title: Bioprofiling Response to Mineralocorticoid Receptor Antagonists for the Prevention of Heart Failure. A Proof of Concept Clinical Trial Within the EU FP 7 (European Union FP7) "HOMAGE" Programme " Heart OMics in AGing "

acronym: Homage

summary:
Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed. Prevention is most efficient when directed toward patients at risk and when mechanistically targeted to patients most likely to respond. An increase in myocardial and possibly vascular collagen content (fibrosis) may be a major determinant of the transition to HF. In patients with hypertension and diabetes, two important risk-factors for HF, changes in blood markers of fibrosis occur before clinically overt HF develops. These markers are also related to prognosis.

In the general population, Galectin-3 (Gal-3), a potential marker of fibrosis, is associated with cardiovascular (CV) risk factors, and predicts development of HF. In animal models, Gal-3 is a key mediator of aldosterone-induced CV and renal fibrosis and dysfunction.

The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA), spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio of spironolactone might be superior in patients with a higher compared to lower plasma concentrations of Gal-3.

Main objective is to investigate whether spironolactone can favourably alter extra-cellular matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III N-Terminal Peptide (PIIINP), in patients at increased risk of developing heart failure and whether this effect is greater in patients with increased plasma concentrations of Gal-3.

primary_purpose: Other

ReferenceCitation: Verdonschot JAJ, Ferreira JP, Pellicori P, Brunner-La Rocca HP, Clark AL, Cosmi F, Cuthbert J, Girerd N, Mariottoni B, Petutschnigg J, Rossignol P, Cleland JGF, Zannad F, Heymans SRB; HOMAGE "Heart Omics in AGEing" consortium. Proteomic mechanistic profile of patients with diabetes at risk of developing heart failure: insights from the HOMAGE trial. Cardiovasc Diabetol. 2021 Aug 9;20(1):163. doi: 10.1186/s12933-021-01357-9.

family: Verdonschot

full_name: Job A. J. Verdonschot

given: Job A. J.

family: Ferreira

full_name: João Pedro Ferreira

given: João Pedro

family: Pellicori

full_name: Pierpaolo Pellicori

given: Pierpaolo

family: Brunner-La Rocca

full_name: Hans-Peter Brunner-La Rocca

given: Hans-Peter

family: Clark

full_name: Andrew L. Clark

given: Andrew L.

family: Cosmi

full_name: Franco Cosmi

given: Franco

family: Cuthbert

full_name: Joe Cuthbert

given: Joe

family: Girerd

full_name: Nicolas Girerd

given: Nicolas

family: Mariottoni

full_name: Beatrice Mariottoni

given: Beatrice

family: Petutschnigg

full_name: Johannes Petutschnigg

given: Johannes

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

family: Cleland

full_name: John G. F. Cleland

given: John G. F.

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Heymans

full_name: Stephane R. B. Heymans

given: Stephane R. B.

name: HOMAGE “Heart Omics in AGEing” consortium

journal_name: Cardiovascular Diabetology

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repository_institution: The University of Glasgow - Enlighten: Publications

repositories:
HAL
PubMed Central
Zenodo
eprints.gla.ac.uk

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

ReferenceCitation: Ferreira JP, Verdonschot J, Wang P, Pizard A, Collier T, Ahmed FZ, Brunner-La-Rocca HP, Clark AL, Cosmi F, Cuthbert J, Díez J, Edelmann F, Girerd N, González A, Grojean S, Hazebroek M, Khan J, Latini R, Mamas MA, Mariottoni B, Mujaj B, Pellicori P, Petutschnigg J, Pieske B, Rossignol P, Rouet P, Staessen JA, Cleland JGF, Heymans S, Zannad F; HOMAGE (Heart Omics in AGEing) Consortium. Proteomic and Mechanistic Analysis of Spironolactone in Patients at Risk for HF. JACC Heart Fail. 2021 Apr;9(4):268-277. doi: 10.1016/j.jchf.2020.11.010. Epub 2021 Feb 3.

ReferenceCitation: Pellicori P, Ferreira JP, Mariottoni B, Brunner-La Rocca HP, Ahmed FZ, Verdonschot J, Collier T, Cuthbert JJ, Petutschnigg J, Mujaj B, Girerd N, González A, Clark AL, Cosmi F, Staessen JA, Heymans S, Latini R, Rossignol P, Zannad F, Cleland JGF. Effects of spironolactone on serum markers of fibrosis in people at high risk of developing heart failure: rationale, design and baseline characteristics of a proof-of-concept, randomised, precision-medicine, prevention trial. The Heart OMics in AGing (HOMAGE) trial. Eur J Heart Fail. 2020 Sep;22(9):1711-1723. doi: 10.1002/ejhf.1716. Epub 2020 Jan 16.

name: Robertson Institute of Biostatistics and Clinical Trials Unit University of Glasgow  Glasgow UK

name: Université de Lorraine, INSERM, Centre d'Investigations Cliniques Plurithématique, INSERM 1433, CHRU de Nancy,Institut Lorrain du Coeur et des Vaisseaux, FCRIN INI‐CRCT  Nancy France

name: Department of Cardiology Cortona Hospital  Arezzo Italy

name: Department of Cardiology Maastricht University Medical Center  Maastricht The Netherlands

name: Manchester Heart Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Sciences Centre  Manchester UK

name: Department of Medical Statistics London School of Hygiene and Tropical Medicine  London UK

name: Department of Academic Cardiology Castle Hill Hospital, Hull York Medical School (at University of Hull)  Kingston upon Hull UK

name: Department of Cardiology Charité Universitätsmedizin Berlin  Berlin Germany

name: DZHK (German Center of Cardiovascular Research), Partner Site Berlin  Berlin Germany

name: Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences, University of Leuven  Leuven Belgium

name: Program of Cardiovascular Diseases, CIMA Universidad de Navarra and IdiSNA  Pamplona Spain

name: CIBERCV, Carlos III Institute of Health  Madrid Spain

name: Department of Cardiovascular Sciences Centre for Molecular and Vascular Biology, KU Leuven  Leuven Belgium

name: The Netherlands Heart Institute  Utrecht The Netherlands

name: Department of Cardiovascular Medicine Istituto di Ricerche Farmacologiche Mario Negri, IRCCS  Milan Italy

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

title: Effects of spironolactone on serum markers of fibrosis in people at high risk of developing heart failure: rationale, design and baseline characteristics of a proof‐of‐concept, randomised, precision‐medicine, prevention trial. The Heart OMics in AGing (HOMAGE) trial

ReferenceCitation: Ferreira JP, Verdonschot J, Collier T, Wang P, Pizard A, Bär C, Björkman J, Boccanelli A, Butler J, Clark A, Cleland JG, Delles C, Diez J, Girerd N, González A, Hazebroek M, Huby AC, Jukema W, Latini R, Leenders J, Levy D, Mebazaa A, Mischak H, Pinet F, Rossignol P, Sattar N, Sever P, Staessen JA, Thum T, Vodovar N, Zhang ZY, Heymans S, Zannad F. Proteomic Bioprofiles and Mechanistic Pathways of Progression to Heart Failure. Circ Heart Fail. 2019 May;12(5):e005897. doi: 10.1161/CIRCHEARTFAILURE.118.005897.

name: Université de Lorraine, Inserm, Centre d’Investigations Cliniques-Plurithématique 14–33, and Inserm U1116, CHRU, F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France (J.P.F., A.P., N.G., A.-C.H., P.R., F.Z.).

name: Department of Physiology and Cardiothoracic Surgery, Cardiovascular Research and Development Unit, Faculty of Medicine, University of Porto, Portugal (J.P.F.).

name: Department of Cardiology, Maastricht University Medical Centre, Center for Heart Failure Research, Cardiovascular Research Institute Maastricht (CARIM), University Hospital Maastricht, the Netherlands (J.V., M.H., S.H.).

name: Department of Clinical Genetics, Maastricht University Medical Center, the Netherlands (J.V., P.W.).

name: London School of Hygiene and Tropical Medicine, United Kingdom (T.C.).

name: Inserm 1024, Institut de Biologie de l’École Normale Supérieure (IBENS), PSL University of Paris, France (A.P.).

name: Institute of Molecular and Translational Therapeutic Strategies (IMTTS), Hannover Medical School, Germany (C.B., T.T.).

name: Casa di Cura Quisisana, Rome, Italy (A.B.).

name: TATAA Biocenter AB, Gothenburg, Sweden (J.B.).

name: Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.).

name: Excellence Cluster REBIRTH, Hannover Medical School, Germany (J.B.).

name: Hull York Medical School, Castle Hill Hospital, Cottingham, United Kingdom (A.C.).

name: Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Wellbeing, Glasgow, United Kingdom (J.G.C.).

name: National Heart and Lung Institute, Royal Brompton and Harefield Hospitals, Imperial College, University of Glasgow, London, United Kingdom (J.G.C.).

name: Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland, United Kingdom (C.D.).

name: Program of Cardiovascular Diseases, Centre for Applied Medical Research, University of Navarra, Pamplona, Spain (J.D., A.G.).

name: CIBERCV, Carlos III Institute of Health, Madrid, Spain (J.D., A.G.).

name: Instituto de Investigación Sanitaria de Navarra (IdiSNA), Spain (J.D., A.G.).

name: Departments of Nephrology, and Cardiology and Cardiac Surgery, University of Navarra Clinic, Pamplona, Spain (J.D.).

name: Department of Cardiology, Leiden University Medical Center, the Netherlands (W.J.).

name: IRCCS-Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy (R.L.).

name: ACS Biomarker BV, Amsterdam, the Netherlands (J.L.).

name: National Heart, Lung, and Blood Institute’s and Boston University’s Framingham Heart Study, MA (D.L.).

name: Population Sciences Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, Bethesda, MD (D.L.). UMRS 942, University Paris Diderot

name: APHP, University Hospitals Saint Louis Lariboisière, France (A.M., N.V.).

