acronym: LEUCOPRO

title: Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.

lead_sponsor: University Hospital, Angers

location_facility: CHU CHRU CH

summary:
Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical technetium 99mTc-HMPAO.

The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis infection.


title: Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis ("NASH-Safety")

summary:
Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH.

The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes.

Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria.

Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo).

The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan.

70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

study_start_date_type: Anticipated

status: Withdrawn

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Yaqrit Ltd

location_country:
Portugal
Spain
Italy
United Kingdom
Switzerland
France

location_facility: Hospital Ramon y Cajal, Department of Gastroenterology and Hepatology

location_facility: Azienda Ospedaliera di Padova, Hepatic Emergencies Unit

location_facility: Hospital Clinic of Barcelona , Liver Unit,

location_facility: Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine

location_facility: Hospital Beaujon, Hepatology and Liver Intensive Care,

location_facility: Policlinico S.Orsola Malpighi, Department of Medical and Surgical Sciences

location_facility: Royal Free Hospital, Institute of Liver and Digestive Disease

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: Canaux de COmmuniCAtion et Fonctionnement du CErveau: Étude Pilote en IRMf

acronym: COCACE

summary:
Communication is a social process involving individuals exchanging messages. It is usual to observe different reactions according to the manner of communication, the manner in which such information is exchanged.

In this work, it will be examined how different communication modalities cause different reactions in a person. We make the assumption that each communication modality is based on a different brain network.

study_start_date_type: Actual

status: Unknown status

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: University Hospital, Tours

lead_sponsor_type: academique


title: Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients

acronym: COPD-OSAS

summary:
The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational physiological study.

An interim analysis will be performed when 100 patients will be included.

status: Terminated

study_completion_date_type: Actual

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet. 2007 Sep 1;370(9589):797-9.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital of Grenoble
Mutualist Hospital group
University Hospital of Angers


title: Calcified Aortic Valve Stenosis (AVS). Markers of Fibrosis Using Cardiac Magnetic Resonance

acronym: RACINE

summary: Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. however these marker are a poor reflect of the clinical severity of AVS. The aim of the study is to validate new markers assessing cardiac fibrosis that might best or complementary markers.

status: Completed

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Departement of Radiology, Hopital Europeen Georges Pompidou,

intervention_type: Procedure

status_simplified: Completed


title: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

acronym: IEI-CEM

summary: The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.

location_facility: Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre

intervention_type: Other


title: Safety and Tolerability of Yaq-001 in Patients With Cirrhosis ("CARBALIVE-SAFETY")

summary:
In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood.

Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have the ability to bind these bacterial fragments and so confine them to the gut. The purpose of this clinical trial is to test the product Yaq-001 for the first time in patients with cirrhosis.

This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it helps improve the overall health status of the cirrhotic patients.

Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis for any cause. Only postmenopausal women or with surgical sterilisation are eligible. Additional inclusion and exclusion criteria of medical nature will be determined with the investigator at the screening visit, by means of standard care routines plus an additional test to assess the bowel transit time.

Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001, or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to better understand how safe and tolerable Yaq-001 really is.

The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study doctor 5 times. At all the visits the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital.

56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

primary_purpose: Device Feasibility

location_facility: Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine,


title: Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients

acronym: HAD-Covid

summary: To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)

status: Recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CH Aurillac
CH Moulins
CH Grenoble
CH Périgueux
CH Rodez
Centre Jean Perrin
University hospital, Clermont-Ferrand
CH Cannes
CH Vichy
CH Le Puy-en-Velay
University hopistal, Lyon

status_simplified: Ongoing


title: Vaccine Attitudes and Practices of Hospital Specialists

acronym: SPECIVAC

summary: This study aims to evaluate the perceptions and knowledge of hospital specialists regarding vaccine recommendations targeting their patients, to study their behavior with respect to these recommendations and to quantify their vaccine hesitancy.

location_facility: Service d'Hygiène, Epidémiologie et Prévention, Groupement Hospitalier Edouard Herriot et Unité de recherche clinique ne Immunologie du centre hospitalier Lyon Sud

intervention_type: Behavioral


title: A Phase I and Phase II Study of the Efficacy and Safety of Maintenance Treatment With Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes Who Achieved Hematological Response to Azacitidine

summary: A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who achieved a hematological response after 6 cycles of azacitidine. After approval by an independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an open label randomized phase II study designed to characterize the efficacy, safety, and tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of azacitidine.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital Edouard Heriot, dpt Hématologie Clinique

location_facility: Centre Hospitalier Universitaire de STRASBOURG

location_facility: Hopital Purpan Service d'Hématologie Clinique

intervention_type: Drug


title: Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage

acronym: MIVAR

summary:
Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality.

Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.

This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).

ReferenceType: derived

ReferenceCitation: Lasocki S, Bruckert V, Campfort M, Leger M, Rineau E. Restrictive transfusion targets the heart now! Insight from the REALITY study. Anaesth Crit Care Pain Med. 2021 Apr;40(2):100854. doi: 10.1016/j.accpm.2021.100854. Epub 2021 Mar 27.

location_facility:
CHU Nantes
Hôpital Gui de Chauliac
Hôpital Gabriel Montpied
CHU Angers
CHU Rennes
Hôpital de Hautepierre


title: Impact of COVID-19 Pandemic in Perinatal Mental Health

summary: Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

ReferenceCitation: Yu N, Li W, Kang Q, Xiong Z, Wang S, Lin X, Liu Y, Xiao J, Liu H, Deng D, Chen S, Zeng W, Feng L, Wu J. Clinical features and obstetric and neonatal outcomes of pregnant patients with COVID-19 in Wuhan, China: a retrospective, single-centre, descriptive study. Lancet Infect Dis. 2020 May;20(5):559-564. doi: 10.1016/S1473-3099(20)30176-6. Epub 2020 Mar 24.

ReferenceCitation: World Health Organization (2020). WHO guidelines on Intrapartum care for a positive childbirth experience and Interim guidance on Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf

ReferenceCitation: Royal College of Obstetricians & Gynaecologists: Coronavirus (COVID-19) infection and pregnancy https://www.rcog.org.uk/globalassets/documents/guidelines/2020-04-03-coronavirus-covid-19-infection-in-pregnancy.pdf

ReferenceCitation: Hahn-Holbrook J, Cornwell-Hinrichs T, Anaya I. Economic and Health Predictors of National Postpartum Depression Prevalence: A Systematic Review, Meta-analysis, and Meta-Regression of 291 Studies from 56 Countries. Front Psychiatry. 2018 Feb 1;8:248. doi: 10.3389/fpsyt.2017.00248. eCollection 2017.

ReferenceCitation: Shorey S, Chee CYI, Ng ED, Chan YH, Tam WWS, Chong YS. Prevalence and incidence of postpartum depression among healthy mothers: A systematic review and meta-analysis. J Psychiatr Res. 2018 Sep;104:235-248. doi: 10.1016/j.jpsychires.2018.08.001. Epub 2018 Aug 3. Review.

ReferenceCitation: Caparros-Gonzalez RA. [Maternal and neonatal consequences of coronavirus COVID-19 infection during pregnancy: a scoping review]. Rev Esp Salud Publica. 2020 Apr 17;94. pii: e202004033. Review. Spanish.

ReferenceCitation: Moraes EV, Toledo OR, David FL, Godoi BN, Monteiro KA, Deluqui TC, Teixeira TW, Carvalho AL, Avelino MM. Implications of the clinical gestational diagnosis of ZIKV infection in the manifestation of symptoms of postpartum depression: a case-control study. BMC Psychiatry. 2019 Jun 26;19(1):199. doi: 10.1186/s12888-019-2157-9.

ReferenceCitation: Dos Santos Oliveira SJG, Dos Reis CL, Cipolotti R, Gurgel RQ, Santos VS, Martins-Filho PRS. Anxiety, depression, and quality of life in mothers of newborns with microcephaly and presumed congenital Zika virus infection: a follow-up study during the first year after birth. Arch Womens Ment Health. 2017 Jun;20(3):473-475. doi: 10.1007/s00737-017-0724-y. Epub 2017 Apr 21.

ReferenceCitation: Lebel C, MacKinnon A, Bagshawe M, Tomfohr-Madsen L, Giesbrecht G. Elevated depression and anxiety symptoms among pregnant individuals during the COVID-19 pandemic. J Affect Disord. 2020 Dec 1;277:5-13. doi: 10.1016/j.jad.2020.07.126. Epub 2020 Aug 1. Erratum in: J Affect Disord. 2021 Jan 15;279:377-379.

