title: Prognostic Factors Associated With Mortality Within 6 Months Among Critically Ill Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis

acronym: ANGIOCHOLREA

summary:
The aging of the population goes along with an increased demand for intensive care among very elderly patients (above 75-80 years old). At the same time, there is a decline in the supply of intensive care units (ICU). The 1-year mortality of patients above 80 years old in ICU ranged from 40 to 70%. Moreover, many survivors suffer from long-term sequelae as poor quality of life, cognitive impairment and functional disability.

It is unclear under what conditions older patients may benefit from ICU admission. Cholangitis frequently occured in older patient. Moreover, severe acute cholangitis is a potentially life threatening disease characterized by a biliary obstruction and an infection of the bile possibly evolving towards systemic infection, shock and death. Because of its potential rapid reversibility of symptom thanks to early intravenous antibiotics and biliary decompression with drainage, old patients suffering from acute cholangitis are easily admitted to intensive care unit.

To date, there is a lack of data about the outcome in this population admitted to the intensive care unit with acute cholangitis.

The aim of the current study is to describe the outcomes in elderly patients (> 75 years old) admitted to the ICU with acute cholangitis and to identify prognostics factors associated with long term mortality (6 months).

ReferenceCitation: Novy E, Carrara L, Remen T, Chevaux JB, Losser MR, Louis G, Guerci P. Prognostic factors associated with six month mortality of critically ill elderly patients admitted to the intensive care unit with severe acute cholangitis. HPB (Oxford). 2021 Mar;23(3):459-467. doi: 10.1016/j.hpb.2020.08.003. Epub 2020 Aug 22.

family: Carrara

full_name: Lucie Carrara

given: Lucie

family: Remen

full_name: Thomas Remen

given: Thomas

family: Chevaux

full_name: Jean-Baptiste Chevaux

given: Jean-Baptiste

family: Losser

full_name: Marie-Reine Losser

given: Marie-Reine

family: Guerci

full_name: Philippe Guerci

given: Philippe

journal_name: HPB

location_facility:
Emmanuel NOVY
CHR Mercy


title: Outcome of Hodgkin Lymphoma Patients Over Than 60 Years Treated by Chemotherapy and/or Radiotherapy: a Retrospective Study

acronym: HODGSA

summary: Outcome of Hodgkin lymphoma patients over than 60 years treated by chemotherapy and/or radiotherapy: retrospective analysis.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHU Dijon
CHRU Nancy

lead_sponsor_type: academique

status_simplified: Unknown


title: Epidemiologic Study of Persistent Polyclonal B-cell Lymphocytosis (PPBL) - Observatory 1990-2012

acronym: LPLB

summary:
The main purpose of this study is the description of all French cases of PPBL and the establishment of minimal criteria for the pathology diagnosis and its follow-up.

The secondary objective is the immunologic and genetic characterization of lymphoid cells causing the disease.

status: Completed

study_completion_date_type: Actual

time_perspective: Cross-Sectional

location_facility: group GFHC and intergroup LLC (GCFLL-MW / GOELAMS)

intervention_type: Biological

status_simplified: Completed


title: High Risk Myelodysplasia Treated by Azacytidine : Genetic and Epigenetic (MYRAGE)

acronym: MYRAGE

summary:
Myelodysplastic syndromes (MDS) are the most frequent myeloid neoplasms in Western Countries.They mainly affect patients aged 65 years or older. This is a very heterogenous group of diseases, which prognosis is evaluated with International Prognosis Scoring System. High risk MDS present with high frequency of transformation into acute myeloid leukemia. Treatment of high risk MDS often is based on hypomethylating agents, such as 5'-azacytidine (Azacytidine), with a complete response in approximativel 20% of cases..

This treatment is based on 4-week cycles, with daily injection during the first week and rest during the 3 next weeks of the cycle.

Azacytidine efficacy is commonly evaluated with clinical and biological parameters determined by the International Working Group 2006. These parameters are usually evaluated after at least 6 cycles of treatments.

There is a response with Azacytidine treatment in 60% of cases, including 40% of partial responses and 20% of complete responses. In 40% of patients, there is no response, which means that the disases is stable or in progression under therapy.

In this regard, early evaluation of treatment response is an issue. We want to improve our knowledge about early response criteria in Azacytidine-treated high-risk MDS, focusing on SMD with excess blasts, which represent 30 to 40% of total MDS.

Then, the investigator team want to compare DNA methylation profile at diagnosis and after 3 cycles of Azacytidine treatment.

Main objective :

Identify DNA methylation profiles related to response to Azacytidine therapy, after only 3 cycles of treatment, in high risk MDS with excess blasts.

Secondary objective :

Identify at diagnosis DNA methylation profiles that are predicitive of response to Azacytidin, in high risk MDS with excess blasts.

status: Recruiting

study_type: Interventional

primary_purpose: Screening

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11. Review.

name: Department of Pathology, Stanford University, Stanford, CA;

family: Arber

full_name: Daniel A. Arber

given: Daniel A.

sequence: first

name: Department of Pathology, Weill Cornell Medical College, New York, NY;

family: Orazi

full_name: Attilio Orazi

given: Attilio

sequence: additional

name: Department of Pathology, Massachusetts General Hospital, Boston, MA;

family: Hasserjian

full_name: Robert Hasserjian

given: Robert

name: Institute of Pathology, University of Cologne, Cologne, Germany;

family: Thiele

full_name: Jürgen Thiele

given: Jürgen

name: Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD;

family: Borowitz

full_name: Michael J. Borowitz

given: Michael J.

name: Section of Hematology/Oncology, University of Chicago, Chicago, IL;

family: Le Beau

full_name: Michelle M. Le Beau

given: Michelle M.

name: Comprehensive Cancer Center, James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH;

family: Bloomfield

full_name: Clara D. Bloomfield

given: Clara D.

name: Department of Molecular Medicine, University of Pavia, and Department of Hematology Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; and

family: Cazzola

full_name: Mario Cazzola

given: Mario

name: Department of Pathology, University of Chicago, Chicago, IL

family: Vardiman

full_name: James W. Vardiman

given: James W.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Blood

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Bejar R, Stevenson K, Abdel-Wahab O, Galili N, Nilsson B, Garcia-Manero G, Kantarjian H, Raza A, Levine RL, Neuberg D, Ebert BL. Clinical effect of point mutations in myelodysplastic syndromes. N Engl J Med. 2011 Jun 30;364(26):2496-506. doi: 10.1056/NEJMoa1013343.

family: Bejar

full_name: Rafael Bejar

given: Rafael

family: Stevenson

full_name: Kristen Stevenson

given: Kristen

family: Abdel-Wahab

full_name: Omar Abdel-Wahab

given: Omar

family: Galili

full_name: Naomi Galili

given: Naomi

family: Nilsson

full_name: Björn Nilsson

given: Björn

family: Garcia-Manero

full_name: Guillermo Garcia-Manero

given: Guillermo

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

family: Raza

full_name: Azra Raza

given: Azra

family: Levine

full_name: Ross L. Levine

given: Ross L.

family: Neuberg

full_name: Donna Neuberg

given: Donna

family: Ebert

title: Clinical Effect of Point Mutations in Myelodysplastic Syndromes

ReferenceCitation: Chen G, Broséus J, Hergalant S, Donnart A, Chevalier C, Bolaños-Jiménez F, Guéant JL, Houlgatte R. Identification of master genes involved in liver key functions through transcriptomics and epigenomics of methyl donor deficiency in rat: relevance to nonalcoholic liver disease. Mol Nutr Food Res. 2015 Feb;59(2):293-302. doi: 10.1002/mnfr.201400483. Epub 2014 Dec 9.

name: Institut National de la Santé et de la Recherche Médicale (INSERM); Faculté de Médecine Vandœuvre-lès-Nancy France

name: CHU de Nancy; rue du Morvan Vandœuvre-lès-Nancy France

name: Plateforme de Génomique Intégrative de Nantes; l'IRS-Un Institut de Recherche en Santé de Nantes; Nantes France

name: Institut National de la Recherche Agronomique (INRA); Nantes France

title: Identification of master genes involved in liver key functions through transcriptomics and epigenomics of methyl donor deficiency in rat: Relevance to nonalcoholic liver disease

ReferenceCitation: Cheson BD, Greenberg PL, Bennett JM, Lowenberg B, Wijermans PW, Nimer SD, Pinto A, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Gore SD, Schiffer CA, Kantarjian H. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood. 2006 Jul 15;108(2):419-25. Epub 2006 Apr 11.

