title: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial

acronym: DIPLOMA

summary:
Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.

Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints.

Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)

Control: Open distal pancreatectomy

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
AIDS Malignancy Consortium

location_facility:
Hôpital Paul Brousse
Centre Hospitalier Orléans
CHU Saint Eloi - Montpellier
Institut Mutualiste Montsouris
Hôpital Beaujon - APHP


title: ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device

acronym: ECI-BLAD

summary: In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Dijon-Bourgoigne
CHU de Toulouse
CHU de Montpellier
CHU de Rennes
CHU de Bordeaux

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients

summary: Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: Rennes University Hospital

location_facility:
Centre Hospitalier de Saint-Brieuc
Hôtel Dieu Paris
Centre Hospitalier Bretagne Atlantique
CHU Rennes
Centre Hospitalier de Cornouaille


title: ONCOVID-AURA: Excess Risk of Morbi-mortality Due to COVID-19 in Patients With Cancer

acronym: ONCOVID-AURA

summary:
Context:

Based on currently available data, most of national health authorities and consensus expert groups have written guidelines for the management of cancer patients in the context of COVID. However, the preparation of these guidelines was limited by the scarcity of solid epidemiological data. For example, the experts were uncomfortable to formulate precise guidelines on which anti-cancer treatment should be interrupted or replaced, on which patients, and how to adapt supportive drug prescriptions.

Objectives :

To measure the excess risk of mortality and morbidity of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection.
To identify factors associated with the risk of death and morbidity among patients with cancer.

Methodology:

Retrospective inclusion of n=200 cancer patients hospitalized for COVID and n=400 matched (based on age, gender, and comorbidity) non-cancer patients hospitalized for COVID. Two analyses will be performed (after the inclusion of n=100 and n=200 patients with cancer). A logistic modeling of the odds ratio of death associated to the exposition factor (i.e. cancer) and adjusted for the matching parameters (age, gender, comorbidities) will be proposed.

We will then look for the factors (related to the patients, the cancer or the treatment) that modify the odds radio.

Expected results:

The data generated will help the medical and scientific community to evaluate the increasing risk of cancer patients infected by SARS-CoV-2 compared to the non-cancer population, to identify patients at higher risk of severe infection, but also the anticancer treatments associated with an increased risk of severe infections.

Impact:

These data will contribute to guide the future recommendations concerning cancer patient's care in the context of the COVID-19 pandemic. There is a real risk that the SARS-CoV epidemic, or other respiratory viruses epidemic, will become recurrent in the future. Thus, it is of crucial importance for now and for the future to know which are the major factors associated with severe infections

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de lutte contre le Cancer JEAN PERRIN

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: Centre Hospitalier Uniersitaire de Clermont-Ferrand

location_facility: Institut de Cancérologie de la Loire Lucien Neurwirth

status_simplified: Unknown


title: Chilblains, COVID-19 and Lockdown: Epidemiologic Study

acronym: ECCES

summary:
Chilblains (inflammatory lesion of the feet or hands) have been reported with an unusual frequency during the confinement period, most commonly in children, teenagers and young adults. The aim of the ECCES study is to find out whether these manifestations of chilblains can be linked to the SARS-CoV-2 coronavirus.

For this, an epidemiologic study will compare two types of family (or more precisely people who were confined together in March-April-May):

"case family" in which at least one of the members had chilblains
"comparator family" in which none of the members had chilblains Environment (home lockdown) of the two types of family will be analyzed. Each member of the "family" will be suggested doing a serological test.

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Poizeau F, Barbarot S, Le Corre Y, Brenaut E, Samimi M, Aubert H, Toubel A, Dupuy A. Long-term Outcome of Chilblains Associated with SARS-CoV-2. Acta Derm Venereol. 2021 Dec 13;101(12):adv00614. doi: 10.2340/00015555-3930.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

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

repository_normalized: HAL

version: submittedVersion

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Medical Journals Sweden AB

ReferenceCitation: Poizeau F, Oger E, Barbarot S, Le Corre Y, Samimi M, Brenaut E, Aubert H, Chambrelan E, Droitcourt C, Gissot V, Heslan C, Laurent C, Martin L, Misery L, Tattevin P, Toubel A, Thibault V, Dupuy A. Chilblains during lockdown are associated with household exposure to SARS-CoV-2: a multicentre case-control study. Clin Microbiol Infect. 2022 Feb;28(2):285-291. doi: 10.1016/j.cmi.2021.09.032. Epub 2021 Oct 4.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

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

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_facility:
CHRU Brest
CHU Nantes
CHU Rennes
CHRU Tours
CHU Angers

intervention_type: Diagnostic Test


type: Registry Identifier

title: Étude Post-marché, Prospective, Multicentrique, Ouverte, d'évaluation de la prothèse Totale d'épaule inversée Medacta Shoulder System.

acronym: MSS

summary:
The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy.

The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.

status: Recruiting

lead_sponsor: University Hospital, Tours

location_facility:
Polyclinique santé atlantique
Chu Angers
Chu Tours
Chu Rennes
Clinique Mutualiste la Sagesse

intervention_type: Device

status_simplified: Ongoing


title: Evaluation of Emergency Department (ED) Staff Stress Level During COVID-19 Pandemic

acronym: COVER-PRO

summary:
In the context of the COVID-19 pandemic, Emergency Department (ED) are in front line for the reception of patients presenting COVID-19 symptoms and have to face a new situation given the expected number of patients. Staff participate in suspect patients triage, in the diagnosis and the management of Covid-19 patients, having to follow the instructions and recommendations that evolve in real time, depending on the stage, resources and means available. This situation requires that the staff immediately adaptation within this reorganization and redeployment of the activity. Then; they are subject to many stress and anxiety factors such as:

Increased activity: massive influx of patients, overload of work, lack of material and human resources
Modification of practices: training in procedures, measures isolation and prevention of contamination of other patients, replacement by professionals reassigned from other departments
Ethical dilemma: decisions to be made in an emergency, patient prioritization
Numerous, evolving information, from various sources and sometimes contradictory (national, governance, service, media)
Individual: fear of personal contamination and of those close to you, personal organization in a situation of confinement of the population, loss of usual social support
Anxiety and stress management of patients and relatives, their entourage and colleagues In this study, it is proposed to study the psychic impact of the COVID-19 pandemic on emergency department staff.