ReferenceCitation: Wu, Y. T., Zhang, C., Liu, H., Duan, C. C., Li, C., Fan, J. X., ... & Guo, Y. (2020). Perinatal Depression of Women Along with 2019 Novel Coronavirus Breakout in China. Available at SSRN: https://ssrn.com/abstract=3539359 or http://dx.doi.org/10.2139/ssrn.3539359

ReferenceCitation: Thomason, M.E., Graham, A., VanTieghem, M.R. (2020). The COPE-IS: Coronavirus Perinatal Experiences - Impact Survey. Available on the Open Science Framework (OSF) at https://osf.io/uqhcv/.

ReferenceCitation: Thomason, M.E., Graham, A., Smyser, C.D., Rogers, C.E. (2020). The COPE-IU: Coronavirus Perinatal Experiences - Impact Update. Available on the Open Science Framework (OSF) at https://osf.io/uqhcv/

ReferenceCitation: Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems

ReferenceCitation: Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6.

ReferenceCitation: Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.

ReferenceCitation: Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The PTSD Checklist for DSM-5 (PCL-5) - Extended Criterion A [Measurement instrument]. Available from https://www.ptsd.va.gov/

ReferenceCitation: Bracken-Roche D, Bell E, Macdonald ME, Racine E. The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017 Feb 7;15(1):8. doi: 10.1186/s12961-016-0164-6. Erratum in: Health Res Policy Syst. 2017 Apr 3;15(1):29.

ReferenceCitation: Wilson CA, Gómez-Gómez I, Parsons J, Costa R, Mesquita A, Vousoura E, Contreras-García Y, Levy D, Mateus V, Christoforou A, Felice E, Dikmen-Yildiz P, Domínguez-Salas S, Motrico E. The Mental Health of Women with Gestational Diabetes During the COVID-19 Pandemic: An International Cross-Sectional Survey. J Womens Health (Larchmt). 2022 Sep;31(9):1232-1240. doi: 10.1089/jwh.2021.0584. Epub 2022 Jul 19.

ReferenceCitation: Gómez-Baya D, Gómez-Gómez I, Domínguez-Salas S, Rodríguez-Domínguez C, Motrico E. The influence of lifestyles to cope with stress over mental health in pregnant and postpartum women during the COVID-19 pandemic. Curr Psychol. 2022 Jun 15:1-20. doi: 10.1007/s12144-022-03287-5. [Epub ahead of print]

ReferenceCitation: Motrico E, Bina R, Domínguez-Salas S, Mateus V, Contreras-García Y, Carrasco-Portiño M, Ajaz E, Apter G, Christoforou A, Dikmen-Yildiz P, Felice E, Hancheva C, Vousoura E, Wilson CA, Buhagiar R, Cadarso-Suárez C, Costa R, Devouche E, Ganho-Ávila A, Gómez-Baya D, Gude F, Hadjigeorgiou E, Levy D, Osorio A, Rodriguez MF, Saldivia S, González MF, Mattioli M, Mesquita A; Riseup-PPD-COVID-19 Group. Impact of the Covid-19 pandemic on perinatal mental health (Riseup-PPD-COVID-19): protocol for an international prospective cohort study. BMC Public Health. 2021 Feb 17;21(1):368. doi: 10.1186/s12889-021-10330-w.

lead_sponsor: University of Minho

location_country:
Albania
Brazil
Portugal
Greece
Spain
United Kingdom
France
Chile
Israel
Malta
Turkey
Bulgaria
Cyprus

location_facility:
Sofia University
University of Athens
King'S College London
European University Cyprus
Groupe Hospitalier du Havre
Universidad Loyola Andalucia
Kırklareli Üniversitesi
Bar-Ilan University
Universidade do Minho
Beder College University
Universidad de Concepción
University of Malta
Universidade Presbiteriana Mackenzie


title: Phase II Evaluating the Efficacy of the Dual Inhibition of Phosphoinositide 3 Kinase (PI3K)/Akt /Mammalian Target Of Rapamycine (mTOR) Signaling Pathway by PF-05212384 (PKI-587) for Patients With Myeloid Neoplasm Secondary to Chemo-radiotherapy (t-AML/MDS) or de Novo Relapsed or Refractory AML.

acronym: LAM-PIK

summary: Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384 (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.

lead_sponsor: Institut Curie

location_facility:
Institut Curie - Hôpital René Huguenin
Institut Paoli Calmette
Hôpital Cochin
CHU de Toulouse
Hôpital Saint-Louis


type: Other Identifier

title: Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale

acronym: TELEBARIA

summary:
Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation.

This study will assess a new care pathway in which the patients are follow-up according to the weight evolution measured by the patient using a connected scale.

primary_purpose: Prevention

lead_sponsor: University Hospital, Lille

location_facility:
Ch Boulogne-Sur-Mer - Boulogne Sur Mer
Hop Claude Huriez Chu Lille


title: Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

acronym: APT'x

summary: Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Clermont-Ferrand, CHU Site Gabriel-Montpied


title: Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients: a Multicenter Randomized, Double-blind Study. The ALDOCURE Trial

acronym: ALDOCURE

summary:
Study hypothesis : Pre-operative aldosterone receptor blockade may reduce post-operative atrial fibrillation (POAF) occurrence within 5 days after coronary artery bypass graft surgery (CABG) ± aortic valve replacement (AVR) without any heart failure or any mitral surgery.

Primary efficacy criterion : occurrence of POAF occurring from randomization and within 5 days after surgery, assess, in a standardized manner, by continuous ECG monitoring (during the ICU stay) or Holter-ECG monitoring (during the stepdown unit stay).

Primary objective: To establish whether pre-operative administration of spironolactone leads to a reduction in POAF incidence occurring from randomization and within 5 days after surgery, compared with placebo, in patients referred for on-pump elective CABG surgery ± AVR without heart failure.

Study design : Phase III drug trial - Randomized, double blind, multicentre, prospective study.

ReferenceCitation: Alexandre J, Ollitrault P, Fischer MO, Fellahi JL, Rozec B, Cholley B, Dolladille C, Chequel M, Allouche S, Legallois D, Saplacan V, Buklas D, Beygui F, Parienti JJ, Milliez P. Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: Rationale and design of the ALDOCURE trial. Am Heart J. 2019 Aug;214:88-96. doi: 10.1016/j.ahj.2019.04.023. Epub 2019 May 9.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Caen

location_facility:
CHU Caen
Gaillard


type: EudraCT Number

title: Evaluation of the Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations of Poor Prognosis

acronym: RAPAMALYMPH

summary:
To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.

The success rate is determined by volume reduction superior to 1/5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.

location_facility:
Hu Robert Debre Aphp - Paris
Hôpital Jeanne de Flandres, CHU

intervention_type: Biological


title: Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy

acronym: MITOX

summary:
The aim of the present study is to compare Resting Energy Expenditure (REE) between normal fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced thermogenesis (DIT) and body composition between NFD vs HFD.

This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids, 45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 % lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry ). 36 included MID subjects will be included in this study. Main evaluation criteria and second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.


title: Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies: the Model of an Oral Glucose Load

acronym: HYPOSOMNPARK

summary: Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It is a major complain and represents a socially relevant problem as unintended episodes of sleep can also occur while driving for example. Arterial hypotension is frequently observed in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness is known to occur preferentially when patients are having arterial hypotension whatever the cause (i.e. postprandial period, administration of hypotensive medication such as dopamine agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness. We have observed this association in an on-going epidemiological survey Hyperglycaemia induced by oral glucose load - a standardized model simulating food intake during a meal - provokes arterial hypotension in the majority of Parkinson's disease patients with dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated by this fall in blood pressure.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Toulouse

location_facility: UHBordeaux UHToulouse


title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

acronym: MEC ORL

summary: The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.

ReferenceCitation: Villard A, Breuskin I, Casiraghi O, Asmandar S, Laplace-Builhe C, Abbaci M, Moya Plana A. Confocal laser endomicroscopy and confocal microscopy for head and neck cancer imaging: Recent updates and future perspectives. Oral Oncol. 2022 Apr;127:105826. doi: 10.1016/j.oraloncology.2022.105826. Epub 2022 Mar 19. Review.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial

acronym: IMT

summary: The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60 cmH2O).

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Brest

location_facility:
Hospital of Morlaix
Brest University Hospital


title: What Should be the Best Physiotherapy Early After Stroke ?

acronym: AMOBES

summary: This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.

ReferenceType: result

ReferenceCitation: Yelnik AP, Quintaine V, Andriantsifanetra C, Wannepain M, Reiner P, Marnef H, Evrard M, Meseguer E, Devailly JP, Lozano M, Lamy C, Colle F, Vicaut E; AMOBES Group. AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial. Stroke. 2017 Feb;48(2):400-405. doi: 10.1161/STROKEAHA.116.014803. Epub 2016 Dec 22.

location_facility: Service de Neurologie - Hôpital Lariboisière


title: Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects: Longitudinal Multicentric Study

acronym: POLLAIR

summary: Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects.

location_facility:
CHU Saint-Etienne
Hospices Civiles de Lyon


title: Prospective Follow-up of a Multicentric Cohort of Children With Prenatal Discovery of Mild Isolated Cerebral Ventriculomegaly. Evaluation at 2 and 5 Years.

summary:
Isolated uni or bilateral mild cerebral ventriculomegaly represents the most frequent "minor" cerebral anomalies discovered by antenatal echography. There are not French data making it possible to specify the incidence and the prevalence of this pathology and international data of the prevalence are very heterogeneous, going, according to the published series, of 1.48 to 22 per 1000 births.

