title: Digital Action Plan for Asthma Exacerbations (PANAME)

acronym: PANAME

summary:
It is recommended that patients with asthma owned a written action plan which must include the names, doses and dosing of the treatment they should take when acute respiratory symptoms occur.

Current written action plans must be short to be readily used (1 page) and, therefore, cannot fit all acute situations. Moreover, they may not be available where and when required.

The investigators sought that a digital action plan, available through Smartphone or tablet computer connected to the internet, could adequately provide suitable action plans according to the severity of the described exacerbation, and would be more easily available when useful.

The aim of the study is to study the effect of the use of a digital action plan for asthma exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to physicians or to emergency departments, hospitalizations) in children and in adults with asthma. The investigators hypothesized that the use of the digital action plan could reduce avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be managed by the patient or his/her caregivers.

location_facility: MulticEnter French study coordinate by AP-HP

acronyme: PANAME

titre: Plan d'Action Numérique pour l'AsthMe en Exacerbation

nom_porteur: BEYDON

prenom_porteur: Nicole


title: Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored

acronym: ISDETSEEG

summary: This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of cortical electrical stimulation to identify major anatomical and functional networks in epileptic patients candidates for surgery and explored by stereoencephalography, to minimize risk of post-surgical cognitive deficits.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Prevention

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital Grenoble
University Hospital Lyon

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation de l'Effet de la Stimulation Transcranienne en Courant Continu Chez Les Personnes Tabagiques dépendantes

acronym: TabaSCo

summary: The purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial Direct Current Stimulation (tDCS - 1 mA) applied to left vs right CDLPF of tobacco-dependent subjects compared to the application of a placebo tDCS (sham procedure) on the craving, which is evaluated by the item 1 of Fagerström test between day 1 and day 10. Craving is also evaluated 1 month post-treatment.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808)

intervention_type: Device

status_simplified: Unknown


title: Study of the ISotopic Repartition of cOpper in Head and Neck TumOral and lymPhomatous pathologiEs

acronym: ISOTOPE

summary:
The distribution of stable (non-radioactive) isotopes in living organisms is increasingly studied, in particular the zinc (Zn), copper (Cu) and iron (Fe), not only in primitive organisms, but also in mammals.

The scientific community shows a growing interest in the study of the isotopic distribution of Cu in humans: this distribution can vary according to gender or nutrition. Concerning pathology, the isotopic distribution of Cu seems interesting in Wilson's disease or in cirrhosis.

Additionally, a promising area of study focuses on the role of Cu in cancerous tumors, neoangiogenesis, the mechanisms of free radicals reduction and signaling pathways.

Head and neck cancers are sensitive to platinum salts. Links between platinum and Cu are important: platinum penetrates into the cell through a Cu receptor, it interacts with the regulation mechanisms of Cu and platinum.

Preliminary studies suggest a variation of the measurable isotopic distribution of Zn in patients with breast tumor and of Cu in patients presenting breast as well as colorectal tumors.

The Larner et al. study suggest a promising role of Zn in breast cancer, indeed, results highlight a variation of distribution of Zn in 10 breast tumors. Concerning the study of Télouk et al. on 8 patients presenting colorectal tumors and 20 patients presenting breast tumors, results are in favor of an increase of mortality when Cu 65 is decreased in the serum and the isotopic modifications happen earlier than usual modifications of biochemical tumor markers such as: carbohydrate antigen (CA) 19.9, Carcinoma Antigen (CA) 15.3, Carcinoembryonic antigen (CEA).

Currently, there is no information about the distribution of the stable isotopes of Cu in head and neck tumors.

The objective of the study is to determine if the distribution of 65Cu / 63Cu is modified in tumoral tissues compared to healthy tissues. The isotopic distribution of the Cu in 2 tumor types, head and neck tumors and lymphomas, will be also investigated in order to determine if this distribution is specific of a tumor type or not.

In case of positivity of this variation, the prognostic interest of these parameters will be evaluated.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

lead_sponsor: Lille Catholic University

sponsor_collaborators:
Lille Catholic University
Ecole Normale Supérieure de Lyon

location_facility:
GHICL
ENS Lyon


title: Human PapillomaVirus (HPV) Anal Infection: Study of Prevalence and Risk Factors Among 1000 Patients Benefiting From a Colonoscopy

acronym: PAPILLAN

summary: Human papillomavirus (HPV) are involved in up to 95 % of anal canal neoplastic lesions. Little is known about HPV carriage in anal canal previous to cancer occurrence in the population and pre-neoplastic lesions, and their risk factors. PAPILLAN is a prospective study that aims to study HPV infection (HPV low grade and high grade genotypes) prevalence in anal canal in a population non selected by its HIV status. In that purpose patients are prospectively recruited in a french university hospital gastroenterology unit and anal smears are collected during a colonoscopy with cytobrush.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Intercommunal de la Haute Saône

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: CONDOL01: Evaluation on the Experience of Bereavement, of a Medical Consultation, Proposed by a Letter of CONDOLence to the Patients' Relatives Versus Standard Practice After the Death of the Patient: A Multicenter, Randomized Trial

summary: The aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
GRAVIS
Institut Paoli Calmettes

intervention_type: Behavioral

appel_a_projets: PHRCK

region: Provence-Alpes-Côte d'Azur

nom_etablissement: INSTITUT PAOLI CALMETTES

type_etablissement: CLCC

titre: Evaluation d'un rendez-vous médical, proposé par une lettre de condoléance versus la prise en charge standard sur l'expérience du deuil de l'entourage, après le décès d'un patient : étude multicentrique randomisée.

discipline_principale: medical oncology, social sciences

nom_porteur: GRAVIS

prenom_porteur: Gwenaëlle


title: FSH-R (Follicle-stimulating Hormone Receptor ): Diagnostic Application for Localized Tumors in Cancerology

acronym: FRACTal

summary:
FRACTal study is the first exploration of detection of FSHR as a blood biomarker for the diagnosis of cancer.

A first cohort will explore several common (e.g. breast, prostate) or rare (e.g. uveal melanoma) cancers, that are frequently treated at Institut Curie. This first cohort will include n=10 patients per histological type except for breast cancer (n=50). 100 patients are expected in this cohort.

A second cohort will explore the more promising histological type (if any) in term of incidence of detection. 100 patients are expected for this second cohort.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Institut Curie

location_facility:
Centre René Huguenin
Institut Curie


title: Cognitive Inhibition Impairment and Suicide Attempt in Elderly: Eye Tracking Characterization and Impact of Psychosocial Interactions

acronym: OBSUIVAL

summary: The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.

primary_purpose: Screening

location_facility:
CHS Bavilliers
CHU Besancon


acronym: VESTIBULE

summary: The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.

location_facility:
CHU Besançon
Hôpital Tenon

intervention_type: Drug


summary:
This data base has been set in order to gather oncogeriatric information from elderly patients with pancreatic cancer who underwent an oncogeriatric evaluation.

ONCOGEPAN database gathers data from deux institutions (Institut Paoli-Calmettes and Assistance Publique des Hôpitaux de Marseille) involved in Marseille SIRIC (Integrated Cancer Research Site).

intervention_type: Other


type: EudraCT Number

title: Predictive Factors of ANTI-TNF Response in Luminal Crohn's Disease Complicated by Abscess A Multicenter Prospective, Observational Cohort Study

acronym: MICA

summary: To identify predictive factors of adalimumab (anti TNF) response in patients with luminal Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection.

ipd_sharing: Undecided

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Beaujon Hospital
Aphp St Louis

lead_sponsor_type: industriel


title: Comparison of the Incidence of 3 Inspiratory Muscle Training Programs on Inspiratory Strength, on Difficult to Wean Patients in Intensive Care Unit: a Multi-centre Randomised Trial.

acronym: PREDRIC

summary:
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations.

In this study, the investigators want to compare the incidence of 3 inspiratory muscle training programs on inspiratory strength, on difficult to wean patients in intensive care unit.

This is a multi-center randomized trial not blinded with 3 parallels groups:

Martin's group: a threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase.
Cader's group: a threshold-based IMT is performed like used by Cader in a randomized trial in 2010 , in a view of inspiratory endurance increase.
EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory strength and endurance increase.

The investigators think that a new threshold-based IMT performed in a view of both inspiratory strength and endurance increase, is more effective and well tolerated than the 2 others protocols.

lead_sponsor: University Hospital, Bordeaux

appel_a_projets: PHRIP

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: PREDRIC

titre: Comparaison de l'impact de 3 programmes de renforcement des muscles inspiratoires sur leur gain de force musculaire, chez des patients intubés/ventilés en réanimation en situation de sevrage ventilatoire difficile: étude multicentrique randomisée contrôlée.

discipline_principale: anesthésiologie / réanimation

nom_porteur: VARGAS

prenom_porteur: Frédéric


title: Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté

acronym: STeF-BFC

summary:
Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. The infectious side effects of transfusion are largely considered under control, non-infectious side effects are taking center stage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource.

