title: SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

acronym: SMART

summary:
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.

Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.

status: Active, not recruiting

ReferenceCitation: Herrmann HC, Abdel-Wahab M, Attizzani GF, Batchelor W, Bleiziffer S, Verdoliva S, Chang Y, Gada H, Gillam L, Guerrero M, Mahoney PD, Petronio AS, Rogers T, Rovin J, Szerlip M, Whisenant B, Mehran R, Tchetche D. Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial). Am Heart J. 2022 Jan;243:92-102. doi: 10.1016/j.ahj.2021.09.011. Epub 2021 Sep 26.

lead_sponsor: Medtronic Cardiovascular

location_country:
Finland
Germany
Italy
Portugal
Israel
United Kingdom
Denmark
Netherlands
Switzerland
United States
Spain
Canada
France

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure

location_facility: The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

location_facility: Kath. St.-Johannes-Gesellschaft Dortmund gGmbH - St. Johannes-Hospital Dortmund

location_facility: Victoria Heart Institute Foundation/Royal Jubilee Hospital

location_facility: Texas Health Presbyterian Hospital/Dallas

location_facility: Emory Structural Heart Clinic and Emory University Midtown

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hers-und Diabeteszentrum NRW - Ruhr -Universitati Bochum

location_facility: J.W. Ruby Memorial Hospital/West Virginia University

location_facility: St. Michaels Hospital/Unity Health Toronto

location_facility: The Icahn School of Medicine at Mount Sinai

location_facility: The University of Texas Health Science Center at Houston

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz

location_facility: Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

location_facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Hospital of the University of Pennsylvania

location_facility: AscensionVia Christi St. Francis Hospital


type: Other Identifier

title: Evaluation of the Beckman Coulter Access Hepatitis B Virus (HBV) Serological Marker Assays as an Aid in the Diagnosis of HBV Infection: EU Clinical Trial Protocol

summary:
The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.

The study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Hepatitis B Virus assays as required per the European Union Common Technical Specification. All samples collected will be anonymized or pseudo-anonymised, leftover, remnant samples. Pseudo-anonymised collection of samples will require documented patient consent (oral or written).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Beckman Coulter, Inc.

location_facility: Etablissement Français du Sang (EFS) Hauts-de-France - Normandie

location_facility: Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie

location_facility: Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen

intervention_type: Diagnostic Test

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Identification of Dysglycemia With Continuous Glucose Monitoring: A Prospective Study to Assess the Relationship With Clinical Evolution in Cystic Fibrosis

acronym: ProspeC-F

summary:
Cystic fibrosis (CF)-related diabetes (CFRD) is the most important emerging complication after pulmonary complications. This specific form of diabetes is associated with an increased morbidity and mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while a similar percentage is afflicted with milder dysglycemia also called pre-diabetes abnormalities.

In order to identify patients at risk and to implement early therapeutic measures, an annual CFRD screening test is recommended for CF patients after 10 years of age. The standard 2-hour oral glucose tolerance test (OGTT) is the recommended screening test. However, this test is perceived by both patients and CF care teams as unpleasant while adding a significant burden and workload, resulting in screening rates lower than 50% in most centers. An ideal alternative test should be simpler, less invasive, more sensitive than an OGTT to establish risks for lung function and/or nutritional deterioration, and predict future CFRD risk. To date, compared to the OGTT, no alternative screening method has demonstrated its effectiveness. However, continuous glucose monitoring (CGM) is emerging as a possible alternative method.

In patients living with CF, CGM is easy to use and can identify early dysglycemia, which in turn, can predict increased risk of accelerated decline of pulmonary function and/or weight, higher risk of pseudomonas colonization, and future risk of CFRD. However, these observations are based on studies of small sample size with very limited prospective data. Furthermore, many of the multiple CGM metrics that have been standardized are based on the risk of complications associated with Type 1 and Type 2 Diabetes.

Thus, there is a need for prospective studies to identify the CGM metrics and the cut-off level that is relevant as a predictor of clinical deterioration and/or CFRD risk in CF. The identification of such CF-specific criteria would provide important information to target at-risk patients.

lead_sponsor: Institut de Recherches Cliniques de Montreal

collaborators: Centre hospitalier de l'Université de Montréal (CHUM)

collaborators: Fondation Francophone pour la Recherche sur le Diabete

location_country: Canada France

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Institut de recherches cliniques de Montréal


type: EudraCT Number

title: A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, Compared With Placebo in Combination With Docetaxel, in Patients Receiving Second Line Treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

summary: The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Soria JC, Fulop A, Maciel C, Fischer JR, Girotto G, Lago S, Smit E, Ostoros G, Eberhardt WEE, Lishkovska P, Lovick S, Mariani G, McKeown A, Kilgour E, Smith P, Bowen K, Kohlmann A, Carlile DJ, Janne PA. SELECT-2: a phase II, double-blind, randomized, placebo-controlled study to assess the efficacy of selumetinib plus docetaxel as a second-line treatment of patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2017 Dec 1;28(12):3028-3036. doi: 10.1093/annonc/mdx628.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Hungary
Brazil
Netherlands
United States
Bulgaria
France

intervention_type: Drug

status_simplified: Completed


title: Evaluation of the Implementation and Results of the Health Digital Territories Program in the Five Pilot Territories (EvaTSN Project )

acronym: EvaTSN

summary: The aim is to evaluate a national health information technology-based program to improve healthcare coordination and access to information.

time_perspective: Prospective

ReferenceCitation: Saillour-Glenisson F, Duhamel S, Fourneyron E, Huiart L, Joseph JP, Langlois E, Pincemail S, Ramel V, Renaud T, Roberts T, Sibe M, Thiessard F, Wittwer J, Salmi LR; EvaTSN Research group. Protocole of a controlled before-after evaluation of a national health information technology-based program to improve healthcare coordination and access to information. BMC Health Serv Res. 2017 Apr 21;17(1):297. doi: 10.1186/s12913-017-2199-y.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
University of Bordeaux

location_facility: Agence régionale de santé de Rhône Alpes

location_facility: Agence Régionale de Santé (ARS) Ile-de-France

lead_sponsor_type: academique

appel_a_projets: PREPS-TSN

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: EvaTSN

titre: Evaluation de la mise en uvre et des résultats du programme Territoire de soins numérique (TSN) dans les cinq territoires pilotes

discipline_principale: autre

nom_porteur: SALMI

prenom_porteur: Rachid


title: Treating Atopic Dermatitis With Abrocitinib and Its Impact in Real Life: An Observational Cohort Study To Describe the Effectiveness of Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis

acronym: ADAIR

summary:
The purpose of this study is to learn about the safety and effects of Abrocitinib in the real-life clinical setting given for the treatment of moderate to severe atopic dermatitis. Atopic dermatitis, or AD, is a long-lasting disease that causes inflammation, redness, and irritation of the skin.

This study is seeking participant who are older than 18 years with moderate-to-severe chronic AD. Participants must have no underlying medical conditions that prevent them from taking Abrocitinib.

All participants in this study will receive Abrocitinib as a tablet once daily. They can take Abrocitinib and use medicated topical treatment for AD at the same time.

We will examine the experiences of patients receiving the study medicine. This will help us determine if the study medicine is safe and helps in treating AD.

Participants will take part in this study for 24 months. During this time, they will visit the study clinic about 5 times (about 1 time every 4 to 6 months).

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied


title: Prevalence of Fabry's Disease in a Population of Patients With Chronic Pain

acronym: DOUFABIS

summary: Fabry disease is a rare inherited metabolic disorder that predominantly affects heart, kidneys and nervous system. Fabry disease has been searched in series of patients presenting different isolated signs caused by the affection of one of these organs. Acroparesthesias and chronic crises of pain of different origins are reported in the large majority of patients during the progression of the disease. Moreover, this signs are frequently inaugurating the disease. The investigators have previously performed a preliminary single-center study which permitted to identify one female patient with Fabry disease in a series of 147 consecutive patients with chronic pain tested. The investigators now propose to confirm the results of our preliminary study. The investigators plan to evaluate the prevalence of Fabry disease in a series of 1000 patients suffering from chronic pains of undetermined aetiology and consecutively recruited.

primary_purpose: Diagnostic

location_facility: Centre Douleurs Chroniques, CHU de Bordeaux

location_facility: Service de Médecine de la Douleur et de Médecine Palliative, Hôpital Lariboisière-APHP

location_facility: Unité Douleur et Soins Palliatifs, CH La Rochelle-Réaunis

location_facility: Service d'Explorations Fonctionnelles et Consultations Neurologiques, CH Lyon-Sud

location_facility: Cs douleur chronique GHSR, CHU Sud Réunion

location_facility: Centre de la douleur de l'Adulte et de l'Enfant, CHU de Grenoble

location_facility: Centre d'Analgésie Pédiatrique, Equipe Régionale Ressource en Soins Palliatifs-Equipe " Enfant-Do ", CHU de Toulouse

location_facility: Centre d'évaluation et de traitement de la Douleur, Hôpital Pierre-Paul Ricquet

location_facility: Service de lutte contre la douleur et d'Anesthésie, CH Périgueux

location_facility: Pole enfant - CETD Salengro, CHRU de Lille

location_facility: CeRCa, Unité de Neuromyologie, CHU de Fort de France

location_facility: Centre de la Douleur, CHRU de Strasbourg

location_facility: Médecine - Consultations Douleur, CH de La Réole

location_facility: Centre Douleurs Chroniques, CH de la Côte Basque

location_facility: Service de médecine Polyvalent, CH de La Dracénie

location_facility: Centre d'Evaluation et de Traitement de la Douleur, CHU de Nîmes

location_facility: Pôle Anesthésie Consultation douleur, CHRU de Lille

intervention_type: Genetic


title: Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy in the Era of Neuroprotective Treatment With Hypothermia

acronym: LyTONEPAL

summary:
The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large population-based cohort of full-term and late preterm neonates with moderate or severe HIE.

