title: Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus

acronym: ISOLED

summary: The study aims at determining if dietary phytoestrogens can be risk factors for Systemic Lupus Erythematosus (SLE). Dietary enquiry and phytoestrogens measurements will be performed in blood and urine of patients with SLE in an active phase of the disease, in patient with other autoimmune diseases and in healthy volunteers. Subjects will be premenopausal women and when possible at a define stage of the menstrual cycle. Free blood estradiol will be assayed as a confounding risk factor.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - service de médecine interne


type: Other Identifier

title: Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence

acronym: CHRU-WCMC

summary:
Developing a genetic study on localized or locally advanced prostate cancer. The aim of the study is to identify genomic alteration predictive of metastatic recurrence in the context of primary heterogeneity, by using the next generation sequencing (NGS) techniques.

Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Lille

collaborators: Weill Medical College of Cornell University

lead_sponsor_type: academique

status_simplified: Unknown


title: Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families

acronym: ATREL

summary:
Negative symptoms in cancer in palliative care, such as pain, can lead to a withdrawal that can lead to a form of social exclusion. Maintaining pre-illness relationships is often difficult for the patient, especially since he is often not available to relationships.

Art therapy defined as the exploitation of artistic potential in a therapeutic and humanitarian aim can contribute to the reduction of symptoms, to adaptation and to well-being. A recent review shows that positive affective states and meaningful social connections are important factors contributing to more effective adaptation to pain. Study hypothesis is that art therapy could play on these two factors.

The objective of the qualitative study is to measure, using a questionnaire, the indirect impact of art therapy sessions on parents, during support and after death, from a relational and emotional point of view.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other

status_simplified: Completed


title: Study of the Respiratory Mechanics Characteristics With Esophageal PREssure Measurements in Mechanically Ventilated Patients in IntensivE caRe Unit

acronym: PREMIER

summary: This study aims at assessing the respiratory mechanics of intubated patients in intensive care unit.

study_type: Interventional

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Beloncle FM, Merdji H, Lesimple A, Pavlovsky B, Yvin E, Savary D, Mercat A, Meziani F, Richard JC. Gas Exchange and Respiratory Mechanics after a Cardiac Arrest: A Clinical Description of Cardiopulmonary Resuscitation-associated Lung Edema. Am J Respir Crit Care Med. 2022 Sep 1;206(5):637-640. doi: 10.1164/rccm.202111-2644LE. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Thoracic Society

ipd_sharing: No

lead_sponsor: University Hospital, Angers

intervention_type: Device


title: Hemostasis Evolution During Fluid Loading in Abdominal Surgery. Effects of Fluid Choice: Saline Versus Hydroxyethyl Starch (HAEMO Study, an Ancillary Study of FLASH Trial)

acronym: HAEMO

summary:
The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in morbidity and mortality within the first 14 days in patients at moderate-to-high risk of postoperative complications after abdominal surgery.

Further investigation include the analysis of hemostasis modifications according to the fluid group during the first 7 days after abdominal surgery.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Puechal X, DeBandt M, Berthelot JM, Breban M, Dubost JJ, Fain O, Kahn JE, Lequen L, Longy-Boursier M, Perdriger A, Schaeverbeke T, Toussirot E, Sibilia J; Club Rhumatismes Et Inflammation. Tocilizumab in refractory adult Still's disease. Arthritis Care Res (Hoboken). 2011 Jan;63(1):155-9. doi: 10.1002/acr.20319.

ReferenceCitation: Tournadre A, Dubost JJ, Soubrier M. Treatment of inflammatory muscle disease in adults. Joint Bone Spine. 2010 Oct;77(5):390-4. doi: 10.1016/j.jbspin.2010.04.007. Epub 2010 Jun 2.

ReferenceCitation: Soubrier M, Mathieu S, Payet S, Dubost JJ, Ristori JM. Elderly-onset rheumatoid arthritis. Joint Bone Spine. 2010 Jul;77(4):290-6. doi: 10.1016/j.jbspin.2010.04.004. Epub 2010 May 31.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Biological


title: Impact of 18 FDG PET/CT on the Management of Patients With Staphylococcus Aureus Bloodstream Infection. An Open-comparative Randomized Trial

acronym: TEPSTAR

summary:
S. aureus bloodstream infection (SAB) is a severe disease associated with a 30% case-fatality rate at 12 weeks. Severity of this disease is related to the high prevalence of staphylococcal Deep Foci of Infection (SA-DFI), which require prolonged duration of antimicrobial therapy and specific treatment. Timely diagnosis and management of SA-DFI is associated with an improvement of prognosis during SAB. 18 FDG PET/CT (PET/CT) is a useful tool in the diagnosis of infectious foci during bacterial infections.

An ecological study performed in the Netherlands has shown that use of PET/CT in patients with Gram positive cocci bloodstream infection was associated with an increase of detection of DFI and a decrease of recurrences and mortality compared to historical controls.

The investigators hypothesize that SAB poor prognosis is in part related to the lack of diagnosis of all infectious foci and consequently to a suboptimal treatment.

status: Recruiting

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure

status_simplified: Ongoing


title: Clinical and Genetic Study of Familial Sarcoidosis (SARCFAM)

acronym: SARCFAM

summary:
Major impacts of air pollution are lung diseases such as granulomatous diseases and mainly sarcoidosis. Understanding the respective role of inorganic / nanoparticles and genetic background in these chronic diseases is a major challenge for the management of patients and prevention strategies. Granulomas are characterized by giant epithelioid and multinucleated cells, reflecting a severe disturbance in immunological pathways induced both by toxic exposure and genetic predisposition. Previous studies demonstrated that professional environmental context and acute exposures (the World Trade Center disaster) to micro/nanoparticles have a pathogenic impact with a sharp increase in sarcoidosis. Sarcoidosis is a multifactorial disease occurring in a genetically vulnerable context. Many gene variants have been linked to an increased odds-ratio of the disease, such BTNL2, CCDC88B, ANNEXIN A11 involved in regulation of T-cell activation and maturation pathways. We have contributed since 2008 to a national cohort (GSF, 28 centers) of ≈ 800 sarcoidosis patients with familial and sporadic presentation of the disease. This collection has been an exceptional (and worldwide unique) tool for the implementation of an exhaustive clinical database on sarcoidosis, modelling of disease evolution and identification of clinical / genetic criteria differentiating sporadic and familial forms.

The main goals of the project are:

Completion of the genetic data in order to establish a pattern of gene variants segregating with familial forms of the disease, compared to sporadic one. This will be done by WES (WHOLE EXOME) analysis on the previously collected DNA samples. The informed consent for the patients included the information about the BTNL2 gene, which has been already tested since 2008, and related genes connected to immune pathways, thus allowing a unambiguous information about the research finality of the project.
Completion of the clinical data about each patient, in cooperation with the GSF network, management of the database established since 2008. The data collected are those which are commonly detailed in the normal follow-up of the patients. The project do not include any new interventions on the patient (neither radiological or invasive tests).
Specific biological studies might be done on the white blood cells of the patients, and might need in such cases a new blood sampling, both in patients and first degree related healthy controls. Theses specific studies will be presented to an ethical committee (CCP) in order to validate the feasibility in term of 'new intervention' on the cohort. The samples collected will be at the same volume of a classical blood sampling (2*7 ml).
Any other projects, submitted to the GSF network will needed a specific registration and ethical committee validation.

time_perspective: Prospective

ReferenceCitation: Calender A, Rollat Farnier PA, Buisson A, Pinson S, Bentaher A, Lebecque S, Corvol H, Abou Taam R, Houdouin V, Bardel C, Roy P, Devouassoux G, Cottin V, Seve P, Bernaudin JF, Lim CX, Weichhart T, Valeyre D, Pacheco Y, Clement A, Nathan N; in the frame of GSF (Groupe Sarcoidose France). Whole exome sequencing in three families segregating a pediatric case of sarcoidosis. BMC Med Genomics. 2018 Mar 6;11(1):23. doi: 10.1186/s12920-018-0338-x.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_normalized: HAL

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

location_facility: Hospices Civils de Lyon / Hopital Edouard Herriot

intervention_type: Genetic


intervention_type: Drug

lead_sponsor: UCB Biopharma S.P.R.L.

summary: The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms

status: Terminated

title: An Open-label Adaptive Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Radiprodil in Subjects With Drug-resistant Infantile Spasms

type: EudraCT Number

source: euctr

lead_sponsor_type: industriel


title: Evaluation of the Animal Intervention Used as Therapy. Impact of Animal-assisted Therapy on the Well-being in Patients With Alzheimer's Disease

acronym: ELIAUT

summary:
The animal-assisted therapy (AAT) is now considered a non-drug care and is often used in geriatrics. Many studies have shown a link between the presence of the animal and the psycho-behavioral symptoms decrease in dementia (PBSD) such as depression, anxiety or irritability that affects their quality of life and improved cognitive abilities. However, many methodological flaws in these researches exist.