The investigators aim to study the impact of donor and RBC characteristics on patient survival.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Desmarets M, Bardiaux L, Benzenine E, Dussaucy A, Binda D, Tiberghien P, Quantin C, Monnet E. Effect of storage time and donor sex of transfused red blood cells on 1-year survival in patients undergoing cardiac surgery: an observational study. Transfusion. 2016 May;56(5):1213-22. doi: 10.1111/trf.13537. Epub 2016 Mar 2.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

collaborators:
Centre Hospitalier Universitaire Dijon
Etablissement Français du Sang

location_facility: Département d'information Médicale, CHU Dijon

location_facility: Centre d'Investigation Clinique, CHU de Besançon


title: PREMODEUR. "Odors to Insufflate Life". Implementation of a Controlled Olfactory Sensorial Method to Decrease Apneas in Premature Newborns. Proof of Concept Study. Latin-square Open Study With Blind Evaluation of Primary Outcome.

acronym: PREMODEUR

summary: Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of pregnancy. They are considered as an important risk factor for subsequent neuropsychological deficiency. Current pharmacological treatments are not very effective, and have side effects (agitation, irritability, sleep disorders, tachycardia). Some studies suggest that in NBs with apneas resisting to drugs, a permanent odorisation with a drop of vanillin on the incubator's pillow might reduce the frequency of apneas. This latin square design study will test a controlled olfactory stimulation method, i.e. an olfactometer which controls the odor duration, intensity, and sequence using three different odors, to reduce apneic episodes measured using 24-registration of heart and respiratory rates.

status: Recruiting

ReferenceType: derived

ReferenceCitation: Duchamp-Viret P, Nguyen HK, Maucort-Boulch D, Remontet L, Guyon A, Franco P, Cividjian A, Thevenet M, Iwaz J, Galletti S, Kassai B, Cornaton E, Plaisant F, Claris O, Gauthier-Moulinier H. Protocol of controlled odorant stimulation for reducing apnoeic episodes in premature newborns: a randomised open-label Latin-square study with independent evaluation of the main endpoint (PREMODEUR). BMJ Open. 2021 Sep 13;11(9):e047141. doi: 10.1136/bmjopen-2020-047141.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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 - Diderot

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hopital Femme Mère Enfant
CHU de Saint-Etienne

status_simplified: Ongoing

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: PREMODEUR

titre: Les Odeurs pour insuffler la vie  Mise en place d'une méthode de stimulation sensorielle olfactive contrôlée visant à diminuer l'occurrence des épisodes apnéiques chez les nouveau-nés prématurés - Etude preuve de concept.

discipline_principale: autre

nom_porteur: GAUTHIER MOULINIER

prenom_porteur: Hélène


title: Etude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte Pour l'évaluation de la Fixation Osseuse d'Une Cupule hémisphérique, le Mpact® Double Mobilité

summary: This study aims to evaluate long term fixation of the Mpact Double Mobility cup trough IMAGIKA technology.

status: Active, not recruiting

lead_sponsor: Medacta International SA

location_facility:
Clinique Générale
Orthéo - Espace Fauriel


title: Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study

summary: Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

location_facility:
Hôpital Lariboisière
Institut Curie


type: Other Identifier

title: Memory for Action in Neurological Patients

acronym: EMBODIMENT

summary:
Memory for action is especially important in everyday life although current literature is not very abundant. The enactment effect (i.e. better memory for performed actions than for verbally encoded sentences) is usually described as a robust effect in aging and can be found in many diseases. Although the enactment effect has been studied for three decades, there is still no consensus on how it enhances memory. Therefore, in order to gain additional insight into the representational basis of the enactment effect, in the present study, the investigators propose to test neurological patients. The investigators suggested that memory for action should be better than memory for verbally encoded information in Alzheimer's disease and Parkinson's disease.

If patients with Alzheimer's disease (AD) and Parkinson's disease (PD) have no cognitive assessment during the last 6 months, then they will realize different tests: MMSE (1), HAD (2), a cognitive assessment (3); (4); BREF (5); Assessment of apraxia, (6). Controls will perform the same tests to verify that they have no cognitive impairment. Then, two experimental conditions will be presented in all patients and controls: a first in which participants will have to name drawings (verbal learning) and a second in which they will have to reproduce an action associated with drawings (action learning). Immediately after this learning phase, a recognition task will be available and therefore participants will have to recognize drawings that had been presented previously. The main criteria used in the statistical analysis will be the correct recognition score.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hcl - Cm2R
CHU de Saint-Etienne


title: Hydrosorb® Versus Control (Water Based Spray) in the Management of Radio-induced Skin Toxicity: Multicentre Controlled Phase III Randomized Trial

acronym: HYDROSORB

summary: The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.

sponsor_collaborators:
Institut Curie
Paul Hartmann


title: Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life

acronym: PRISM

summary: To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.


title: Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer

summary: The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.

location_facility: Centre Hospitalier Universitaire de Besançon


title: Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors

acronym: EPICentro

summary: This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).


type: Other Grant/Funding Number

title: Development of a Risk Prediction Model for Identifying Potentially Avoidable Readmissions of Patients Hospitalized With Community-Acquired Pneumonia

summary:
From 10% to 30% of patients hospitalized with community-acquired pneumonia (CAP) are readmitted within 30 days of discharge. These readmissions have negative consequences for the patients and the hospitals where they are treated, including impaired quality of life, exposure to hospital-related adverse events, and increased resource utilization.

Risk-adjusted readmission rates can be easily computed and tracked from computerized hospital discharge data, using validated models. As part of the Hospital Readmission Reduction Program (HRRP) effective in fiscal year 2013, United States hospitals with higher than expected 30-day readmission rates after pneumonia hospitalization have been subject to financial penalties from the Center for Medicare and Medicaid Services (CMS). The underlying logic of the HRRP is based upon the notion that short-term readmission is often a preventable adverse outcome, reflecting suboptimal quality of care during index hospitalization. Yet, published evidence suggests that less than one in four all-cause readmissions are deemed avoidable. Because only avoidable readmissions can be influenced by interventions designed to decrease readmission rates, avoidable readmission is a more relevant metric than all-cause readmission for tracking quality of hospital care for pneumonia.

The purpose of this study is to develop an administrative data-based risk prediction model for identifying potentially avoidable readmissions within 30 days of discharge for patients hospitalized with CAP.

R3P is a retrospective observational cohort study of consecutive adult patients discharged from two hospitals with a diagnosis code of CAP. Data sources include routinely collected hospital discharge data and retrospective chart reviews.

ReferenceType: background

ReferenceCitation: Halfon P, Eggli Y, van Melle G, Chevalier J, Wasserfallen JB, Burnand B. Measuring potentially avoidable hospital readmissions. J Clin Epidemiol. 2002 Jun;55(6):573-87. doi: 10.1016/s0895-4356(01)00521-2.

ReferenceCitation: Jasti H, Mortensen EM, Obrosky DS, Kapoor WN, Fine MJ. Causes and risk factors for rehospitalization of patients hospitalized with community-acquired pneumonia. Clin Infect Dis. 2008 Feb 15;46(4):550-6. doi: 10.1086/526526.

ReferenceCitation: Skull SA, Andrews RM, Byrnes GB, Campbell DA, Nolan TM, Brown GV, Kelly HA. ICD-10 codes are a valid tool for identification of pneumonia in hospitalized patients aged > or = 65 years. Epidemiol Infect. 2008 Feb;136(2):232-40. doi: 10.1017/S0950268807008564. Epub 2007 Apr 20.

ReferenceCitation: van Walraven C, Bennett C, Jennings A, Austin PC, Forster AJ. Proportion of hospital readmissions deemed avoidable: a systematic review. CMAJ. 2011 Apr 19;183(7):E391-402. doi: 10.1503/cmaj.101860. Epub 2011 Mar 28.

ReferenceCitation: van Walraven C, Jennings A, Taljaard M, Dhalla I, English S, Mulpuru S, Blecker S, Forster AJ. Incidence of potentially avoidable urgent readmissions and their relation to all-cause urgent readmissions. CMAJ. 2011 Oct 4;183(14):E1067-72. doi: 10.1503/cmaj.110400. Epub 2011 Aug 22.

ReferenceCitation: Lindenauer PK, Normand SL, Drye EE, Lin Z, Goodrich K, Desai MM, Bratzler DW, O'Donnell WJ, Metersky ML, Krumholz HM. Development, validation, and results of a measure of 30-day readmission following hospitalization for pneumonia. J Hosp Med. 2011 Mar;6(3):142-50. doi: 10.1002/jhm.890. Epub 2011 Jan 5.

ReferenceCitation: Mounayar AL, Francois P, Pavese P, Sellier E, Gaillat J, Camara B, Degano B, Maillet M, Bouisse M, Courtois X, Labarere J, Seigneurin A. Development of a risk prediction model of potentially avoidable readmission for patients hospitalised with community-acquired pneumonia: study protocol and population. BMJ Open. 2020 Nov 11;10(11):e040573. doi: 10.1136/bmjopen-2020-040573.

repositories_concat: PubMed Central

sponsor_collaborators:
University Hospital, Grenoble
Centre Hospitalier Annecy Genevois

location_facility: Centre Hospitalier Annecy Genevois,1 avenue de l'hôpital, Epagny Metz-Tessy,BP 90074

location_facility: Grenoble University Hospital CS10217 Grenoble Cedex 9

appel_a_projets: PREPS-IQ

nom_etablissement: CHU GRENOBLE ALPES

titre: Réadmission précoce des patients hospitalisés pour infection respiratoire basse

nom_porteur: FRANCOIS

prenom_porteur: Patrice


title: Central Mechanisms of Chronic Pruritus: Functional and Structural Brain Imaging.

acronym: PRURIM

summary:
The main objective of this study is to identify by functional and structural MRI which are the brain areas activated in various pruritic situations to deduct a model describing the different causes of pruritus.

The investigators are going to compare two chronic pruritus conditions (histaminergic urticaria and non histaminergic: psoriasis) to a healthy control group.

The secondary objective of this study is to specify a classification index from the physiological results obtained by brain imaging to differentiate multiple types of pruritus.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Brest

location_facility:
Laurent MISERY
CHRU de Brest


title: Clinical and Therapeutic Impact of Molecular Markers in Myeloproliferative Neoplasms (CTIM3)

summary: Myeloproliferative neoplasms (MPN) are clonal hematopoietic disorders sharing a common natural evolution: a chronic phase, characterized by a major risk of vascular events, followed by an accelerated phase eventually leading to transformation to acute leukemia. MPN include polycythemia vera, essential thrombocythemia, primary myelofibrosis, and rarer entities. During the past years, CML became a paradigm for targeted therapy and personalized cancer medicine. For other MPNs, the discovery of the JAK2V617F mutation followed by many other mutations, opened similar perspectives. However, several questions remain to be answered in MPNs regarding the clinical implication of these major scientific discoveries: what is the clinical impact of JAK2V617F and other molecular biomarkers on the risks of complications and progression? Can these new biomarkers be used in the perspective of a personalized therapy of MPNs? his project will focus on the qualification of a series of known mutations as biomarkers in MPNs based on large multicenter cohorts of patients with well-annotated samples

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PRTK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

titre: Impact Clinique et thérapeutique des marqueurs moléculaires dans les syndromes myéloprolifératifs

discipline_principale: cancer

nom_porteur: KILADJIAN

prenom_porteur: Jean-Jacques


title: Study of the Interest of the Parametric Imaging in Positron Emission Tomography on the Recurrence Prognosis at One Year in Patient With Non Small Cell Lung Cancer

acronym: PARAPET

summary:
The purpose of this study is to evaluate the concordance between Positron E mission tomography parametric imaging versus standard PET for the 1 year prognosis of patients with NSCLC treated by radiochemotherapy.