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Douplat M, Termoz A, Subtil F, Haesebaert J, Jacquin L, Durand G, Potinet V, Hernu R, Nohales L, Mazza S, Berthiller J, Tazarourte K. Changes over time in anxiety, depression, and stress symptoms among healthcare workers in French emergency departments during the first COVID-19 outbreak. J Affect Disord. 2022 Nov 1;316:194-200. doi: 10.1016/j.jad.2022.08.028. Epub 2022 Aug 15.

oa_colors: green hybrid

evidence: open (via crossref license)

repositories_concat: PubMed Central

location_facility: Service d'accueil des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon

location_facility: Service d'accueil des urgences, Hôpital Lyon Sud, Hospices Civils de Lyon

location_facility: Service d'accueil des urgences, Hôpital Edouard Herriot, Hospices Civlis de Lyon


type: Other Identifier

title: Detection of Intracorporeal Bioresistant Nanocomposites Tracing Short- and Long-term Neurological Disorders in a Collective Fulguration

acronym: Fulgurnano

summary:
Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14 healthy subjects.

Hypothesis: Lightning discharge in the human body reveals the presence of multi-functional nanoparticles which are reassembled under the impact of the electric discharge into nanostructured films, filaments and aggregates; they consist of dispersed graphene-like nanoparticles embedded in an aliphatic cross-reticulated matrix. The high electrical conductivity of the nanoinclusions, their refractory properties and the cross-reticulation of the nanoassemblages explain their biorésistance.

The graphene-like multi-functional nanoparticles are assumed to trace a population of aerosols formed in the atmosphere by plasma discharge which is present in air, water and all natural resources. Their ability to undergo changes from folded nanosheets to confined ultra-fine nanoparticles allow them to be inhaled or absorbed by the human body, or to be ingested with food.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: LPC UMR 6533, Campus Universitaire des Cézeaux

location_facility:
CH Henri Mondor
CHRU de Nancy
CH de SAINT-DIE-DES-VOSGES
CHRU Bradois
CH de Luneville


title: Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City

acronym: COVIDGHPSJCite

summary:
The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory pathologies, cardiovascular history (stroke or coronary artery disease), chronic respiratory conditions, high blood pressure, diabetes, and cancer. Covid-19 is manifested by a risk of acute respiratory distress syndrome requiring management by invasive ventilation. The lethality of this infection is around 4% in the current data.

Drastic precautionary measures for the transmission of the virus, as well as the provision of critical care beds by canceling any scheduled non-urgent intervention or consultation, have shaken up the hospital organization.

In this context, it is essential to have forward-looking data in real time to adjust the care offer and better understand the impact of Covid-19 on the patient populations treated.

time_perspective: Other

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Fondation Sainte-Marie
AURA Paris Plaisance
Hôpital Marie Lannelongue
Hôpital Bellan
Groupe Hospitalier Paris Saint-Joseph


title: Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum During an Emergency Laparoscopy Conducted on Confirmed or Suspected COVID-19 Patients

acronym: LAPTRANSCOV

summary: The purpose of this study is to determine whether the virus SARS-CoV-2, responsible for the disease COVID-19, is present in the abdominal cavity during emergency laparoscopic exploration in confirmed or suspected COVID-19 patients.

lead_sponsor: Hôpital NOVO

location_facility: Department of Gynecology-Obstetrics, Hospital René Dubos

location_facility: Department of General and Digestive Surgery, Hospital René Dubos


title: Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial

acronym: CORIMUNO-VIRO

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe 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 investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.

status: Suspended

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
AP-HP Hôpital Saint Antoine
AP-HP Hôpital Pitié Salpétrière
AP-HP Hôpital Ambroise Paré
AP-HP Hôpital Avicenne
AP-HP Hôpital Beaujon

intervention_type: Drug


title: Multidimensional Assessment of Dyspnea in Asthma

acronym: MIDAS

summary:
Breathlessness is a symptom of asthma that occurs in relation with lower airway obstruction. However, this sensation is not specific of asthma and may be the expression of other disorders. In particular, it can testify to anxiety or hyperventilation, two disorders frequently associated with asthma. The systematic interpretation of dyspnea as a manifestation of asthma in asthmatic patients may lead to an inappropriate increase in asthma controllers.

Identifying the cause of dyspnea in asthmatic patients (airway obstruction, anxiety or hyperventilation) is therefore crucial for the clinician.

This could be facilitated by a multidimensional assessment of dyspnea, evaluating the kind of sensation felt by the patient (for example chest tightness, air hunger etc.) and emotions associated to respiratory sensations (for example anxiety, fear etc.).

The objectives of this project are to assess: (1) the sensory and affective dimensions of dyspnea in asthma and, (2) their connection to asthma control, anxiety and depression.

status: Terminated

lead_sponsor: University Hospital, Lille

location_facility: Hopital Saint Vincent - Saint Antoine - Lille

location_facility: Hu Paris Nord Site Bichat Aphp - Paris 18

location_facility: Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre


title: Efficacy of 10 Days Intravenous Milrinone Treatment to Optimize Cerebral Hemodynamic and Prevent Delayed Cerebral Ischemia (DCI) in Patients With Severe Subarachnoid Hemorrhage Due to Intracranial Aneurysm Rupture

acronym: OPTIMIL

summary: The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital of La Réunion
HCL
University Hospital of Toulouse
University Hospital Bordeaux
CHUGA


title: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma

acronym: UCPVax-Glio

summary:
Glioblastoma (GBM) is the most frequent primary brain tumor and the brain tumor with the poorest prognosis. The current treatment relies on surgical resection of gross tumor followed by radiochemotherapy and adjuvant therapy with temozolomide.

After such therapy, most patients experiment recurrence and few therapeutic option are available. Despite such therapies, median survival only reaches around fifteen months.

There is a strong rational to develop telomerase vaccine in GBM. Telomerase (TERT) is a major oncogene, particularly in primary brain tumors 24. Alterations in TERT are very frequent in central nervous system tumors, seen most commonly in gliomas25. Mutations in the TERT promoter are found in approximately 80% of primary glioblastoma (GBM). These findings strongly support the rational to develop vaccine targeting telomerase in GBM.

