acronym: EASE

lead_sponsor: Amryt Research Limited

summary:
This was a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited Epidermolysis Bullosa (EB).

EB is a rare group of genetic skin fragility disorders characterised by blistering of the skin in response to minor injury. In most cases, onset of EB is at birth or shortly after. All participants affected by any type of EB share the main characteristic of repeatedly developing painful wounds that take days to months to heal. Current treatment of EB is primarily preventative and supportive including protection from mechanical forces by avoiding rubbing, early treatment of wounds to prevent infections, and protection of the wound with adequate non-adhesive dressings to enable healing.

The active pharmaceutical ingredient in Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin.

This clinical study of Oleogel-S10 in patients with inherited EB has been carried out to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe for long-term use.

Oleogel-S10 was compared to a control gel. The control gel matched Oleogel-S10 in terms of texture and visual appearance to allow for double-blinding. The packaging for Oleogel-S10 gel and the control gel were identical. The participant received either Oleogel-S10 or control gel for a double-blind study phase of 90 days. The probability that the participant received Oleogel-S10 was 50%, which means that they had a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants were treated with Oleogel-S10 for a period of 24 months.

This clinical study was performed at 49 study sites in 26 countries (Argentina, Australia, Austria, Brazil, Chile, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong [China], Hungary, Ireland, Israel, Italy, Romania, Russia, Serbia, Singapore, Spain, Switzerland, Ukraine, United Kingdom, and the United States); 223 participants participated in total.

location_facility: Semmelweis University, Faculty of Medicine

location_facility: Birmingham Children's Hospital NHS Trust

location_facility: S/R National Center of Dermatology and Venerology

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitari de la Vall d'Hebron

location_facility: Hospital of Skin and Veneral Diseases "A. Syggros"

location_facility: Istituto Dermopatico dell'Immacolata IDI-IRCCS

location_facility: Centro de investigaciones Metabolicas, CINME

location_facility: National Children Specialized Hospital "Ohmatdyt" of Ministry of Health of Ukraine

location_facility: University Hospital Brno, Children´s Hospital

location_facility: Murdoch Childrens Research Institute Royal Children's Hospital

location_facility: Prince of Wales Hospital, The Chinese University of Hong Kong

location_facility: Kinder- und Jugendkrankenhaus AUF DER BULT

location_facility: Consutorios Medicos (Instituto de Neumonologia y Dermatologia)

location_facility: Kandang Kerbau (KK) Women's and Children's Hospital

location_facility: University of Belgrade, School of Medicine

location_facility: State Scientific Center for Dermatovenerology and Cosmetology

title: Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow-up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Chile
Czechia
Serbia
France
Colombia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Romania
Italy
United Kingdom
Singapore
Austria
Spain
Greece
Georgia
Russian Federation
Israel


title: NEoadjuvant Dose-dense MVAC In cOmbination With Durvalumab (MEDI4736) and Tremelimumab in Muscle-invasive Urothelial Carcinoma

acronym: NEMIO

summary: This is an open label, phase I/II clinical trial to evaluate the efficacy and safety of 2 cycles of durvalumab without (Arm A) or with (Arm B) tremelimumab in association with ddMVAC as neoadjuvant therapy in patients with MIUC.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Thibault C, Elaidi R, Vano YA, Rouabah M, Braychenko E, Helali I, Audenet F, Oudard S. Open-label phase II to evaluate the efficacy of NEoadjuvant dose-dense MVAC In cOmbination with durvalumab and tremelimumab in muscle-invasive urothelial carcinoma: NEMIO. Bull Cancer. 2020 Jun;107(5S):eS8-eS15. doi: 10.1016/S0007-4551(20)30281-2.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: No

ipd_sharing_description: No plan to share

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Cochin
Hôpital Saint André, CHU de Bordeaux
Centre Antoine Lacassagne
CHU Henri-Mondor
Institut Mutualiste Montsouris
Centre Eugene Marquis
Hôpitaux universitaires de Strasbourg
Institut Claudius Regaud
Centre Leon Berard
Groupe Hospitalier Pitié-Salpetrière
Sasu Roc37
Institut Gustave Roussy
Institut Paoli Calmettes
Hia Begin

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome With Analysis of the Impact on Quality of Life and Functional Capacity of Patients

acronym: EPO-QoL

summary:
Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. The historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid response in 40-60% of patients treated.

In this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia <10 g / dL in the context of a myelodysplastic syndrome with IPSS score <1.

In addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance.

Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24 weeks of treatment.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Centre Hospitalier Universitaire de STRASBOURG

location_facility: Centre Hospitalier de la région d'Annecy

status_simplified: Completed


acronym: TIME

lead_sponsor: UNICANCER

summary: National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.

location_facility: Centre hospitalier Départemental de Vendée - Les Oudairies

location_facility: Centre Hospitalier Intercommunal Cote Basque

location_facility: Centre de Cancérologie du Grand Montpellier - Clinique Clementville

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Intercommunal de Toulon

title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer

type: EudraCT Number

source: euctr


title: A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia

summary: The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion.

ReferenceCitation: Itzykson R, Kosmider O, Renneville A, Gelsi-Boyer V, Meggendorfer M, Morabito M, Berthon C, Ades L, Fenaux P, Beyne-Rauzy O, Vey N, Braun T, Haferlach T, Dreyfus F, Cross NC, Preudhomme C, Bernard OA, Fontenay M, Vainchenker W, Schnittger S, Birnbaum D, Droin N, Solary E. Prognostic score including gene mutations in chronic myelomonocytic leukemia. J Clin Oncol. 2013 Jul 1;31(19):2428-36. doi: 10.1200/JCO.2012.47.3314. Epub 2013 May 20.

evidence: open (via free pdf)

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Braun T, Itzykson R, Renneville A, de Renzis B, Dreyfus F, Laribi K, Bouabdallah K, Vey N, Toma A, Recher C, Royer B, Joly B, Vekhoff A, Lafon I, Sanhes L, Meurice G, Orear C, Preudhomme C, Gardin C, Ades L, Fontenay M, Fenaux P, Droin N, Solary E; Groupe Francophone des Myelodysplasies. Molecular predictors of response to decitabine in advanced chronic myelomonocytic leukemia: a phase 2 trial. Blood. 2011 Oct 6;118(14):3824-31. doi: 10.1182/blood-2011-05-352039. Epub 2011 Aug 9.

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Janssen-Cilag Ltd.

location_facility:
Hôpital Avicenne
Centre Hospitalier Sud-Francilien
Hôpital Boulogne Sur Mer
Hôpital Saint-Antoine.
Hopital de la Cote Basque
Centre Hospitalier du Mans
Hôpital Avignon
CHU d'Amiens
Hôpital Versailles
CHU Haut-Lévèque
CHU de Dijon
Hoiptal St Louis
CHU Bretoneau
Hopital Cochin
Hopital Necker
CH Angers
CHU Caremeau
Hopital Hotel Dieu
CHU de Reims
CHU de
Institut gustave Roussy
CHU de Bicêtre
Institut Paoli Calmettes
CHU de nantes
Hematology Dpt, Hopital Purpan
Hopital d'Instruction des Armées Percy
Hopital Henri Mondor
CHR La Source orléans
Centre Hospitalier Joffre
Hôpital Archet1
Centre Henri Becquerel


title: CAlcified Lesion Intervention Planning Steered by OCT.

acronym: CALIPSO

summary:
Calcified lesions are very frequent among coronary artery disease stenotic lesions.

The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.

Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.

The presence of calcifications increases the risk of adverse evolution after PCI , including stent restenosis, thrombosis and need for repeat revascularisation. Specific and appropriate tools can be used for calcified lesions management , including high pressure non compliant balloons, intravascular lithotripsy and rotablator. Intra vascular OCT has a high sensitivity and specificity for calcium detection among coronary artery lesions. Compared to IVUS, OCT allows a better quantification of calcium sheets (depth extension ) . Several intra coronary imaging based calcified lesions management algorithms have been proposed , but none have been validated in clinical practice.

lead_sponsor: Institut Mutualiste Montsouris

sponsor_collaborators:
Institut Mutualiste Montsouris
Abbott

location_facility:
CHU de Poitiers
CHU Nîmes
CHU de Clermont-Ferrand
Clinique Saint-Hilaire
Institut Arnaud Tzanck,
Ch de Bastia
Clinique Saint Augustin
CHU de Besançon
Polyclinique les Fleurs
Clinique Pasteur
Institut Mutualiste montsouris
L'Hôpital Privé du Confluent
CHU de Bordeaux
Hôpital Louis Pasteur

intervention_type: Procedure


title: Triple Site Ventricular Stimulation for CRT Candidates

acronym: TRIV

summary:
Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT.