The prognostic of ventriculomegaly remains dubious : the studies have small populations, are for the majority retrospectives with a short and often vague follow-up. The announced rate of after-effects varies between 0 and 48 %.

The objective of this study is to evaluate the neuropsychological development until the 5 years age of the children for whom a prenatally diagnosis of mild isolated ventriculomegaly was carried (absence of another cerebral or extra-cerebral anomaly in imagery and a negative aetiology). This prospective cohort will be compared with children for whom no neurological anomaly was prenatally detected.

The children diagnosed for an mild isolated cerebral ventriculomegaly will be identified by the investigators among medical files of the Centers of Prenatal Diagnosis (CPDPN) of the UH of Angers and the UH of Nantes. The patient inclusion will be done at the 2 years age after parental agreement, with a follow-up at 5 years. The control children will be included under the same conditions after having ensured of the normality of the echographies of 22 and 30 gestational weeks. The follow-up of these 2 cohorts will be based on the 2 years obligatory paediatric examination, and on the network "Naitre ensemble" set up in the Pays de la Loire Loire. In addition to the clinical routine examinations, standardized neuropsychological examinations will be done (Brunet Lezine Revised score at 2 years, NEPSY at 5 years and ASQ at 2 and 5 years).

This study will allow to compare the neuropsychological development at school age of the children diagnosed for a foetal mild, apparently isolated, cerebral ventriculomegaly from children not presenting any foetal anomaly, to evaluate the incidence of the mild isolated ventriculomegaly, to identify the predictive factors of the neuropsychological anomalies in the children diagnosed for ventriculomegaly and to compare (in the children diagnosed for ventriculomegaly), the neuropsychological development at the school age of the children having a ventricular atrium between 10 and 12 mm with those having a ventricular atrium between 12,1 and 15 mm.

This study will allow to define the neuropsychological morbidity of the foetal mild isolated cerebral ventriculomegaly and will allow to define the best clinical and educational follow up of these children and their family.

location_facility:
UH of Angers
UH of Nantes


title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.

summary: Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.

ReferenceCitation: Chaix C, Durand-Zaleski I, Alberti C, Brun-Buisson C. Control of endemic methicillin-resistant Staphylococcus aureus: a cost-benefit analysis in an intensive care unit. JAMA. 1999 Nov 10;282(18):1745-51.

ReferenceCitation: Girou E, Pujade G, Legrand P, Cizeau F, Brun-Buisson C. Selective screening of carriers for control of methicillin-resistant Staphylococcus aureus (MRSA) in high-risk hospital areas with a high level of endemic MRSA. Clin Infect Dis. 1998 Sep;27(3):543-50.

ReferenceCitation: Camus C, Bellissant E, Sebille V, Perrotin D, Garo B, Legras A, Renault A, Le Corre P, Donnio PY, Gacouin A, Le Tulzo Y, Thomas R. Prevention of acquired infections in intubated patients with the combination of two decontamination regimens. Crit Care Med. 2005 Feb;33(2):307-14.

ReferenceCitation: Camus C, Bellissant E, Legras A, Renault A, Gacouin A, Lavoué S, Branger B, Donnio PY, le Corre P, Le Tulzo Y, Perrotin D, Thomas R. Randomized comparison of 2 protocols to prevent acquisition of methicillin-resistant Staphylococcus aureus: results of a 2-center study involving 500 patients. Infect Control Hosp Epidemiol. 2011 Nov;32(11):1064-72. doi: 10.1086/662180. Epub 2011 Sep 29.

lead_sponsor: Rennes University Hospital

location_facility: Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou

location_facility: Service de Réanimation Médicale - Hôpital Bretonneau


title: Cytochrome P450 2E1 and Iron Overload

summary: The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.

location_facility: Unité d'Investigation Clinique - Hôpital Pontchaillou


title: Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients

acronym: ASAP

summary: Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

lead_sponsor: MicroPort CRM


title: Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock

acronym: LevoHeartShock

summary: Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.

status: Not yet recruiting

lead_sponsor: Central Hospital, Nancy, France

location_facility: CHU Montpellier, Arnaud de Villeneuve Hospital

location_facility: Hospices Civils de Lyon - Louis Pradel Hospital

location_facility: APHP, La Pitié Salpêtrière (medical intensive care unit)

location_facility: APHP, Lariboisière Hospital (intensive care unit and toxicology)

location_facility: APHP -Lariboisière Hospital (Cardiology department)


title: Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors. Comparison of the Taking of Kidney by cœliosurgery (Pure or " Hand-assisted "), by cœliosurgery Assisted by Robot and by the Classic Technique of Open Donor Nephrectomy.

acronym: DOVIREIN

summary:
The main objective of this multicentre study is to conduct the evaluation of cost-efficiency of various techniques of kidney taking with regard the quality of life of the kidney living donors.

It will allow to compare three techniques of taking (open donor nephrectomy, cœliosurgery pure or " hand-assisted " and cœliosurgery assisted by robot) and to determine their respective advantages in quality of life, then their medico-economic consequences in a cost-efficiency approach from the point of view of the society.

The evaluation will concern the donor and the receiver followed three months after the taking.

The open donor nephrectomy will be the technique of reference with which will be compared the two others.

ReferenceCitation: Achit H, Guillemin F, Karam G, Ladrière M, Baumann C, Frimat L, Hosseini K, Hubert J. Cost-effectiveness of four living-donor nephrectomy techniques from a hospital perspective. Nephrol Dial Transplant. 2020 Nov 1;35(11):2004-2012. doi: 10.1093/ndt/gfz143.

location_facility:
CHU Saint Etienne
CHU Hôpital de la Conception
CHU Henri Mondor
CHU Côte de Nacre de CAEN
CMC Foch
CHU Saint Jacques de Besançon
CHU Hautepierre
CHU Brabois
Hôpital Pitié Salpêtrière
CHU Hôpital Michallon de Grenoble
Hôpital Charles Nicolle
Hôpital de Rangueil
CHU Bicêtre
Hôpital Claude Huriez
Hôpital Necker
CHU Montpied de Clermont-Ferrand
CHU Bretonneau
Hôpital Saint-Louis
CHU Lapeyronie
Hôpital Edouard Herriot de Lyon
CHU Pasteur
Hôpital Tenon
CHU Lyon Sud
CHU Hôtel Dieu


title: Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)

acronym: HYPO-ECMO

summary:
A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C) during 24 hours ± 1h versus normothermia (36°C≤ T°C ≤37°C), comparative open trial will be conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.

The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between 33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality in comparison with the normothermia group (36°C≤ T°C ≤37°C).

ReferenceCitation: Levy B, Girerd N, Amour J, Besnier E, Nesseler N, Helms J, Delmas C, Sonneville R, Guidon C, Rozec B, David H, Bougon D, Chaouch O, Walid O, Hervé D, Belin N, Gaide-Chevronnay L, Rossignol P, Kimmoun A, Duarte K, Slutsky AS, Brodie D, Fellahi JL, Ouattara A, Combes A; HYPO-ECMO Trial Group and the International ECMO Network (ECMONet). Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial. JAMA. 2022 Feb 1;327(5):442-453. doi: 10.1001/jama.2021.24776.

ReferenceCitation: Jacquot A, Lepage X, Merckle L, Girerd N, Levy B. Protocol for a multicentre randomised controlled trial evaluating the effects of moderate hypothermia versus normothermia on mortality in patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYPO-ECMO study). BMJ Open. 2019 Oct 14;9(10):e031697. doi: 10.1136/bmjopen-2019-031697.

location_facility: CHU Bordeaux - Groupe Hospitalier SaintAndré

location_facility: CHU Clermont-Ferrand -Hopital G. Montpied

location_facility: CHU Toulouse Hôpital - Pierre Paul Riquet


title: Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study

acronym: ALPHO

summary:
The main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine exposure in matched anaesthetised patients with injection of NMBA, who did not present with an anaphylactic reaction (controls).

