title: Institutional Management and Professional Experience During the Pandemic COVID-19 by Health Care Institutions in the Auvergne-Rhône-Alpes Region: Assessment and Lessons Learned

acronym: COPING

summary:
Covid-19 has increased organizational tensions within health services (lack of resources, difficulties in recruiting healthcare professionals , elderly and polypathological patients, etc.) and tested the reliability of health facilities. This project aims to draw lessons so that hospitals can transform themselves while improving their reliability to face future crises and other exceptional situations.

Research hypothesis:

Crisis management arrangements lack sensitivity to uncertainty, which manifests itself in lower quality of care and efficiency losses for the entire institution.

The virtuous practices implemented during the crisis spontaneously incorporated principles of the highly reliable organization.

The integration of principles from complexity theory into the management of institutions promotes high reliability organization.

Sustaining these virtuous practices in order to anticipate and cope with crises requires the activation of two interconnected levers: a shared vision (by patients, healthcare professionals, ARS, HAS, and the Ministry in the first place) of the meaning of the action taken by hospitals, and the development of a policy enabling hospitals to become both learning and highly reliable.

Main objective:

To evaluate the management process of the Covid-19 epidemic by the university hospitals of the Auvergne-Rhône-Alpes region, and the structures linked to them (establishments in their territory, ARS, user associations), in terms of points of improvement and good practices. This evaluation concerns the preparation, management and exit phases of the crisis.

lead_sponsor: Hospices Civils de Lyon

location_facility: CHU Grenoble, Pôle Santé Publique, service de veille sanitaire

location_facility: CHU Saint-Etienne , Unité de gestion du risque infectieux

location_facility: CHU Clermont-Ferrand , Pôle de Santé Publique, unité d'Epidémiologie, Economie de la Santé et Prévention


title: Double-blind, Parallel Group, Placebo-controlled Trial of the Efficacy and Tolerability of Memantine (20 mg) in Frontotemporal Dementia (FTD) Patients

summary: The purpose of this trial is to assess the efficacy and tolerability of memantine (anti-excitotoxic, neuroprotective treatment currently used in Alzheimer's disease [AD]) in frontotemporal dementia patients after a one-year treatment.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Boutoleau-Bretonniere C, Lebouvier T, Volteau C, Jaulin P, Lacomblez L, Damier P, Thomas-Anterion C, Vercelletto M. Prospective evaluation of behavioral scales in the behavioral variant of frontotemporal dementia. Dement Geriatr Cogn Disord. 2012;34(2):75-82. doi: 10.1159/000341784. Epub 2012 Aug 23.

ReferenceCitation: Vercelletto M, Boutoleau-Bretonniere C, Volteau C, Puel M, Auriacombe S, Sarazin M, Michel BF, Couratier P, Thomas-Anterion C, Verpillat P, Gabelle A, Golfier V, Cerato E, Lacomblez L; French research network on Frontotemporal dementia. Memantine in behavioral variant frontotemporal dementia: negative results. J Alzheimers Dis. 2011;23(4):749-59. doi: 10.3233/JAD-2010-101632.

lead_sponsor: Nantes University Hospital

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Multidimensional Assessment of Tele-expertise for Frozen Section Diagnosis

acronym: Télé-extempo

summary: The purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique.

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Gould PV, Saikali S. A comparison of digitized frozen section and smear preparations for intraoperative neurotelepathology. Anal Cell Pathol (Amst). 2012;35(2):85-91. doi: 10.3233/ACP-2011-0026.

ReferenceCitation: Tetu B, Fortin JP, Gagnon MP, Louahlia S. The challenges of implementing a "patient-oriented" telepathology network; the Eastern Quebec telepathology project experience. Anal Cell Pathol (Amst). 2012;35(1):11-8. doi: 10.3233/ACP-2011-0023.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Agence Regionale de Sante d'Ile de France

location_facility: Service d'anatomie pathologique. Hôpital Bicêtre

location_facility: Service de chirurgie viscérale. Hôpital des Diaconnesses

location_facility: Service d'Anatomie pathologique. Hôpital Antoine Béclère

location_facility: Service d'anatomie pathologique. Hôpital Saint Antoine

location_facility: Service d'ORL. Hôpital du Raincy-Montfermeil

location_facility: Service d'anatomie pathologique. Hôpital de Raincy-Montfermeil

intervention_type: Device


title: Phase I/II Study of AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

acronym: NANO-GBM

summary:
This is a phase I/II clinical trial evaluating the association of AGuIX nanoparticles with radiotherapy plus concomitant Temozolomide in the treatment of newly diagnosed glioblastoma.

The primary objectives of this study were to determine the recommended dose of AGuIX in combination with radiotherapy and TMZ during the concomitant radiochemotherapy period (phase I) and to estimate the efficacy of the combination radiochemotherapy + AGuIX (recommended dose), measured by the 6-month progression-free survival rate (PFS) (phase II)

Three dose levels of intravenous AGuIX nanoparticles will be explored: 50 mg/kg, 75 mg/kg and 100 mg/kg.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Centre Jean Perrin

collaborators: Ministry for Health and Solidarity, France

location_facility: Institut de Cancérologie Strasbourg Europe

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Comparison of Non-invasive Oxygenation Strategies in ICU Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome

summary:
Acute Respiratory Distress Syndrome (ARDS) is the main clinical presentation of SARS-CoV-2 (Covid-19) infected patients admitted in Intensive Care Unit (ICU).

During the first phase of the outbreak (between February and May 2020), the use of invasive Mechanical Ventilation (MV) was largely required with 63% of ICU patients intubated in the first 24 hours after admission and up to 80% of patients during the overall ICU stay. Mortality was especially higher when using MV in the first 24 hours. In contrast, the use of non-invasive oxygenation strategies in the first 24 hours was only 19% for High Flow Nasal Cannula oxygen therapy (HFNC) and 6% for Non-Invasive Ventilation (NIV).

Several non-invasive oxygenation strategies were proposed in order to delay or avoid MV in ICU patients suffering from Covid-19 ARDS. The use of HFNC became the recommended oxygenation strategy, based in particular on publications prior to the outbreak. The use of NIV or Continuous Positive Airway Pressure (CPAP) combined with HFNC have also been proposed. Although these non-invasive oxygenation strategies seem widely used in the second phase of the outbreak, they have not yet confirmed their clinical impact on MV requirement and patient's outcome. Moreover, no comparison has been made between these different non-invasive oxygenation strategies.

The aim of this study is to compare different non-invasive oxygenation strategies (HFNC, NIV, CPAP) on MV requirement and outcome in ICU patients treated for ARDS related to Covid-19.

time_perspective: Retrospective

ReferenceCitation: COVID-ICU Group on behalf of the REVA Network and the COVID-ICU Investigators. Clinical characteristics and day-90 outcomes of 4244 critically ill adults with COVID-19: a prospective cohort study. Intensive Care Med. 2021 Jan;47(1):60-73. doi: 10.1007/s00134-020-06294-x. Epub 2020 Oct 29.

ReferenceCitation: Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.

ReferenceCitation: Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.

ReferenceCitation: Nightingale R, Nwosu N, Kutubudin F, Fletcher T, Lewis J, Frost F, Haigh K, Robinson R, Kumar A, Jones G, Brown D, Abouyannis M, Beadsworth M, Hampshire P, Aston S, Gautam M, Burhan H. Is continuous positive airway pressure (CPAP) a new standard of care for type 1 respiratory failure in COVID-19 patients? A retrospective observational study of a dedicated COVID-19 CPAP service. BMJ Open Respir Res. 2020 Jul;7(1):e000639. doi: 10.1136/bmjresp-2020-000639.

ReferenceCitation: Avdeev SN, Yaroshetskiy AI, Tsareva NA, Merzhoeva ZM, Trushenko NV, Nekludova GV, Chikina SY. Noninvasive ventilation for acute hypoxemic respiratory failure in patients with COVID-19. Am J Emerg Med. 2021 Jan;39:154-157. doi: 10.1016/j.ajem.2020.09.075. Epub 2020 Oct 1.

ReferenceType: result

ReferenceCitation: Chelly J, Coupry LM, van Phach Vong L, Kamel T, Marzouk M, Terzi N, Bruel C, Autret A, Garnero A, Arnal JM. Comparison of high-flow nasal therapy, noninvasive ventilation, and continuous positive airway pressure on outcomes in critically ill patients admitted for COVID-19 with acute respiratory failure. Minerva Anestesiol. 2023 Jan-Feb;89(1-2):66-73. doi: 10.23736/S0375-9393.22.16918-X. Epub 2022 Nov 30.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Edizioni Minerva Medica

ipd_sharing: No

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

intervention_type: Other


title: Double-Blind, Placebo Controlled Randomized Study of Co-Administering Testosterone With PDE5 Inhibitors in Patients Non-Responders to PDE5 Inhibitors Alone

summary: 30 to 50% of the patients presenting with Erectile Dysfunction (ED) do not respond to PDE V Inhibitor therapy, which is presently considered as the first choice treatment for most ED patients. Recent reports stated a high prevalence of low serum testosterone levels in such non responders, and an improvement of their response by combining testosterone therapy with the PDE V Inhibitor. This suggests there may be a minimum threshold level of blood testosterone for a full effectiveness of PDE V Inhibitor therapy. Two double blind, placebo controlled studies have added support to this hypothesis but one involved only 20 patients while in the other the benefit of combining testosterone was transient. This is a multi-centric study, double blind placebo controlled and randomized as concerns testosterone administration, that aims to objectively assess the efficacy of co-administering testosterone with the PDE 5 inhibitor Tadalafil to improve the erectile function of a large group of ED patients non-responders to PDE V inhibitors alone. Patients will be screened to ensure inclusion and exclusion criteria completion, including a serum testosterone level < 4 ng/ml for total testosterone or < 1 ng/ ml for bioavailable testosterone. They will then enter a four week run-in period in the meanwhile they will receive Tadalafil 10 mg only, once daily, in order to confirm their non responsiveness to PDE V inhibitors and their eligibility to enter the treatment phase based on IIEF scoring, SEP diaries and a Global Assessment Question (GAQ). The patients still non responders after 4 weeks of Tadalafil 10 mg daily will enter a 12 weeks treatment phase including visits at weeks 4, 8, 12 and 16. Treatment procedure will include: 1. continuation of Tadalafil at 10 mg dose daily followed by routine assessment using SEP diaries, IIEF scoring, GAQ and Aging Male Symptoms scale administered at each study visit. Safety assessments will be performed in addition during the last visit (physical examination including DRE, PSA and BCC). 2. Randomization in 2 parallel arms (Placebo gel + Tadalafil 10 mg daily, and Testosterone gel 50 mg + Tadalafil 10 mg daily). If indicated according to suboptimal clinical response of the patient, the dose of study medication will be increased at the 8 or 12 weeks visit to 100mg of testosterone or to 2 sachets of placebo gel. Up to 430 patients will be screened in order that 172 are enrolled in the double blind treatment phase.