ReferenceCitation: Delhommeau F, Dupont S, Della Valle V, James C, Trannoy S, Massé A, Kosmider O, Le Couedic JP, Robert F, Alberdi A, Lécluse Y, Plo I, Dreyfus FJ, Marzac C, Casadevall N, Lacombe C, Romana SP, Dessen P, Soulier J, Viguié F, Fontenay M, Vainchenker W, Bernard OA. Mutation in TET2 in myeloid cancers. N Engl J Med. 2009 May 28;360(22):2289-301. doi: 10.1056/NEJMoa0810069.

title: Mutation inTET2in Myeloid Cancers

ReferenceCitation: Fandy TE, Herman JG, Kerns P, Jiemjit A, Sugar EA, Choi SH, Yang AS, Aucott T, Dauses T, Odchimar-Reissig R, Licht J, McConnell MJ, Nasrallah C, Kim MK, Zhang W, Sun Y, Murgo A, Espinoza-Delgado I, Oteiza K, Owoeye I, Silverman LR, Gore SD, Carraway HE. Early epigenetic changes and DNA damage do not predict clinical response in an overlapping schedule of 5-azacytidine and entinostat in patients with myeloid malignancies. Blood. 2009 Sep 24;114(13):2764-73. doi: 10.1182/blood-2009-02-203547. Epub 2009 Jun 22.

name: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD;

name: Departments of Epidemiology and Biostatistics, The Bloomberg School of Public Health at Johns Hopkins University, Baltimore, MD;

name: Division of Hematology, University of Southern California, Norris Cancer Center, Los Angeles;

name: Division of Medical Oncology, Mount Sinai Medical Center, New York, NY;

name: Division of Hematology/Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL;

name: Malaghan Institute of Medical Research, Wellington, New Zealand;

name: Center for Theoretical Evolutionary Genetics, University of California, Berkeley;

name: Division of Hematology/Oncology, Mount Sinai School of Medicine, New York, NY;

name: Personalized Medicine Research Program, Mount Sinai School of Medicine, New York, NY; and

name: Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, MD

ReferenceCitation: Greenberg PL, Tuechler H, Schanz J, Sanz G, Garcia-Manero G, Solé F, Bennett JM, Bowen D, Fenaux P, Dreyfus F, Kantarjian H, Kuendgen A, Levis A, Malcovati L, Cazzola M, Cermak J, Fonatsch C, Le Beau MM, Slovak ML, Krieger O, Luebbert M, Maciejewski J, Magalhaes SM, Miyazaki Y, Pfeilstöcker M, Sekeres M, Sperr WR, Stauder R, Tauro S, Valent P, Vallespi T, van de Loosdrecht AA, Germing U, Haase D. Revised international prognostic scoring system for myelodysplastic syndromes. Blood. 2012 Sep 20;120(12):2454-65. Epub 2012 Jun 27.

ReferenceCitation: Itzykson R, Kosmider O, Cluzeau T, Mansat-De Mas V, Dreyfus F, Beyne-Rauzy O, Quesnel B, Vey N, Gelsi-Boyer V, Raynaud S, Preudhomme C, Adès L, Fenaux P, Fontenay M; Groupe Francophone des Myelodysplasies (GFM). Impact of TET2 mutations on response rate to azacitidine in myelodysplastic syndromes and low blast count acute myeloid leukemias. Leukemia. 2011 Jul;25(7):1147-52. doi: 10.1038/leu.2011.71. Epub 2011 Apr 15.

name: on behalf of the Groupe Francophone des Myelodysplasies (GFM)

ReferenceCitation: Meldi K, Qin T, Buchi F, Droin N, Sotzen J, Micol JB, Selimoglu-Buet D, Masala E, Allione B, Gioia D, Poloni A, Lunghi M, Solary E, Abdel-Wahab O, Santini V, Figueroa ME. Specific molecular signatures predict decitabine response in chronic myelomonocytic leukemia. J Clin Invest. 2015 May;125(5):1857-72. doi: 10.1172/JCI78752. Epub 2015 Mar 30.

publisher: American Society for Clinical Investigation

ReferenceCitation: Nazha A, Narkhede M, Radivoyevitch T, Seastone DJ, Patel BJ, Gerds AT, Mukherjee S, Kalaycio M, Advani A, Przychodzen B, Carraway HE, Maciejewski JP, Sekeres MA. Incorporation of molecular data into the Revised International Prognostic Scoring System in treated patients with myelodysplastic syndromes. Leukemia. 2016 Nov;30(11):2214-2220. doi: 10.1038/leu.2016.138. Epub 2016 May 20.

ReferenceCitation: Rasmussen KD, Jia G, Johansen JV, Pedersen MT, Rapin N, Bagger FO, Porse BT, Bernard OA, Christensen J, Helin K. Loss of TET2 in hematopoietic cells leads to DNA hypermethylation of active enhancers and induction of leukemogenesis. Genes Dev. 2015 May 1;29(9):910-22. doi: 10.1101/gad.260174.115. Epub 2015 Apr 17.

repository_institution: University of Dundee - Discovery Research Portal

title: Loss ofTET2in hematopoietic cells leads to DNA hypermethylation of active enhancers and induction of leukemogenesis

ReferenceCitation: Santini V, Melnick A, Maciejewski JP, Duprez E, Nervi C, Cocco L, Ford KG, Mufti G. Epigenetics in focus: pathogenesis of myelodysplastic syndromes and the role of hypomethylating agents. Crit Rev Oncol Hematol. 2013 Nov;88(2):231-45. doi: 10.1016/j.critrevonc.2013.06.004. Epub 2013 Jul 7. Review.

title: Epigenetics in focus: Pathogenesis of myelodysplastic syndromes and the role of hypomethylating agents

ReferenceCitation: Sperling AS, Gibson CJ, Ebert BL. The genetics of myelodysplastic syndrome: from clonal haematopoiesis to secondary leukaemia. Nat Rev Cancer. 2017 Jan;17(1):5-19. doi: 10.1038/nrc.2016.112. Epub 2016 Nov 11. Review.


title: Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident

acronym: MEMOIRE ET EMO

summary:
The purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsychological assessment concerning cognitive processes (working and episodic memory) sensitive to different dimensions of anxiety will be analyzed.

The secondary purpose is to evaluate how some neurological (hemispherical lateralization of lesions), psychological (depression) and demographic (quality of life) variables can increase the effects of different dimensions of anxiety on cognitive processes, during the acute and/or chronic phase of CVA.

time_perspective: Prospective

location_facility: Service de Neurologie - Hôpital Central - CHU de Nancy

location_facility: Service de Neurologie - Hôpital Bon Secours - CHR de Metz-Thionville

intervention_type: Other


title: Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis

acronym: EMBOL-EI

summary:
EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in infective endocarditis) is a prospective cohort study with a biological collection.

The main objective is: to re-evaluate the potential value of antiphospholipid (aPL) antibodies as predictors of embolic events in IE in the light of the improved current knowledge on these aPL.

The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von Willebrand factor) will be taken into account in the analysis, and interest in predicting embolic risk, alone or in combination with aPL will be investigated.

location_facility:
CHU de Nancy
CHU de Besancon


title: Study of the Concordance Between a Traditional Protocol of Stress and Rest Myocardial Tomoscintigraphy Using 99mTc-sestamibi and a Double Isotope Protocol Using Thallium-201 and 99mTc-sestamibi, With a Semiconductor Camera

acronym: D-SPECT BIS

summary:
The purpose is to demonstrate the concordance of diagnostic information obtained with:

a conventional examination with 2 distinct recordings on D.SPECT camera after 99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours later,

and

a double isotope examination with a supplementary recording after injection of a little activity of thallium-201 at rest after the first recording and before the second injection of 99mTc-sestamibi for conventional recording at rest,

in patients showing abnormalities of myocardial perfusion in stress myocardial tomoscintigraphy.

primary_purpose: Diagnostic

location_facility: Service de Médecine Nucléaire - CLCC Jean Perrin

location_facility: Service de Médecine Nucléaire - Hôpital de Brabois

intervention_type: Procedure


title: Magnetic Resonance (MR) Imaging Quantitative Functional Perfusion Analysis of the Musculoskeletal System: Clinical Application in Non-tumoral Pathology

acronym: AFRONT

summary: Study on quantitative perfusion parameters acquired on MR imaging of patients with non-tumoral pathology of the musculoskeletal system.

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Mueller D, Schaeffeler C, Baum T, Walter F, Rechl H, Rummeny EJ, Woertler K. Magnetic resonance perfusion and diffusion imaging characteristics of transient bone marrow edema, avascular necrosis and subchondral insufficiency fractures of the proximal femur. Eur J Radiol. 2014 Oct;83(10):1862-9. doi: 10.1016/j.ejrad.2014.07.017. Epub 2014 Jul 30.

ReferenceCitation: Müller GM, Månsson S, Müller MF, Ekberg O, Björkman A. Assessment of perfusion in normal carpal bones with dynamic gadolinium-enhanced MRI at 3 Tesla. J Magn Reson Imaging. 2013 Jul;38(1):168-72. doi: 10.1002/jmri.23951. Epub 2012 Nov 27.

ReferenceCitation: Bervian MR, Ribak S, Livani B. Scaphoid fracture nonunion: correlation of radiographic imaging, proximal fragment histologic viability evaluation, and estimation of viability at surgery: diagnosis of scaphoid pseudarthrosis. Int Orthop. 2015 Jan;39(1):67-72. doi: 10.1007/s00264-014-2579-4. Epub 2014 Nov 16.