name: Mosaiquesdiagnostics, Hannover, Germany (H.M.).

name: Inserm U1167, Institut Pasteur de Lille, Université de Lille, FHU-REMOD-VHF, France (F.P.).

name: Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom (N.S.).

name: International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, England (P.S.).

name: Studies Coordinating Centre, Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences, University of Leuven, Belgium (J.A.S., Z.-Y.Z.).

name: Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, the Netherlands (J.A.S.).

name: National Heart and Lung Institute, Imperial College London, United Kingdom (T.T.).

name: Department of Cardiovascular Research, University of Leuven, Belgium (S.H.). Netherlands Heart Institute (ICIN), Utrecht, the Netherlands (S.H.).

location_country:
Italy
Netherlands
France
Ireland
Germany
United Kingdom

location_facility: Central Manchester University Hospitals NHS

location_facility: Charite Universitatsmedizin Berlin, Kardiologie


type: EudraCT Number

type: Other Identifier

title: A Phase II/III Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

summary: Pembrolizumab is a new type of drug for mesothelioma (immunotherapy). Laboratory tests show that this drug works by helping improve the body's immune response to help fight cancer. Pembrolizumab may help the immune system to recognize cancer cells and slow down the growth and/or spreading of cancer.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2.

family: Uprety

full_name: Dipesh Uprety

given: Dipesh

sequence: first

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Lung Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: No

lead_sponsor: Canadian Cancer Trials Group

location_country: Italy Canada France

location_facility: Oncologia Medica Humanitas Gavazzeni Bergamo

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: AOU Policlinico Vittorio Emanuele UOC di Oncologia

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: IRCCS Ospedale Oncologico Giovanni Paolo II

location_facility: CHUM-Centre Hospitalier de l'Universite de Montreal

location_facility: Unita Sperimentazioni Cliniche Istituto per lo

location_facility: PO A Perrino ASL Brindisi - UOC Oncologia Medica

location_facility: BCCA - Cancer Centre for the Southern Interior

location_facility: Azienda USL di Piacenza, Ospedale Gugliemimo Salieto

location_facility: Azienda Ospedaliera di Rilievo Nazionale

location_facility: U.O.S.D. Day Hospital Oncologico-Pneumologico

location_facility: Istituti Fisioterapici Ospitalieri IFO Istituto

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Oncologia SS Antonio e Biagio Alessandria

location_facility: Dott. Fortunato Ciardiello,Cattedra Oncologia Medica

location_facility: Oncologia Medica IRCCS Arcispedale Maria

location_facility: The Research Institute of the McGill University

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Completed

lead_sponsor: Innate Pharma

acronym: EFFIKIR

location_facility:
Hôpital Henri Mondor
Hôpital Necker
CHU de Bordeaux - Hôpital Haut-Lévêque
Hôpital Morvan CHU Brest
CH Saint-Quentin
CHU d'Amiens
Hôpital Militaire Percy
CHG de Béziers
Centre Hospitalier de Mulhouse
Centre hospitalier sud francilien
CH René Dubos
CH de Blois
Hôpital Saint-Antoine
Centre Henri Becquerel
CHU de Besançon
Institut Paoli - Calmettes
Centre Antoine Lacassagne
Centre hospitalier Victor Dupouy
Hôpital Claude Huriez
CHU Estaing
CHU de Poitiers
CH Valenciennes
CHU de Grenoble
CH Saint-Jean
CHU Purpan
CHR d'Annecy
Hôpital Saint-Louis
CHU Saint Eloi
CHU de Nantes
Hôpital Haute Pierre et Hôpital Civil
Centre René Huguenin
Centre hospitalier de la côte Basque
Hôpital Avicenne
CH de Meaux
Institut Gustave Roussy
CHU Angers
CHU de Reims
CHR d'Orléans
CHU de Limoges
Centre hospitalier Lyon Sud
Centre Hospitalier de Versailles
CHU Caremeau
CHU de Nancy Hôpitaux de Brabois

study_completion_date_type: Actual

source: euctr

title: Double-Blind Placebo-Controlled Randomized Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission

summary: Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission

status_simplified: Completed


title: Impact of SARS-CoV-2 Infection in a Population Aged 70 Years or Older on Loss of Autonomy

acronym: CovAged

summary: In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Moreover, since infection by the SARS-CoV-2 virus is new to humans, the investigators do not yet have sufficient information on the fate of the elderly, in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. the investigators therefore assume that the clinical pictures in the elderly will present specificities that will need to be described. The investigators hypothesize that an acute infection of this type will have short-, medium-, and long-term repercussions in the elderly.

status: Recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital Center of Martinique

location_country: Martinique France Guadeloupe

location_facility:
University hospital of Rennes
Va de Lys-Ramsay Gds group Clinic
Hopsital of Valenciennes
University hospital of Guadeloupe
University hospital of Martinique

lead_sponsor_type: academique


title: Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Severe to Very Severe Chronicle Obstructive Pulmonary Disease

summary:
Chronicle obstructive pulmonary disease is a worldwide cause of mortality and morbidity. This systemic disease progressively leads to dyspnea, muscle wasting and exercise capacity impairment.

Pulmonary rehabilitation is a cornerstone in the management of these systemic effects. Unfortunately, access to pulmonary rehabilitation is limited for many people who would benefit from it, primarily because of a lack of pulmonary rehabilitation and assessment centers. Optimal assessment should include cardiopulmonary exercise testing to determine both the optimal training settings as well as any cardiopulmonary contraindications to pulmonary rehabilitation. However, this is not available in most centers and when it is, consultations are limited. Therefore, pulmonary rehabilitation is often delayed for several weeks and patients can lose motivation.

In order to promote pulmonary rehabilitation, the incremental cardiopulmonary exercise testing could be replaced by field tests to individualize pulmonary rehabilitation prescription.

The 6-minute stepper test is a new field tool. Its sensitivity and reproducibility have previously been reported in patients with chronicle obstructive pulmonary disease. It is easy to set up in the clinical setting and could be used to individualize pulmonary rehabilitation.

The aim of this study was to develop and validate a prediction equation to set rehabilitation intensity for patients with severe to very severe chronicle obstructive pulmonary disease attending pulmonary rehabilitation, with the use of a simple, readily available field test. Therefore the investigators sought to determine, if it exists, a relationship between the plateau heart rate from the first and last 3 minutes of the 6-minute stepper test and the heart rate from the first ventilatory threshold from the cardiopulmonary exercise testing in order to individualize pulmonary rehabilitation in patients with severe to very severe chronicle obstructive pulmonary disease.

lead_sponsor: ADIR Association

location_facility: Centre Hostalier Intercommunal Elbeuf-Louviers-Val de Reuil

intervention_type: Other


title: Use of the 6-minute Stepper Test to Individualise Pulmonary Rehabilitation in Patients With Mild to Moderate Chronicle Obstructive Pulmonary Disease

summary: The purpose of this study is to determine, if it exists, a relation between plateau heart rate from the last 3 minutes of the 6-minute stepper test and heart rate from first ventilatory threshold from cardiopulmonary exercise testing in order to individualise pulmonary rehabilitation in patients with mild to moderate chronicle obstructive pulmonary disease.


title: A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate Midazolam in Patients With ALK-Positive or ROS1-Positive Solid Tumors

summary: The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.

ipd_sharing: Yes

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Ariad Pharmaceuticals

location_country: Italy Spain France Netherlands

location_facility: HM Centro Integral Oncologico Clara Campal

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Groupe Hospitalier Bichat-Claude Bernard - Hopital Bichat


title: Assessment of Helical Tomotherapy Radiotherapy (54 Gy) Followed by Surgery in Retro-peritoneal Liposarcoma

acronym: TOMOREP

summary:
Retro peritoneal liposarcomas are rare (less than 15% of sarcomas) whose prognosis is locoregional.

In the treatment of retroperitoneal liposarcomas main prognostic factor is the quality of the surgical resection. The effect of radiotherapy combined with surgery is uncertain and until now limited perhaps because of limited prescribed doses (of the order of 45Gy to 50Gy) due to high risk of organ toxicity nearby.

The helical tomotherapy is an innovative equipment radiotherapy to make conformational radiotherapy modulation intensity and is particularly suitable for irradiations precision (imaging mode associated with daily scanner) in large complex volumes. Increasing doses (increase of the prescribed dose to 54 Gy, thus potentially curative), the helical tomotherapy should allow to improve the efficacy of radiotherapy.

lead_sponsor: Institut Bergonié

location_facility:
Centre Claudius Regaud
Centre Paul Strauss
Institut Curie
Centre René Gauducheau
Institut Bergonié

intervention_type: Radiation


title: Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal/Pubertal Cancer Patients

acronym: CHANCE

summary:
While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Fertility preservation is currently proposed for selected prepubertal patients with a high risk of premature ovarian failure after treatment (mostly conditioning regimen for bone marrow transplantation). For patients with low or moderate risks, counselling is very difficult and no fertility preservation procedure is usually proposed for these patients as no marker of the ovarian reserve has been validated in this young population to assess the individual risk.

The primary objective of the study is to prevent long-term treatment-related infertility by detecting the young patients who normally progressed to menarche but have a reduced ovarian reserve. These patients may benefit from particular follow-up and fertility preservation procedure.

ReferenceType: background

ReferenceCitation: Brougham MF, Crofton PM, Johnson EJ, Evans N, Anderson RA, Wallace WH. Anti-Müllerian hormone is a marker of gonadotoxicity in pre- and postpubertal girls treated for cancer: a prospective study. J Clin Endocrinol Metab. 2012 Jun;97(6):2059-67. doi: 10.1210/jc.2011-3180. Epub 2012 Apr 3.

ReferenceCitation: Wallace WH, Smith AG, Kelsey TW, Edgar AE, Anderson RA. Fertility preservation for girls and young women with cancer: population-based validation of criteria for ovarian tissue cryopreservation. Lancet Oncol. 2014 Sep;15(10):1129-36. doi: 10.1016/S1470-2045(14)70334-1. Epub 2014 Aug 14.