lead_sponsor: SELARL du Dr Jacques BUVAT

sponsor_collaborators:
SELARL du Dr Jacques BUVAT
Bayer


title: Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia

summary: Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.

primary_purpose: Diagnostic

ReferenceCitation: Roman S, Huot L, Zerbib F, Bruley des Varannes S, Gourcerol G, Coffin B, Ropert A, Roux A, Mion F. High-Resolution Manometry Improves the Diagnosis of Esophageal Motility Disorders in Patients With Dysphagia: A Randomized Multicenter Study. Am J Gastroenterol. 2016 Mar;111(3):372-80. doi: 10.1038/ajg.2016.1. Epub 2016 Feb 2.

publisher_dissemination: Wolters Kluwer Health

location_facility: Unité d'Exploration Fonctionnelle Digestive - Hopital Edouard Herriot - 69437 LYON Cedex 03


title: Sleep and Appetite Measures as Suicidal Risk Factors in a French- Spanish Cohort of Suicidal Patients.

acronym: SmartCriseS

summary:
Sleep and appetite disorders as well as social exclusion, have been linked to the emergence of suicidal ideation (SI) and suicide attempts.This study aims to evaluate the relationship between those factors and suicidal ideation and behaviour. To assess those factors an ecological momentary assessment (EMA) desing will be used.

EMA will be carried out using 2 applications integrated into the smartphone of participants (Android or iOS), one to make an explicit data collection with questions and another one for the implicit collection of data from mobile sensors.

1044 suicide attempters will be included in three sites and followed for 6 months. Participants will be evaluated at inclusion and at the end of follow-up. The hypothesis is that sleep, appetite and social exclusion factors collected with the smartphone application will be linked to the intensity of death wish, suicidal ideations and suicidal attempts.

An auxiliary study will also be led with 300 patients carrying an actimeter for the 30 first days after inclusion. This will help collecting more accurate data on various sleep parameters.

primary_purpose: Prevention

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

oa_host_type: repository

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

repository_institution: University of Bristol - Bristol Research

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Nottingham - Repository@Nottingham

version: acceptedVersion

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Berrouiguet S, Barrigon ML, Castroman JL, Courtet P, Artes-Rodriguez A, Baca-Garcia E. Combining mobile-health (mHealth) and artificial intelligence (AI) methods to avoid suicide attempts: the Smartcrises study protocol. BMC Psychiatry. 2019 Sep 7;19(1):277. doi: 10.1186/s12888-019-2260-y.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Carlos III University of Madrid - e-Archivo

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

repository_normalized: HAL

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

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

lead_sponsor: University Hospital, Montpellier

collaborators: Centre Hospitalier Universitaire de Nīmes

collaborators: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

collaborators: INSERM U1061 Neuropsychiatry Montpellier, France

location_country: Spain France

location_facility:
Fundacion Jimenez Diaz Hospital
CHU Montpellier


type: Registry Identifier

title: Effects of a Long-term and Regular Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism : a Cross-over Designed Study to Determine the Specific Role of Naringin

summary:
Epidemiological studies definitively show that fruit and vegetable consumption is an important factor for the prevention of age-related diseases such as cardiovascular diseases (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently consumed worldwide, essentially as juices.

Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively significant source of a specific flavanone called naringin.

ReferenceCitation: Krga I, Corral-Jara KF, Barber-Chamoux N, Dubray C, Morand C, Milenkovic D. Grapefruit Juice Flavanones Modulate the Expression of Genes Regulating Inflammation, Cell Interactions and Vascular Function in Peripheral Blood Mononuclear Cells of Postmenopausal Women. Front Nutr. 2022 May 26;9:907595. doi: 10.3389/fnut.2022.907595. eCollection 2022.

repository_institution: Institute for Medical Research, University of Belgrade - RIMI - Repository of the Institute for Medical Research

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

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

repositories:
HAL
PubMed Central
rimi.imi.bg.ac.rs

repositories_concat: HAL;PubMed Central;rimi.imi.bg.ac.rs

publisher_dissemination: Frontiers

ReferenceCitation: Habauzit V, Verny MA, Milenkovic D, Barber-Chamoux N, Mazur A, Dubray C, Morand C. Flavanones protect from arterial stiffness in postmenopausal women consuming grapefruit juice for 6 mo: a randomized, controlled, crossover trial. Am J Clin Nutr. 2015 Jul;102(1):66-74. doi: 10.3945/ajcn.114.104646. Epub 2015 May 27.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
INRA de Clermont-Fd / Theix
UMR 1019 Unité de Nutrition Humaine
Equipe MiMes
63122 Saint-Genès Champanelle
FRANCE

intervention_type: Behavioral


title: Study of Quality of Life After Aneurysmal Subarachnoid Hemorrhage in Patients Aged 70 Years or Older.

acronym: FASHE

summary:
In all the Western populations, the annual incidence of subarachnoid hemorrhage (SAH) increase with age. In patients older than 70 years, the occurrence of SAH exposes them to high risk of morbidity and a poor quality of life.

In this age bracket, the single randomized which compared endovascular coiling to microsurgical clipping (ISAT Study) showed that the relative risk of morbidity increased after coiling. Moreover, some prospectives studies about endovascular coiling described favorable outcome in 48% to 63% of patients, complete occlusion in 51% to 69% and a procedural complication rate in 13% to 19%. From prospectives series, the proportion of favorable outcome after microsurgical clipping was estimated around 66% but the procedural complications are few reported. The outcome for patients treated conservatively was catastrophic. Lastly, the hydrocephalus in this age class is common, occurring in 55% of patients.

The study hypothesis is that, in this age class, no difference exists between the 2 obliteration procedures.

An accurate evaluation of result in term of functional disability, quality of life and prognosis predictive factors seems a judicious question.

ReferenceCitation: Proust F, Gerardin E, Derrey S, Lesveque S, Ramos S, Langlois O, Tollard E, Benichou J, Chassagne P, Clavier E, Freger P. Interdisciplinary treatment of ruptured cerebral aneurysms in elderly patients. J Neurosurg. 2010 Jun;112(6):1200-7. doi: 10.3171/2009.10.JNS08754.

ReferenceCitation: Proust F, Bracard S, Thines L, Leclerc X, Penchet G, Berge J, Vignes JR, Irthum B, Gabrillargues J, Chazal J, Bataille B, Drouinau J, Mourier K, Ricolfi F, Gay E, Bessou P, Lonjon M, Sedat J, David P, Lajaunias P, Morandi X, Gauvrit JY, Pelissou I, Turjman F, Roche PH, Dufour H, Levrier O, Emery E, Courtheoux P, Laguarrigue J, Cognard C, Civit T, Lejeune JP. [Aneurismal subarachnoid hemorrhage in the elderly subject. Should this patient participate in a randomized clinical trial?]. Neurochirurgie. 2010 Feb;56(1):67-72. doi: 10.1016/j.neuchi.2009.11.002. Epub 2010 Jan 8. No abstract available. French.

lead_sponsor: University Hospital, Rouen

location_facility:
Rouen University Hospital
PROUST


title: Role of Tyrosine Kinase Lyn and Cleaved Form by Caspases in Psoriasis

summary:
Psoriasis is a chronic autoimmune disorder of the skin. In this disease, the inflammatory caspases, cysteine proteases involved in the processing of many proteins, are activated. Transgenic mice expressing the cleaved form of caspases by Lyn, a tyrosine kinase Src family, develop an inflammatory syndrome with the characteristics of human psoriasis.

To clarify the relationship between the cleaved form of Lyn by caspases and psoriasis, the investigators intend to develop a clinical study to analyze the expression, cleavage and activity of Lyn and the activation of caspases from skin biopsies of patients with this disease.

This study will be conducted on a cohort of patients with different forms of psoriasis (plaque, pustular and erythrodermic) and atopic dermatitis, another skin disorder associated with chronic inflammation. Thus, the investigators will evaluate the expression and activity of Lyn from skin lesion (L) and non-lesional (NL) from the same patient in parallel with the level of caspase activation and apoptotic inflammatory.

Thus, the investigators will verify that the cleavage by caspases of Lyn is associated specifically with psoriasis, as the investigators believe, or more generally to the skin inflammation. The investigators work would then define the cleavage by caspases of Lyn as a new potential marker of human psoriasis.

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceCitation: Aira LE, Goncalves D, Bossowski JP, Rubio-Patino C, Chiche J, Paul-Bellon R, Mondragon L, Gesson M, Lecucq-Ottavi P, Obba S, Colosetti P, Luciano F, Bailly-Maitre B, Boyer L, Jacquel A, Robert G, Ricci JE, Ortonne JP, Passeron T, Lacour JP, Auberger P, Marchetti S. Caspase 1/11 Deficiency or Pharmacological Inhibition Mitigates Psoriasis-Like Phenotype in Mice. J Invest Dermatol. 2019 Jun;139(6):1306-1317. doi: 10.1016/j.jid.2018.11.031. Epub 2018 Dec 17.

