement of the patients in this adapted program.

lead_sponsor: Nantes University Hospital


title: Validation of a Predictive Nomogram of Response or Resistance to Targeted Therapies in Metastatic Clear Cell Renal Cell Carcinoma

acronym: RTKI

summary: The purpose of this study is to validate of a predictive nomogram of response or resistance to targeted therapies in metastatic clear cell renal cell carcinoma

time_perspective: Retrospective

lead_sponsor: Rennes University Hospital


type: Registry Identifier

title: Study " COFLORES ":Imaging of Coronary Reserve Without Tracers

summary:
Myocardial perfusion is a major parameter characterizing the status of capillary circulation of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI) during the 1st pass of a contrast agent through the capillary system. This technique is radiation-free, but it is difficult to repeat measurements during a single exam. Also, a number of patients suffering from cardiac disease cannot receive contrast agent injections. The investigators have developed a totally non-invasive approach for quantifying myocardial perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the capillaries (Arterial spin labeling, ASL).

Goal : The major goal of this research protocol is to validate a totally non-invasive method of myocardial blood flow quantification using MRI without contrast agent injection

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Device

status_simplified: Unknown


title: Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol

acronym: ANTICONEURORAD

summary: To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. However, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. Furthermore, the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: The Value of the Neutrophil to Lymphocyte Ratio in the Diagnosis of Bacterial Infections

acronym: RNL-MI

summary:
The "gold standard" for diagnosing a bacterial infection is isolation of the pathogenic germ, which is not easy in routine clinical practice.

Conventional markers do not have sufficient diagnostic value for making a rapid diagnosis on admission. A 2004 literature calculated the diagnostic values of C-reactive protein (CRP) and procalcitonin (PCT) levels for the diagnosis of bacterial infections, relative to other causes of inflammation. For CRP, the sensitivity was 75% (95% CI: 62%-84%) and the specificity was 67% (95% CI: 56%-77%). For PCT, the sensitivity was 88% (95% CI: 62%-84%) and the specificity was 81% (95% CI: 67%-90%).

The first cellular immune response to infection consists of the mobilization of polynuclear neutrophils from the bone marrow to the infection site under the effect of pre-inflammatory cytokines, as well as the apoptosis of lymphocytes and their sequestration at the infection site. This results in lymphopenia and the elevated polynuclear neutrophil count (PNN) observed in bacterial infections.

Hence, it is legitimate to hypothesize that the neutrophil to lymphocyte ratio (NLR) can be used in the diagnosis of bacterial infection. This ratio's value in the diagnosis of sepsis in the emergency department was studied and the researchers found higher diagnostic values than for CRP and PCT.

The NLR's potential value in the diagnosis of a bacterial infection in a context of fever or hyperthermia (regardless of the presence or absence of bacteraemia) has not been studied before. This ratio could also be compared with standard biomarkers (CRP and PCT levels, the white blood cell count and the PNN).


title: Metformin in Moderate and Severe Renal Failure (CKD 3-4): A Follow-up Study

acronym: METsuiviIRC

summary: To validate on the mid-term in moderate and severe renal failure (CKD 3-4) a nomogram to adapt a fixed metformin daily posology according to renal function on the basis of the first short-term study made by the investigators.

status: Withdrawn

design_allocation: Non-Randomized


title: Pediatric Immune Response to Infectious Shock

acronym: PedIRIS

summary:
Infectious shocks are associated with high mortality rates (20-40%). Anti-inflammatory strategies based on the postulate that mortality related to sepsis is mainly due to an overwhelming pro-inflammatory immune response have failed. Some patients surviving this initial phase can develop immune dysfunctions because the compensatory mechanisms become deleterious when they persist over time. The persistence of immunosuppression at day 3 or 5 is independently associated with more nosocomial infections and higher mortality rate. The clinical and laboratory evidence for sepsis induced immunosuppression have been recently reviewed by Hotchkiss et al. Apoptosis-induced depletion of immune effector and blood studies from septic patients showed decreased production of pro-inflammatory cytokines, decreased HLA-DR expression, increased percentage of regulatory T cells, and increased production of programmed cell death (PD)-1. Some small positive phase 2 trials of biomarker guided immune enhancing agents granulocyte-macrophage colony stimulating factor (GM-CSF) and interferon γ (IFN γ) have been reported.

There are insufficient data showing that such an immunosuppression exists in children. Only one study performed in children with organ dysfunctions admitted to pediatric intensive care unit (PICU), showed that 34% of them developed immunosuppression. This study was performed on a heterogeneous population and immunological analyses were limited. Therefore, there is a crucial need of studies on septic patients with matched controls to provide more evidence that the same paradigm exists in children. The collaboration of laboratories with a high level of experience in this domain, and a clinical unit with a high potential of recruitment of children with severe infectious shock should allow us to perform the first prospective study specifically done in children with infectious shock.

The main hypothesis is that children with severe infectious shock developed sepsis-induced immunosuppression as shown in adults. This will be assessed by the expression of HLA-DR on monocytes' surface. We make the hypothesis that children who become immunosuppressed are more prone to develop secondary nosocomial infectious and stayed longer in PICU and in hospital.

Children aged from 1 month to 17 years, admitted to PICU at HFME Lyon-Bron are eligible if they have the criteria for severe sepsis or septic shock, defined by the "Surviving Sepsis Campaign 2012" or those of Toxic Shock Syndrome (TSS) (definitions of CDC - Center for Disease Control). An information leaflet will be issued to parents and children / adolescents and they will be informed of their right to object to the search. Are provided as part of this research:

Immunological measures (mHLA -DR) in three stages: in the first 48 hours, between D3/5 and D7/9. The volume of collected blood will not exceed 2.4 ml / kg.
The collection of nosocomial infections and status at D30 A control group of patients hospitalized for surgery without sepsis or toxic shock criteria will be recruited in the same hospital by ICU investigators and matched for age. Similarly controls will be given oral and written information and they will have the opportunity to deny inclusion. They will have the same exams as the first group of patients.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Remy S, Kolev-Descamps K, Gossez M, Venet F, Demaret J, Javouhey E, Monneret G. Occurrence of marked sepsis-induced immunosuppression in pediatric septic shock: a pilot study. Ann Intensive Care. 2018 Mar 13;8(1):36. doi: 10.1186/s13613-018-0382-x.

family: Remy

full_name: Solenn Remy

given: Solenn

sequence: first

family: Kolev-Descamps

full_name: Karine Kolev-Descamps

given: Karine

sequence: additional

family: Gossez

full_name: Morgane Gossez

given: Morgane

family: Venet

full_name: Fabienne Venet

given: Fabienne

family: Demaret

full_name: Julie Demaret

given: Julie

family: Javouhey

full_name: Etienne Javouhey

family: Monneret

full_name: Guillaume Monneret

given: Guillaume

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via 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 - Hospices Civils de Lyon

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

lead_sponsor: Hospices Civils de Lyon


title: Prevention of Loss of Mobility From a Care Pathway Focused on Exercise and Nutrition in Elderly Patients Over 70 Years, in Primary Care. Cluster Randomized Controlled Trial

summary:
Loss of mobility is predictive of a loss of autonomy and is often the first sign of functional decline. Loss of mobility is also associated with poor perceived quality of life, depressive symptoms, high risk of adverse events such as falls and fractures, to an increased risk to input in institution and mortality's increase.

Consequences and frequency of loss of mobility make essential its identification, evaluation and the practice of preventive measures in primary care.

The implementation of effective interventions in primary care to prevent or delay the loss of mobility is a public health priority.