ReferenceCitation: Demeestere I, Simon P, Dedeken L, Moffa F, Tsépélidis S, Brachet C, Delbaere A, Devreker F, Ferster A. Live birth after autograft of ovarian tissue cryopreserved during childhood. Hum Reprod. 2015 Sep;30(9):2107-9. doi: 10.1093/humrep/dev128. Epub 2015 Jun 9.

ReferenceCitation: Imbert R, Moffa F, Tsepelidis S, Simon P, Delbaere A, Devreker F, Dechene J, Ferster A, Veys I, Fastrez M, Englert Y, Demeestere I. Safety and usefulness of cryopreservation of ovarian tissue to preserve fertility: a 12-year retrospective analysis. Hum Reprod. 2014 Sep;29(9):1931-40. doi: 10.1093/humrep/deu158. Epub 2014 Jun 22.

lead_sponsor: Erasme University Hospital

location_country: Belgium France

location_facility: Centre Hospitalier Régional (CHR)-Citadelle

location_facility: Hôpital Universitaire Reine Fabiola (HUDERF)

location_facility: Centre Hospitalier Chrétien (CHC)- Clinique de l'espérance


title: Prediction of Left Ventricular Function Changes Using Low Dose Dobutamine Gated SPECT in Patients Referred for Viability Assessment: The DOGS (DObutamine Gated Spect)Study.

summary:
Viability assessment remains a clinical challenge in patient with coronary artery disease and left ventricular dysfunction. Several imaging modalities are available for evaluating myocardial viability, based either on perfusion or on contractile reserve analysis. Briefly, perfusion analysis is highly sensitive and contractile reserve highly specific. A combined analysis of both perfusion and contractile reserve has been proposed to improve the diagnostic accuracy in patient referred for a revascularization procedure. However, the value of this combined analysis has not been validated in unselected patients referred for viability assessment.

The patients enrolled in the study will undergo a nitrate enhanced rest gated SPECT using a Tc-99m labeled tracer (sestamibi or tetrofosmine) followed by a second gated SPECT acquired during a low-dose dobutamine infusion (10 mcg/kg/mn). All patients will have a 6-month clinical and imaging follow-up, including physical examination and a nitrate enhanced rest gated SPECT using the same radiopharmaceutical. All treatments received during this 6-month period will be recorded, including medical therapy and coronary revascularization (angioplasty, stenting and CABG).

Finally, the value of baseline perfusion and contractile reserve analysis in predicting left ventricular ejection fraction changes at 6-month follow-up will be evaluated.

ReferenceCitation: Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol. 2002 Apr 3;39(7):1151-8.

ReferenceCitation: Everaert H, Vanhove C, Franken PR. Effects of low-dose dobutamine on left ventricular function in normal subjects as assessed by gated single-photon emission tomography myocardial perfusion studies. Eur J Nucl Med. 1999 Oct;26(10):1298-303.

ReferenceCitation: Everaert H, Vanhove C, Franken PR. Effect of beta-blockade on low-dose dobutamine-induced changes in left ventricular function in healthy volunteers: assessment by gated SPET myocardial perfusion scintigraphy. Eur J Nucl Med. 2000 Apr;27(4):419-24.

ReferenceCitation: Leoncini M, Sciagrà R, Maioli M, Bellandi F, Marcucci G, Sestini S, Chiocchini S, Dabizzi RP. Usefulness of dobutamine Tc-99m sestamibi-gated single-photon emission computed tomography for prediction of left ventricular ejection fraction outcome after coronary revascularization for ischemic cardiomyopathy. Am J Cardiol. 2002 Apr 1;89(7):817-21.

lead_sponsor: University Hospital, Rouen

location_facility:
Hopital Avicenne
University Hospital of Nancy
Hopital Sud-Francilien
AZ-VUB
Hopital Européen Georges Pompidou
University Hospital of Rouen
University Hospital of Caen
CHU de Brest


title: Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions

acronym: IRM SAOS

summary: The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.

design_allocation: Non-Randomized

ipd_sharing: Undecided

lead_sponsor: CHU de Reims

intervention_type: Diagnostic Test


title: Estimation of the Precision of the Icare200 in the Measurement of Intraocular Pressure in Comparison to the Gold Standard : Goldmann Applanation Tonometer

summary:
In adult patients, intraocular pression readings are often taken with an air puff tonometer or goldmann tonometer. The current gold standard for IOP measurement is the Goldmann Applanation Tonometry (GAT). In some patients, measurement of intraocular pressure taken by applanation or by air puff may prove to be impossible for various reasons (obesity, handicap, mental disorder, blindness for Air Puff Tonometry, Anxiety, etc).

There are also many other devices that can be used to measure IOP, including those using rebound tonometry like the Icare 200.

The rebound tonometer would systematize IOP screening because of its ease of use, provided its measurements are reliable. In this prospective study, investigators will be measuring participant's IOP with Goldmann Applanation Tonometry, Icare 200 Tonometer and Air Puff Tonometry to see if there is an agreement in IOP between the different devices. Investigators will also look if there is a concordance between central corneal thickness and IOP. Moreover, investigators will look if there is a IOP concordance between the 3 different devices for hight BMI people. Indeed, higher body mass index tend to have difficulties with proper positioning at the slit lamp that may lead to inaccurate GAT measurements. Additionally, stress level of the patients with different tonometry devices will be recorded using a visual analog scale.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance.

acronym: NUTRIGUS 2

summary:
In intensive care, gastrointestinal dysfunction may occur in response to systemic insult. Acute gastrointestinal dysfunction (AGID) has been clinically defined by consensus and several grades of severity have been defined. Biomarkers of digestive distress have also been described in intensive care and can be measured directly in the plasma (lipopolysaccharide, intestinal fatty acid binding protein, citrulline, glucagon-like peptide-1).

Enteral nutrition is a frequent therapy in intensive care patients, and its administration is recommended. In general, nurtition is resumed early via a nasogastric tube in patients placed on mechanical ventilation. The resumption of nutrition can be seen as a "challenge" to the gastrointestinal tract, and may thus unmask underlying gastrointestinal dysfunction. Intolerance of enteral nutrition is a symptom of gastrointestinal dysfunction and is associated with poor clinical outcomes. Indeed, it is both a marker of severity by reflecting organ dysfunction and responsible for a reduction in caloric intake that can influence prognosis.

There is no consensus on the definition of intolerance to enteral nutrition. In practice, it is most often recognized because of regurgitation or vomiting, requiring reduction or discontinuation. In a recent review, the authors emphasize the need for digestive monitoring for early diagnosis of nutritional intolerance.

Gastric echography is a minimally invasive and reliable means of monitoring the gastric contents. In particular, the surface of the antrum has been validated as a way to diagnose a full stomach in intensive care. The measurement of echographic variations in gastric residue with the resumption of enteral nutrition could thus allow the early diagnosis of gastrointestinal dysfunction and food intolerance by preceding vomiting.

Our objective is to show the interest of echographic monitoring of the stomach during the resumption of enteral feeding for the diagnosis of nutritional intolerance. As nutritional intolerance is a symptom of gastrointestinal dysfunction, we will also study this phenomenon by measuring the associations between echographic data, clinical data and biomarkers of gastrointestinal dysfunction.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of a Modified Schedule Including a Day Without Clinical Activity Before Night Shift on Non-technical Skills of French Residents in Intensive Care Unit, a Prospective Randomized Multi Center Study: REPOPREGARD Protocol Study

acronym: REPOPREGARD

summary:
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be:

To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule

To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule


title: Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)

acronym: EPERICARDIM

summary: This study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent, microvascular obstruction and intra myocardial hemorrhage found on MRI made beyond one week and before the 3rd month of the constitution of the necrosis.

primary_purpose: Health Services Research

lead_sponsor: Ramsay Générale de Santé

intervention_type: Procedure


title: Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Patients With Systemic Lupus Erythematosus

acronym: HEMATOPLUS

summary: Accelerated atherosclerosis in patients with systemic lupus erythematosus (SLE) is not fully explained by Framingham risk factors. The detection in asymptomatic patients of somatic mutations in genes involved in hematopoietic malignancy- defining clonal hematopoiesis of indeterminate potential (CHIP) - predisposes to cardiovascular events (CVE) in general population. We aimed to determine whether CHIP is associated with CVE in SLE.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Personalization of 99mTc-Sestamibi Activities in SPECT/CT Myocardial Perfusion Imaging With the Cardiofocal SmartZoom® Collimator

acronym: OSPECT

summary: This work suggests a methodology to adapt the injected radionuclide activity to the level of attenuation of each patient. The investigators propose a dose reduction adapted to the patient's weight, with no significant degradation of the image quality, in order to improve patients and staff radioprotection, standardize the image quality for easier clinical interpretation, and lead to radiopharmaceutical saving in the context of myocardial perfusion Imaging.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study

acronym: PARAVA

summary: The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.

lead_sponsor: Centre Henri Becquerel

intervention_type: Device


title: Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study

acronym: APOSIA

summary:
The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months.

The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.

lead_sponsor: Elsan

intervention_type: Behavioral


title: Non-Randomized, Single-Center Pilot Trial Assessing The Safety/Efficacy Of Targeting Peripheral And Central Humoral Alloimmune Memory With Daratumumab And With Belatacept In Highly HLA-Sensitized Patients Awaiting Kidney Transplantation

acronym: COMBAT

summary: While the number of kidney transplants is increasing worldwide every year, there is a clear imbalance between the high number of patients in the waiting list and those receiving a transplant and importantly, among waitlist patients there is a progressively higher number of highly sensitised patients that have very low or even no chance to receive a compatible organ. These patients remain for very long periods of time on dialysis therapy, having lower quality of life, lower life expectancy and produce higher health-related costs. Unfortunately, current desensitization therapies have shown very poor success and patients usually lose these grafts very fast if transplanted across a positive cross-match. Therefore, there is an urgent need for novel desensitization strategies capable of overcoming this immunological barrier and allow an increasing number of patients to receive a HLA-compatible kidney allograft.This is a non-randomized, single arm study, combination trial designed according to the Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee. The study will enroll 12 patients with cPRA or TGI ≥99% on the deceased donor kidney transplant waiting list, who have not received a compatible donor offer for >3 year. According to inclusion and exclusion criteria patients will be screened to participate in the trial.