The aim of the study is to evaluate the effectiveness of AAT on the well-being of patients with Alzheimer disease (AD) at the stage of Major Neuro Cognitive Disorder (NCD) at short and medium term (before care, during care (at the beginning and end of each session), 1 week after, 2 weeks and 1 month after the last session) compared to a group receiving the same stimulation without the dog's response.

Patients will be seen in groups of 4 to 6 people at 8 workshops. 2 groups will be formed: AAT group versus control group. The only difference between these two groups is the intervention of the dog at each workshop in the AAT group.

Each workshop will consist of three identical times. It will begin with a 15 minute introductory activity, the first goal will be to establish a relationship with patients (patients-patients and patients-caregivers) and a 40 minute cognitive stimulation, identical in the 2 groups, will be proposed and finally 5 minutes will be devoted to the closing of the session This study should highlight a positive effect of animal assisted therapy on the well-being, PBSD, depression, anxiety and cognitive abilities and a long-term retention of these positive effects.

intervention_type: Behavioral


title: Precarious Elderly Patient Supported For Cancer Impact on Quality Of Life of a Domotic And Remote Assistance Approach for Elderly Patients Supported For Locally Advanced or Metastatic Cancer, Socially Isolated: Randomized, Comparative, Prospective Multi-Centre Study

acronym: PREDOMOS

summary: The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of isolation, treated for locally advanced or metastatic cancer.

primary_purpose: Supportive Care

ReferenceCitation: Couderc AL, Nouguerede E, Baumstarck K, Loubiere S, Le Caer H, Guillem O, Rousseau F, Greillier L, Norguet-Monnereau E, Cecile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Kirscher S, Diaz N, Morando C, Villani P, Auquier P, Daumas A. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial. Trials. 2019 Jan 15;20(1):54. doi: 10.1186/s13063-018-3127-0.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

ReferenceCitation: Cretel-Durand E, Nouguerede E, Le Caer H, Rousseau F, Retornaz F, Guillem O, Couderc AL, Greillier L, Norguet E, Cecile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Poudens L, Kirscher S, Loubiere S, Diaz N, Dhorne J, Auquier P, Baumstarck K. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial. Trials. 2017 Apr 12;18(1):174. doi: 10.1186/s13063-017-1894-7.

repositories_concat: PubMed Central

ipd_sharing: Undecided

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

appel_a_projets: PREPS

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

type_etablissement: CHUR

acronyme: PREDOMOS

titre: PREDOMOS : PREcarité chez le sujet âgé atteint de cancer : Impact sur la qualité de vie d'une approche DOMOtique et par téléassistance pour les patients âgés pris en charge pour un cancer métastatique ou localement avancé et isolés Socialement : Etude multicentrique, prospective, comparative, randomisée.

discipline_principale: organisation des soins

nom_porteur: CRÉTEL DURAND

prenom_porteur: Elodie


title: A European, Multicenter, Randomized Study Comparing the Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse

acronym: MITRACHORD

summary: The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.

study_start_date_type: Anticipated

status: Withdrawn

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: MITRA CHORD

titre: Etude randomisée, multicentrique, européenne comparant l'efficacité et la tolérance de la réparation de la valve mitrale par le système de délivrance de néochordage artificiel NeoChord DS1000 à la chirurgie conventionnelle chez les patients avec régurgitation mitrale organique liée à un prolapsus de feuillet isolé

discipline_principale: cardiologie

nom_porteur: OBADIA

prenom_porteur: Jean François


title: Implementation and Evaluation of a Paediatric Nurse-driven Sedation Protocol in a Paediatric Intensive Care Unit

acronym: SEDATIDE

summary:
Management of analgesia and sedation is an integral component of the medical care of a critically-ill child. Its role is to assure comfort and safety to a patient undergoing painful cares and technical procedures; it can also be, in particular situations like acute respiratory distress syndrome or acute brain injury, a full processing treatment.

Sedation involves, most of the time, the association of an opioid and a sedative. The use of these drugs is difficult in children, because of a specific metabolism, inducing tolerance and withdrawal in case of prolonged administration.

The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to avoid inadequate sedation.

Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation, longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the treatment to the patient's need and permit a reduction in the duration of mechanical ventilation.

The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric intensive care unit on duration of mechanical ventilation, total doses and duration of medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of ventilator-associated-pneumonia and occurrence of withdrawal.

location_facility: service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel


title: Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

summary:
Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances such as nitric oxide.

The present study assess the vascular properties of carotid and brachial arteries in children with SCD compared with a control group without cardiovascular risk factors.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Hadeed K, Hascoet S, Castex MP, Munzer C, Acar P, Dulac Y. Endothelial Function and Vascular Properties in Children with Sickle Cell Disease. Echocardiography. 2015 Aug;32(8):1285-90. doi: 10.1111/echo.12851. Epub 2014 Dec 3.

publisher_dissemination: Wiley

lead_sponsor: University Hospital, Toulouse


type: Other Grant/Funding Number

title: Ghrelin Cellular Resistance Study in Adolescents With Idiopathic Scoliosis

summary:
Adolescent idiopathic Scoliosis (AIS) is the most common spine pathology. It is opposed to secondary scoliosis due to chronic diseases. Many hypotheses have been made to elucidate the origin of this illness. Recently, the melatonin pathway has been investigated as pinealectomy of the chicken creates a scoliosis that resembles AIS and melatonin supplementation reverses the process. In addition administration of melatonin to AIS patients improved the pathology. However this hypothesis has shown controversial results. Recent studies have demonstrated melatonin cellular resistance in osteoblastic cells from AIS patients. Melatonin acts through G protein coupled receptor (GPCR), mainly using the Gi pathway. In AIS osteoblasts, this pathway is blocked leading to a decrease in the inactivation of the adenylyl cyclase and therefore maintenance of high level of cyclic adenosine monophosphate (cAMP) concentrations in the cells. As modulation of cAMP is important for osteogenesis such resistance may be critical for the initiation or the development of AIS.

Gi signalization is used by several other GPCR, thus, this hormonal resistance could logically be found in other hormonal or mediator pathways. A precedent study previously focused on ghrelin in AIS, and demonstrated that AIS patients possess elevated plasmatic values of ghrelin. This study also observed decreased response to ghrelin in AIS cultures osteoblasts.

primary_purpose: Basic Science

ReferenceCitation: Sales de Gauzy J, Gennero I, Delrous O, Salles JP, Lepage B, Accadbled F. Fasting total ghrelin levels are increased in patients with adolescent idiopathic scoliosis. Scoliosis. 2015 Nov 30;10:33. doi: 10.1186/s13013-015-0054-7. eCollection 2015.

oa_colors: green hybrid

evidence: open (via page says license)

unpaywall_oa_status: hybrid


title: Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis

acronym: METHOBIO

summary: The overall purpose of this trial is to assess efficacy and safety of the combination of low doses of Methotrexate (MTX) with anti Tumor Necrosis Factor (TNF) alpha to improve initial efficacy and maintenance rate of anti-TNF alpha treatment in patients with psoriasis.

status: Active, not recruiting

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

acronyme: METHO BIO

titre: Etude multicentrique randomisée double aveugle contrôlée évaluant l'intérêt du méthotrexate versus placebo dans la potentialisation et le maintien de la réponse au long cours des traitements par anti TNFalpha dans le psoriasis modéré à sévère de l'adulte

discipline_principale: dermatologie

nom_porteur: RICHARD

prenom_porteur: Marie Aleth


title: Hemodynamic and Biochemical Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage

summary: The risk of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) is associated with large cerebral artery vasospasm, but vasospasm is not a strong predictor for DCI. Assessment of cerebral autoregulation with transcranial Doppler (TCD) may improve the prediction of DCI. The aim of this prospective study was to assess the value of TCD-derived variables to be used alone or in combination for prediction of DCI

ReferenceCitation: Calviere L, Nasr N, Arnaud C, Czosnyka M, Viguier A, Tissot B, Sol JC, Larrue V. Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Cerebral Blood Flow Velocities and Cerebral Autoregulation Assessment. Neurocrit Care. 2015 Oct;23(2):253-8. doi: 10.1007/s12028-015-0125-x.


title: Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries in Normal and Pathological Cases

acronym: IRM-de-FLUX

summary:
The phase-contrast MRI offers the advantage to combine precisely vascular flow measurements data with morphological images.

Even if the anatomy of the external carotid artery is well known, data obtained through Phase contrast MRI could permit to progress in several fields of cranio-maxillofacial surgery as for example arteriovenous malformations,radionecrosis, head and neck micro-reconstructive surgery.

The aim of this study is to establish and develop Phase-contrast MRI sequences for vascular flow characterization branches of the external carotid artery in healthy patients and in pathological cases.

ReferenceCitation: Baledent O, Fin L, Khuoy L, Ambarki K, Gauvin AC, Gondry-Jouet C, Meyer ME. Brain hydrodynamics study by phase-contrast magnetic resonance imaging and transcranial color doppler. J Magn Reson Imaging. 2006 Nov;24(5):995-1004. doi: 10.1002/jmri.20722.