PRISME-3P program aims to develop and evaluate a dedicated care pathway, in primary care, based on a personalized multimodal intervention: screening, support combining physician, teaching exercises by a specialized Monitor in Adapted Physical Activities (MAPA) and nutritional counseling.

study_start_date_type: Anticipated

primary_purpose: Prevention

ReferenceCitation: Perrotin S, Gilbert T, Dupuis M, Villeneuve L, Bin-Dorel S, Klich A, Letrilliart L, Bonnefoy M. A multimodal and multidisciplinary program to prevent loss of mobility in patients aged over 70 years: study protocol of a multicenter cluster randomized study in primary care (the PRISME-3P study). BMC Geriatr. 2019 Feb 19;19(1):48. doi: 10.1186/s12877-019-1059-5.

apc_source: openAPC

family: Perrotin

full_name: Sofia Perrotin

given: Sofia

family: Gilbert

full_name: Thomas Gilbert

given: Thomas

family: Dupuis

full_name: Marine Dupuis

given: Marine

family: Villeneuve

full_name: Laurent Villeneuve

given: Laurent

family: Bin-Dorel

full_name: Sylvie Bin-Dorel

given: Sylvie

family: Klich

full_name: Amna Klich

given: Amna

family: Letrilliart

full_name: Laurent Letrilliart

family: Bonnefoy

full_name: Marc Bonnefoy

given: Marc

journal_name: BMC Geriatrics

location_facility: Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.

intervention_type: Behavioral


acronym: STEROSENS

summary:
Sexual steroids administered to supra-physiological doses are likely to change the carbohydrate and lipid metabolism.

Investigators propose to study in 12 hypogonadal men hypogonadotropic or hypergonadotropic treated with aromatase inhibitor, the respective effects of estradiol, testosterone or both steroids administered in a cross-over Latin squares plan on insulin sensitivity measured by the reference method of the hyperinsulinemic euglycemic clamp.

lead_sponsor: University Hospital, Caen

location_facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen


type: Other Identifier

title: Predictive Nature of Total Cholesterol Threshold: Possible Link to Suicidal Behavior

summary: Suicidal behavior (SB) is a public health problem. The clinical model currently admitted to the understanding of SB is a stress vulnerability model, but so far, all scientific works has no clinical application. The management of psychiatric patients, including depressed subjects, faces the inability to detect those with a high risk of SB. Many studies have shown a link between low cholesterol and SB. A study has recently proposed a total cholesterol threshold below which the risk of suicide could be increased. However, a prospective study is needed to assess the predictive nature of such an indicator.

lead_sponsor: University Hospital, Montpellier


title: Validation of the Dynamometer LABIN

acronym: DYNAVAL

summary:
The main objective of this work is to validate the dynamometer LABIN in comparison with the technique of gold-standard reference JAMAR, in a healthy population.

The infringement of the prehension is frequent and impacts on the social and professional quality of life of the patients. There are numerous instruments measuring the strength of prehension. The JAMAR is a mechanical, hydraulic dynamometer, exploring in kilograms the maximal strength of the prehension. It is at present Gold Standard for the measure of the strength of prehension. There is for the moment no electronic known instrument exploring the endurance of the strength of prehension during an effort of tightening. This parameter would indeed be interesting for the exploration in geriatrics and in the neuromuscular pathologies.

This study justifies itself by the fact that the dynamometer LABIN should allow the evaluation of the muscular endurance of the strength of hand as complement of the peak of strength

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Hamilton GF, McDonald C, Chenier TC. Measurement of grip strength: validity and reliability of the sphygmomanometer and jamar grip dynamometer. J Orthop Sports Phys Ther. 1992;16(5):215-9.

ReferenceCitation: Härkönen R, Harju R, Alaranta H. Accuracy of the Jamar dynamometer. J Hand Ther. 1993 Oct-Dec;6(4):259-62.

ReferenceCitation: Bautmans I, Mets T. A fatigue resistance test for elderly persons based on grip strength: reliability and comparison with healthy young subjects. Aging Clin Exp Res. 2005 Jun;17(3):217-22.

ReferenceCitation: Bellace JV, Healy D, Besser MP, Byron T, Hohman L. Validity of the Dexter Evaluation System's Jamar dynamometer attachment for assessment of hand grip strength in a normal population. J Hand Ther. 2000 Jan-Mar;13(1):46-51.

ReferenceCitation: Martín-Ponce E, Hernández-Betancor I, González-Reimers E, Hernández-Luis R, Martínez-Riera A, Santolaria F. Prognostic value of physical function tests: hand grip strength and six-minute walking test in elderly hospitalized patients. Sci Rep. 2014 Dec 22;4:7530. doi: 10.1038/srep07530.

family: Martín-Ponce

full_name: Esther Martín-Ponce

given: Esther

family: Hernández-Betancor

full_name: Iván Hernández-Betancor

given: Iván

family: González-Reimers

full_name: Emilio González-Reimers

given: Emilio

family: Hernández-Luis

full_name: Rubén Hernández-Luis

given: Rubén

family: Martínez-Riera

full_name: Antonio Martínez-Riera

given: Antonio

family: Santolaria

full_name: Francisco Santolaria

given: Francisco

currency_apc_doaj: USD

journal_name: Scientific Reports

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: University Hospital, Clermont-Ferrand


title: Inflammatory Markers and Resistant Depression

acronym: InDep

summary: This study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.

primary_purpose: Screening

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Procedure


acronym: CHAPS

summary: If the addiction to games of chance and gambling is a disease of increasing knowledge, the emergence of poker rout evaluation procedures, prevention and treatment usually offered to players in need. In the case of poker, which unlike other games has a real part to address and which damages are expressed differently, the evaluation can not be done identically to other games. This problem has often been emphasized in the literature, in particular the lack of specific tools for the identification of poker gambling problems. Thus, the fact of developing a specific evaluation tool could allow poker to take into account the specificity of poker among other games. This would be part of the evaluation complement batteries currently available to players in general by offering a specific tool, and secondly to allow the assessment of the aspects of the problems often absent for other games . The goal here is to develop and validate a specific tool detection of problem gambling in the particular context of poker.


title: Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an Early Predictive Factor of Overall Survival in Patients With Advanced Hepatocellular Carcinoma Treated With Sorafenib

acronym: PREMETHEP

summary:
Hepatocellular carcinoma (HCC) is the third cause of death by cancer. For patients with inoperable advanced HCC, systematic therapy with Sorafenib, a multikinase inhibitor that has both antiangiogenic and antiproliferative effect, is the only therapeutic with proven survival benefits. However, the efficacy of Sorafenib remains inconstant with a media overall survival of 10,7 months and a disease control rate only 35 to 43%; moreover, the overall incidence of treatment-related adverse event is 80%. Thus, it appears essential to find an early and accurate way to determine which patients are best responding to therapy in order to avoid the toxicity and cost of ineffective therapy.

Positron Emission Tomography (PET) with 18F-Fluorodeoxyglucose (FDG) has shown limited performance in the setting of HCC because of lack of sensitivity, in particular for well-differentiated tumours. However FDG uptake is related to proliferation rate and is an efficient marker survival following liver transplantation and selective internal radiation therapy. Moreover, the addition of a dynamic first-pass acquisition to the standard static scan provides better characterization of the tumour by adding information on tumour perfusion.