ReferenceCitation: Loupy A, Lefaucheur C. Antibody-Mediated Rejection of Solid-Organ Allografts. N Engl J Med. 2018 Sep 20;379(12):1150-1160. doi: 10.1056/NEJMra1802677. Review.

ReferenceCitation: Pruthi R, Hilton R, Pankhurst L, Mamode N, Hudson A, Roderick P, Ravanan R. UK Renal Registry 16th annual report: chapter 4 demography of patients waitlisted for renal transplantation in the UK: national and centre-specific analyses. Nephron Clin Pract. 2013;125(1-4):81-98. doi: 10.1159/000360023. Epub 2014 Feb 14.

ReferenceCitation: Wiebe C, Tambur A, Nickerson PW. A call to action-The transplant recipient's expectation of precision in transplant medicine. Am J Transplant. 2018 Dec;18(12):2845-2846. doi: 10.1111/ajt.15027. Epub 2018 Aug 13.

ReferenceCitation: Kiernan JJ, Ellison CA, Tinckam KJ. Measuring alloantibodies: a matter of quantity and quality. Curr Opin Organ Transplant. 2019 Feb;24(1):20-30. doi: 10.1097/MOT.0000000000000593. Review.

ReferenceCitation: Djamali A, Kaufman DB, Ellis TM, Zhong W, Matas A, Samaniego M. Diagnosis and management of antibody-mediated rejection: current status and novel approaches. Am J Transplant. 2014 Feb;14(2):255-71. doi: 10.1111/ajt.12589. Epub 2014 Jan 8. Review.

ReferenceCitation: Formica RN Jr, Kulkarni S. Being Thoughtful about Desensitization. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1878-1880. doi: 10.2215/CJN.09000817. Epub 2017 Oct 3.

ReferenceCitation: Cornell LD, Schinstock CA, Gandhi MJ, Kremers WK, Stegall MD. Positive crossmatch kidney transplant recipients treated with eculizumab: outcomes beyond 1 year. Am J Transplant. 2015 May;15(5):1293-302. doi: 10.1111/ajt.13168. Epub 2015 Mar 2.

ReferenceCitation: Luque S, Lúcia M, Crespo E, Jarque M, Grinyó JM, Bestard O. A multicolour HLA-specific B-cell FluoroSpot assay to functionally track circulating HLA-specific memory B cells. J Immunol Methods. 2018 Nov;462:23-33. doi: 10.1016/j.jim.2018.07.011. Epub 2018 Jul 31.

ReferenceCitation: Lúcia M, Luque S, Crespo E, Melilli E, Cruzado JM, Martorell J, Jarque M, Gil-Vernet S, Manonelles A, Grinyó JM, Bestard O. Preformed circulating HLA-specific memory B cells predict high risk of humoral rejection in kidney transplantation. Kidney Int. 2015 Oct;88(4):874-87. doi: 10.1038/ki.2015.205. Epub 2015 Jul 15.

ReferenceCitation: Perry DK, Pollinger HS, Burns JM, Rea D, Ramos E, Platt JL, Gloor JM, Stegall MD. Two novel assays of alloantibody-secreting cells demonstrating resistance to desensitization with IVIG and rATG. Am J Transplant. 2008 Jan;8(1):133-43. doi: 10.1111/j.1600-6143.2007.02039.x.

ReferenceCitation: Moreno Gonzales MA, Gandhi MJ, Schinstock CA, Moore NA, Smith BH, Braaten NY, Stegall MD. 32 Doses of Bortezomib for Desensitization Is Not Well Tolerated and Is Associated With Only Modest Reductions in Anti-HLA Antibody. Transplantation. 2017 Jun;101(6):1222-1227. doi: 10.1097/TP.0000000000001330.

ReferenceCitation: Kwun J, Burghuber C, Manook M, Iwakoshi N, Gibby A, Hong JJ, Knechtle S. Humoral Compensation after Bortezomib Treatment of Allosensitized Recipients. J Am Soc Nephrol. 2017 Jul;28(7):1991-1996. doi: 10.1681/ASN.2016070727. Epub 2017 Feb 23.

ReferenceCitation: Chen J, Yin H, Xu J, Wang Q, Edelblum KL, Sciammas R, Chong AS. Reversing endogenous alloreactive B cell GC responses with anti-CD154 or CTLA-4Ig. Am J Transplant. 2013 Sep;13(9):2280-92. doi: 10.1111/ajt.12350. Epub 2013 Jul 15.

ReferenceCitation: Yang J, Chen J, Young JS, Wang Q, Yin D, Sciammas R, Chong AS. Tracing Donor-MHC Class II Reactive B cells in Mouse Cardiac Transplantation: Delayed CTLA4-Ig Treatment Prevents Memory Alloreactive B-Cell Generation. Transplantation. 2016 Aug;100(8):1683-91. doi: 10.1097/TP.0000000000001253.

ReferenceCitation: Kim EJ, Kwun J, Gibby AC, Hong JJ, Farris AB 3rd, Iwakoshi NN, Villinger F, Kirk AD, Knechtle SJ. Costimulation blockade alters germinal center responses and prevents antibody-mediated rejection. Am J Transplant. 2014 Jan;14(1):59-69. doi: 10.1111/ajt.12526.

ReferenceCitation: Leibler C, Thiolat A, Hénique C, Samson C, Pilon C, Tamagne M, Pirenne F, Vingert B, Cohen JL, Grimbert P. Control of Humoral Response in Renal Transplantation by Belatacept Depends on a Direct Effect on B Cells and Impaired T Follicular Helper-B Cell Crosstalk. J Am Soc Nephrol. 2018 Mar;29(3):1049-1062. doi: 10.1681/ASN.2017060679. Epub 2018 Jan 10.

ReferenceCitation: Leibler C, Matignon M, Pilon C, Montespan F, Bigot J, Lang P, Carosella ED, Cohen J, Rouas-Freiss N, Grimbert P, Menier C. Kidney transplant recipients treated with belatacept exhibit increased naïve and transitional B cells. Am J Transplant. 2014 May;14(5):1173-82. doi: 10.1111/ajt.12721. Epub 2014 Apr 14.

ReferenceCitation: Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027. Erratum in: N Engl J Med. 2016 Feb 18;374(7):698.

family: Vincenti

full_name: Flavio Vincenti

given: Flavio

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

sequence: additional

family: Grinyo

full_name: Joseph Grinyo

given: Joseph

family: Rice

full_name: Kim Rice

given: Kim

family: Steinberg

full_name: Steven Steinberg

given: Steven

family: Gaite

full_name: Luis Gaite

given: Luis

family: Moal

full_name: Marie-Christine Moal

given: Marie-Christine

family: Mondragon-Ramirez

full_name: Guillermo A. Mondragon-Ramirez

given: Guillermo A.

family: Kothari

full_name: Jatin Kothari

given: Jatin

family: Polinsky

full_name: Martin S. Polinsky

given: Martin S.

family: Meier-Kriesche

full_name: Herwig-Ulf Meier-Kriesche

given: Herwig-Ulf

family: Munier

full_name: Stephane Munier

given: Stephane

family: Larsen

full_name: Christian P. Larsen

given: Christian P.

journal_name: New England Journal of Medicine

oa_host_type: repository

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

host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

version: publishedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Bray RA, Gebel HM, Townsend R, Roberts ME, Polinsky M, Yang L, Meier-Kriesche HU, Larsen CP. Posttransplant reduction in preexisting donor-specific antibody levels after belatacept- versus cyclosporine-based immunosuppression: Post hoc analyses of BENEFIT and BENEFIT-EXT. Am J Transplant. 2018 Jul;18(7):1774-1782. doi: 10.1111/ajt.14738. Epub 2018 Apr 17.

ReferenceCitation: Kwun J, Burghuber C, Manook M, Ezekian B, Park J, Yoon J, Yi JS, Iwakoshi N, Gibby A, Hong JJ, Farris AB, Kirk AD, Knechtle SJ. Successful desensitization with proteasome inhibition and costimulation blockade in sensitized nonhuman primates. Blood Adv. 2017 Oct 26;1(24):2115-2119. doi: 10.1182/bloodadvances.2017010991. eCollection 2017 Nov 14. Erratum in: Blood Adv. 2018 Jan 23;2(2):89.

ReferenceCitation: Alishetti S, Farr M, Jennings D, Serban G, Uriel N, Sayer G, Vasilescu R, Restaino S, Chong AS, Habal MV. Desensitizing highly sensitized heart transplant candidates with the combination of belatacept and proteasome inhibition. Am J Transplant. 2020 Dec;20(12):3620-3630. doi: 10.1111/ajt.16113. Epub 2020 Jul 7.

ReferenceCitation: Jain D, Rajab A, Young JS, Yin D, Nadasdy T, Chong AS, Pelletier RP. Reversing donor-specific antibody responses and antibody-mediated rejection with bortezomib and belatacept in mice and kidney transplant recipients. Am J Transplant. 2020 Oct;20(10):2675-2685. doi: 10.1111/ajt.15881. Epub 2020 Apr 28.