ReferenceCitation: Rominger MB, Lukosch CJ, Bachmann GF. MR imaging of compartment syndrome of the lower leg: a case control study. Eur Radiol. 2004 Aug;14(8):1432-9. Epub 2004 Apr 6.

ReferenceCitation: Teixeira PA, Chanson A, Beaumont M, Lecocq S, Louis M, Marie B, Sirveaux F, Blum A. Dynamic MR imaging of osteoid osteomas: correlation of semiquantitative and quantitative perfusion parameters with patient symptoms and treatment outcome. Eur Radiol. 2013 Sep;23(9):2602-11. doi: 10.1007/s00330-013-2867-1. Epub 2013 May 22.

family: Teixeira

full_name: Pedro A. Gondim Teixeira

given: Pedro A. Gondim

family: Chanson

full_name: Anne Chanson

given: Anne

family: Beaumont

full_name: Marine Beaumont

given: Marine

family: Lecocq

full_name: Sophie Lecocq

given: Sophie

family: Louis

full_name: Matthias Louis

given: Matthias

family: Marie

full_name: Béatrice Marie

given: Béatrice

family: Sirveaux

full_name: François Sirveaux

given: François

family: Blum

full_name: Alain Blum

given: Alain

journal_name: European Radiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_facility:
CCIAL, CHRU-Lille
Service d'Imagerie Guilloz, CHRU-Nancy


title: ANALYSE EN MORPHO-TEP AU FDG DE L'EVOLUTIVITE DES ANEVRISMES ABDOMINAUX AORTIQUES NON CHIRURGICAUX UNE ETUDE MULTICENTRIQUE DE L'INTER-REGION NORD-EST

acronym: AAA

summary: The primary aim of the study is to determine if the evolutivity of global and segmentary captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is predictive of the 9 month evolution of diameter and volume of the aneurysm, measured globally and segmentary in angioscan.

location_facility: Service de Médecine Nucléaire - CHU JEAN Minjoz


title: Evaluation of the Effect of Hydration About Orthostatic Hypotension in the Elderly. Difference With Venous Compression. A Randomized Controlled Crossover Trial.

acronym: CHHO

summary:
Primary objective: To compare the decrease in systolic blood pressure between hydration and venous contention when switching to a standing position. Hypothesis in that hydration is better than venous contention.

Secondary objective: To evaluate the effect of hydration on lowering systolic blood pressure during the passage standing in elderly patients with orthostatic hypotension.

Inclusion criteria: Patient aged over 75 years old with orthostatic hypotension proved to 1 and / or 3 min

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Gorelik O, Almoznino-Sarafian D, Litvinov V, Alon I, Shteinshnaider M, Dotan E, Modai D, Cohen N. Seating-induced postural hypotension is common in older patients with decompensated heart failure and may be prevented by lower limb compression bandaging. Gerontology. 2009;55(2):138-44. doi: 10.1159/000141920. Epub 2008 Jun 27.

ReferenceCitation: Tyberghein M, Philips JC, Krzesinski JM, Scheen AJ. [Orthostatic hypotension: definition, symptoms, assessment and pathophysiology]. Rev Med Liege. 2013 Feb;68(2):65-73. French.

ReferenceCitation: Schols JM, De Groot CP, van der Cammen TJ, Olde Rikkert MG. Preventing and treating dehydration in the elderly during periods of illness and warm weather. J Nutr Health Aging. 2009 Feb;13(2):150-7.

ReferenceCitation: Rutan GH, Hermanson B, Bild DE, Kittner SJ, LaBaw F, Tell GS. Orthostatic hypotension in older adults. The Cardiovascular Health Study. CHS Collaborative Research Group. Hypertension. 1992 Jun;19(6 Pt 1):508-19.

location_facility: Centre Hospitalier Régional Universitaire de Nancy


title: Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing

summary:
Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight?

The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent

The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC < 5)

primary_purpose: Treatment

location_facility:
CHU Nancy
CHU Strasbourg Hôpital Civil

intervention_type: Drug


title: Family Heritability, Investigating Gene-gene and Gene-environment Interactions in the Field of Cardiovascular Diseases - 4th VISIT (at 17 Years) of the STANISLAS COHORT

summary:
The Stanislas Cohort is a monocentric familial longitudinal cohort comprised of 1006 families (4295 subjects) from the Nancy region recruited in 1993-1995 at the Centre for Preventive Medicine (Centre de Médecine Préventive, CMP), Vandoeuvre lès Nancy for a 5-year periodic health examination, under the auspices of the Caisse Nationale d'Assurance Maladie (CNAM).

This cohort was established with the primary objective of investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases, based on the study of inter-individual variability and familial segregation analysis of biological and morphological intermediate phenotypes of cardiovascular risk. The longitudinal nature of this study should enable to take into account the evolution of intermediate phenotypes related to genetic factors throughout the follow-up period. The families, consisting of two parents and at least two biological children, were deemed healthy, free of declared acute and/or chronic illness, in order to assess the effect of genetics on the variability of intermediate phenotypes studied under physiological conditions (without the influence, in the absence) of pathology.

The Stanislas Cohort is, both nationally and internationally, the only longitudinal familial cohort of supposedly healthy subjects on such a large scale.

Brief summary of ancillary study "Cardiac Functional Indices Comparison Between MRI and Echocardiography" : the ESCIF study is an ancillary study of the Stanislas cohort aiming at comparing in a cohort of supposedly healthy subjects different cardiac functional indices between two different modalities : Echocardiography and MRI. Indeed, new cardiac functional indices have been recently developed in the scope of echocardiography and would be very useful in MRI. In echography they are computed either from tissue Doppler imaging or from a specific image analysis called speckle tracking. These two techniques are accessible in MRI with the Generalized Reconstruction by Inversion of Coupled Systems (GRICS) technology which provides a motion model from which strains and strain rates may be derived and which allow longer acquisition without the constraint of breath holding (mandatory to reach high temporal resolution).

ReferenceType: derived

ReferenceCitation: Kobayashi M, Huttin O, Magnusson M, Ferreira JP, Bozec E, Huby AC, Preud'homme G, Duarte K, Lamiral Z, Dalleau K, Bresso E, Smaïl-Tabbone M, Devignes MD, Nilsson PM, Leosdottir M, Boivin JM, Zannad F, Rossignol P, Girerd N; STANISLAS study. Machine Learning-Derived Echocardiographic Phenotypes Predict Heart Failure Incidence in Asymptomatic Individuals. JACC Cardiovasc Imaging. 2021 Sep 8. pii: S1936-878X(21)00556-8. doi: 10.1016/j.jcmg.2021.07.004. [Epub ahead of print]

family: Kobayashi

full_name: Masatake Kobayashi

given: Masatake

family: Huttin

full_name: Olivier Huttin

given: Olivier

family: Magnusson

full_name: Martin Magnusson

given: Martin

family: Ferreira

full_name: João Pedro Ferreira

given: João Pedro

family: Bozec

full_name: Erwan Bozec

given: Erwan

family: Huby

full_name: Anne-Cecile Huby

given: Anne-Cecile

family: Preud’homme

full_name: Gregoire Preud’homme

given: Gregoire

family: Duarte

full_name: Kevin Duarte

given: Kevin

family: Lamiral

full_name: Zohra Lamiral

given: Zohra

family: Dalleau

full_name: Kevin Dalleau

family: Bresso

full_name: Emmanuel Bresso

given: Emmanuel

family: Smaïl-Tabbone

full_name: Malika Smaïl-Tabbone

given: Malika

family: Devignes

full_name: Marie-Dominique Devignes

given: Marie-Dominique

full_name: Peter M. Nilsson

given: Peter M.

family: Leosdottir

full_name: Margret Leosdottir

given: Margret

family: Boivin

full_name: Jean-Marc Boivin

given: Jean-Marc

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

family: Girerd

full_name: Nicolas Girerd

given: Nicolas

journal_name: JACC: Cardiovascular Imaging

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

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

repository_normalized: HAL

ReferenceCitation: Monzo L, Ferreira JP, Lamiral Z, Bozec E, Boivin JM, Huttin O, Lopez-Sublet M, Girerd N, Zannad F, Rossignol P. Isolated diastolic hypertension and target organ damage: Findings from the STANISLAS cohort. Clin Cardiol. 2021 Nov;44(11):1516-1525. doi: 10.1002/clc.23713. Epub 2021 Sep 15.

name: Université de Lorraine, Inserm, Centre d'Investigations Cliniques, ‐ Plurithématique 14‐33, and Inserm U1116, CHRU Nancy, F‐CRIN INI‐CRCT (Cardiovascular and Renal Clinical Trialists)  Nancy France

name: Department of Clinical, Internal, Anesthesiologic and Cardiovascular Sciences Sapienza University  Rome Italy

name: Department of Internal Medicine ESH Hypertension Excellence Centre, CHU Avicenne, AP‐HP, F‐CRIN INI‐CRCT  Nancy France