Contrary to most previous studies which have often analyzed the accuracy of one factor among all other clinical investigations, the investigators objective's is to seek a relevant combination of several factors among the following list:

Neonatal characteristics: gestational age and birthweight, maternal disease, acute intrapartum event, delivery mode, acidosis, neurological examination, place of birth and neonatal transfer
Laboratory investigations: pH, lactates and new biological markers as detailed below
Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI

status: Unknown status

ReferenceType: background

ReferenceCitation: Volpe JJ. Neonatal encephalopathy: an inadequate term for hypoxic-ischemic encephalopathy. Ann Neurol. 2012 Aug;72(2):156-66. doi: 10.1002/ana.23647.

ReferenceCitation: Use and abuse of the Apgar score. Committee on Fetus and Newborn, American Academy of Pediatrics, and Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Pediatrics. 1996 Jul;98(1):141-2.

ReferenceCitation: Fenichel GM. Hypoxic-ischemic encephalopathy in the newborn. Arch Neurol. 1983 May;40(5):261-6. doi: 10.1001/archneur.1983.04050050029002.

ReferenceCitation: Levene ML, Kornberg J, Williams TH. The incidence and severity of post-asphyxial encephalopathy in full-term infants. Early Hum Dev. 1985 May;11(1):21-6. doi: 10.1016/0378-3782(85)90115-x.

ReferenceCitation: Debillon T, Sentilhes L, Kayem G, Chevallier M, Zeitlin J, Baud O, Vilotitch A, Pierrat V, Guellec I, Ancel PY, Bednarek N, Ego A. Risk factors for unfavorable outcome at discharge of newborns with hypoxic-ischemic encephalopathy in the era of hypothermia. Pediatr Res. 2023 Jun;93(7):1975-1982. doi: 10.1038/s41390-022-02352-w. Epub 2022 Oct 22.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Beck J, Debillon T, Guellec I, Vilotitch A, Loron G, Bednarek N, Ancel PY, Pierrat V, Ego A. Healthcare organizational factors associated with delayed therapeutic hypothermia in neonatal hypoxic-ischemic encephalopathy: the LyTONEPAL cohort. Eur J Pediatr. 2023 Jan;182(1):181-190. doi: 10.1007/s00431-022-04666-7. Epub 2022 Oct 21.

ReferenceCitation: Beck J, Bednarek N, Pierrat V, Vilotitch A, Loron G, Alison M, Guellec I, Hertz-Pannier L, de Launay C, Ego A, Vo-Van P, Ancel PY, Debillon T. Cerebral injuries in neonatal encephalopathy treated with hypothermia: French LyTONEPAL cohort. Pediatr Res. 2022 Sep;92(3):880-887. doi: 10.1038/s41390-021-01846-3. Epub 2021 Nov 20.

ReferenceCitation: Debillon T, Bednarek N, Ego A; LyTONEPAL Writing Group. LyTONEPAL: long term outcome of neonatal hypoxic encephalopathy in the era of neuroprotective treatment with hypothermia: a French population-based cohort. BMC Pediatr. 2018 Aug 1;18(1):255. doi: 10.1186/s12887-018-1232-6.

repository_institution: University of Geneva - Archive ouverte UNIGE

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

repositories:
HAL
PubMed Central
unige.ch

repositories_concat: HAL;PubMed Central;unige.ch

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

lead_sponsor: University Hospital, Grenoble

location_facility:
Chu Marseille
CHU CAEN
Chu Limoges
Chu Bordeaux
Chu Brest
Chu Dijon
Chu Amiens
CHU Montpellier
Chu Toulouse
Chi Creteil
Chu Strasbourg
Chu Besancon
Chru Lille
Chu Rouen
Chu Grenoble
Chu La Miletrie
CHU Clermond-Ferrand
CHU St Pierre
Chu Tours
Chu Reims
CHU St Denis
CHU FORT de France

status_simplified: Unknown

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

acronyme: LyTONEPAL

titre: Pronostic à long terme des encéphalopathies anoxo ischémiques néonatales à l'ère de la neuroprotection par hypothermie

discipline_principale: néonatalogie

nom_porteur: DEBILLON

prenom_porteur: Thierry


title: Identification of Genetic Factors Predisposing to Dysglobulinemia

acronym: PreFamDys

summary:
Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown and no lifestyle or environmental exposure factors have been identified that are consistently linked to increased risk of MM, MGUS or the transition between the two.

The overall goal is to identify risk genes for dysglobulinemia, and more specifically Multiple Myeloma. This will involve the conservation of cells in a bank and genetic sequencing on samples obtained from families with at least two cases of dysglobulinemia. Material used for sequencing is likely to include fresh peripheral blood cells or lymphoblastoid lines established from peripheral blood lymphocytes of patients.

primary_purpose: Screening

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Hématologie, CHU de Versailles

location_facility: CHU Groupe Hospitalier Sud Hématologie Clinique

location_facility: Hôpital Saint-Eloi, Département d'Hématologie clinique

location_facility: CH William Morey, Service d'Hémato-Oncologie

location_facility: Service de Médecine Interne-Hématologie, CHU de Fort de France Fort de France

location_facility: Service d'Hématologie clinique et Thérapie Cellulaire, CHU de BORDEAUX

location_facility: Service d'Oncologie Médical, Centre Azuréen de Canrérologie-1

location_facility: Département d'Hématologie à l'Institut de Cancérologie de la Loire

location_facility: Hématolgie- Hôpital privé Cesson-Sévigné

location_facility: Service d'Hématologie Clinique, CHU de Dijon

location_facility: Département d'Oncogénétique, Centre Paoli Calmettes

location_facility: Département d'Oncogénitique - Centre Jean Perrin

location_facility: Hôpital Robert Debré Service du Professeur A. DELMER Hématologie Clinique

location_facility: Jean Paul FermandService Immuno-Hématologie Hôpital Saint Louis

location_facility: CHR-Metz-Thionville, Hôpital de Mercy, Service d'Hématologie

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Hôpital St Antoine Service des maladies du Sang

location_facility: Service d'Oncologie-Radiothérapie - CHU Pointe-à-Pitre/Abymes Guadeloupe

location_facility: Service d'Onco-hématologie, Hôpital Saint-Vincent GH-ICL


title: Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction

acronym: PRIMACY

summary: The purpose of this research project is to improve how we treat heart attacks. The study will assess whether it might not be better to wait a few hours before implanting the coronary stent into the coronary artery rather than implanting it immediately, in order to allow the drugs to completely dissolve the clot. This might help to reduce the risks of the clot migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able to reduce the size of the infarction and reduce the risk of suffering from heart failure following a heart attack.

lead_sponsor: Montreal Heart Institute

location_facility: Ch de Montpellier-Hôpital A. de Villneuve

location_facility: Centre Hospitalier Régional de Lanaudière

intervention_type: Procedure


title: Comparison of Subclavian, Femoral and Internal Jugular Venous Catheterization in Term of Complications in the Intensive Care Unit: a Randomized Controlled Trial

summary:
Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.

The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Pages J, Hazera P, Megarbane B, du Cheyron D, Thuong M, Dutheil JJ, Valette X, Fournel F, Mermel LA, Mira JP, Daubin C, Parienti JJ; 3SITES Study Group. Comparison of alcoholic chlorhexidine and povidone-iodine cutaneous antiseptics for the prevention of central venous catheter-related infection: a cohort and quasi-experimental multicenter study. Intensive Care Med. 2016 Sep;42(9):1418-26. doi: 10.1007/s00134-016-4406-4. Epub 2016 Jun 16.