The secondary objectives of the study are:

To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
To study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.
To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.
To study the association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one NMBA.

design_allocation: Non-Randomized

location_facility:
CHU de Rouen
CHU de Saint Etienne
CHU d' ANGERS
CHU de Caen
CHU de Strasbourg
CHU de Clermont-Ferrand
CHU de Toulouse
CHU de MONTPELLIER
CHU de NANTES
CHU de Nice
Fondation Hôpital St Joseph
CHRU de Nancy
CHU de Bordeaux
CHU de Reims
Hospices Civils de Lyon
CHU de Besançon
AP-HP Paris TENON
CHU de TOURS
CHU de Poitiers
CHU de Dijon
CHU de Limoges
CHRU de Lille
AP-HM
AP-HP- Hôpital Bichat


title: Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults

summary: The objective of functional Uro MR is to add to an initial morphological phase, based on T2 and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain functional semi-quantitative parameters from time-intensity curves from ROIs placed on the aorta, renal parenchyma and cavities. If the equivalence with the renal scintigraphy is demonstrated, it would be possible to have both the morphological and functional approach of an obstructed kidney in one MR examination, without exposure to diagnostic irradiation.

location_facility:
Fondation LENVAL
Ap-Hm Marseille
Chu Strasbourg
Chu Poitiers
Chu Bordeaux
AP-HP Saint Vincent de Paul
AP-HP Robert Debré
Chu Rouen
Chu Reims
Chru Lille
Chu Angers
Chu Tours
AP-HP Bicêtre
AP-HP Trousseau
Chu Rennes
CHU NANCY Hôpital Brabois enfant


title: Occupational Respiratory Allergies and Gene-environment Interactions

acronym: ARPEIGE

summary:
The purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma.

Secondary purposes are:

to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration;
to estimate medical-social becoming of diagnosed work-related asthma after one year;
to establish a biobank of blood samples of individuals with work related asthma for measurement of cytokines and search for genetic polymorphisms associated with asthma.

location_facility: Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse

location_facility: Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen

location_facility: Centre de consultation de pathologies professionnelles, CHRU Nancy

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Civil - CHU de Strasbourg

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Michallon - CHU de Grenoble

location_facility: Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes

location_facility: Centre de consultation de pathologies professionnelles, Centre Hospitalier Intercommunal de Créteil

location_facility: Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Fernand-Widal

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Lyautey - CHU de Strasbourg


acronym: OptimaCC

title: Optimizing the Use of Vasopressor After Coronary Reperfusion in Cardiogenic Shock Secondary to Myocardial Infarction. Pathophysiological Study Comparing the Efficacy and Cardio-circulatory Tolerability of Epinephrine and Norepinephrine

source: euctr

ReferenceCitation: Takagi K, Blet A, Levy B, Deniau B, Azibani F, Feliot E, Bergmann A, Santos K, Hartmann O, Gayat E, Mebazaa A, Kimmoun A. Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial. Eur J Heart Fail. 2020 Feb;22(2):279-286. doi: 10.1002/ejhf.1600. Epub 2019 Aug 31.

ReferenceCitation: Levy B, Clere-Jehl R, Legras A, Morichau-Beauchant T, Leone M, Frederique G, Quenot JP, Kimmoun A, Cariou A, Lassus J, Harjola VP, Meziani F, Louis G, Rossignol P, Duarte K, Girerd N, Mebazaa A, Vignon P; Collaborators. Epinephrine Versus Norepinephrine for Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2018 Jul 10;72(2):173-182. doi: 10.1016/j.jacc.2018.04.051.

location_facility:
CH de MULHOUSE
CHU de DIJON
Nancy Brabois university hospital
CHU de STRASBOURG / NHC
CHU Toulouse
CHU de BESANCON / Hôpital Jean Minjoz
AP-HP-Hôpital Cochin
CHU de LIMOGES Hôpital Dupuytren
APHM Hôpital NORD
Chr Metz Thionville
Chru Tours

summary: The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction will be compared, by following cardiac index evolution as main criteria. The study is a pilot pathophysiological study, randomized, double blind and multicenter.


title: A Multicentre Controlled and Randomized Study Assessing the Effect of Dulaglutide add-on to Dietary Reinforcement Versus Dietary Reinforcement Alone in Patients With Type 2 Diabetes and Carriers of a Non-alcoholic Steatohepatitis

acronym: REALIST

summary:
GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. More recently, LEAN study has shown that Liraglutide will result in improvements in liver histology in patients with NASH. It should be of high interest to investigate the effect of another GLP-1 Agonist as effective as Liraglutide, i.e. Dulaglutide in NASH.

Dulaglutide is one of the five GLP-1 receptor agonists approved for type 2 diabetes mellitus (T2DM). It is an effective treatment because it is dosed once-weekly, provides HbA1c reduction similar to Liraglutide, weight reduction similar to Exenatide, and has an adverse effect profile similar to other GLP-1 receptor agonists. Reduction in body weight was observed in patients treated with Dulaglutide, irrespective of nausea and/or vomiting.The search for a direct effect of Dulaglutide on liver fat overload in patients with type2 diabetes is required before considering the effectiveness of this treatment in NASH in diabetic populations. No current GLP-1 study has been designed with a control group with the same weight loss than as in the treatment group.

Primary objective: The investigators aim to study the effect of Dulaglutide 1.5 mg (TRULICITY®) add-on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis.

Secondary objectives:

After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile, glycemic control and weight. The effect of the treatment will also be assessed on quality of life.
At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.

location_facility:
CHU de DIJON
CHU de TOULOUSE
CHU de ROUEN
G.H.M les Portes du Sud
Chu Marseille
CHRU de NANCY
CHU de CAEN
CHRU de MONTPELLIER
CHU de REIMS


title: Search for New Genes Involved in Molecular Etiology of Rett Syndrome Through Comparative Genomic Hybridization on DNA Microarrays

acronym: RETT

summary:
Rett syndrome (RTT) is a genetic encephalopathy and the typical form is caused by mutations in the gene MECP2. It is a genetically heterogeneous pathology. CDKL5 and FOXG1 have been recently discovered being involved in other forms of RTT. However, at least 5% of typical forms and more other atypical forms are not linked to any of 3 genes known to be involved in the disease.

The purpose of this study is to identify new genes involved in molecular etiology of typical and atypical forms of RTT.

primary_purpose: Basic Science

location_facility: Centre de Génétique Hôpital d'Enfants, CHU de Dijon

location_facility: Laboratoire de Génétique, Hôpitaux de Brabois, CHU de Nancy

location_facility: Service de Neuropédiatrie, Hôpital St Jacques, CHU de Besançon

location_facility: Service de neuropédiatrie, CHU Hôpital Gui de Chauliac

location_facility: Laboratoire de Génétique chromosomique, CHU Hôpital l'Archet 2

location_facility: Handicaps de l'Enfant - Pavillon Ste Marie, CHU St Jacques

location_facility: Service de génétique médicale, CHU Hôpital Purpan, CHU de Toulouse

location_facility: Unité de génétique, Groupe hospitalier Hôpital Flaubert


title: Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma

acronym: MYOCET

summary:
The purpose of this study is to determine the toxicity and tolerance of Myocet® in children and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20% of the dose recommended for adults and a dose recommended for adults, administered in single dose in 1-hour perfusion each 21 days.

Other purposes are to determine the recommended dose of Myocet and to assess the response to drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite doxorubicinol during 72 hours after Myocet administration will also be studied.

location_facility: Unité d'Hémato-Oncologie, CHU, Hôpital des enfants


title: Study of the Agreement Between Two Methods of Measuring Brachial Systolic Pressure (SFATI or Auscultatory) in Pregnant Women With or Without Blood Pressure Disorders and Search for Markers of Arterial Stiffness in Pre-eclampsia.

acronym: SFATI GROPE

summary: The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method is an accurate means of measuring systolic blood pressure in pregnant women at a risk of pre-eclampsia. As the presence of arterial calcifications only changes the concordance between the SFATI method and the auscultatory reference method if calcifications are very severe, it should make it possible to identify, at an early stage, those women with a higher risk of developing pre-eclampsia. This is a transversal study with monocentric prospective recruitment to evaluate a non-CE (Conformité Européenne) -marked medical device in a diagnostic situation.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Recherche de Marqueurs Pronostiques électro-physiologiques précoces Chez l'Aphasique après un Accident Vasculaire cérébral.APHA-TMS

acronym: APHA-TMS

summary: The purpose of this study is to study, among the aphasic person, if motor function ( studied by Motor Evoked Potentials) performed within the first 14 days after a stroke can predict a good recovery from aphasia 6 months of the initial episode.

ReferenceCitation: Dickey, L., A. Kagan, et al. (2010).

ReferenceCitation: El Hachioui, H., H. F. Lingsma, et al. (2013).

ReferenceCitation: Fadiga L, Craighero L, Buccino G, Rizzolatti G. Speech listening specifically modulates the excitability of tongue muscles: a TMS study. Eur J Neurosci. 2002 Jan;15(2):399-402.