FCH which reflects lipids metabolism and specifically choline kinase activity, has shown promising results for detection of HCC when compared with FDG alone. Moreover, choline activity is related to a kinase pathway in mammalian cells, which is specifically inhibited by Sorafenib. However FCH uptake remains inconstant in HCC, and is related to tumour differentiation, by opposition to FDG. Therefore, several studies have suggested that combined evaluation of tumour glucose and lipid metabolism could play a complementary role for the evaluation of HCC in the setting of detection, staging and to predict recurrence following surgical resection. Thus, the investigator hypothesize that the combination of FDG and FCH may be the most accurate imaging evaluation of HCC.

Thus the aim of the present study is to determine the predictive performance of survival of lipid and glucose metabolism and perfusion changes during Sorafenib therapy in patients with advanced HCC.

lead_sponsor: Centre Georges Francois Leclerc

lead_sponsor_type: industriel


title: Exploratory Phase 0/1 of Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC

acronym: IMKRUN 2

summary:
The development of biomarkers will lead the dynamic of personalized medicine and fill the unsatisfied needs in oncology for prediction of therapeutic response.

Molecular imaging enables non invasive quantification of biomarkers. The development of molecular imaging biomarkers is closely related to the development of therapeutic molecules. Among the potential targets, kinases offer a lot of advantages: (i) they play a central role in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic (imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the most sensitive and dedicated to evaluate small molecules. However few radiotracers are available and their specificity limits their clinical use. The IMAkinib® approach is an innovative method proposed to develop new PET radiotracers adapted to current medical and economical challenges.

The epidermal growth factor receptor (EGFR) is an established target for the treatment of advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs) Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19). Unfortunately the majority of patients will develop a resistance to the TKI in the long term (6-12 months). If the mechanism of resistance is not yet fully characterized, most patients (50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated ([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.


title: Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery

summary: Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new 4-wavelength generation of NIRS monitors which could reliably assess real-time absolute values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.

location_facility: Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon


title: Assessing Cough Peak Flow (CPF) Using Ventilator built-in Flow-meter to Predict Extubation Success: A Single Centre Study

acronym: CPF

summary:
Successful weaning from mechanical ventilation in ICU patients depends on patient ability to breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a dedicated flow-meter that required patient disconnection from the ventilator, limiting the generalizability of this procedure. This study aimed to predict extubation outcome in a consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF measurements were done by freezing ventilator screen and scrolling the cursor to the maximal value of CPF during expiration and Tidal Volume (TV) in preceding inspiration.

The objective was to assess the performance of CPF to predict early extubation outcome.

ReferenceCitation: Gobert F, Yonis H, Tapponnier R, Fernandez R, Labaune MA, Burle JF, Barbier J, Vincent B, Cleyet M, Richard JC, Guérin C. Predicting Extubation Outcome by Cough Peak Flow Measured Using a Built-in Ventilator Flow Meter. Respir Care. 2017 Dec;62(12):1505-1519. doi: 10.4187/respcare.05460. Epub 2017 Sep 12.

family: Gobert

full_name: Florent Gobert

given: Florent

family: Yonis

full_name: Hodane Yonis

given: Hodane

family: Tapponnier

full_name: Romain Tapponnier

given: Romain

family: Fernandez

full_name: Raul Fernandez

given: Raul

family: Labaune

full_name: Marie-Aude Labaune

given: Marie-Aude

family: Burle

full_name: Jean-François Burle

given: Jean-François

family: Barbier

full_name: Jack Barbier

given: Jack

family: Vincent

full_name: Bernard Vincent

given: Bernard

family: Cleyet

full_name: Maria Cleyet

given: Maria

family: Richard

full_name: Jean-Christophe Richard

given: Jean-Christophe

family: Guérin

full_name: Claude Guérin

given: Claude

journal_name: Respiratory Care

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

publisher_normalized: Daedalus Enterprises

location_facility: Medical Intensive care unit, Croix-Rousse Hospital. 103 Grande Rue de la Croix-Rousse


title: Contraceptive Practices and Cervical Screening in Women With Cystic Fibrosis

summary:
Little is known about gynaecological follow-up and cervical screening in Cystic Fibrosis (CF). Only few studies have described contraceptive practices in cohorts of CF women.

The investigators did a cross-sectional study in a cohort of 155 CF women attending the Lyon adult centre. Women attending the CF adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. Other clinical data were collected from the CF adult centre registry.

One hundred and twenty women (100%) answered the questionnaire, among whom two were post-menopausal (46 and 59 years of age), and five were pregnant.

Seventy-four per cent of the women declared they had undergone gynaecological followup (89% of the women with transplantation), and only 55% reported having at least one previous Pap smear test. Among the transplanted patients, only 58% had had a Papsmear test, despite immunosuppressive treatment. The overall rate of contraception was only 64% and in diabetic women, it was 61%. Among contraception users; 65% used oral contraception, predominantly combined estrogen-progestagen (47%); among diabetic patients, 26% used progestin-only contraception. Intrauterine device accounted for 10% of patients using contraception, and tubal ligation only 4%.

This study is limited by its cross-sectional design. Despite an internal validation of the questionnaire showing an almost perfect agreement, the risk of recall bias has to be taken into account.

This study of practices highlights the importance of improved information regarding sexuality, fertility and reproductive health in young women with CF. A regular gynaecological follow-up and cervical screening is mandatory in this population.

Better gynaecological care and contraceptive advice would help to avoid unplanned pregnancies, and optimize contraceptive selection in relationship to specific clinical conditions.

time_perspective: Cross-Sectional

location_facility: Cystic Fibrosis Adult Referral Centre, Department of Internal Medicine, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon


title: A Cross Over Randomized Controlled Trial of the Effect of Nasal Ocytocine on Cerebral Activations in Relation With Attachement in the General Population

acronym: OTACLA

summary: The study aims to characterize the cerebral activation modifications related to nasal oxytocin administration during vizualisation of distress images in population of healthy people with different attachement styles.


title: Study Single-center, Uncontrolled, Retrospective, the Association Between Advancing Age and Mortality at 30 Days in Patients With Bacteremia E. Coli Beta-lactamase Phenotype Extended Spectrum

acronym: MoBaCo

summary: In the US and Europe, bacteremia are ranked the 7th leading cause of death from all causes. E. coli is one of the main microorganism involved, responsible for 30% to 45% of bacteremia. In Europe, bacteremia E. coli, including BLSE phenotype, have a strong impact on public health, causing increased mortality, particularly in the elderly, and an increase in the average hospital stay. However, few studies have specifically concerned with the criteria associated with mortality of elderly patients with BLSE E. coli bacteremia. Finally, improving epidemiological knowledge of the elderly patients with bacteremia due to BLSE E. coli has importance in terms of public health and is a prerequisite to the development of preventive strategies and to improve the short-term prognosis.


title: Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study

summary:
The research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular basis responsible for this electrocardiographic abnormality.

To try to answer these many questions, the approach will be twofold: clinical and genetic.

Establishment of a clinical database containing information of patients who have been identified as carriers of the anomaly based on the initial clinical presentation in order to determine their prognoses.
Physiological approach will be based on a molecular approach to identify genetic abnormalities may be involved in this syndrome.
200 asymptomatic patients and an unlimited number of patients who presented syncope or aborted sudden death will be included.