The ancillary study will evaluate the interest of parametric PET imaging during the treatment (around 42 Gray) to detect the local relapse of the lesion in order to propose a treatment re-planification or intensification (not realized on the present study).

ReferenceCitation: Colard E, Delcourt S, Padovani L, Thureau S, Dumouchel A, Gouel P, Lequesne J, Ara BF, Vera P, Taieb D, Gardin I, Barbolosi D, Hapdey S. A new methodology to derive 3D kinetic parametric FDG PET images based on a mathematical approach integrating an error model of measurement. EJNMMI Res. 2018 Nov 15;8(1):99. doi: 10.1186/s13550-018-0454-9.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

lead_sponsor: Centre Henri Becquerel

collaborators: Assistance Publique Hopitaux De Marseille

location_facility:
APHM
Centre Henri Becquerel


title: Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery

acronym: CARDIOX

summary: The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.

ReferenceCitation: Abou-Arab O, Huette P, Martineau L, Beauvalot C, Beyls C, Josse E, Touati G, Bouchot O, Bouhemad B, Diouf M, Lorne E, Guinot PG. Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1413-1421. doi: 10.1007/s00134-019-05761-4. Epub 2019 Oct 1.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Dijon-Bourgogne
CHU Amiens-Picardie


title: Evaluation and Characterization of Behavioural Disorders and Dementias by the Behavioural Dysexecutive Syndrome Inventory (BDSI)

acronym: ISDC

summary: Behavioural disorders are very common right from the initial stage of dementia and contribute to loss of autonomy. Behavioural dysexecutive disorders have a particular status due to their prevalence and their diagnostic importance, as they often constitute the initial symptoms of Frontotemporal Dementia (FTD), Semantic Dementia (SD) and Huntington's disease (HD) and they are classically more frequent in vascular dementia (VaD) than in Alzheimer's disease (AD). The presence of these disorders at the stage of Mild Cognitive Impairment (MCI) has only been partially evaluated and would increase the risk of progression to dementia. These classical data are based on non-standardized assessments and non-validated diagnostic criteria. The Groupe de Reflexion pour l'Evaluation des Fonctions EXécutives (GREFEX) has developed a standardized assessment tool for behavioural dysexecutive disorders, the Behavioural Dysexecutive Syndrome Inventory (BDSI) and has validated diagnostic criteria for this syndrome.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Strasbourg
CHU Amiens


title: Prospective, Two-center , Randomized, ITT , Parallel Group Evaluating the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care

acronym: VSD

summary:
Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.

In order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.

As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.

In recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.

However, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.

status: Withdrawn

location_facility:
CH Beauvais
CHU Amiens


title: Modification of Digestive Flora After Gastric Bypass : Pilot Study on Microbial Overgrowth Using Gas Chromatography

acronym: SIBOB

summary: The objective of this research is to determine the incidence of microbial overgrowth of the small intestine before and after a gastric bypass. For this purpose, the study is based on the analysis of the expired hydrogen H2 with gas chromatography before surgery and at 1, 3, 6, 12, 18 and 24 months.

sponsor_collaborators:
Lille Catholic University
Santelys Association

location_facility:
Centre Hospitalier de Douai
Centre Hospitalier d'Arras


title: Study of the Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesterol Ester Transfer Protein (CETP) in Type-1 Diabetes Patients

summary:
In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is slowed down.

ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that regulates cholesterol transfer in the body.

The aim of this study is to determine whether it is possible to correct apoC1 function by improving glycaemic balance.

240 persons will be recruited in this study and allocated to one of two groups:

160 Type-1 diabetes patients with uncontrolled diabetes:

4 additional blood samples will be taken at the time of the systematic biological examination at inclusion and then again 3 months later.

80 control subjects with normal lipids and normal glycaemia balance will be included in the study following the results of the biological assays.

4 blood samples will be taken at the time of inclusion.

ReferenceCitation: Denimal D, Monier S, Simoneau I, Duvillard L, Verges B, Bouillet B. HDL functionality in type 1 diabetes: enhancement of cholesterol efflux capacity in relationship with decreased HDL carbamylation after improvement of glycemic control. Cardiovasc Diabetol. 2022 Aug 12;21(1):154. doi: 10.1186/s12933-022-01591-9.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de Besançon
CHU Dijon Bourgogne

intervention_type: Biological


acronym: ESYBRECHE

summary: The aim of the study is to assess the efficacy and safety of Synacthène® versus placebo in the treatment of post-dural puncture syndrome in patients receiving epidural analgesia, spinal analgesia, or combined spinal-epidural analgesia for labour.

ReferenceCitation: Depaulis C, Steer N, Garessus L, Chassard D, Aubrun F. Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial. Trials. 2020 Jan 8;21(1):55. doi: 10.1186/s13063-019-4015-y.

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Hospices Civils de Lyon / hôpital de la Croix rousse

title: Evaluation of the Effectiveness and Tolerance of Tetracosactide Synacthen® in the Treatment of Post Dural Puncture Headaches (ESYBRECHE)

source: euctr


acronym: PFAPA

summary: This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.

lead_sponsor: Versailles Hospital

location_facility:
CH de Bicètre
Centre hospitalier de Versailles

nom_etablissement: CENTRE HOSPITALIER  DE VERSAILLES

acronyme: PFAPACOL

titre: Etude de l'efficacité de la colchicine dans le syndrome PFAPA : étude prospective randomisée en double aveugle

nom_porteur: HENTGEN

prenom_porteur: Véronique


title: Stereotactic Radiotherapy for Renal Cancers: Phase I Study

summary:
Stereotactic radiotherapy is a technique that allows the delivery of a high dose of radiation over few fractions (3-6) with great precision. It thus allows "tumor ablation" and optimal preservation of healthy tissues. Initially developed in small-sized (<5 cm) lung cancers this technique it gives results very close and or even equivalent to those of surgery.

Stereotactic radiotherapy of brain metastases of renal cancers has shown that high doses of radiation allows local control in 90 to 98% of cases. A study conducted in Sweden (Wersall et al.) underline the interest to develop stereotactic radiotherapy in primary renal tumors. In Cleveland (USA) two phase I studies are already underway.

The investigators propose to develop a phase I study for tumors of less than 4 cm. As found in lung cancers, stereotactic radiotherapy can provide a non-invasive, painless and rapid (4 to 5 fractions) method for the treatment of renal cancers with a high rate of local control.

The primary objective is to define the maximal tolerated dose for one fraction in stereotactic mode of renal tumors ≤ 4 cm in length using an a four-step dose increase:

Step 1: 4 x 8 Gy.
Step 2: 5 x 8 Gy.
Step 3: 4 x 10 Gy.
Step 4: 4 x 12 Gy.

The patients will be followed during treatment with evaluation of acute toxicities before each session, then at 15 days, 6 weeks, 3 months, 9 months, 12 months, and then every 6 months for a total duration of 5 years after treatment.

location_facility: Service de Radiothérapie - Centre Georges François Leclerc

location_facility: Service d'Oncologie-Radiothérapie - Centre Hospitalier Lyon Sud - HCL

intervention_type: Radiation


type: Registry Identifier

title: Kinetics of the Plasmatic Concentration of L-Ascorbic Acid in Patient With Myelodysplastic Syndromes and Control Subjects

acronym: PLASMYC

summary:
Myelodysplastic syndromes (MDS) is a group of heterogeneous diseases characterised by the clonal evolution of dysplastic hematopoietic stem cells. This evolution is associated with accumulation of cytogenetic mutations which leads to acute myeloid leukaemia (AML). Evolution of MDS is also associated with increase of reactive oxygen species (ROS). The increase of ROS is associated with accumulation of cytogenetic mutations. Ascorbic acid (AA) is an actor of the regulation of the oxidative metabolism in the human body.

Studies showed that supplementation with AA can change the proliferation status of MDS cells. Adjuvant treatment with AA is associated with a beneficial effect on the evolution of MDS and AML. The present study aim at describing the variations of plasmatic ascorbic acid concentrations between healthy volunteers and patients with myelodysplastic syndromes advanced in their treatment or recently diagnosed during a follow-up of 12 months.

primary_purpose: Health Services Research

ReferenceCitation: Das A, Dey N, Ghosh A, Das T, Chatterjee IB. NAD(P)H: quinone oxidoreductase 1 deficiency conjoint with marginal vitamin C deficiency causes cigarette smoke induced myelodysplastic syndromes. PLoS One. 2011;6(5):e20590. doi: 10.1371/journal.pone.0020590. Epub 2011 May 31.

ReferenceCitation: Ghoti H, Amer J, Winder A, Rachmilewitz E, Fibach E. Oxidative stress in red blood cells, platelets and polymorphonuclear leukocytes from patients with myelodysplastic syndrome. Eur J Haematol. 2007 Dec;79(6):463-7. doi: 10.1111/j.1600-0609.2007.00972.x. Epub 2007 Nov 1.

ReferenceCitation: Hole PS, Darley RL, Tonks A. Do reactive oxygen species play a role in myeloid leukemias? Blood. 2011 Jun 2;117(22):5816-26. doi: 10.1182/blood-2011-01-326025. Epub 2011 Mar 11. Erratum In: Blood. 2014 Jan 30;123(5):798.