ReferenceCitation: Meister IG, Wilson SM, Deblieck C, Wu AD, Iacoboni M. The essential role of premotor cortex in speech perception. Curr Biol. 2007 Oct 9;17(19):1692-6. Epub 2007 Sep 27.

ReferenceCitation: Meister IG, Sparing R, Foltys H, Gebert D, Huber W, Töpper R, Boroojerdi B. Functional connectivity between cortical hand motor and language areas during recovery from aphasia. J Neurol Sci. 2006 Sep 25;247(2):165-8. Epub 2006 Jun 5.

ReferenceCitation: Meister IG, Buelte D, Staedtgen M, Boroojerdi B, Sparing R. The dorsal premotor cortex orchestrates concurrent speech and fingertapping movements. Eur J Neurosci. 2009 May;29(10):2074-82. doi: 10.1111/j.1460-9568.2009.06729.x. Epub 2009 May 9.

ReferenceCitation: Tokimura H, Tokimura Y, Oliviero A, Asakura T, Rothwell JC. Speech-induced changes in corticospinal excitability. Ann Neurol. 1996 Oct;40(4):628-34.

publications_result: Dickey, L., A. Kagan, et al. (2010).

lead_sponsor: University Hospital, Bordeaux


title: Evaluation de la COagulopathie et de la Dysfonction enDOthéliale Comme Facteur prédictif de la gravité de l'Infection Par SARS-CoV-2 / COVID-19

acronym: SARCODO

summary:
On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency of international concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003, SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations of SARS-CoV-2 are dominated by respiratory symptoms, some patients have severe cardiovascular damage. In addition, patients with underlying cardiovascular disease may be at increased risk of death. Therefore, understanding the impairments caused by SARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmost importance.

Circulating endothelial cells (CECs) are generally considered markers of lesions and may be non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection. Another marker of endothelial activation could be circulating extracellular vesicles. They could also be involved in the spread of the virus. Thus this project proposes to study different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose to fully study activation state of coagulation and endothelium on a plasma and cellular side in patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will be included: without lung disease, with a more or less severe lung disease, i.e. having evolved or not towards acute respiratory distress syndrome (ARDS). Extensive research of biomarkers will be compared to the detection of the virus in the respiratory tract as well as in the blood. This work will contribute to a better description of disease pathophysiology and should allow us to identify a patient profile in whom preventive or curative anticoagulant therapy could be considered.

ipd_sharing: Yes

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

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Cochin


title: Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications

acronym: GLUTADIAB

summary: Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans

location_facility:
Diabetologie Bichat
Diabétologie - Hôpital Lariboisière


title: Clinical and Multi-omics Cross-phenotyping of Patients With Autoimmune and Auto-inflammatory Diseases

acronym: TRANSIMMUNOM

summary: The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.

ReferenceCitation: Lorenzon R, Mariotti-Ferrandiz E, Aheng C, Ribet C, Toumi F, Pitoiset F, Chaara W, Derian N, Johanet C, Drakos I, Harris S, Amselem S, Berenbaum F, Benveniste O, Bodaghi B, Cacoub P, Grateau G, Amouyal C, Hartemann A, Saadoun D, Sellam J, Seksik P, Sokol H, Salem JE, Vicaut E, Six A, Rosenzwajg M, Bernard C, Klatzmann D. Clinical and multi-omics cross-phenotyping of patients with autoimmune and autoinflammatory diseases: the observational TRANSIMMUNOM protocol. BMJ Open. 2018 Aug 30;8(8):e021037. doi: 10.1136/bmjopen-2017-021037.

location_facility: CIC Paris-Est, Hôpital PITIE SALPETRIERE


summary: The project aims to precisely quantify the postprandial amino acid utilization of egg proteins in vivo in humans, and also to assess their satiating power, in relation with nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an egg test meal. The second one is a cross over design performed on 30 volunteers to compare the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.

ReferenceCitation: Fromentin C, Tomé D, Nau F, Flet L, Luengo C, Azzout-Marniche D, Sanders P, Fromentin G, Gaudichon C. Dietary proteins contribute little to glucose production, even under optimal gluconeogenic conditions in healthy humans. Diabetes. 2013 May;62(5):1435-42. doi: 10.2337/db12-1208. Epub 2012 Dec 28.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility:
Centre de recherche sur Volontaires
Centre de recherche sur volontaires

intervention_type: Dietary Supplement


title: Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer

acronym: NANOCOL

summary:
This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method.

Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).

location_facility:
Centre Hospitalier Lyon Sud
Gustave Roussy

intervention_type: Radiation


title: IMPACT: International Post Market Product Surveillance Study of IntrACranial Aneurysms Treated With an Endovascular Approach

acronym: IMPACT

summary: IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.

ipd_sharing_description: After completion of the 12-month primary endpoint report, and under the guidance of a physician lead publication committee, a multi-center abstract reporting the results will be prepared and may be presented at a major meeting(s). A multi-center publication may also be prepared for publication in a peer reviewed scientific journal.

lead_sponsor: Stryker Neurovascular

location_country:
United Kingdom
Italy
Austria
Finland
Switzerland
France
Germany

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: University Hospital Knappschaftskrankenhaus Bochum


type: Registry Identifier

title: Pathogenic Study of Adult Immune Enteropathies

acronym: ENTEROPAH

summary: The study focuses the mechanisms underlying the loss of intestinal homeostasis in celiac disease, refractory celiac disease and other immune diseases such as monogenic enteropathy, inflammatory bowel diseases or drug induced intestinal diseases. Mechanisms of transformation of lymphocytes leading to onset of lymphomatous complications of immune enteropathies will be investigated. Mechanisms of loss of hepatic lymphocytic homeostasis will also be assessed in liver associated diseases.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Hôpital Bicêtre
Hôpital Saint Antoine
Hôpital Saint Louis
Hôpital Cochin
Hôpital Beaujon
Hôpital Henri Mondor

intervention_type: Genetic


title: Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test

acronym: HeMO

summary: Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.

primary_purpose: Screening

ReferenceCitation: Raginel T, Puvinel J, Ferrand O, Bouvier V, Levillain R, Ruiz A, Lantieri O, Launoy G, Guittet L. A population-based comparison of immunochemical fecal occult blood tests for colorectal cancer screening. Gastroenterology. 2013 May;144(5):918-25. doi: 10.1053/j.gastro.2013.01.042. Epub 2013 Feb 1.

location_facility:
Adoc18 - Irsa
ADECA


title: Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.

acronym: EXEPUMP

summary: The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.

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


title: Epidemiological, Immunological, Pathological and Pharmacogenetic Study of Cancers Occuring After Solid Organs Transplants

acronym: K-GREF

summary:
About 1500 solid organs transplants are performed each year in the Paris agglomeration.

Cancer risk in the transplanted is about three times higher than in a population of the same age without any organ transplant. Thus cancer is an important problem for organ transplant.

These cancers can be related to many factors :

Post-transplant cancers are due in part to the non specific immunosuppression, which leads to oncogenic viruses replication, and then produces virus inducted cancers (as lymphoma due to EBV virus).
Post-transplant cancers can also be due to the carcinogenic factors of the immunosuppressive drugs (as cyclosporine or tacrolimus, which can cause the appearance of metastases). However, a new type of immunosuppressive drugs (mTOR inhibitors) appear to have anti-cancer properties.
Post-transplant cancers which are not virus-inducted can be relied to genetic factors of the transplanted patient and/or the transplant donor.

There are 4 axes in this study :

Axis 1 : Epidemiological, clinical and biological study of the incident cancers in transplanted patients.
Axis 2 : Qualitative and quantitative immunological study of lymphocyte cells by the transplanted patient (determine their characteristics when a cancer appears).
Axis 3 : Pathological and genetic study of the post-transplant cancer cells (see if the cancer is caused by the donor or the recipient). Creation of a biobank.
Axis 4 : Pharmacogenetic study of the immunosuppressive drugs (determine the impact of patient genetic variability on tolerance and efficiency of the immunosuppressive drugs).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Bicêtre - Assistance Publique-Hôpitaux de Paris


title: Definition of Crises in Medical Oncology: a Two-way Perspective of Patients and Caregivers, a Prospective Observational Study.

acronym: COPE

summary: Our objective is to identify the main crises facing the patients and caregivers in medical oncology and rank them by order of importance. Each group of participant will also express its perception of other participants' list of crises.

ReferenceCitation: Carnevale FA, Farrell C, Cremer R, Canoui P, Séguret S, Gaudreault J, de Bérail B, Lacroix J, Leclerc F, Hubert P. Struggling to do what is right for the child: pediatric life-support decisions among physicians and nurses in France and Quebec. J Child Health Care. 2012 Jun;16(2):109-23. doi: 10.1177/1367493511420184. Epub 2012 Jan 13.