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

ReferenceCitation: Wagner S, Lioret S, Girerd N, Duarte K, Lamiral Z, Bozec E, Van den Berghe L, Hoge A, Donneau AF, Boivin JM, Mercklé L, Zannad F, Laville M, Rossignol P, Nazare JA. Association of Dietary Patterns Derived Using Reduced-Rank Regression With Subclinical Cardiovascular Damage According to Generation and Sex in the STANISLAS Cohort. J Am Heart Assoc. 2020 Apr 7;9(7):e013836. doi: 10.1161/JAHA.119.013836. Epub 2020 Mar 21.

name: INSERM CIC 1433 Nancy CHRU Inserm U1116 FCRIN INI‐CRCT University of Lorraine Nancy France

name: UMR1153 Center for Research in Epidemiology and StatisticS (CRESS) Research Team on Early Life Origins of Health Inserm Paris France

name: CarMeN Laboratory Centre de Recherche en Nutrition Humaine Rhône‐Alpes Univ‐Lyon Université Claude Bernard Lyon1 Hospices Civils de Lyon F‐CRIN/FORCE Network Pierre Bénite, Lyon France

name: Département des Sciences de la Santé Publique Université de Liège Belgium

journal_name: Journal of the American Heart Association

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Association of Dietary Patterns Derived Using Reduced‐Rank Regression With Subclinical Cardiovascular Damage According to Generation and Sex in the STANISLAS Cohort

ReferenceCitation: Benetos A, Verhulst S, Labat C, Lai TP, Girerd N, Toupance S, Zannad F, Rossignol P, Aviv A. Telomere length tracking in children and their parents: implications for adult onset diseases. FASEB J. 2019 Dec;33(12):14248-14253. doi: 10.1096/fj.201901275R. Epub 2019 Oct 25.

name: Défaillance Cardiovasculaire Aigüe et Chronique (DCAC) Université de Lorraine, Nancy, France;

name: Department of Geriatric Medicine, Centre Hospitalier Régional et Universitaire (CHRU)-Plurithématiques–Nancy, INSERM, Unité Mixte de Recherche (UMR)_S 1116, Université de Lorraine, Nancy, France;

name: Groningen Institute for Evolutionary Life Sciences, University of Groningen, Groningen, The Netherlands;

name: Center of Human Development and Aging, Rutgers New Jersey Medical School, The State University of New Jersey, Newark, New Jersey, USA;

name: Centre Hospitalier Régional et Universitaire (CHRU)–Nancy, INSERM, Centre d'Investigation Clinique Pluridisciplinaire (CIC-P) 14-33, Nancy, France;

name: Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (F-CRIN INI-CRCT), Nancy, France

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ReferenceCitation: Ferreira JP, Girerd N, Bozec E, Machu JL, Boivin JM, London GM, Zannad F, Rossignol P. Intima-Media Thickness Is Linearly and Continuously Associated With Systolic Blood Pressure in a Population-Based Cohort (STANISLAS Cohort Study). J Am Heart Assoc. 2016 Jun 16;5(6). pii: e003529. doi: 10.1161/JAHA.116.003529.

name: INSERM, Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine, CHRU de Nancy, Nancy, France

name: Cardiovascular Research and Development Unit, Department of Physiology and Cardiothoracic Surgery, Faculty of Medicine, University of Porto, Portugal

name: Department of Nephrology, Manhès Hospital, Fleury Mérogis, Paris, France

name: Department of Pharmacology, Georges Pompidou European Hospital, National Institute of Health and Medical Research U970, Paris, France

title: Intima–Media Thickness Is Linearly and Continuously Associated With Systolic Blood Pressure in a Population‐Based Cohort (STANISLAS Cohort Study)

location_facility: Centre d'Investigation Clinique- INNOVATIONS TECHNOLOGIQUES

location_facility: Centre d'Investigation Clinique -Plurithématique


title: Post CVA Persistent Hypetension, Interest of Caring by Tensional Auto-measures

acronym: Hippocrate

summary:
The study HIPPOCRATE is a prospective open comparative study with a control group.

The objective of this study is to show that an optimization of the caring of non controlled hypertended patients following a CVA (including a preliminary Tensional auto-measure (TAM) at the follow-up visit, an education of the patient with a decision support tree for the generalist and/or a visit in the multidisciplinary AHT department), allow to obtain a better tensional control copared to the usual caring.

location_facility:
CH Bar Le Duc
CHU de Nancy


title: Expectations and Needs of Patients With Cystic Fibrosis Becoming Parents - Exploratory Study

acronym: MucoPar

summary:
The purpose of this study is to explore and collect the perceptions, expectations and needs of CF patients about parenting. This will be done in the context of several small groups of patients led by a psychologist who will ensure that all the participants express themselves; he will encourage them to develop their points of view, their divergences and their common points about what constitutes to be a parent.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Cochin Hospital
Foch Hospital

intervention_type: Behavioral


title: Analgesia by 50%/50% Nitrous Oxide/Oxygen Mixture for Nasogastric Catheterization in Children Aged 3 Months to 3 Years

acronym: SONGER

summary:
Since nitrous oxide/oxygen mixture is effective to reduce pain and anxiety induced by various painful procedures in children, the investigators hypothesized that its inhalation would reduce pain during nasogastric tube placement in young children.

The purpose of this study is to evaluate the analgesic efficacy of 50%/50% nitrous/oxide mixture in reducing pain induced by nasogastric tube insertion in children aged 3 months to 3 years in the pediatric emergency department.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Poissy Hospital, Pediatric emergency department

location_facility: Trousseau Hospital, Pediatric emergency department

status_simplified: Ongoing


title: Study of Viral Transduction of Human Auditory Sensory Cells for the Development of Gene Therapy

acronym: TREATGENE

summary:
Gene therapy is a promising strategy to treat hearing loss and vestibular disorders, and Associated adenovirus (AAV) is shown as a good viral vector for inner ear therapy in animal models.

This study aims to study in vitro viral transduction of AAV in human inner ear cells, collected during non-conservative surgeries for vestibular schwannoma.

lead_sponsor: Institut Pasteur

location_facility:
Hôpital de Bicêtre
Hôpital Pitié-Salpétrière


title: Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography

acronym: TOPHERO-CT

summary:
The main objective is to evaluate the decrease in crystalline volume of the target tophus using Dual-Energy Computed Tomography (DECT), after 6 months +/- 1 month of urate-lowering therapy with target uricemia.

Study hypothesis

The dynamics of tophus resolution with urate-lowering therapy is poorly understood.
It is variable according to the location of the tophus, peri articular / intratendinous, but also probably at the feet / hands, the initial overall volume of the tophus, the initial crystal charge of the tophus. Knowledge of prognostic factors for tophus resolution will help determine the best target for treatment follow-up for each patient.
Erosions are the consequence of tophus. Tophus resolution could be associated with repair of erosions and stabilization of joint destruction.

primary_purpose: Other

location_facility: Radiology Department Lariboisière Hospital

location_facility: Reumatology Department Lariboisière Hospital


title: Does Optiflow Anesthesia Allow Anethesia Induction "Without Hands" ?

acronym: OPTIFLOW

summary:
Preoxygenation remains an important determinant of morbidity and mortality in anesthesia despite advances in mask ventilation and difficult intubation management.

The usual practice Preoxygenation prior to the injection of the anesthetic agents is the administration of pure oxygen to delay the occurrence of hypoxemia during the apnea phase and intubation maneuvers. It consists of applying a mask on the patient's face and allowing it to ventilate, ensuring a perfect seal of the device. The end of oxygen exhalation fraction is a good reflection of the alveolar oxygenation and a value of 95% corresponds to a "total" alveolar oxygenation. When this value is reached, the injection of the anesthetic agents (hypnotic, morphine and myorelaxant) leads to the loss of consciousness and apnea, which forces to continue the manual ventilation to the mask. Intubation is performed when the myorelaxation is complete.
Anesthetic induction "without the hands" The Optiflow Anesthesia (Fisher and Paykel Healthcare, Auckland, New Zealand) device provides heated, Humidified High-Flow Nasal Oxygen.

The hypothesis of this study is that Humidified High-Flow Nasal Oxygen, should allow anesthetic induction without having to impose the patient the establishment of a facial mask for several minutes before anesthetic induction and the doctor anesthetist assisted ventilation with the mask before intubation.

lead_sponsor: CMC Ambroise Paré

location_facility:
Hôpital Foch
CMC Ambroise Paré

intervention_type: Device


title: Apneic Oxygenation Using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Adult Patients Undergoing Suspension Laryngoscopy Under General Anesthesia: a Multicenter Study

acronym: OxALa

summary:
Patients undergoing suspension laryngoscopy under general anaesthesia have oxygen delivered to their lungs through different methods. Inserting a tube in the trachea is the best means for oxygen delivery. However, it does not allow for optimal visibility of the operated area. Other techniques can be used but have disadvantages with some being associated with serious complications. No consensus exists regarding the best airway management technique for this intervention.

The aim of the study is to investigate a new device that delivers oxygen at very high flow through a nasal cannula in patients undergoing suspension laryngoscopy under general anaesthesia. This technique allows the surgeon to have a perfect visualisation of the laryngeal structures while allowing the delivery of oxygen for the lungs.