ReferenceCitation: Chung YJ, Robert C, Gough SM, Rassool FV, Aplan PD. Oxidative stress leads to increased mutation frequency in a murine model of myelodysplastic syndrome. Leuk Res. 2014 Jan;38(1):95-102. doi: 10.1016/j.leukres.2013.07.008. Epub 2013 Aug 16.

ReferenceCitation: Levine M, Rumsey SC, Daruwala R, Park JB, Wang Y. Criteria and recommendations for vitamin C intake. JAMA. 1999 Apr 21;281(15):1415-23. doi: 10.1001/jama.281.15.1415.

ReferenceCitation: Park CH. Vitamin C in leukemia and preleukemia cell growth. Prog Clin Biol Res. 1988;259:321-30.

ReferenceCitation: Park CH, Kimler BF. Growth modulation of human leukemic, preleukemic, and myeloma progenitor cells by L-ascorbic acid. Am J Clin Nutr. 1991 Dec;54(6 Suppl):1241S-1246S. doi: 10.1093/ajcn/54.6.1241s.

ReferenceCitation: Park CH, Kimler BF, Bodensteiner D, Lynch SR, Hassanein RS. In vitro growth modulation by L-ascorbic acid of colony-forming cells from bone marrow of patients with myelodysplastic syndromes. Cancer Res. 1992 Aug 15;52(16):4458-66.

ReferenceCitation: Park CH, Kimler BF, Yi SY, Park SH, Kim K, Jung CW, Kim SH, Lee ER, Rha M, Kim S, Park MH, Lee SJ, Park HK, Lee MH, Yoon SS, Min YH, Kim BS, Kim JA, Kim WS. Depletion of L-ascorbic acid alternating with its supplementation in the treatment of patients with acute myeloid leukemia or myelodysplastic syndromes. Eur J Haematol. 2009 Aug;83(2):108-18. doi: 10.1111/j.1600-0609.2009.01252.x. Epub 2009 Mar 5.

ReferenceCitation: Parker JE, Fishlock KL, Mijovic A, Czepulkowski B, Pagliuca A, Mufti GJ. 'Low-risk' myelodysplastic syndrome is associated with excessive apoptosis and an increased ratio of pro- versus anti-apoptotic bcl-2-related proteins. Br J Haematol. 1998 Dec;103(4):1075-82. doi: 10.1046/j.1365-2141.1998.01114.x.

ReferenceCitation: Parker JE, Mufti GJ, Rasool F, Mijovic A, Devereux S, Pagliuca A. The role of apoptosis, proliferation, and the Bcl-2-related proteins in the myelodysplastic syndromes and acute myeloid leukemia secondary to MDS. Blood. 2000 Dec 1;96(12):3932-8.

ReferenceCitation: Saito N, Miyamoto M, Gotoh U, Yoshitomi S. Effect of biscoclaurine alkaloids, prednisolone and ascorbic acid on myelodysplastic syndrome with pancytopenia: a case report. Eur J Haematol. 2000 Jan;64(1):61-5. doi: 10.1034/j.1600-0609.2000.9l036.x. No abstract available.

ReferenceCitation: Welch JS, Klco JM, Gao F, Procknow E, Uy GL, Stockerl-Goldstein KE, Abboud CN, Westervelt P, DiPersio JF, Hassan A, Cashen AF, Vij R. Combination decitabine, arsenic trioxide, and ascorbic acid for the treatment of myelodysplastic syndrome and acute myeloid leukemia: a phase I study. Am J Hematol. 2011 Sep;86(9):796-800. doi: 10.1002/ajh.22092. Epub 2011 Aug 3. No abstract available.

lead_sponsor: University Hospital, Tours

collaborators:
Tours Autogreffe
Novartis

sponsor_collaborators:
University Hospital, Tours
Tours Autogreffe
Novartis

location_facility: Clinical Research Center, University Hospital, Tours

location_facility: Department of Haematology and Cell Therapy, University Hospital, Tours


title: Risk Factors for Early Remodelling in Severe Asthma in Children

acronym: P'tit-ASTHME

summary:
Background: Asthma is a frequent disease characterized by bronchial hyperresponsiveness, inflammation and remodeling. Consistent epidemiological data indicate that outcome of asthma in adults may be determined in early childhood. This may be due to bronchial remodeling, an abnormal repair process that contributes to the development of poorly reversible airway narrowing. It appears very early in the natural history of the disease and involves increased mass of bronchial smooth muscle (BSM). The mechanism of such an increase has been related with an increase in smooth muscle cell proliferation. Recently, we have demonstrated that in severe asthma, BSM increased proliferation is induced by an enhanced mitochondrial biogenesis. Moreover, we have also shown that immature human, non-asthmatic airway smooth muscle cells (ASMC) proliferate to a greater extent than normal adult ASMC, in a similar fashion to adult asthmatic ASMC. Immature ASMC may thus have great potential to stimulate airway remodeling. We thus hypothesized that remodeling is an early process and certain characteristics of ASMC in severe preschool asthma may predispose such children to persistent remodeling with airway obstruction later in life.
Purpose: To investigate prognostic factors of airway remodeling in preschool children, with special attention to ASMC proliferation (mitochondrial mass & biogenesis).
Methods: In the initial phase of the project, 75 severe asthmatic preschool children (<5 yr) will be prospectively recruited from the "CHU de Bordeaux" and the "CHU de Toulouse" according to the "Haute Autorité de Santé" criteria. Inclusion visit will include written informed consent, asthma control evaluation, clinical examination, lung function testing (exhaled NO, plethysmography), prick tests, chest X Ray and blood sample for total IgE levels. Bronchial specimens from all subjects will be obtained by fiberoptic bronchoscopy at visit 2. Airway remodeling will be evaluated by morphological analysis. After smooth muscle mitochondria will be analyzed by electronic microscopy & immunoblotting. Comparison between the 2 groups will be performed by unpaired t tests for parametric data and x2-tests for non-parametric data. In the second phase of the project, patients will then be followed-up till the age of 7-10 yrs, when another bronchoscopy with biopsies will be performed.

location_facility:
Hôpital des Enfants
CHU de Bordeaux


title: Impact of Male Smoking on the Couple's Infertility: Two-centre Case-control Study

acronym: TABAFERTIMASC

summary:
About 15% of couples consult for difficulties achieving pregnancy. In about two-thirds of cases, a male component is identified, but is not always sufficient to explain infertility. In the majority of cases, the cause cannot be clearly identified and multiple abnormalities may be detected in both partners.

Many factors concerning lifestyle and environment (medications, alcohol, smoking, pollution, exposure to heat, toxins, xenobiotic oestrogens, etc.) may impact on fertility. These factors may also impact on the fertility of the children conceived, which is described as an intergenerational effect (alteration of the fertility of boys exposed to smoking in utero).

Few scientific studies with a high level of proof have been published on the impact of smoking on the couple's fertility. Gonadal functioning and the quality of gametes can be altered by these environmental factors, which may trigger a process of apoptosis or alteration of the DNA of gametes (sperm DNA fragmentation). Other modifications include DNA methylation and histone acetylation, which control gene expression and are grouped under the term epigenetic modifications. More recently, oestrogens has been shown to be involved in male reproductive function by acting on spermatogenesis, spermiogenesis and epididymal maturation. Demonstration of an active aromatase (Arom) (mRNA, protein and activity) in ejaculated human spermatozoa suggests the synthesis of small quantities of oestrogens in spermatozoa. The study of transcript profiles could provide information about the quality of spermatogenesis and/or spermiogenesis and during the first steps of embryonic development. Confocal microscopy has colocalized the aromatase on the head, midpiece and tail and can be used to assess the quality of the acrosome with anti-CD-46 monoclonal antibody. Even low concentrations of xenobiotic oestrogens can exert biological effects on certain functions of murine or human spermatozoa, accelerating capacitation and the acrosome reaction. These factors are all the more effective when they act in combination, as human gametes appear to be more sensitive to their action than murine gametes All studies conducted to date have investigated the impact of toxins either on one of the partners or in the children born to the couple. No detailed and high-level scientific study has studied both partners and the quality of their embryos.

location_facility:
CHU Caen
CHU Amiens


title: Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide: Investigation of Disruptive Mood Dysregulation Disorder

acronym: ACTIHUMEUR

summary: An excess suicide-related morbidity is observed among young people in the Picardie region, as reflected by the > 100% occupation rate of the Amiens University Hospital Adolescent Medicine Unit

location_facility:
AP HP
CHU Amiens


title: Evaluation of the Efficacy of Citrulline Supplementation on the Delay of Delivery for Women Hospitalized for Pre-eclampsia (CITRUPE)

acronym: CITRUPE

summary:
Pre-eclampsia (PE) complicates 2-8 % of pregnancies and is associated with high maternal and fetal morbidity and mortality. The early clinical manifestations are the occurrence of a maternal blood pressure and proteinuria. Placental dysfunction impairs the nutrient supply to the fetus, and may be the cause of an intrauterine growth retardation (IUGR). This is a disease that causes prematurity and currently the only known cure is delivery of the placenta. Nitrogen monoxide (NO) regulates the placental blood flow. However, pre-eclampsia is directly related to a failure of placental NO production. In this context, several clinical trials have tested the effect of NO donors such as L- arginine. However, supplementation with L -Arginine in a randomized trial in Nantes, has proved to be ineffective in severe vascular IUGR.

Citrulline is a natural aminoacid precursor to arginine and in contrast to L-arginine escapes uptake in the liver and appears directly in the peripheral blood converted by the kidney in arginine, released into the systemic circulation, Citrulline may therefore be more effective in the treatment of pre-eclampsia.