ReferenceCitation: Coast J, Bailey C, Orlando R, Armour K, Perry R, Jones L, Kinghorn P. Adaptation, Acceptance and Adaptive Preferences in Health and Capability Well-Being Measurement Amongst Those Approaching End of Life. Patient. 2018 Oct;11(5):539-546. doi: 10.1007/s40271-018-0310-z.

ReferenceCitation: Hong P, Maguire E, Purcell M, Ritchie KC, Chorney J. Decision-Making Quality in Parents Considering Adenotonsillectomy or Tympanostomy Tube Insertion for Their Children. JAMA Otolaryngol Head Neck Surg. 2017 Mar 1;143(3):260-266. doi: 10.1001/jamaoto.2016.3365.

ReferenceCitation: Bochatay N, Bajwa NM, Cullati S, Muller-Juge V, Blondon KS, Junod Perron N, Maître F, Chopard P, Vu NV, Kim S, Savoldelli GL, Hudelson P, Nendaz MR. A Multilevel Analysis of Professional Conflicts in Health Care Teams: Insight for Future Training. Acad Med. 2017 Nov;92(11S Association of American Medical Colleges Learn Serve Lead: Proceedings of the 56th Annual Research in Medical Education Sessions):S84-S92. doi: 10.1097/ACM.0000000000001912.

ReferenceCitation: Walrath JM, Dang D, Nyberg D. An organizational assessment of disruptive clinician behavior: findings and implications. J Nurs Care Qual. 2013 Apr-Jun;28(2):110-21. doi: 10.1097/NCQ.0b013e318270d2ba.

ReferenceCitation: Knickle K, McNaughton N, Downar J. Beyond winning: mediation, conflict resolution, and non-rational sources of conflict in the ICU. Crit Care. 2012 Jun 19;16(3):308. doi: 10.1186/CC11141.

ReferenceCitation: Back AL, Arnold RM. Dealing With Conflict in Caring for the Seriously Ill n.d.:8.

ReferenceCitation: Chiarchiaro J, White DB, Ernecoff NC, Buddadhumaruk P, Schuster RA, Arnold RM. Conflict Management Strategies in the ICU Differ Between Palliative Care Specialists and Intensivists. Crit Care Med. 2016 May;44(5):934-42. doi: 10.1097/CCM.0000000000001583.

ReferenceCitation: Park M, Jeon SH, Hong HJ, Cho SH. A comparison of ethical issues in nursing practice across nursing units. Nurs Ethics. 2014 Aug;21(5):594-607. doi: 10.1177/0969733013513212. Epub 2014 Jan 21.

ReferenceCitation: Breslin JM, MacRae SK, Bell J, Singer PA; University of Toronto Joint Centre for Bioethics Clinical Ethics Group. Top 10 health care ethics challenges facing the public: views of Toronto bioethicists. BMC Med Ethics. 2005 Jun 26;6:E5.

ReferenceCitation: Killen AR, Fry ST, Damrosch S. Ethics and human rights issues in perioperative nurses: a subsample of Maryland nurses. Semin Perioper Nurs. 1996 Apr;5(2):77-83.

ReferenceCitation: Hsu C-C, Sandford BA. The Delphi Technique: Making Sense Of Consensus n.d.;12:8.

ReferenceCitation: Blackwood B, Albarran JW, Latour JM. Research priorities of adult intensive care nurses in 20 European countries: a Delphi study. J Adv Nurs. 2011 Mar;67(3):550-62. doi: 10.1111/j.1365-2648.2010.05512.x. Epub 2010 Nov 23.

ReferenceCitation: Meskell P, Murphy K, Shaw DG, Casey D. Insights into the use and complexities of the Policy Delphi technique. Nurse Res. 2014 Jan;21(3):32-9. doi: 10.7748/nr2014.01.21.3.32.e342.

ReferenceCitation: Démographie des professionnels de santé : qui sont les médecins en 2018 ? Quelle accessibilité aux médecins généralistes ? Combien d'infirmiers en 2040 ? Un outil de projections d'effectifs de médecins - Ministère des Solidarités et de la Santé n.d. http://drees.solidarites-sante.gouv.fr/etudes-et-statistiques/publications/communiques-de-presse/article/demographie-des-professionnels-de-sante-qui-sont-les-medecins-en-2018-quelle.

ReferenceCitation: La profession d'infirmière : situation démographique et trajectoires professionnelles - Data.gouv.fr n.d. /fr/datasets/la-profession-d-infirmiere-situation-demographique-et-trajectoires-professionnelles-30378340/ .

location_facility: APHP Assistance Publique des Hôpitaux de Paris


title: Randomized Double-Blind Study of Food Supplement Phytalgic on Symptoms of Osteoarthritis

summary: The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics on a regular basis.

ReferenceCitation: Jacquet A, Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial. Arthritis Res Ther. 2009;11(6):R192. doi: 10.1186/ar2891. Epub 2009 Dec 16.

lead_sponsor: Université Victor Segalen Bordeaux 2


title: Study of Pimavanserin Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease

acronym: PIMPARK

summary:
There is no consensus on the treatment of Impulse Control Disorder (ICD) in Parkinson Disease (PD) though it is recommended to reduce the dosage of dopamine agonists (DA).

Reduction of DA frequently leads to a worsening of motor signs (parkinsonism or dyskinesias due to the concomitant increase of levodopa doses) and non-motor signs with the appearance of a DA withdrawal syndrome (DAWS).

Chronic stimulation of the sub-thalamic nuclei may reduce ICD but is restricted to a minority of patients and cases of new-onset ICD symptoms post stimulation have been reported. The benefit of amantadine in pathological gambling is controversial and the efficacy of clozapine has been reported in a few cases but with serious safety limitations. Very recently, naltrexone did not significantly improve ICD.

Thus, an efficacious and safe treatment of ICD in PD remains an unmet need for clinical practice.

Recently, it has been reported that pimavanserin, a selective serotonin 5-HT2A inverse agonist with a satisfactory safety profile without motor side effects, was efficient in improving psychosis, insomnia and day-time sleep in PD.

Pimavanserin, marketed under the tradename NUPLAZID® was approved in 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

The link between serotonin and ICD has been well established, since the enhancement of 5HT2A receptors stimulation is associated to ICD, since serotonin modulates mesolimbic dopaminergic reward system transmission and given that serotonin neurotransmission is increased during chronic intake of dopamine agonist such as pramipexole which is well-known to induce ICD in PD patients. Thus, there is a large body of evidence suggesting that the decrease of the 5HT2A activity could be efficient in reducing ICD in PD. This further supports the concept of testing the efficacy of pimavanserin (a selective 5HT2A inverse agonist) for treating ICD in PD. Our aim is to conduct a study evaluating the efficacy and safety of pimavanserin on ICD in PD.

This clinical trial is conducted with the support of the French NS-Park/FCRIN (French Clinical Research Infrastructure Network) network.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvement Anormaux/Centre expert Parkinson, CHU de Lille, Hopital Roger Salengro

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CIC, CHU de Nantes, Hopital Laennec

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson CHU Clermont-Ferrand, Hopital Gabriel Montpied

location_facility: SERVICE DE NEUROLOGIE Unité de Mouvements Anormaux/Centre expert Parkinson, CHU de Strasbourg, Hopital de Hautepierre

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Limoges

location_facility: SERVICE DE NEUROLOGIE Centre Expert Parkinson Hopital de la Pitié-Salpêtrière

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Rouen, Hopital Charles Nicolle

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvement Anormaux/Centre expert Parkinson, Hopital de la Timone

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CIC, CHU de Toulouse, Hopital Pierre-Paul Riquet

location_facility: SERVICE DE NEUROLOGIE C, Unité mouvement anormaux/Centre expert Parkinson, CHU de Lyon, Hopital neurologique Pierre Wertheimer

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, Hopital Henri Mondor

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Rennes, Hopital Pontchaillou

location_facility: Centre d'Inverstigation Clinique, CHU de Poitiers

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Grenoble Alpes


title: Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation

acronym: AVKDIAL

summary:
Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. However, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths.

The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients with atrial fibrillation.

status: Active, not recruiting

location_facility: Centre Hospitalier de Haguenau - service de Néphrologie

location_facility: Service de Néphrologie et médecine interne

location_facility: Service Néphrologie, Dialyse, Transplantation


title: Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis : a Pilot Study

acronym: PIM

summary: Patients with end-stage cystic fibrosis (CF) and severe CF-related diabetes (CFRD) may benefit from combined lung-pancreatic islet transplantation. A recent case series showed that combined bilateral lung and pancreatic islet transplantation is a viable therapeutic option for patients with end-stage CF and CFRD. The use of different organs from a single donor may lead to reduced immunogenicity. As the prevalence of CFRD has increased dramatically with the improved life expectancy of patients with CF, islet transplantation should be considered at the end-stage CF. By restoring metabolic control, the investigators hypothesize that islet transplantation may improve the management of CF patients undergoing lung transplant and decrease the complication rate in the early postoperative period.