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

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

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

repositories_concat: HAL

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

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

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Impact of a Therapeutic Education Program Specifically Adapted to the Precarious People Supported in Therapeutic Coordination Apartments on the Acceptance of Their Disease and the Management of Their Care

acronym: EDUPACT

summary:
Through its patient-centered approach and focus on developing coping skills and coping strategies, Health Education could be an effective approach in therapeutic coordination apartments to reduce the perceived treatment burden among people in precarious situations with one or more chronic diseases. Decreasing perception of burden would improve their quality of life and adherence to treatment.

The general hypothesis explored in this project is that the experience of the disease, the perception of the burden of treatment, the autonomy and the quality of life of the residents improve more importantly in therapeutic coordination apartments having implemented a formalized and structured Health Education approach (experimental group) than in those who did not set up formalized and structured Health Education approach (control group).

status: Unknown status

collaborators: Institut de Recherche en Santé Publique, France

location_facility:
Act Passerelle
ACT Louis Guilloux
Act Acothe
ACT Le Logis Montjoie
Act Aurore
CHU de Nantes

status_simplified: Unknown


title: Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus (I-Seizure)

acronym: I-Seizure

summary: Isoflurane might be used as anticonvulsive therapy in refractory status epilepticus. The aim of the study is to assess the efficiency of Isoflurane in this indication.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.

ReferenceCitation: Stetefeld HR, Schaal A, Scheibe F, Nichtweiss J, Lehmann F, Muller M, Gerner ST, Huttner HB, Luger S, Fuhrer H, Bosel J, Schonenberger S, Dimitriadis K, Neumann B, Fuchs K, Fink GR, Malter MP; IGNITE Study Group, with support from the German Neurocritical Care Society (DGNI). Isoflurane in (Super-) Refractory Status Epilepticus: A Multicenter Evaluation. Neurocrit Care. 2021 Dec;35(3):631-639. doi: 10.1007/s12028-021-01250-z. Epub 2021 Jul 20.

repository_institution: ZB MED - Informationszentrum Lebenswissenschaften - PUBLISSO-Fachrepositorium Lebenswissenschaften

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg - OPUS Repository

ipd_sharing: Undecided

ipd_sharing_description: After study completion, on justified demand and after review board authorization

lead_sponsor: Hopital of Melun

location_facility: GH Sud Ile de France, Hôpital de Melun-Sénart


type: Other Identifier

title: Point-of-care Haemostasis Testing of Von Willebrand Factor Function Embedded in Catheterization Laboratory to Improve Real-time Management of Paravalvular Regurgitation During Minimally Invasive TAVI

acronym: WITAVI-REAL

summary:
Paravalvular regurgitation (PVR) is an important complication of Transcatheter Aortic Valve Implantation (TAVI) that is associated with a 2.5-fold increase risk of mortality. Transesophageal echocardiographic (TEE) is considered as the gold standard to assess the severity of PVR and guide the physician to perform corrective procedures during TAVI, but it requires general anesthesia (GA). With such approach (TEE+GA), the PARTNERII trial has demonstrated that very low rate of PVR (3,5%) can be achieved with current devices. Registries have demonstrated a strong trend for using a mini-invasive approach in which the procedure is performed under conscious sedation (CS) without TEE. However, several studies raised concerns on the safety of this mini-invasive approach concerning the PVR rate. Thus, the accurate and real-time assessment of the presence and severity of PVR is an unmet clinical need to optimize TAVI without TEE guidance. A recent study reported that a blood biomarker reflecting the Von Willebrand factor (VWF) activity, i.e. the closure time with adenosine diphosphate (CT-ADP), is a valuable non-invasive, highly reproducible, and easy to perform alternative to TEE for PVR evaluation.

The hypothesis is that the measurement of CT-ADP during TAVI performed without TEE guidance can improve both the detection of significant PVR and thus the procedural and clinical outcomes (primary objective).

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Siemens Healthineers, France
Ministry of Health, France

location_facility: Hopital Estaing - Chu63 - Clermont Ferrand

location_facility: Hopital Civil / Nouvel Hopital Civil - Strasbourg

intervention_type: Diagnostic Test

appel_a_projets: PHRCN

region: Hauts-de-France

nom_etablissement: CHR LILLE

type_etablissement: CH

acronyme: WITAVI-REAL

titre: Utilisation du facteur willebrand pour améliorer la prise en charge en temps réel des fuites paravalvulaires per-procédure TAVI mini-invasives : WITAVI-REAL

discipline_principale: cardiologie

nom_porteur: Vanbelle

prenom_porteur: Eric


title: Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part II: Detection of Pyelocaliceal Dilation and Hepatic Steatosis

acronym: CLIN-ECHO-II

summary:
In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize and measure anatomical structures and fluid and provide the clinical examination with additional signs allowing quicker and more confident clinical decisions.

This innovative approach is slowed down by the accessibility of these miniaturized devices, the price of which remains high.

The echOpen device includes an ultra-portable ultrasound probe and a mobile application that allows the image to be displayed on a smartphone via a WIFI protocol.

The objective of the clinical investigation is to show that the echOpen device, using three frequencies 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, allows identifying the semiological signs or anatomical structures of interest located at several depths of the body, with a performance similar to other devices routinely used in clinical departments.

primary_purpose: Screening

collaborators:
ECHOPEN
EIT Health

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
ECHOPEN
EIT Health

location_facility: Paul Brousse Hospital - APHP - Hepatobiliary Center

location_facility: Groupe Hospitalier Sud Ile de France (GHSIF) - Emergency Department

location_facility: Avicenne Hospital - APHP- Hepatology Department

location_facility: APHP COCHIN HOSPITAL - Emergency Department


title: Low Dose of Hydrocortisone and Fludrocortisone in Adult Cardiogenic Shock. A Multicenter, Prospective, Double-blind, Randomized, Placebo-controlled Study

acronym: COCCA

summary: The purpose of this randomized controlled trial is to evaluate the hemodynamic effect of low dose corticosteroid therapy (hydrocortisone and fludrocortisone) in the treatment of adult cardiogenic shock.

ReferenceCitation: Mekontso Dessap A, Bagate F, Delmas C, Morichau-Beauchant T, Cholley B, Cariou A, Lattuca B, Moussa M, Mongardon N, Fard D, Schmidt M, Bougle A, Kerneis M, Vivier E, Roubille F, Duprey M, Decalf V, Genet T, Merzoug M, Audureau E, Squara P. Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial. Trials. 2022 Jan 3;23(1):4. doi: 10.1186/s13063-021-05947-6.

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

lead_sponsor: CMC Ambroise Paré

location_facility: CH Intercommunal de Villeneuve Saint Georges

location_facility: Hôpitaux Universitaires Pitié Salpêtrière

location_facility: Centre cardiologique du nord saint denis

location_facility: Centre Hospitalier Saint Joseph Saint Luc


title: Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

summary: Mosunetuzumab is a T-cell bispecific antibody targeting CD20 and CD3 aiming to redirect T cells to engage and eliminate malignant B cells. Bispecific antibodies (BsAb) are a promising treatment option which can induce long-term responses in refractory and relapsed B cell lymphoma patients. However, the factors determining the quality and duration of responses are poorly understood.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: CHU Saint Eloi; Service d'Hématologie Clinique

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Hopital Saint Antoine; Hematologie Clinique

location_facility: CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique


title: Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets

acronym: BAT-VTE

summary:
Venous thromboembolism (VTE) and atherosclerotic cardiovascular disease share common risk factors and frequently coexist in the same patients.

Their management requires use of antithrombotic agents: anticoagulant therapy (AC) for secondary prevention of VTE recurrence, antiplatelet (AP) for secondary prevention of major adverse ischemic cardiovascular and cerebrovascular event (MACCE) in patients with atherosclerotic cardiovascular disease (coronary artery disease, atherosclerotic cerebrovascular disease, lower extremity peripheral arterial disease).

Side effects of antithrombotic drugs are the 1st cause of emergency admission and hospitalization for an adverse drug reaction (mainly bleeding), and the combination of AC with AP strongly increases this risk.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: APHP - Hôpital Européen Georges Pompidou HEGP

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied


title: Balloon-Expandable Versus Self-expanding Transcatheter Heart Valve for Treatment of Native Aortic Valve Stenosis

acronym: BEST

summary:
Over the last years, several randomized studies comparing transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) have established TAVI as a treatment option in symptomatic patients with aortic stenosis (AS) (1,2,3). Most transcatheter heart valves (THV) available are designed on either a balloon-expandable (BE) or a self-expanding (SE) concept.

Despite major differences, both designs are recommended to be used indifferently in most of the clinical situations and a significant number of centers only implant one of this two THV design. It remains unclear however, whether these 2 very different THV concepts are achieving similar or different clinical outcomes and could be considered a single "Class" of device. While there is an urgent clinical need to clarify this issue in an exponentially growing therapeutic field, to date no large randomized study powered to compare the 2 THV designs on individual endpoints has been conducted or initiated. Recently, two large-scale French registry-based propensity matched analyses, including more than 30,000 patients, have reported a higher 90 days and 1-year mortality with the use of SE as compared to BE-valve (4,5). However, as the propensity-score matching-approach cannot rule out residual confounders, and as some of the most recent THV iterations were not part of the investigation, there is an urgent need to conduct a randomized trial sufficiently powered to compare head-to-head the latest generation of SE and BE-valve on all-cause mortality. In addition, two small randomized studies have recently showed the inferiority of a new SE-valve compared to BE-valve and SE-THV (SCOPE1 trial, J Lanz. Lancet. 2019 Nov 2;394(10209):1619-1628. and SCOPE 2 trial, Circulation in press), thus further questioning wether THV should be considered as a single "Class" regardless the THV design.

The objective of the present randomized clinical investigation will be to evaluate the impact of THV design (SE vs BE) on the risk of all-cause mortality at 90 days and 1 year.