ReferenceCitation: Moreno L, Perez C, Zabaleta A, Manrique I, Alignani D, Ajona D, Blanco L, Lasa M, Maiso P, Rodriguez I, Garate S, Jelinek T, Segura V, Moreno C, Merino J, Rodriguez-Otero P, Panizo C, Prosper F, San-Miguel JF, Paiva B. The Mechanism of Action of the Anti-CD38 Monoclonal Antibody Isatuximab in Multiple Myeloma. Clin Cancer Res. 2019 May 15;25(10):3176-3187. doi: 10.1158/1078-0432.CCR-18-1597. Epub 2019 Jan 28.

ReferenceCitation: Kwun J, Matignon M, Manook M, Guendouz S, Audard V, Kheav D, Poullot E, Gautreau C, Ezekian B, Bodez D, Damy T, Faivre L, Menouche D, Yoon J, Park J, Belhadj K, Chen D, Bilewski AM, Yi JS, Collins B, Stegall M, Farris AB, Knechtle S, Grimbert P. Daratumumab in Sensitized Kidney Transplantation: Potentials and Limitations of Experimental and Clinical Use. J Am Soc Nephrol. 2019 Jul;30(7):1206-1219. doi: 10.1681/ASN.2018121254. Epub 2019 Jun 21.

ReferenceCitation: Paller CJ, Bradbury PA, Ivy SP, Seymour L, LoRusso PM, Baker L, Rubinstein L, Huang E, Collyar D, Groshen S, Reeves S, Ellis LM, Sargent DJ, Rosner GL, LeBlanc ML, Ratain MJ. Design of phase I combination trials: recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee. Clin Cancer Res. 2014 Aug 15;20(16):4210-7. doi: 10.1158/1078-0432.CCR-14-0521. Review.

lead_sponsor: University Hospital, Grenoble

intervention_type: Combination Product


title: Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions

summary:
The major aim is to evaluate accuracy of 2 Continuous Glucose Monitoring Systems (CGMS) : Dexcom G6® and FreeStyle Libre® in standardized hypoxemia conditions (artificial normobaric hypoxia).

Our purpose is to demonstrate the good performance and calibration of these CGM sensors in hypoxemia conditions.

primary_purpose: Basic Science

lead_sponsor: Poitiers University Hospital


title: Constitution of a Prospective Twin Pregnancy Cohort in Order to Study the Risk Factors for Obstetric Complications COGEM

acronym: COGEM

summary:
The investigators know that multiple factors are involved in the risk of obstetric complications. The twin pregnancy model appears to be an interesting model for a bio-statistical analysis of data collected in the context of a complete pregnancy, in particular because it can reveal differences for a common exposure.

The aim of the study is to constitute a prospective cohort of twin pregnancies. The collection of data on the health of mothers, pregnancies, childbirth, and the health of twins at birth should make it possible to reveal results with sufficient statistical power for a prospective study.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Assessment of Visual and Refractive Results, and Rotational Stability of the TECNIS® Eyhance Toric II 1-piece Posterior Chamber Lens in Patients With Astigmatism Undergoing Cataract Surgery: a Prospective Cohort Study - STATE

acronym: STATE

summary:
Cataract surgery is one of the most common procedures performed worldwide. Astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. Access to astigmatism correction during cataract surgery allows for improved visual outcomes for patients. Toric intraocular lenses (IOLs) are the procedure of choice to correct corneal astigmatism of one diopter or more in cases undergoing cataract surgery. Rotational stability is a key factor for successful outcomes with toric IOLs. Postoperative toric IOL misalignment is the major factor responsible for suboptimal visual outcomes after toric IOL implantation.

The TECNIS® Eyhance Toric II 1-piece posterior chamber lens is a new toric IOL which is FDA approved and CE marked. Marketed by Johnson & Johnson Vision, it is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder.

No study assessing the early rotational stability of the TECNIS® Eyhance Toric II IOL has been published yet.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines Using Delphi Consensus Statement

summary: French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults have been developed by the psoriasis research group of the French Society of Dermatology using literature available until July 2017 (Amatore et al, 2019). Because several systemic treatments have been marketed since then, new guidelines are mandatory. The aim of this study coordinated by the Centre of Evidence of the French Society of Dermatology is to update the available French guidelines using a Delphi method.

ReferenceType: result

ReferenceCitation: Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Société Française de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.

name: Dermatology Department Timone Hospital Aix‐Marseille University Marseille France

family: Amatore

full_name: F. Amatore

given: F.

name: Dermatology Department Edouard Herriot Hospital Lyon University Lyon France

family: Villani

full_name: A.‐P. Villani

name: Dermatology and Allergology Department Larrey Hospital Toulouse University Toulouse France

family: Tauber

full_name: M. Tauber

given: M.

name: Dermatology Department Robert Debré Hospital Reims University Reims France

name: Centre de Preuves en Dermatologie Paris France

family: Viguier

full_name: M. Viguier

name: Dermatology Department CHU of Montpellier Montpellier University Montpellier France

family: Guillot

full_name: B. Guillot

given: B.

name: the Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Société Française de Dermatologie)

journal_name: Journal of the European Academy of Dermatology and Venereology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: French guidelines on the use of systemic treatments for moderate‐to‐severe psoriasis in adults


title: Evaluation of the Effectiveness of Self-hypnosis on Anxiety and Burnout of Nursing Staff

acronym: ESHABC

summary: Its a prospective, non-interventional, single-center study, involving the human person evaluating the impact of self-hypnosis training on anxiety level and burn out in nursing and medical staff


title: Study of Pulmonary Infections (Pneumonia) in Kidney Transplant Recipients Admitted to Hospital

summary: The investigators aimed to assess the epidemiology, management, and outcomes of community-acquired pneumonia in a kidney transplant recipients' cohort and identify prognosis factors associated with in-hospital complications. The investigatorsintend to identify each stay by a national database. Then they will be consulted by 2 clinicians to assert CAP clinical definition. After that radiographic evidence will be reviewed to validate CAP diagnoses. Then clinical data are collected in each center.


title: A Retrospective Study Using Mass Spectrometry to Characterize Post-translational Modifications to Circulating Histones in Pregnant Women Developing Pre-eclampsia

acronym: GHISPE

summary:
This is a descriptive pilot study on a ready-constituted biobank (outside the Jardé Law). It is an ancillary study to the "GrossPath" cohort (RCB ID number: 2014-A01120-47).

Pregnancy generates an increased risk of thrombosis, and placenta-mediated diseases constitute a risk factor for cardiovascular pathologies responsible for significant maternal-fetal morbidity and mortality. Understanding and exploring the cellular and molecular mechanisms of dysfunctions of the vascular-placental interface could provide arguments to understand the systemic vascular risk, characterize it and finally detect it on the basis of new markers, thus opening the way for targeted preventive management to reinforce the general principles of precision medicine.

Netosis is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Netosis occurs in pregnancy and is increased in vascular-placental complications. It can be studied by measuring circulating histones, particularly the citrullinated histone H3. Levels of this modified histone H3, as well as those of two other modifications, have recently been shown to increase during pregnancy. These levels have also been shown to be even greater in pregnancy complications.

The aim of this study is to complete this mapping in order to obtain a precise signature for all post-translational histone modifications in normal pregnancies and pregnancies complicated by pre-eclampsia from the "GrossPath" cohort in order to propose new circulating biomarkers for placental vascular pathologies.

The post-translational histone modification profiles (mapping) of pregnant women with normal pregnancies will be compared with those developing pre-eclampsia.

ipd_sharing_description:
All data collection and management will be carried out by the BESPIM (Biostatistique, Epidémiologie clinique, Santé Publique & Innovation en Méthodologie).

The conditions of transfer of all or part of the research database are decided by the principal investigator and the research sponsor and are the subject of a written contract.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Fall Risk Assessment in a Population of Charcot-Marie-Tooth Disease Type 1A (CMT 1A) by Timed Up and Go Test.

acronym: DeteCTCMT

summary:
The main objective of this study is to explore the relationship between the onset of fall and the time taken to complete the Timed Up and Go test (TUG) in this CMT1A patient population.

The investigators hypothesize that patients with balance disorders and therefore a risk of major fall will require a longer time to perform the Timed Up and Go test. In addition, it seems important to confirm that the severity of the disease has a negative impact on the frequency of balance disorders.

ReferenceCitation: Reilly MM, Shy ME, Muntoni F, Pareyson D. 168th ENMC International Workshop: outcome measures and clinical trials in Charcot-Marie-Tooth disease (CMT). Neuromuscul Disord. 2010 Dec;20(12):839-46. doi: 10.1016/j.nmd.2010.08.001. Epub 2010 Sep 17.

family: Reilly

full_name: M.M. Reilly

family: Shy

full_name: M.E. Shy

family: Muntoni

full_name: F. Muntoni

family: Pareyson

full_name: D. Pareyson

given: D.

journal_name: Neuromuscular Disorders

title: 168th ENMC International Workshop: Outcome measures and clinical trials in Charcot–Marie–Tooth disease (CMT)

ReferenceCitation: Ramdharry GM, Thornhill A, Mein G, Reilly MM, Marsden JF. Exploring the experience of fatigue in people with Charcot-Marie-Tooth disease. Neuromuscul Disord. 2012 Dec;22 Suppl 3:S208-13. doi: 10.1016/j.nmd.2012.10.016.

family: Ramdharry

full_name: Gita M. Ramdharry

given: Gita M.

family: Thornhill

full_name: Anna Thornhill

given: Anna

family: Mein

full_name: Gill Mein

given: Gill

full_name: Mary M. Reilly

given: Mary M.

family: Marsden

full_name: Jonathan F. Marsden

given: Jonathan F.

title: Exploring the experience of fatigue in people with Charcot–Marie–Tooth disease

ReferenceCitation: Ribiere C, Bernardin M, Sacconi S, Delmont E, Fournier-Mehouas M, Rauscent H, Benchortane M, Staccini P, Lantéri-Minet M, Desnuelle C. Pain assessment in Charcot-Marie-Tooth (CMT) disease. Ann Phys Rehabil Med. 2012 Apr;55(3):160-73. doi: 10.1016/j.rehab.2012.02.005. Epub 2012 Mar 6. English, French.