A blood sample (15 ml) will be performed at inclusion.

status: Active, not recruiting

intervention_type: Genetic

status_simplified: Ongoing


title: Prospective, Multicentric, Non-controlled, Non-randomized Clinical Survey to Evaluate Mpact Cup Performance After Total Hip Arthroplasty

summary: The main objective of this study is to evaluate the 10 year performances of Mpact cup in total hip arthroplasty.

status: Recruiting

lead_sponsor: Medacta International SA


title: Effect of Intensive Sports Practice on Lower Limb Varicose Veins

acronym: VARISPORT

summary: Compare the frequency of varicose veins in the lower limbs in a population exposed to intensive sport compared to individuals matched by sex, age and body mass index (BMI) did not have an intensive sport.

ipd_sharing_description: If a venous pathology is detected during this study, the data are passed on to the doctor of the subject

lead_sponsor: University of Franche-Comté


title: Study to Compare Strategies to Improve Detection of Nutritional Disorders in Hospitalized Adults (Compass Project)

acronym: CompaS

summary:
The prevalence of malnutrition in hospital is very high (30 percent) with major consequences in terms of morbidity and mortality, generating significant health care costs. The positive impact of its support is demonstrated.

The HAS (French High Sanitary Authority) recommends a screening of all adult hospitalized in the first 48 hours, with no consensus regarding the organization of screening within care services. Various strategies have been implemented. Although this screening is part of the nursing role, old and recent studies show that it is not done systematically and nutritional disorders are largely under-diagnosed and therefore untreated.

The investigators assume that an organization of screening for eating disorders, based on a caregiver dedicated to this activity, improves the indicator IPAQSS (Indicateurs Pour l'Amélioration de la Qualité et de la Sécurité des Soins) which is an indicator for the improvement of the quality and security of care) Screening indicator of nutritional disorders Level 3, compared to an organization "classic" involving the care teams in their entirety. This indicator reflects the care system performance.

In this study, patients will have no intervention. Only the organization of the care staff will be adapted but with no changes on the care of patients?

ReferenceCitation: Schindler K, Pernicka E, Laviano A, Howard P, Schütz T, Bauer P, Grecu I, Jonkers C, Kondrup J, Ljungqvist O, Mouhieddine M, Pichard C, Singer P, Schneider S, Schuh C, Hiesmayr M; NutritionDay Audit Team. How nutritional risk is assessed and managed in European hospitals: a survey of 21,007 patients findings from the 2007-2008 cross-sectional nutritionDay survey. Clin Nutr. 2010 Oct;29(5):552-9. doi: 10.1016/j.clnu.2010.04.001.

ReferenceCitation: Imoberdorf R, Meier R, Krebs P, Hangartner PJ, Hess B, Stäubli M, Wegmann D, Rühlin M, Ballmer PE. Prevalence of undernutrition on admission to Swiss hospitals. Clin Nutr. 2010 Feb;29(1):38-41. doi: 10.1016/j.clnu.2009.06.005. Epub 2009 Jul 1.

ReferenceCitation: Korfali G, Gündoğdu H, Aydintuğ S, Bahar M, Besler T, Moral AR, Oğuz M, Sakarya M, Uyar M, Kiliçturgay S. Nutritional risk of hospitalized patients in Turkey. Clin Nutr. 2009 Oct;28(5):533-7. doi: 10.1016/j.clnu.2009.04.015. Epub 2009 May 28.

ReferenceCitation: Sorensen J, Kondrup J, Prokopowicz J, Schiesser M, Krähenbühl L, Meier R, Liberda M; EuroOOPS study group. EuroOOPS: an international, multicentre study to implement nutritional risk screening and evaluate clinical outcome. Clin Nutr. 2008 Jun;27(3):340-9. doi: 10.1016/j.clnu.2008.03.012. Epub 2008 May 27.

ReferenceCitation: Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9.

ReferenceCitation: Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. Epub 2007 Dec 3. Review.

ReferenceCitation: Lim SL, Daniels L. Reply--Malnutrition and its impact on cost of hospitalization, length of stay, readmission and 3-year mortality. Clin Nutr. 2013 Jun;32(3):489-90. doi: 10.1016/j.clnu.2012.12.014. Epub 2013 Jan 11.

ReferenceCitation: Starke J, Schneider H, Alteheld B, Stehle P, Meier R. Short-term individual nutritional care as part of routine clinical setting improves outcome and quality of life in malnourished medical patients. Clin Nutr. 2011 Apr;30(2):194-201. doi: 10.1016/j.clnu.2010.07.021.

ReferenceCitation: Johansen N, Kondrup J, Plum LM, Bak L, Nørregaard P, Bunch E, Baernthsen H, Andersen JR, Larsen IH, Martinsen A. Effect of nutritional support on clinical outcome in patients at nutritional risk. Clin Nutr. 2004 Aug;23(4):539-50.

ReferenceCitation: Norman K, Kirchner H, Freudenreich M, Ockenga J, Lochs H, Pirlich M. Three month intervention with protein and energy rich supplements improve muscle function and quality of life in malnourished patients with non-neoplastic gastrointestinal disease--a randomized controlled trial. Clin Nutr. 2008 Feb;27(1):48-56. Epub 2007 Oct 25.

ReferenceCitation: Braga M, Gianotti L, Vignali A, Carlo VD. Preoperative oral arginine and n-3 fatty acid supplementation improves the immunometabolic host response and outcome after colorectal resection for cancer. Surgery. 2002 Nov;132(5):805-14.

ReferenceCitation: Kruizenga HM, Van Tulder MW, Seidell JC, Thijs A, Ader HJ, Van Bokhorst-de van der Schueren MA. Effectiveness and cost-effectiveness of early screening and treatment of malnourished patients. Am J Clin Nutr. 2005 Nov;82(5):1082-9.

ReferenceCitation: Elia M, Zellipour L, Stratton RJ. To screen or not to screen for adult malnutrition? Clin Nutr. 2005 Dec;24(6):867-84. Review.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre hospitalier Universitaire de Toulouse


title: Requests for Euthanasia and Assisted Suicide: a Prospective, Multicenter and Qualitative Study of Their Frequency and Characteristics, of Patients' Motivations and Their Evolution

acronym: DESA

summary:
This study take place in the palliative care units of Burgundy-Franche-Comté regions and at the Maison Médicale Jeanne Garnier. The main aim of this project is to analyze and understand the meaning of explicit requests to hasten death (euthanasia and assisted suicide).

This involves conducting interviews with patients, carers to whom the request has been expressed and a relative chosen by the patient. This study aims to describe the request over time. This will be done through two series of interviews, one as soon as it is first expressed, then one week later.


title: Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly

summary:
Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy, such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best Supportive care (BSC). Blood transfusion requirement represents one of the most significant cost driver associated with AML.

The present study assesses the cost-effectiveness of intensive chemotherapy versus Best Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a French payer perspective. Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly AML according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy.

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet


title: A Rising Single Oral Dose Study to Investigate the Tolerability, Pharmacokinetics and Dopamine ß-hydroxylase (DßH) Inhibition Profile of BIA 5-453 in Healthy Male Volunteers

summary: The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single oral doses

lead_sponsor: Bial - Portela C S.A.


acronym: Painkiller

summary:
Pain is a common problem encountered in about 60 % of critically ill patients who can communicate. Its occurrence can be related to several causes, mainly dominated by invasive procedures.

Pain management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Music therapy is one of them and that has been evaluated in various medical conditions.

The aim of our study is to evaluate the analgesic effect of music therapy in critically ill patients during potentially painful nursing procedures.