The aim of this project is to evaluate UCPVax treatment in glioblastoma. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Hôpital Saint-Louis
CHU Besançon
CHU La Timone
CHU Bordeaux
Centre Georges François Leclerc

appel_a_projets: PHRCI

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

acronyme: UCPVax-Glio-MGMT

titre: Evaluation d'un vaccin dérivé de la télomérase (UCPVax) dans les patients atteints de glioblastomes avec la méthylation du gène MGMT

discipline_principale: autre

nom_porteur: CURTIT

prenom_porteur: Elsa


title: Development Of A Predictive Score For Maxillary Osteochimionecrosis After Invasive Oral Surgery In Patients Treated Whith Biphosphonates Or Biotherapies: The PREV-ONM Study

acronym: PREV-ONM

summary:
Non-interventional prospective multicentre cohort study to determine a predictive score for the occurrence of osteochimionecrosis of the jaws after invasive oral surgery in patients who have received biphosphonates or antangiogenic drugs as part of chemotherapy with malignant bone disease (multiple myeloma or bone metastasis of a solid tumour).

Data are collected during the usual follow-up of patients during the first 3 months following surgery.

ReferenceCitation: Marx RE. Pamidronate (Aredia) and zoledronate (Zometa) induced avascular necrosis of the jaws: a growing epidemic. J Oral Maxillofac Surg. 2003 Sep;61(9):1115-7. doi: 10.1016/s0278-2391(03)00720-1. No abstract available.

ReferenceCitation: Advisory Task Force on Bisphosphonate-Related Ostenonecrosis of the Jaws, American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on bisphosphonate-related osteonecrosis of the jaws. J Oral Maxillofac Surg. 2007 Mar;65(3):369-76. doi: 10.1016/j.joms.2006.11.003. No abstract available.

ReferenceCitation: Ruggiero SL, Dodson TB, Fantasia J, Goodday R, Aghaloo T, Mehrotra B, O'Ryan F; American Association of Oral and Maxillofacial Surgeons. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update. J Oral Maxillofac Surg. 2014 Oct;72(10):1938-56. doi: 10.1016/j.joms.2014.04.031. Epub 2014 May 5. Erratum In: J Oral Maxillofac Surg. 2015 Jul;73(7):1440. J Oral Maxillofac Surg. 2015 Sep;73(9):1879.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Qi WX, Tang LN, He AN, Yao Y, Shen Z. Risk of osteonecrosis of the jaw in cancer patients receiving denosumab: a meta-analysis of seven randomized controlled trials. Int J Clin Oncol. 2014 Apr;19(2):403-10. doi: 10.1007/s10147-013-0561-6. Epub 2013 Apr 20.

publisher_dissemination: Springer

ReferenceCitation: Allen MR, Burr DB. The pathogenesis of bisphosphonate-related osteonecrosis of the jaw: so many hypotheses, so few data. J Oral Maxillofac Surg. 2009 May;67(5 Suppl):61-70. doi: 10.1016/j.joms.2009.01.007.

ReferenceCitation: Gaudin E, Seidel L, Bacevic M, Rompen E, Lambert F. Occurrence and risk indicators of medication-related osteonecrosis of the jaw after dental extraction: a systematic review and meta-analysis. J Clin Periodontol. 2015 Oct;42(10):922-32. doi: 10.1111/jcpe.12455. Epub 2015 Nov 3.

publisher_dissemination: Wiley

ReferenceCitation: Peddi P, Lopez-Olivo MA, Pratt GF, Suarez-Almazor ME. Denosumab in patients with cancer and skeletal metastases: a systematic review and meta-analysis. Cancer Treat Rev. 2013 Feb;39(1):97-104. doi: 10.1016/j.ctrv.2012.07.002. Epub 2012 Aug 13.

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: green

ReferenceCitation: Landesberg R, Woo V, Cremers S, Cozin M, Marolt D, Vunjak-Novakovic G, Kousteni S, Raghavan S. Potential pathophysiological mechanisms in osteonecrosis of the jaw. Ann N Y Acad Sci. 2011 Feb;1218:62-79. doi: 10.1111/j.1749-6632.2010.05835.x.

ReferenceCitation: Reich W, Bilkenroth U, Schubert J, Wickenhauser C, Eckert AW. Surgical treatment of bisphosphonate-associated osteonecrosis: Prognostic score and long-term results. J Craniomaxillofac Surg. 2015 Nov;43(9):1809-22. doi: 10.1016/j.jcms.2015.07.035. Epub 2015 Aug 6.

lead_sponsor: Centre Hospitalier Sud Francilien

location_facility: Centre Hospitalier Intercommunal Robert Ballanger

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Evaluation of the Patient Skin Dose in Interventional Radiology

acronym: DPPRI

summary:
Studies on radiation induced patients' skin lesions in interventional radiology highlighted the need for optimized and personalized patient dosimetry and adapted patient follow-up. Measurements using Gafchromic® films or thermoluminescent dosimeters have long been the only way to accurately evaluate the maximum absorbed dose to the patient skin. However as these dose measurements are tedious and expensive, they could not be systematically applicable in clinical practice. Therefore, more practical calculation methods have been developed. These software programs calculate the skin dose using dosimetric information from images DICOM header or radiation dose structured reports (RDSRs). Validation studies of these software programs are rare and when existent have many limitations.

Radiation Dose Monitor (RDM from Medsquare) is a software program for archiving and monitoring of radiation dose (DACS, Dosimetry Archiving Communication System) used in routine in the investigator's hospitals. A new functionality developed in RDM allows quick estimation without in-vivo measurements of the absorbed dose to the skin of the patient. Comparing RDM calculations with in-vivo measurements will enable this software validation so that it can be used in clinical routine.

Main objective: to validate RDM software for calculating patient skin dose in interventional radiology.

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Food and Drug Administration (FDA). Avoidance of serious x-ray-induced skin injuries to patients during fluoroscopically-guided procedures, 1994.

ReferenceCitation: Valentin J. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP. 2000;30(2):7-67. doi: 10.1016/S0146-6453(01)00004-5.

ReferenceCitation: Miller DL. Efforts to optimize radiation protection in interventional fluoroscopy. Health Phys. 2013 Nov;105(5):435-44. doi: 10.1097/HP.0b013e31829c355a.