family: Ribiere

full_name: C. Ribiere

given: C.

family: Bernardin

full_name: M. Bernardin

family: Sacconi

full_name: S. Sacconi

given: S.

family: Delmont

full_name: E. Delmont

given: E.

family: Fournier-Mehouas

full_name: M. Fournier-Mehouas

family: Rauscent

full_name: H. Rauscent

given: H.

family: Benchortane

full_name: M. Benchortane

family: Staccini

full_name: P. Staccini

given: P.

family: Lantéri-Minet

full_name: M. Lantéri-Minet

family: Desnuelle

journal_name: Annals of Physical and Rehabilitation Medicine

ReferenceCitation: Reynaud V, Muti D, Pereira B, Greil A, Caillaud D, Richard R, Coudeyre E, Costes F. A TUG Value Longer Than 11 s Predicts Fall Risk at 6-Month in Individuals with COPD. J Clin Med. 2019 Oct 22;8(10). pii: E1752. doi: 10.3390/jcm8101752.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

ReferenceCitation: Anens E, Emtner M, Hellström K. Exploratory study of physical activity in persons with Charcot-Marie-Tooth disease. Arch Phys Med Rehabil. 2015 Feb;96(2):260-8. doi: 10.1016/j.apmr.2014.09.013. Epub 2014 Oct 5.

journal_name: Archives of Physical Medicine and Rehabilitation

title: Exploratory Study of Physical Activity in Persons With Charcot-Marie-Tooth Disease


title: Comparative Study of Diagnostic and Prognosis Biomarkers of Prostate Cancer in Liquid Biopsy

acronym: HOPE

summary:
Constitution of a biological collection within the framework of the establishment of a diagnostic, prognostic and active surveillance test for prostate cancer from long non-coding RNA biomarkers, in 3 cohorts of patients, with cancer of the prostate, with suspected cancer without biopsy confirmation or with prostatic hyperplasia and healthy donors.

This biological collection will also be used as a support for further researches on the identification of biomarkers and genetic markers to improve the prognosis and diagnostic management of patients with prostate pathologies.

lead_sponsor: Institut Curie


title: Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery

summary: This study is a Pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named CATSYS.

lead_sponsor: Ilasis Laser

location_facility: Institut Opthalmologique Sourdille Atlantique


title: Identification of the Determinants of the Perceived Workload of Intensive Care and Pediatric Continuous Monitoring Nurses

acronym: CHARMIREA

summary: The purpose of this study is to identify the determinants of the perceived workload of intensive care and pediatric continuous monitoring nurses (factors liked to the care service, staff, patients treated)

time_perspective: Cross-Sectional

ReferenceCitation: Lebet RM, Hasbani NR, Sisko MT, Agus MSD, Nadkarni VM, Wypij D, Curley MAQ. Nurses' Perceptions of Workload Burden in Pediatric Critical Care. Am J Crit Care. 2021 Jan 1;30(1):27-35. doi: 10.4037/ajcc2021725.

ReferenceCitation: Helmreich RL. On error management: lessons from aviation. BMJ. 2000 Mar 18;320(7237):781-5.

ReferenceCitation: Llenore E, Ogle KR. Nurse-patient communication in the intensive care unit: a review of the literature. Aust Crit Care. 1999 Dec;12(4):142-5. Review.

ReferenceCitation: Gurses AP, Carayon P, Wall M. Impact of performance obstacles on intensive care nurses' workload, perceived quality and safety of care, and quality of working life. Health Serv Res. 2009 Apr;44(2 Pt 1):422-43. doi: 10.1111/j.1475-6773.2008.00934.x. Epub 2008 Dec 16.

ReferenceCitation: Nasirizad Moghadam K, Chehrzad MM, Reza Masouleh S, Maleki M, Mardani A, Atharyan S, Harding C. Nursing physical workload and mental workload in intensive care units: Are they related? Nurs Open. 2021 Jul;8(4):1625-1633. doi: 10.1002/nop2.785. Epub 2021 Feb 17.

ReferenceCitation: Young G, Zavelina L, Hooper V. Assessment of workload using NASA Task Load Index in perianesthesia nursing. J Perianesth Nurs. 2008 Apr;23(2):102-10. doi: 10.1016/j.jopan.2008.01.008.

ReferenceCitation: Tubbs-Cooley HL, Mara CA, Carle AC, Gurses AP. The NASA Task Load Index as a measure of overall workload among neonatal, paediatric and adult intensive care nurses. Intensive Crit Care Nurs. 2018 Jun;46:64-69. doi: 10.1016/j.iccn.2018.01.004. Epub 2018 Feb 12.


title: Clinical Perfomance Study of the ABTEST© Card in Vitro Medical Device

summary: The study confirms the performance equivalence of the in vitro Diagnostic reagent ABTEST card used with the new reformulated WS solution

lead_sponsor: Diagast


title: 5 Years Hemodynamic and Clinical Follow-up of the SAPIEN 3 Transcatheter Heart Valve According to the Implantation Strategy: Insight From the Randomized DIRECTAVI Trial

acronym: DIRECTAVILONG

summary: A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Whether the initial implantation strategy may impact the long-term trans catheter heart valve (THV) performances and patient outcomes remains unknown to date. The Investigators therefore aimed to evaluate the 5-years impact of the implantation strategy on THV hemodynamic performances and clinical outcomes in patients included in the DIRECTAVI trial.


title: EVALUATION OF 30-DAY MORTALITY AFTER A VISIT TO THE LAPEYRONIE ADULT EMERGENCY DEPARTMENT OF THE CHU MONTPELLIER FOR SEPSIS OR SEPTIC SHOCK: A STUDY BEFORE/AFTER THE IMPLEMENTATION OF AN ANTI-INFECTIOUS PRESCRIPTION AID

summary: Anti-infective strategy is a major public health problem. This is a before-and-after study of an anti-infectious prescription tool with a comparison of mortality at 30 days (then 3 and 6 months) between the two inclusion phases of 6 months each.


title: Effectiveness Randomized Controlled Trial on Eating Disorders Group Treatment: a Cognitive Dissonance, a Mindfulness and a Person-centered Based Program

summary: This trial aims at comparing three group treatments designed for eating disorders: a Cognitive-dissonance, a Mindfulness and a Person-centered based programs. Women with eating disorders will be recruited and randomized to one of the three programs. Participants will complete a pretest, a posttest, a 3-months follow-up and a 1-year follow-up. This trial aims to compare the programs to analyze the specific dimensions upon which each program acts. The investigators therefore made hypotheses according to the programs' theory: participants in the Cognitive-dissonance based program should experience a greater decrease in eating disorders symptoms, thin-ideal internalization and body dissatisfaction and a greater improvement in quality of life than other participants. Participants in the Mindfulness-based program should show a greater improvement in negative affect and in equanimity than other participants. Participants in the Person-Centered based program should report a greater increase in congruence than other participants.

lead_sponsor: University Grenoble Alps


title: Measurement of the Prevalence of Sensory Integration Disorders in Babies Having Heart Disease Surgery for Transposition of the Great Vessels Before 6 Months of Age

acronym: SENSOCOEUR

summary: The purpose of this study is to mesure the prevalence of severe sensory integration disorders in babies after one week of their heart surgery.

ReferenceCitation: Dagenais L, Materassi M, Desnous B, Vinay MC, Doussau A, Sabeh P, Prud'homme J, BSc KG, Lenoir M, Charron MA, Nuyt AM, Poirier N, Beaulieu-Genest L, Carmant L, Birca A. Superior Performance in Prone in Infants With Congenital Heart Disease Predicts an Earlier Onset of Walking. J Child Neurol. 2018 Dec;33(14):894-900. doi: 10.1177/0883073818798194. Epub 2018 Sep 18.

ReferenceCitation: Abadie V. [Apparently isolated feeding behavior troubles in infant]. Arch Pediatr. 2008 Jun;15(5):837-9. doi: 10.1016/S0929-693X(08)71932-8. French.

ReferenceCitation: Dunn W, Westman K. The sensory profile: the performance of a national sample of children without disabilities. Am J Occup Ther. 1997 Jan;51(1):25-34.

ReferenceCitation: Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17.


title: Mercuri Analysis Contribution on Handicap Evaluation in ArthrogypOsis, a Congenital Neuromuscular Disease

acronym: MACHAON

summary: The aim is to evaluate the correlation of quantified fibro-adipous infiltration of muscles, using the MRI-based Mercuri score, with deficiencies, activity limitations and social participation in patients with arthrogryposis multiplex congenita.

ReferenceCitation: Liu CY, Yao J, Kovacs WC, Shrader JA, Joe G, Ouwerkerk R, Mankodi AK, Gahl WA, Summers RM, Carrillo N. Skeletal Muscle Magnetic Resonance Biomarkers in GNE Myopathy. Neurology. 2021 Feb 2;96(5):e798-e808. doi: 10.1212/WNL.0000000000011231. Epub 2020 Nov 20.

ReferenceCitation: Hall JG. Arthrogryposis multiplex congenita: etiology, genetics, classification, diagnostic approach, and general aspects. J Pediatr Orthop B. 1997 Jul;6(3):159-66. Review.

ReferenceCitation: Mercuri E, Pichiecchio A, Counsell S, Allsop J, Cini C, Jungbluth H, Uggetti C, Bydder G. A short protocol for muscle MRI in children with muscular dystrophies. Eur J Paediatr Neurol. 2002;6(6):305-7.