After informed consent, adult patients undergoing suspension laryngoscopy under general anaesthesia in two French hospitals will receive high flow oxygen throughout the procedure. At the end of surgery or, whenever applicable, at the time of technique failure (with a decrease in blood oxygen saturation to less than 92%), blood will be drawn for analysis. All patients will have a thin security catheter inserted in their trachea (the currently used technique in both participating hospitals), allowing for rescue high frequency ventilation if ever the study technique fails.

The safety of the device will also be assessed by analysing the blood samples for signs of carbon dioxide accumulation and by collecting any intra or post-operative complications.

If the device shows to be effective at maintaining blood oxygenation without significant associated risks, it could be used for other surgical situations where airway management is expected to be difficult.

status: Terminated

location_facility:
Hôpital René Huguenin - Institut Curie
Hôpital Foch


title: Erector Spinae Plane Block in Lumbar Spinal Fusion : Double-blind, Randomized Controlled Trial.

acronym: MERFUSION

summary: The aim of this study is to observe or not a reduction in the consumption of morphine within 72 hours of the realization of an erector spinae plane block when preparing for a lumbar spinal fusion.

ReferenceCitation: Chen K, Wang L, Ning M, Dou L, Li W, Li Y. Evaluation of ultrasound-guided lateral thoracolumbar interfascial plane block for postoperative analgesia in lumbar spine fusion surgery: a prospective, randomized, and controlled clinical trial. PeerJ. 2019 Oct 28;7:e7967. doi: 10.7717/peerj.7967. eCollection 2019.

ReferenceCitation: Ren Z, Li Z, Li S, Sheng L, Xu D, Chen X, Wu WKK, Chan MTV, Ho J. Local infiltration with cocktail analgesics during 2 level lumbar spinal fusion surgery: Study protocol of a randomized controlled trial. Medicine (Baltimore). 2019 May;98(19):e15526. doi: 10.1097/MD.0000000000015526.

ReferenceCitation: Breebaart MB, Van Aken D, De Fré O, Sermeus L, Kamerling N, de Jong L, Michielsen J, Roelant E, Saldien V, Versyck B. A prospective randomized double-blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar inter-body fusion surgery. Trials. 2019 Jul 17;20(1):441. doi: 10.1186/s13063-019-3541-y.

ReferenceCitation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

ReferenceCitation: Qiu Y, Zhang TJ, Hua Z. Erector Spinae Plane Block for Lumbar Spinal Surgery: A Systematic Review. J Pain Res. 2020 Jul 1;13:1611-1619. doi: 10.2147/JPR.S256205. eCollection 2020. Review.

ReferenceCitation: Ince I, Atalay C, Ozmen O, Ozturk V, Hassan M, Aksoy M, Calikoglu C. Comparison of ultrasound-guided thoracolumbar interfascial plane block versus wound infiltration for postoperative analgesia after single-level discectomy. J Clin Anesth. 2019 Sep;56:113-114. doi: 10.1016/j.jclinane.2019.01.017. Epub 2019 Feb 8.

ReferenceCitation: Cesur S, Yayik AM, Ozturk F, Ahiskalioglu A. Ultrasound-guided Low Thoracic Erector Spinae Plane Block for Effective Postoperative Analgesia after Lumbar Surgery: Report of Five Cases. Cureus. 2018 Nov 16;10(11):e3603. doi: 10.7759/cureus.3603.

ReferenceCitation: Mathiesen O, Dahl B, Thomsen BA, Kitter B, Sonne N, Dahl JB, Kehlet H. A comprehensive multimodal pain treatment reduces opioid consumption after multilevel spine surgery. Eur Spine J. 2013 Sep;22(9):2089-96. doi: 10.1007/s00586-013-2826-1. Epub 2013 May 17.

ReferenceCitation: Davies AF, Segar EP, Murdoch J, Wright DE, Wilson IH. Epidural infusion or combined femoral and sciatic nerve blocks as perioperative analgesia for knee arthroplasty. Br J Anaesth. 2004 Sep;93(3):368-74. Epub 2004 Jul 9.

ReferenceCitation: Benyahia NM, Verster A, Saldien V, Breebaart M, Sermeus L, Vercauteren M. Regional anaesthesia and postoperative analgesia techniques for spine surgery - a review. Rom J Anaesth Intensive Care. 2015 Apr;22(1):25-33.

ReferenceCitation: Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3. Review.

ReferenceCitation: Kendall MC, Alves L, Traill LL, De Oliveira GS. The effect of ultrasound-guided erector spinae plane block on postsurgical pain: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 May 1;20(1):99. doi: 10.1186/s12871-020-01016-8.

ReferenceCitation: Nielsen RV, Fomsgaard JS, Dahl JB, Mathiesen O. Insufficient pain management after spine surgery. Dan Med J. 2014 May;61(5):A4835.

ReferenceCitation: Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

lead_sponsor: Clinique Saint Jean, France

lead_sponsor_type: industriel


title: One-stage Adjustable Strabismus Surgery Under AIVOC

acronym: AIVOC

summary: The purpose of this study is to note that one-stage adjustable surgery can be enough to provide satisfactory results for the correction of strabismus in adults thanks to the use of an anesthesia type AIVOC (Target-controlled infusion of Propofol-Remifentanyl)

ReferenceCitation: Morris RJ, Luff AJ. Adjustable sutures in squint surgery. Br J Ophthalmol. 1992 Sep;76(9):560-2. Review.

ReferenceCitation: Hassan S, Haridas A, Sundaram V. Adjustable versus non-adjustable sutures for strabismus. Cochrane Database Syst Rev. 2018 Mar 12;3:CD004240. doi: 10.1002/14651858.CD004240.pub4. Review.

ReferenceCitation: Farr AK, Guyton DL. Strabismus after retinal detachment surgery. Curr Opin Ophthalmol. 2000 Jun;11(3):207-10. Review.

ReferenceCitation: Garrity JA. The surgical management of Graves' ophthalmopathy. Curr Opin Ophthalmol. 1994 Oct;5(5):39-44. Review.

ReferenceCitation: Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Ophthalmic Nurs Technol. 2000 May-Jun;19(3):142-7. Review.

ReferenceCitation: Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Pediatr Ophthalmol Strabismus. 1999 May-Jun;36(3):112-7; quiz 134-5. Review.

ReferenceCitation: Vallés-Torres J, Garcia-Martin E, Fernández-Tirado FJ, Gil-Arribas LM, Pablo LE, Peña-Calvo P. Contact topical anesthesia versus general anaesthesia in strabismus surgery. Arch Soc Esp Oftalmol. 2016 Mar;91(3):108-13. doi: 10.1016/j.oftal.2015.11.012. Epub 2015 Dec 30. English, Spanish.

ReferenceCitation: Tatham A, Amaya L. Immediate post-operative adjustable suture strabismus surgery using a target-controlled infusion of propofol-remifentanil. Ophthalmologica. 2009;223(3):192-5. doi: 10.1159/000200766. Epub 2009 Feb 10.

ReferenceCitation: Karaba VL, Elibol O. One-stage vs. two-stage adjustable sutures for the correction of esotropia. Strabismus. 2004 Mar;12(1):27-34.

ReferenceCitation: Hakim OM, El-Hag YG, Haikal MA. Strabismus surgery under augmented topical anesthesia. J AAPOS. 2005 Jun;9(3):279-84.

ReferenceCitation: Bleik JH, Karam VY. Comparison of the immediate with the 24-hour postoperative prism and cover measurements in adjustable muscle surgery: is immediate postoperative adjustment reliable? J AAPOS. 2004 Dec;8(6):528-33.


title: Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.

acronym: VRBLOC

summary: The purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.

ReferenceCitation: Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.

ReferenceCitation: Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16.

ReferenceCitation: Patterson DR, Jensen MP, Wiechman SA, Sharar SR. Virtual reality hypnosis for pain associated with recovery from physical trauma. Int J Clin Exp Hypn. 2010 Jul;58(3):288-300. doi: 10.1080/00207141003760595.

ReferenceCitation: Nilsson S, Finnström B, Kokinsky E, Enskär K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.

ReferenceCitation: Konstantatos AH, Angliss M, Costello V, Cleland H, Stafrace S. Predicting the effectiveness of virtual reality relaxation on pain and anxiety when added to PCA morphine in patients having burns dressings changes. Burns. 2009 Jun;35(4):491-9. doi: 10.1016/j.burns.2008.08.017. Epub 2008 Dec 27.

ReferenceCitation: Wright JL, Hoffman HG, Sweet RM. Virtual reality as an adjunctive pain control during transurethral microwave thermotherapy. Urology. 2005 Dec;66(6):1320.