One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony.

The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.

ReferenceCitation: Anselme F, Bordachar P, Pasquie JL, Klug D, Leclercq C, Milhem A, Alonso C, Deharo JC, Gras D, Probst V, Piot O, Savoure A. Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization. Heart Rhythm. 2016 Jan;13(1):183-9. doi: 10.1016/j.hrthm.2015.08.036. Epub 2015 Sep 26.

oa_host_type: repository

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

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

repositories_concat: HAL

unpaywall_oa_status: green

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_facility:
University hospital La Timone
Nouvelles Cliniques Nantaises
University Hospital of Rennes
Hôpital Saint Louis
University hospital of Bordeaux
University hospital of Rouen
Clinique Bizet
Centre Cardiologique du Nord
University hospital of Montpellier
University hospital of Nantes
University hospital of Lille
University hospital of Nancy

intervention_type: Device


title: Evaluation of the Efficacy of 3-month Continuous Extended Treatment With Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults: a Multicentre Randomised Controlled Trial

acronym: SOPAZITHRO

summary:
Purulent Oedematous Sinusitis (POS) is a particular form of chronic rhinosinusitis observed in 2% of the general population. In spite of its heavy impact on the quality of life, There is no established recommendation for the treatment of primary POS. Long-term low-dose macrolides are currently proposed for these forms of chronic rhinosinusitis when conventional treatments (local corticosteroids, saline rinsing, iterative short courses of antibiotics targeted on pathogens, and surgical opening and drainage) have failed. This treatment with macrolides is currently applied off-label.

This study aims to assess the efficacy of macrolides in POS. An extensive workup is fulfilled to exclude other forms of chronic rhinosinusitis (Th2 biased inflammatory diseases, allergic diseases) (allergy, nasosinusal polyposis) or those due to cystic fibrosis or immune deficiency.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Hôpitaux Universitaires de Marseille Conception

location_facility: Centre Hospitalier Universitaire De Nantes

lead_sponsor_type: academique

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: CENTRE HOSPITALIER INTERCOM DE CRETEIL

type_etablissement: CH

acronyme: SOPAZITHRO

titre: Evaluation de l'efficacité de l'azithromicine au long cours dans les sinusites oedémato-purulentes idiopathiques : essai multicentrique contrôlé randomisé en double aveugle

discipline_principale: autre

nom_porteur: BEQUIGNON

prenom_porteur: Emilie


acronym: PEPSI

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: Randomized controlled trial on focal motor status epilepticus (SE), studying the add-on efficacy of the enteral administration of perampanel (PER) to a conventional intravenous antiepileptic drug.

location_facility: Accueil des Urgences, Centre Hospitalier de Versailles - André Mignot

location_facility: Neuro-physiologie clinique, CHU Lille (Hôpital Roger Salengro)

location_facility: Réanimation polyvalente, CHU (Hopital Roger Salengro)

location_facility: Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital

location_facility: Neurologie et Neurovasculaire, GH Paris Saint Joseph

location_facility: Réanimation Polyvalente, GH Paris Saint Joseph

location_facility: Neurologie, Centre Hospitalier de Versailles - André Mignot

location_facility: Urgences, CHU Lille (Hôpital Roger Salengro)

status: Terminated

title: Efficacy of add-on PEramPanel in Focal Motor Status Epilepticus

status_simplified: Unknown

appel_a_projets: PHRCN

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: PEPSI

titre: Perampanel et fosphenytoïne dans le traitement de l'état de mal épileptique focal moteur

discipline_principale: neurologie

nom_porteur: NAVARRO

prenom_porteur: Vincent


title: NEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients

acronym: NECESSITY

summary:
There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS.

Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.

location_facility:
Jacques-Eric Gottenberg
Eric Hachulla
Christophe Richez
Valérie Devauchelle
Jacques Morel
Véronique Le Guern
Raphaele Seror


title: A Comparative, Randomized, Double-blind, 3-arm Parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction

summary: This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.

lead_sponsor: Unither Pharmaceuticals, France

sponsor_collaborators:
Unither Pharmaceuticals, France
EXCELYA Bordeaux

location_country:
Hungary
United Kingdom
Belgium
Russian Federation
France

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház,

location_facility: LLC Center for interdisciplinary dentistry & neuro

location_facility: State Medico-stomato Univ., by A.I. Evdokimov

location_facility: BARTS HEALTH NHS TRUST Royal London Hospital


title: Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study

acronym: LARMOMIQUE

summary: Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting the motor neuron. Currently, there is no diagnostic test and no examination that can predict the evolution of this pathology. The search for diagnostic and prognostic biomarkers is therefore essential for a better understanding of the pathophysiology of ALS, which remains poorly understood, and also for better clinical management. The ocular surface, made up of liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a biomarker in ALS

design_allocation: Non-Randomized

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Tours

location_facility: Ophthalmology Department, University Hospital of Tours, France

location_facility: Neurology Department, University Hospital of Tours, France

location_facility: Centre d'Investigation Clinique_CIC 1415

intervention_type: Other


title: Validation of OphtAI Software Diagnostic Performance for Automated Screening of Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and ARMD: a Multicentre Study

acronym: OPHTAI-EVAL

summary: Evolucare OphtAI is a medical device offering automated, artificial intelligence powered, screening capabilities for Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and AMD, whose performances will by tested through the OphtAI-EVAL.

primary_purpose: Screening

lead_sponsor: Evolucare Technologies

sponsor_collaborators:
Evolucare Technologies
Slb Pharma
Assistance Publique - Hôpitaux de Paris
BPIfrance

location_facility:
Centre Ophtalmologique Brétigny Essonne
Centre d'examens de santé de la CPAM 93
Retinodiab Franche-Comté
CHU Nantes
OPHDIAT
Diabète Occitanie
Retinodiab Bourgogne
Centre Aix Vision
CHU Toulouse
CHU Brest
Clinique Honoré Cave
CH SUD Francilien Corbeil Essonne


title: EURopean Study on Encephalitis in Intensive CAre

acronym: EURECA

summary: Prospective observational multicenter study in European ICUs. All patients admitted to the ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of America criteria) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.

study_type: Observational

time_perspective: Prospective

lead_sponsor: ICUREsearch

location_country: Italy India Netherlands Austria Spain France

location_facility: Fondation Opthalmologique Adolphe de Rothschild

location_facility: Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE

location_facility: Institute Of Medical Sciences Banaras Hindu University

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hôpitaux universitaires Est Parisien, Tenon

location_facility: Sri Ramachandra Institute of Higher Education and Research

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences


title: Assessment of the Safety and Performance of Ankle Ligament Supports in the Context of a Return to Sport After Sprain

summary:
Decathlon has developed Ankle STRONG products which are medical devices that must be positioned around the ankle to limit ankle sprain occurrence.

The Ankle STRONG devices cover a range of 3 products (Ankle STRONG 100/500/900). The differences between the devices is based on the strength of compression and the ankle maintain.

The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Ankle STRONG products to demonstrate safety and performance of these devices in a real-world setting.

lead_sponsor: Decathlon SE

sponsor_collaborators:
Decathlon SE
EFOR, France

location_facility: Centre Hospitalier Universitaire de Lille


type: Registry Identifier

title: Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease (AETIONOMY)

acronym: AETIONOMY

summary: The AETIONOMY project will generate a refined taxonomy and testable mechanisms underlying the derived stratification of patients.

time_perspective: Cross-Sectional

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

collaborators: Institut d'Investigacions Biomèdiques August Pi i Sunyer

location_country: Germany Spain Sweden France

location_facility: Universitaetsklinikum Bonn (UKB), Sigmund-Freud 25 Strasse

location_facility: Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Rossello 149- 153

location_facility: Karolinska Institutet (KI), Karolinska University Hospital S3:01

location_facility: CIC Neurosciences - ICM - Hôpital Pitié-Salpêtrière, 47-83 Bd de l'Hôpital


title: A Multicenter Randomized Superiority Study To Compare The Effects Of An 8-Weeks Mindfulness-based Intervention Versus Health Education Programme On Mental Health And Wellbeing In Individuals With Subjective Cognitive Decline

acronym: SCD-WELL

summary:
The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective Cognitive Decline (SCD), in comparison to an active comparison condition.