ReferenceCitation: Cadenat H, Barthelemy R, Combelles R, Fabie M, Maneaud M. [Importance of mandibular vascularization in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1972 Jan-Feb;73(1):60-5. No abstract available. French.

ReferenceCitation: Castelli WA, Nasjleti CE, Diaz-Perez R. Interruption of the arterial inferior alveolar flow and its effects on mandibular collateral circulation and dental tissues. J Dent Res. 1975 Jul-Aug;54(4):708-15. doi: 10.1177/00220345750540040301.

ReferenceCitation: Combelles R, Manelfe C, Hugot B, Pasturel J, Barthelemy R, Fabie M, Cadenat H. [Selective catherization of the external carotid in stomatology]. Rev Odontostomatol Midi Fr. 1974;32(1):19-37. No abstract available. French.

ReferenceCitation: Dakpé, S., 2007. Allotransplantation faciale composite: reflexion à propos de l'intégration de trois greffons expérimentaux.Université Paris XI.

ReferenceCitation: Decorato I, Kharboutly Z, Vassallo T, Penrose J, Legallais C, Salsac AV. Numerical simulation of the fluid structure interactions in a compliant patient-specific arteriovenous fistula. Int J Numer Method Biomed Eng. 2014 Feb;30(2):143-59. doi: 10.1002/cnm.2595. Epub 2013 Nov 5.

ReferenceCitation: d'Hauthuille C, Testelin S, Moure C, Gbaguidi C, Devauchelle B. [Mandibular osteoradionecrosis. Part II: efficiency of revascularization surgery]. Rev Stomatol Chir Maxillofac. 2008 Nov;109(5):296-300. doi: 10.1016/j.stomax.2007.12.009. Epub 2008 Jun 4. French.

ReferenceCitation: Frydrychowicz A, Francois CJ, Turski PA. Four-dimensional phase contrast magnetic resonance angiography: potential clinical applications. Eur J Radiol. 2011 Oct;80(1):24-35. doi: 10.1016/j.ejrad.2011.01.094. Epub 2011 Feb 17.

ReferenceCitation: Gauvrit J, Trystram D, Oppenheim C, Leclerc X. [Advanced vascular imaging techniques of supra-aortic, encephalic and medullary vessels]. J Radiol. 2007 Mar;88(3 Pt 2):472-82. doi: 10.1016/s0221-0363(07)89847-7. French.

ReferenceCitation: Herment A, Lefort M, Kachenoura N, De Cesare A, Taviani V, Graves MJ, Pellot-Barakat C, Frouin F, Mousseaux E. Automated estimation of aortic strain from steady-state free-precession and phase contrast MR images. Magn Reson Med. 2011 Apr;65(4):986-93. doi: 10.1002/mrm.22678. Epub 2010 Nov 3.

ReferenceCitation: Houseman ND, Taylor GI, Pan WR. The angiosomes of the head and neck: anatomic study and clinical applications. Plast Reconstr Surg. 2000 Jun;105(7):2287-313. doi: 10.1097/00006534-200006000-00001.

ReferenceCitation: Maurits NM, Loots GE, Veldman AE. The influence of vessel wall elasticity and peripheral resistance on the carotid artery flow wave form: a CFD model compared to in vivo ultrasound measurements. J Biomech. 2007;40(2):427-36. doi: 10.1016/j.jbiomech.2005.12.008. Epub 2006 Feb 7.

ReferenceCitation: Morita S, Suzuki K, Masukawa A, Kojima S, Hirata M, Ueno E. Identification of efferent flow in the superior vena cava and azygos vein confluence using cine phase-contrast MRI: speculation of the role of the azygos arch valves. Magn Reson Imaging. 2010 Nov;28(9):1306-10. doi: 10.1016/j.mri.2010.06.005. Epub 2010 Aug 4.

ReferenceCitation: Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.

ReferenceCitation: Nayler GL, Firmin DN, Longmore DB. Blood flow imaging by cine magnetic resonance. J Comput Assist Tomogr. 1986 Sep-Oct;10(5):715-22. doi: 10.1097/00004728-198609000-00001.

ReferenceCitation: Pomahac B, Lengele B, Ridgway EB, Matros E, Andrews BT, Cooper JS, Kutz R, Pribaz JJ. Vascular considerations in composite midfacial allotransplantation. Plast Reconstr Surg. 2010 Feb;125(2):517-522. doi: 10.1097/PRS.0b013e3181c82e6f.

ReferenceCitation: Rebergen SA, van der Wall EE, Doornbos J, de Roos A. Magnetic resonance measurement of velocity and flow: technique, validation, and cardiovascular applications. Am Heart J. 1993 Dec;126(6):1439-56. doi: 10.1016/0002-8703(93)90544-j.

ReferenceCitation: Saliou G, Baledent O, Lehmann P, Paradot G, Gondry-Jouet C, Bouzerar R, Devisme G, Theaudin M, Deramond H, Le Gars D, Meyer ME, Vallee JN. [Acute CSF changes in the mesencephalon aqueduct after subarachnoid hemorrhage as measured by PC-MRI]. J Neuroradiol. 2009 Mar;36(1):41-7. doi: 10.1016/j.neurad.2008.07.004. Epub 2008 Aug 12. French.

ReferenceCitation: Testelin, Sylvie, 2000. Incidence du flux microvasculaire sur le comportement des tissus transplantés. Exploration par vélocimétrie doppler laser. Université de Picardie Jules Verne-Amiens.

ReferenceCitation: Yim PJ, Tilara A, Nosher JL. The paradoxical flow hypothesis of the carotid artery: supporting evidence from phase-contrast magnetic resonance imaging. J Stroke Cerebrovasc Dis. 2008 Mar-Apr;17(2):101-8. doi: 10.1016/j.jstrokecerebrovasdis.2007.10.004.

ReferenceCitation: Yzet T, Bouzerar R, Baledent O, Renard C, Lumbala DM, Nguyen-Khac E, Regimbeau JM, Deramond H, Meyer ME. Dynamic measurements of total hepatic blood flow with Phase Contrast MRI. Eur J Radiol. 2010 Jan;73(1):119-24. doi: 10.1016/j.ejrad.2008.09.032. Epub 2008 Nov 12.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Departement of Maxillo-Facial Surgery, Amiens University Hospital


title: Clinical Trajectory of Children and Adolescents With Disruptive Behavior Admitted to Pediatric and Psychiatric Emergencies.

acronym: TRAJECTORY

summary:
Conduct disorders are defined as "repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate norms are violated". So defined, these disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder management is a public health issue and a societal question. Conduct disorders affect 5 to 9% of 15-year old boys.

Care management of children and adolescents admitted for disruptive behaviors in emergency rooms is an issue. No consensus or official recommendation exists. However, use of emergency care in this context is increasing in most western countries and it exposes to several risks (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and suicide risk). The Trajectories project is designed to describe children and adolescents with disruptive behaviors, their care management and to follow their life trajectory and psychiatric evolution after admission to emergency rooms. Better understanding this population will improve their medical and social care management, thereby giving professionals the right tools.

The main objective of this project is to implement a multidisciplinary and integrative research combining clinical considerations and social sciences to determine the "trajectory" of this population.


title: Study of the Platelet Function During the Last Month of Pregnancy

summary:
The objective is to compare women's platelet answer in the last month of pregnancy to women old enough to procreate, no pregnancy and without hormonal treatment.

The hypothesis of research is that the decrease of platelet answer in pregnant women could not only limit the occurence of embolic accidents but also explain the lowest incidence of the arterial thrombosis in comparison with the venous thrombosis.

primary_purpose: Prevention

ReferenceCitation: Valera MC, Parant O, Cenac C, Arnaud C, Gallini A, Hamdi S, Sie P, Arnal JF, Payrastre B. Platelet Adhesion and Thrombus Formation in Whole Blood at Arterial Shear Rate at the End of Pregnancy. Am J Reprod Immunol. 2015 Dec;74(6):533-41. doi: 10.1111/aji.12433. Epub 2015 Oct 4.


title: Cartography of Allodynic and Hypoasthetic Territories Associated With Neuropathic Pain Following Total Knee Arthroplasty (TKA)

acronym: CARTODOL

summary: The purpose of this study is to realize a cartography of the allodynic and hypoasthetic territories associated with a neuropathic pain appearing in patients who underwent a Total Knee Arthroplasty (TKA)

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

acronym: TFH and AIHA

summary:
T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known.

We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics

acronym: CAPRI

summary:
The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program's potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact.