ReferenceCitation: Burt DE. Virtual reality in anaesthesia. Br J Anaesth. 1995 Oct;75(4):472-80. Review.


title: Pilot Study: Secure Outsourcing of Carfilzomib in the Treatment of Multiple Myeloma to the Hospital at Home (HAH) Setting. Care Organisation Model for New Short Intravenous Infusion Chemotherapies

acronym: Carfil-HAD

summary:
Since 2009, the Department of Clinical Haematology at Limoges University Hospital Centre, supported by the HEMATOLIM network, has been operating the regional "ESCADHEM" system: [Secure outsourcing of injectable chemotherapy to the home care setting for malignant blood diseases]. In addition to Limoges University Hospital, Brive Hospital and Guéret Hospital, this system involves four Hospital at Home (HAH) structures across the three départements of the former Limousin region.

In this process, chemotherapy administered by subcutaneous injection is prescribed by a hospital physician in one of the hospitals "authorised to deliver cancer treatments" in the former region of Limousin: Limoges University Hospital Centre, Brive Hospital or Guéret Hospital. This chemotherapy is then prepared in one of the three hospital pharmacies authorised to perform centralised reconstitution, in accordance with current standards. The preparation is then transferred to one of the four Hospital at Home (HAH) structures, which transports the product to the patient's home where it is administered by the nurse (IDE). This last step in the process is under the responsibility of the HAH structure coordinating physician, who is also responsible for waste collection.

Supported by its experience within the ESCADHEM system with subcutaneous drugs and in the context of the arrival of new intravenous drugs, in short infusion form, the Department of Clinical Haematology, supported by the HEMATOLIM network (which became the HEMATOLIM association on 1 January 2020) and the professionals involved began the process of outsourcing these drugs to the HAH setting. One of these drugs is carfilzomib, used to treat multiple myeloma, and its outsourcing to the HAH setting was put in place from the end of 2018.

In parallel with this, the Department of Clinical Haematology would like to set up a study to evaluate the feasibility of outsourcing this new drug, administered intravenously, based on a model that we know to be operational and secure for chemotherapies administered by subcutaneous injection.

the Department of Clinical Haematology hope to be able to confirm the value of caring for multiple myeloma patients in an HAH setting by improving their quality of life and optimising their care pathway in organisational and economic terms. the Department of Clinical Haematology hope to be able to demonstrate that this organisation is not only efficient in the view of patients, but also for the healthcare professionals working in the Hospital, the HAH structure and in the community, involved throughout the care process.

To conduct our study, the Department of Clinical Haematology selected the novel drug carfilzomib, used in the treatment of multiple myeloma.

The prescribing conditions, treatment administration regimen and outsourcing quality processes for this drug are available in the annexes. These standard regimens were constructed on the basis of the protocols in the ESCADHEM system, extensively trialled and validated by the HAS, for drugs injected subcutaneously and following a collegial approach. We thus hope to demonstrate that the protocols used for drugs administered by subcutaneous injection - in particular, bortezomib and azacytidine - are applicable to carfilzomib following minor modifications to the procedures given the IV administration of the latter drug as a short infusion.

It should be noted that it is essential that the first cycle of carfilzomib be administered, in its entirety, in an outpatient clinic setting. Thereafter, if the patient is eligible for treatment in an HAH setting, the 1st day of each cycle will be performed in an outpatient clinic.

Following this study, the Department of Clinical Haematology hope to be able to publish our research and promote it at national and/or international congresses. This research should further reinforce our already significant experience in this type of care strategy for malignant blood diseases in the HAH setting, which we believe is simultaneously innovative, practical and beneficial for all the players in the care pathway concerned. The model will probably be useful for outsourcing to the HAH setting other novel drugs progressively arriving on the market with profiles similar to that of the drug we wish to study.

Finally, our project aims to demonstrate that our procedures for the secure outsourcing of carfilzomib to the HAH setting, in place since the end of 2018 are valid and could be extended to other regions of France. Furthermore, the current health landscape is undergoing profound changes associated with budget constraints, as well as societal and technological evolutions, with the result that home care, and hence HAH structures, appear, more than ever, to be the model of the future.

lead_sponsor: University Hospital, Limoges


title: Postnatal Depression, Attachment and Self-defining Memories

acronym: PNDattachMEMO

summary:
The specificity of postnatal depression (PND) was acted as full entity within the depressions, by B. Pitt in 1968, through the description of a specific nosography which describes "an atypical depression of the post-partum ".

Actually, the epidemiological studies agree on prevalence from 10 to 15 % of PND. With two peaks of frequency, the first one around the 6th and 12th week comment native and the second during the second half-year. This rate of PND represents in France 75000 to 100000 women a year.

The professionals of the perinatal period are interested in this disorder because of the consequences for the woman herself, and of the impact on the premature interactions mother-baby. These interactions and the direct effects of the PND on the mother will have for influence an important slowing down on the development of the baby. Moreover, the study of Lemaitre and Candilis in 1999, brings the figure of 15 % of the PND which will have an impact on the development of the baby.

The sensation of the depression testifies of a process of change and of psychic conflict favored by the psychic transparency of the pregnancy.

Although the first treaty on this specific nosography dates more than 150 years of numerous questions stay suspends it.

These questions and the reflections which surround them found on their path tools ensuing from the theory of the attachment, formalized by John Bowlby. For more than three decades, these profiles of attachment, specified by Mary Ainsworth: secure, anxious-ambivalent, anxious-avoided and disorganized later, disrupted, is studied, estimated and their evolution during a life is observed. Thanks to these models well known for the same person at a time t, it is now their effects in the interpersonal relations which are studied. Between the people but also on the person himself, its image of her, and its autobiographical memory.

The autobiographical memory represents a central component of the human memory. At a very general level, it's possible to define it as the capacity of a person to remember its past experiences. The review of the literature on the functioning of the episodic autobiographical memory during the depression highlights three main results: the too bi generalization of the memories, the congruence in the humor and the frequency of the intrusive memories characterized by an involuntary reminder, fast and effortlessly (Lemogne and al., 2006; Lemogne and al., 2012). The authors specify that there are links between strategies of avoidance of the intrusive memories and the phenomenon of generalization. These links ask to be explored within a model integrating, self and episodic autobiographical memory in the field of the depression. The use of the memories defining the one could allow to study more specifically this kind of memories. The memories defining the one were introduced to Ape and Moffitt (1991) to characterize a specific category of autobiographical memories. The memories defining the one are important personal memories which help a person to understand whom this person is as individual. In a way, they build the life story and support the personal identity. Connected to other similar memories, the self-defining memories contain numerous sensory details and are often associated to a strong emotional charge. They are also connected to long-term purposes, to concerns or to unsolved conflicts.

Recent studies used the self-defining memories (French version adapted by Mr van der Linden's team, Switzerland) as tool to understand better the psychological disorders from which certain people suffer. The studies show that the self-defining memories undergo modifications the characteristics of which are in connection with every pathology (works of the team of J.M. Danion).

In 1994, Moffit and al. studied a group of students with evaluation of the depressive symptomatology. They established that the presenting subjects of high scores of depression develop more generalized memories than the other participants when is asked to them a self-defining memorie positive. For the memories with negative valence, no difference is found among the tested students. There are no data in the literature on the self-defining memories and the postnatal depression. Besides, there is only a single search, not published which explores the links between the attachment and the memories defining the one (Tagini, Conway and Meins, looks for not published, quoted by Conway, to Ape and Tagini, on 2004). The authors present the results according to the styles of attachment. So, autobiographical memories would vary according to the cognitive and emotional dimensions, in connection with differences in the style of attachment. In every style of attachment would correspond certain specificities in the contents and in the form of the self-defining memories.

primary_purpose: Basic Science

lead_sponsor: CHU de Reims


type: Other Identifier

title: Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort

summary: The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Assessment of Metabolic and Immune Profiles in Patients Receiving Immune Checkpoint Inhibitors (ICI) for Advanced Renal Cell Carcinoma or Lung Carcinoma.

acronym: RIMEC

summary:
Recent EMA and FDA approvals have made immune checkpoint inhibitors (ICI) a standard of care in cancer treatment. ICI, used alone or as a combination are now the backbone of renal cell and lung carcinoma treatment. However, a significant proportion of patients does not respond to ICI. Thus the identification of predictive response factor is a major issue.

While factors associated with the tumour and its micro environment have been widely studied, factors associated with the patient such as metabolism could also affect the response to ICI and remain poorly studied.

The hypothesis of the investigators is that dysmetabolims, via the induction of a chronic inflammatory state could induce a defect of lymphocyte production and activation as well as a modification of the immunogenicity of tumor cells and immune cells infiltration. The consequences could be a decrease in ICI response rate as well as an increase in immune related adverse events (irAEs).

To test this hypothesis, the investigators propose a prospective bi-centric exploratory study including 60 patients treated with ICI for advanced lung or renal cell carcinoma.

The data collected will be :

Clinical (calorimetry, impedancemetry, survey of eating habits, tumour characteristics, epidemiological data),
Biologics (baseline and 3-months plasma bio banking for standard biology, inflammation markers TNF- α, IL1-6-8-11-17, TGF-ß, TWEAK, complement study C3, C4, C4d, CH50, C1q, CD46)

Primary objective is to assess the response to ICI depending on metabolic status.

Secondary objectives are to study the relationships between metabolism / cytokines profile/ complement profile and ICI response.