It is increasingly recognized that most neuropathological processes start years before the onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target individuals in the earliest stages for intervention when neurodegeneration is still limited. Individuals clinically judged to have SCD, defined by subjectively experienced cognitive decline but normal performance on cognitive tests, are at increased risk for future cognitive decline and AD. These individuals with SCD currently have no established treatment options. Symptoms of anxiety have high prevalence in this population, and evidence from recent longitudinal research links anxiety with significantly accelerated cognitive decline in at risk individuals. Effectively reducing anxiety in this population may therefore not only relieve participants from burdensome symptoms, but may also slow cognitive decline and delay or prevent the onset of AD.

The investigators chose to study the efficacy of a mindfulness-based intervention to reduce anxiety in this population because this type of intervention has been shown to reduce anxiety in a number of populations, including in older adults. Further, accumulating evidence indicates that intensive mindfulness training effectively down-regulates a number of other adverse psychological and biological risk factors for AD, such as stress, depression, insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These findings are relevant to AD because approximately a third of AD cases worldwide might be attributable to potentially modifiable risk factors. In spite of the increased use of mindfulness-based interventions to treat clinical symptoms, these trials often suffer from the lack of an adequate comparison condition and lack of follow up to know whether initial benefits are maintained.

primary_purpose: Other

ReferenceCitation: Whitfield T, Demnitz-King H, Schlosser M, Barnhofer T, Frison E, Coll-Padros N, Dautricourt S, Requier F, Delarue M, Gonneaud J, Klimecki OM, Lutz A, Paly L, Salmon E, Schild AK, Walker Z, Jessen F, Chetelat G, Collette F, Wirth M, Marchant NL; Medit-Ageing Research Group. Effects of a mindfulness-based versus a health self-management intervention on objective cognitive performance in older adults with subjective cognitive decline (SCD): a secondary analysis of the SCD-Well randomized controlled trial. Alzheimers Res Ther. 2022 Sep 6;14(1):125. doi: 10.1186/s13195-022-01057-w.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: DZNE - DZNE Pub

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Demnitz-King H, Gonneaud J, Klimecki OM, Chocat A, Collette F, Dautricourt S, Jessen F, Krolak-Salmon P, Lutz A, Morse RM, Molinuevo JL, Poisnel G, Touron E, Wirth M, Walker Z, Chetelat G, Marchant NL; Medit-Ageing Research Group. Association of Self-reflection With Cognition and Brain Health in Cognitively Unimpaired Older Adults. Neurology. 2022 Sep 27;99(13):e1422-e1431. doi: 10.1212/WNL.0000000000200951. Epub 2022 Jul 19.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Marchant NL, Barnhofer T, Coueron R, Wirth M, Lutz A, Arenaza-Urquijo EM, Collette F, Poisnel G, Demnitz-King H, Schild AK, Coll-Padros N, Delphin-Combe F, Whitfield T, Schlosser M, Gonneaud J, Asselineau J, Walker Z, Krolak-Salmon P, Molinuevo JL, Frison E, Chetelat G, Jessen F, Klimecki OM; The Medit-Ageing Research Group. Effects of a Mindfulness-Based Intervention versus Health Self-Management on Subclinical Anxiety in Older Adults with Subjective Cognitive Decline: The SCD-Well Randomized Superiority Trial. Psychother Psychosom. 2021;90(5):341-350. doi: 10.1159/000515669. Epub 2021 Apr 19.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

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

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

location_facility: The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)

location_facility: The Clinical Research Memory Centre of Lyon (CMRR), department of the University Hospitals of Lyon - Hospices Civils de Lyon (HCL)

location_facility: The Department of Psychiatry at University of Cologne (UKK)

location_facility: The Division of Psychiatry at University College London (UCL).


title: Multicentric, Prospective Study of Efficacy and Safety of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Marrow

acronym: MatriBone

summary: The main objective of this clinical study is the estimation of the rate of intersomatic fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous substitute with a biomaterial (MatriBONE associated with the autologous bone marrow), associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow. Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar canal and\or spondylolisthesis.

ReferenceType: background

ReferenceCitation: Anand N, Hamilton JF, Perri B, Miraliakbar H, Goldstein T. Cantilever TLIF with structural allograft and RhBMP2 for correction and maintenance of segmental sagittal lordosis: long-term clinical, radiographic, and functional outcome. Spine (Phila Pa 1976). 2006 Sep 15;31(20):E748-53. doi: 10.1097/01.brs.0000240211.23617.ae.

ReferenceCitation: Battie MC, Videman T, Levalahti E, Gill K, Kaprio J. Genetic and environmental effects on disc degeneration by phenotype and spinal level: a multivariate twin study. Spine (Phila Pa 1976). 2008 Dec 1;33(25):2801-8. doi: 10.1097/BRS.0b013e31818043b7.

ReferenceCitation: Battie MC, Videman T, Kaprio J, Gibbons LE, Gill K, Manninen H, Saarela J, Peltonen L. The Twin Spine Study: contributions to a changing view of disc degeneration. Spine J. 2009 Jan-Feb;9(1):47-59. doi: 10.1016/j.spinee.2008.11.011.

ReferenceCitation: Carter JD, Swearingen AB, Chaput CD, Rahm MD. Clinical and radiographic assessment of transforaminal lumbar interbody fusion using HEALOS collagen-hydroxyapatite sponge with autologous bone marrow aspirate. Spine J. 2009 Jun;9(6):434-8. doi: 10.1016/j.spinee.2008.11.004. Epub 2008 Dec 25.

ReferenceCitation: Chen Z, Zhao J, Liu A, Yuan J, Li Z. Surgical treatment of recurrent lumbar disc herniation by transforaminal lumbar interbody fusion. Int Orthop. 2009 Feb;33(1):197-201. doi: 10.1007/s00264-008-0531-1. Epub 2008 Mar 21.

ReferenceCitation: el-Masry MA, Khayal H, Salah H. Unilateral transforaminal lumbar interbody fusion (TLIF) using a single cage for treatment of low grade lytic spondylolisthesis. Acta Orthop Belg. 2008 Oct;74(5):667-71.

ReferenceCitation: Goyal N, Wimberley DW, Hyatt A, Zeiller S, Vaccaro AR, Hilibrand AS, Albert TJ. Radiographic and clinical outcomes after instrumented reduction and transforaminal lumbar interbody fusion of mid and high-grade isthmic spondylolisthesis. J Spinal Disord Tech. 2009 Jul;22(5):321-7. doi: 10.1097/BSD.0b013e318182cdab.

ReferenceCitation: Houten JK, Post NH, Dryer JW, Errico TJ. Clinical and radiographically/neuroimaging documented outcome in transforaminal lumbar interbody fusion. Neurosurg Focus. 2006 Mar 15;20(3):E8. doi: 10.3171/foc.2006.20.3.9.

ReferenceCitation: Jagannathan J, Sansur CA, Oskouian RJ Jr, Fu KM, Shaffrey CI. Radiographic restoration of lumbar alignment after transforaminal lumbar interbody fusion. Neurosurgery. 2009 May;64(5):955-63; discussion 963-4. doi: 10.1227/01.NEU.0000343544.77456.46.

ReferenceCitation: Lauber S, Schulte TL, Liljenqvist U, Halm H, Hackenberg L. Clinical and radiologic 2-4-year results of transforaminal lumbar interbody fusion in degenerative and isthmic spondylolisthesis grades 1 and 2. Spine (Phila Pa 1976). 2006 Jul 1;31(15):1693-8. doi: 10.1097/01.brs.0000224530.08481.4e.

ReferenceCitation: Rihn JA, Patel R, Makda J, Hong J, Anderson DG, Vaccaro AR, Hilibrand AS, Albert TJ. Complications associated with single-level transforaminal lumbar interbody fusion. Spine J. 2009 Aug;9(8):623-9. doi: 10.1016/j.spinee.2009.04.004. Epub 2009 May 30.