ReferenceCitation: Bor D, Olgar T, Toklu T, Caglan A, Onal E, Padovani R. Patient doses and dosimetric evaluations in interventional cardiology. Phys Med. 2009 Mar;25(1):31-42. doi: 10.1016/j.ejmp.2008.03.002. Epub 2008 Apr 25.

ReferenceCitation: Ying CK, Kandaiya S. Patient skin dose measurements during coronary interventional procedures using Gafchromic film. J Radiol Prot. 2010 Sep;30(3):585-96. doi: 10.1088/0952-4746/30/3/012. Epub 2010 Sep 8.

ReferenceCitation: Giordano C, D'Ercole L, Gobbi R, Bocchiola M, Passerini F. Coronary angiography and percutaneous transluminal coronary angioplasty procedures: Evaluation of patients' maximum skin dose using Gafchromic films and a comparison of local levels with reference levels proposed in the literature. Phys Med. 2010 Oct;26(4):224-32. doi: 10.1016/j.ejmp.2010.01.001. Epub 2010 Feb 8.

ReferenceCitation: den Boer A, de Feijter PJ, Serruys PW, Roelandt JR. Real-time quantification and display of skin radiation during coronary angiography and intervention. Circulation. 2001 Oct 9;104(15):1779-84. doi: 10.1161/hc4001.097057.

ReferenceCitation: Balter S. Methods for measuring fluoroscopic skin dose. Pediatr Radiol. 2006 Sep;36 Suppl 2(Suppl 2):136-40. doi: 10.1007/s00247-006-0193-3.

ReferenceCitation: Chida K, Kagaya Y, Saito H, Takai Y, Takahashi S, Yamada S, Kohzuki M, Zuguchi M. Total entrance skin dose: an effective indicator of maximum radiation dose to the skin during percutaneous coronary intervention. AJR Am J Roentgenol. 2007 Oct;189(4):W224-7. doi: 10.2214/AJR.07.2422.

ReferenceCitation: Khodadadegan Y, Zhang M, Pavlicek W, Paden RG, Chong B, Schueler BA, Fetterly KA, Langer SG, Wu T. Automatic monitoring of localized skin dose with fluoroscopic and interventional procedures. J Digit Imaging. 2011 Aug;24(4):626-39. doi: 10.1007/s10278-010-9320-7.

ReferenceCitation: Sanchez RM, Vano E, Fernandez JM, Escaned J. Evaluation of a real-time display for skin dose map in cardiac catheterisation procedures. Radiat Prot Dosimetry. 2015 Jul;165(1-4):240-3. doi: 10.1093/rpd/ncv033. Epub 2015 Mar 18.

ReferenceCitation: Digital Imaging and Communications in Medicine (DICOM). Supplement 94: Diagnostic X-Ray radiation Dose Reporting (Dose SR), 2005.

ReferenceCitation: 1IEC/PAS 61910-1. Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured report for radiography and radioscopy, 2007.

ReferenceCitation: IEC/PAS 61910-1. Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured report for radiography and radioscopy, 2014.

ReferenceCitation: Johnson PB, Borrego D, Balter S, Johnson K, Siragusa D, Bolch WE. Skin dose mapping for fluoroscopically guided interventions. Med Phys. 2011 Oct;38(10):5490-9. doi: 10.1118/1.3633935.

ReferenceCitation: Khodadadegan Y, Zhang M, Pavlicek W, Paden RG, Chong B, Huettl EA, Schueler BA, Fetterly KA, Langer SG, Wu T. Validation and initial clinical use of automatic peak skin dose localization with fluoroscopic and interventional procedures. Radiology. 2013 Jan;266(1):246-55. doi: 10.1148/radiol.12112295. Epub 2012 Nov 9.

ReferenceCitation: Bordier C, Klausz R, Desponds L. Patient dose map indications on interventional X-ray systems and validation with Gafchromic XR-RV3 film. Radiat Prot Dosimetry. 2015 Feb;163(3):306-18. doi: 10.1093/rpd/ncu181. Epub 2014 Jun 17.

ReferenceCitation: Bednarek DR, Barbarits J, Rana VK, Nagaraja SP, Josan MS, Rudin S. Verification of the performance accuracy of a real-time skin-dose tracking system for interventional fluoroscopic procedures. Proc SPIE Int Soc Opt Eng. 2011 Feb 13;7961(796127):796127_1. doi: 10.1117/12.877677.

ReferenceCitation: Rana VK, Rudin S, Bednarek DR. A tracking system to calculate patient skin dose in real-time during neurointerventional procedures using a biplane x-ray imaging system. Med Phys. 2016 Sep;43(9):5131. doi: 10.1118/1.4960368.

ReferenceCitation: Greffier J, Van Ngoc Ty C, Bonniaud G, Moliner G, Ledermann B, Schmutz L, Cornillet L, Cayla G, Beregi JP, Pereira F. Assessment of peak skin dose in interventional cardiology: A comparison between Gafchromic film and dosimetric software em.dose. Phys Med. 2017 Jun;38:16-22. doi: 10.1016/j.ejmp.2017.05.044. Epub 2017 May 8.

ReferenceCitation: Magnier F, Poulin M, Van Ngoc Ty C, Osmond E, Bonniaud G, Coulot J, Pereira B, Boyer L, Guersen J, Cassagnes L. Comparison of Patient Skin Dose Evaluated Using Radiochromic Film and Dose Calculation Software. Cardiovasc Intervent Radiol. 2018 May;41(5):762-771. doi: 10.1007/s00270-018-1888-1. Epub 2018 Feb 7.

ReferenceCitation: Jones AK, Pasciak AS. Calculating the peak skin dose resulting from fluoroscopically guided interventions. Part I: Methods. J Appl Clin Med Phys. 2011 Nov 15;12(4):3670. doi: 10.1120/jacmp.v12i4.3670. Erratum In: J Appl Clin Med Phys. 2014 Jul;15(4):402.

ReferenceCitation: Benmakhlouf H, Bouchard H, Fransson A, Andreo P. Backscatter factors and mass energy-absorption coefficient ratios for diagnostic radiology dosimetry. Phys Med Biol. 2011 Nov 21;56(22):7179-204. doi: 10.1088/0031-9155/56/22/012. Epub 2011 Oct 25.