The investigators seek to generate hypotheses and to obtain exploratory data before submission of a Hospital Clinical Research Program whose objective will be to evaluate the impact of dysmetabolism on overall survival and to characterize immune and anatomopathological profiles (using DNA microarrays and flow cytometry techinques) of patients treated with ICI for renal cell or lung carcinoma.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

location_facility: AP-HP - Hôpital Européen Georges-Pompidou Paris

intervention_type: Diagnostic Test


title: Study of Interindividual Variability in the Response to New Oral Direct Anticoagulants (Dabigatran Etexilate, Rivaroxaban or Apixaban) in Patients 80 Years Old and Over, Using a Population Pharmacokinetics Approach.

acronym: ADAGE

summary: Several new oral direct anticoagulants have been recently marketed. However, only a few, limited, studies have provided data about the pharmacology of new oral direct anticoagulants in older persons. This study try to better define wether the pharmacology of each of these 3 drugs (dabigatran, rivaroxaban and apixaban) is actually significantly different in very older patients (over 80) and to which extend. The investigators also try to characterize the main determinants (age, weight, renal function, co-morbidities, etc) of the variability observed between individuals in their response to he drugs studied. The method employed is a population pharmacokinetic/pharmacodynamic study.

lead_sponsor: Hôpital Charles Foix

location_facility:
Hôpital Charles Foix
Hôpital Européen Georges Pompidou


acronym: ClinBio-GNE

summary: The objective of the study is to identify the best clinical and biological outcome measures for further therapeutics approaches.

lead_sponsor: Institut de Myologie, France


title: Induction of Pluripotent Stem Cells From Human Fibroblasts of DM1 Patients

summary: The objective of the study is the modelisation of human cardiomyocyts from pluripotent stem cells in order to study the cardiac alterations induced by CTG expansions.


title: Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients

acronym: Pre-Acti

summary:
Validation of a measure specifically suitable to evaluate the residual function of upper limbs of non-ambulant neuromuscular patients, especially with Duchenne muscular dystrophy and spinal muscular atrophy.

This approach is of fundamental importance for clinical monitoring and preparing the future therapeutic trials.

ReferenceCitation: Le Moing AG, Seferian AM, Moraux A, Annoussamy M, Dorveaux E, Gasnier E, Hogrel JY, Voit T, Vissière D, Servais L. A Movement Monitor Based on Magneto-Inertial Sensors for Non-Ambulant Patients with Duchenne Muscular Dystrophy: A Pilot Study in Controlled Environment. PLoS One. 2016 Jun 7;11(6):e0156696. doi: 10.1371/journal.pone.0156696. eCollection 2016.

family: Le Moing

full_name: Anne-Gaëlle Le Moing

given: Anne-Gaëlle

family: Seferian

full_name: Andreea Mihaela Seferian

given: Andreea Mihaela

family: Moraux

full_name: Amélie Moraux

given: Amélie

family: Annoussamy

full_name: Mélanie Annoussamy

given: Mélanie

family: Dorveaux

full_name: Eric Dorveaux

given: Eric

family: Gasnier

full_name: Erwan Gasnier

family: Hogrel

full_name: Jean-Yves Hogrel

given: Jean-Yves

family: Voit

full_name: Thomas Voit

given: Thomas

family: Vissière

full_name: David Vissière

given: David

family: Servais

full_name: Laurent Servais

given: Laurent

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repositories:
PubMed Central
UCL Discovery

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

location_facility: Institut de Myologie - GH Pitié Salpétrière


title: Prospective Follow-up of Patients With Glycogen Storage Disease Type III

acronym: PRO GSDIII

summary: The aim of this study is to improve knowledge of natural history and methods of monitoring the evolution of Glycogen storage disease type III regarding the muscle and to study the prospective approach of large series of patients, and using the same protocol for the follow up of the children and adults.


title: Assessment of Accelerometric Measurement Devices for Gait Analysis

acronym: ACCELERIX

summary: The objective of this study is to obtain normative accelerometry data during the six minute walk test and a 30 second walk test on healthy subjects in order to determine the accelerometric variables that are the most relevant to describe gait disorders in patient populations. Secondary objectives of this study are to investigate the impact of walking speed and muscle strength on the accelerometric parameters, to assess the reproducibility of the method and to compare accelerometric data obtained with two different devices.

location_facility: Institut de Myologie - GH Pitié Salpêtrière


title: Evaluation of Muscle Strength and Inflammatory Response in Patients With Inclusion Body Myositis

acronym: IBMan

summary: Comparison of a group of 20 IBM patients with 20 controls matched on age, gender and weight.


type: Other Grant/Funding Number

title: Observational Prolonged Trial in Myotonic Dystrophy Type 1 to Improve Quality of Life Standards, a Target Identification Collaboration

acronym: OPTIMISTIC

summary:
Myotonic dystrophy type1 (DM1) is a rare, inherited, chronic progressive disease as well as an autosomal dominant multisystemic disorder. It is the most common adult form of muscular dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733 million people in Europe, we estimate that 75,000 people are DM1 patients in Europe.

The aim of OPTIMISTIC is to improve clinical practice in the management of patients with this rare disease for which no dedicated treatment is currently available. OPTIMISTIC is a multi-centre, randomised controlled trial designed to compare a two component tailored behavioural change intervention to increase physical activity against standard patient management regimes, with particular attention given to the definition of appropriate outcome measures and new clinical guidelines for DM1 management. The two components of the intervention are 1) cognitive behavioural therapy (CBT) and 2) graded physical activity and we will evaluate the intervention's effectiveness and safety against standard patient management.

Participants will be recruited from myotonic dystrophy clinics and neuromuscular centres in France, Germany, the Netherlands and the UK. A total of 286 male and female patients aged 18 years and older with genetically proven classical or adult DM1 suffering from severe fatigue (only DM1 patients with a CIS subscale fatigue score > 35 are likely to benefit from the intervention), able to walk independently and able to complete the trial interventions will be included.

A key objective of OPTIMISTIC is to provide outcome measures that are relevant for the patients and have a rate of change that is appropriate for a clinical trial timeframe. In addition, OPTIMISTIC will identify genetic factors that predict outcome and potential biomarkers as surrogate outcome measures that best explain the observed clinical variation.

ReferenceCitation: van Engelen B; OPTIMISTIC Consortium. Cognitive behaviour therapy plus aerobic exercise training to increase activity in patients with myotonic dystrophy type 1 (DM1) compared to usual care (OPTIMISTIC): study protocol for randomised controlled trial. Trials. 2015 May 23;16:224. doi: 10.1186/s13063-015-0737-7.

ReferenceCitation: Wenninger S, Cumming SA, Gutschmidt K, Okkersen K, Jimenez-Moreno AC, Daidj F, Lochmüller H, Hogarth F, Knoop H, Bassez G, Monckton DG, van Engelen BGM, Schoser B. Associations Between Variant Repeat Interruptions and Clinical Outcomes in Myotonic Dystrophy Type 1. Neurol Genet. 2021 Mar 9;7(2):e572. doi: 10.1212/NXG.0000000000000572. eCollection 2021 Apr.

family: Wenninger

full_name: Stephan Wenninger

given: Stephan

family: Cumming

full_name: Sarah A. Cumming

given: Sarah A.

family: Gutschmidt

full_name: Kristina Gutschmidt

given: Kristina

family: Okkersen

full_name: Kees Okkersen

given: Kees

family: Jimenez-Moreno

full_name: Aura Cecilia Jimenez-Moreno

given: Aura Cecilia

family: Daidj

full_name: Ferroudja Daidj

given: Ferroudja

family: Lochmüller

full_name: Hanns Lochmüller

given: Hanns

family: Hogarth

full_name: Fiona Hogarth

given: Fiona

family: Knoop

full_name: Hans Knoop

given: Hans

family: Bassez

full_name: Guillaume Bassez

given: Guillaume

family: Monckton

full_name: Darren G. Monckton

given: Darren G.

family: van Engelen

full_name: Baziel G.M. van Engelen

given: Baziel G.M.

family: Schoser

full_name: Benedikt Schoser

given: Benedikt

journal_name: Neurology Genetics

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_institution: University of Dundee - Discovery Research Portal

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Heskamp L, van Nimwegen M, Ploegmakers MJ, Bassez G, Deux JF, Cumming SA, Monckton DG, van Engelen BGM, Heerschap A. Lower extremity muscle pathology in myotonic dystrophy type 1 assessed by quantitative MRI. Neurology. 2019 Jun 11;92(24):e2803-e2814. doi: 10.1212/WNL.0000000000007648. Epub 2019 May 22.

family: Heskamp

full_name: Linda Heskamp

given: Linda

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Okkersen K, Jimenez-Moreno C, Wenninger S, Daidj F, Glennon J, Cumming S, Littleford R, Monckton DG, Lochmüller H, Catt M, Faber CG, Hapca A, Donnan PT, Gorman G, Bassez G, Schoser B, Knoop H, Treweek S, van Engelen BGM; OPTIMISTIC consortium. Cognitive behavioural therapy with optional graded exercise therapy in patients with severe fatigue with myotonic dystrophy type 1: a multicentre, single-blind, randomised trial. Lancet Neurol. 2018 Aug;17(8):671-680. doi: 10.1016/S1474-4422(18)30203-5. Epub 2018 Jun 19.

repository_institution: Aberdeen University - Aberdeen University Research Archive

location_country:
Germany
United Kingdom
France
Netherlands

location_facility: Radboud University Nijmegen Medical Centre


title: Multifactorial Analysis of the Influence of Alcohol Marketing Stimuli in Adults With Regular Alcohol Consumption on the Perception of Alcohol Risks and According to Types of Use and Individual Vulnerabilities

acronym: DEPREV_Phase 2

summary:
Alcohol use is the second leading cause of preventable death after smoking. The Evin law was built in 1991 with the goal of reducing exposure to alcohol marketing among the youngest. But this law is currently extremely weakened, and in a press release of February 26, 2018, the French Society of Alcoology is alarmed by these developments.