ReferenceCitation: Rihn JA, Makda J, Hong J, Patel R, Hilibrand AS, Anderson DG, Vaccaro AR, Albert TJ. The use of RhBMP-2 in single-level transforaminal lumbar interbody fusion: a clinical and radiographic analysis. Eur Spine J. 2009 Nov;18(11):1629-36. doi: 10.1007/s00586-009-1046-1. Epub 2009 May 28.

ReferenceCitation: Sasso RC, LeHuec JC, Shaffrey C; Spine Interbody Research Group. Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment. J Spinal Disord Tech. 2005 Feb;18 Suppl:S77-81. doi: 10.1097/01.bsd.0000112045.36255.83.

ReferenceCitation: Schleicher P, Beth P, Ottenbacher A, Pflugmacher R, Scholz M, Schnake KJ, Haas NP, Kandziora F. Biomechanical evaluation of different asymmetrical posterior stabilization methods for minimally invasive transforaminal lumbar interbody fusion. J Neurosurg Spine. 2008 Oct;9(4):363-71. doi: 10.3171/SPI.2008.9.10.363.

ReferenceCitation: Xiao Y, Li F, Chen Q. Transforaminal lumbar interbody fusion with one cage and excised local bone. Arch Orthop Trauma Surg. 2010 May;130(5):591-7. doi: 10.1007/s00402-009-0917-6. Epub 2009 Jun 30.

ReferenceCitation: Xiao YX, Chen QX, Li FC. Unilateral transforaminal lumbar interbody fusion: a review of the technique, indications and graft materials. J Int Med Res. 2009 May-Jun;37(3):908-17. doi: 10.1177/147323000903700337.

ReferenceCitation: Yan DL, Pei FX, Li J, Soo CL. Comparative study of PILF and TLIF treatment in adult degenerative spondylolisthesis. Eur Spine J. 2008 Oct;17(10):1311-6. doi: 10.1007/s00586-008-0739-1. Epub 2008 Aug 7.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Biom'Up France SAS

location_facility: Unité d'Orthopédie-Traumatologie rachis II, Pellegrin


title: Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion

acronym: VIDMED

summary:
Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.

There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.

Usually surgery is proposed in second intention after failure of medical drainage.

Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.

Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.

To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.

lead_sponsor: University Hospital, Rouen

location_facility:
UH Rouen
University Hospital


title: Randomized Trial Comparing Digestive and Urinary Dysfunction Secondary to 2 Surgical Techniques Used in the Management of Deep Endometriosis Infiltrating the Rectum: Colorectal Resection and Rectal Nodules Excision (ENDORE)

acronym: ENDORE

summary: The purpose of this study is to determine whether performing colorectal resection in deep endometriosis infiltrating the rectum is responsible for a higher rate of postoperative digestive and urinary dysfunction when compared to rectal nodules excision (conservation of the rectum).

status: Unknown status

ReferenceCitation: Roman H, Tuech JJ, Huet E, Bridoux V, Khalil H, Hennetier C, Bubenheim M, Branduse LA. Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial. Hum Reprod. 2019 Dec 1;34(12):2362-2371. doi: 10.1093/humrep/dez217. Erratum In: Hum Reprod. 2020 Mar 27;35(3):736.

repository_institution: PubMed Central - Europe PMC

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

repositories_institution:
Elsevier - Scopus
PubMed Central - Europe PMC

publisher_dissemination: Oxford University Press

ReferenceCitation: Roman H, Chanavaz-Lacheray I, Ballester M, Bendifallah S, Touleimat S, Tuech JJ, Farella M, Merlot B. High postoperative fertility rate following surgical management of colorectal endometriosis. Hum Reprod. 2018 Sep 1;33(9):1669-1676. doi: 10.1093/humrep/dey146.

repositories_concat: PubMed Central

location_facility: Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6

location_facility: Service de Gynécologie et Obstétrique, CHU Jean de Flandre


title: Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions_COVID-19

acronym: REMPAR-EHPAD

summary: REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).

time_perspective: Retrospective

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes


title: Incidence of Symptomatic and Asymptomatic Influenza Among Healthcare Workers : A Multicenter Cohort Study

acronym: AFP

summary: Although clinical presentation of influenza is often symptomatic, asymptomatic cases also occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is very important because of the risk of cross-transmission to hospitalized patients. The principal objective of the study is to estimate the incidence of symptomatic and asymptomatic influenza among healthcare workers in short-stay wards. The results of this study will lead to a better understanding of the burden of asymptomatic influenza among healthcare workers and might be used as an argument to increase influenza vaccine coverage among healthcare workers.

primary_purpose: Prevention

ReferenceCitation: Benet T, Amour S, Valette M, Saadatian-Elahi M, Aho-Glele LS, Berthelot P, Denis MA, Grando J, Landelle C, Astruc K, Paris A, Pillet S, Lina B, Vanhems P; AFP Study Group. Incidence of Asymptomatic and Symptomatic Influenza Among Healthcare Workers: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2021 May 4;72(9):e311-e318. doi: 10.1093/cid/ciaa1109.

lead_sponsor: Hospices Civils de Lyon

location_facility: Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health


title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO

acronym: EuroECMO-COVID

summary:
In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.

In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively.

Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%.

The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality.

Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project.

The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.

ReferenceCitation: Bolotin S, Pebody R, White PJ, McMenamin J, Perera L, Nguyen-Van-Tam JS, Barlow T, Watson JM; UK Severe Influenza Surveillance System (USISS) Steering Group. A new sentinel surveillance system for severe influenza in England shows a shift in age distribution of hospitalised cases in the post-pandemic period. PLoS One. 2012;7(1):e30279. doi: 10.1371/journal.pone.0030279. Epub 2012 Jan 23.

ReferenceCitation: Dawood FS, Iuliano AD, Reed C, Meltzer MI, Shay DK, Cheng PY, Bandaranayake D, Breiman RF, Brooks WA, Buchy P, Feikin DR, Fowler KB, Gordon A, Hien NT, Horby P, Huang QS, Katz MA, Krishnan A, Lal R, Montgomery JM, Molbak K, Pebody R, Presanis AM, Razuri H, Steens A, Tinoco YO, Wallinga J, Yu H, Vong S, Bresee J, Widdowson MA. Estimated global mortality associated with the first 12 months of 2009 pandemic influenza A H1N1 virus circulation: a modelling study. Lancet Infect Dis. 2012 Sep;12(9):687-95. doi: 10.1016/S1473-3099(12)70121-4. Epub 2012 Jun 26. Erratum In: Lancet Infect Dis. 2012 Sep;12(9):655.

ReferenceCitation: Simonsen L, Spreeuwenberg P, Lustig R, Taylor RJ, Fleming DM, Kroneman M, Van Kerkhove MD, Mounts AW, Paget WJ; GLaMOR Collaborating Teams. Global mortality estimates for the 2009 Influenza Pandemic from the GLaMOR project: a modeling study. PLoS Med. 2013 Nov;10(11):e1001558. doi: 10.1371/journal.pmed.1001558. Epub 2013 Nov 26.

ReferenceCitation: Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

ReferenceCitation: Drosten C, Gunther S, Preiser W, van der Werf S, Brodt HR, Becker S, Rabenau H, Panning M, Kolesnikova L, Fouchier RA, Berger A, Burguiere AM, Cinatl J, Eickmann M, Escriou N, Grywna K, Kramme S, Manuguerra JC, Muller S, Rickerts V, Sturmer M, Vieth S, Klenk HD, Osterhaus AD, Schmitz H, Doerr HW. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1967-76. doi: 10.1056/NEJMoa030747. Epub 2003 Apr 10.

ReferenceCitation: Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. doi: 10.1056/NEJMoa030781. Epub 2003 Apr 10.

ReferenceCitation: Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17. Erratum In: N Engl J Med. 2013 Jul 25;369(4):394.

ReferenceCitation: de Groot RJ, Baker SC, Baric RS, Brown CS, Drosten C, Enjuanes L, Fouchier RA, Galiano M, Gorbalenya AE, Memish ZA, Perlman S, Poon LL, Snijder EJ, Stephens GM, Woo PC, Zaki AM, Zambon M, Ziebuhr J. Middle East respiratory syndrome coronavirus (MERS-CoV): announcement of the Coronavirus Study Group. J Virol. 2013 Jul;87(14):7790-2. doi: 10.1128/JVI.01244-13. Epub 2013 May 15. No abstract available.