ReferenceCitation: Menzel HG, Clement C, DeLuca P. ICRP Publication 110. Realistic reference phantoms: an ICRP/ICRU joint effort. A report of adult reference computational phantoms. Ann ICRP. 2009;39(2):1-164. doi: 10.1016/j.icrp.2009.09.001. No abstract available. Erratum In: Ann ICRP. 2009;39(2):165.

ReferenceCitation: IEC 61267. Medical Diagnostic X-ray Equipment - Radiation Conditions for Use in the Determination of Characteristics, 2005.

ReferenceCitation: Greffier J, Van Ngoc Ty C, Agelou M, Coulot J, Ledermann B, Ovtchinnikoff S, Pereira F, Beregi JP, Bonniaud G. Impact of the calibration conditions of XR-RV3 films on peak skin dose measurements in interventional radiology. Radiat Prot Dosimetry. 2017 Apr 25;174(2):207-215. doi: 10.1093/rpd/ncw116.

ReferenceCitation: McCabe BP, Speidel MA, Pike TL, Van Lysel MS. Calibration of GafChromic XR-RV3 radiochromic film for skin dose measurement using standardized x-ray spectra and a commercial flatbed scanner. Med Phys. 2011 Apr;38(4):1919-30. doi: 10.1118/1.3560422.

ReferenceCitation: Farah J, Trianni A, Ciraj-Bjelac O, Clairand I, De Angelis C, Delle Canne S, Hadid L, Huet C, Jarvinen H, Negri A, Novak L, Pinto M, Siiskonen T, Waryn MJ, Knezevic Z. Characterization of XR-RV3 GafChromic((R)) films in standard laboratory and in clinical conditions and means to evaluate uncertainties and reduce errors. Med Phys. 2015 Jul;42(7):4211-26. doi: 10.1118/1.4922132.

ReferenceCitation: Miyake Et Al H. [Medical electrical equipment - part 2-43: particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures]. Nihon Hoshasen Gijutsu Gakkai Zasshi. 2011;67(3):298-301. doi: 10.6009/jjrt.67.298. No abstract available. Japanese.

location_facility: AP-HP, Cochin Hospital, Radiology A department

location_facility: AP-HP, Lariboisière Hospital, Cardiology department

location_facility: AP-HP, Bicêtre Hospital, Nuclear medicine department

location_facility: AP-HP, Necker-Enfants Malades Hospital, Pediatric radiology department

location_facility: AP-HP, Lariboisière Hospital, Neuroradiology department

intervention_type: Procedure


title: Score of Echogenicity and Pancreatic Echo-endoscopy

acronym: OBELIX

summary:
Metabolic syndrome is defined by the presence of at least two of the following five criteria: abdominal perimeter> 94 cm in men, 80 cm in women, high triglycerides, low HDL cholesterol, HTA and hyperglycemia.

The metabolic syndrome can lead to ultrasound hepatic steatosis in 20 to 40% of cases depending on the population studied (overweight vs obesity). What is the impact of this syndrome on pancreatic echogenicity?

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

location_facility:
Hôpital privé Jean Mermoz
Polyclinique du Beaujolais
Clinique des Portes du Sud
Clinique du Trocadéro
Clinique du Val d'Ouest


title: Ostomy in Continuity or Conventional Ileostomy for Complex Pediatric Intestinal Diseases: a Retrospective Multicentric Analysis

acronym: StomaPed

summary:
Surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. The traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the Santulli or the Bishop-Koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. Nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made.

The aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population.

It is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.

study_start_date_type: Anticipated

ReferenceCitation: BISHOP HC, KOOP CE. Management of meconium ileus; resection, Roux-en-Y anastomosis and ileostomy irrigation with pancreatic enzymes. Ann Surg. 1957 Mar;145(3):410-4. doi: 10.1097/00000658-195703000-00017. No abstract available.

ReferenceCitation: SANTULLI TV, BLANC WA. Congenital atresia of the intestine: pathogenesis and treatment. Ann Surg. 1961 Dec;154(6):939-48. No abstract available.

ReferenceCitation: Sehgal S, Sandler AD, Alfred Chahine A, Mohan P, Torres C. Ostomy in continuity: A novel approach for the management of children with complex short bowel syndrome. J Pediatr Surg. 2018 Oct;53(10):1989-1995. doi: 10.1016/j.jpedsurg.2018.02.059. Epub 2018 Mar 4.

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Rennes
University Hospital of Nantes
Necker Enfants Malades Hospital
University Hospital of Tours
University Hospital of Brest


title: Echography in Pregnant Obese Women and Ultrasound Speed.

acronym: EPOWUS

summary: Ultrasound (US) image construction uses equations that contain the value of the propagation velocity of sound waves; this velocity is assumed conventionally to be constant and equal to 1540 m/s in the human body. Since 1977, all manufacturers of US scanners have used this value, which was first established in 1950. In fatty tissue, however, the actual propagation velocity is only in the order of 1450 m/s. US velocity in fat tissue is slower than in other soft tissues (ie:1450 m/s vs 1540 m/s) therefore the intrinsic image quality in terms of sharpness and precision is improved when considering this parameter for image construction The main objective of this study is to evaluate the impact of ultrasound propagation velocity setting on completeness of ultrasound exams and images quality during the second and third trimester fetal ultrasound examination in obese patients.

primary_purpose: Diagnostic

ReferenceCitation: Delabaere A, Chauveau B, Lemery D, Ollier A, Guiguet-Auclair C, Mourgues C, Legrand A. Protocol for the e-POWUS Project: multicentre blinded-randomised controlled trial of ultrasound speed choice to improve sonography quality in pregnant women with obesity. BMJ Open. 2021 Sep 21;11(9):e038684. doi: 10.1136/bmjopen-2020-038684.