The present clinical investigation will the first randomized clinical investigation to compare head to head the benefit of BE-valve over SE-valve on total mortality at 90 days and 1-year using a superiority design. Previous head-to-head studies included only a small number of patients, non-inferiority designs and combined endpoints. This clinical investigation will be the first to generate sufficient evidences to change clinical practice and international guidelines to clarify whether one THV design is superior (or not) to the other one (BE vs SE-valve). The result of the clinical investigation is key for clinicians indicating the treatment and for the patients receiving the treatment

sponsor_collaborators:
University Hospital, Lille
Ministry of Health, France

location_facility: AP-HP Hôpitaux Universitaires Pitié Salpêtrière

location_facility: Centre Médico Chirurgical Arnault Tzanck

location_facility: AP-HP Hôpitaux Universitaires Henri Mondor


title: Evaluation of Glucocorticoids Plus Rituximab Compared to Glucocorticoids Plus Placebo for the Treatment of Patients With Newly-Diagnosed or Relapsing IgA Vasculitis: A Prospective, Randomized, Controlled, Double-blind Study

acronym: RIGA

summary:
Systemic vasculitis are inflammatory diseases of the blood vessels, responsible for systemic manifestations. Among the systemic vasculitis affecting small blood vessels, IgA vasculitis (IgAV) is one of the most common forms and mainly affects the skin, joints, kidneys and gastrointestinal tract. Kidney and gastrointestinal damage can be serious, causing complications and life-threatening sequelae, especially in adults. The treatment of adult-onset IgAV is still a matter of debate. Glucocorticoids have been the standard of care for inducing remission for years in severe forms of IgAV. However, not all patients achieve remission and may experience disease flares associated with increased morbidity and mortality. In addition, the cumulative side effects of glucocorticoids are also major causes of long-term adverse events and death.Rituximab (RTX), an anti-CD20 monoclonal antibody, has been shown to be spectacularly effective in inducing remission in d 'other small vascular vessels, in particular ANCA-associated vasculitis and cryoglobulinemic vasculitis, with an acceptable safety profile.

Recently, a multicenter observational study suggested that RTX was an effective and safe therapeutic option for treating relapsed and / or refractory adult IgAV.

Overall, RTX may be an effective and safe therapeutic approach in adult IgAVs, justifying the need for a prospective randomized controlled trial evaluating Rituximab as an induction of remission for adult IgAV.

lead_sponsor: Hopital Foch

sponsor_collaborators:
Hopital Foch
Ministry of Health, France

location_facility:
Hôpital André Grégoire
CHU Nantes
CHU Nîmes (Caremeau)
Hôpital Cochin
CHU Toulouse
Hôpital Foch
CHRU Bretonneau
Hôpital Edouard Herriot
Hopital La Cavale Blanche
APHM de La Timone
CHU Clermont Ferrand
CHU Strasbourg
CHU Marseille

region: Île-de-France

nom_etablissement: HOPITAL FOCH

type_etablissement: EBNL

acronyme: RIGA

titre: Évaluation du RITUXIMAB en association a? un traitement par corticoi?des versus corticoïdes et placebo de RITUXIMAB en traitement d'induction et d'entretien au cours des vascularites à IgA de l'adulte. Étude randomisée contre placebo en double aveugle.

discipline_principale: médecine interne

nom_porteur: Paule

prenom_porteur: Romain


acronym: THERAMAG

summary: Anti-MAG neuropathy is a progressively disabling orphan rare disorder due to a monoclonal immunoglobulin M(IgM) gammopathy displaying reactivity toward MAG, a glycoprotein of the peripheral nervous system. Its prevalence is around 1/100000 and to date, no treatment has proven efficacy in this disease, including rituximab in 2 Randomized Controlled Trails(RCTs).

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Grenoble - La tronche
CHU Toulouse - Pierre-Paul Riquet
CHU Strasbourg - Hautepierre
APHP Pitié Salpêtrière
CHU Lille - Roger Salengro
CHU Nancy- Hôpital central
CHU Nice - Pasteur
APHP - Kremlin-Bicêtre
CHU de Saint-Etienne
CHU Tours - Bretonneau
CHU La Timone - APHM
HCL lyon
CHU Brest - La cavale blanche
CHU Limoges - Dupuytren

title: Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders:

type: EudraCT Number

source: euctr

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE SAINT-ETIENNE

acronyme: THERAMAG

titre: Traitement par rituximab d'un sous groupe de patients présumés répondeurs présentant une neuropathie anti-MAG

discipline_principale: neurologie

nom_porteur: LACOUR

prenom_porteur: Arnaud


acronym: DiabOUT

summary: This study is a randomized trial that evaluates the effect of metformin addition or not to standard care on the duration of diabetes remission after bariatric surgery.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

location_facility: CH de Saint-Denis - hôpital Delafontaire

location_facility: AP-HP - hôpital européen Georges-Pompidou

location_facility: Centre hospitalier intercommunal de Créteil

title: Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care

type: Other Grant/Funding Number

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

ipd_sharing: Yes

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: DIABOUT

titre: Augmenter la rémission du diabète après chirurgie bariatrique : essai randomisé contrôlé avec traitement par metformine en regard de la prise en charge habituelle.

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: Carette

prenom_porteur: Claire


title: Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection SINBIOSE-H.

acronym: SINBIOSE-H

summary:
Each year, around 1500 infected Total Hip Arthroplasties (THA) need non-conservative surgery, remaining an issue for patients and healthcare units. The recommended treatment, relying on cohort reviews and international consensus follows a two-stage protocol. This protocol implies a first surgery to remove all infected implants and at least 6 weeks of antibiotic treatment without implant, then usually an antibiotic-free period and only then a second surgery to put back new implants and start the rehabilitation protocol, with usually more than a week of a second hospital stay. Between both surgeries, full-weight bearing is prohibited and joint stiffness and/or pain are rather usual complications. Failure rate is estimated at 10% in this two-stage strategy. The single-stage procedure (i.e. implanting back a new prosthesis during the same surgery after implant removal, synovectomy and lavage) is thought to be less susceptible to late functional complications (i.e. pain, stiffness and muscle deficiency) with a shorter, single hospital stay.

Although, with single-stage surgery, infection control could be less efficient because most pathogens produce during the first hours of infection an antibiotic-resistant layer called biofilm, allowing them to colonize and adhere to foreign objects like implants. This single-surgery protocol thus highly relies on antibiotics and has a list of contra-indications (based on experts' consensus): the presence of damaged soft tissues or a sinus tract, unknown pathogens, difficult to treat micro-organisms, severe immunosuppression and for many surgeons, each time a bone graft is necessary. Most of these contra-indications are directly related to the biofilm.

As no randomized control trial has ever compared single-stage versus two-stage surgery, the level of evidence for recommending one procedure over the other is low.

We conducted a survey that showed that most of the French reference centers have already switched to single stage surgery for single-stage non contra-indicated cases.

An antibiotic-loaded hydrogel coating (Defensive Antiadhesive Coating®, Novagenit SRL), has been proven to mechanically prevent the biofilm formation, while allowing a prolonged intraarticular antibiotic release, in a randomized controlled trial in primary prevention of infection in THA.

The addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for secondary prevention of peri-prosthetic hip joint infection. Moreover, using this device to prevent biofilm formation could expand one stage surgery to patients that are "normally" contra-indicated to one stage surgery.

location_facility:
CHU Nancy
HCL - Hôpital de la Croix Rousse
CHU Nantes
Chu Saint-Etienne
HCL - Hôpital Edouard Herriot
CHU Toulouse
CHU Nice
CHU Clermont-Ferrand
CHU Caen
CHU Bordeaux
CHU Dijon
CHU Lille
CHU Marseille
CHU Amiens

acronyme: SINBIOSE-H

titre: Chirurgie en un temps associant un inhibiteur du biofilm et un antibiotique topique versus chirurgie en deux temps pour la prévention secondaire des infections chroniques péri prothétiques de hanche. Etude randomisée de non-infériorité SINBIOSE-H

discipline_principale: orthopedics / traumatology

nom_porteur: BOYER

prenom_porteur: Bertrand


title: Cost-utility Analysis of Ambulatory Care Compared to Conventional Patient Care of Permanent Pacemakers Replacement for Elective Replacement Indicator

acronym: START

summary:
START study is a comparison of cost-utility between permanent pacemaker replacement ambulatory care and permanent pacemaker replacement conventional hospitalization care.

The hypothesis of the study is that ambulatory care compared to conventional hospitalization, involving a stay of more than 24 hours, would reduce hospitalization and care expenses without loss of quality of care and without increasing the complication rate for patients.

primary_purpose: Health Services Research

sponsor_collaborators:
Nantes University Hospital
Ministry of Health, France

location_facility:
Montpellier University Hospital
AP-HP, La Pitié Salpétrière
Nancy University Hospital
Lyon University Hospital
Toulouse University Hospital
Tours University Hopsital
Angers University Hospital
Grenoble University Hospital
Brest University Hospital
Rennes University Hospital
Strasbourg University Hospital
Saint-Etienne University Hospital
AP-HM
Dijon University Hospital

intervention_type: Procedure

appel_a_projets: PRME

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: START

titre: Analyse coût-utilité de la prise en charge en ambulatoire comparée à la prise en charge en hospitalisation conventionnelle du remplacement de stimulateurs cardiaques permanents pour usure élective

nom_porteur: Probst

prenom_porteur: Vincent


acronym: ROC-SPA

summary:
Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by inflammatory arthritis and enthesitis involving the spine. AxSpA prevalence is around 0.17% of the French population. Tumor necrosis factor (TNF) was the first target defined in axSpA. Since one third of axSpA patients failed to the first TNF blocker, many axSpA patients received a second biological Disease-Modifying AntiRheumatic Drugs (bDMARDs). Until few months, the only choice was to use a second TNF blocker.Since 2003, pharmaceutical companies investigated efficacy of TNF blockers already used in rheumatoid arthritis. Etanercept is a fusion protein with TNF receptor type II p75 and IgG1 Fc fragment, whereas adalimumab, infliximab, and golimumab are monoclonal antibodies. Certolizumab is a fusion between a fab fragment targeting TNF and a Peg fraction. All demonstrated efficacy versus placebo in a randomized double blinded study

In case of failure to the first TNF blockers, rheumatologists will follow the "Treat-to-Target" principle. This approach already demonstrated its benefit in rheumatoid arthritis or in psoriatic arthritis. This concept was also suggested for axSpA with low levels of evidence and recommendation. So rheumatologist will provide the best treatment in case of failure to the first TNF blockers, which is a daily clinical situation. Since few months, rheumatologists have the choice between targeting IL-23/17 axis compared to a second TNF blocker.

location_facility: CHU Montpellier - 2 - Unité Clinique thérapeutique des Maladies Ostéo-Articulaires

title: Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis

location_country: Monaco France

acronyme: ROC SpA

titre: Rotation ou changement de biothérapie après l'échec du traitement anti-TNF au cours de la spondyloarthrite axiale

discipline_principale: rhumatologie

nom_porteur: MAROTTE

prenom_porteur: Hubert


title: TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)

summary: The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).