ReferenceCitation: Spina S, Marrazzo F, Migliari M, Stucchi R, Sforza A, Fumagalli R. The response of Milan's Emergency Medical System to the COVID-19 outbreak in Italy. Lancet. 2020 Mar 14;395(10227):e49-e50. doi: 10.1016/S0140-6736(20)30493-1. Epub 2020 Feb 28. No abstract available.

ReferenceCitation: Ebrahim SH, Memish ZA. COVID-19: preparing for superspreader potential among Umrah pilgrims to Saudi Arabia. Lancet. 2020 Mar 14;395(10227):e48. doi: 10.1016/S0140-6736(20)30466-9. Epub 2020 Feb 27. No abstract available.

ReferenceCitation: Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.

publisher_dissemination: American Medical Association

ReferenceCitation: Lorusso R, De Piero ME, Mariani S, Di Mauro M, Folliguet T, Taccone FS, Camporota L, Swol J, Wiedemann D, Belliato M, Broman LM, Vuylsteke A, Kassif Y, Scandroglio AM, Fanelli V, Gaudard P, Ledot S, Barker J, Boeken U, Maier S, Kersten A, Meyns B, Pozzi M, Pedersen FM, Schellongowski P, Kirali K, Barrett N, Riera J, Mueller T, Belohlavek J; EuroECMO-COVID Study Group. In-hospital and 6-month outcomes in patients with COVID-19 supported with extracorporeal membrane oxygenation (EuroECMO-COVID): a multicentre, prospective observational study. Lancet Respir Med. 2023 Feb;11(2):151-162. doi: 10.1016/S2213-2600(22)00403-9. Epub 2022 Nov 16.

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

lead_sponsor: Maastricht University Medical Center

collaborators: European chapter of the Extracorporeal Life Support Organization

collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna

collaborators: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

collaborators: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

collaborators: Vilnius University Hospital Santaros Klinikos

collaborators: Heart Center Leipzig - University Hospital

collaborators: University Heart Center Freiburg - Bad Krozingen

collaborators: Centre Hospitalier Universitaire Saint Pierre

collaborators: Guy's and St Thomas' NHS Foundation Trust

collaborators: City Clinical Hospital No. 67, Moscow, Russia

collaborators: City Hospital No 40, Saint Petersburg, Russia

collaborators: Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash

collaborators: City Hospital No 41, Ekaterinburg, Russia

collaborators: Bambino Gesù Hospital and Research Institute

collaborators: Children's Medical Hospital, University of Essen, Essen, Germany

collaborators: Great Ormond Street Hospital for Children NHS Foundation Trust

collaborators: Royal Brompton & Harefield NHS Foundation Trust

collaborators: Copenhagen University Hospital at Herlev

collaborators: A.O.U. Città della Salute e della Scienza - Molinette Hospital

collaborators: Centre Hospitalier Universitaire de Liege

sponsor_collaborators: Guy's and St Thomas' NHS Foundation Trust

sponsor_collaborators: City Hospital No 41, Ekaterinburg, Russia

sponsor_collaborators: Copenhagen University Hospital at Herlev

sponsor_collaborators: Centre Hospitalier Universitaire de Liege

location_country:
Germany
Poland
Czechia
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Russian Federation
Israel

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Copenhagen University Hospital at Herlev

location_facility: City Hospital No 41, Ekaterinburg, Russia


type: Other Identifier

title: Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients?

acronym: ETPARK-REMED

summary: Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management. This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group.

ReferenceCitation: Canivet C, Costa N, Ory-Magne F, Arcari C, Mohara C, Pourcel L, Derumeaux H, Berard E, Bourrel R, Molinier L, Brefel-Courbon C. Clinical Impact and Cost-Effectiveness of an Education Program for PD Patients: A Randomized Controlled Trial. PLoS One. 2016 Sep 29;11(9):e0162646. doi: 10.1371/journal.pone.0162646. eCollection 2016.

ReferenceCitation: Ory Magne F, Arcari C, Canivet C, Sarrail M, Fabre MH, Mohara C, Brefel Courbon C. [A therapeutic educational program in Parkinson's disease: ETPARK]. Rev Neurol (Paris). 2014 Feb;170(2):128-33. doi: 10.1016/j.neurol.2013.08.007. Epub 2013 Nov 20. French.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
France Parkinson Association


title: Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease

acronym: Prodygi-II

summary:
Pilot study:

Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)
Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy
Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
France Parkinson Association


title: High Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714

acronym: INFLAPARK

summary:
There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in the neurodegenerative process of Parkinson's disease (PD). It is considered that microglial activation would be part of self-propelling cycle of neuroinflammation that fuels the progressive dopaminergic neurodegeneration. It is however hard to evidence microglial activation in vivo, especially in the substantia nigra: first, the investigators need very high resolution imaging tools and then, the only ligand available to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous results.

18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to explore the topography and intensity of microglial activation in several different groups of PD patients: 1) de novo, drug-naïve subjects (n = 6); 2) non-fluctuating treated patients ("honeymoon") (n = 10); 3) advanced drug-responsive patients motor fluctuations (wearing-off or dyskinesia) (n = 6); 4) patients with LRRK2 gene mutation (n = 6); and 5) related to healthy patients carriers of the mutation LRRK2(n = 6). PET imaging will be performed with a new generation tomography having a very high resolution.

This study might reveal significant neuroinflammatory process in the midbrain of PD patients and will determine if such process is present in both sporadic and genetic forms of PD. The results of this study might provide a new biomarker of disease pathological progression and help as identifying subjects who might most benefit from a specific anti-inflammatory drug.

primary_purpose: Basic Science

ReferenceCitation: Ricigliano VAG, Louapre C, Poirion E, Colombi A, Yazdan Panah A, Lazzarotto A, Morena E, Martin E, Bottlaender M, Bodini B, Seilhean D, Stankoff B. Imaging Characteristics of Choroid Plexuses in Presymptomatic Multiple Sclerosis: A Retrospective Study. Neurol Neuroimmunol Neuroinflamm. 2022 Oct 13;9(6):e200026. doi: 10.1212/NXI.0000000000200026. Print 2022 Nov.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: PubMed Central;iris.uniroma1.it

ReferenceCitation: Lavisse S, Goutal S, Wimberley C, Tonietto M, Bottlaender M, Gervais P, Kuhnast B, Peyronneau MA, Barret O, Lagarde J, Sarazin M, Hantraye P, Thiriez C, Remy P. Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging. Parkinsonism Relat Disord. 2021 Jan;82:29-36. doi: 10.1016/j.parkreldis.2020.11.011. Epub 2020 Nov 17.

oa_colors: green other

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
France Parkinson Association


title: Conversion of in Vitro Fertilization Cycles to Intrauterine Inseminations in Patients With a Poor Ovarian Response to Stimulation

acronym: ConFIRM

summary: The purpose of this study is to compare the efficiency of conversion to IUI and IVF in patients with a poor ovarian response to stimulation

ReferenceCitation: Delbos L, Parot-Schinkel E, El Hachem H, Legendre G, Descamps P, Boucret L, Ferre-L'Hotellier V, Jeanneteau P, Dreux C, Moriniere C, May-Panloup P, Bouet PE. ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial. Trials. 2018 Oct 17;19(1):565. doi: 10.1186/s13063-018-2936-5.

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

lead_sponsor: University Hospital, Angers

location_country: Guadeloupe France

location_facility:
Victor Pauchet Clinic
Clinique Mutualiste de la Sagesse
Antoine Béclère Hospital AP-HP
Polyclinique de L'Atlantique
Lorient Hospital
Hospital of Orléans
UH Grenoble
UH Rouen
UH Pointe-à-Pitre
UH Caen
UH Besançon
UHR Tours
Polyclinique Jean Villar
Cochin Hospital, APHP
UH Toulouse
Clinique Pierre Cherest
Poissy Saint Germain en Laye Hospital
UH La conception AP-HM
UH Lille
Cholet Hospital
UH Strasbourg
Sud Francilien Hospital
UH Nantes
Clinique Jules Verne
UH Nîmes
Clinique Léonard de Vinci
Jean Verdier Hospital, APHP
UH Rennes
IHC Créteil
UH Angers
UH Potiers
Tertre Rouge Clinic


title: Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients

summary:
Critically ill and intubated patients on mechanical ventilation (IMV) often present retention of respiratory secretions, increasing the risk of respiratory infections and associated morbidity. Endotracheal suctioning (ETS) is the main strategy to prevent mucus retention, but its effects are limited to the first bronchial bifurcation.