ReferenceCitation: Jacq G, Melot K, Bezou M, Foucault L, Courau-Courtois J, Cavelot S, Lang A, Bedos JP, Le-Boeuf D, Boussard JM, Legriel S. Music for pain relief during bed bathing of mechanically ventilated patients: A pilot study. PLoS One. 2018 Nov 14;13(11):e0207174. doi: 10.1371/journal.pone.0207174. eCollection 2018.

family: Jacq

full_name: Gwenaëlle Jacq

given: Gwenaëlle

family: Melot

full_name: Karine Melot

given: Karine

family: Bezou

full_name: Mathilde Bezou

given: Mathilde

family: Foucault

full_name: Laura Foucault

given: Laura

family: Courau-Courtois

full_name: Josette Courau-Courtois

given: Josette

family: Cavelot

full_name: Sebastien Cavelot

given: Sebastien

family: Lang

full_name: Annie Lang

given: Annie

family: Bedos

full_name: Jean-Pierre Bedos

given: Jean-Pierre

family: Le-Boeuf

full_name: Dominique Le-Boeuf

given: Dominique

family: Boussard

full_name: Jean-Marc Boussard

given: Jean-Marc

family: Legriel

full_name: Stephane Legriel

given: Stephane

journal_name: PLOS ONE

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: Versailles Hospital


title: Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

acronym: RITUX-LEUKEMIA

summary:
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients.

However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse.

Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.

ReferenceCitation: Leclerc M, Suarez F, Noël MP, Vekhoff A, Troussard X, Claisse JF, Thieblemont C, Maloisel F, Beguin Y, Tamburini J, Barbe C, Delmer A. Rituximab therapy for hairy cell leukemia: a retrospective study of 41 cases. Ann Hematol. 2015 Jan;94(1):89-95. doi: 10.1007/s00277-014-2175-0. Epub 2014 Sep 7.

lead_sponsor: CHU de Reims


title: Clinical and Histological Features of Head and Neck Melanoma

acronym: head neck-mel

summary: The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.

ReferenceCitation: Dabouz F, Barbe C, Lesage C, Le Clainche A, Arnoult G, Hibon E, Bernard P, Grange F. Clinical and histological features of head and neck melanoma: a population-based study in France. Br J Dermatol. 2015 Mar;172(3):707-15. doi: 10.1111/bjd.13489. Epub 2015 Feb 11.


title: Work-related Respiratory Symptoms in Champagne Vineyard Workers

acronym: VIN-ALLERGO

summary: Work related asthma and rhinitis are frequent diseases with a significant morbidity and a social and economic impact. Farmers are highly exposed to various inhaled agents such as organic or inorganic dust, endotoxin, micro-organisms, pollen, mites, moulds, animal danders and pesticides, inducing rhinitis, asthma, chronic bronchitis, hypersensitivity pneumonitis and organic dust toxic syndrome. Work related respiratory symptoms are frequent in crop farmers. Allergic rhinitis and respiratory symptoms in fruit farmers are mainly related to pollen allergy, especially gramineae pollen. They can also be related to the use of pesticides or exposure to mites .

ReferenceCitation: Perotin JM, Barbe C, Nguyen KL, Fontaine JF, Gabignon Y, Nardi J, Launois C, Lebargy F, Lavaud F, Deslee G. Work-related respiratory symptoms in Champagne vineyard workers. Eur Ann Allergy Clin Immunol. 2015 Sep;47(5):140-4.


title: Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis

summary:
The main objective of this study is to show that there is a concordance between lung disease at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis asymptomatically.

This will identify at the first examination at 8 weeks, newborns who have the most impaired lung function at 13 months. To meet this objective an assessment of their lung function at 9 weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.


summary: The main objective of this study is to identify the superficial muscle groups involved in gene-related tremor and assess the reduction in the intensity of the tremor after transient electrical stimulation.


title: Study of Predictors of Response to Anti Epilepsy in Epilepsy

acronym: RESISTANT

summary: Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as exemplified by some genetic diseases. However, the lack of specific guidelines for the choice of the anti epileptic drugs (apart from generalized and partial epilepsy) and the very large number of drugs with different and sometimes complex metabolism are challenges for neurologists. Among the 30 % of pharmacoresistant epilepsy, there is a part related to pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage and pharmacogenetics tools). Moreover, the new anti epileptic drugs have metabolism more unrelated with the cytochrome P450 and less generalised adverse events. However, their metabolism could be more complexe (i.e. the less known Uridine 5'-diphospho-glucuronyltransferase (UGT) pathway) and bring more insidious neurological adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which could largely impede the observance and the quality of life even if the number of seizure is reduced or not. The goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug) from a cohort of 1000 patients.

status: Terminated

lead_sponsor: University Hospital, Lille


ReferenceCitation: Maubec E, Boubaya M, Petrow P, Beylot-Barry M, Basset-Seguin N, Deschamps L, Grob JJ, Dréno B, Scheer-Senyarich I, Bloch-Queyrat C, Leccia MT, Stefan A, Saiag P, Grange F, Meyer N, de Quatrebarbes J, Dinulescu M, Legoupil D, Machet L, Dereure O, Zehou O, Montaudié H, Wierzbicka-Hainaut E, Le Corre Y, Mansard S, Guégan S, Arnault JP, Dalac S, Aubin F, Alloux C, Lopez I, Cherbal S, Tibi A, Lévy V; Groupe de Cancérologie Cutanée30. Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas. J Clin Oncol. 2020 Sep 10;38(26):3051-3061. doi: 10.1200/JCO.19.03357. Epub 2020 Jul 30.

name: Assistance Publique–Hôpitaux de Paris, Hôpital Avicenne, Bobigny, France

family: Maubec

full_name: Eve Maubec

given: Eve

family: Boubaya

full_name: Marouane Boubaya

given: Marouane

name: Association de Cabinet de Radiologie et d’Imagérie Médicale, Service de Radiologie, Polyclinique Saint-Côme, Compiègne, France

name: Institut Curie, Service de Radiodiagnostic, Paris, France

family: Petrow

full_name: Peter Petrow

given: Peter

name: Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France

family: Beylot-Barry

full_name: Marie Beylot-Barry

given: Marie

name: Assistance Publique–Hôpitaux de Paris, Hôpital Saint-Louis, Paris, France

family: Basset-Seguin

full_name: Nicole Basset-Seguin

given: Nicole

name: Assistance Publique–Hôpitaux de Paris, Hôpital Bichat, Paris, France

family: Deschamps

full_name: Lydia Deschamps

given: Lydia

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

name: Service Oncodermatologie, Centre Hospitalier Universitaire Nantes, Centre d’Investigation Clinique 1413, Centre de Recherche en Cancérologie et Immunologie Nantes Angers, Université de Nantes, Nantes, France

family: Dréno

full_name: Brigitte Dréno

given: Brigitte

family: Scheer-Senyarich

full_name: Isabelle Scheer-Senyarich

given: Isabelle

family: Bloch-Queyrat

full_name: Coralie Bloch-Queyrat

given: Coralie

name: Centre Hospitalier Universitaire de Grenoble, Genoble, France

family: Leccia

full_name: Marie-Thérèse Leccia

given: Marie-Thérèse

name: Centre Hospitalier Universitaire de Caen, Caen, France

family: Stefan

full_name: Andreea Stefan

given: Andreea

name: Assistance Publique–Hôpitaux de Paris, Hôpital Ambroise-Paré, Boulogne, France

family: Saiag

full_name: Philippe Saiag

given: Philippe

name: Centre Hospitalier Universitaire Reims, Hôpital Robert-Debré, Reims, France

family: Grange

full_name: Florent Grange

given: Florent

name: Institut Universitaire du Cancer and Centre Hospitalier Universitaire de Toulouse, Toulouse, France