ReferenceCitation: Sentilhes L, Senat MV, Le Lous M, Winer N, Rozenberg P, Kayem G, Verspyck E, Fuchs F, Azria E, Gallot D, Korb D, Desbriere R, Le Ray C, Chauleur C, de Marcillac F, Perrotin F, Parant O, Salomon LJ, Gauchotte E, Bretelle F, Sananes N, Bohec C, Mottet N, Legendre G, Letouzey V, Haddad B, Vardon D, Madar H, Mattuizzi A, Daniel V, Regueme S, Roussillon C, Benard A, Georget A, Darsonval A, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. N Engl J Med. 2021 Apr 29;384(17):1623-1634. doi: 10.1056/NEJMoa2028788.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Sentilhes L, Daniel V, Deneux-Tharaux C; TRAAP2 Study Group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol. BMC Pregnancy Childbirth. 2020 Jan 31;20(1):63. doi: 10.1186/s12884-019-2718-4.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Ministry of Health, France

location_facility: Centre Hospitalier Intercommunal Poissy-Saint Germain

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Hôpital universitaire Necker-Enfants malades

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: TRAAPCD

titre: Acide tranéxamique pour la prévention de l'hémorragie du postpartum après un accouchement par césarienne: une étude multicentrique randomisée en double aveugle contre placébo.

discipline_principale: obstétrique

nom_porteur: SENTILHES

prenom_porteur: Loïc


acronym: FAIR-ALS II

summary: The alteration of iron metabolism is reported in animal models of amyotrophic lateral sclerosis (ALS) as well as in sporadic and genetic forms (SOD1 and C9orf72) of ALS. The high iron concentration of the brain, due to its high energy demand (high oxygen consumption), makes motor neurons particularly vulnerable to energy deficit and oxidative stress. Post-mortem examinations and MRI scans in patients with ALS have found signs of iron accumulation in the central motor tract; and a high level of serum ferritin, which is a marker of iron levels, is associated with a lower prognosis. In ALS mouse models, the use of iron chelators has demonstrated neuroprotection and increased life expectancy, suggesting that elimination of excess iron from the brain can prevent neuronal loss and, consequently, a slow progression of the disease. Conservative chelation of iron refers to a modality whereby much of the iron that binds to the chelator is redistributed in the body rather than exhausted. Using a chelator, deferiprone, with this feature, in a safety pilot study, a very good safety profile was observed. Deferiprone eliminated excess iron from brain regions, reduced oxidative damage and cell death associated with regional iron deposits with no apparent negative impact on the iron levels needed. Now, the efficacy of this new therapeutic modality of neuroprotection is being evaluated in a randomized, double-blind, placebo-controlled, multicenter study.

location_facility:
C H U Dupuytren Limoges
Chru Brest
Hopital de Hautepierre
Chu Toulouse
Aphm Hopital La Timone
Chu Cote de Nacre - Caen
Chr Angers
Hu Pitie Salpetriere Aphp
Chu de Bordeaux - Talence
Chu de Clermont-Ferrand
Chu de Nice Hopital Pasteur
Hôpital Roger Salengro, CHU
Chu de Nancy
Hopital Pierre Wertheimer - Hcl - Bron
Chu de Tours

status: Active, not recruiting

title: Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis: Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of Deferiprone

acronyme: FAIR ALS II

titre: Chelation conservatrice du fer comme stratégie de neuroprotection dans la sclérose latérale amyotrophique Essai thérapeutique multicentrique randomisé en double aveugle de la deferiprone versus placebo en groupe parallèle

nom_porteur: DEVOS

prenom_porteur: David


acronym: FLUNEXT

summary: The aim of this study is to evaluate the possibility to repropose marketed drugs as antiviral ones, based on their ability to reverse the transcriptomic signature of the infected cells. This strategy has to be considered is the context of emerging viral diseases and of increase of resistance to antivirals. Concerning infection by Influenza viruses, the main drugs were identified and evaluated on in vitro and in vivo models: diltiazem. Therefore, it will be assess the efficacy of these the drug, compared to placebo, to treat severe flu.

location_facility: Gpe Hosp Cochin Saint Vincent de Paul - Paris

location_facility: Centre Hospitalier de Versailles - Le Chesnay Rocquencourt

location_facility: Hôpital Edouard Herriot Hospices Civils de Lyon

status: Terminated

title: Validation of the Efficiency of Molecules Reproposed on the Basis of Their Cellular Transcriptomic Signature, Antagonist of the Signature Determined in Infection Due to Virus Influenza A.

acronyme: Flunext

titre: Validation de l'efficacité antigrippale de molécules repositionnées sur la base de leur signature transcriptomique cellulaire antagoniste de celle de l'infection par les virus influenza A. Essai flunext.

discipline_principale: anesthésiologie / réanimation

nom_porteur: POISSY

prenom_porteur: Julien


title: Impact of Therapeutic Hypothermia in Expanded Criteria Brain-dead Donors on Kidney-graft Function in the Kidney-transplant Recipients: Multicenter Randomized Controlled Trial" HYPOREME

acronym: HYPOREME

summary:
Each year, only one third of patients registered on the waiting list receive a kidney transplant. Numerous paths are being explored with the aim of reversing this shortage. The first is to increase the number of organs by developing harvesting from donors in a state of brain-death (BD) termed "expanded criteria donors" or from patients deceased from circulatory arrest.

Another fundamental factor is to insure the success of the transplant by limiting the dysfunction of donor kidneys, marked by a delayed graft function (DFG).

The development of techniques to insure correct perfusion of harvested organs, and the optimization of reanimation and intensive care of brain-dead donors constitute important factors in DGF reduction.

Therapeutic Hypothermia could to be an attractive care strategy for BD patients.

primary_purpose: Other

ReferenceCitation: Brule N, Canet E, Pere M, Feuillet F, Hourmant M, Asehnoune K, Rozec B, Duveau A, Dube L, Pierrot M, Humbert S, Tirot P, Boyer JM, Martin-Lefevre L, Labadie F, Robert R, Benard T, Kerforne T, Thierry A, Lesieur O, Vincent JF, Lesouhaitier M, Larmet R, Vigneau C, Goepp A, Bouju P, Quentin C, Egreteau PY, Huet O, Renault A, Le Meur Y, Venhard JC, Buchler M, Michel O, Voellmy MH, Herve F, Schnell D, Courte A, Glotz D, Amrouche L, Hazzan M, Kamar N, Moal V, Bourenne J, Le Quintrec-Donnette M, Morelon E, Boulain T, Grimbert P, Heng AE, Merville P, Garin A, Hiesse C, Fermier B, Mousson C, Guyot-Colosio C, Bouvier N, Rerolle JP, Durrbach A, Drouin S, Caillard S, Frimat L, Girerd S, Albano L, Rostaing L, Bertrand D, Hertig A, Westeel PF, Montini F, Delpierre E, Dorez D, Alamartine E, Ouisse C, Sebille V, Reignier J. Impact of targeted hypothermia in expanded-criteria organ donors on recipient kidney-graft function: study protocol for a multicentre randomised controlled trial (HYPOREME). BMJ Open. 2022 Mar 28;12(3):e052845. doi: 10.1136/bmjopen-2021-052845.

publisher_dissemination: British Medical Journal

location_facility:
CH Avignon
Nantes University Hospital
CHU Toulouse
CHU Foch
Ch Cholet
CHU Nice
CHU Rennes
CHU Brest
CHU Limoges
CHU Tours
CH Bourges
Chu Clermont Ferrand
CH Angouleme
CH Morlaix
CHU de Lyon
CH La Rochelle
CHU de Dijon
Hopital de la Timone
CHU d'Angers
Hopital de la Conception
CHU Rouen
Hopital Necker
CH La Roche sur Yon
CH Annecy Genevois
CH Le Mans
Hopital de la Pitié Salpetriere
CHU Tenon
CHU Montpellier
CH de Blois
CH Saintes
Hopital Bicetre
CHU Reims
CHRU Nancy
CH Marne la Vallée (GHEF)
CHRU Lille
CHU Caen
CH Saint Nazaire
CHU Strasbourg
CHU de Bordeaux
CHRU Saint-Etienne
CH Cornouaille
CH Lorient
CHU Grenoble
Hopital Saint Louis
CH Saint Brieuc
CH Laval
CH Orléans
CH Saint Malo
CH Vannes
CHU Poitiers
CHU Amiens-Picardie
CH de Dreux
Hopital Henri Mondor
CH de Meaux (GHEF)

appel_a_projets: PHRCI

acronyme: HYPOREME

titre: Impact de l'hypothermie thérapeutique chez les donneurs d'organes en mort encéphalique à critères élargis sur la reprise fonctionnelle du greffon rénal chez le patient transplanté: Essai clinique contrôlé randomisé multicentrique « HYPOREME»

discipline_principale: autre

nom_porteur: BRULE

prenom_porteur: Noelle


title: Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detoxification: a Randomized Clinical Trial Comparing Safety and Costs

acronym: SAMBA

summary:
The SAMBA study aims to assess the safety and cost comparison of the management of outpatient alcohol detoxification, between an advanced nurse protocol on the one hand (experimental group), and a GP-based treatment on the other hand (standard-of-care group).