ReferenceCitation: Figueroa-Bonaparte S, Segovia S, Llauger J, Belmonte I, Pedrosa I, Alejaldre A, Mayos M, Suárez-Cuartín G, Gallardo E, Illa I, Díaz-Manera J; Spanish Pompe Study Group. Muscle MRI Findings in Childhood/Adult Onset Pompe Disease Correlate with Muscle Function. PLoS One. 2016 Oct 6;11(10):e0163493. doi: 10.1371/journal.pone.0163493. eCollection 2016.

family: Figueroa-Bonaparte

full_name: Sebastián Figueroa-Bonaparte

given: Sebastián

family: Segovia

full_name: Sonia Segovia

given: Sonia

family: Llauger

full_name: Jaume Llauger

given: Jaume

family: Belmonte

full_name: Izaskun Belmonte

given: Izaskun

family: Pedrosa

full_name: Irene Pedrosa

given: Irene

family: Alejaldre

full_name: Aída Alejaldre

given: Aída

family: Mayos

full_name: Mercè Mayos

given: Mercè

family: Suárez-Cuartín

full_name: Guillermo Suárez-Cuartín

given: Guillermo

family: Gallardo

full_name: Eduard Gallardo

given: Eduard

family: Illa

full_name: Isabel Illa

given: Isabel

family: Díaz-Manera

full_name: Jordi Díaz-Manera

given: Jordi

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

ReferenceCitation: Dai S, Dieterich K, Jaeger M, Wuyam B, Jouk PS, Pérennou D. Disability in adults with arthrogryposis is severe, partly invisible, and varies by genotype. Neurology. 2018 May 1;90(18):e1596-e1604. doi: 10.1212/WNL.0000000000005418. Epub 2018 Apr 6.

family: Dai

full_name: Shenhao Dai

given: Shenhao

family: Dieterich

full_name: Klaus Dieterich

given: Klaus

family: Jaeger

full_name: Marie Jaeger

publisher: Ovid Technologies (Wolters Kluwer Health)


title: Evaluation of a Cohort of Patients With Ehlers-Danlos Syndrome Treated With Orthopedic Surgery (SED-eval)

acronym: SED-eval

summary: The aim of this study is to assess the joint involvement (shoulder - ankle - knee - elbow - wrist) in patients with Ehlers-Danlos Syndrome and treated by surgery.


title: Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.

acronym: CLIO

summary:
In kidney transplantation, donor selection is based in part on the assessment of the functional capacity of the kidneys. For this purpose, it is recommended to measure the glomerular filtration rate (GFR) by a reference technique. To estimate GFR, several approaches are possible depending on the type of measurement (urinary or plasma) and the marker (exogenous or endogenous) used. Among these methods, the measurement of inulin clearance has long been considered the reference method. The occurrence of anaphylactic reactions led to its withdrawal from the market. Iohexol, an iodinated contrast agent, has characteristics similar to inulin. It is eliminated by glomerular filtration and its biological determination is simple.

Nevertheless, the techniques currently used to calculate plasma clearance of Iohexol have been imperfectly validated and are not always easy to implement in practice. We propose to develop a Bayesian estimator for estimating Iohexol clearance applied to a population of healthy subjects, representative of potential kidney donors.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

acronym: LISRACC

summary: Since the 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.


title: Assessment of DEXAMETHASONE to Prevent Respiratory Complications After Non Urgent Thoracic Surgery

acronym: SURTHODEX

summary:
Thoracic surgery is at high risk of respiratory complications. Despite the improvement of surgical procedures such as video-thoracoscopy, respiratory complications appear in 15 to -20% of procedures. Thoracic surgery induces local pulmonary inflammation which is involved in the occurrence of post-operative respiratory failure. Similarly to the example of the acute respiratory distress syndrome, corticosteroids could reduce lung injury secondary to immunological stress. In addition, recent studies suggest that dexamethasone could lead to a reduction of respiratory complications after major non cardiothoracic surgery.

Since dexamethasone is recommended to prevent postoperative nausea and vomiting, around one in two patients receive dexamethasone during anesthetic induction. By retrospective analysis with compensation of bias by propensity score, the investigators aim to assess the effect of dexamethasone to prevent respiratory complications

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery, the LIGA-PACK Study

acronym: Liga-PACK

summary: This randomised clinical trial evaluates the analgesia provided by an iPack block associated with an adductor canal block in patients who undergo anterior cruciate ligament reconstruction surgery, compared to an adductor canal block alone. The objective is to prove the superiority of this locoregional anesthesia in terms of analgesia and functional rehabilitation.

lead_sponsor: University Hospital, Toulouse


title: Dose Dense Re-challenge of High Dose Methotrexate (HD-MTX) With Glucarpidase (CPG2) for Relapsed Primary Central Nervous System Lymphoma (PCNSL): A Phase I Trial

acronym: METHOGLU

summary:
High dose intravenous Methotrexate (HD-MTX) is the key drug in the treatment of primary central nervous system lymphoma (PCNSL). HD-MTX is usually delivered with time interval ranging from 10 to 21 days. Reduction of injection time interval is limited by MTX renal excretion and systemic toxicity.

Glucarpidase (CPG2) is a recombinant bacterial rescue enzyme that cleaves circulating MTX into inactive metabolites, reducing plasma MTX concentrations within few minutes.

The research hypothesis is that CPG2 used after HD-MTX injection allows to reduce time interval between MTX injections, increase dose intensity of the chemotherapy, reduce systemic toxicity and duration of hospitalization.

ipd_sharing_description:
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Study of the Evolution of Olfactory Disorders in Patients With Persistent Loss of Smell Following COVID-19

acronym: ETOC

summary:
The COVID-19 pandemic is a novel medical challenge, particularly because of the systemic nature of this disease. Indeed, COVID-19 affects several organs and systems at once. The brain is affected in several ways: direct infection of nerve cells by SARS-CoV-2, inflammation of the central nervous system, severe systemic inflammation damaging nerve cells, global cerebral ischaemia related to respiratory failure, thromboembolic events related to increased intravascular coagulation and severe psychological stress. As a result, COVID-19 sometimes manifests as neurological and neuropsychiatric symptoms such as dizziness, sleep disturbances, cognitive deficits, delirium, or severe depression.

Sudden loss of smell is a common symptom associated with COVID-19 and SARS-CoV-2 infection of neurons in the olfactory system has been reported in both hamsters and humans. The vast majority of COVID-19 patients recover their olfactory function within a few weeks. However, a significant minority of infected individuals (1 in 5 cases) still suffers from olfactory disorders (anosmia, hyposmia and/or parosmia) several months after the primary infection. These olfactory disorders are frequently associated with depressive behaviour and cognitive complaints. In PET scans, it is even possible to correlate this cognitive dysfunction with hypometabolism of certain brain regions, including the olfactory gyrus.

This project proposes, during one year, to evaluate and follow the evolution of the olfactory capacities of patients suffering from persistent smell disorder since one year (+/- 4 months) following COVID-19. We propose to study the link between viral persistence in the olfactory sensory organ, chronic inflammation, and central damage to the olfactory system. The follow-up of the evolution of olfactory and neurocognitive capacities, in an integrative way by means of molecular, physiological and behavioural approaches, will inform us on the specificities of "COVID-long" and on the level of peripheral and/or central damage of the olfactory system.

lead_sponsor: Institut Pasteur


title: Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas

summary: Primary central nervous system diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. The investigators aimed to characterise TIM-3/Gal-9 immune checkpoints by using immunohistochemistry in the tumor microenvironment of primary central nervous system diffuse large B cell lymphoma.


title: Evaluation of the Effectiveness of the Therapeutic Education Program "Living Better With ADHD" in Improving the Quality of Life of Children With ADHD and Their Parents

summary:
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by attention deficit, impulsivity and hyperactivity. It's one of the most frequently encoutered disorder in child psychiatry. ADHD has a significant impact on the quality of life of children and their parents.

In the child psychiatry department of the MPEA Peyre Plantade, a Therapeutic Education program specific to ADHD has been set up for children and their parents. This program consists of different workshops whose aim is to reduce the ADHD repercussions on the daily life of children and their families and thus improve their quality of life.

The principal aim of our study is to evaluate the effectiveness of this program in improving the quality of life of children with ADHD and their parents.


title: Assessment of the Value of Passive Leg Raising (PLR) in Predicting the Onset of Maternal Arterial Hypotension and Phenylephrine Requirements After Spinal Anesthesia for Scheduled Cesarean Section.

acronym: EDLIDL

summary:
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.

The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients Using 8 Sites Score

summary: Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.


title: Nasality Evolution in a Nasal Polyposis Context: Multiparametric Evaluation: Articulatory (Imaging), Aerodynamics, Acoustics and Perception

acronym: MultiNas

summary:
"Nasal polyposis is a chronic inflammation of the sinonasal mucosa which is characterized by the development of polyps in the sinonasal cavities. In the general population, its prevalence is 4% with a clear increase from the age of 50 years.

When drug treatment is not effective, and the patient's quality of life is impaired, surgery is proposed. It allows to widen the nasal cavities with aerodynamic and acoustics effects on speech. There are few studies, that have focused on the impact of NP and its treatment on speech. Yet there is a real demand from patients to obtain answers related to the impact of this surgery on their voice.

Preoperatively and postoperatively, the resonance will be disturbed: polyps will impacted the quality of the nasal sounds. And after surgery, the new anatomical shape can create an excessive resonance in the nasal cavities.

Indeed, there is a diversity of acoustic effects that differ according to the sinuses involved, the nature and type of surgery and the anatomical and physiological specificities of the patient.

The impairment of acoustic properties after surgery is diverse and little known.

The surgery improves the communication between sinuses and nasal cavities but the real impact on nasal resonance still unknown.

The particularity of this pathology stands in the obstruction of the sinonasal cavity by polyps. On this study, it represents a model of nasality disturbance/impairment ? Indeed, all aspects of nasality will be altered : the articulation by the obstruction of the sino-nasal cavities, the aerodynamic by a disturbance of the circulation of the airflow within the nasal cavity, acoustics by an alteration of the resonance of this flow, and finally the perception of speech by others where the comprehension of speech is difficult. Thus, the investigators wish to observe this dysfunction in a multipara metric way in order to have an accurate approach.