The investigators are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including toxic side effects, patient quality of life and patient experience . An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health care resources' used. A parallel process evaluation will be conducted to describe implementation of the intervention

ReferenceCitation: Mir O, Ferrua M, Fourcade A, Mathivon D, Duflot-Boukobza A, Dumont S, Baudin E, Delaloge S, Malka D, Albiges L, Pautier P, Robert C, Planchard D, de Botton S, Scotte F, Lemare F, Abbas M, Guillet M, Puglisi V, Di Palma M, Minvielle E. Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial. Nat Med. 2022 Jun;28(6):1224-1231. doi: 10.1038/s41591-022-01788-1. Epub 2022 Apr 25.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

repositories_concat: HAL

unpaywall_oa_status: bronze

ReferenceCitation: Gerves-Pinquie C, Daumas-Yatim F, Lalloue B, Girault A, Ferrua M, Fourcade A, Lemare F, Dipalma M, Minvielle E. Impacts of a navigation program based on health information technology for patients receiving oral anticancer therapy: the CAPRI randomized controlled trial. BMC Health Serv Res. 2017 Feb 13;17(1):133. doi: 10.1186/s12913-017-2066-x.

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

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Improvement of the Etiological Diagnosis of the Pericarditis

acronym: PERICARDITE

summary: Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to improve the diagnosis of this syndrome investigators have developed a strategy of systematic prescription of biological tests by kit. This prescription by 'kit' strategy proved its interest by comparison with an intuitive requirement of biological. In this study investigators want to improve the diagnostic causative of pericarditis by implementing a new diagnostic strategy. This new strategy includes (i) samples additional less invasive for the patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective diagnostic techniques: specific Polymerase Chain Reaction (PCR)

location_facility: Assistance Publique Hopitaux de Marseille


title: Retrospective Study on the Evaluation of Intra-disc Infiltration in the Active Disc Disease

acronym: MODIC

summary: Active discopathies or MODIC 1, are a diagnostic entity discovery with the contribution of MRI in which the first cases were described by Dr. Michael MODIC in 1988. It is characterized by a vertebral bone edema secondary to active discarthrose. Its prevalence is estimated at 6% of the general population and up to 40% of the CLBP according to studies. Following the discovery of this recent diagnostic entity, responsible for low back pain, the question of its management is debate in the medical community. Early studies demonstrate the effectiveness of corticosteroid injections in intra-disc. Other works, most recent, suggest the contrary, infectious, incriminating a pathogenic role of certain bacteria such as Propionibacterium acness or Corynebacterium propinquum recommending, in contrast, treatment with prolonged antibiotic therapy. This study will aim to assess the effectiveness of intra-disc infiltration GHPSJ carried out between 2007 and 2014. The innovation of our work will be to assess these infiltrations in various subgroups such as patients with a previous surgery of the spine or a history of scoliosis or spondylolisthesis.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Prospective Study of Technical Optimization of the Detection of KRAS Mutations, BRAF and NRAS by Next Generation Sequencing on Tumor DNA Circulating in Metastatic Colorectal Cancer.

summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin

lead_sponsor: Institut de Cancérologie de Lorraine


title: Study of the Strategies of Visual Perception of Social Scenes During Emotional States Induced to Subjects With an Intrusive Disorder of the Development: Pilot Study

acronym: VisioTED

summary:
The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. However, the results of studies on these issues are very divergent. The PDD also been described as a disorder of emotion regulation, but few studies address the emotional feelings of individuals with ASD and their neuropsychological implications.

The main objective is to study the effect of induced emotion in the children with ASD on his visual exploration strategies.

This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy terms of the look in a group of children with ASD, in a context of emotional induction (joy, fear, sadness or anger) using of sound stimuli.


title: Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)

acronym: PRIMIMMUNO

summary: The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART).

location_facility: Hospices Civils de Lyon / Hôpital de la Croix Rousse


title: Evaluation of the Effectiveness of a Diagnostic Kit in the Etiological Diagnosis of Fevers of the Traveler

summary:
Annually about 10 to 15 million international travelers from Europe visit tropical countries. Returning from a journey, fever is the cardinal symptom of many infections. This is the second reason for consultation (23%) for return from a trip, after digestive disorders (42%). Urgent evaluation must always be proposed. Although that may be the manifestation of a benign disease, fever of return can also presage a rapidly progressive and lethal disease. In 50% of cases, patients return home, after treatment and disappearance of symptoms, though the microorganism responsible for the pathology is not able to be identified. The prescription of a series of systematic biological examinations in the form of a diagnostic kit has shown its relevance and its effectiveness in improving the etiological diagnosis of endocarditis and pericardites for optimal support. In this study we propose to assess the effectiveness of the systematic prescription of a diagnostic kit 'fever of the traveler' to all patients hospitalized with a fever after returning from a trip. "Ready to use" kit brings together in a single bag (i) instructions for use, (ii) the tubes, bottles and jars for the etiological diagnosis of fever of the traveler in the usual support (iii) an additional blood tube for research of pathogens emerging.

Primary:

To assess the effectiveness of a diagnostic kit for the etiological diagnosis of fevers of travelers on the return.

Hypothesis:

Improvement of at least 15% of the etiological diagnosis of fevers of travelers on the return through the development of a diagnostic kit.

location_facility: Asssitance Publique Hopitaux de Marseille


title: Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors

summary: Urinary measure of 5-hydroxyindolacetic acid (5HIAA) is an important marker for the diagnosis and follow-up of patients with small-intestine neuroendocrine tumors. Although this marker has good specificity, its sensitivity is moderate and its dosage is constraining, since it requires urine collection over 2-3 days and specific diet. Preliminary data suggested that overnight 5HIAA value may be representative of 24-hour 5HIAA value, and that plasma 5HIAA dosage could be a valuable alternative to urine 5HIAA dosage. The main objective of this study is to compare sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors.

ReferenceCitation: de Mestier L, Savagner F, Brixi H, Do Cao C, Dominguez-Tinajero S, Roquin G, Goichot B, Hentic O, Dubreuil O, Hautefeuille V, Walter T, Cadiot G. Plasmatic and Urinary 5-Hydroxyindolacetic Acid Measurements in Patients With Midgut Neuroendocrine Tumors: A GTE Study. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1673-e1682. doi: 10.1210/clinem/dgaa924.

oa_host_type: publisher

evidence: open (via free article)

publisher_dissemination: The Endocrine Society

lead_sponsor: CHU de Reims


title: Electro- Hemodynamic Activity in Children: Combined Analysis by Video -EEG Spectroscopy and Near-infrared (NIRS )

acronym: AEHCEE

summary: Epilepsy in children is a major public health issue. It is the first neurological disease of the child.


title: Evaluation of the Implementation of the Hemispheric Dominance During Development : Electrometabolic and Hemodynamics Study in the Newborn Born Premature or Term

acronym: HEMISPHERENOR

summary:
Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the right hemisphere. Many studies helped to highlight the presence of anatomical and functional asymmetries both in the first months of life. What are the causes of these imbalances? How do they develop? Are they necessary for operation or for effective learning?

The investigators would like in this work, in collaboration with applied mathematics team of Compiègne and INSERM team, to determine from which period the development of hemispheric dominance is set up for recognition of language and in which brain structure it occurs in preterm infants whose sound environment is usually very different from that of the fetus. The impact of this environment on brain development of infants and their early learning will be assessed.


title: Use of Compressed Sensing in Breast MRI

acronym: COMPRIM

summary:
Breast MRI is increasingly important in breast screening imaging. It is currently based on dynamic sequences after contrast injection whose temporal resolution must be less than 90 seconds with dynamic acquisitions at different times.

These curves profiles are designed to differentiate benign from malignant lesions. Recently, Mann et al, (2014) showed that increasing the temporal resolution of dynamic acquisitions; lesion enhancement curves over time were more accurate than the curves usually performed.

It seems necessary to work on sequences having better temporal resolution without compromising however spatial resolution.


title: Evaluation du caractère Neuropathique Des Douleurs Post opératoires. Enquête 2 Jours : DN4-SFAR

summary: Chronic postsurgical pain (CPSP) is defined by pain persisting longer than 2 months after surgery (1). Its incidence varies from 10 to 50 % in the literature (2). A high proportion of CPSP is neuropathic (CPSNP) (4). Postoperative pain is traditionally classified as nociceptive pain and the more intense is this pain on a numeric pain scale (NPS), higher are the risks of pain chronicization and the duration of the severe pain is longer (5,6). However, acute neuropathic pain (ANP) can be present in the postoperative setting. However, data on the prevalence of ANP immediately after surgery are scarce and no screening tool has been validated so far in this setting. Therefore, the first objective of this multicenter observational study is to prospectively describe the incidence of APSNP in a large population using the DN4 questionnaire. The second objective of our study is to confirm the hypothetic link between APSNP and CPSNP at 1 and 2 months after surgery in a large population. It is hypothesized that the systematic use of the DN4 questionnaire in postoperative could help detect patients at risk of CPSNP.