Mechanical in-exsufflation devices (MI-E) are a non-invasive chest physiotherapy (CPT) technique that aims to improve mucus clearance in proximal airways by generating high expiratory flows and simulating cough. Currently there are no studies that have specifically assessed the effects of MI-E in critically ill and intubated patients. Thus, the aims of this study are to evaluate efficacy and safety of MI-E to improve mucus clearance in critically ill and intubated patients.

ReferenceType: result

ReferenceCitation: Konrad F, Schreiber T, Brecht-Kraus D, Georgieff M. Mucociliary transport in ICU patients. Chest. 1994 Jan;105(1):237-41. doi: 10.1378/chest.105.1.237.

ReferenceCitation: American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.

ReferenceCitation: Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.

ReferenceCitation: Guerin C, Bourdin G, Leray V, Delannoy B, Bayle F, Germain M, Richard JC. Performance of the coughassist insufflation-exsufflation device in the presence of an endotracheal tube or tracheostomy tube: a bench study. Respir Care. 2011 Aug;56(8):1108-14. doi: 10.4187/respcare.01121.

ReferenceCitation: Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004.

ReferenceCitation: Martinez-Alejos R, Marti JD, Li Bassi G, Gonzalez-Anton D, Pilar-Diaz X, Reginault T, Wibart P, Ntoumenopoulos G, Tronstad O, Gabarrus A, Quinart A, Torres A. Effects of Mechanical Insufflation-Exsufflation on Sputum Volume in Mechanically Ventilated Critically Ill Subjects. Respir Care. 2021 Sep;66(9):1371-1379. doi: 10.4187/respcare.08641. Epub 2021 Jun 8.

publisher_dissemination: Daedalus Enterprises

ipd_sharing: Undecided

collaborators: Sociedad Española de Neumología y Cirugía Torácica

location_facility: Polyvalent ICU. Centre medico-chirurgicale Magellan 2.


title: Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study

summary: This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).

lead_sponsor: Poitiers University Hospital

location_facility:
Pascal DERKINDEREN
Chu de Poitiers
Marc VERIN


title: Transplantation of Ex-vivo Expanded Human Cord Blood Hematopoietic Stem Cells Expanded: Evaluation of Hematopoietic and Immunologic Reconstitution After a Reduced-intensity Conditioning Regimen

acronym: GRAPA

summary:
This program offers the opportunity to receive an allogeneic transplant to try to control the malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit ratio equivalent to that which would be expected with a transplant from a more conventional donor.

An economy of means in that this method could serve as an alternative to 2 units of placental blood transplantation. The current cost of disposal of a unit of placental blood from a bank is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The amplification process as controlled by "EFSAL" is 12000 €. Therefore, buying a unit and ex-vivo amplification is more economical. Moreover, the availability of placental blood is not infinite, and the use of one unit per patient will also save resources that can be valuable for certain groups of patients.

In the longer term, methods of amplification of specific immunocompetent cells (from the fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to consider a faster recovery, better and more targeted, including cells against the disease for which transplantation is performed.

ReferenceCitation: Petersdorf EW. Risk assessment in haematopoietic stem cell transplantation: histocompatibility. Best Pract Res Clin Haematol. 2007 Jun;20(2):155-70. doi: 10.1016/j.beha.2006.09.001.

ReferenceCitation: Koh LP, Chao NJ. Umbilical cord blood transplantation in adults using myeloablative and nonmyeloablative preparative regimens. Biol Blood Marrow Transplant. 2004 Jan;10(1):1-22. doi: 10.1016/j.bbmt.2003.09.009.

ReferenceCitation: Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB, Miller JS, Verfaillie CM, Wagner JE. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005 Feb 1;105(3):1343-7. doi: 10.1182/blood-2004-07-2717. Epub 2004 Oct 5.

ReferenceCitation: Castello S, Podesta M, Menditto VG, Ibatici A, Pitto A, Figari O, Scarpati D, Magrassi L, Bacigalupo A, Piaggio G, Frassoni F. Intra-bone marrow injection of bone marrow and cord blood cells: an alternative way of transplantation associated with a higher seeding efficiency. Exp Hematol. 2004 Aug;32(8):782-7. doi: 10.1016/j.exphem.2004.05.026.

ReferenceCitation: Shpall EJ, Quinones R, Giller R, Zeng C, Baron AE, Jones RB, Bearman SI, Nieto Y, Freed B, Madinger N, Hogan CJ, Slat-Vasquez V, Russell P, Blunk B, Schissel D, Hild E, Malcolm J, Ward W, McNiece IK. Transplantation of ex vivo expanded cord blood. Biol Blood Marrow Transplant. 2002;8(7):368-76. doi: 10.1053/bbmt.2002.v8.pm12171483.

ReferenceCitation: Ljungman P, Urbano-Ispizua A, Cavazzana-Calvo M, Demirer T, Dini G, Einsele H, Gratwohl A, Madrigal A, Niederwieser D, Passweg J, Rocha V, Saccardi R, Schouten H, Schmitz N, Socie G, Sureda A, Apperley J; European Group for Blood and Marrow. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: definitions and current practice in Europe. Bone Marrow Transplant. 2006 Mar;37(5):439-49. doi: 10.1038/sj.bmt.1705265.

ReferenceCitation: Brunstein CG, Barker JN, Weisdorf DJ, DeFor TE, Miller JS, Blazar BR, McGlave PB, Wagner JE. Umbilical cord blood transplantation after nonmyeloablative conditioning: impact on transplantation outcomes in 110 adults with hematologic disease. Blood. 2007 Oct 15;110(8):3064-70. doi: 10.1182/blood-2007-04-067215. Epub 2007 Jun 14.

ReferenceCitation: Gluckman E, Rocha V. Donor selection for unrelated cord blood transplants. Curr Opin Immunol. 2006 Oct;18(5):565-70. doi: 10.1016/j.coi.2006.07.014. Epub 2006 Aug 8.

ReferenceCitation: Takahashi S. Leukemia: cord blood for allogeneic stem cell transplantation. Curr Opin Oncol. 2007 Nov;19(6):667-72. doi: 10.1097/CCO.0b013e3282f0e1a1.

ReferenceCitation: Kobari L, Pflumio F, Giarratana M, Li X, Titeux M, Izac B, Leteurtre F, Coulombel L, Douay L. In vitro and in vivo evidence for the long-term multilineage (myeloid, B, NK, and T) reconstitution capacity of ex vivo expanded human CD34(+) cord blood cells. Exp Hematol. 2000 Dec;28(12):1470-80. doi: 10.1016/s0301-472x(00)00557-9.

ReferenceCitation: Duchez P, Dazey B, Douay L, Vezon G, Ivanovic Z. An efficient large-scale thawing procedure for cord blood cells destined for selection and ex vivo expansion of CD34+ cells. J Hematother Stem Cell Res. 2003 Oct;12(5):587-9. doi: 10.1089/152581603322448295. No abstract available.

ReferenceCitation: Dazey B, Duchez P, Letellier C, Vezon G, Ivanovic Z; French Cord Blood Network. Cord blood processing by using a standard manual technique and automated closed system "Sepax" (Kit CS-530). Stem Cells Dev. 2005 Feb;14(1):6-10. doi: 10.1089/scd.2005.14.6. No abstract available.

ReferenceCitation: Ivanovic Z, Duchez P, Dazey B, Hermitte F, Lamrissi-Garcia I, Mazurier F, Praloran V, Reiffers J, Vezon G, Boiron JM. A clinical-scale expansion of mobilized CD 34+ hematopoietic stem and progenitor cells by use of a new serum-free medium. Transfusion. 2006 Jan;46(1):126-31. doi: 10.1111/j.1537-2995.2005.00675.x.

ReferenceCitation: Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, Miller JS, Wagner JE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003 Sep 1;102(5):1915-9. doi: 10.1182/blood-2002-11-3337. Epub 2003 May 8.