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

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

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

publisher_dissemination: British Medical Journal

location_facility: Hôpital de la Croix Rousse - Hospices Civils de Lyon

location_facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier

location_facility: Hôpital Femme Mére Enfant - Hospices Civils de Lyon

location_facility: Hôpital Estaing - Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Hôpital Cochin - Assistance Publique - Hôpitaux de Paris

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

acronyme: EPOWUS

discipline_principale: obstetrics

nom_porteur: DELABAERE

prenom_porteur: Amélie


title: Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data

summary: To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.

lead_sponsor: Octapharma

location_facility:
Nantes Study Site
Bordeaux Study Site
Valence Study Site
Marseille Study Site
Le Plessis Robinsin Study Site

lead_sponsor_type: industriel


acronym: CONGRATS

lead_sponsor: Institut Bergonié

summary: This is a multicenter study assessing the efficacy of nivolumab in association with relatlimab.

sponsor_collaborators:
Institut Bergonié
Bristol-Myers Squibb

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

title: Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study.

type: EudraCT Number

source: euctr

region: Nouvelle-Aquitaine

nom_etablissement: INSTITUT BERGONIE

type_etablissement: CLCC

acronyme: CONGRATS

titre: Combination of Nivolumab plus Relatlimab in patients with advanced or metastatic soft-tissue sarcoma: a proof-of-concept randomized phase II study

nom_porteur: SPALATO-CERUSO

prenom_porteur: Mariella


title: Multicenter Prospective Longitudinal Study on the Efficacy of Exclusive Odontological and Medical Treatment in the Management of Chronic Dental Maxillary Sinusitis

acronym: DENTASINUS

summary: The study will be offered to patients for whom chronic maxillary sinusitis will be diagnosed in the first ENT (ear, nose and throat) consultation. These patients will then be seen in a stomatology consultation to determine whether or not a dental cause is objective

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hopitalier Intercommunal Robert Ballanger


title: French Validation of a Severity Scale in REM Sleep Behavior Disorder

acronym: SEV-TCSP

summary:
REM (Rapid Eye Movements) Sleep Behavior Disorder (RBD) is a parasomnia characterized by episodes of elaborate or violent motor activity during dreams, which can lead to injury and sleep disruption in patient and / or his/her spouse. This is due to the loss of the normal muscle atonia during REM Sleep. RBD is often associated to neurodegenerative diseases, and may even precede them for several years as an early marker. Currently, there is no scale or tool for assessing the severity of RBD. Nevertheless, it is crucial to have a tool of severity when one wants to study the natural evolution of this disorder, as well as the possible effect of a drug in the context of a clinical trial. A Severity Scale of RBD has recently been proposed within the International RBD Study Group and an international validation study in several languages is being considered.

The main objective of this study is to validate a new scale of severity of the REM sleep behavior disorder (RBD Severity Scale or RBDSS) and to characterize its metrological properties, in particular its concurrent validity, internal consistency and reproducibility

collaborators: Société Française de Recherche et Médecine du Sommeil

location_facility:
CHU Nantes
Clinique beausoleil
AP-HP
Hôpital de la Croix Rousse
CHU Clermont-Ferrand


title: MObile Technologies In the preVention of POSt-stroke DEPression

acronym: MOTIV-POSDEP

summary: The recent development of acute phase treatments has dramatically improved stroke functional outcome but post-stroke neuropsychiatric disorders, notably post-stroke depression, continue to contribute to the heavy burden of stroke. While these conditions affect about 25% of stroke patients at 3 months, they are under-reported spontaneously by patients and are under-evaluated and treated by clinicians. Other than stroke severity and psychiatric history, risk factors for post-stroke depression remain a matter of debate, thus preventing identification of high-risk patients. Moreover, to date, neither pharmacological nor nonpharmacological treatments have demonstrated a significant benefit in the prevention of this disorder, thereby also impeding the development of early treatment strategies. Yet,the early management of post-stroke depression is critical given its negative influence on long-term functional outcomes, medication adherence, efficient use of rehabilitation services and the risk of stroke recurrence or vascular events. There is a pressing need to develop new tools allowing for the early detection of post-stroke neuropsychiatric complications for each individual patient. The rapid expansion of ambulatory monitoring techniques, such as Ecological Momentary Assessment (EMA), allows daily evaluations of mood symptoms in real time and in the natural contexts of daily life. The investigators have previously validated the feasibility and validity of EMA to assess daily life emotional symptoms after stroke, demonstrating its utility to investigate their evolution during the 3 months following stroke and to identify early predictors of post-stroke depression such as stress reactivity and social support, suggesting that EMA could be used in the early personalized care management of these neuropsychiatric complications. Recently, preliminary data have also emphasized the potential of EMA interventions to improve the outcome of psychiatric disorders.

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux

location_facility: Assistance Publique Hopitaux de Paris - Groupe Hospitalier Paris Saint Joseph

intervention_type: Biological

appel_a_projets: PHRCN

nom_etablissement: CHU DE BORDEAUX

acronyme: MOTIV-POSDEP

titre: Technologies Mobiles et Prévention de la Dépression Post-AVC

discipline_principale: neurologie

nom_porteur: Sibon

prenom_porteur: Igor


title: Chronic Pain and Functional Prognosis After Total Knee Replacement: Continuous Locoregional Analgesia by Catheter to the Femoral Triangle Versus Tissue Infiltration as Part of an Improved Rehabilitation After Surgery Approach

acronym: TKAFTER

summary:
The prevalence of Chronic Post-Surgical Pain (CPSP) after knee replacement, defined as pain greater than or equal to 4/10 on the visual analogue scale after the third postoperative month, is recognised as high, with an average of 20% (extremes of 7 to 45%).

These CPSP, when present, cause poor long-term joint functional prognosis and impaired quality of life for patients. Many predictive, pre-, per- and post-operative factors of these CPSP have been identified in recent years. The most common postoperative risk factor found in the literature is the intensity of early pain.

The treatment protocols for this early post-surgical pain are currently and mainly multimodal in nature, combining systemic analgesics (paracetamol, NSAIDs, morphine, gabapentins) and local anaesthetics, administered either in the form of peripheral nerve blocks (continuous or single injection) or in the form of tissue infiltration (TI) performed by the surgeon during the operation.

Very few of these techniques have been evaluated for their ability to reduce the incidence of CPSP. Drugs with antihyperalgesic properties such as ketamine or nefopam have been shown to be of no interest, except to reduce the proportion of pain of a neuropathic nature. Only the continuous femoral block has shown, to date, an interest in IT to reduce the incidence of these CPSP.