This prospective, randomized, comparative and double-blinded study aims to prolong pregnancy for patients with pre-eclampsia before 36 weeks.

lead_sponsor: Nantes University Hospital

location_facility:
Hôpital Cochin (Maternité Port-Royal)
CHU de Nantes


title: Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification

acronym: CALCILUP

summary:
Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of osteoporosis and cardiovascular calcification. It has also been suggested that bone remodelling and cardiovascular calcification are regulated by the same mechanisms, but inversely in terms of calcium deposition, as osteoporosis is often associated with cardiovascular calcification. Inflammatory and immune factors have been implicated in these two processes.

The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts, while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly established, its role in vascular calcification is only hypothetical at the present time.

This study will focus on patients with SLE diagnosed and followed in the Amiens University Hospital Internal Medicine and Nephrology departments

location_facility:
CHU Rouen
CHU Amiens


title: Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population

acronym: DIABONE

summary:
Patients with type 2 diabetes have many complications in different organs. These complications are extremely frequent and severe: cardiovascular and renal disease, visual impairment, and, more recently, complications affecting bone such as fractures. Conventional methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in patients with type 2 diabetes compared to patients not suffering from this disease, independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a high BMD has led to the hypothesis that diabetes induces a modification of the quality and not the quantity of bone. However, there is a lack of data as to bone quality in patients with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are extremely rare.

The objective of the study is to compare bone quality in patients with type 2 diabetes to that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone quality in biopsies (advanced glycation end products (AGE), contents of bone matrix and analysis of mineralization).

The results will then be correlated with blood/urinary markers with the objective to determine one/several non-invasive biomarkers for bone status in diabetic patients.

location_facility: Hôpital Edouard Herriot, Hospices Civisl de Lyon

acronyme: DIABONE

titre: Comparaison de la qualité osseuse de patients atteints de diabète de type 2 avec une population contrôle non diabétique.

nom_porteur: WEGRZYN

prenom_porteur: Julien


title: Performance Evaluation of Von Willebrand:Collagen-Binding Assays to Diagnose Von Willebrand Factor Deficiency in Patients With Increased Risk of Bleeding

acronym: PERICOLL

summary:
Von Willebrand Disease (VWD) is defined as an inherited bleeding disorder that is caused by deficiency or dysfunction of von Willebrand factor (VWF), a plasma protein that mediates the initial adhesion of platelets at sites of vascular injury and also binds and stabilizes blood clotting factor VIII (FVIII) in the circulation. The most severe forms of VWD are usually easy to diagnose (obvious hemorrhagic symptoms and major VWF deficiency), whereas the mild forms of the disease are still difficult to confirm. It is indeed reported that about 1% of the population carry mild biological VWF deficiency without any bleeding tendency and any "actual disease". On the contrary, some patients with severe bleeding history can carry a true VWF abnormality, well-confirmed by genetic studies, without any VWF deficiency when evaluated with standard biological methods, such as Ristocetin Cofactor activity (VWF:RCo). However, in these patients, the use of alternative methods, such as PFA-100 (Platelet Fonction Analyzer-100), the study of Factor VIII (FVIII:C) to VWF (FVIII:C/VWF) ratio or the evaluation of VWF activity using more specialized methods such as VWF:CB (VWF-Collagen Binding) assay can detect the VWF deficiency and possible hemorrhagic predisposition.

In this project, the investigators plan to assess the performance of VWF:CB in the diagnosis of VWF deficiency in patients with unexplained bleeding history.

location_facility:
Nantes University Hospital
Dijon University Hospital

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: PERICOLL

titre: Evaluation des PErformances, chez les patients à RIsque hémorragique, du dosage du facteur Willebrand par technique du COLLagen-Binding pour le diagnostic du déficit en facteur Willebrand

discipline_principale: biologie

nom_porteur: TROSSAERT

prenom_porteur: Marc


title: Consequences of a Brain Lesion or of Migraine on Auditory Processing: Attention, Memory and Emotion

summary: The project studies auditory processing after brain damage (in temporal and/or frontal areas) and in migraine. The auditory processes investigated are attention, short-term memory, sound-induced emotions. To characterize auditory deficits after brain damage or in migraine, neuropsychological assessments are combined with neurophysiological markers (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging: MRI).

ReferenceCitation: Masson R, Demarquay G, Meunier D, Leveque Y, Hannoun S, Bidet-Caulet A, Caclin A. Is Migraine Associated to Brain Anatomical Alterations? New Data and Coordinate-Based Meta-analysis. Brain Topogr. 2021 May;34(3):384-401. doi: 10.1007/s10548-021-00824-6. Epub 2021 Feb 19.

oa_host_type: repository

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

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

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

repositories_concat: HAL

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

unpaywall_oa_status: green

location_facility: Service Explorations Fonctionnelles Neurologiques, Hôpital de la Croix-Rousse


title: Using Nasal Broadband Glasses HFNC (High Flow Nasal Cannula) in the Initial Management of Severe Bronchiolitis in Infants Admitted in ICU: Bicentric Observational Study on the 2013-2014 Epidemic

acronym: HFNC

summary:
The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow Nasal Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU.

Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. This device generates a continuous positive pressure in the airways, to reduce the work of breathing. The sealing absence of the HFNC at the nasal interface improves patient comfort and avoiding nasal trauma.

lead_sponsor: Fondation Lenval

location_facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier

location_facility: Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin

acronym: FUO

summary:
Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are two frequent causes of hospitalization or consultation in infectious disease unit and internal medicine.

There are many etiologies, in four categories: infections, auto-immune disease, cancer and miscellaneous causes. Currently there is no specifics recommendations to follow a "diagnosis way" of FUO and SII.

Purpose: Evaluation of clinical practices in the diagnosis of fever and biologic inflammatory syndrome of unknown origin, in two units of the University Grenoble Hospital.

ReferenceCitation: PETERSDORF RG, BEESON PB. Fever of unexplained origin: report on 100 cases. Medicine (Baltimore). 1961 Feb;40:1-30. doi: 10.1097/00005792-196102000-00001. No abstract available.

ReferenceCitation: Durack DT, Street AC. Fever of unknown origin--reexamined and redefined. Curr Clin Top Infect Dis. 1991;11:35-51. No abstract available.

ReferenceCitation: Knockaert DC, Vanderschueren S, Blockmans D. Fever of unknown origin in adults: 40 years on. J Intern Med. 2003 Mar;253(3):263-75. doi: 10.1046/j.1365-2796.2003.01120.x.

ReferenceCitation: Bleeker-Rovers CP, Vos FJ, de Kleijn EMHA, Mudde AH, Dofferhoff TSM, Richter C, Smilde TJ, Krabbe PFM, Oyen WJG, van der Meer JWM. A prospective multicenter study on fever of unknown origin: the yield of a structured diagnostic protocol. Medicine (Baltimore). 2007 Jan;86(1):26-38. doi: 10.1097/MD.0b013e31802fe858.

ReferenceCitation: Kucukardali Y, Oncul O, Cavuslu S, Danaci M, Calangu S, Erdem H, Topcu AW, Adibelli Z, Akova M, Karaali EA, Ozel AM, Bolaman Z, Caka B, Cetin B, Coban E, Karabay O, Karakoc C, Karan MA, Korkmaz S, Sahin GO, Pahsa A, Sirmatel F, Solmazgul E, Ozmen N, Tokatli I, Uzun C, Yakupoglu G, Besirbellioglu BA, Gul HC; Fever of Unknown Origin Study Group. The spectrum of diseases causing fever of unknown origin in Turkey: a multicenter study. Int J Infect Dis. 2008 Jan;12(1):71-9. doi: 10.1016/j.ijid.2007.04.013. Epub 2007 Jul 12.

lead_sponsor: University Hospital, Grenoble

location_facility:
CHU Grenoble
University Hospital


title: Register of Patients With Anti-Phospholipids Syndrome (APS) and/or Systemic Lupus Erythematosus (SLE)

acronym: SAPL-LUPUS

summary: The purpose of that register is to collect medical information about patients suffering of APS with or without associated SLE.

time_perspective: Other

ReferenceCitation: Morel N, Bonnet C, Mehawej H, Le Guern V, Perard L, Roumier M, Brezin A, Godeau B, Haroche J, Benhamou Y, Lambert M, Yelnik CM, Maillard N, Bodaghi B, Piette JC, Costedoat-Chalumeau N. CATASTROPHIC ANTIPHOSPHOLIPID SYNDROME AND POSTERIOR OCULAR INVOLVEMENT: Case Series of 11 Patients and Literature Review. Retina. 2021 Nov 1;41(11):2332-2341. doi: 10.1097/IAE.0000000000003185.

publisher_dissemination: Wolters Kluwer Health

location_facility:
Hôpital Cochin
Hôpital Claude Huriez


title: Efficacy of Therapeutic Management of Periodontitis on the Clinical Manifestations of Rheumatoid Arthritis: the Randomized, Controlled ESPERA Trial.

acronym: ESPERA

summary:
Although RA pathomechanisms remains incompletely understood, periodontitis and RA share pathogenic features : genetic and environmental influences, chronic inflammatory disease, immunoregulatory imbalance, bacterial factors, persistence of antigen/peptide and clinical factors (conjunctive and hard tissues destruction). Several hypothesis can be evocated : Gram negative bacterial systemic spreading, inflammatory transmitter substance systemic spreading (IL1, IL6, IL17, PGE2), systemic spreading of bacterial degradation products (LPS for example).

Currently Porphyromonas gingivalis (PG) might be a susceptibility factor to RA because PG has an enzyme, the peptidylarginine deiminase leading to auto antibodies creation and RA increasing. As periodontitis, RA is chronic disease with a cyclic increase evolution, needing a complex pluridisciplinary treatment approach. Recent studies have reported an increased prevalence of RA patients with periodontal disease. Others studies show that periodontal treatment induces a significant decrease of the sedimentation rate and of the DAS28. Periodontitis is suspected to be an independent, aggravating factor in patients with RA (given the definition from NIH : an aggravating factor is something that makes a condition worse). So periodontal treatment cannot be considered as a RA treatment per se. But it is hypothesised that treating periodontitis in RA patients showing signs of periodontitis could result in improvement in RA disease activity. To date the role of periodontitis as an aggravating factor in these patients remains unclear, and only RCT designs can reasonably be used to test this causal hypothesis. There still remains some RA patients who have persistent symptoms and frequent exacerbations despite specialist care and continuous treatment, so results of treating aggravating factors are needed. As the majority of patients will benefit from a systematic evaluation and treatment of aggravating factors, the periodontal treatment strategy need to be tested.