ReferenceCitation: Beloeil H, Sion B, Rousseau C, Albaladejo P, Raux M, Aubrun F, Martinez V; SFAR research network. Early postoperative neuropathic pain assessed by the DN4 score predicts an increased risk of persistent postsurgical neuropathic pain. Eur J Anaesthesiol. 2017 Oct;34(10):652-657. doi: 10.1097/EJA.0000000000000634.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Rennes University Hospital


title: Study Protocol: Reference Values for External Genitalia and Androgen Blood Level in New Born Girls

acronym: VOGE

summary:
Normal values for female external genitalia size at birth, particularly clitoris and blood level of androgens are not well known. This study's aim is to collect normal values in 180 newborn girls of 24 to 41 weeks of pregnancy, and to build genitalia growth charts according to gestational age and birth weight.

The investigators will measure clitoris, genito-anal ratio using a small plastic caliper, at birth, and their evolution until Day 3 of life (if the child is still at the hospital).

The investigators also want to establish normal values of blood testosterone, 17-hydroxyprogesterone, delta4-androstenedione, 21-deoxycortisol, 11-deoxycortisol, deoxycorticosterone, corticosterone, dehydroepiandrostenedione, and dihydrotestosterone), using samples taken for systematic post natal screening of diseases (only in new born of 35 or more weeks of birth).

This is an observational prospective study.


title: Randomized, Double-blind Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia and on Lipoprotein Kinetics

acronym: XXS SYMPA

summary: Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of natural polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative stress notably with a decrease in certain markers of oxidative stress and on plasma lipid parameters, the investigator proposes to study the effect of 6 months of treatment with XXS in a controlled study against placebo in a population of persons presenting a lipid profile at the upper limit of normal.

intervention_type: Dietary Supplement


title: Study of the Effect of Class III Elastic Venous Compression Focused on 33 mmHg on Water Balance Change in Healthy Subjects. Exploratory, Randomized, Open-label, Controlled and Crossover Study

summary: The main objective of this study is to compare precisely, under standardized test conditions, water balance changes in healthy subjects with or without the daytime use of compression stocking.

lead_sponsor: Laboratoires Innothera

sponsor_collaborators:
Laboratoires Innothera
Biotrial


title: Creation et Characterization of Two Groups of Elderly Subjects so as to Evaluate the Link Between the Characteristics of Oral Physiology, Sensory Sensitivity, the Release in Vivo Aromatic Compounds, and In-mouth Comfort During the Consumption of Foods

acronym: ALIMASSENS

summary:
There are few data on elderly people concerning mechanisms involved in the in vivo release and perception of aromatic compounds. Any knowledge on this point would be of great interest to the scientific community. Concerning the dimensions of sensory perception and in-mouth comfort, there is, to our knowledge, no methodology to describe them. These dimensions are truly original and innovative, and investigating them will lead to the development of foods adapted to elderly populations with chewing and salivation disorders.

The expected results are:

to obtain two groups of subjects with differences in chewing abilities and saliva production
the characterization of flavour release profiles in elderly subjects with regard to oral physiology (mastication and salivation) and saliva composition
a sensory profile describing in-mouth comfort when food is eaten

location_facility: Hôpital Champmaillot Geriatric Department


acronym: CurHaTOF

summary:
Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by stimulation of the ulnar nerve at the wrist.

However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort, arterial catheterization), it is impossible to access the patient's wrists, delaying monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient extubation , leading in some cases to single injections lack of control of the reversal of the patient.

To overcome these technical difficulties, a group nerve / muscle looks interesting and often easily accessible to the anesthesiologist.

The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis brevis muscle and allows quick access to monitoring the reversal before the end of the intervention.

The primary outcome was to compare the speed of recovery from neuromuscular block flexor hallux versus that of the adductor pollicis.

The secondary objective was to compare the speed of installation of deep neuromuscular block flexor hallucis versus that of the adductor pollicis.

This is a prospective, exploratory, uncontrolled, single-center for routine care.

Are included all aged patients over 18 years, ASA I or II, without guardianship, having no known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach, predictable difficult intubation .

ReferenceCitation: Le Merrer M, Frasca D, Dupuis M, Debaene B, Boisson M. A comparison between the flexor hallucis brevis and adductor pollicis muscles in atracurium-induced neuromuscular blockade using acceleromyography: A prospective observational study. Eur J Anaesthesiol. 2020 Jan;37(1):38-43. doi: 10.1097/EJA.0000000000001090.

lead_sponsor: Poitiers University Hospital


title: Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants

summary:
The purpose of the study is to evaluate prospectively the clinical benefits of 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants.

Design: Prospective, controlled, randomized, multi-center.

Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups:HFNC "2l/min/kg" or HFNC "3l/min/kg" during 24 hours.

Conditions of measurements:

Primary endpoint: Proportion of failure in both arms during the first 24 hours.

Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.

Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2

Statistic: Intention to treat Analysis.

Expected number of patients: 135 per arm: 270 children.

ReferenceCitation: Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.

ipd_sharing: Yes

ipd_sharing_description: All data will be centralized at the sponsor office for the final analysis


title: Evaluation of Clinical Perfectionism in Parkinson Disease

summary: Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer of depression and / or anxiety.


title: Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder

acronym: MP-TCSP-IRMf

summary:
Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem.

Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so-called "reward system".

A strong link was found between these two disorders and therefore the investigators believe that RBD is associated with impaired reward system.

The main objective of this study is to evaluate differences in brain activation between PD patients with and without RBD.

The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Neurodis Foundation


title: Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study

acronym: OSGOOD

summary:
The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually considered a benign pathology that cures in the majority of cases. However, in 5-10% of cases there is persistent residual pain in adulthood.

The classic complication is the avulsion fracture of the tibial tuberosity in adolescents who continued his sports without restriction.

The possible consequences are numerous including the presence of a free bone fragment at the insertion of the tendon originally described by Osgood the establishment of a genu recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying sport.

The main two treatments are complete rest from sport activity or cast immobilization.

The main objective is to compare these two technics according to the proportion of full sporting recovering at 12 months

location_facility: Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval


summary:
Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib.

Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month.

ReferenceCitation: Gallais F, Ysebaert L, Despas F, De Barros S, Dupre L, Quillet-Mary A, Protin C, Thomas F, Oberic L, Allal B, Chatelut E, White-Koning M. Population Pharmacokinetics of Ibrutinib and Its Dihydrodiol Metabolite in Patients with Lymphoid Malignancies. Clin Pharmacokinet. 2020 Sep;59(9):1171-1183. doi: 10.1007/s40262-020-00884-0.

oa_host_type: repository

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

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

unpaywall_oa_status: green

location_facility: Cancer University Institute of Toulouse Oncopole

title: Real Life Assessment of the Association and Its Determinants Between Side Effects and Plasmatic Concentrations of Two Protein Kinase Inhibitors: Ibrutinib (IMBRUVICA®) and Idelalisib (ZYDELIG®) in Hematological Malignancies Treatment.


acronym: TARGET

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
The investigators will look for the presence of the fusion gene in all patients operated on for glioma. This search will be limited to all gliomas that show no IDH1 mutation, the latter being sought in both routine and anomalies never co-existing.

The hypothesis is that the rate of progression-free survival in grade IV gliomas and III without IDH1 mutation, with the usual chemotherapy, only 15% at 6 months (ie, 85% of patients relapse before 6 months of treatment), must be with this new treatment 35% (primary endpoint).

The main objective is the evaluation of disease-free survival at 6 months.

location_facility: Neuro onsology unit - Groupe Hospitalier Pitié-Salpêtrière

title: A Phase I/II, Open-Label, Multicentre Study to Assess The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of AZD4547 in Patients With Relapsed/Refractory Glioma Positive for an FGFR Fusion


title: INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention

summary:
The aim of this study is to identify groups of subjects at risk of recurrence in secondary prevention based on Psychosocial Factors.

The aim is also to propose novel levers to reduce health inequalities in this population so as to develop new prevention strategies for neuro- and cardio-vascular health This study is based on data from questionnaires (Quality of life at work, perceived stress, perceived disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking, obesity, sedentarity).

Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study because of blood sample


title: Neuroinflammation, Serotonin, Impulsivity and Suicide

acronym: NISIS

summary:
Suicide is a major health problem that causes annually a million death worlwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition (personality, family history of SB…) and stressful conditions (early life adversity).

Studies show that suicide ideations could favour inflammation and that depression is associated with an elevated inflammation.

Recent evidences also suggest that inflammatory mediators play a critical role in SB.

The aim of the study is to evaluate the inflammatory markers rate on depressed patients with or without personal history of SB.

In the second part of the study, the relations between the rates of inflammatory markers and characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression of 5HT2B receptor will be investigated.


title: Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers of Inflammation

acronym: RIFIFI

summary:
An intense inflammatory reaction is triggered by the ischemic injury during myocardial infarction. The inflammatory processes involved are complex and haven't been explored in detail in human patients. This inflammatory response can increase myocardial damage following reperfusion, leading to adverse remodeling and adverse events (heart failure, sudden cardiac death).