Studies on the impact of alcohol marketing focus for the most part on young adolescents and the links between marketing exposure and alcohol initiation. But beyond these links, little work has been done on the impact of alcohol marketing on vulnerable subjects with regular alcohol consumption. Alcohol consumption is one of the very first causes of hospitalization in France. The damage is often limited to the notion of risks of dependence, but it can appear as soon as consumption of 1 standard unit/day and mainly concerns the 45-64 year olds. To our knowledge, there are no studies on the impact of alcohol marketing carried out among regular alcohol users with moderate or severe alcohol use disorders.

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest

location_facility:
Benoit SCHRECK
Morgane GUILLOU-LANDREAT
Jean-Pierre SIMSON


title: Usefulness of Pro-adrenomedullin (MR proADM)as a Predictor of Outcome in Acute Exacerbations of COPD Visiting the Emergency Room

acronym: UTAPE BPCO

summary: The purpose of this study is to determine whether pro-adrenomedullin (Mr proADM)in addition to clinical evaluation is effective to predict outcome of acute exacerbations of COPD patients visiting the emergency room(ER).

lead_sponsor: ThermoFisher Scientific Brahms Biomarkers France

location_facility:
Pitié Salpétrière Hospital
Hôpital Lariboisière


title: Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care

summary: Depression has emotional consequences, social and important business. Reaching at least 7.5% of French aged 15 to 85 years. General Practitioners are the first professional consulted in terms of frequency of consultations. Indeed, in primary care, 10 to 25% of patients with depression that General Practitioners are often alone to support and follow. But General Practitioners are faced with diagnostic difficulties facing the diagnosis of depression, because if the patient does not engage itself, no tool is validated in France to help them in their diagnosis. However, standardized questionary exist that allow to overcome this difficulty. Questionary used in other european countries. Among them, the HSCL25 scale was selected by a systematic review of literature and a RAND UCLA type of consensus procedure. This HSCL25 scale is the most efficient for the diagnosis of depression in terms of efficiency tool, reproducibility and ergonomics. However, it remains necessary to confirm its validity in terms of the French translation and in terms of efficiency.

location_facility: Cabinet médical en zone rurale - Pôle Santé Universitaire


title: Quantification in Nuclear Medicine: Interest of the in SPECT-CT Scan SUVspect in Thea New Generation of Gamma-cameras With Semiconductor. Data Collection for the Constitution of an Observatory of Scintigraphies

acronym: GAMMA-CAM

summary:
Since 2017, a revolution began in the departments of nuclear medicine, with the routine use of gamma-cameras with semiconductor. These gamma-cameras (which obtained the CE-marking in 2016), offer a technological breakthrough by providing an additional information. They allow "to quantify" for the 1st time in clinical routine conditions, the quantity of radioactivity, by means of a "SUVspect", in a volume of interest, while respecting the recommendations of best practice of the learned societies of French nuclear medicine (SFMN), European (EANM) and American (SNM), without injection of tracer nor acquisition or additional irradiation. The SUVspect is therefore an indicator of the quantity of tracer in a given volume of acquisition.

Until now, the interpretation criteria of scintigraphies are based on the homogeneity of distribution of a tracer in the explored organ (for single organs such as the heart or the thyroid, for example) or in the asymmetry of distribution of the tracer (for the double organs, such as the kidney or the joints).

This new gamma-camera allows to study the distribution of the radio-tracers in "list" mode, allowing to retrospectively reconstruct the images in various ways (for example, by modifying the size of the matrix of acquisition, the energy windows, the time of acquisition). Therefore, we can simulate and propose modifications in current procedures.

Every patient referred to our department of nuclear medicine to undergo a scintigraphy with a tracer of nuclear medicine (with a marketing authorization) can, while benefiting from an examination by this gamma-camera, to be the object of this study, and to profit from this additional information.

So, without changing the diagnosis or the usual care, we wish to take advantage of this additional information to improve the criteria of interpretation of our examinations.

This possibility being new, there is no available bibliography (our department is the 5th department of nuclear medicine in Europe to equip itself with this large field-of-view gamma-camera CZT, the DNM 670, made by General Electric), while 2961 articles speak about the SUVmax (in PET) in Pubmed.

lead_sponsor: Lille Catholic University

location_facility:
Hopital Privé Le Bois
Humanitep


title: Benefit of Analyzing Exosomes in the Cerebrospinal Fluid During the Medical Care of Breast Cancer Patients With Suspicion of Leptomeningeal Metastasis.

summary: This is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. The current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.

status: Withdrawn

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Digital Phenotyping (Physical Activity, Heart Rate, Sleep) in Young Breast Cancer Patients Treated With Neoadjuvant Chemotherapy

acronym: NeoFit

summary:
BACKGROUND: In young women, breast cancer (BC) has particular characteristics, such as a more advanced stage at diagnosis, aggressive tumor characteristics, and a poorer prognosis. NeoFit aims to use an activity tracker to identify and describe various digital profiles (physical activity, heart rate, sleep) in women under 45 years of age treated with neoadjuvant chemotherapy for BC.

METHODS: NeoFit is a prospective, national, multicenter, single-arm open-label study. It will include a total of 300 participants under the age of 45 years treated with neoadjuvant chemotherapy for BC. Participants will receive a Withing Steel HR activity tracker, which they will be asked to wear 24 h per day for 12 months. The principal assessments will be performed at baseline, at the end of neoadjuvant chemotherapy and at 12 months. We will evaluate clinical (e.g. toxicity, efficacy of chemotherapy), lifestyle, quality of life, fatigue, and physical activity parameters. All questionnaires will be completed on a REDCap form, via a secure internet link.

DISCUSSION: NeoFit will make it possible, through the use of an activity tracker, to visualize changes, over a one-year period, in the lifestyle of young women treated for BC by neoadjuvant chemotherapy. This exploratory study will provide fundamental knowledge about the digital phenotypes of young BC patients treated with NAC and their relationships to chemotherapy toxicity and efficacy. This trial will pave the way for interventional studies on physical activity and sleep interventions.

lead_sponsor: Institut Curie


title: Cellular Effects of Training in Healthy Sedentary Subjects

summary: The purpose of this study is to understand underlying mechanisms of improved exercise tolerance in Healthy Sedentary Subjects after training program.

lead_sponsor: 5 Santé

location_facility:
Clinique du souffle La valonie
Clinique du souffle La solane
hopital Arnaud de Vilneuve


title: Identification of Social Categorisation Process Who Intervene During Patient Nurse Triage and Research of Them Impacts in Cares.

acronym: SOCIALSORTING

summary:
Social Sorting is a: non interventional, observational, qualitative and multicenter research. It investigates three French emergency units in three French centers (UH of Angers, H of Le Mans, H of Laval).

It is a research based on nursing sciences and social-psychology and it proposes to study the process of social categorization that intervenes during triage nursing.

The process of social categorization has developped since the beginning of XX century (LIPPMANN, in 1922, in United States, he gave the first definition of stereotype// DURKHEIM, in France described step by step the individuals and the collectives representations.

During XX century the social psychology developed a lot of studs about group dynamics (social categorization, influence phenomenon, conspiracy theories,...) within several domains : industry, politics, public services as police, social units,... and also in healthcare (but always about a social categorisation in particular and often with a limited study of impacts).

Social Sorting includes all social categorization as possible and search to do a scientific evaluation of their impact.

lead_sponsor: University Hospital, Angers

location_facility:
CHU Angers
CH Laval
CH Le Mans


title: Monitoring Electronique à Distance Des Patients Insuffisants Cardiaques

acronym: MEDIC

summary:
The main objective of the study is to evaluate the effect of telemonitoring on mortality and rehospitalization due to heart failure on patients with chronic heart failure which have follow an educational program compared to a conventional follow-up during 1 year.

The secondary objectives of the study are :

Evaluate the cost of health
Qualitatively evaluate telemonitoring on uses
Evaluate quality of life

lead_sponsor: Centre Hospitalier Universitaire de Besancon


type: Registry Identifier

title: Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography

summary:
RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment.

PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.

lead_sponsor: National Cancer Institute, France

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX

acronym: ERBIFORT

summary:
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.