The main objective of this study is to show that a multimodal analgesia protocol based on continuous locoregional analgesia by femoral triangle catheterization could reduce the incidence of chronic post surgical pain compared to a protocol based on tissue infiltration.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Hôpital des Diaconesses Croix Saint Simon


title: A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE

acronym: IMMUCARE-BASE

summary:
The number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities. The care of patients treated with these molecules require the development of multidisciplinary skills and the introduction of a professional network capable of taking care of immunotherapy related toxicity (irAE) that can affect different organs and for which immediate and effective interventions are necessary for patient survival.

IMMUCARE-BASE will comprehensively enable the collection, of clinical and biological data of patients treated with anticancer immunotherapy. The creation of this database is essential to identify clinico-biological factors predisposing to toxicity, and to define the best strategies to prevent the early onset of irAE and/or to treat them. Ultimately, the objective of this database is to collect enough data to be able to personalise in the future the immunotherapy treatment according to the benefits and to anticipate risks for each patient.

The objective of the biological collection is to perform ancillary studies for understanding mechanism leading to toxicity and for the development of research programs in the field of immunotherapy.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hôpital L. Pradel
Hôpital de la Croix Rousse
Hôpital E Herriot
Centre Hospitalier LYON SUD
Hôpital Pierre Wertheimer


title: Feasibility and Safety of CareMin650 in Cancer Patients at High Risk of or Suffering From Oral Mucositis and/or Radiation Dermatitis Due to the Administration of Radiotherapy: A Prospective Non-comparative Study

acronym: SafePBM

summary: The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head & neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.

lead_sponsor: NeoMedLight

sponsor_collaborators: NeoMedLight Qualissima

location_facility: Institut de radiothérapie et radiochirurgie Hartmann

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Do the Head-elevated Position and the Use of a Videolaryngoscope Facilitate Orotracheal Intubation in a Patient Population Without Predictable Difficulty of Intubation

acronym: HELP-VDL

summary:
The main hypothesis of this study is that there is a synergy between the use of the HELP position and the use of a McGrath® Mac videolaryngoscope to facilitate tracheal intubation during anesthesia.

The HELP position is the patient positioning on the AirPal RAMP, the two cushions inflated, bringing the external auditory canal to the same level as the sus-sternal notch.

ReferenceCitation: Le Guen M, Coppere Z, Dufour G, Ouattara J, Trichereau J, Fischler M. HELP-VDL: study protocol for a multicentre, open, randomised, controlled clinical trial comparing the use of the head-elevated laryngoscopy position and the use of a videolaryngoscope to facilitate orotracheal intubation in a patient population without predictable difficulty of intubation. BMJ Open. 2020 Jul 8;10(7):e036570. doi: 10.1136/bmjopen-2019-036570.

ipd_sharing: Yes

ipd_sharing_description: Data will be available in the Dryad repository.

lead_sponsor: Hopital Foch

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs

acronym: PREMIS

summary: The prospect of effective immunotherapies for the treatment of patients with cancer is now a clinical reality thanks to the approval of monoclonal antibodies (mAbs) specifically blocking immune checkpoints or ligands such as CTLA-4, PD-1 and PD-L1. However, these drugs can also induce inflammatory and/or auto-immune complications (Immune-related Adverse Events; IrAE). IrAE can affect all tissues and sometimes irreversibly. IrAE may be severe or fatal in the absence of timely and adequate care with anti-inflammatory drugs (steroids) or more specific immunosuppressants. Thus, IrAE are a new type of toxicities in oncology and represent one of the major limitations for the development of immunotherapy combination therapies. These IrAE are yet unpredictable. Indeed, the induction of immunity relies on the host's immune status and it differs from one patient to another and so far nobody has identified the underlying mechanisms responsible for irAE outbreaks.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Hôpital Bicêtre
Gustave Roussy
Hôpital Marie Lannelongue
Hôpital Paul Brousse


title: Multicenter Double Blind Randomized Placebo-controlled Trial Assessing the Efficacy of Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults

acronym: MUCILA

summary: To assess the efficacy of preventive Low-Level Laser Therapy (LLLT) for reducing the incidence of WHO's grade 3-4 oral mucositis in children and young adults receiving chemotherapy regimens associated with a high rate of mucositis: conventional chemotherapy or High Dose Chemotherapy (HDC) conditioning regimens with Hematological Stem Cell Transplantation (HSCT).

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Gustave Roussy
CHU de Rennes
Centre Oscar Lambret
Hôpital Robert Debré
Institut Curie


acronym: CHLOROTRAMMEL

summary:
Patients with metastatic Neuroblastoma RAS (NRAS) melanoma are currently treated with first line immune checkpoint inhibitors (nivolumab, pembrolizumab). Thus far, no targeted therapy has been approved in NRAS mutated melanoma as a second line treatment, because although the use of a MEK inhibitor (binimetinib) alone was superior to the gold standard chemotherapy (dacarbazine) in a phase 3 trial, the progression free survival gain was very modest.

In vitro and in vivo work from the study team's lab (McMAHON, Huntsman Cancer Institute (HCI), Salt Lake City), as well as, Ravi Amaravardi and Jean Mulchey-Levy suggests that the activation of autophagy is a mechanism of resistance to BRAF and MEK inhibitors in RAS and RAF mutated cancers, such as melanoma, pediatric brain tumors and pancreatic adenocarcinoma. The study team has shown in vivo, in four different NRAS mutated melanoma Patient Derived Xenograft (PDX) models that the combination of the MEK inhibitor trametinib and the autophagy inhibitor chloroquine results in a more dramatic tumor regression and inhibition than trametinib or chloroquine used as single agents (Nat Med. 2019 Apr;25(4):620-627. doi: 10.1038/s41591-019-0367-9. Epub 2019 Mar 4). In two of the PDX models, the combination resulted in almost complete tumor regression (quasi disappearance) that was not observed in the single agent treatment arms.