ReferenceCitation: Ljungman P, Bregni M, Brune M, Cornelissen J, de Witte T, Dini G, Einsele H, Gaspar HB, Gratwohl A, Passweg J, Peters C, Rocha V, Saccardi R, Schouten H, Sureda A, Tichelli A, Velardi A, Niederwieser D; European Group for Blood and Marrow Transplantation. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe 2009. Bone Marrow Transplant. 2010 Feb;45(2):219-34. doi: 10.1038/bmt.2009.141. Epub 2009 Jul 6.

location_facility: Service d'hématologie et d'Oncologie Clinique - Hôpital Lapeyronie - 371 avenue du Doyen Gaston GIRAUD

location_facility: Service d'Hématologie, Hôpital Hôtel Dieu, CHU de Nantes - 1 Place Alexis Ricordeau

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan


title: Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing in Patients With Delayed Consolidation After Long Bone Fracture Requiring Graft Apposition or Alternative Orthobiologics

summary:
Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal tissue. In Europe, about one million patients encounter a surgical bone reconstruction annually and the numbers are increasing due to our ageing population. Bone grafting intends to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of damage, but this is only attained presently by including cells capable of forming bone into the augmentation.

Bone autograft is the safest and most effective grafting procedure, since it contains patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance osteoinduction), and it providing a scaffold for the new bone to grow into (osteoconduction). However, bone autograft is limited in quantity (about 20 cc) and its harvesting (e.g. from the iliac crest) represents an additional surgical intervention, with frequent consequent pain and complications.

We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically implanted with synthetic bone substitutes contribute to the resolution of the health and socioeconomic complications of delayed union or non-union after diaphyseal and metaphyseal-diaphyseal fractures with safety and efficacy.

location_country: Germany Italy Spain France

location_facility: Depatment of Orthopaedic Surgery, Hôpital Henri Mondor

location_facility: Department of Orthopaedic Trauma, University of Ulm

location_facility: Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

location_facility: Department of Orthopaedic Surgery, CHRU Tours


title: Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department

acronym: SEPSISEO

summary:
Several studies have described the interest of eosinopenia as a marker of infection in internal medicine or in intensive care units. Eosinopenia is an inexpensive and easily accessible biological marker of sepsis. Retrospective work in the adult emergency departments of Strasbourg University Hospitals has shown the good specificity of this biological sign for the diagnosis of infection. Our work aims to confirm the results by a more meaningful study.

Main objective: Evaluation of the interest of eosinopenia in the diagnosis of bacterial infection in ED.

Methodology: inclusion of all patients with criteria for bacterial infection in ED, inclusion of an equivalent number of uninfected control patients.

Duration : 12 months Multicentric prospective study 6 centers : Strasbourg, Hôpital Nord Franche comté, Sélestat, Wissembourg, Colmar, Mulhouse

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Prevalence of Strokes Secondary to a Reversible Cerebral Vasoconstriction Attributable to Cannabis Consumption in Young Subjects (≤ 45 Years) Hospitalized for an Ischaemic Stroke

acronym: CANNASTROKE

summary:
Incidence of strokes has increased these last 20 years in young population. This rise could be linked to alcohol, tobacco or drug use like cannabis. Cannabis has previously been descripted as a potential factor of reversible vasoconstriction. The main objective is to show that an exhaustive assessment of a stroke facing a young person frequently lead to a diagnostic of reversible vasoconstriction due to cannabis use. Evaluation will focus on prevalence of strokes secondary to a reversible vasoconstriction attributable to cannabis in young subjects.

There's a real public healthcare interest in terms of primary and secondary prevention to evaluate the role of cannabis as a risk factor of stroke in young population.

region: Grand Est

nom_etablissement: HOPITAUX UNIVERSITAIRES DE STRASBOURG

acronyme: CannaStroke

titre: Prévalence des infarctus cérébraux secondaires à une vasoconstriction cérébrale réversible imputables à la consommation de résine de cannabis parmi des sujets jeunes (< 45 ans) hospitalisés pour un infarctus cérébral

nom_porteur: WOLFF

prenom_porteur: Valérie


title: Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

acronym: ILEHOS

summary:
Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30 days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and renal failure. Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit to decrease significantly gastrointestinal secretions. Several teams use these analogs in order to decrease the flow of highly productive ileostomy.

The aim of the study is to evaluate the efficacy first line treatment with lanreotide associated with current anti-diarrheal treatment for patients with high output ileostomy (or greater throughput 1.5l / 24h) with or without associated dehydration

sponsor_collaborators:
University Hospital, Strasbourg, France
Ipsen

location_facility: Hôpitaux Civils de Colmar - Service de Chirurgie Digestive

location_facility: CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne

location_facility: Hôpital Emile MULLER - Service de Chirurgie Digestive

location_facility: Hôpital Jean Minjoz - Service de Chirurgie Digestive

location_facility: Hôpital de Hautepierre-Service de Chirurgie Digestive

location_facility: Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive


title: Detect, Monitor and Prevent Vascular Abnormalities Associated With Turner Syndrome

acronym: AVAST

summary:
Turner syndrome is a genetic condition, rare, due to the total or partial absence of one X chromosome, affecting 1/2500 newborn female. It combines almost constantly short stature and ovarian failure with infertility.

Other anomalies are inconstant: morphological characteristics of varying intensity, associated malformations, and increased risk of acquired diseases ...

The prognosis of patients reaching the Turner Syndrome is linked to cardiovascular complications (congenital heart disease, dilatation of the ascending aorta with risk of dissection or rupture of aneurysm), causing early mortality with reduction of life expectancy of at least 10 years.

For these reasons, screening for heart disease and dilatation of the ascending aorta is established and is intended to prevent the complications associated with medical treatment and / or surgery to increase life expectancy and reduce the co-morbidities.

On the vascular level, the recommendations other than those relating to the monitoring of the diameter of the ascending aorta include research of renal artery stenosis by doppler ultrasound if the patient is hypertensive and looking for lymphedema.

However, other arterial lesions were described in the literature, outside of the aneurysm of the ascending aorta. These peripheral arterial lesions can also be life and / or functional prognosis of the patient. Ascending aorta dilation seems not to be exclusive in Turner syndrome.

In addition, specific vascular lesions outside the affected artery are described: hepatic cirrhosis by vascular depletion, lymphedema and varicose veins. The prevalence of venous or lymphatic disease is unknown.

A single-center review of 9 cases of patients followed at the University Hospital of Strasbourg showed the presence of vascular lesions discovered incidentally during assessments performed for reasons other than cardiovascular screening: cystic lymphangioma, internal carotid aneurysm, agenesis of the inferior vena cava, early varicose veins, embryonic cerebral artery, etc ... None of these patients showed any dilatation of the ascending aorta or heart disease. Peripheral vascular abnormalities in this patient group are exclusive.

In this study, we seek to demonstrate that arterial disease in Turner syndrome involve the entire arterial territory and is not confined to the ascending aorta. Screening for arterial lesions should be performed on the entire arterial vascular tree and regularly in the course of time, especially as the presence of cardiovascular risk factors increases with the age of these patients.

The venous and lymphatic vascular damage in the literature and in our series of cases in University Hospital of Strasbourg description should also lead to the detection of these lesions.

These vascular complications can be alone responsible for the reduction in life expectancy or responsible for serious morbidity. Improved screening of associated vascular lesions is necessary to enable the best prevention of cardiovascular complications.

It is also to establish the prevalence of vascular anomalies, whether arterial, venous or lymphatic, to better understand the disease and its management. By collecting systematically karyotype leading to diagnosis, it may be possible to make a link between the genetic defect and heart or vascular disease.

status: Active, not recruiting

location_facility: Service de Chirurgie et Médecine Vasculaire, CHU Jean Minjoz

location_facility: Service d'explorations fonctionnelles non invasives cardio-vasculaires, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires

location_facility: Service d'endocrinologie, Hôpital Civil, Hôpitaux Universitaires

location_facility: Service HTA, maladies vasculaires et pharmacologie clinique, Nouvel Hôpital Civil, Hôpitaux Universitaires


summary: The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. Yet the birth of a child affected by CL/P is a particularly stressing and traumatising event for the parents. The investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by CL/P over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. The time of the first surgical intervention varies amongst the treatment centres. The investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. The results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the CL/P through embryo diagnosis and those who found out at their child's birth. The mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).