Cardiac MRI can assess the size of myocardial infarction and many other parameters associated with myocardial injury: edema, hemorrhage, micro-vascular obstruction.

(However the association between biomarkers of inflammation and these imaging parameters is not known).

There is very little data correlating imaging markers of myocardial injury to the biokinetics of inflammation biomarkers.

In this study, the aim is to assess the relationship between the kinetics of specific inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, Tumor Necrosis Factor (TNF)-alpha, C reactive protein (CRP), soluble toll-like receptor-2 (ST2), neutrophils) and imaging markers of injury measured by cardiac MRI at the acute phase in 20 acute mycardial infarction (AMI) patients.

lead_sponsor: Hospices Civils de Lyon


title: MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach

acronym: HP

summary:
Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for consultation, among the most frequent, in general or pediatric medicine. Among the different clinical forms of instability, ADHD appears to be an especially disabling condition for the development of the child, both in psychomotor, cognitive, emotional and relational aspects. Further, a significant link between ADHD children and some children with High Potential (HP) is observed. HP children show overall ahead cognitive developments compared to children with the same age. In these children, as well as in children with ADHD, an attention vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits that significantly contrasted with some of their cognitive skills. Regarding the HP, the hypothesis is that children with significantly heterogeneous results (Complex) to the Wechsler IV scales are affected by this shift, and hence, by the difficulty of a differential diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that are more homogeneous (Laminar).

The goal of this work was to study a population of 80 children aged from 8 to 12 years (20 subjects per group) to evaluate the functional and structural brain development by:

Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations, involving attention, working memory and semantic processing, and emotional stimulations,
fMRI acquisitions at rest (without activation),
diffusion tensor magnetic resonance imaging (DTI) acquisitions,
3D anatomic acquisitions. Identification of developmental differences in certain cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or functional networks preferentially used by one or other of these groups, will help to better understand this disease, and to improve the differential diagnosis in order to implement a more appropriate and personalized management of the patients via new therapeutic strategies.

location_facility: Service de psychiatrie infantile, Hôpital Pierre Wertheimer, 59 Boulevard Pinel


title: Obstetric and Proctology Support of Patients With Perineums Suits. Prospective Cohort

summary:
Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the series), and are a source of potentially serious complications, even long time after delivery (especially disorders of anal continence, psychological trauma). If a number of risk factors are well described, the support arrangements at the time of delivery and the characteristics of the review Proctological remote delivery and its relationship to the clinical status of patients is little known and rarely studied.

In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.

The same support on both sites allows to consider the creation of a relatively homogeneous cohort in terms of support and consider an important recruitment. Moreover, the geographical proximity of the inclusions sites (maternity) with proctology service is likely to limit the risk of lost sight of.


title: Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)

acronym: MBL INFFONG

summary: The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.


title: Aortic Calcification and Vitamin K Antagonists

acronym: AVKAL

summary: The vitamin K antagonists (VKA) are necessary drugs of prevention and treatment of thrombo-embolic disease. The AVKAL study assesses the impact of VKA treatment on the aortic calcifications development. This is a biomedical research without health product, transversal and monocentric study which compares the aortic calcifications levels of two populations : one treated by VKA and the other which has never been treated by VKA.

ReferenceCitation: Price PA, Urist MR, Otawara Y. Matrix Gla protein, a new gamma-carboxyglutamic acid-containing protein which is associated with the organic matrix of bone. Biochem Biophys Res Commun. 1983 Dec 28;117(3):765-71. doi: 10.1016/0006-291x(83)91663-7.

ReferenceCitation: Schurgers LJ, Aebert H, Vermeer C, Bultmann B, Janzen J. Oral anticoagulant treatment: friend or foe in cardiovascular disease? Blood. 2004 Nov 15;104(10):3231-2. doi: 10.1182/blood-2004-04-1277. Epub 2004 Jul 20.

ReferenceCitation: Price PA, Faus SA, Williamson MK. Warfarin causes rapid calcification of the elastic lamellae in rat arteries and heart valves. Arterioscler Thromb Vasc Biol. 1998 Sep;18(9):1400-7. doi: 10.1161/01.atv.18.9.1400.

ReferenceCitation: Schurgers LJ, Cranenburg EC, Vermeer C. Matrix Gla-protein: the calcification inhibitor in need of vitamin K. Thromb Haemost. 2008 Oct;100(4):593-603.


title: One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery

acronym: VUPPAM

summary: Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is usually taking to restore coronary revascularization, and its dissection can lead to accidental or voluntary pleural effusions. Respiratory complications are frequent, due to the drainage required. In this study, the investigators propose one-lung ventilation to facilitate artery grafting and surgical procedure. The investigators will include all adult patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in a prospective, controlled, randomized and monocentric study. The main objective is to demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined by presence of drainage and/or pneumothorax on X-ray chest in the ICU.


title: Evaluation of Diagnostic Qualities of Lung Ultrasonography to Monitor the Position of the Intubation Probe

acronym: ECOVERA

summary:
The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe.

The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently :

sonography
chest radiography

A correct position of the intubation probe will be considered if there is :

Highlighting of the extremity of the intubation probe in endo tracheal
Highlighting bilateral lung sliding

ReferenceCitation: Knapp S, Kofler J, Stoiser B, Thalhammer F, Burgmann H, Posch M, Hofbauer R, Stanzel M, Frass M. The assessment of four different methods to verify tracheal tube placement in the critical care setting. Anesth Analg. 1999 Apr;88(4):766-70. doi: 10.1097/00000539-199904000-00016.

ReferenceCitation: Harris EA, Arheart KL, Penning DH. Endotracheal tube malposition within the pediatric population: a common event despite clinical evidence of correct placement. Can J Anaesth. 2008 Oct;55(10):685-90. doi: 10.1007/BF03017744.

ReferenceCitation: Schmolzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1.

ReferenceCitation: Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013. Epub 2015 Feb 21.

ReferenceCitation: Pfeiffer P, Rudolph SS, Borglum J, Isbye DL. Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. Acta Anaesthesiol Scand. 2011 Nov;55(10):1190-5. doi: 10.1111/j.1399-6576.2011.02501.x. Epub 2011 Sep 8.

ReferenceCitation: American College of Emergency Physicians. Clinical Policies Committee. Verification of endotracheal tube placement. Ann Emerg Med. 2002 Nov;40(5):551-2. No abstract available.

ReferenceCitation: Guerder M, Maurin O, Merckx A, Foissac F, Oualha M, Renolleau S, Vedrenne-Cloquet M. Diagnostic value of pleural ultrasound to refine endotracheal tube placement in pediatric intensive care unit. Arch Pediatr. 2021 Nov;28(8):712-717. doi: 10.1016/j.arcped.2021.09.006. Epub 2021 Oct 6.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

publisher_dissemination: Elsevier


title: Q Fever and Auto-immunity

acronym: Q Fever

summary: The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is associated with secretion by the body both many antibodies against the bacteria but also against certain cells of the body (autoantibodies). These autoantibodies may have no effect or be associated with specific symptoms. Anti-Phospholipid antibodies are especially prevalent in the Q fever. Apart from this infection, they are associated with thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These conditions have also been described as complications during Q fever. In a retrospective preliminary work on Q fever, we have shown that the presence of high levels of IgG anti-cardiolipin was associated with the presence of valvular and the evolution to endocarditis. Such associations have a therapeutic involvement and must therefore be confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could be systematically proposed to patients with valvular disease of trans-thoracique ultrasound but IgG anticardiolipin high levels. Other special attention could be given to patients with high autoantibodies.

location_facility: Assistance Publique - Hôpitaux de Marseille


title: CoHort of STEMI Patients

acronym: STEMI

summary:
Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention.

However, death and heart failure incidence after STEMI remain elevated: up to 20% at one year.

Also, therapeutic management following international guidelines is standardized toward a "one-size fits all" therapeutic management.

In order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (LV) remodeling ….

This knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine.

The aim objective of this cohort of STEMI patients is to identify new biological markers of injury and prognosis.

location_facility: Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine


title: Efficacity of a Standardized Hypnotic Message on Pain Experienced During the Application of a Qutenza (Capsaicin) 8% Patch in Patients With Peripheral Neuropathic Pain

acronym: ENHYZA

summary: QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other analgesics. Acute pain experienced during and after the procedure can be relieved by local cooling methods and oral analgesics but the pain remains intense. The hypothesis is that hypnosis via a standardized hypnotic message would increase the local tolerance of the treatment when applying the patch QUTENZA®. To date, there are no studies that can confirm or refute this hypothesis.

ReferenceCitation: Etienne R, Laurent M, Henry A, Bioy A, Salleron J, Schohn CH, Cretineau N. Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial. BMC Complement Med Ther. 2021 May 27;21(1):154. doi: 10.1186/s12906-021-03329-8.