ReferenceCitation: Rakotoarisoa L, Wagner C, Munch M, Renaud Picard B, Grenet D, Olland A, Greget M, Enescu I, Bouilloud F, Bonnette P, Guth A, Bosco D, Mercier C, Rabilloud M, Berney T, Yves Benhamou P, Massard G, Camilo C, Colin C, Arnold C, Kessler R, Kessler L; GRAGIL-TREPID Group. Feasibility and efficacy of combined pancreatic islet-lung transplantation in cystic fibrosis-related diabetes-PIM study: A multicenter phase 1-2 trial. Am J Transplant. 2022 Jul;22(7):1861-1872. doi: 10.1111/ajt.17058. Epub 2022 Apr 26.

location_facility: Service de chirurgie, Nouvel Hôpital Civil

location_facility: Service de Néphrologie et Immuno-transplantation

location_facility: Service de pneumologie, Hôpital Louis Pradel

location_facility: Service de médecine de la transplantation et immunologie clinique, Hôpital Edouard Herriot

location_facility: Service d'endocrinologie, diabète et maladies métaboliques

location_facility: Service d'Endocrinologie, CHU de Grenoble

location_facility: Service de la Clinique d'Endocrinologie, maladies métaboliques et Nutrition

location_facility: Service de Radiologie Interventionnelle, CHU de Grenoble

location_facility: Service de Chirurgie Thoracique et Transplantation Pulmonaire - Hôpital Foch

location_facility: Service d'Endocrinologie, Pavillon médical

location_facility: Service de Pneumologie, Hôpital A. MICHALLON , CHU de Grenoble

location_facility: CRCM adulte, Centre Hospitalier Lyon-Sud

location_facility: Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon

location_facility: Service d'Anesthésie-Réanimations chirurgicales, Nouvel Hôpital Civil

location_facility: Service de Chirurgie Cardiaque, CHU Grenoble

location_facility: Service d'imagerie radiologique et de médecine nucléaire, Centre Hospitalier Lyon-Sud

location_facility: Service de Chirurgie Thoracique, HOPITAL LOUIS PRADEL

location_facility: Unité d'Endocrinologie, Diabétologie et Médecine Métabolique - Hôpital Foch

location_facility: Service d'Urologie et chirurgie de la Transplantation, Groupement Hospitalier Edouard Herriot

location_facility: Service de Radiologie, Hôpital de Hautepierre

location_facility: CRCM AdulteCHU de Grenoble, Hôpital A. Michallon

location_facility: Service de pneumologie, Nouvel Hôpital Civil


title: Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

acronym: ROC

summary: Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.

ReferenceCitation: Nguyen MVC, Courtier A, Adrait A, Defendi F, Couté Y, Baillet A, Guigue L, Gottenberg JE, Dumestre-Pérard C, Brun V, Gaudin P. Fetuin-A and thyroxin binding globulin predict rituximab response in rheumatoid arthritis patients with insufficient response to anti-TNFα. Clin Rheumatol. 2020 Sep;39(9):2553-2562. doi: 10.1007/s10067-020-05030-6. Epub 2020 Mar 24.

ReferenceCitation: Virone A, Bastard JP, Fellahi S, Capeau J, Rouanet S, Sibilia J, Ravaud P, Berenbaum F, Gottenberg JE, Sellam J. Comparative effect of tumour necrosis factor inhibitors versus other biological agents on cardiovascular risk-associated biomarkers in patients with rheumatoid arthritis. RMD Open. 2019 Jul 21;5(2):e000897. doi: 10.1136/rmdopen-2019-000897. eCollection 2019.

ReferenceCitation: Rivière E, Sellam J, Pascaud J, Ravaud P, Gottenberg JE, Mariette X. Serum IL-33 level is associated with auto-antibodies but not with clinical response to biologic agents in rheumatoid arthritis. Arthritis Res Ther. 2018 Jun 8;20(1):122. doi: 10.1186/s13075-018-1628-6.

ReferenceCitation: Gottenberg JE, Brocq O, Perdriger A, Lassoued S, Berthelot JM, Wendling D, Euller-Ziegler L, Soubrier M, Richez C, Fautrel B, Constantin AL, Mariette X, Morel J, Gilson M, Cormier G, Salmon JH, Rist S, Lioté F, Marotte H, Bonnet C, Marcelli C, Sellam J, Meyer O, Solau-Gervais E, Guis S, Ziza JM, Zarnitsky C, Chary-Valckenaere I, Vittecoq O, Saraux A, Pers YM, Gayraud M, Bolla G, Claudepierre P, Ardizzone M, Dernis E, Breban MA, Fain O, Balblanc JC, Aberkane O, Vazel M, Back C, Candon S, Chatenoud L, Perrodeau E, Sibilia J, Ravaud P. Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug: A Randomized Clinical Trial. JAMA. 2016 Sep 20;316(11):1172-1180. doi: 10.1001/jama.2016.13512.

location_country: France Monaco

location_facility: Centre Hospitalier de Belfort-Montbéliard

location_facility: Centre Hospitalier - Princesse Grâce de Monaco

location_facility: Centre Hospitalier Régional d'Orléans, Hôpital de la Source

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre Hospitalier de Mulhouse - Hôpital Emile Muller

location_facility: Groupe Hospitalier du Havre - Hôpital J.Monod

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon


title: Place de l'Iode RadioActif Dans l'HyperThyroïdiE Sub-clinique (PIRHATES)/ Evaluation of the Interest of Subclinical Hyperthyroidism Treatment

summary: Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition.

location_facility:
Centre Paul Strauss
Marie-Pierre Teissier
Bernard Conte-Delvox
Michel Rodier
Hopitaux Universitaires de Strasbourg
Jean-Louis Wemeau
Philippe Caron
Jacques Orgiazzi
Jean-Marc Kuhn
Philippe Thiéblot
Jean-Marcel Brun
Bruno Estour
Marc Klein
Claire Schvartz
CH de Montbrison
Patrick Roger
Brigitte Delemer
Jacques Bringer
Laurence Leenhardt
Pierre Lecomte
Richard Marechaud


title: EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES (ICA-MEESSI)

acronym: ICA-MEESSI

summary:
Our primary purpose is to assess MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.

European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI score is not prospectively validated out of Spain.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Comparison of Thoracolumbar Back Pain After Brace Treatment Versus Percutaneous Instrumentation in Adult Pyogenic Spondylodiscitis Combined With Antibiotic Treatment

acronym: COROSIVE

summary: Pyogenic spondylitis in adults is usually treated by antibiotics according to bacteria evidenced in a diagnostic intervertebral disc puncture. Brace treatment is associated in patients presenting back pain and a risk for vertebral body collapse due to infection with subsequent kyphotic deformity of the thoracolumbar spine. Percutaneous minimally invasive posterior spinal instrumentation has evolved over the last decade and indications in infections arouse over the last years. This procedure is interesting as it is performed through small skin incisions only. It avoids paravertebral muscle dissection and thus limits intraoperative bleeding and access morbidity. Recent retrospective data suggests that this internal fixation represents a theoretical advantage over brace treatment by lowering back pain and increasing patient's quality of life in the short run, up to 3 months, but no randomized study was published. The patient's autonomy, including walking ability and daily activities, might improve more rapidly after a percutaneous procedure. Additionally, the sagittal alignment of the thoracolumbar spine could be better maintained by internal fixation, which might prevent progression into kyphosis and improve long-term outcome. The hypothesis is the superiority of percutaneous minimally invasive instrumentation on brace treatment in term of quality of life, back pain and quality of osseous healing.