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

name: Centre Hospitalier Genevois, Pringy, France

family: de Quatrebarbes

full_name: Julie de Quatrebarbes

given: Julie

family: Dinulescu

full_name: Monica Dinulescu

given: Monica

name: Centre Hospitalier Régional Universitaire de Brest, Brest, France

family: Legoupil

full_name: Delphine Legoupil

given: Delphine

name: Centre Hospitalier Régional Universitaire de Tours, Chambray-les-Tours, France

family: Machet

full_name: Laurent Machet

given: Laurent

name: Université de Montpellier, Montpellier, France

family: Dereure

full_name: Olivier Dereure

given: Olivier

name: Assistance Publique–Hôpitaux de Paris, Hôpital Henri-Mondor, Créteil, France

family: Zehou

full_name: Ouidad Zehou

given: Ouidad

name: Hôpital Archet 2, Centre Hospitalier Universitaire de Nice, Nice, France

family: Montaudié

full_name: Henri Montaudié

given: Henri

name: Centre Hospitalier Universitaire La Milétrie, Poitiers, France

family: Wierzbicka-Hainaut

full_name: Ewa Wierzbicka-Hainaut

given: Ewa

name: Centre Hospitalier Universitaire d'Angers, Angers, France

family: Le Corre

full_name: Yannick Le Corre

given: Yannick

name: Centre Hospitalier Universitaire Estaing, Clermont-Ferrand, Clermont-Ferrand, France

family: Mansard

full_name: Sandrine Mansard

given: Sandrine

name: Assistance Publique–Hôpitaux de Paris, Hôpital Cochin, Paris, France

name: Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France

name: Centre Hospitalier Universitaire de Dijon, Dijon, France

name: Centre Hospitalier Régional Universitaire Besançon, France

name: Assistance Publique–Hôpitaux de Paris, Agence Générale des Equipements et Produits de Santé, Paris, France

name: on behalf of Groupe de Cancérologie Cutanée

publisher: American Society of Clinical Oncology (ASCO)

title: Phase II Study of Pembrolizumab (MK-3475) as First Line Single Drug Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin

summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab in patient with locally advanced or metastatic squamous cell carcinoma of the skin


title: Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive Cutaneous Lymphomas

acronym: MATULILA

summary: To evaluate the possibility of detecting cell-free circulating tumoral DNA in potentially aggressive primary cutaneous lymphomas, the investigator opted to search a representative tumor sample mutation in the blood of these patients, by digital PCR. Patients with mycosis fungoides, primary cutaneous T-cell lymphoma helper follicular phenotype and primary cutaneous diffuse large B-cell lymphoma, leg-type will be included and 4 blood samples will be collected during 12 months.

lead_sponsor: University Hospital, Bordeaux

location_facility: University Hospital of Bordeaux - Hospital Saint André


title: Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure

acronym: EUROFILLING

summary: The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal for performing an echocardiography in the routine clinical practice. Conflicting evidence exists about mitral E/e' ratio reliability for predicting high LVeDP

lead_sponsor: Rennes University Hospital


title: Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist

acronym: TARIFF

summary: The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still diagnosed late. This delay in diagnosis is due to the non-specificity of clinical, electrocardiographic and echocardiographic disease, but also by a certain ignorance of this pathology in the medical community. The importance of early diagnosis of Fabry disease and heart disease is well established: enzyme replacement therapy is most effective when instituted early, before the onset of irreversible damage such as fibrosis. With the blotter, we now have a simple and robust screening tool for Fabry disease, achievable consultation. Targeted educational interventions to physicians have shown their effectiveness in improving the screening and diagnosis of rare diseases. We offer a prospective observational type before / after study, which aims to assess the value of an educational brochure for cardiologists to improve the screening and diagnosis of Fabry disease in Normandy.


title: Analysis of Immune Response In Bacterial Infection of Obese Subject

acronym: ARIIBO

summary: Improve knowledge of the immune response to sepsis in obese patients. Define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude

primary_purpose: Supportive Care


title: Quality of Life Assessment in Routine Clinical Oncology Practice at the University Hospital of Besancon

acronym: QOLIBRY

summary:
Symptoms related to the disease and/or treatment are common in cancer patients and can affect patient health-related quality of life (HRQol). Unfortunately these symptoms can be underestimated and underreported by the physician. Measure of the HRQoL has been significantly developed in clinical trials and has become a key endpoint to assess clinical benefit of new therapeutic strategies and as prognostic factor of overall survival for several cancer as in women breast cancer, glioblastomas, metastatic colorectal cancer, prostate cancer and hepatocellular carcinoma.

Moreover, a recent study conducted in patients receiving routine outpatient chemotherapy for advanced solid tumors showed that clinical benefits were associated with symptom self-reporting during cancer care, including the improvement of the overall survival.

The aim of the QOLIBRY project is to introduce the collection of HRQoL of cancer patients in daily clinical practice in the University Hospital of Besançon. Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to physician, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on the perception of the patients of their HRQoL and symptoms.

ReferenceCitation: Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7. Erratum in: J Clin Oncol. 2016 Jun 20;34(18):2198. Erratum in: J Clin Oncol. 2019 Feb 20;37(6):528.

ReferenceCitation: Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24.

ReferenceCitation: Velikova G, Awad N, Coles-Gale R, Wright EP, Brown JM, Selby PJ. The clinical value of quality of life assessment in oncology practice-a qualitative study of patient and physician views. Psychooncology. 2008 Jul;17(7):690-8.

ReferenceCitation: Holzner B, Giesinger JM, Pinggera J, Zugal S, Schöpf F, Oberguggenberger AS, Gamper EM, Zabernigg A, Weber B, Rumpold G. The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring. BMC Med Inform Decis Mak. 2012 Nov 9;12:126. doi: 10.1186/1472-6947-12-126.

ReferenceCitation: Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004 Sep 1;22(17):3485-90.

ReferenceCitation: Fisch MJ, Lee JW, Weiss M, Wagner LI, Chang VT, Cella D, Manola JB, Minasian LM, McCaskill-Stevens W, Mendoza TR, Cleeland CS. Prospective, observational study of pain and analgesic prescribing in medical oncology outpatients with breast, colorectal, lung, or prostate cancer. J Clin Oncol. 2012 Jun 1;30(16):1980-8. doi: 10.1200/JCO.2011.39.2381. Epub 2012 Apr 16.

ReferenceCitation: Seow H, Sussman J, Martelli-Reid L, Pond G, Bainbridge D. Do high symptom scores trigger clinical actions? An audit after implementing electronic symptom screening. J Oncol Pract. 2012 Nov;8(6):e142-8. doi: 10.1200/JOP.2011.000525. Epub 2012 Aug 21.

ReferenceCitation: Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240-8. doi: 10.1001/jama.2014.7689.

ReferenceCitation: Gilbert JE, Howell D, King S, Sawka C, Hughes E, Angus H, Dudgeon D. Quality improvement in cancer symptom assessment and control: the Provincial Palliative Care Integration Project (PPCIP). J Pain Symptom Manage. 2012 Apr;43(4):663-78. doi: 10.1016/j.jpainsymman.2011.04.028.

ReferenceCitation: Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4. Review.

ReferenceCitation: Berry DL, Blumenstein BA, Halpenny B, Wolpin S, Fann JR, Austin-Seymour M, Bush N, Karras BT, Lober WB, McCorkle R. Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol. 2011 Mar 10;29(8):1029-35. doi: 10.1200/JCO.2010.30.3909. Epub 2011 Jan 31.

ReferenceCitation: Diouf M, Chibaudel B, Filleron T, Tournigand C, Hug de Larauze M, Garcia-Larnicol ML, Dumont S, Louvet C, Perez-Staub N, Hadengue A, de Gramont A, Bonnetain F. Could baseline health-related quality of life (QoL) predict overall survival in metastatic colorectal cancer? The results of the GERCOR OPTIMOX 1 study. Health Qual Life Outcomes. 2014 May 13;12:69. doi: 10.1186/1477-7525-12-69.