The aim of this randomised controlled trial is to assess the effectiveness of periodontal treatment for rheumatoid arthritis patients.

To assess the effectiveness of periodontal treatment to reduce the severity of rheumatoid arthritis (RA), in patients suffering from both periodontitis and rheumatoid arthritis. The hypothesis is that periodontal treatment reduce the severity of rheumatoid arthritis.

lead_sponsor: University Hospital, Toulouse

location_facility: Pôle Odontologie Hôpital Purpan - Pavillon Rayer


title: A Dose Escalation Phase I Study With an Extension Part Evaluating the Safety and Activity of an Anti-PDL1 Antibody (DURVALUMAB) Combined With a Small Molecule CSF-1R Tyrosine Kinase Inhibitor (PEXIDARTINIB) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers

acronym: MEDIPLEX

summary: Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common gastrointestinal cancers in Western countries and are both associated with significant morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have limited efficacy as single agents in both of these tumor types. Recent preclinical studies point towards alternatively activated (M2-type) macrophages as possible culprits in inducing local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents. We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2 macrophages, thus favoring the induction of a cytotoxic anti-tumor T-cell response following PD-L1 blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I dose escalation study in order to evaluate the safety and clinical activity of a combined treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part will determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical activity of the combination at the RP2D.

lead_sponsor: Centre Leon Berard

collaborators: AstraZeneca Plexxikon

sponsor_collaborators:
Centre Leon Berard
AstraZeneca
Plexxikon

location_facility:
Centre Léon Bérard
IUCT-oncopole


title: Resting State MRI Connectivity in Acute Ischemic Stroke: Serotonin Selective Reuptake Inhibitor (SSRI) in Enhancing Motor Recovery: a Placebo Controlled Study

acronym: RECONISE

summary: Fluoxetine action on cerebral connectivity changes in acute ischemic stroke patients

location_facility:
CHU Toulouse
Hôpital Pellegrin

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: RECONISE

titre: REsting state MRI CONnectivity in Acute Ischemic stroke : SSRI in Enhancing motor recovery : a placebo controlled study

nom_porteur: SATTLER

prenom_porteur: Virginie


title: Medico-economic Evaluation of Complicated Obesity in Primary Care

summary:
The investigators developed the Aviitam® online platform. The purpose of the project is to test the medico-economic impact related to the utilization of the Aviitam online platform in primary care.

Primary objective: To assess the cost-effectiveness at 24 months follow-up of the utilization of the Aviitam® online software in primary care for people with obesity and at least one comorbidity compared to a usual follow-up in primary care.

Secondary objectives: Weight loss; quality of life ; blood pressure change; changes in lipid profile, blood glucose and HbA1c; physician satisfaction; patients satisfaction, profiling of patients and data mining analysis on the collected data.

Method : Overweight & obese patients with associated comorbidities will receive a 24 months follow-up to assess the impact of the use of the online platform Aviitam®.

Practitioners will be randomized by lot between an Aviitam® group and a control group (usual care).

A medico-economic analysis will be conducted with a cost-effectiveness analysis and a budget impact analysis.

With no hypothesis on the primary endpoint, the calculation of the required number of subjects was based on the quality of life. 150 patients will be included per group Patients of the 2 groups will be assessed at baseline and after 24 months. The first day of each month, each patient included in the study will receive a questionnaire to fill online to evaluate their health care consumption in the previous month and the EQ5D questionnaire , a standardized questionnaire validated in French to assess the effects on health and to be used to calculate cost - utility.

Expected results and perspectives Proving the effectiveness of the Aviitam® online program focused on non-drug therapies and therapeutic lifestyle changes for overweight and obesity management with reduced health costs, improvement in quality of life, reduction in weight and improvement of comorbidities.

In terms of public health, the use of the platform Aviitam® can be expect to improve management of excess body weight and reduced health costs. Furthermore, Aviitam® could be a valuable tool to support healthcare professionals in outpatient therapeutic education approaches.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Montpellier

location_facility: Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud

appel_a_projets: PRME

nom_etablissement: CHU MONTPELLIER

acronyme: GPS-WebMobilite

titre: Evaluation médico-économique d'un programme de Gestion Personnalisée de la Santé (GPS-santé) à l'aide d'une solution « Web-Mobilité » pour la prise en charge de l'obésité compliquée en soins primaires

discipline_principale: nutrition et obésité

nom_porteur: Avignon

prenom_porteur: Antoine


title: Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.

acronym: ADERADHTA

summary: The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma concerning the efficacy on blood pressure control. The safety of the procedure is one of the secondary outcomes.

ReferenceCitation: Costa N, Mounie M, Gombault-Datzenko E, Boulestreau R, Cremer A, Delchier MC, Gosse P, Lagarde S, Lepage B, Molinier L, Papadopoulos P, Trillaud H, Rousseau H, Bouhanick B. Cost Analysis of Radiofrequency Ablation for Adrenal Adenoma in Patients with Primary Aldosteronism and Hypertension: Results from the ADERADHTA Pilot Study and Comparison with Surgical Adrenalectomy. Cardiovasc Intervent Radiol. 2023 Jan;46(1):89-97. doi: 10.1007/s00270-022-03295-9. Epub 2022 Nov 15.

location_facility:
CHU de Toulouse
CHU Bordeaux

acronyme: ADERADHTA

titre: Traitement de l'adénome de Conn par radiofréquence : étude pilote sur le devenir du contrôle tensionnel, biologique et hormonal

discipline_principale: hypertension artérielle

nom_porteur: DULY-BOUHANICK

prenom_porteur: Béatrice


title: Dose-escalation, Phase I Multicentric Trial, Evaluating the Combination of Ribociclib and Capecitabine in Locally Advanced or Metastatic Breast Cancer HER2 Negative in Patients Previously Treated With Anthracyclines and Taxanes

summary:
The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced or metastatic breast cancer HER2 negative patients and divided into 2 parts:

STEP 1: a dose escalation part (n= up to 30) to evaluate the safety profile and pharmacokinetics and to define the MTD and RP2D to recommend in a phase II.
STEP 2: an expansion cohort part to confirm the safety and tolerability of ribociclib and capecitabine association on a longer follow-up, and to obtain preliminary evidence of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients. Up to 14 patients in each cohort, taking into account patients already included in step one at this DL, may be enrolled, for a total of 28 at the RP2D.

lead_sponsor: UNICANCER

sponsor_collaborators: UNICANCER Novartis

location_facility:
Centre Leon Berard
Institut de Cancérologie de l'Ouest


title: Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation

acronym: REVISON

summary:
Speech is a privileged means of communication for humans: its trouble can thus prove being extremely handicapping. Standard speech therapy is limited in some cases by the lack of sensory feedback available to the patient (hearing, surgery, neural damage, etc.).

The present study aims at quantify the contribution of the tongue articulatory visual feedback offered by ultrasound echography to speech trouble rehabilitation.

Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and 10 childrens with important speech troubles due to central nervous system damage.

The principle is to conduct standard speech therapy sessions, alternating series of sessions with the use of visual feedback and sessions without visual feedback.

The progress will be regularly measured by means of standard batteries of speech articulation tests.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Institut d'Education Motrice
Centre Médical Rocheplane


title: Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations and Living at Home

acronym: OPTIM

summary:
Aging is often associated with multiple chronic conditions conducting increased consumption of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy, increases the iatrogenic risks and can lead to adverse events such as falls, cognitive decline, increased use to the health system: hospital admissions, emergency room visits, and institutionalization. These problems are common since about 20% of emergency room use in elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events related to drug prescriptions could be avoided.

Interventions to optimize drug therapy showed a reduction in the number of potentially inappropriate medications, but their impact on health, has rarely been evaluated. If an association with death has been established, the link with the loss of functional autonomy, which leads to reduced quality of life and significant cost of care, has not been investigated. The evolution towards functional disabilities, frequent with aging has many causes, among which some could be prevented. The optimization of drug prescriptions could thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse events, such as falls or cognitive decline and improving the management of chronic diseases. Our hypothesis is that an optimization program of the drug prescribing may slow progression to functional dependence. To assess the effect of the optimization program of drug prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial will be conducted in geriatric and memory consultations.

Expected results The implementation of the "OPTIM" program should enable optimization of drug prescribing in elderly patients and therefore slow or prevent progression to addiction. It should also help to develop and strengthen collaboration and communication between the team of geriatric consultation, the clinician pharmacist and referring physicians in town (private practice). In addition, pharmaceutical notice sent to referring physicians should help raise awareness of the prescription of drugs in these patients.

ReferenceCitation: Dauphinot V, Jean-Bart E, Krolak-Salmon P, Mouchoux C. A multi-center, randomized, controlled trial to assess the efficacy of optimization of drug prescribing in an elderly population, at 18 months of follow-up, in the evolution of functional autonomy: the OPTIM study protocol. BMC Geriatr. 2017 Aug 30;17(1):195. doi: 10.1186/s12877-017-0600-7.

location_facility:
Hôpital des Charpennes
Hôpital gériatrique du Mont d'Or


title: Evaluation of the Effect of Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule: A Prospective, Bicentric, Pilot Study

acronym: INREG 1

summary: The main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients

acronym: SPAD

summary: The main objective of this study is to confirm the existence of risky decision making in a non strategic situation (Iowa Gambling Task) and a deficit of decision making in social situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of trust (Trust Game) in elderly depressed patients with a history of suicide attempts in comparison with older depressed patients without a history of suicidal acts and healthy subjects.