ReferenceCitation: Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

repositories_concat: PubMed Central;unige.ch

repositories_institution: University of Geneva - Archive ouverte UNIGE

lead_sponsor: University Hospital, Caen

location_facility: Médical Intensive Care Unit, Lariboisière, AP-HP

location_facility: Medical Intensive Care Unit, Cochin, AP-HP

location_facility: Polyvalent Intensive Care Unit, Mémorial France Etats-Unis


acronym: AVC-MODE

summary:
The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing, Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered, isolated or associated manner, causing major disorders and representing a source of handicap for patients.

Understanding the swallowing mechanisms is therefore a major challenge to guide the rehabilitation and improve the initial and long-term prognosis of patients with stroke.

The main objective of this study is to describe and modeling, thanks to a clinical, physiological and radiological knowledge base, swallowing, speech and breathing, in patients with stroke and in healthy subjects.

sponsor_collaborators:
University Hospital, Grenoble
National Research Agency, France
University Hospital, Caen
University Hospital, Montpellier
Centre Hospitalier du Pays d'Aix
Université Joseph Fourier

location_facility:
University hospital
Hospital

intervention_type: Other


title: Contribution of Preoperative Biological Data in Risk Assessment in Cardiac Surgery in Addition to the EuroSCORE

acronym: EuroSCOREbio

summary:
In cardiac surgery, the assessment of operative risk and quality of care is a major challenge for both patient, and surgical team. It is also important for health care decisionmakers to have predictive tools to compare alternative technics such as conventional cardiac surgery and interventional cardiology. Since 1998, the European System for Cardiac Operative Risk Evaluation (EuroSCORE), updated in 2012 (EuroSCORE II) is the most universally used system in this purpose. Its success is the result of a good balance between predictive capability and simplicity. It consists almost exclusively of clinical variables.

However, the objectivity and the predictive ability of some of those clinical items remain controversial, particularly those addressing severity of illness for high-risk patients. For instance, the degree of priority is submitted to the subjective assessment by the surgical team at the time of surgery. Objective data describing the severity of patients arriving in the operating room are still missing.

Many biomarkers are relevant in qualifying severity of syndromes: shock (PH, lactates, LDH), heart disease (N-terminal pro b-type natriuretic peptide (NTproBNP), troponin T and I), respiratory disorder (blood gaz analysis), liver insufficiency (TP, factor V), renal impairment (serum creatinine, creatinine clearance), inflammatory condition (fibrinogen, CRP), or the underlying medical condition such as diabetes (HbA1c, microalbuminuria) and nutritional status (albumin).

In ICU, many scores use biological data to measure, on daily basis, the severity of the patient status. Their routine use is simplified by applications available on smartphones. They are drawn into hospital information systems.

In cardiac surgery, some studies seem to demonstrate the measurement of some preoperative biological variables (eg NT Pro-BNP ...) in risk prediction. In terms of diabetes, HbA1c is of particular interest because it detects underlying diabetes if unknown (emergent situation) or reflects its poor control before surgery. This criterion could be more reliable than the simple information of patient treated by insulin (EuroSCORE II criterion).

Finally, the reinforcement of existing scores with biological variables is recommended by the group of recommendations in prognostic research strategy (PROGRESS 2014), rather than creating new scores ex nihilo.

The hypothesis is that adding biological data collected at the time of arrival of the patient in the operating room would better qualify the patients' severity condition and therefore increase the risk prediction of early mortality and severe morbidity after cardiac surgery. The purpose of this study is to test this hypothesis and especially test whether the biological data would increase the EuroSCORE II performance, by improving the prediction for high-risk patients.

lead_sponsor: University Hospital Center of Martinique

collaborators: Assistance Publique - Hôpitaux de Paris, FRANCE

collaborators: Centre Hospitalier Universitaire de Bordeaux, FRANCE

collaborators: Centre Hospitalier Universitaire de Toulouse, FRANCE

collaborators: Centre Hospitalier Universitaire de Clermont-Ferrand, FRANCE

collaborators: Centre Hospitalier Universitaire de La Réunion, FRANCE

collaborators: Centre Hospitalier Universitaire d'Angers, FRANCE

location_facility:
Hôpital Pitié-Salpêtrière (AP-HP)
Hôpital Bichat (AP-HP)
CHU de Dijon
CHU de Clermont-Ferrand
CHU de Toulouse
CHU de Limoges
CHU de Martinique
CHU d'Angers
CHU de La Réunion
CHU de Bordeaux

appel_a_projets: PHRCI

region: Martinique

nom_etablissement: CHU DE MARTINIQUE

type_etablissement: CHUR

acronyme: EuroSCOREbio

titre: Apport des données biologiques pré-opératoires dans l'évaluation  du risque en chirurgie cardiaque en complément de l'EuroSCORE

nom_porteur: SABBAH

prenom_porteur: Nadia


title: Histoplasmosis in the Guiana Shield and the French West Indies: Evaluating Prevalence in HIV + Patients With a Rapid Diagnostic Test Using an ELISA Capture Method for the Detection of Histoplasma Antigens in Blood and Urine.

acronym: EDIRAPHIS

summary: Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The diagnosis of this disease requires invasives procedures, laboratory performance, and delays up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and urine samples that looks interesting in endemic areas, particularly in developing countries. The study aims to measure the proportion of HIV-infected patients hospitalized or in outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum.

time_perspective: Cross-Sectional

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: Suriname France

location_facility: Academisch Ziekenhuis Paramaribo Hospital


title: Safety Evaluation of a Combination of Brain Radiation Therapy and Bevacizumab (Avastin®) for Treatment of Brain Metastasis

summary:
This phase I pilot study aims to define the safety of a combined treatment of bevacizumab and whole brain radiation therapy for the treatment of patients with brain metastasis of solid tumors. If this therapeutic scheme confirms it's safety profile, the investigators can expect:

first, to allow that all patients can receive bevacizumab for their advanced and/or metastatic cancer if necessary, even in case of brain metastasis.
Secondly, if this trial confirm a synergic effect of the combination of angiogenesis inhibitors and brain radiotherapy for local control of brain metastasis, an improvement of the therapeutic results for these patients which have a poor hope of survival and for which none innovative approach is currently suggested.

Moreover, the investigators hope that the analysis of the different data of MRI evaluation - morphological and functional - will allow better definition of radiological evaluation of the therapeutic effect of angiogenesis inhibitors on brain metastasis.

design_allocation: Non-Randomized

ReferenceCitation: Levy C, Allouache D, Lacroix J, Dugue AE, Supiot S, Campone M, Mahe M, Kichou S, Leheurteur M, Hanzen C, Dieras V, Kirova Y, Campana F, Le Rhun E, Gras L, Bachelot T, Sunyach MP, Hrab I, Geffrelot J, Gunzer K, Constans JM, Grellard JM, Clarisse B, Paoletti X. REBECA: a phase I study of bevacizumab and whole-brain radiation therapy for the treatment of brain metastasis from solid tumours. Ann Oncol. 2014 Dec;25(12):2351-2356. doi: 10.1093/annonc/mdu465. Epub 2014 Oct 1. Erratum In: Ann Oncol. 2015 Nov;26(11):2359.

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
National Cancer Institute, France
Roche Pharma AG
Institut Curie

location_facility:
Centre Léon Bérard
Centre René Gauducheau
Centre Oscar Lambret
Centre François Baclesse
Centre Henri Becquerel
Institut Curie


title: A Phase II Study Evaluating FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation

acronym: OPTIPRIME

summary: Single-arm, multi-centre phase II study The primary objective is to evaluate the time to failure of the strategy.

ipd_sharing: Undecided

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: Martinique France

location_facility:
Ch de Beauvais
Hopital Europeen Marseille
Centre Hospitalier General
Ch de Cholet
Chu D'Angers
Chru Hopital Claude Huriez 4Eme Est
Ch de Niort - Sce D'Oncologie
Hopital Prive Du Confluent Sas
Ch Du Mans
Hopital Les Bonnettes
Hopital Morvan - Chu
Centre Francois Baclesse
Groupe Hospitalier Pitie-Salpetriere
Chd Vendee
Clinique Claude Bernard
Hopital Duchenne
Chi de Frejus Saint-Raphael
Hopital Sud
Centre Hospitalier
Chu de Fort de France
Polyclinique de L'Ormeau
Polyclinique Saint Privat
Cmco Cote D'Opale
Centre Marie Curie
Hopitaux Civils de Colmar
Centre Paul Strauss
Centre Hospitalier Schaffner
Polyclinique de Courlancy
Hopital Jacques Monod
CH
Hopital Prive D'Antony
Clinique Pasteur
Clinique Trenel
Ch Cote Basque
Service de Medecine
Ch Cahors
Ch de Meaux
Ch de Beziers Cedex
Clinique de L'Europe
Polyclinique de Blois - 3Eme Etage
Polyclinique de Gentilly
Clinique Ste Anne
Ch St Joseph-St Luc
Hopital Layne
Chu Cochin

intervention_type: Combination Product


title: Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen

acronym: TELESAGE

summary:
The aim of the TELESAGE study is to demonstrate

the superiority of follow up with the DIABEO system (software alone) versus usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.
the superiority of follow up with the DIABEO system (software + telemonitoring) compared to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.