In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores, which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In case of any serious adverse event or uncontrolled withdrawal complication, an addiction specialist stands in back-up and can be appealed to decide whether the outpatient detox can be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage patients as they wish.

location_facility:
CH Boulogne
CH Limoux
Centre LOGOS
CH Lens - CSAPA Le Square
CH Roubaix
CHU Brest
CH Troyes
Csapa Anpaa63
CSAPA Arc-en-Ciel
CH Perpignan
Csapa Anpaa66
CHU Rouen
CHU Nancy
CH Dunkerque
Les Apsyades
CHU Nantes
CSAPA CHRU - Le PARI
CH du Rouvray
CHU Clermont-Ferrand
CSAPA La Trame - ANPAA59
CHU Strasbourg
CH Beziers
CHU Grenoble
CH Tourcoing
CH Alpes-Isère
CHU Créteil


title: Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery Using Conventional Blood Coagulation Tests or Thrombo-elastographic Point of Care Test - IMOTEC

acronym: IMOTEC

summary:
Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac surgical interventions.

Treatment of such complication often necessitates various combinations therapeutic intervention including allogenic blood products administration, drug use and/or surgical intervention. All are expensive treatment and decision making is guided by patient clinical status and biological tests of the haemostatic function.

A key point is the time frame of the clinical process. Therapeutic choices have to be done as fast as possible to minimize bleeding consequences on patient haemodynamic and physiological status. Conventional coagulation test results availability time usually exceed 45' after blood drawing. In such situation, the results may not reflect precisely the coagulation system current state. This downside is often counterbalanced by clinicians empirical choices preceding lab test results knowledge that may conduct to inappropriate treatment, blood product overuse and undue expense.

Viscoelastic point of care test may compensate for the limitations of conventional coagulation tests. In perioperative haemorrhage, faster and more precise information about haemostatic function may help for more accurate therapeutic choices.

The IMOTEC study aims to compare haemorrhage management following cardiac surgery using conventional blood coagulation tests or thrombo-elastogaphic point of care test.

Primary endpoint is a cost utility analysis of the technology and secondary endpoints include blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative infection (any cause), organ failure, in hospital length of stay and death.

ReferenceCitation: Rigal JC, Boissier E, Lakhal K, Riche VP, Durand-Zaleski I, Rozec B. Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study). BMJ Open. 2019 Nov 5;9(11):e029751. doi: 10.1136/bmjopen-2019-029751.

location_facility:
Clermont-Ferrand University Hospital
Strasbourg Universtiy Hospital
Nancy University Hospital
HEGP, Hôpital Européen Georges Pompidou
Toulouse University Hospital
Tours University Hospital
Bordeaux University hospital
Angers University Hospital
Rouen University Hospital
APHP, La Pitié Salpétrière
Caen University Hospital
Marseille AP-HM La Timone
Saint-Etienne University Hospital
Lille University hospital
Dijon University Hospital

acronyme: IMOTEC

titre: Intérêt médico-économique de la thrombo-élastographie dans le management transfusionnel des hémorragies péri-opératoires de chirurgies cardiaques sous circulation extracorporelle

nom_porteur: Rozec


title: The OPTI-AGED Study : Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality in Elderly Patients. A Randomized, Multicentre, Prospective Controlled Study

acronym: OPTI-AGED

summary:
With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes.

Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

primary_purpose: Supportive Care

ReferenceCitation: Molliex S, Passot S, Futier E, Bonnefoi M, Rancon F, Lemanach Y, Pereira B. Stepped wedge cluster randomised controlled trial to assess the effectiveness of an optimisation strategy for general anaesthesia on postoperative morbidity and mortality in elderly patients (the OPTI-AGED study): a study protocol. BMJ Open. 2018 Jun 19;8(6):e021053. doi: 10.1136/bmjopen-2017-021053.

location_facility:
CHU LILLE - Huriez
Chu Saint Etienne
CHU CAEN
Chu Marseille La Timone
Chu Nancy
Chu Rennes
Ch Paris Saint Antoine
Chu Nimes
Ch Paris Bichat
CHRU Lille - Salengro
Ch Saint Louis-Lariboisiere
Chu Clermont-Ferrand
CHU LYON
Chu Dijon
CHU de Nantes
CHU NICE
Chu Toulouse
Ch Paris Beaujon
Hopital Central Strasbourg
Chu Rouen
Chu Grenoble
Chu Poitiers
Chu Montpellier
Hopital Hautepierre Strasbourg
Médipôle Lyon - Villeurbanne
Lyon Sud - CHU
Chu Marseille Nord
Ch Paris Pitie Salpetriere
CHU Amiens - Picardie

acronyme: OPTI AGED

titre: Influence d'une stratégie d'optimisation multiparamétrique de l'anesthésie générale chez le sujet âgé à risque élevé de morbi-mortalité postopératoire. Etude multicentrique prospective randomisée contrôlée.

nom_porteur: MOLLIEX

prenom_porteur: Serge


title: Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants

acronym: VERDICT

summary:
In renally impaired patients with acute venous thromboembolism (VTE), standard-of-care (SOC) anticoagulation, i.e. heparins-vitamin K antagonists (VKA), at therapeutic dosage is associated with an increased risk of thromboembolic and bleeding complications compared to patients with normal renal function. Direct oral anticoagulants (DOAs) have been shown to be at least as effective and safe as SOC in VTE treatment. But in the clinical trials, moderate renally impaired patients were poorly represented and patients with severe renal insufficiency not at all. So no dose reduction was considered.

Surprisingly, DOAs have been approved for VTE treatment in moderate and severe renally impaired patients. There is need to evaluate a reduced dose of DOAs for VTE treatment in patients with moderate and severe renal insufficiency.

We plan to evaluate reduced doses of 2 DOAs (apixaban, rivaroxaban) compared to SOC in VTE patients with moderate or severe renal insufficiency in terms of net clinical benefit (recurrent VTE and major bleeding) at 3 months.

ReferenceCitation: Wetmore JB, Herzog CA, Yan H, Reyes JL, Weinhandl ED, Roetker NS. Apixaban versus Warfarin for Treatment of Venous Thromboembolism in Patients Receiving Long-Term Dialysis. Clin J Am Soc Nephrol. 2022 May;17(5):693-702. doi: 10.2215/CJN.14021021. Epub 2022 Apr 25.

oa_colors: green other

location_facility: Hôpital Charles Foix - APHP Ivry sur Seine

acronyme: VERDICT

titre: Maladie thromboembolique veineuse chez des patients insuffisants rénaux et anticoagulants oraux directs : étude randomisée VERDICT

discipline_principale: médecine vasculaire

nom_porteur: MISMETTI

prenom_porteur: Patrick


acronym: ARCADE

summary: This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their vasculature affected by a defect in type III collagen in addition to the effects celiprolol. This randomized, double blind, placebo controlled trial compares the administration of the Ang II type I receptor blocker (ARB) - irbesartan- to placebo over a 2-year period in vEDS patients with the main objective to reduce the incidence of both symptomatic and asymptomatic vascular events.

ReferenceCitation: Frank M, Albuisson J, Ranque B, Golmard L, Mazzella JM, Bal-Theoleyre L, Fauret AL, Mirault T, Denarie N, Mousseaux E, Boutouyrie P, Fiessinger JN, Emmerich J, Messas E, Jeunemaitre X. The type of variants at the COL3A1 gene associates with the phenotype and severity of vascular Ehlers-Danlos syndrome. Eur J Hum Genet. 2015 Dec;23(12):1657-64. doi: 10.1038/ejhg.2015.32. Epub 2015 Mar 11.

ReferenceCitation: Faugeroux J, Nematalla H, Li W, Clement M, Robidel E, Frank M, Curis E, Ait-Oufella H, Caligiuri G, Nicoletti A, Hagege A, Messas E, Bruneval P, Jeunemaitre X, Bergaya S. Angiotensin II promotes thoracic aortic dissections and ruptures in Col3a1 haploinsufficient mice. Hypertension. 2013 Jul;62(1):203-8. doi: 10.1161/HYPERTENSIONAHA.111.00974. Epub 2013 Apr 29.

evidence: open (via free pdf)

ReferenceCitation: Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. doi: 10.1016/S0140-6736(10)60960-9. Epub 2010 Sep 7. Erratum In: Lancet. 2016 Aug 6;388(10044):564. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.

location_facility: CHU DE GRENOBLE - Hopital Albert Michallon

location_facility: CHRU DE NANCY - Institut Lorrain du Coeur et des Vaisseaux

location_facility: AP-HP - Hopital Europeen Georges-Pompidou

title: Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome: a Double Blind, Randomized, Placebo Controlled, Multicenter Trial.

acronyme: ARCADE

titre: Blocage du Récepteur de l'Angiotensine II associé au celiprolol chez des sujets atteints de syndrome d'Ehlers-Danlos vasculaire : essai randomisé contrôlé en double insu contre placebo

nom_porteur: JEUNEMAITRE

prenom_porteur: Xavier


title: Optimum and Stepped Care Standardised Antihypertensive Treatment With or Without Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis. ANDORRA TRIAL

acronym: ANDORRA

summary: The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting + standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration in patients with confirmed resistant hypertension (RH) and angiographically proven grade III unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.

location_facility: Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu

location_facility: Hopital Europeen Georges Pompidou (HEGP)

acronyme: ANDORRA

titre: Stenting des sténoses athéroscléreuses des artères rénales chez les patients ayant une hypertension artérielles résistante

nom_porteur: AZIZI

prenom_porteur: Michel


acronym: PEAGE

summary:
The treatment of the venous thromboembolic disease, including pulmonary embolism (PE), is based on anticoagulants. During the last decade, all the randomized clinical trials evaluating these anticoagulants have included PE patients with an average age below 60 years. But in clinical pratice, approximately 50% of PE patients are older than 75 years.