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square


title: Pain in Psychiatry : Impact on Length of Hospital Stays

acronym: D-PSY

summary: For several decades, authors are interested in the existence and meaning of painful symptoms in a population of psychiatric inpatients. But, to date, studies specifically focused on the impact of pain in patient populations in psychiatric hospitals are few. More recently, a review of the literature highlights the difficulties of evaluation of pain in populations of psychiatric patients but also the complex interrelationships between painful symptoms and psychiatric diseases. The first national survey conducted among 172 health which evaluate pain and its management in the field of psychiatry concluded on the need to develop research in this area.


title: Assessment of Cystatin C as a Tubular and Glomerular Marker of Nephrotoxicity in Pediatric Oncology

acronym: CysPed

summary: Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve renal toxic threats in children given their immature kidney. This toxicity is increased especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the available evaluation methods of the renal function could be very restrictive to perform on children. In this study, the investigators intend to test the use of the cystatin C as an effective and reliable biological marker of renal toxicity in children treated with cisplatin and / or ifosfamide.

ReferenceCitation: Lambert M, White-Koning M, Alonso M, Garnier A, Alphonsa G, Puiseux C, Munzer C, Berthier J, Malard L, Pasquet M, Chatelut E. Plasma cystatin C is a marker of renal glomerular injury in children treated with cisplatin or ifosfamide. Pediatr Blood Cancer. 2021 Jan;68(1):e28747. doi: 10.1002/pbc.28747. Epub 2020 Oct 15.


title: Evaluation of the Impact of a Coordinating Nurse in a Personalized Care Program on Quality of Care, Coordination of the Actors and on Quality of Life for Patients With Lung Cancer. A French Randomized Monocentric Prospective Study

acronym: EVIDEC

summary:
The prognosis of patients with lung cancer is related to the stage of the diagnosis : 73% of one-year-survival rate at stage IA and only 13% one-year-survival rate at stage IV. Controlling the timelines in a care program seems crucial to improve prognosis of lung cancer.

The project aims to evaluate the impact of a coordinating nurse (CN) in a personalized care program for patients of thoracic oncology.

ReferenceCitation: Martin F, Piquet J, Orlando JP, Blanchon F, Lebas FX. [Clinical research in pneumology in French general hospitals]. Rev Mal Respir. 2014 Nov;31(9):801-3. doi: 10.1016/j.rmr.2014.10.726. Epub 2014 Nov 5. No abstract available. French.

ReferenceCitation: Locher C, Debieuvre D, Coetmeur D, Goupil F, Molinier O, Collon T, Dayen C, Le Treut J, Asselain B, Martin F, Blanchon F, Grivaux M. Major changes in lung cancer over the last ten years in France: the KBP-CPHG studies. Lung Cancer. 2013 Jul;81(1):32-8. doi: 10.1016/j.lungcan.2013.03.001. Epub 2013 Mar 29.

ReferenceCitation: Grivaux M, Locher C, Bombaron P, Collon T, Coetmeur D, Dayen C, Debieuvre D, Goupil F, Le Treut J, Martin F, Molinier O, Asselain B, Zureik M, Blanchon F. [Study KBP-2010-CPHG: inclusion of new cases of primary lung cancer diagnosed in general hospital pneumology departments between 1st January and 31 December 2010]. Rev Pneumol Clin. 2010 Dec;66(6):375-82. doi: 10.1016/j.pneumo.2010.08.001. Epub 2010 Dec 3. French.

ReferenceCitation: Leveque N, Brouchet L, Lepage B, Hermant C, Bigay-Game L, Plat G, Dahan M, Riviere D, Didier A, Mazieres J. [An analysis of treatment delays of thoracic cancers: a prospective study]. Rev Mal Respir. 2014 Mar;31(3):208-13. doi: 10.1016/j.rmr.2013.10.001. Epub 2013 Oct 28. French.

ReferenceCitation: Goldstraw P, Crowley J, Chansky K, Giroux DJ, Groome PA, Rami-Porta R, Postmus PE, Rusch V, Sobin L; International Association for the Study of Lung Cancer International Staging Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol. 2007 Aug;2(8):706-14. doi: 10.1097/JTO.0b013e31812f3c1a. Erratum In: J Thorac Oncol. 2007 Oct;2(10):985.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung

acronym: KBPCT

summary: Treatment of a stage IV NSCLC is based on chemotherapy and requires before each session to check clinically, biologically and radiologically absence of infection. This biological evaluation is based on the CRP rate. Lots of infections may occur in this situation and could reduce by three the patient's life duration. However it is very important to make as early as possible a correct diagnosis of infection. CRP rate is classically higher for those patients even without any infection. In comparison with CRP, Procalcitonin (PCT) is well-known for its better sensibility and specificity for the infection diagnosis but has never been study in case of active cancer. The aim of this study is to evaluate the Procalcitonin basal rate for those patients suffering from NSCLC. It could be a simple and reliable method to use. So the investigators decided to include each new patient with NSCLC stage IV coming for his first-line chemotherapy without any infection sign, and to realize a Procalcitonin dosage before the start of the treatment. This sample will be analyzed at the chemical laboratory and the result will not be communicated to the patient physician. A new clinical evaluation will be realized either at the hospital or by phone at day 7 to search any sign of infection. In absence of infection, patient will be reevaluated at day 14, 21 and 30. In case of infection, a new Procalcitonin (and CRP) dosage will be performed.


title: Value of Target-controlled Intravenous Anaesthesia (TCIVA) to Optimize Coverage of the Low Back Pain Territory in Patients With Chronic Refractory Postoperative Multifocal Low Back and Legpain

acronym: AIVOC

summary: Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted with a multicolumn lead.


title: Expectations and Priorities of Elderly Patients for a First Medical Treatment for Cancer : PRIORITY Study

acronym: PRIORITY

summary: The main objective of study is to describe the priorities of elderly patients (70 years and over) undergoing a first medical treatment for cancer, at initiation of treatment and after 3 months of treatment. The main criterion is a prioritization of 4 items per patient from a list of 8 expectations regarding the objectives of their treatment: treatment efficacy, life expectancy, autonomy, daily activities, social activities, heaviness of treatment, toxicity, economics.

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Fondation Université de Bordeaux
AG2R La Mondiale


title: Impact of an Effort Rehabilitation Program for Overweight or Obese Children and Teens on Quality of Life and Wellbeing: A French Monocentric Prospective Study

acronym: PRESEVAL

summary: Obese and overweight children or teens can join the Prevention and Care of Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse. Those patients who are no longer able to exercize because of their physical condition start an effort rehabilitation program at the Organization. The study will evaluate the impact of this rehabilitation program on quality of life and appetency to physical activity for these children and teens.

ReferenceCitation: Fulton JE, Garg M, Galuska DA, Rattay KT, Caspersen CJ. Public health and clinical recommendations for physical activity and physical fitness: special focus on overweight youth. Sports Med. 2004;34(9):581-99. doi: 10.2165/00007256-200434090-00003.

ReferenceCitation: Bar-or O. Médecine du Sport chez l'enfant. Principes physiologiques et applications cliniques. Paris : Masson ; 1987

sponsor_collaborators: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)

acronym: PTI Fc

summary:
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a peripheral destruction of platelets responsible for bleedings.

Monocytes/macrophages play a double role by phagocyting platelets recognized by autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell functions.

Fcgamma receptors (FcγR), that are represented by activating receptors (FcγRI, FcγRIIa, FcγRIII) and an inhibiting one (FcγRIIb), are involved in the regulation of macrophages and have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematous.

The aim of this study is to compare the expression of FcγR in patients with ITP on circulating monocytes and on splenic macrophages.


acronym: EROS

summary:
Raltitrexed is a potent thymidylate synthase (TS) inhibitor. Conversely to 5-fluorouracil (5FU), raltitrexed can be administered safely in patients with cardiovascular disease, as well as in patients with dihydropyrimidine dehydrogenase deficit. Since raltitrexed is administered in 15-minutes infusion, complications related to continuous infusion can be avoided, and it becomes a potential good candidate for locoregional treatments as hepatic intra-arterial or intra-peritoneal infusion. Despite these potential benefits over 5FU, clinical trials failed in their temptation to replace the 5FU in colorectal cancer patients, mainly due to raltitrexed toxicity at 3mg/m2 every 3 weeks. Oxaliplatin has demonstrated a synergic effect when combined with TS inhibitors, and its association with raltitrexed was evaluated at 130mg/m2 of oxaliplatin and 3mg/m2 of raltitrexed, every 3 weeks. Actually, one of the first-line standard regimens in metastatic colorectal cancer patients is the biweekly FOLFOX (85mg/m2 of oxaliplatin, and infusional 5FU) plus bevacizumab regimen, since a significant progression-free survival (PFS) benefit was observed over FOLFOX plus placebo. Biweekly administration of raltitrexed at 2mg/m2 demonstrated a favorable toxicity profile even in patients aged >65 years. Besides, the association of raltitrexed, oxaliplatin and bevacizumab seems safe.