location_facility: CHU François Mitterand - Bocage central - Service de Neurochirurgie

location_facility: Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie

location_facility: Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie

location_facility: CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne

location_facility: CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I

location_facility: Hôpital Gui de Chauliac - Service de Neurochirurgie

location_facility: Hôpital Central - Service de Neurochirurgie

location_facility: CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie

location_facility: Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

location_facility: CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis

location_facility: CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique

location_facility: Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique

location_facility: CHU Hôtel Dieu - Service de Neurotraumatologie


title: Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia After Reduction of Immunosuppression Alone vs. Reduction of Immunosuppression and Replacement of Mycophenolate Mofetil by Everolimus

acronym: BK EVER

summary: BK virus nephropathy (BKVN), a consequence of the strong immunosuppressive therapy given after kidney transplantation, represents a growing problem in the kidney transplant (KT) setting. In recent cohorts, BKVN concerns up to 10% of kidney transplant recipients and early signs of BK virus (BKV) infection as development of asymptomatic viruria and viremia are even much more frequent (40% and 20% of patients, respectively). In this context, finding strategies to prevent BKV infection or treat patients before the occurrence of BKV nephropathy is challenging. For several years, detection of BKV replication by real-time PCR in urine and/or blood of kidney transplant recipients at early stages of infection allowed adaptation of their therapy. As BKV reactivates essentially in patients with over-immunosuppression, the first step of the treatment is the reduction of immunosuppression. However, reducing immunosuppression (IS) can lead to acute rejection and allograft loss. Other treatments have been proposed (cidofovir, quinolones) but their toxicity profile or their lack of clinical efficacy are now demonstrated. Hence, an efficient and safe strategy against uncontrolled BKV replication is urgently needed. MTor-inhibitors are well known immunosuppressive drugs used in organ transplantation to prevent graft-rejection. They have furthermore anti-viral effects that can be beneficial for prevention of viral infections after transplantation. Recent evidence that inhibition of mTor pathway had an impact on BK infected cells provides additional insight into the observed benefits associated with these drugs. The aim of our study is to evaluate the effect of the mTor inhibitor everolimus on the prevention of severe BKV infection (BKV nephropathy or loss of the allograft) after kidney transplantation compared to the reduction of immunosuppression alone in kidney recipients with BK viremia.

location_facility:
CHU - Hôpital Maison Blanche
Hôpital Edouard Herriot
Les Hôpitaux Universitaires
CHRU d'Angers
CHRU - Hôpital Bretonneau
CHU Poitiers - Hôpital Jean Bernard
CHU Hôpital Gabriel Montpied
CHU Côte de Nacre
CHU - Hôpital de la Cavale Blanche
CHU - Hôpital Sud
AP-HP Hôpital Necker
CHU - Hôpital Dupuytren
CHU Rennes - Hôpital Pontchaillou
AP-HP - Hôpital Georges Pompidou


title: Clinical Study of a Single Ciliopathy: Alström Syndrome

summary:
The aim of the study is to characterize the clinical manifestations of ALMS within the ciliopathies to prevent complications and determine preventive and therapeutic targets.

The investigators believe that the clinical consequences of mutations in the gene result ALMS1 unprecedented protests and the ALMS study should help to be informed, not only about the understanding and decision support other ciliopathies, but also about some common diseases, as some physiopathogenic roads could be common; the rare disease being exacerbated a model of the channel concerned. Secondarily, the clinical data generated by this project will also be used as part of basic research (eg comparison with results in animal models, use of human cells for in vitro studies or transcriptomic ....) (which will be a secondary upgrading to this work).

location_facility: Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de physiologie et des Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service de Génétique Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service d'Imagerie 1, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de Pédiatrie 1, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de Psychothérapie pour Enfants et Adolescents, Hôpital Civil, Hôpitaux Universitaires

location_facility: Clinique Psychiatrique, Hôpital Civil, Hôpitaux Universitaires

location_facility: Service de Médecine Interne, Endocrinologie et Nutrition, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de Cardiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service de néphrologie et hémodialyse, Hôpital Civil, Hôpitaux Universitaires

location_facility: Centre d'Investigation Clinique, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Centre de Référence pour les Affections Rares en Génétique Ophtalmologique (CARGO), Hôpitaux Universitaires


title: Multicenter Randomized Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery.

acronym: SIGMOIDITE

summary:
Sigmoid diverticular diseases is a pathologie frequent in patients above 60 years old. A person with diverticulosis may have few or no symptoms. When a diverticulum ruptures and infection sets in around the diverticulum the condition is called diverticulitis. An individual suffering from diverticulitis may have abdominal pain, abdominal tenderness, and fever. Bleeding originates from a diverticulum, it is called diverticular bleeding. Frequent hospitalisations as a result of the evolution of purulent peritonitis that originates from diverticulitis treated by mini-invasive surgery results.

Radiological percutaneous drainage and washing of the abdominal cavity during laparoscopic generalized purulent peritonitis of diverticular origin have been identified as therapeutic options by HAS (French health authorities), followed by second stage resection-anastomosis under elective surgery. It has been observed in patients that if only drainage and washing are performed (without resection), then the morbidity (10%) and mortality (1.5%) rates are much lower than usual rates (after resection) respectively 20-40% and 10-30%. Furthermore this reduces the risks of postoperatory complications.

Some studies have shown that the attitude of non-distance resection of the acute episode was associated with a recurrence rate of diverticulitis less than 5% recurrence without gravity. In addition, the morbidity associated with intervention sigmoid resection is around 30%.

The question arises in our daily practice, or not to propose systematic resection of sigmoid diverticulitis after an acute episode of severe purulent peritonitis or abscess types supported initially by minimally invasive.

The primary objective of the study is to determine, after clinical improvement linked to conservative treatment of perforated diverticulitis Hinchey peritonitis stage II and III, if a conservative approach reduces morbidity compared with a cold sigmoid resection attitude as currently recommended.

The secondary objective of the study is to determine if conservative treatment reduces mortality, length of hospital stay compared with cumulative sigmoid diverticular disease and improves quality of life.

location_facility: Service de chirurgie digestive Hotel Dieu

location_facility: Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire

location_facility: Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,

location_facility: chirurgie digestive et générale, Hôpital C Huriez Place de Verdun

location_facility: Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière

location_facility: Service de chirurgie digestiveCentre Hospitalier Bretagne Sud

location_facility: Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré

location_facility: Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers

location_facility: Clinique Universitaire de Chirurgie Digestive et de l'Urgence

location_facility: Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054

location_facility: Chirurgie générale et digestive,Hôpital de Hautepierre,

location_facility: Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec


title: Schnitzler Syndrome: Clinical Study, Physiopathological and Search for Genetic

summary: The Schnitzler syndrome is a rare entity characterized by an urticarial rash and recurrent fever in a patient with a monoclonal IgM component. Other frequent signs include joint, bone and muscle pain, enlarged spleen, liver and lymph nodes, increased blood sedimentation rate (BSR), elevated neutrophil count and abnormalities on bone morphologic investigations. In 2001, the investigators proposed criteria to diagnose this syndrome, which are currently admitted in the literature. The main complications of the Schnitzler syndrome are a difficult-to-control inflammatory anemia, AA-amyloidosis and malignant B lymphoproliferative disorders. About 15% of patients with a Schnitzler will eventually develop a lymphoproliferative disorder; thus this syndrome allows studying the relationship between lymphomagenesis and inflammation. By many aspects, the Schnitzler syndrome is reminiscent of auto-inflammatory syndromes. Though the term auto-inflammatory disease is as to yet restricted to diseases with Mendelian inheritance, some polygenic inflammatory diseases like for example Crohn's disease clearly involve pathogenetic pathways shared with the monogenic auto-inflammatory syndromes. The investigators stipulate that this could also be the case in the Schnitzler syndrome for the following reasons: (1) this is a recurrent fever of unknown cause; (2) the peculiar eruption, characterized pathologically by a neutrophilic infiltrate very similar to the one observed in the auto-inflammatory cryopyrinopathies (CINCA/NOMID syndrome, Muckle-Wells syndrome and familial cold-urticaria); the investigators recently individualized this particular eruption, significantly associated with systemic inflammatory disease, within the group of neutrophilic urticarias (Kieffer et al. Medicine, in press); (3) the occurrence of aseptic neutrophilic osteitis, very similar to the one reported in patients with Majeed syndrome, another auto-inflammatory syndrome; (4) a significant increase of neutrophil count, not otherwise explained; (5) a spectacular response to the IL-1 inhibitor, within hours after the first injection, similar to what is reported in the PAPA (pyogenic arthritis, pyoderma gangrenosum and acne) syndrome or the cryopyrinopathies, suggesting a direct pathogenic effect of IL-1.

location_country: France Italy

location_facility: Unité de médecine interne Centre Hospitalier G. Renon

location_facility: Service d'immuno-hématologie Hôpital St-Louis 1 av Claude Vellefaux

location_facility: Centre Hospitalier Général Bd Yves du Manoir

location_facility: Service de DermatologieCHU Morvan5 avenue Foch

location_facility: Azienda Ospedaliero Universitaria Policlinico

location_facility: Service de Médecine Interne Hôpital Claude-Huriez

location_facility: Clinica DermatologicaUnivesité de GênesVialle Benedetto

location_facility: Service de médecine interne-néphrologie Centre Hospitalier Valenciennes

location_facility: Service médecine interne et thérapeutique Hôpital sainte marguerite

location_facility: Service de dermatologie CHU Hôtel Dieu1 place Alexis Ricordeau

location_facility: Service de médecine interne Hôpital Tenon4, rue de la Chine

location_facility: Service de Rhumatologie Centre Hospitalier du Mans

location_facility: Service de Dermatologie Hôpital Saint Eloi 80 avenue A Fliche

location_facility: Service de dermatologieCHU GUERIN2 rue de la Milétrie