ReferenceCitation: Perez Martinez C, Grollemund B, Gavelle P, Viaux-Savelon S, Guedeney A. The Prevalence of Social Withdrawal in Infants With Cleft Lip and Palate: The Feasibility of the Full and the Modified Versions of the Alarm Distress Baby Scale. Front Pediatr. 2022 Jul 7;10:804802. doi: 10.3389/fped.2022.804802. eCollection 2022.

publisher_dissemination: Frontiers

ReferenceCitation: Grollemund B, Dissaux C, Gavelle P, Martinez CP, Mullaert J, Alfaiate T, Guedeney A; CLIP team (Cleft Lip & palate Infant Parent). The impact of having a baby with cleft lip and palate on parents and on parent-baby relationship: the first French prospective multicentre study. BMC Pediatr. 2020 May 18;20(1):230. doi: 10.1186/s12887-020-02118-5.

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

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
HAL
PubMed Central
Research Square

repositories_concat: HAL;PubMed Central;Research Square

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

ReferenceCitation: Grollemund B, Guedeney A, Vazquez MP, Picard A, Soupre V, Pellerin P, Simon E, Velten M, Dissaux C, Kauffmann I, Bruant-Rodier C, Danion-Grilliat A. Relational development in children with cleft lip and palate: influence of the waiting period prior to the first surgical intervention and parental psychological perceptions of the abnormality. BMC Pediatr. 2012 Jun 8;12:65. doi: 10.1186/1471-2431-12-65.

location_facility: CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1

location_facility: CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central

location_facility: APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale

location_facility: CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro


title: A Role for Light Therapy at Immediate Recovery From Short Duration Ambulatory Anesthesia to Prevent Dysregulation of Circadian Rest-Activity Rhythm in Patients Submitted to Colonoscopy.

acronym: LI-AMB

summary: We previously evidenced in both animal models and patients that a short duration ambulatory anesthesia impacts the circadian rest-activity biological rhythm, at least during the first 3 days. The light is the main, natural synchronisateur, of the biological cerebral clock, and is used as therapeutics in chronic disturbances of the circadian rest activity rhythm and of the sleep (Alzheimer disease for example). We would like to test for a simple and safe strategy to prevent such a long-lasting effect of anesthesia on biological clock:the increase of the light intensity at a still physiological level during the initial phase of recovery from anesthesia by using a particular artificial light of color spectrum similar to natural sun daylight.

location_facility: Service d'Anesthésie et Réanimation - Hôpital Pasteur

location_facility: Service d'Anesthésie et Réanimation - Hôpital de Hautepierre

location_facility: Service d'Anestésie et Réanimation - Hôpital Beaujon

location_facility: Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest


title: A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants

summary: The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

time_perspective: Other

lead_sponsor: Corin

location_facility: Hopital de la Croix-Rousse, Hospices Civils de Lyon


acronym:
HyQvia

 HyQvia

summary: Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV infusions or have difficulties with venous access. No head-to-head data are available to directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration frequencies from daily up to every other week dosing while HyQvia is indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks

sponsor_collaborators:
University Hospital, Lille
Shire

location_facility:
CHU de Nantes - Hôtel Dieu
CHRU, Hôpital Claude Huriez
Hôpital de la Conception
Hôpital St Louis
CHU de Strasbourg
Hôpital Haut Lévèque
Hôpital Necker

title: Assessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQvia


title: Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment

summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.

ReferenceCitation: Ray-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.

evidence: open (via free article)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Tampere University - Tampere University Institutional Repository

repositories_concat: LIRIAS (KU Leuven);trepo.tuni.fi

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Gonzalez-Martin A, Desauw C, Heitz F, Cropet C, Gargiulo P, Berger R, Ochi H, Vergote I, Colombo N, Mirza MR, Tazi Y, Canzler U, Zamagni C, Guerra-Alia EM, Levache CB, Marme F, Bazan F, de Gregorio N, Dohollou N, Fasching PA, Scambia G, Rubio-Perez MJ, Milenkova T, Costan C, Pautier P, Ray-Coquard I; PAOLA1/ENGOT-ov25 investigators. Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial. Eur J Cancer. 2022 Oct;174:221-231. doi: 10.1016/j.ejca.2022.07.022. Epub 2022 Sep 5.

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Fujiwara K, Fujiwara H, Yoshida H, Satoh T, Yonemori K, Nagao S, Matsumoto T, Kobayashi H, Bourgeois H, Harter P, Mosconi AM, Vazquez IP, Reinthaller A, Fujita T, Rowe P, Pujade-Lauraine E, Ray-Coquard I. Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial. J Gynecol Oncol. 2021 Sep;32(5):e82. doi: 10.3802/jgo.2021.32.e82.

oa_colors: green diamond

publisher_dissemination: Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology and Colposcopy

lead_sponsor: Arcagy Research

collaborators: Arbeitsgemeinschaft Gynaekologishe Onkologie Germany

collaborators: Arbeitsgemeinschaft Gynaekologische Onkologie Austria

collaborators: Grupo Español de Investigación en Cáncer de Ovario

collaborators: Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies

collaborators: Mario Negri Gynecologic Oncology group (MaNGO)

collaborators: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

collaborators: Gynecologic Oncology Trial & Investigation Consortium

location_country: Finland Germany Italy Denmark Japan Sweden Austria Belgium Spain Monaco France

location_facility: Hôpital de la Milétrie - CHU de Poitiers - Pôle Régional de Cancérologie

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Centre Catherine de Sienne - Group confluent

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez

location_facility: Istituto Nazionale Tumori - IRCCS Pascale

location_facility: Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: Saitama Medical University International Medical Center

location_facility: Charité - Universitätsmedizin Berlin (CVK)

location_facility: Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Institut Curie - Hopital Claudius Régaud

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne


title: Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities

acronym: Explor-AVD

summary: The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.

lead_sponsor: Hopital Foch

sponsor_collaborators:
Hopital Foch
Collège de France


title: Prospective, Controlled, Single-arm Clinical Investigation for the Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Man

summary: This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man

ReferenceCitation: Messas E, IJsselmuiden A, Goudot G, Vlieger S, Zarka S, Puymirat E, Cholley B, Spaulding C, Hagege AA, Marijon E, Tanter M, Bertrand B, Remond MC, Penot R, Ren B, den Heijer P, Pernot M, Spaargaren R. Feasibility and Performance of Noninvasive Ultrasound Therapy in Patients With Severe Symptomatic Aortic Valve Stenosis: A First-in-Human Study. Circulation. 2021 Mar 2;143(9):968-970. doi: 10.1161/CIRCULATIONAHA.120.050672. Epub 2021 Jan 25. No abstract available.

lead_sponsor: Cardiawave SA

location_country: Netherlands France

location_facility:
Hôpital Européen Georges Pompidou
Amphia Hospital


title: Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers

summary: This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet (ER) formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D. Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a, the cohort will be further expanded by up to 19 more patients to a total of 29 patients to confirm the efficacy and safety profile of onapristone in this selected patient population (Stage 2b).

ReferenceCitation: Cottu PH, Bonneterre J, Varga A, Campone M, Leary A, Floquet A, Berton-Rigaud D, Sablin MP, Lesoin A, Rezai K, Lokiec FM, Lhomme C, Bosq J, Bexon AS, Gilles EM, Proniuk S, Dieras V, Jackson DM, Zukiwski A, Italiano A. Phase I study of onapristone, a type I antiprogestin, in female patients with previously treated recurrent or metastatic progesterone receptor-expressing cancers. PLoS One. 2018 Oct 10;13(10):e0204973. doi: 10.1371/journal.pone.0204973. eCollection 2018.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

lead_sponsor: Arno Therapeutics

location_facility:
Centre Oscar Lambret
Institut Gustave Roussy
Institut Curie Oncologie Medicale


title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

acronym: CORIMUNO-SARI

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Sarilumab administration to patients enrolled in the CORIMUNO-19 cohort. Sarilumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Sarilumab will receive standard of care. Outcomes of Sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

ReferenceCitation: CORIMUNO-19 Collaborative group. Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial. Lancet Rheumatol. 2022 Jan;4(1):e24-e32. doi: 10.1016/S2665-9913(21)00315-5. Epub 2021 Nov 17.

ipd_sharing: Yes

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
NECKER Hospital
HEGP
Kremlin Bicetre hospital APHP
Cochin Aphp