Then, the investigators decided to perform a randomized pharmacokinetic comparative study between biweekly TOMOX (raltitrexed 2 mg/m2 and oxaliplatin 85mg/m2) and triweekly TOMOX (raltitrexed 3 mg/m2 and oxaliplatin 130mg/m2) regimens in metastatic colorectal cancer patients, in a "ping-pong" crossover strategy to reduce the intra-individual variability. Bevacizumab was allowed at the dose of 5mg/kg or 7.5mg/kg, in biweekly and triweekly schedules, respectively. The secondary end-points were, objective response rate evaluated by RECIST 1.1 criteria, PFS, overall survival (OS), toxicity, and the comparison of toxicity between two arms for the first 2 cycles.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators: Hospira, now a wholly owned subsidiary of Pfizer


title: Respiratory Weaning Following Cardiac Surgery. Potential Interest of Combined Thoracic Echography in the Characterization of the Failure Causes.

acronym: ETCCCV

summary:
Respiratory weaning failure worsens prognostic of patients following on-pump cardiac surgery. There are increasing evidences that pulmonary, diaphragmatic or cardiologic echographies are useful in order to improve this critical medical status.

Based both on a previous study conducted in the critical care unit of Purpan and on literature we hypothesize that a combined thoracic echography score could be of interest. We make the hypothesis that the use of a score based on thoracic combined echography (ETC = cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning in cardiac surgery and allows to improve the characterization of the causes of this failure


title: Clinical Evaluation of the Efficacity of Epilepsy Surgery in Infants and Children

acronym: PEPSI

summary:
The Pediatric Neurosurgery Service of the Rothschild Foundation (Paris) is the French leader center for surgery of epilepsy in infants and children.

Postoperative follow-up of these children is performed during medical and neurosurgical consultations in order to assess the frequency of attacks and to reduce medication.

On average, two postoperative consultations are carried out between 3 and 5 months and between 12 and 18 months. Beyond 18 months, some children may benefit from long-term monitoring at this center, but most children are followed by their neurologist .

Therefore, the center has no rigorous and systematic collection of standardized data on the outcome of these patients.

The purpose of this study is to evaluate the efficacy of the epilepsy surgery in children with a monitoring of 3 years.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: The Sleepless Brain: Neuroimaging Support for a Differential Diagnosis of Insomnia

acronym: SOMNET

summary:
One-tenth of the population suffers from insomnia, increasing their risk on other health problems such as depression. Self-reported sleep quality only was historically leading for insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated with insomnia, either physiological (increased heart rate, higher frequency EEG) or predominant cognitive-emotional hyperarousal (worry, rumination, repetitive thoughts). Strong evidence shows that those suffering from insomnia with physiological hyperarousal are at higher risk of short and long term severe health problems such as inflammation and hypertension than the group without physiological hyperarousal. The neurophysiological basis of these insomnia phenotypes has however barely been investigated, although its results can have major consequences for how this limiting condition will be treated.

To support the development of a differential diagnosis of insomnia, structural and functional brain connectivity in insomnia patients with different levels of hyperarousal will be investigated and related to sleep variables. Investigators will compare the insomnia group to a normal sleeping control group. Investigators expect that the emotion processing circuit (amygdala-ventromedial prefrontal cortex) is a) more affected in insomniacs compared to normal sleeping controls and b) the directionality of this effect to depend on the level and type of hyperarousal in insomniacs. Further, investigators expect c) amygdala activity to be positive correlated with physiological hyperarousal level and d) prefrontal activity to be positively correlated with cognitive-emotional hyperarousal level. Investigators expect a higher physiological hyperarousal level to be reflected in affected afferent pathways of the amygdala towards the ventromedial prefrontal cortex and investigators expect higher cognitive-emotional hyperarousal to be related to affected efferent pathways from the ventromedial prefrontal cortex to the amygdala. Investigators expect sleep quality to play a mediating role in both types of hyperarousal and their brain activation patterns in insomnia patients and normal sleeping controls.

These data can lead to the definition of new insomnia phenotypes and to new customized and effective insomnia treatment, focused not only on improving sleep but also on changing dysfunctional hyperarousal levels that currently put insomniacs at risk of numerous severe health problems.

ReferenceCitation: Sanz-Arigita E, Daviaux Y, Joliot M, Dilharreguy B, Micoulaud-Franchi JA, Bioulac S, Taillard J, Philip P, Altena E. Brain reactivity to humorous films is affected by insomnia. Sleep. 2021 Sep 13;44(9):zsab081. doi: 10.1093/sleep/zsab081.

publisher_dissemination: Oxford University Press

lead_sponsor: University Hospital, Bordeaux

collaborators: Institut des Maladies Neurodégénératives (UMR5293)


title: Assessment and Prognostic Factors of Quality of Life in Patients With Psychogenic Nonepileptic Seizures

acronym: PronoCNEP

summary: The goal of this study is to identify the prognostic factors of quality of life in patients with psychogenic non-epileptic seizures

location_facility: University Hospital of Bordeaux - Hospital Pellegrin


title: Impact of Infiltration in the Region of the Palatine Ganglion Spheno by Ropivacaine on Postoperative Pain in the Setting of Endoscopic Sinonasal Surgery.

summary: Endoscopic sinus surgery (ESS) is a prevalent surgical procedure. It is required in many chronic rhinosinusitis for whom the medical treatment failed. In order to improve the postoperative management of patients treated with ESS, we aim to assess the analgesic action of local injection of ropivacaine in the nasal fossa.

ReferenceCitation: Morisse M, Rysman B, Szymanski C, Fackeure R, Mouawad F, Mortuaire G. A randomized placebo-controlled trial assessing sphenopalatine ganglion block in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2021 Sep;11(9):1384-1386. doi: 10.1002/alr.22804. Epub 2021 May 19. No abstract available.

lead_sponsor: University Hospital, Lille


title: Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level

acronym: HEPAFLUX

summary: The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency

ReferenceCitation: Yzet T, Bouzerar R, Baledent O, Renard C, Lumbala DM, Nguyen-Khac E, Regimbeau JM, Deramond H, Meyer ME. Dynamic measurements of total hepatic blood flow with Phase Contrast MRI. Eur J Radiol. 2010 Jan;73(1):119-24. doi: 10.1016/j.ejrad.2008.09.032. Epub 2008 Nov 12.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Pharmacokinetics and Pharmacodynamic (PK/PD) of Extended-infusion Meropenem, Piperacillin-tazobactam and Cefepime in the Early Phase of Septic Shock

acronym: PAACS

summary: This study evaluates PK/PD of an extended-infusion protocol of meropenem, piperacillin-tazobactam and cefepime, in the early phase of septic shock.

ReferenceCitation: Taccone FS, Laterre PF, Dugernier T, Spapen H, Delattre I, Wittebole X, De Backer D, Layeux B, Wallemacq P, Vincent JL, Jacobs F. Insufficient beta-lactam concentrations in the early phase of severe sepsis and septic shock. Crit Care. 2010;14(4):R126. doi: 10.1186/cc9091. Epub 2010 Jul 1.

ReferenceCitation: Winiszewski H, Despres C, Puyraveau M, Lagoutte-Renosi J, Montange D, Besch G, Floury SP, Chaignat C, Labro G, Vettoretti L, Clairet AL, Capellier G, Vivet B, Piton G. beta-lactam dosing at the early phase of sepsis: Performance of a pragmatic protocol for target concentration achievement in a prospective cohort study. J Crit Care. 2022 Feb;67:141-146. doi: 10.1016/j.jcrc.2021.10.023. Epub 2021 Nov 9.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit: A Controlled, Randomized Trial: The ECHOGUIDE Study

acronym: ECHOGUIDE

summary:
The femoral approach is the preferred vascular access for the set-up of emergency catheters in severely traumatized patient. This location combines simplicity and speed of installation, it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few complications and failures.

The ultrasound guidance has greatly reduced installation times, failures and complications related to the set-up of central venous catheter. This was amply demonstrated in the internal jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011, Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the set-up of arterial and venous catheters in the femoral emergency has not been evaluated in terms of reduction in complications.

Then the main objective of this study is to demonstrate that the ultrasound guidance reduces early complications related to the set-up of arterial and venous catheters in the femoral emergency, among severely traumatized patient compared to the reference anatomical technique.

ReferenceCitation: Lazaar S, Mazaud A, Delsuc C, Durand M, Delwarde B, Debord S, Hengy B, Marcotte G, Floccard B, Dailler F, Chirossel P, Bureau-Du-Colombier P, Berthiller J, Rimmele T. Ultrasound guidance for urgent arterial and venous catheterisation: randomised controlled study. Br J Anaesth. 2021 Dec;127(6):871-878. doi: 10.1016/j.bja.2021.07.023. Epub 2021 Sep 6.

location_facility: Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval


title: Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in Newborns

acronym: OMEGAROP

summary: The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).

lead_sponsor: Centre Hospitalier Universitaire Dijon