ReferenceCitation: Mann JJ. The neurobiology of suicide. Nat Med. 1998 Jan;4(1):25-30. doi: 10.1038/nm0198-025. No abstract available.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Study of Modifications of the Composition and Structure in the Aseptic Osteonecrosis of the Femoral Head and Etiopathogenic MRI Correlations

acronym: ONTF

summary: In this study, the aim is to identify the modifications responsible for aseptic osteonecrosis of the femoral head and its structural evolution by the association of the micro scanner analysis and Raman spectrometry performed on the femoral heads removed during hip replacements. The study of femoral heads will allow the analysis of bone tissue at two different scales, both correlated with the biomechanical properties of the bone. Also, the association with preliminary MRI analysis will provide pathogenic explanations correlated to these modifications.

lead_sponsor: Lille Catholic University

location_facility: Hospital Group of the Catholic Institute of Lille


title: French National Observatory of Patients With Thymic Epithelial Tumor

acronym: RYTHMIC

summary: RYTHMIC (Réseau tumeurs THYMiques et Cancer) is a French nationwide network for TET with the objective of territorial coverage by regional expert centers and systematic discussion of patients management at national tumor board.

ReferenceCitation: Chalabreysse L, Thomas De Montpreville V, De Muret A, Hofman V, Lantuejoul S, Parrens M, Payan MJ, Rouquette I, Secq V, Girard N, Marx A, Besse B, Molina TJ. [Rythmic-pathology: the French national pathology network for thymic epithelial tumours]. Ann Pathol. 2014 Feb;34(1):87-91. doi: 10.1016/j.annpat.2014.01.010. Epub 2014 Feb 21. French.

publisher_dissemination: Elsevier

ReferenceCitation: Hadoux J, Girard N, Besse B. [Thymic epithelial neoplasms: updates on diagnosis, staging, biology and management in France]. Bull Cancer. 2012 Nov;99(11):1045-55. doi: 10.1684/bdc.2012.1659. French.

ReferenceCitation: Thomas de Montpreville V, Quilhot P, Chalabreysse L, De Muret A, Hofman V, Lantuejoul S, Parrens M, Payan MJ, Rouquette I, Secq V, Girard N, Besse B, Marx A, Molina TJ. Glut-1 intensity and pattern of expression in thymic epithelial tumors are predictive of WHO subtypes. Pathol Res Pract. 2015 Dec;211(12):996-1002. doi: 10.1016/j.prp.2015.10.005. Epub 2015 Oct 19.

ReferenceCitation: Remon J, Girard N, Mazieres J, Dansin E, Pichon E, Greillier L, Dubos C, Lindsay CR, Besse B. Sunitinib in patients with advanced thymic malignancies: Cohort from the French RYTHMIC network. Lung Cancer. 2016 Jul;97:99-104. doi: 10.1016/j.lungcan.2016.04.024. Epub 2016 May 3. Erratum In: Lung Cancer. 2016 Nov;101:146.

ReferenceCitation: Merveilleux du Vignaux C, Dansin E, Mhanna L, Greillier L, Pichon E, Kerjouan M, Clement-Duchene C, Mennecier B, Westeel V, Robert M, Quantin X, Zalcman G, Thiberville L, Lena H, Molina T, Calcagno F, Fournel P, Mazieres J, Besse B, Girard N. Systemic Therapy in Advanced Thymic Epithelial Tumors: Insights from the RYTHMIC Prospective Cohort. J Thorac Oncol. 2018 Nov;13(11):1762-1770. doi: 10.1016/j.jtho.2018.08.005. Epub 2018 Aug 21.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

ReferenceCitation: Basse C, Thureau S, Bota S, Dansin E, Thomas PA, Pichon E, Lena H, Massabeau C, Clement-Duchene C, Massard G, Westeel V, Quantin X, Oulkhouir Y, Danhier S, Lerouge D, Tanguy R, Thillays F, Le Pechoux C, Dubray B, Thiberville L, Besse B, Girard N. Multidisciplinary Tumor Board Decision Making for Postoperative Radiotherapy in Thymic Epithelial Tumors: Insights from the RYTHMIC Prospective Cohort. J Thorac Oncol. 2017 Nov;12(11):1715-1722. doi: 10.1016/j.jtho.2017.07.023. Epub 2017 Jul 31.

ReferenceCitation: Drevet G, Collaud S, Tronc F, Girard N, Maury JM. Optimal management of thymic malignancies: current perspectives. Cancer Manag Res. 2019 Jul 22;11:6803-6814. doi: 10.2147/CMAR.S171683. eCollection 2019.

publisher_dissemination: Informa

ReferenceCitation: Remon J, Girard N, Mazieres J, Dansin E, Pichon E, Greillier L, Dubos C, Lindsay CR, Besse B. Erratum to "Sunitinib in patients with advanced thymic malignancies: cohort from the French RYTHMIC network" [Lung Cancer, 97 (July 2016), 99-104]. Lung Cancer. 2016 Nov;101:146. doi: 10.1016/j.lungcan.2016.09.014. Epub 2016 Oct 6. No abstract available.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Rouquette I, Taranchon-Clermont E, Gilhodes J, Bluthgen MV, Perallon R, Chalabreysse L, De Muret A, Hofman V, Marx A, Parrens M, Secq V, Thomas de Montpreville V, Galateau-Salle F, Brousset P, Milia J, Girard N, Besse B, Molina TJ, Mazieres J. Immune biomarkers in thymic epithelial tumors: expression patterns, prognostic value and comparison of diagnostic tests for PD-L1. Biomark Res. 2019 Dec 4;7:28. doi: 10.1186/s40364-019-0177-8. eCollection 2019.

ReferenceCitation: Girard N, Merveilleux Du Vignaux C, Molina T, Besse B, Rythmic R. [Thymic tumors]. Rev Prat. 2017 Apr;67(4):430-434. French.

ReferenceCitation: Chalabreysse L, Dubois R, Hofman V, Le Naoures C, Mansuet-Lupo A, de Montpreville VT, De Muret A, Parrens M, Piton N, Rouquette I, Secq V, Singeorzan C, Marx A, Girard N, Besse B, Molina TJ. [Thymoma and squamous thymic carcinoma diagnosis; experience from the RYTHMIC network]. Ann Pathol. 2021 Apr;41(2):154-165. doi: 10.1016/j.annpat.2020.11.002. Epub 2020 Dec 10. French.

evidence: open (via crossref license, author manuscript)

ReferenceCitation: Molina TJ, Bluthgen MV, Chalabreysse L, de Montpreville VT, de Muret A, Dubois R, Hofman V, Lantuejoul S, le Naoures C, Mansuet-Lupo A, Parrens M, Piton N, Rouquette I, Secq V, Girard N, Marx A, Besse B. Impact of expert pathologic review of thymic epithelial tumours on diagnosis and management in a real-life setting: A RYTHMIC study. Eur J Cancer. 2021 Jan;143:158-167. doi: 10.1016/j.ejca.2020.11.011. Epub 2020 Dec 11.

ReferenceCitation: Petat A, Dansin E, Calcagno F, Greillier L, Pichon E, Kerjouan M, Clement-Duchene C, Mennecier B, Westeel V, Thillays F, Quantin X, Oulkhouir Y, Thiberville L, Ricordel C, Thomas De Montpreville V, Chalabreysse L, Hofman V, Molina T, Fournel P, Bigay Game L, Besse B, Girard N. Treatment strategies for thymic carcinoma in a real-life setting. Insights from the RYTHMIC network. Eur J Cancer. 2022 Feb;162:118-127. doi: 10.1016/j.ejca.2021.11.028. Epub 2021 Dec 26.

ReferenceCitation: Thomas de Montpreville V, Mansuet-Lupo A, Le Naoures C, Chalabreysse L, De Muret A, Hofman V, Rouquette I, Piton N, Dubois R, Benitez JC, Girard N, Besse B, Marx A, Molina TJ. Micronodular thymic carcinoma with lymphoid hyperplasia: relevance of immunohistochemistry with a small panel of antibodies for diagnosis-a RYTHMIC study. Virchows Arch. 2021 Oct;479(4):741-746. doi: 10.1007/s00428-021-03044-2. Epub 2021 Feb 24.

ReferenceCitation: Benitez JC, Boucher ME, Dansin E, Kerjouan M, Bigay-Game L, Pichon E, Thillays F, Falcoz PE, Lyubimova S, Oulkhouir Y, Calcagno F, Thiberville L, Clement-Duchene C, Westeel V, Missy P, Thomas PA, Maury JM, Molina T, Girard N, Besse B. Central Nervous System Metastases in Thymic Epithelial Tumors: A Brief Report of Real-World Insight From RYTHMIC. J Thorac Oncol. 2021 Dec;16(12):2144-2149. doi: 10.1016/j.jtho.2021.08.008. Epub 2021 Aug 26.

ReferenceCitation: Basse C, Botticella A, Molina TJ, Falcoz PE, Oulkhouir Y, Kerjouan M, Pichon E, Westeel V, Thiberville L, Quantin X, Clement-Duchene C, Khalifa J, Tinier FL, Ginoux M, Thillays F, Mordant P, Besse B, Thomas PA, Pechoux CL, Girard N. RADIORYTHMIC: Phase III, Opened, Randomized Study of Postoperative Radiotherapy Versus Surveillance in Stage IIb/III of Masaoka Koga Thymoma after Complete Surgical Resection. Clin Lung Cancer. 2021 Sep;22(5):469-472. doi: 10.1016/j.cllc.2021.01.020. Epub 2021 Feb 4.