The DIABEO software alone is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system.

The DIABEO software added by paramedical telemonitoring is the electronic diary combined with remote paramedical monitoring of data (telemeonitoring)

ReferenceCitation: Jeandidier N, Chaillous L, Franc S, Benhamou PY, Schaepelynck P, Hanaire H, Catargi B, Farret A, Fontaine P, Guerci B, Reznik Y, Penfornis A, Borot S, Serusclat P, Kherbachi Y, D'Orsay G, Detournay B, Simon P, Charpentier G. DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 19;7(4):e66. doi: 10.2196/resprot.9154.

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: JMIR Publications

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre hospitalier de Bigorre site La Gespe

intervention_type: Device


title: ESCORT-HU Extension: European Sickle Cell Disease Cohort - Hydroxyurea - Extension

summary: As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.

lead_sponsor: ADDMEDICA SASA

collaborators: International Clinical Trials Association

location_country:
Germany
Italy
Réunion
Guadeloupe
French Guiana
Martinique
Greece
France

location_facility: Centre Hospitalier de l'Ouest Guyanais Franck Joly Children

location_facility: Hôpital RICOU - CHU Pointe-à-Pitre Abymes Children

location_facility: Toulouse University Institute of cancer Adults

location_facility: Clocheville Regional University Hospital Center Children

location_facility: Hematology and oncology institute Children

location_facility: Intercommunal Hospital Center of Créteil Adults and Children

location_facility: Tours Regional University Hospital Center Adults

location_facility: Georges Pompidou European Hospital Adults

location_facility: Marne-La-Vallée Hospital Center Children

location_facility: Centre Hospitalier de l'Ouest Guyanais Franck Joly Adults


title: Multicenter Large-scale Validation Study of the Interest of Broadband Spectroscopy Analysis (Femto/Attosecond by Infrared Laser) on Liquid Biopsies in Breast Cancer Screening

summary: The purpose of this study is to validate the interest of broadband spectroscopy analysis (femto/attosecond by infrared laser) on liquid biopsies in breast cancer screening.

primary_purpose: Other

lead_sponsor: Centre Jean Perrin

sponsor_collaborators:
Centre Jean Perrin
International Cancer Research Group
Institut Max Planck d'optique quantique

location_facility:
Hôpital Saint-Louis
Pôle Santé République
La Chataigneraie (Selimed 63)
Hôpital Tenon
Centre Jean PERRIN
Hôpital La Pitié Salpêtrière


title: Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS

acronym: HERACLES

summary: It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes

lead_sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_country: Italy Canada France


title: Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer.

summary: This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.

ReferenceCitation: Francois E, Mineur L, Deplanque G, Laplaige P, Smith D, Gourgou S, Tanang A, Ionescu-Goga M, Veerabudun K, Lelarge Y, Kim S, Rollot F. Efficacy and Safety of Bevacizumab Combined With First-Line Chemotherapy in Elderly (>/=75 Years) Patients With Metastatic Colorectal Cancer: A Real-World Study. Clin Colorectal Cancer. 2020 Sep;19(3):e100-e109. doi: 10.1016/j.clcc.2020.02.009. Epub 2020 Apr 13.

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

lead_sponsor: Hoffmann-La Roche

location_facility: Chi De Frejus Saint Raphael; Hopital De Jour

location_facility: Hopital Joseph Ducuing; Medecine Interne

location_facility: Clinique Claude Bernard; Onco Hematologie

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Hopital Cote De Nacre; Gastro Enterologie

location_facility: Memorial France Etats Unis; Hopital De Jour

location_facility: Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Ghi Le Raincy Montfermeil; Gastro Medecine Interne

location_facility: Ch Lyon Sud; Gastro Secteur Jules Courmont

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

location_facility: Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Hop Europeen Georges Pompidou; Gastro Enterologie

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: Ch Lyon Sud; Chir Visc Sect Jules Courmont

location_facility: Hopital Prive Armand Brillard; Groupe Sein Paris Est

location_facility: Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: Hopitaux Du Leman Site Thonon; Gastro Enterologie

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie

location_facility: Hopital Timone Adultes; Oncologie Digestive

location_facility: Polyclinique De La Louviere; Chimiotherapie

location_facility: Hopital Saint Antoine; Oncologie Medicale

location_facility: Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie

location_facility: Centre Hospitalier de La Cote Basque; Oncologie

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Clinique sainte marie; chimiotherapie ambulatoire

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE

location_facility: Clinique Sainte Catherine; Hopital De Semaine

location_facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

location_facility: CH Pitie Salpetriere; Hepathologie Gastro Enterologie

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Hopital De La Croix Rousse;Hepato Gastro Entero

location_facility: Polyclinique Du Languedoc; Chimiotherapie

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Clinique D Occitanie; Chimiotherapie Ambulatoire

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hopital Alpha Sante De Hayange; Medecine B

location_facility: Infirmerie Protestante; Endos Digestive Coelioscopie

location_facility: Ghi Le Raincy Montfermeil; Radiotherapie Oncologie

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Hopital Victor Jousselin; Gastro Enterologie

location_facility: Clinique Des 4 Pavillons; Chimiotherapie

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Hopital De Falconaja Furiani; Hopital De Jour

location_facility: Polyclinique Saint Come; Hopital De Jour Oncologie

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: CH Prive Clairval; Chimiotherapie Ambulatoire

location_facility: Hopital Yves Le Foll; Hematologie Oncologie

location_facility: Ctre Hosp Des Vals D Ardeche; Medecine C

location_facility: Hopital Prive Du Vert Galant; Cons Specialisees

location_facility: Clinique Du Parc; Centre de Radiotherapie Gray

location_facility: Clinique Pasteur; Oncologie Medicale, Hematologie

location_facility: Hopital Saint Jean; Hospitalisation Oncologie

location_facility: Ch De Saint Quentin; Gastro Enterologie Endoscopie

location_facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie

location_facility: Ch De Montelimar; Gastro Enterologie Oncologie

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: Hopital Edouard Herriot; Pavillon E Oncologie Medicale

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: Hopital Jacques Monod; Hopital De Semaine Unite 53

location_facility: Clinique Saint Francois; Oncologie Medicale

location_facility: Ch Arrondissement De Montreuil; Medecine 1

location_facility: Clinique Mutualiste Bonneveine; Oncologie Medicale

location_facility: Medipole De Savoie; Departement Oncologie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Clin Mut De Lyon Eugene Andre; Hopital De Jour 1er B

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Clinique Chir De L Orangerie; Chimiotherapie

location_facility: Centre Hospitalier Saint Louis; Oncologie Medicale

location_facility: Chi Eure Seine D Evreux; Oncologie Conventionnelle

location_facility: Clinique Anne D Artois; Gastro Enterologie

location_facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

location_facility: Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie

location_facility: Fondation Maison Sante Bagatelle; Gastro Enterologie


summary:
The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR).

Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer.

In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer.

The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.

ReferenceCitation: Planchard D, Feng PH, Karaseva N, Kim SW, Kim TM, Lee CK, Poltoratskiy A, Yanagitani N, Marshall R, Huang X, Howarth P, Janne PA, Kobayashi K. Osimertinib plus platinum-pemetrexed in newly diagnosed epidermal growth factor receptor mutation-positive advanced/metastatic non-small-cell lung cancer: safety run-in results from the FLAURA2 study. ESMO Open. 2021 Oct;6(5):100271. doi: 10.1016/j.esmoop.2021.100271. Epub 2021 Sep 17.

ReferenceCitation: White MN, Piotrowska Z, Stirling K, Liu SV, Banwait MK, Cunanan K, Sequist LV, Wakelee HA, Hausrath D, Neal JW. Combining Osimertinib With Chemotherapy in EGFR-Mutant NSCLC at Progression. Clin Lung Cancer. 2021 May;22(3):201-209. doi: 10.1016/j.cllc.2021.01.010. Epub 2021 Jan 27.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Asahina H, Tanaka K, Morita S, Maemondo M, Seike M, Okamoto I, Oizumi S, Kagamu H, Takahashi K, Kikuchi T, Isobe T, Sugio K, Kobayashi K. A Phase II Study of Osimertinib Combined With Platinum Plus Pemetrexed in Patients With EGFR-Mutated Advanced Non-Small-cell Lung Cancer: The OPAL Study (NEJ032C/LOGIK1801). Clin Lung Cancer. 2021 Mar;22(2):147-151. doi: 10.1016/j.cllc.2020.09.023. Epub 2020 Oct 16.

title: A Phase III, Open-label, Randomized Study of Osimertinib With or Without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).

source: euctr

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Chile
Czechia
Canada
France
Slovakia
United States
India
China
Peru
Philippines
United Kingdom
Korea, Republic of
South Africa
Taiwan
Russian Federation


title: GENetic & Immunologic Abnomalies in Systemic Lupus Erythematosus

acronym: GENIAL

summary:
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease for which the aetiology includes genet-ic and environmental factors. It is rare in children as compared to adults. The severity may be related to greater involvement of genetic factors in children. The impact of genetics in the development of SLE is important, and the risk of recurrence in siblings evaluated by lambda S ratio is 30 in SLE, while it is 15 for type-1 diabetes and 8 rheumatoid arthritis, thereby indicating high impact of genetics in SLE.