This population is therefore ideal. In preoperative, it will allow to measure by aerodynamic, articulatory, acoustic, and perceptive data taking this dysfunction, to give precise answers. Then, postoperatively, these measurements will be repeated to observe a return to the expected functioning of the nasal cavity. Indeed, the cavities being no longer congested, a greater flow of nasal air would be expected, which would have acoustic consequences on the resonance of nasal sounds. This could be accentuated because of the new anatomical configuration due to the surgery. Perceptually, the voice after surgery should no longer be considered as pathological.

In addition to the linguistics aspect, this population has the particularity of having a strongly impacted quality of life. The investigators would therefore like to measure this impact on quality of life before and after surgery.

For this study, the main objective is to measure the articulatory, aerodynamics, acoustics and perceptive impact of the nasal polyposis on speech before and after surgery.

the secondaries objectives are to:

Compare the differences in aerodynamic, acoustic, articulatory and perceptual changes between the ""presence of polyps in the nasal and sinus cavities"" group and the ""presence of polyps in the sinus cavities"" group
Compare the modifications on the speech of the pathology before and after surgical treatment
Identify the elements related to the quality of life impacted by this pathology.
Identify the glottic compensation strategies induced by the pathology
Compare preoperative and postoperative nasal resonance and the relationship between nasal and sinus cavities using 3D models
Validate the adequacy of the nasality-speech questionnaire for patients with sinonasal polyposis"


title: Evaluation of Preload Dependence During a Pressure Step Alveolar Recruitment Maneuver Via Analysis of Peripheral Venous Pressure Variation in the Operating Room.

summary:
The decision to give fluids or not should not be taken lightly. Indeed, excessive or insufficient fluid administration is associated with increased morbidity and mortality. Prediction of fluid responsiveness relies on the use of a hemodynamic variable to determine how likely a patient is going to respond to a fluid bolus with a significant increase in their cardiac output or stroke volume. Depending on the response to fluids, patients are either responders or non-responders.

Today, we have many techniques to predict fluid responsiveness. However, almost all require the use of an advanced hemodynamic monitoring device.

lead_sponsor: Erasme University Hospital


title: Neurofunctional Characterization of Emotional Regulation and Its Links With the Eating Behaviour of Patients Suffering From Obesity, With or Without Binge Eating Disorder and Seeking Bariatric Surgery. Pilot Study

acronym: OBéMO

summary: Obesity is a major public health problem and Binge eating disorder (BED) is very frequently observed in patients considered for weight loss surgery and seems to influence their outcome critically. Literature highlights a global emotional overload in individuals with BED, but few are known on the mechanisms involved. The purpose of this study is to fill this gap by comparing the neurofunctional profiles of emotion regulation between patients suffering from obesity, with or without BED and healthy participants during the performance of emotion regulation tasks. Results may help to understand the neural bases of the impairments observed in patients with obesity, with or without BED, which may in turn help to propose, in the long term, potential new therapeutic approaches.

lead_sponsor: CHU de Reims


title: Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)

acronym: DyScapLat

summary: The aim of this study is to assess the influence of anterior abutment surgery using the Latarjet method on the kinematics of the scapula. The sub-objectives will be to show that Latarjet-type surgery does not lead to scapular dyskinesia and modification of muscle activity compared to a control group that has not undergone an operation.

lead_sponsor: Ramsay Générale de Santé


title: Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia: PHARM-LMC Study

acronym: PHARM-LMC

summary:
The aim of this trial is therefore to identify concomitant treatments with taking Tyrosine Kinase Inhibitor (=TKI) in the indication of Chronic Myeloid Leukemia (CML), whatever the stage of the disease, via pharmaceutical conciliation. These concomitant treatments as well as their dosages will be correlated with the TKI dosage since patients must have a sufficient residual concentration to be considered effective and to confirm adherence to treatment, the leading cause of treatment failure.

In the event of unsatisfactory results, pharmaceutical interventions may take place: changes in treatments (TKI and not TKI) and / or dosages. In case of modification, a new dosage of TKI should be carried out.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Cognitive Disorders and Brain Pulse

acronym: COG-PULCE

summary: Following an initial consultation with a memory, resources and research centre (MRRC) doctor, a day hospital may be prescribed to carry out an assessment of cognitive disorders. Patients are then usually followed up in consultation at least once a year, in the framework of a new day hospital and/or consultations with a MRRC doctor.

lead_sponsor: University Hospital, Tours


title: Acute Effects of Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: the PROTECT-06 Study

summary: Chemotherapy treatments such as epirubicin-cyclophosphamid or paclitaxel lead to severe off-target side effects such as skeletal muscle deconditioning. To date, three different studies investigated skeletal muscle decontioning in breast cancer patients, through long term protocols including all chemotherapy cycle treatment, and highlighted both structural alterations and impaired cellular processes. However, no study is currently availbale on the acute effect of one single chemotherapy administration in breast cancer patients skeletal muscle tissue. Our study is therefore dedicated to the investigation of the acute effect of the first dose administration of both Epuribicin/cyclophosphamide and Paclitaxel chemotherapies on skeletal muscle of breast cancer patients.

lead_sponsor: Institut de cancérologie Strasbourg Europe

location_facility: Institut de Cancerologie Strasbourg Europe


title: Bone Microarchitecture in Men With Hemophilia

acronym: HEMOS

summary:
Hemophilia A and B are hereditary sex-linked deficiencies of coagulation factors VIII and IX characterized by bleeding. Their modern therapy increases life expectancy and risk of age-related diseases, e.g., osteoporosis.

Hemophilia-specific risk factors impair formation of peak bone mass and accelerate bone loss. Fractures are more frequent in hemophilic men vs. age-matched men and induce bleeding which is aggravated by manipulations and surgical intervention.

The hypothesis of this study is that hemophilic men have poor bone microarchitecture (assessed by High-resolution peripheral quantitative computed tomography (HR-pQCT)) related to an imbalance between bone formation and resorption (assessed by bone turnover markers (BTM) and bone biomarkers).

The study aims to assess the difference in low trabecular number (Tb.N) at the distal radius between hemophilic men (cases) and age- height-weight-ethnicity and smoking-matched healthy men (controls). Correlation between BTM and Tb.N will be also studied.

Biologic markers of bone remodeling (C-terminal telopeptide of type I collagen (PINP), N-terminal propeptide of type I procollagen (CTX-I), periostin) will be studied.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Cardio-Vasculaire et Pneumologique


title: Estimation of the Prevalence of HIV, Hepatitis C and Hepatitis B Infection Among Detainees in the Nîmes Administrative Detention Center

acronym: TRODUMCRA

summary:
People in Administrative Detention Centers often come from areas of medium or high HIV, hepatitis C & B endemic, and are often unaware of their serological status. Currently, HIV, hepatitis C & B screening is not systematically performed at the CRA of Nîmes, and when performed, serological tests are used. The main disadvantage of this method is the length of time it takes to obtain the results, with subjects frequently discharged before receiving their results.

To improve the care of these vulnerable persons, the aim of this study is to estimate the prevalence of HIV, hepatitis C and hepatitis B in the detainees of the administrative detention center of Nîmes, by systematically screening with a rapid diagnosis test. In case of a positive rapid diagnosis test test, a serology test will confirm the rapid diagnosis test result.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Multicentre Real-life Follow-up Study of Rare Epileptic Syndromes in Children and Adolescents

acronym: EPIRARE

summary:
Rare epilepsies as a whole account for 20-30% of epilepsies, but knowledge about prognostic factors is currently limited. This means that it is difficult to provide adequate information to families at diagnosis and during follow-up. Prognostic factors are also important for management as they can have an impact on the patient's outcome (time to intervention, choice of one molecule over another, etc.). Finally, few treatments are currently available for these epilepsies. One of the limitations to the development of treatments is the lack of real life data as it is difficult to create reliable primary endpoints such as the rate of patients becoming seizure free naturally compared to a therapeutic intervention.

The aim of this real-life study is to evaluate the response to treatment as well as to see the evolution of cognitive and psychiatric comorbidities. As explained above, there are very few randomised trials except for 3 rare epilepsies (infantile spasm syndrome, Dravet syndrome, Lennox-Gastaut syndrome). This has led to the virtual absence of management recommendations, including for the three syndromes mentioned above, where attempts at treatment algorithms have been proposed, although these have not been able to be considered as evidence-based recommendations.

As a result, there is some diversity in the management of rare epilepsies from one centre to another. However, this diversity in management can be an asset in a real-life study. This will make it possible to compare different management methods, both in terms of seizure control and medium-term outcome.

ipd_sharing_description: non available


title: Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)

acronym: ATMAGD

summary:
Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. The effects of auriculotherapy are known in particular in reducing preoperative anxiety, pain in cancer patients and postoperative pain.

The aim of this study is to assess the effectiveness of adding auriculotherapy to the standard global anesthetic protocol, compared to this single reference protocol, on the incidence at 3 months post-intervention of Chronic Post-Surgical Pain, in patients operated for a mastectomy with reconstruction immediate by latissimus dorsi flap.

status: Terminated

primary_purpose: Supportive Care

status_simplified: Unknown


title: Evaluation of the Decurarisation Kinetics of Rocuronium in Cervical Surgery

acronym: CIDEROC

summary:
Recurrent nerve monitoring for thyroid and parathyroid surgery contraindicates the pharmacologically active presence of muscle relaxant agents at the time of dissection. A recent formalized expert guideline (RFE 2018) from the French Society of Anesthesia and Resuscitation, SFAR recommends administering a curare to facilitate tracheal intubation and limit laryngeal trauma . This study aims to determine if the level of neuromuscular recovery is consistent with monitoring the recurrent nerve after the use of rocuronium for intubation.

Primary endpoint: Achievement of quality intraoperative laryngeal recurrent nerve monitoring.

location_facility: Surgical anesthesia service - Cochin Hospital