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

ReferenceCitation: Noel N, Le Roy A, Hot A, Saadoun D, Lazaro E, Levesque H, Le Gouellec N, Meaux-Ruault N, Nguyen T, Costedoat-Chalumeau N, Amieux B, Fontana A, De Gennes C, Fulpin J, Thomas PA, Bluthgen MV, Besse B, Lambotte O. Systemic lupus erythematosus associated with thymoma: A fifteen-year observational study in France. Autoimmun Rev. 2020 Mar;19(3):102464. doi: 10.1016/j.autrev.2020.102464. Epub 2020 Jan 7.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Villejuif - Institut Gustave Roussy
Paris - Institut Curie


title: IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

acronym: ActiMon

summary: The primary objective of this study is to search for, in vitro, elements associated with IgG-dependent monocyte activation (signaling pathway activation, expression of pro-coagulant and pro-inflammatory factors) and to describe their prevalence in female patients with a history of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) compared to control women.

time_perspective: Cross-Sectional

location_facility: CHRU de Montpellier - Hôpital Saint-Eloi


title: Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis

acronym: EMOSOCIAL-MS

summary:
In addition to the physical, cognitive and psychological symptoms experienced by individuals with Multiple Sclerosis (MS), there is new research which indicates that some individuals with MS have a deficit in emotional processing, specifically, facial affect recognition. Emotional processing is defined as "a central aspect of social cognition". Models of social cognition indicate that emotional processing is an essential component of interpersonal relationships. The failure to accurately perceive other's emotions has been shown to lead to difficulty in social relationships, misinterpreting other's affect, and consequently, inappropriate responding.

However, even though a significant number of individuals with MS have impairments in emotional processing, we do not yet have an understanding of how these impairments affect the social functioning of individuals with MS, including the impact of these deficits on family structure. It is well-known that MS impacts one's social functioning including factors such as employment, daily living activities and interpersonal relationships. Recently a strong correlation was observed between reduced social participation in MS and quality of life. There is evidence to suggest that emotional processing deficits lie at the heart of this reduced social participation in persons with MS, leading to decreased social functioning and thus reduced quality of life. However, to date, this hypothesis has not been tested.

lead_sponsor: University Hospital, Bordeaux

collaborators: FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES

location_facility:
CHU de Dijon
CHU de Bordeaux


title: Early Biomarkers of Sepsis Identification in the Emergency Department

acronym: BIPS

summary: Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.

lead_sponsor: Pitié-Salpêtrière Hospital

collaborators:
Institut Pasteur
Bio-Rad Laboratories

sponsor_collaborators:
Pitié-Salpêtrière Hospital
Institut Pasteur
Bio-Rad Laboratories

location_facility:
Institut Pasteur
Hôpital Pitié Salpêtrière


title: Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?

acronym: IPOLAP

summary:
The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients.

Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis

location_facility: CHU de Grenoble - Médecine Physique et de Réadapatation

location_facility: CHU de Grenoble - Unité des troubles du mouvement


title: Cerebral NIRS Profiles During Premedication for Neonatal Intubation

summary:
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.

Primary outcome:

Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before premedication).
Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.

ReferenceCitation: Vedrenne-Cloquet M, Breinig S, Dechartres A, Jung C, Renolleau S, Marchand-Martin L, Durrmeyer X. Cerebral Oxygenation During Neonatal Intubation-Ancillary Study of the Prettineo-Study. Front Pediatr. 2019 Mar 1;7:40. doi: 10.3389/fped.2019.00040. eCollection 2019.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

publisher_dissemination: Frontiers

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Association Clinique Thérapeutique Infantile du val de Marne

location_facility:
Hôpital intercommunal de Créteil
Hôpital des enfants


title: A Randomized, Multicenter, Open-label, Bayesian-based Phase II Study of the Feasibility of Kyphoplasty in the Local Treatment of Spine Metastases From Solid Tumors

summary:
Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.

The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments.

Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space.

In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.

To date, no data from randomized study are available in the population of cancer patients.

location_facility:
Hopital Nord
Centre Léon Bérard

nom_etablissement: CENTRE LEON BERARD

titre: Etude de phase II multicentrique, randomisée, en ouvert, utilisant une méthode bayésienne, évaluant la faisabilité de la kyphoplastie dans le traitement local

nom_porteur: RICHIOUD

prenom_porteur: Bertrand


acronym: RECAP 2

summary:
The main objective is to identify obstacles and elements facilitating the implementation of a tracking device Broncho Pulmonary Cancer during the course of care.

The secondary objective is to assess patient knowledge and information received on their previous occupational exposure during their professional activity.

This is a prospective multicenter study of qualitative methodology through in-depth interviews conducted with patients treated at ICLN and CHU Saint-Etienne

lead_sponsor: Institut de Cancérologie de la Loire

collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
ICLN
CHU Saint-Etienne


title: Radiation Therapy and Venous Thromboembolic Events

acronym: RIT

summary: The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation.

ReferenceCitation: Daguenet E, Maison M, Tinquaut F, Giroux EA, Bertoletti L, Suchaud JP, Rancoule C, Guy JB, Magne N. Venous thromboembolism and radiation therapy: The final radiation-induced thrombosis study analysis. Cancer Med. 2022 Apr;11(8):1753-1762. doi: 10.1002/cam4.4559. Epub 2022 Feb 24.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Institut de cancérologie Lucien Neuwirth


title: Prospective Multicenter Study for the Endovascular Treatment of Iliac Aneurysm With the Branched E-liac Stent Graft

acronym: TAILOR

summary:
In this study, patients will be observed who receive an E-liac Stent Graft for treatment of isolated iliac aneurysms or an E-liac Stent Graft in combination with one of the following AAA stent grafts: E-tegra Stent Graft, Endurant AAA Stent Graft, Zenith AAA Endovascular Graft, Gore Excluder AAA Endoprosthesis for treatment of aorto-iliac aneurysms.

Objectives of this post-market registry are:

Primary: To prevent the risk of rupture and death by the treatment of common iliac aneurysm with an iliac branched stent graft (E-liac, JOTEC) Secondary: Evaluation of safety and feasibility of the E-liac Stent Graft System used in endovascular treatment of uni- or bilateral aorto-iliac or iliac aneurysm.

lead_sponsor: JOTEC GmbH

location_facility:
CHU Rennes
CHU Nantes


title: Non-invasive Neurological Evaluation During Cardiopulmonary Resuscitation for Out of Hospital Cardiac Arrest Patients Neuro-E-CPR Study

acronym: Neuro-E-CPR

summary:
Cardiac arrest remains a leading cause of death, currently affecting >250,000 Europeans outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between 15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest, the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with trained resuscitation teams. However, only 5-10% of patients will survive with good neurological status. A good quality CPR, a short time before initiation of the resuscitation and a short delay before the first defibrillation have been associated with improved neurological outcome. Unfortunately it is currently impossible to obtain reliable information on the quality of the perfusion and oxygenation of organs during CPR. The current monitoring during CPR is limited to heart rhythm analysis, pulse rate evaluation and end tidal CO2 (EtCO2). The last one is the only parameter which have been linked with probability of ROSC and its value gives no indication of the long-term prognosis nor the neurological status.

Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation. This technique has been recently used in cardiac arrest showing a possible association between rSO2 measured during CPR and the occurrence of ROSC or survival. The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome in the hospital for patient successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility study has shown that its use was also possible during CPR in the pre-hospital setting.

The investigators aim to study a composite prognostic factor combining quantitative rSO2 and automated pupillometry measured during CPR. The investigators hypothesized that the rate of survival with good neurologic outcome at 30 days will be lower in patients with rSO2 <30% for more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR .

ReferenceCitation: Levine RL, Wayne MA, Miller CC. End-tidal carbon dioxide and outcome of out-of-hospital cardiac arrest. N Engl J Med. 1997 Jul 31;337(5):301-6. doi: 10.1056/NEJM199707313370503.

ReferenceCitation: Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.

ReferenceCitation: Ito N, Nishiyama K, Callaway CW, Orita T, Hayashida K, Arimoto H, Abe M, Endo T, Murai A, Ishikura K, Yamada N, Mizobuchi M, Anan H, Okuchi K, Yasuda H, Mochizuki T, Tsujimura Y, Nakayama T, Hatanaka T, Nagao K; J-POP Registry Investigators. Noninvasive regional cerebral oxygen saturation for neurological prognostication of patients with out-of-hospital cardiac arrest: a prospective multicenter observational study. Resuscitation. 2014 Jun;85(6):778-84. doi: 10.1016/j.resuscitation.2014.02.012. Epub 2014 Mar 5.

oa_colors: green hybrid

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

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

repository_institution: Kyoto University - Kyoto University Research Information Repository

ReferenceCitation: Singer AJ, Ahn A, Inigo-Santiago LA, Thode HC Jr, Henry MC, Parnia S. Cerebral oximetry levels during CPR are associated with return of spontaneous circulation following cardiac arrest: an observational study. Emerg Med J. 2015 May;32(5):353-6. doi: 10.1136/emermed-2013-203467. Epub 2014 Mar 24.

ReferenceCitation: Schewe JC, Thudium MO, Kappler J, Steinhagen F, Eichhorn L, Erdfelder F, Heister U, Ellerkmann R. Monitoring of cerebral oxygen saturation during resuscitation in out-of-hospital cardiac arrest: a feasibility study in a physician staffed emergency medical system. Scand J Trauma Resusc Emerg Med. 2014 Oct 5;22:58. doi: 10.1186/s13049-014-0058-y.

publisher_dissemination: Springer

ReferenceCitation: Suys T, Bouzat P, Marques-Vidal P, Sala N, Payen JF, Rossetti AO, Oddo M. Automated quantitative pupillometry for the prognostication of coma after cardiac arrest. Neurocrit Care. 2014 Oct;21(2):300-8. doi: 10.1007/s12028-014-9981-z.

repository_institution: Université de Lausanne - SERVAL

repository_institution: reroDoc Digital Library

repositories_institution:
Université de Lausanne - SERVAL
reroDoc Digital Library

ReferenceCitation: Behrends M, Niemann CU, Larson MD. Infrared pupillometry to detect the light reflex during cardiopulmonary resuscitation: a case series. Resuscitation. 2012 Oct;83(10):1223-8. doi: 10.1016/j.resuscitation.2012.05.013. Epub 2012 May 30.

location_facility:
SAMU 38
SAMU 74