ReferenceCitation: Mauer M, Stupp R, Taphoorn MJ, Coens C, Osoba D, Marosi C, Wong R, de Witte O, Cairncross JG, Efficace F, Mirimanoff RO, Forsyth P, van den Bent MJ, Weller M, Bottomley A. The prognostic value of health-related quality-of-life data in predicting survival in glioblastoma cancer patients: results from an international randomised phase III EORTC Brain Tumour and Radiation Oncology Groups, and NCIC Clinical Trials Group study. Br J Cancer. 2007 Aug 6;97(3):302-7. Epub 2007 Jul 3.

location_facility: Centre Hospitalier régional Universitaire de Besançon


title: Randomized Phase II Study Evaluating the Efficacy of 90Yttrium-epratuzumab Tetraxetan Radioimmunotherapy in Adults With CD22+ Relapsed/Refractory B-ALL

acronym: RITEPRALL

summary: The investigators propose a randomized phase 2 study evaluating 90Y-epratuzumab tetraxetan for relapsed/refractory CD22+ B-ALL adult patients using the recommended activity of 370 MBq/m² x 2. in order to confirm the investigators' previous results. The cut-off of 70% for the expression of CD22 has been chosen in order to propose this protocol to all adults with CD22+ B ALL in relapse or with refractory disease. Indeed, median expression of CD22 is almost 100% in this setting but some patients are documented between 70 and 100%. RIT will be assessed in comparison with standard of care salvage chemotherapy regimens. Only three standard salvage chemotherapy regimens will be permitted in order to avoid too much bias for the comparative analysis of clinical efficacy.

lead_sponsor: Nantes University Hospital


summary: The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. Because of a high level of risk of developing an Obstructive Sleep Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in order to propose preventive and therapeutic solutions to these patients.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM

intervention_type: Radiation


title: Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B

summary:
Cancer-specific splice variants gain significant interest as they generate neo-antigens, that could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature B cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of membrane expression of the spliced isoform.

The investigators group would now determine if it's possible, in patients with lymphoproliferative B, to detect the presence of a specific memory response to delta-CD20 peptides.

If this memory response exists, it will confirm the interest of this antigen as a target for tumor immunotherapy.

ReferenceCitation: Vauchy C, Gamonet C, Ferrand C, Daguindau E, Galaine J, Beziaud L, Chauchet A, Henry Dunand CJ, Deschamps M, Rohrlich PS, Borg C, Adotevi O, Godet Y. CD20 alternative splicing isoform generates immunogenic CD4 helper T epitopes. Int J Cancer. 2015 Jul 1;137(1):116-26. doi: 10.1002/ijc.29366. Epub 2014 Dec 12.

location_facility: Centre Hospitalier Régional Universitaire de Besançon


acronym: CQFD

summary:
End stage renal disease (ESRD) is a severe pathology, treated by dialysis on standby of graft availability. Being under dialysis requires a recourse to pluri-weekly magazine of health care system, impacting negatively patient's quality of life (QoL) and their entourage, at a psychological, physical and social level.

Although further studies have assessed QoL in ESRD grafted children, a lack of information exists concerning patients' QoL during dialysis before graft. In addition, some limits could be listed, these studies have small samples, 50 patients at all, and only clinical determinants are studied. A larger clinical research assessing children's QoL studying individual and populational factors is necessary.

The aim of the study is to assess the influence of individual and populational determinants on children's QoL with ESRD, treated by dialysis.

Material & Method An exhaustive inclusion of patient with ESRD treated by dialysis will be realized at 20 French Pediatrics Dialysis Centers. Inclusion criteria are i) two genders, ii) younger than 18 years old, iii) having an ESRD treated by dialysis, iv) attending at one of the French Pediatrics Dialysis Centers for treatment between the 1st September 2012 and the 31th August 2014, v) being at their fourth to sixth week of dialysis. Patients will be re-evaluated at 4th month and 7th month after first dialysis. Informed consent will be signed by patient and their mainly caregiver.

Patient's QoL will be assessed using self-administered questionnaires Kidscreen 10 and VSP-A. In addition coping (KidCope), anxiety (STAI-C, STAI-Y), personality / attachment (IPPA), optimism (Y-LOT) measures and socio-demographic data will be collected. Self-administered questionnaires will be used for assessing caregivers' Qol (SF36), anxiety (STAI-Y), coping (BriefCope situational format), health care system satisfaction (Care quality scale) and burden (Zarit Caregiver Burden Inventory). Child's QoL evaluated by caregivers will be assessed using QUALIN, Kidscreen 10 parent and VSP-Ap. In addition, socio-demographic data, urban environment and economic environment will be collected. Clinical data will be collected by health professionals.

Results expected A sample of 136 children with ESRD is expected for identifying individual and populational factors which could influence chronic dialysed children QoL, in order to propose adjustments to optimize these patients quality of life.

primary_purpose: Health Services Research

location_facility: Assistance Publique Hôpitaux de Marseille


title: Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

acronym: EPIDEMYOSITIS

summary:
Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. At present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of Bohan and Peter). However, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population.

Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of Normandy.

lead_sponsor: University Hospital, Rouen


acronym: ASTEQ

summary: The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Variations of High Sensitivity Troponin T in Neonates

acronym: TnTc-us

summary: Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is increasing, yet normal values are still to be determined for the latest generation of tests, such as High sensitivity cardiac troponin T test. This study is an observational study designed to determine biological normal values of High sensitivity cardiac troponin T test (troponin T -us) in newborns.

ReferenceCitation: Lefèvre G. [Troponins: biological and clinical aspects]. Ann Biol Clin (Paris). 2000 Jan-Feb;58(1):39-48. Review. French.

ReferenceCitation: Adamcová M. Troponins in children and neonates. Acta Paediatr. 2003 Dec;92(12):1373-5.

ReferenceCitation: Fortunato G, Carandente Giarrusso P, Martinelli P, Sglavo G, Vassallo M, Tomeo L, Rea M, Paladini D. Cardiac troponin T and amino-terminal pro-natriuretic peptide concentrations in fetuses in the second trimester and in healthy neonates. Clin Chem Lab Med. 2006;44(7):834-6.

ReferenceCitation: Nomura RM, Ortigosa C, Fiorelli LR, Liao AW, Zugaib M. Gender-specific differences in fetal cardiac troponin T in pregnancies complicated by placental insufficiency. Gend Med. 2011 Jun;8(3):202-8. doi: 10.1016/j.genm.2011.05.001.

lead_sponsor: Centre Hospitalier René Dubos


title: Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis

acronym: LymphoEnergy

summary:
Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron metabolism and programmed cell death ...). The platelets are pivotal in the healing system with large range of growth factors. A new therapeutic concept of conservative iron chelation with deferiprone for neuroprotection is under development.

The action of deferiprone on the different mechanisms and notably the oxidative stress are to obtain from a collection of PBMC and platelets from patient having Parkinson's disease and Amyotrophic lateral sclerosis and healthy controls to study ex vivo.

PBMC and platelets will be stored for future analyses.


title: Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound ((Magnetic Resonance Imaging) Obtained in Vivo by the Koelis™ System

acronym: EFEL

summary:
The study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.

Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate cancer will be prospectively offered to enter the study.