Recently, the group of Professor Yanick Crow in Manchester and other teams has identified new forms of lupus Mendelian genetics. The TREX1 and genes involved in the SAMHD1 frostbite lupus.

Nearly 2 % of all adult subjects with SLE have a heterozygous mutation in the TREX1 gene, which therefore represents the first genetic cause of SLE. The team of Professor Crow also identified the ACP5 gene that is responsible for SLE associated with Spondylo-epiphyseal enchondro-epiphyseal dysplasia (syndromic lupus). Other groups have identified mutations in two genes encoding a DNAse (DNAse1 and DNAse1L3) responsible for familial monogenic forms of SLE. These new genes SLE were identified through research of germ-line mutations in cases of lupus syndromic or family. In collaboration with Professor Crow, we are currently undergoing characterization of a novel gene of SLE in a family and we have identified a second locus identified in another family. The identification of these genes provides a better understanding of the mechanisms regulating immune tolerance in humans. The frequency of these genetic forms is not known. There is very little data on the immunological phenotype of these patients.

This is a clinical study to investigate the genetic and immunological abnormalities associated with pediatric SLE. The aim are to:

study the genetics of pediatric SLE (or syndromic or family) and to search for mutations in the known genetic lupus or new genes in collaboration with Professor Yanick Crow.
study the lymphocyte subpopulations and serum cytokines in pediatric patients with SLE (or syndromic or family) in the large Rhône- Alpes- Auvergne area.

ReferenceCitation: Weill O, Decramer S, Malcus C, Kassai B, Rouvet I, Ginhoux T, Crow YJ, Rieux-Laucat F, Soulas-Sprauel P, Pagnier A, Kone-Paut I, Piram M, Galeotti C, Samaille C, Reumaux H, Lanteri A, Dubois SM, Lefebvre H, Burtey S, Maurier F, Carbasse A, Lemelle I, Meinzer U, Despert V, Flodrops H, Fabien N, Ranchin B, Hachulla E, Bader-Meunier B, Belot A. Familial and syndromic lupus share the same phenotype as other early-onset forms of lupus. Joint Bone Spine. 2017 Oct;84(5):589-593. doi: 10.1016/j.jbspin.2016.12.008. Epub 2016 Dec 28.

location_facility: Service de néphrologie, endocrinologie, maladie métabolique et hématologie bénigne pédiatriques - Hôpital Jeanne de Flandre

location_facility: Service de Rhumatologie - Centre Hospitalier Lyon Sud

location_facility: Service de Néphrologie - Hôpital Edouard Herriot

location_facility: Service de pédiatrie générale - Hôpital Robert-Debré

location_facility: édiatrie générale, urgences et maladies infectieuses, Hôpital Salengro

location_facility: Service de médecine infantile- Hôpital Nord

location_facility: Centre de néphrologie et de transplantation rénale - Hôpital de la conception

location_facility: Service de pédiatrie - CHU Fort de France

location_facility: Service de médecine interne - Hôpital Saint Antoine

location_facility: Service de médecine interne - Centre de référence des maladies rares

location_facility: Service de Néphrologie et Rhumatologie Pédiatrique

location_facility: Service de néphrologie pédiatrique - CHU de Nantes

location_facility: Service d'hématologie / oncologie pédiatrique - CHU

location_facility: Service de Rhumatologie Pédiatrique - Hôpital de Bicêtre

location_facility: Service de médecine interne - Hôpitaux privés de Metz

location_facility: ervice d'urgence et post-urgences pédiatriques - CHU Arnaud de Villeneuve

location_facility: Médecine Interne Adulte - Centre Hospitalier Lyon Sud

location_facility: Service de néphrologie - médecine interne - Hypertension pédiatrique - Hôpital des enfants

location_facility: Service pédiatrie grands enfants-adolescents - CHU Hôpital Sud

location_facility: Service de Pédiatrie Générale - CHU Réunion

location_facility: Service d'immunologie et rhumatologie pédiatrique - Centre de référence de maladies rhumatologiques et inflammatoires rares en pédiatrie-Hôpital Necker-Enfants malades


title: Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

acronym: LaparoDAN

summary:
Gastroschisis is a rare congenital malformation consisting in a right para-umbilical defect of the abdominal wall leading to an evisceration of the abdominal content. About 25% of the cases are associated with intestinal malformation, leading to an increase in peri-natal morbidity and mortality. No prospective study has been able to definitely describe predictive factors for complicated gastroschisis on prenatal ultrasound examinations.

The aim of the current study is to prospectively look for US prenatal features predictive of complicated gastroschisis, on a national multicentric cohort.

Patients will be included during the 22 weeks of amenorrhea (WA) ultrasound examination, and pre- and postnatal clinical data will be recorded up to the 6th months of the child.

Data will then be analysed and compared in the groups of simple or complicated gastroschisis, in order to define pre-natal prognostic factors, to correlate them with specific prognosis, and to might better determine specific strategies for better care of these patients.

ReferenceCitation: Geslin D, Clermidi P, Gatibelza ME, Boussion F, Saliou AH, Le Manac'h Dove G, Margaryan M, De Vries P, Sentilhes L, Levard G, Lardy H, Arnaud A, Leclair MD, Podevin G, Schmitt F. What prenatal ultrasound features are predictable of complex or vanishing gastroschisis? A retrospective study. Prenat Diagn. 2017 Feb;37(2):168-175. doi: 10.1002/pd.4984. Epub 2017 Jan 25.

publisher_dissemination: Wiley

ReferenceCitation: Kassa AM, Lilja HE. Predictors of postnatal outcome in neonates with gastroschisis. J Pediatr Surg. 2011 Nov;46(11):2108-14. doi: 10.1016/j.jpedsurg.2011.07.012.

ReferenceCitation: Kuleva M, Khen-Dunlop N, Dumez Y, Ville Y, Salomon LJ. Is complex gastroschisis predictable by prenatal ultrasound? BJOG. 2012 Jan;119(1):102-9. doi: 10.1111/j.1471-0528.2011.03183.x. Epub 2011 Oct 21.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Necker
University Hospital of Bordeaux
University Hospital of Saint-Etienne
University Hospital of Tours
University Hospital of Brest
University Hospital of Grenoble
University Hospital of Le Mans
University Hospital of René Dubos
University Hospital of Lyon
University Hospital of Nîmes
University Hospital of Limoges
University Hospital of Amiens
University Hospital of Angers
University Hospital of Dijon
University Hospital of Rennes
University Hospital of Nantes
University Hospital of Besançon
University Hospital of Fort de France
University Hospital of Toulouse
University Hospital of Marseille
University Hospital of Caen
University Hospital of Trousseau
University Hospital of Reims
University Hospital of Nancy
University Hospital of Robert Debré
University Hospital of Clermont-Ferrand
University Hospital of Lille
University Hospital of Bicêtre
University Hospital of Montpellier
University Hospital of Lens
University Hospital of Rouen
University Hospital of Le Havre
University Hospital of Nice
University Hospital of Poitiers
University Hospital of Orléans
University Hospital of Strasbourg


title: Evaluation of the Diagnostic Value of Level of Bone Marrow Tryptase in Adult Systemic Mastocytosis

acronym: EvaTryMS

summary:
The hypothesis of the study is that Bone Marrow Tryptase (MT) level is a diagnostic marker of Systemic Mastocytosis (SM). Determination of the bone marrow tryptase in Bone Marrow Aspirate (BMA) could be a new diagnostic criteria for systemic mastocytosis with sensitivity close to 100% and a low false negative rate. This new test could be useful to improve the ability to diagnose accurately systemic mastocytosis (in particular the indolent forms). Because of its limited invasiveness compared to bone marrow biopsy, it could also be considered as a test performed before bone marrow biopsy. Only patients with high bone marrow tryptase would then undergo bone marrow biopsy.

In the future and if validated by this study, bone marrow tryptase could be a useful marker of mast cell load and help to monitor the efficacy of treatment in systemic mastocytosis.

ReferenceCitation: Valent P, Horny HP, Escribano L, Longley BJ, Li CY, Schwartz LB, Marone G, Nunez R, Akin C, Sotlar K, Sperr WR, Wolff K, Brunning RD, Parwaresch RM, Austen KF, Lennert K, Metcalfe DD, Vardiman JW, Bennett JM. Diagnostic criteria and classification of mastocytosis: a consensus proposal. Leuk Res. 2001 Jul;25(7):603-25. doi: 10.1016/s0145-2126(01)00038-8.