So the investigators want to perform a french multicentre prospective cohort of consecutive patients receiving an anticoagulant treatment for a symptomatic and confirmed PE. All the validated and available anticoagulant treatments are authorized in this cohort (unfractionnated and low molecular weight heparins, fondaparinux, vitamin K antagonists and direct oral anticoagulants).

This cohort will provide data regarding the bleeding risk and the risk of PE recurrences and regarding the pharmacokinetic (PK) and pharmacodynamic (PD) properties of these anticoagulants in this older population. Using population approach modelling , the investigators will pay particular attention to the sources of PK/PD variability PK / PD such as genetic polymorphisms of P-glycoprotein and cytochrome P450.

Using all these data , the investigators will try to identify significant risk factors for bleeding and venous thromboembolic events.

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Hôpitaux Universitaires Louis Mourier Paris Nord

title: Pharmacoepidemiology Treatment of Symptomatic Pulmonary Embolism in Hospitalized Patients Aged 75 Years or More: Prospective, Multicenter Cohort Study PEAGE


title: Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease

acronym: PREDI-STIM

summary:
This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic .

The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .

ReferenceCitation: Boussac M, Arbus C, Colin O, Laurencin C, Eusebio A, Hainque E, Corvol JC, Versace N, Rascol O, Rousseau V, Harroch E, Ory-Magne F, Fabbri M, Moreau C, Rolland AS, Jarraya B, Maltete D, Drapier S, Marques AR, Auzou N, Wirth T, Meyer M, Giordana B, Tir M, Rouaud T, Devos D, Brefel-Courbon C; PREDISTIM study group. Personality assessment with Temperament and Character Inventory in Parkinson's disease. Parkinsonism Relat Disord. 2022 Oct;103:34-41. doi: 10.1016/j.parkreldis.2022.08.004. Epub 2022 Aug 19.

evidence: open (via crossref license, author manuscript)

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

ReferenceCitation: Besse-Pinot E, Pereira B, Durif F, Fantini ML, Durand E, Debilly B, Derost P, Moreau C, Hainque E, Rouaud T, Eusebio A, Benatru I, Drapier S, Guehl D, Rascol O, Maltete D, Lagha-Boukbiza O, Giordana C, Tir M, Thobois S, Hopes L, Hubsch C, Jarraya B, Rolland AS, Corvol JC, Devos D, Marques A; Predistim Study Group. Preoperative REM Sleep Behavior Disorder and Subthalamic Nucleus Deep Brain Stimulation Outcome in Parkinson Disease 1 Year After Surgery. Neurology. 2021 Nov 16;97(20):e1994-e2006. doi: 10.1212/WNL.0000000000012862. Epub 2021 Oct 19.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

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

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

ReferenceCitation: Betrouni N, Moreau C, Rolland AS, Carriere N, Chupin M, Kuchcinski G, Lopes R, Viard R, Defebvre L, Devos D. Texture-based markers from structural imaging correlate with motor handicap in Parkinson's disease. Sci Rep. 2021 Feb 1;11(1):2724. doi: 10.1038/s41598-021-81209-4.

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

ReferenceCitation: Boussac M, Arbus C, Dupouy J, Harroch E, Rousseau V, Croiset A, Ory-Magne F, Rascol O, Moreau C, Rolland AS, Maltete D, Rouaud T, Meyer M, Drapier S, Giordana B, Anheim M, Hainque E, Jarraya B, Benatru I, Auzou N, Belamri L, Tir M, Marques AR, Thobois S, Eusebio A, Corvol JC, Devos D, Brefel-Courbon C; PREDI-STIM study group. Personality dimensions of patients can change during the course of parkinson's disease. PLoS One. 2021 Jan 7;16(1):e0245142. doi: 10.1371/journal.pone.0245142. eCollection 2021.

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

ReferenceCitation: Santin MDN, Voulleminot P, Vrillon A, Hainque E, Bereau M, Lagha-Boukbiza O, Wirth T, Montaut S, Bardinet E, Kyheng M, Rolland AS, Voirin J, Drapier S, Durif F, Eusebio A, Giordana C, Auzou N, Houeto JL, Hubsch C, Jarraya B, Laurencin C, Maltete D, Meyer M, Rascol O, Rouaud T, Tir M, Moreau C, Corvol JC, Proust F, Grabli D, Devos D, Tranchant C, Anheim M; Predistim Study Group. Impact of Subthalamic Deep Brain Stimulation on Impulse Control Disorders in Parkinson's Disease: A Prospective Study. Mov Disord. 2021 Mar;36(3):750-757. doi: 10.1002/mds.28320. Epub 2020 Oct 6.

ReferenceCitation: Boussac M, Arbus C, Dupouy J, Harroch E, Rousseau V, Ory-Magne F, Rascol O, Moreau C, Maltete D, Rouaud T, Meyer M, Houvenaghel JF, Marse C, Tranchant C, Hainque E, Jarraya B, Ansquer S, Bonnet M, Belamri L, Tir M, Marques AR, Danaila T, Eusebio A, Devos D, Brefel-Courbon C; PREDI-STIM study group*. Personality Dimensions Are Associated with Quality of Life in Fluctuating Parkinson's Disease Patients (PSYCHO-STIM). J Parkinsons Dis. 2020;10(3):1057-1066. doi: 10.3233/JPD-191903.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of the Efficacy of an Antibiotic Combined With Standard Treatment in Severe Alcoholic Hepatitis

acronym: AntibioCor

summary:
Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for 28 days. However, about 25-35% of patients do not take benefit from this treatment and die within the 6 months following the diagnosis. Numerous trials have evaluated the impact of several strategies in association with corticosteroids. None of them has shown an improvement in survival (primary endpoint) as compared to corticosteroids alone.

The project is based on an approach never tested in a randomized controlled trial in severe alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2 months). This approach is based on animal and human studies.Antibiotics are effective in animal models and in other circumstances characterized by liver failure such as gastrointestinal bleeding related to portal hypertension. The interest of studying this population is emphasized by the frequency of infections in these critically ill patients. Antibiotics will be administered before the development of any infection, as it is likely that these patients present with mesenteric bacterial adenitis without systemic signs of infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and treatment is given for 30 days.

ReferenceCitation: Mathurin P, O'Grady J, Carithers RL, Phillips M, Louvet A, Mendenhall CL, Ramond MJ, Naveau S, Maddrey WC, Morgan TR. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis: meta-analysis of individual patient data. Gut. 2011 Feb;60(2):255-60. doi: 10.1136/gut.2010.224097. Epub 2010 Oct 12.

ReferenceCitation: Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.

ReferenceCitation: Lucey MR, Mathurin P, Morgan TR. Alcoholic hepatitis. N Engl J Med. 2009 Jun 25;360(26):2758-69. doi: 10.1056/NEJMra0805786. No abstract available.

ReferenceCitation: Louvet A, Wartel F, Castel H, Dharancy S, Hollebecque A, Canva-Delcambre V, Deltenre P, Mathurin P. Infection in patients with severe alcoholic hepatitis treated with steroids: early response to therapy is the key factor. Gastroenterology. 2009 Aug;137(2):541-8. doi: 10.1053/j.gastro.2009.04.062. Epub 2009 May 13.

ReferenceCitation: Louvet A, Naveau S, Abdelnour M, Ramond MJ, Diaz E, Fartoux L, Dharancy S, Texier F, Hollebecque A, Serfaty L, Boleslawski E, Deltenre P, Canva V, Pruvot FR, Mathurin P. The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids. Hepatology. 2007 Jun;45(6):1348-54. doi: 10.1002/hep.21607.

ReferenceCitation: Mathurin P, Louvet A, Duhamel A, Nahon P, Carbonell N, Boursier J, Anty R, Diaz E, Thabut D, Moirand R, Lebrec D, Moreno C, Talbodec N, Paupard T, Naveau S, Silvain C, Pageaux GP, Sobesky R, Canva-Delcambre V, Dharancy S, Salleron J, Dao T. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial. JAMA. 2013 Sep 11;310(10):1033-41. doi: 10.1001/jama.2013.276300.

publisher_dissemination: American Medical Association

location_facility:
CHU d'Amiens
Hôpital Jean Verdier (AH-HP)
Hôpital BEaujon (AP-HP)
CHU Nantes
Centre hospitalier
CHU Grenoble
CHU de Caen
CHU Montpellier
Hôpital Paul Brousse (AH-HP)
CHU
CHU Nice
Centre Hospitalier
CHU Pontchaillou
CHU de Besançon
CHU Poitiers
Hôpital La Pitié (AP-HP)
Hôpital Saint Antoine (AP-HP)
Hôpital Claude Huriez, CHU

acronyme: ANTIBIOCOR HAA

titre: Evaluation de l'efficacité de l'antibiothérapie en association à la corticothérapie dans l'hépatite alcoolique sévère. Essai contrôlé randomisé en double aveugle.

discipline_principale: hépatologie

nom_porteur: MATHURIN

prenom_porteur: Philippe


title: Controlled Education Of Patients After Stroke

acronym: CEOPS

summary: The main objective of the study is to compare the benefit of optimised follow-up by nursing personnel from the vascular neurology department, including therapeutic follow-up and an educational program directed to the patient and a caregiving member of his social circle, with that of a typical follow-up.

ReferenceCitation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

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

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Mendyk AM, Duhamel A, Bejot Y, Leys D, Derex L, Dereeper O, Detante O, Garcia PY, Godefroy O, Montoro FM, Neau JP, Richard S, Rosolacci T, Sibon I, Sablot D, Timsit S, Zuber M, Cordonnier C, Bordet R; on the behalf of Strokavenir network. Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient's caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial. Trials. 2018 Feb 22;19(1):137. doi: 10.1186/s13063-018-2483-0.

repository_institution: PubMed Central - Europe PMC

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

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

repositories_institution: Université de Lille (University Of Lille) - LillOA

location_facility: Ch Intercommunal Compiègne-Noyon - Compiegne


title: Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery

acronym: préOVNI

summary:
Surgical treatment is the standard treatment for localized forms of lung cancer non-small cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing this procedure is a major public health issue. The non-invasive ventilation is a technique commonly used postoperatively in acute respiratory distress and in the treatment of sleep apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the non-invasive ventilation achieved during 7 days minimum before the intervention could significantly reduce postoperative complications in patients with an obstructive or restrictive disorder, obesity or chronic heart failure.