The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex, midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the prostate will be obtained at the end of the placement. As per our routine procedure, patients will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed by operators of varying experience using the Koelis system. The fiducials (visible on MR and ultrasound images) will be used to quantify the registration error.

lead_sponsor: Hospices Civils de Lyon


title: Enhancing Social Interaction With an AlterEgo Artificial Agent

acronym: ALTEREGO

summary:
The objective of AlterEgo is the creation of an interactive cognitive architecture, implementable in various artificial agents, allowing a continuous interaction with patients suffering from social disorders, by virtue of changes in behavioural (robot-based) as well as morphological (avatar-based) properties of that agent. The project includes research in fundamental and clinical neurosciences, interaction modeling, development of new computer-vision techniques and human-robot interfaces, as well as evaluation of the scenarios with patients before, during, and after training sessions. At the end of the project, the investigators will produce a new avatar-based clinical method able to enhance social interaction of patients.

The first challenge of this project is to create an avatar alter ego of a patient. Based on recent work in social robotics and neurosciences, the investigators hypothesize that if patients face artificial agents morphologically and behaviourally similar to them, they will increase their social interaction. The second challenge is to transform the morphology and the behaviour of the similar artificial agent into that of a healthy and different agent. The investigators assume that the smooth and continuous behavioural shift from similar/unhealthy to complementary/healthy social behaviour will lead to a better social rehabilitation. AlterEgo opens the door to a new generation of social artificial agents in service robotics. AlterEgo is an interdisciplinary project at the interaction of Social Motor Neurosciences (UM1), Robotics (EPFL), Complex Systems Dynamics (UOB), Computer Vision (DFKI), and Psychiatry (CHU).

This project includes a set of experiments that started in april 2014 and will terminate in september 2016 before undergoing a randomised clinical research.

lead_sponsor: University Hospital, Montpellier

location_facility: Service Universitaire de psychiatrie adulte, University Hospital of Montpellier


title: Impact of Hypnosis on the Management of Chronic and Breakthrough Pain of Chronic Dialysis Patients Suffering From Arterial Disease

acronym: HYPNODIAL

summary:
A chronic renal disease can results in the development of cardiovascular complications, including chronic arterial disease ; but a cardiovascular disease may be from a kidney malfunction that will end in end stage renal disease (ESRD). Two thirds of the chronic hemodialysis patients taken in charge in Grenoble in the last years suffered from an arterial disease at a symptomatic stage. Breakthrough pain can appear during the hemodialysis sessions. These sessions induce sudden hemodynamic changes and a peripheral vasoconstriction reaction that increases in particular all pain phenomena related to chronic low limbs ischemia. Therefore, patients have to face pain, sometimes chronic but also breakthrough pain, during the dialysis sessions, in all its dimensions.

The analgesic balance through the classical drug treatment is extremely complex, as they are both at risk of overdose and of partial effectiveness. Strict medical treatment remains unsatisfactory, as it takes into account only the expressions of symptoms during dialysis sessions, when most of the time pain is already installed and analgesic treatment is not completely effective.

The combination of classic pharmacological treatment with hypnosis, already used in other indications (chronic pain, analgesia, depression and anxiety), may mitigate the painful feeling on patients suffering from arterial disease during the dialysis sessions, with a beneficial impact on their overall quality of life. There is also evidence to suggest that hypnosis may be more effective treating neuropathic or vascular pain, those experienced by our patients, than musculoskeletal pain, like back pain.

Hypnosis is a mind-body approach focused on the subject, and not on the disease or the act of dialysis. It can be described at the same time as a modified state of consciousness and a particular intersubjective relation between a practitioner and his patient. The practice of this kind of hypnoanalgesia by the nurses is particularly relevant in hemodialysis, as the trust developed during regular chronic treatment can become an asset to shorten the induction phase and help to install this intersubjective relation.

The high incidence of this complication, the difficulties of current pain management and the impact on everyday life for the patients, justify the choice of this approach, where more further research is needed.

ReferenceCitation: Labeeuw M, Merono Nombret A, Boyer S, Guillermin MN. Rapport du Rein Rhone Alpes Année 2012. Agence de la Biomedicine, Coordination Nationale REIN.

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ReferenceCitation: Santoro D, Satta E, Messina S, Costantino G, Savica V, Bellinghieri G. Pain in end-stage renal disease: a frequent and neglected clinical problem. Clin Nephrol. 2013 Jan;79 Suppl 1:S2-11. Review.

ReferenceCitation: Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. Review.

ReferenceCitation: Bioy A. Traiter la douleur par l'hypnose. Cahier scientifique AFIDTN 2010 Dec, N°93 : 13-15.

ReferenceCitation: Le choix de l'hypnose pour soulager la douleur. Institut Upsa de la Douleur. La Douleur N°7 des recommandations à la pratique Mars 2009.

ReferenceCitation: Elkins G, Jensen MP, Patterson DR. Hypnotherapy for the management of chronic pain. Int J Clin Exp Hypn. 2007 Jul;55(3):275-87. Review.

ReferenceCitation: Dillworth T, Mendoza ME, Jensen MP. Neurophysiology of pain and hypnosis for chronic pain. Transl Behav Med. 2012 Mar;2(1):65-72. doi: 10.1007/s13142-011-0084-5.

ReferenceCitation: Jensen M, Patterson DR. Hypnotic treatment of chronic pain. J Behav Med. 2006 Feb;29(1):95-124. Epub 2006 Jan 11.

ReferenceCitation: Iserson KV. An hypnotic suggestion: review of hypnosis for clinical emergency care. J Emerg Med. 2014 Apr;46(4):588-96. doi: 10.1016/j.jemermed.2013.09.024. Epub 2014 Jan 25. Review.

ReferenceCitation: Kekecs Z, Varga K. Positive suggestion techniques in somatic medicine: A review of the empirical studies. Interv Med Appl Sci. 2013 Sep;5(3):101-11. doi: 10.1556/IMAS.5.2013.3.2. Epub 2013 Sep 16.

ReferenceCitation: Editorial. Comfortably numb. The Association of Anaesthetists of Great Britain and Ireland 2013 ;Vol 68 : 896-898.

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lead_sponsor: University Hospital, Grenoble

location_facility: Hemodialysis Unit University Hospital Grenoble


title: Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia

summary:
Acute myeloid leukaemia (AML) is a haematological malignant disease characterized by an uncontrolled proliferation of immature hematopoietic cells. Over the last two decades, clinical trials have demonstrated an improved response rate in younger adult AML. Aggressive induction plus more potent intensification programs with chemotherapy alone or chemotherapy plus stem cell transplantation (SCT) has improved treatment results. Advances in understanding disease biology, improvements in induction and consolidation program, and better supportive care have also all contributed. A number of clinical and laboratory characteristics influence the response to treatment and, thus, the survival of patients with AML. Among them, cytogenetic at diagnosis represents the most important prognostic variable. However, other factors may have a prognostic value and may influence patient's outcome.

Anaemia and thrombocytopenia are cardinal manifestations of AML. Over the last decades, it has become apparent that the frequency of allogeneic blood transfusions can modify host immunity and clinical outcomes. Anaemia has long been recognized as an adverse prognostic factor in myelodysplastic syndrome (MDS), which represents a pre-leukemic disease. Red blood cell (RBC) transfusion need was identified as a strong and independent risk factor for survival in MDS, for which the presence and severity of anaemia were attributed to a clonally advanced and biologically more aggressive disease.

Based on these data, the investigators retrospectively assessed the prognostic value of RBC and platelet transfusions at the time of diagnosis and the frequency of transfusions during the first induction course of chemotherapy in a large unselected group of patients with previously untreated AML.