ReferenceCitation: Valent P, Akin C, Escribano L, Fodinger M, Hartmann K, Brockow K, Castells M, Sperr WR, Kluin-Nelemans HC, Hamdy NA, Lortholary O, Robyn J, van Doormaal J, Sotlar K, Hauswirth AW, Arock M, Hermine O, Hellmann A, Triggiani M, Niedoszytko M, Schwartz LB, Orfao A, Horny HP, Metcalfe DD. Standards and standardization in mastocytosis: consensus statements on diagnostics, treatment recommendations and response criteria. Eur J Clin Invest. 2007 Jun;37(6):435-53. doi: 10.1111/j.1365-2362.2007.01807.x.

ReferenceCitation: Akin C, Valent P, Metcalfe DD. Mast cell activation syndrome: Proposed diagnostic criteria. J Allergy Clin Immunol. 2010 Dec;126(6):1099-104.e4. doi: 10.1016/j.jaci.2010.08.035. Epub 2010 Oct 28.

ReferenceCitation: Alvarez-Twose I, Gonzalez de Olano D, Sanchez-Munoz L, Matito A, Esteban-Lopez MI, Vega A, Mateo MB, Alonso Diaz de Durana MD, de la Hoz B, Del Pozo Gil MD, Caballero T, Rosado A, Sanchez Matas I, Teodosio C, Jara-Acevedo M, Mollejo M, Garcia-Montero A, Orfao A, Escribano L. Clinical, biological, and molecular characteristics of clonal mast cell disorders presenting with systemic mast cell activation symptoms. J Allergy Clin Immunol. 2010 Jun;125(6):1269-1278.e2. doi: 10.1016/j.jaci.2010.02.019.

ReferenceCitation: Barete S, Assous N, de Gennes C, Grandpeix C, Feger F, Palmerini F, Dubreuil P, Arock M, Roux C, Launay JM, Fraitag S, Canioni D, Billemont B, Suarez F, Lanternier F, Lortholary O, Hermine O, Frances C. Systemic mastocytosis and bone involvement in a cohort of 75 patients. Ann Rheum Dis. 2010 Oct;69(10):1838-41. doi: 10.1136/ard.2009.124511. Epub 2010 Jun 22.

ReferenceCitation: Paul C, Sans B, Suarez F, Casassus P, Barete S, Lanternier F, Grandpeix-Guyodo C, Dubreuil P, Palmerini F, Mansfield CD, Gineste P, Moussy A, Hermine O, Lortholary O. Masitinib for the treatment of systemic and cutaneous mastocytosis with handicap: a phase 2a study. Am J Hematol. 2010 Dec;85(12):921-5. doi: 10.1002/ajh.21894.

lead_sponsor: University Hospital, Toulouse

location_facility: CHU Lyon Sud, service de médecine interne

location_facility: CHU Fort de France, service de dermatologie

location_facility: CHU Toulouse, Hôpital Larrey, service de dermatologie

location_facility: CHU Bordeaux Hôpital Haut-Lévêque, service de dermatologie

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: EvaTryMS

titre: Evaluation de la valeur diagnostique de la tryptase médullaire chez les adultes atteints de la mastocytose systémique

nom_porteur: LIVIDEANU

prenom_porteur: Cristina


lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).

ReferenceCitation: Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017 Mar;4(3):e114-e126. doi: 10.1016/S2352-3026(17)30019-4.

ReferenceCitation: Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL.

ReferenceCitation: Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL.

ReferenceCitation: Robak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congress of the European Hematology Association (EHA); 2015 09-12 June; Copenhagen, Denmark.

ReferenceCitation: Robak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster LB598]. 20th Congress of the European Hematology Association (EHA); 2015 11-14 June; Vienna, Austria.

ReferenceCitation: Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster TPS7131]. American Society of Clinical Oncology (ASCO); 2013 May 31-June 4; Chicago, IL.

ReferenceCitation: Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.

location_facility: Kaiser Permanente Vallejo Medical Center

location_facility: California Cancer Associates for Research and Excellence (CCARE)

location_facility: Center Hospitalier Universitaire de Bordeaux

location_facility: The Ohio State University Medical Center

location_facility: Wojewódzki Szpital Specjalistyczny im. Janusza Kor

location_facility: Collegium Medicum Uniwersytetu Jagiellonskiego w K

location_facility: Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi

location_facility: Centre Hospitalier Universitaire de Montréal

location_facility: Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)

location_facility: Haematology and Oncology Clinics of Australia at Mater

location_facility: Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Samodzielny Publiczny Szpital Kliniczny N1 Klinika

location_facility: Centre Hospitalier Universitaire Hôpital Avicenne

status: Terminated

title: A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Ireland
Poland
United Kingdom
Denmark
Australia
Sweden
Belgium
United States
Spain
Canada
France


title: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

summary: In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.

ReferenceCitation: Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.

ReferenceCitation: Sinnaeve PR, Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Lambert Y, Danays T, Soulat L, Halvorsen S, Ortiz FR, Vandenberghe K, Regelin A, Bluhmki E, Bogaerts K, Van de Werf F; STREAM investigators. ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up. Circulation. 2014 Sep 30;130(14):1139-45. doi: 10.1161/CIRCULATIONAHA.114.009570. Epub 2014 Aug 26.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart. 2014 Oct;100(19):1543-9. doi: 10.1136/heartjnl-2014-306023. Epub 2014 Jun 10.

publisher_dissemination: British Medical Journal

ReferenceCitation: Sinnaeve PR, Danays T, Bogaerts K, Van de Werf F, Armstrong PW. Drug Treatment of STEMI in the Elderly: Focus on Fibrinolytic Therapy and Insights from the STREAM Trial. Drugs Aging. 2016 Feb;33(2):109-18. doi: 10.1007/s40266-016-0345-6.

lead_sponsor: KU Leuven

collaborators: Fund for Clinical Cardiovascular Research at LRD

location_country:
Montenegro
Australia
Brazil
Mexico
Spain
Chile
Canada
Serbia
Russian Federation
France

location_facility: Centro de Pesquisa São Lucas - Hospital E Maternidade Celso Pierro

location_facility: General Hospital "Sveti Luka" Smederevo, Dept of Internal Med - Cardiology Section

location_facility: Military Medical Academy, Clinic for Emergency Internal Medicine

location_facility: General Hospital Pancevo/Department of internal medicine - cardiology section

location_facility: State Budgetary Healthcare Institution of Tverskoy Region "Region Clinical Hospital"

location_facility: Tomsk Regional State Autonomous Healthcare Institution Emergency Care Station

location_facility: Opsta bolnica Vrbas, Cardiology Department

location_facility: Institute for cardiovascular diseases Vojvodina - Sremska Kamenica, Cardiology Clinic

location_facility: Hospital Serrania Ronda, Unidad de Cuidados Intensivos

location_facility: State Budgetary Healthcare Inst. Kemerovo-Clinical Emergency Care Station

location_facility: Hospital Virgen de la Victoria, Unidad de Cuidados Intensivos

location_facility: Tver Region State Budgetary Healthcare Institution "Tver Emergency Station"

location_facility: General Hospital Cuprija, Cardiology Department

location_facility: Institute for cardiovascular diseases Dedinje, Cardiovascular research sector

location_facility: CH Louis Pradel - Hospices civils de Lyon

location_facility: Liverpool Hospital - Cardiology Department

location_facility: Clinical Center of Serbia, Cardiology Clinic

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: General Hospital Vrsac/Cardiology department with coronary unit

location_facility: Groupe Hospitalier Sud Ile de France - CH de Melun - Service SAMU 77

location_facility: Hospital de Antequera, Unidad de Cuidados Intensivos

location_facility: General Hospital Jagodina/Intenal Medicine department

location_facility: Clinical Center Kragujevac, Cardiology Clinic

location_facility: Hospital Comarcal Axarquia, Unidad de Cuidados Intensivos

location_facility: Federal State Budgetary Scientific Inst "Tomsk Nat Research Med.Center of Russian Academy Sciences"

location_facility: General Hospital Danilo the First Cetinje

location_facility: General Hospital "Dr. Laza K. Lazarevic" Sabac, Internal medicine department

location_facility: Federal State Budgetary Inst "Research Inst. for Complex Issues of Card. Diseases"


title: Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU

acronym: PRESSURE

summary: The prevalence of and risk factors for pressure ulcers (PUs) in critically ill patients have been poorly studied. The main objective of this study was to describe the prevalence of PUs in critically ill patients. Secondary objectives were to describe PUs, means of prevention of PUs, and factors associated with occurrence of PUs in the ICU.