The aim of the study is to demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Ministry of Health, France

location_facility: Hôpital Nord Ouest Villefranche Sur Saône


title: A Prospective Randomized Open-labeled Trial Comparing RADIOEMBOLIZATION With Yttrium 90 Microspheres and Sorafenib in Patients With Advanced Hepatocellular Carcinoma

acronym: SARAH

summary: The purpose of this study is to determine whether RADIOEMBOLIZATION with 90 Yttrium microspheres is more effective on overall survival in advanced Hepatocellular carcinoma (HCC) with or without portal venous obstruction and no extrahepatic extension than sorafenib which is now the standard treatment of advanced HCC.

ReferenceCitation: Zarca K, Mimouni M, Pereira H, Chatellier G, Vilgrain V, Durand-Zaleski I; SARAH Trial Group. Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma. Clin Ther. 2021 Jul;43(7):1201-1212. doi: 10.1016/j.clinthera.2021.04.018. Epub 2021 May 28.

repository_institution: Conservatoire national des arts et métiers - HAL CNAM

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

ReferenceCitation: Hermann AL, Dieudonne A, Ronot M, Sanchez M, Pereira H, Chatellier G, Garin E, Castera L, Lebtahi R, Vilgrain V; SARAH Trial Group. Relationship of Tumor Radiation-absorbed Dose to Survival and Response in Hepatocellular Carcinoma Treated with Transarterial Radioembolization with 90Y in the SARAH Study. Radiology. 2020 Sep;296(3):673-684. doi: 10.1148/radiol.2020191606. Epub 2020 Jun 30.

publisher_dissemination: Radiological Society of North America (RSNA)

ReferenceCitation: Vilgrain V, Pereira H, Assenat E, Guiu B, Ilonca AD, Pageaux GP, Sibert A, Bouattour M, Lebtahi R, Allaham W, Barraud H, Laurent V, Mathias E, Bronowicki JP, Tasu JP, Perdrisot R, Silvain C, Gerolami R, Mundler O, Seitz JF, Vidal V, Aube C, Oberti F, Couturier O, Brenot-Rossi I, Raoul JL, Sarran A, Costentin C, Itti E, Luciani A, Adam R, Lewin M, Samuel D, Ronot M, Dinut A, Castera L, Chatellier G; SARAH Trial Group. Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1624-1636. doi: 10.1016/S1470-2045(17)30683-6. Epub 2017 Oct 26.

ReferenceCitation: Vilgrain V, Abdel-Rehim M, Sibert A, Ronot M, Lebtahi R, Castera L, Chatellier G; SARAH Trial Group. Radioembolisation with yttrium-90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial. Trials. 2014 Dec 3;15:474. doi: 10.1186/1745-6215-15-474.

repository_normalized: univOAK

repositories:
PubMed Central
univOAK

repositories_concat: PubMed Central;univOAK

repositories_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

publisher_dissemination: Springer

location_facility:
CHRU Besançon Hôpital Jean Minjoz #21
CHU Grenoble #5
CHU Amiens #2
Hôpital Antoine Béclère #29
CHU Angers #3
Hôpital Jean Verdier #25
Institut Paoli Calmettes #7
Hôpital Edouard Herriot #6
Hôpital Saint Eloi #8
CHU Dijon Hôpital Bocage #22
Hôpital de Hautepierre #18
CHU Robert Debré #28
Institut Gustave Roussy #20
Hôpital Haut Leveque #14
Lyon La croix Rousse #27
Hôpital de Brabois #9
CHU Marseille Hôpital La Timone #23
Paul Brousse #19
Hôpital Côte de Nacre #4
Hôpital Européen Georges Pompidou #13
CHU Poitiers La Milétrie
Hopital beaujon #1
Hôpital de L'Archet #11
Hotel Dieu #10
Henri Mondor #24
CHU Saint Etienne Hôpital Nord #17


title: Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke

summary: Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.

ReferenceCitation: Remy-Neris O, Le Jeannic A, Dion A, Medee B, Nowak E, Poiroux E, Durand-Zaleski I; REM Investigative Team*. Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial. Stroke. 2021 Jun;52(6):1938-1947. doi: 10.1161/STROKEAHA.120.032545. Epub 2021 Apr 29.

location_facility:
CRF de Valmante
APHP - Hôpital La Salpétriere
CHU de Rennes
CH de Garches
CHU d'Amiens
CHU de Lyon
CRRRF
CHU de Dijon
APHP - Hôpital Lariboisière
CHU de Toulouse
CHRU de Lille
CHU de Nantes
CHRU de Brest
CHU de Reims
CHU de Nîmes
CMRRF Kerpape
CHU de Montpellier
CHU de Bordeaux
Centre Bouffard Vercelli
CHU de Clermont-Ferrand
CHU de Limoges
IRR de Nancy
EMPR Le Normandy


title: Effects of Albumin Administration in Septic Cirrhotic Patients With Child > 8 Unrelated to Spontaneous Bacterial Peritonitis on Renal Function and Survival: A Multicenter Randomized Controlled Trial Comparing Use and Non-use of Human Albumin (Vialebex ®)

acronym: ALB-CIRINF

summary:
Patients with cirrhosis present an increased susceptibility to bacterial infections. Spontaneous bacterial peritonitis (SBP) is the most frequent infection and induces severe circulatory dysfunction associated with renal failure in about 30% of cases. Renal failure is a reliable surrogate marker of in-hospital mortality in patients with SBP or with non-SBP infections. Albumin, as an adjuvant to antibiotherapy reduces significantly the rate of renal failure, in-hospital mortality, and overall mortality (Sort P, et al. NEJM 1999). However, little is known regarding the effect of albumin administration in patients with non-SBP infections. Two recent prospective studies demonstrated that non-SBP infections are associated with impairment of the effective circulating volume and precipitate renal failure whatever the presence of ascites.

The aim of this randomized clinical trial is to evaluate the effects of albumin, associated with appropriate antibiotic therapy, on occurrence or deterioration of renal failure and survival in septic (SIRS criteria required) cirrhotic patients with non-SBP infections and presenting with a Child-Pugh score > 8.

ReferenceCitation: Thevenot T, Bureau C, Oberti F, Anty R, Louvet A, Plessier A, Rudler M, Heurgue-Berlot A, Rosa I, Talbodec N, Dao T, Ozenne V, Carbonell N, Causse X, Goria O, Minello A, De Ledinghen V, Amathieu R, Barraud H, Nguyen-Khac E, Becker C, Paupard T, Botta-Fridlung D, Abdelli N, Guillemot F, Monnet E, Di Martino V. Effect of albumin in cirrhotic patients with infection other than spontaneous bacterial peritonitis. A randomized trial. J Hepatol. 2015 Apr;62(4):822-30. doi: 10.1016/j.jhep.2014.11.017. Epub 2014 Nov 21.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier régional Universitaire


title: Pharmacoeconomic and Clinical Prospective Comparison of PET-scan and MRI in Patients With de Novo Multiple Myeloma Less Than 65 Years of Age Treated According to IFM/DFCI 2009 Clinical Trial.

acronym: IMAJEM

summary: Multicenter open-label prospective comparative study of PET-scan and MRI at the time of diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.

ReferenceCitation: Zamagni E, Nanni C, Dozza L, Carlier T, Bailly C, Tacchetti P, Versari A, Chauvie S, Gallamini A, Gamberi B, Caillot D, Patriarca F, Macro M, Boccadoro M, Garderet L, Barbato S, Fanti S, Perrot A, Gay F, Sonneveld P, Karlin L, Cavo M, Bodet-Milin C, Moreau P, Kraeber-Bodere F. Standardization of 18F-FDG-PET/CT According to Deauville Criteria for Metabolic Complete Response Definition in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Jan 10;39(2):116-125. doi: 10.1200/JCO.20.00386. Epub 2020 Nov 5.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Jamet B, Morvan L, Nanni C, Michaud AV, Bailly C, Chauvie S, Moreau P, Touzeau C, Zamagni E, Bodet-Milin C, Kraeber-Bodere F, Mateus D, Carlier T. Random survival forest to predict transplant-eligible newly diagnosed multiple myeloma outcome including FDG-PET radiomics: a combined analysis of two independent prospective European trials. Eur J Nucl Med Mol Imaging. 2021 Apr;48(4):1005-1015. doi: 10.1007/s00259-020-05049-6. Epub 2020 Oct 2.

lead_sponsor: Nantes University Hospital

location_facility: Tours University Hospital "Hôpital Bretonneau"

location_facility: Lille University Hospital "Claude Huriez"

location_facility: Brest University Hospital "CHU du Morvan"

location_facility: Grenoble University Hospital "Hôpital Michallon"

location_facility: Metz University Hospital "Hôpital de Mercy"

location_facility: Nancy University Hospita "Hôpitaux de Brabois"


title: Impact of Small Bowel Preparation Using Polyethylene Glycol for Endoscopic Video-capsule (EVC)Exploration in Unexplained Gastrointestinal Bleedings

acronym: PREPINTEST

summary: The best preparation of small bowel is still unknown. The primary aim of this study is to evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained gastrointestinal bleeding exploration. Three different preparations are evaluated in this study.

ReferenceCitation: Rahmi G, Cholet F, Gaudric M, Filippi J, Duburque C, Bramli S, Quentin V, Alavi Z, Nowak E, Saurin JC, Cellier C, Queneherve L; PREPINTEST working group. Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial. Am J Gastroenterol. 2022 Feb 1;117(2):327-335. doi: 10.14309/ajg.0000000000001597.

location_facility: Centre Hospitalier Universitaire de Nice