time_perspective: Retrospective

lead_sponsor: French Society for Intensive Care

location_facility:
HEGP
CHU Dijon Bourgogne
CHU Nimes
Cochin
Institut Mutualiste Montsouris
Grand Hopital de l'Est Francilien
CHU Grenoble Alpes
Hopital Louis Mourier
Hopital Raymond Poincare
GHIRM
Clinique de l'Union
HIA Clermont Tonnerre
Hopital Privé du Val d'Yerres
Hopital de la Timone
CHU Marseille Hopital Nord
Hopital Laennec
Hopital Privé du Vert Galan
Hopital Ambroise Pare
Hopital Jean Bernard
CHU d'Angers
Groupe Hospitalier Edouard Herriot
Hopital Mercy
CHU Henri Mondor
CHU Kremlin-Bicetre
HIA Percy
Hopital l'Archet
CHU Lapeyronie
CHU Robert Debré
Hopital Européen Marseille
Hopital Privé d'Antony
CHU Nancy
Hopital Privé Claude Galien
Institut Gustave Roussy
CHU Nantes
Hopital Francois Quesnay
Hopital Avicenne
Hopital Nord Franche Comté
Hopital Roger Salengro
Hopital Simone Veil
GH Diaconnesses Croix Saint Simon
La Pitié Salpetriere
Hopital Tenon
CHU Strasbourg
CHU Réunion Saint Pierre
Hôpital Saint-Esprit
CHU Necker Enfants Malades
Hopital St Louis
HIA Béjin
CHU Toulouse Rangueil
Clinique des Cèdres
Hopital Delafontaine
Hopital Notre-Dame de Bon Secours
Hopital Saint Clair
CHU Pellegrin
HIA Desgenettes Lyon
CHU Poitiers
Hopital St-Andre
Hopital Antoine Beclere
Groupe Hospitalier Sud Ile de France
HIA Robert Pique


title: End Of Life in the Critically Ill patiEnt

acronym: EOLE

summary: The purpose of this multicentric study is to evaluate the perception of the quality of the end of life in intensive care units seen from the side of the caregivers, trough the CAESAR scale.

ReferenceCitation: SRLF Trial Group. End of life in the critically ill patient: evaluation of experience of end of life by caregivers (EOLE study). Ann Intensive Care. 2021 Nov 26;11(1):162. doi: 10.1186/s13613-021-00944-z. Erratum In: Ann Intensive Care. 2021 Dec 29;11(1):186.

sponsor_collaborators:
French Society for Intensive Care
Nantes University Hospital

location_facility: Centre Hospitalier Lucie et Raymond Aubrac

location_facility: Centre Hospitalier Communal des Alpes du Sud


title: Safety of Exposure to Natalizumab During Pregnancy

summary:
Multiple sclerosis (MS) preferentially affects young adults with a female predominance. MS is not associated with an increased risk of complications or abnormal pregnancy outcomes. Nevertheless, disease-modifying therapies can have a teratogenic effect. Discussions about discontinuation should be made with a view to or upon discovery of pregnancy, taking into account the risk of untreated relapses and the risk of toxicity to the fetus.

Natalizumab (NTZ) is a humanized anti-alpha4-integrin monoclonal antibody used as a treatment for highly active relapsing-remitting MS (RRMS). When it is stopped, there is frequent reactivation of the disease with possible relapses and a rebound effect could occur. At present, depending on the center, attitudes of neurologist may vary and 3 main scenarios can be observed: Pregnancy and postpartum under NTZ (group1), Pregnancy partially under NTZ (with or without immunomodulator (IM) supplementation, group 2), or NTZ stopped before pregnancy (with or without IM supplementation, group3).

The first part of the BABYZUMAB study, a retrospective study of Natalizumab exposure during pregnancy, analysed the comparison the clinical activity of the disease (annualized relapse rate) according to these 3 scenarios of NTZ treatment The investigators analyzed the annual relapse rate (ARR) during a two-year period (9 months before and 15 months after the beginning of the pregnancy) in 117 patients identified in the OFSEP database. The investigators showed that the risk of relapses was four times higher in Group 2 versus Group 1 (p=0,014) and six times higher in Group 3 versus Group 1 (p=0,001).

In the literature, there are few studies of newborns from NTZ-exposed pregnancies. No specific pattern of birth defects has been found, but mild to moderate transient thrombocytopenia and anemia have been reported in infants born to NTZ-exposed mothers in the third trimester of pregnancy.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Biogen

location_facility: CHRU de Besançon - service de neurologie

location_facility: AP-HP - Hôpital La Pitié Salpétrière - service de neurologie

location_facility: CH Sud Francilien - service de neurologie

location_facility: CHRU de Strasbourg - service de neurologie

location_facility: CHU de Montpellier - service de neurologie

location_facility: AP-HP - Hôpital de Créteil - service de neurologie

location_facility: CH de Saint-Denis - service de neurologie

location_facility: CHU de Fort de France - service de neurologie

location_facility: AP-HP - Hôpital Saint-Antoine - service de neurologie

location_facility: Fondation Rothschild - service de neurologie

intervention_type: Behavioral


title: PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism

summary: This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.

lead_sponsor: Inari Medical

location_country:
Germany
Poland
Switzerland
United States
Spain
France

location_facility: Ohio State University - Wexner Medical Center

location_facility: Hopital Clinico Universitario San Carlos

location_facility: Allegheny Health Network Research Institute

location_facility: SUNY, The University of Buffalo/Gates Vascular

location_facility: Charité Campus Virchow Clinic - Klinik fuer Radiologie

location_facility: West Virginia University Ruby Memorial Hospital


title: Transthyretin Amyloidosis Outcomes Survey (THAOS): A Global, Multi-Center, Longitudinal, Observational Survey of Patients With Documented Transthyretin Gene Mutations or Wild-Type Transthyretin Amyloidosis.

acronym: THAOS

summary: THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin amyloidosis (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years. Patients will be followed as long as they are able to participate. The principal aims of this outcome survey are to better understand and characterize the natural history of the disease by studying a large and heterogenous patient population. Survey data may be used to develop new treatment guidelines and recommendations, and to inform and educate clinicians about the management of this disease.

ReferenceCitation: Coelho T, Conceicao I, Waddington-Cruz M, Keohane D, Sultan MB, Chapman D, Amass L; THAOS investigators. A natural history analysis of asymptomatic TTR gene carriers as they develop symptomatic transthyretin amyloidosis in the Transthyretin Amyloidosis Outcomes Survey (THAOS). Amyloid. 2022 Dec;29(4):228-236. doi: 10.1080/13506129.2022.2070470. Epub 2022 Jun 22.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Informa

ReferenceCitation: Dispenzieri A, Coelho T, Conceicao I, Waddington-Cruz M, Wixner J, Kristen AV, Rapezzi C, Plante-Bordeneuve V, Gonzalez-Moreno J, Maurer MS, Grogan M, Chapman D, Amass L; THAOS investigators. Clinical and genetic profile of patients enrolled in the Transthyretin Amyloidosis Outcomes Survey (THAOS): 14-year update. Orphanet J Rare Dis. 2022 Jun 18;17(1):236. doi: 10.1186/s13023-022-02359-w.

repository_institution: University of Michigan - Deep Blue

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: Umeå University - DiVA at Umeå University

repositories_institution: Umeå University - DiVA at Umeå University

ReferenceCitation: Campbell CM, LoRusso S, Dispenzieri A, Kristen AV, Maurer MS, Rapezzi C, Lairez O, Drachman B, Garcia-Pavia P, Grogan M, Chapman D, Amass L; THAOS investigators. Sex Differences in Wild-Type Transthyretin Amyloidosis: An Analysis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Cardiol Ther. 2022 Sep;11(3):393-405. doi: 10.1007/s40119-022-00265-7. Epub 2022 May 18.

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

repositories_concat: PubMed Central;digitalcommons.wustl.edu

ReferenceCitation: Barroso FA, Coelho T, Dispenzieri A, Conceicao I, Waddington-Cruz M, Wixner J, Maurer MS, Rapezzi C, Plante-Bordeneuve V, Kristen AV, Gonzalez-Duarte A, Chapman D, Stewart M, Amass L; THAOS investigators. Characteristics of patients with autonomic dysfunction in the Transthyretin Amyloidosis Outcomes Survey (THAOS). Amyloid. 2022 Sep;29(3):175-183. doi: 10.1080/13506129.2022.2043270. Epub 2022 Apr 22.

ReferenceCitation: Nativi-Nicolau J, Siu A, Dispenzieri A, Maurer MS, Rapezzi C, Kristen AV, Garcia-Pavia P, LoRusso S, Waddington-Cruz M, Lairez O, Witteles R, Chapman D, Amass L, Grogan M; THAOS Investigators. Temporal Trends of Wild-Type Transthyretin Amyloid Cardiomyopathy in the Transthyretin Amyloidosis Outcomes Survey. JACC CardioOncol. 2021 Oct 19;3(4):537-546. doi: 10.1016/j.jaccao.2021.08.009. eCollection 2021 Oct.

repository_institution: Francisco de Vitoria University - Deposito Digital UFV

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

ReferenceCitation: Gonzalez-Moreno J, Losada-Lopez I, Cisneros-Barroso E, Garcia-Pavia P, Gonzalez-Costello J, Munoz-Beamud F, Campistol JM, Fernandez-Torron R, Chapman D, Amass L. A Descriptive Analysis of ATTR Amyloidosis in Spain from the Transthyretin Amyloidosis Outcomes Survey. Neurol Ther. 2021 Dec;10(2):833-845. doi: 10.1007/s40120-021-00267-y. Epub 2021 Jul 30.

ReferenceCitation: Gentile L, Tournev I, Amass L, Chapman D, Mazzeo A; THAOS investigators. Phenotypic Differences of Glu89Gln Genotype in ATTR Amyloidosis From Endemic Loci: Update From THAOS. Cardiol Ther. 2021 Dec;10(2):481-490. doi: 10.1007/s40119-021-00226-6. Epub 2021 Jun 19.

ReferenceCitation: Waddington-Cruz M, Wixner J, Amass L, Kiszko J, Chapman D, Ando Y; THAOS investigators. Characteristics of Patients with Late- vs. Early-Onset Val30Met Transthyretin Amyloidosis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Neurol Ther. 2021 Dec;10(2):753-766. doi: 10.1007/s40120-021-00258-z. Epub 2021 May 22.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Gonzalez-Duarte A, Barroso F, Mundayat R, Shapiro B. Blood pressure and orthostatic hypotension as measures of autonomic dysfunction in patients from the transthyretin amyloidosis outcomes survey (THAOS). Auton Neurosci. 2019 Dec;222:102590. doi: 10.1016/j.autneu.2019.102590. Epub 2019 Oct 23.

ReferenceCitation: Huber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.

ReferenceCitation: Pinto MV, Pinto LF, Dias M, Rosa RS, Mundayat R, Pedrosa RC, Waddington-Cruz M. Late-onset hereditary ATTR V30M amyloidosis with polyneuropathy: Characterization of Brazilian subjects from the THAOS registry. J Neurol Sci. 2019 Aug 15;403:1-6. doi: 10.1016/j.jns.2019.05.030. Epub 2019 May 28.

ReferenceCitation: Damy T, Kristen AV, Suhr OB, Maurer MS, Plante-Bordeneuve V, Yu CR, Ong ML, Coelho T, Rapezzi C; THAOS Investigators. Transthyretin cardiac amyloidosis in continental Western Europe: an insight through the Transthyretin Amyloidosis Outcomes Survey (THAOS). Eur Heart J. 2022 Feb 3;43(5):391-400. doi: 10.1093/eurheartj/ehz173.

ReferenceCitation: Cruz MW, Pinto MV, Pinto LF, Gervais R, Dias M, Perez C, Mundayat R, Ong ML, Pedrosa RC, Foguel D. Baseline disease characteristics in Brazilian patients enrolled in Transthyretin Amyloidosis Outcome Survey (THAOS). Arq Neuropsiquiatr. 2019 Feb;77(2):96-100. doi: 10.1590/0004-282X20180156.

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

ReferenceCitation: Rubin J, Steidley DE, Carlsson M, Ong ML, Maurer MS. Myocardial Contraction Fraction by M-Mode Echocardiography Is Superior to Ejection Fraction in Predicting Mortality in Transthyretin Amyloidosis. J Card Fail. 2018 Aug;24(8):504-511. doi: 10.1016/j.cardfail.2018.07.001. Epub 2018 Aug 17.

ReferenceCitation: Mundayat R, Stewart M, Alvir J, Short S, Ong ML, Keohane D, Rill D, Sultan MB. Positive Effectiveness of Tafamidis in Delaying Disease Progression in Transthyretin Familial Amyloid Polyneuropathy up to 2 Years: An Analysis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Neurol Ther. 2018 Jun;7(1):87-101. doi: 10.1007/s40120-018-0097-9. Epub 2018 Apr 9.

ReferenceCitation: Kristen AV, Maurer MS, Rapezzi C, Mundayat R, Suhr OB, Damy T; THAOS investigators. Impact of genotype and phenotype on cardiac biomarkers in patients with transthyretin amyloidosis - Report from the Transthyretin Amyloidosis Outcome Survey (THAOS). PLoS One. 2017 Apr 6;12(4):e0173086. doi: 10.1371/journal.pone.0173086. eCollection 2017.

repository_institution: Columbia University - Columbia Academic Commons

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repositories_institution: Columbia University - Columbia Academic Commons

ReferenceCitation: Maurer MS, Hanna M, Grogan M, Dispenzieri A, Witteles R, Drachman B, Judge DP, Lenihan DJ, Gottlieb SS, Shah SJ, Steidley DE, Ventura H, Murali S, Silver MA, Jacoby D, Fedson S, Hummel SL, Kristen AV, Damy T, Plante-Bordeneuve V, Coelho T, Mundayat R, Suhr OB, Waddington Cruz M, Rapezzi C; THAOS Investigators. Genotype and Phenotype of Transthyretin Cardiac Amyloidosis: THAOS (Transthyretin Amyloid Outcome Survey). J Am Coll Cardiol. 2016 Jul 12;68(2):161-72. doi: 10.1016/j.jacc.2016.03.596.

ReferenceCitation: Damy T, Maurer MS, Rapezzi C, Plante-Bordeneuve V, Karayal ON, Mundayat R, Suhr OB, Kristen AV. Clinical, ECG and echocardiographic clues to the diagnosis of TTR-related cardiomyopathy. Open Heart. 2016 Feb 8;3(1):e000289. doi: 10.1136/openhrt-2015-000289. eCollection 2016.

ReferenceCitation: Coelho T, Maurer MS, Suhr OB. THAOS - The Transthyretin Amyloidosis Outcomes Survey: initial report on clinical manifestations in patients with hereditary and wild-type transthyretin amyloidosis. Curr Med Res Opin. 2013 Jan;29(1):63-76. doi: 10.1185/03007995.2012.754348. Epub 2012 Dec 13.

location_country:
Germany
Argentina
Japan
Brazil
Turkey
Canada
France
Portugal
Denmark
United States
Romania
Belgium
Malaysia
Italy
Cyprus
Sweden
Netherlands
Mexico
United Arab Emirates
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Bulgaria
Israel

location_facility: University of Chicago Medical Center IRB

location_facility: Istanbul University,Istanbul Faculty of Medicine,Department of Neurology

location_facility: AOU Policlinico G. Martino - Messina - Dr. Vita

location_facility: Instituto Nacional de Ciencia Medicas y Nutricion Salvador Zubiran

location_facility: King Faisal Specialist Hospital and Research Center

location_facility: Penn Presbyterian Medical Center-University of Pennsylvania

location_facility: Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona

location_facility: AOU Policlinico G. Martino - Messina - Comitato Etico Scientifico

location_facility: Hospital de Rehabilitacion y Traumatologia Virgen de las Nieves

location_facility: Comitato di Bioetica della Fondazione IRCCS Policlinico S. Matteo

location_facility: Institutul De Cardiologie Prof. Dr. C. C. Iliescu Spitalului Fundeni

location_facility: Hospital Universitário Clementino Fraga Filho -HUCFF Universidade Federal do Rio de Janeiro

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Instituto Dante Pazzanese De Cardiologia

location_facility: Montefiore Medical Center-Jack D. Weiler Hospital

location_facility: Vanderbilt University School of Medicine

location_facility: University of Alberta Foothills Medical Centre

location_facility: Samsung Medical Center, Sungkyunkwan University School of Medicine

location_facility: Peters Township Health and Wellness Pavillion

location_facility: Universitatsklinikum Muenster - Transplant Hepatology

location_facility: The University of Utah Health Sciences Center

location_facility: Comitato Etico Indipendente dell Azienda

location_facility: Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria

location_facility: Washington University School of Medicine

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz KöR

location_facility: Instituto De Investigaciones Medicas Dr Alfredo Lanari

location_facility: Cyprus Institute of Neurology and Genetics

location_facility: Hospital Italiano de Buenos Aires (HIBA)

location_facility: University of Maryland School of Medicine

location_facility: Unidade Clinica de Paramiloidose-Centro Hospitalar Porto,EPE-Hospital Geral Santo Antonio

location_facility: University of Pennsylvania - Perelman Center for Advanced Medicine

location_facility: Alexandrovska University Hospital Clinic of Neurology

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University of California - San Francisco, UCSF Department of Neurology

location_facility: Fondazione Policlinico Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Azienda Ospedaliero-Universitaria di Careggi

location_facility: Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica (Ftgm)

location_facility: University Medical Center, Johannes Gutenberg-University Mainz

location_facility: Cardiology Clinic at Montefiore Hutchinson Campus

location_facility: Toronto General Hospital-University Health Network

location_facility: Karolinska University Hospital, Huddinge

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Pavia - Prof. Merlini