Trametinib (MEKINISTR) is an orally available MEK inhibitor that is currently approved in combination with the BRAF inhibitor dabrafenib (TAFINLARR) to treat BRAF mutated metastatic melanoma at the standard dosing of 2 milligrams (mg) once a day. Hydroxychloroquine (PLAQUENILR) is an orally available autophagy inhibitor that has been used for many years to treat autoimmune diseases like lupus, sarcoidosis and rheumatoid arthritis at the standard dosing of 400-600mg/day. For this study, the investigating team would like to evaluate the safety and tolerability of the combination of hydroxychloroquine and trametinib in a phase I trial in patients with NRAS mutated metastatic melanoma.

location_facility:
CHU Estaing
AP-HP_HOPITAL Saint Louis
INSTITUT Claudius Rigaud
CHU Grenoble Alpes
Centre Hospitalier Lyon Sud

title: MEK and Autophagy Inhibition in Metastatic/Locally Advanced, Unresectable Neuroblastoma RAS (NRAS) Melanoma: A Phase Ib/II Trial of Trametinib Plus Hydroxychloroquine in Patients With NRAS Melanoma

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: CHLORO-TRAM MEL

titre: Etude de phase I/II évaluant la tolérance d'un traitement par hydroxychloroquine associé au tramétinib dans le mélanome NRAS muté métastatique ou localement avancé non résécable après échec d'une immunothérapie

discipline_principale: cancer

nom_porteur: BOESPFLUG


title: Validation and Optimization Methods for a Quantitative Characterization of Motion Abnormalities of the Larynx With Echography

acronym: VOCALE

summary:
One of the major risks of endocrine surgery is recurrent nerve palsy (RNP), leading to vocal folds (VF) immobility. It happens in 5% of cases, leading to high morbidity: dysphonia, aspirations, impossibility to work. Guidelines recommend to systematically perform a nasofibroscopy before and after surgery to check vocal fold mobility. However, due to the decreasing number of specialists, the cost of decontamination, and discomfort of this procedure, these guidelines are insufficiently followed.

Transcutaneous Laryngeal Ultrasonography (TLU) appears a good alternative to nasofibroscopy in evaluating VF mobility, as assessed by the recent flourishing literature. Our team is a leader in this research by having developed a dedicated software, which provides objective measures of VF mobility. The aim of the present protocol is to validate the power of TLU for the diagnosis of RNP on a large cohort of patients operated on endocrine surgery. It is a prospective multicentric study that will blindly compare TLU and nasofibroscopy, the latter being the gold standard. TLU is cost effective and painless; its learning curve is fast. If validated, it may be offered as a good alternative to nasofibroscopy in RNP detection and prognosis.

ReferenceCitation: Bergeret-Cassagne H, Lazard DS, Lefort M, Hachi S, Leenhardt L, Menegaux F, Russ G, Tresallet C, Frouin F. Sonographic Dynamic Description of the Laryngeal Tract: Definition of Quantitative Measures to Characterize Vocal Fold Motion and Estimation of Their Normal Values. J Ultrasound Med. 2017 May;36(5):1037-1044. doi: 10.7863/ultra.16.05014. Epub 2017 Jan 10.

ReferenceCitation: Lazard DS, Bergeret-Cassagne H, Lefort M, Leenhardt L, Russ G, Frouin F, Tresallet C. Transcutaneous Laryngeal Ultrasonography for Laryngeal Immobility Diagnosis in Patients with Voice Disorders After Thyroid/Parathyroid Surgery. World J Surg. 2018 Jul;42(7):2102-2108. doi: 10.1007/s00268-017-4428-2.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
MINDRAY

location_facility: CHU Nantes - Clinique de chirurgie Digestive et Endocrinienne

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: VOCALE

titre: Performance de l'échographie laryngée trans-cutanée pour le diagnostic de paralysie des cordes vocales  après chirurgie cervicale endocrinienne

nom_porteur: TRESALLET

prenom_porteur: Christophe


title: Evaluation of Polychemotherapy With XELOXIRI-3 in Elderly or Frail Patients With Advanced Pancreatic Adenocarcinoma (ALIX)

acronym: ALIX

summary:
Current standard of care for patients with metastatic Pancreatic Ductal AdenoCarcinoma (PDAC) is chemotherapy, preferential regimen being FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). Due to more hematologic (neutropenia) and gastrointestinal toxicities, FOLFIRINOX is only administered in fit patients (age < 75 years, ECOG Performance status 0-1, and bilirubin < 1.5 ULN).

However, elderly or frail patients represent more than half of patients with PDAC and are treated with gemcitabine monochemotherapy. Maintaining more than one drug (polychemotherapy) may improve survival and quality of life in this population.

ALIX is a non-comparative randomized 2:1 phase II study. This study will assess the efficacy and safety of the polychemotherapy with XELOXIRI-3 versus gemcitabine as first-line chemotherapy in elderly or frail patients with locally advanced or metastatic PDAC.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility:
University Hospital of Besançon
CHU Reims
Hôpital Nord Franche-Comté
CH Mulhouse
CHU Nancy


title: Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain

acronym: EARS

summary:
The main objective of this work is to validate in French the questionnaire EARS, adapted to chronic low back pain.

Physical exercise is often recognized as necessary for primary and secondary prevention and treatment of chronic diseases. This is particularly true of chronic low back pain. It is therefore of paramount importance that compliance with such treatment be assessed to allow for readjustments, as well as drug treatment. No gold standard6-7 measured patient adherence to exercise programs until the creation of the EARS in 2016 by E.Godfrey and his team (Exercise Adherence Rating Scale, literally "joining physical exercise programs")

EARS is a reliable and validated psychometric assessment questionnaire that assesses adherence to prescribed physical exercise in chronic low back pain.

primary_purpose: Screening

ReferenceCitation: Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. doi: 10.1097/00007632-198709000-00002.

ReferenceCitation: Beinart NA, Goodchild CE, Weinman JA, Ayis S, Godfrey EL. Individual and intervention-related factors associated with adherence to home exercise in chronic low back pain: a systematic review. Spine J. 2013 Dec;13(12):1940-50. doi: 10.1016/j.spinee.2013.08.027. Epub 2013 Oct 26.

ReferenceCitation: Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.

ReferenceCitation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

ReferenceCitation: Hall AM, Kamper SJ, Hernon M, Hughes K, Kelly G, Lonsdale C, Hurley DA, Ostelo R. Measurement tools for adherence to non-pharmacologic self-management treatment for chronic musculoskeletal conditions: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):552-62. doi: 10.1016/j.apmr.2014.07.405. Epub 2014 Aug 6.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU de nîmes
CHU de Lille
CHU de Clermont-Ferrand
CHU de Montpellier
Hôpital COCHIN


title: Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference

summary: To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

ReferenceCitation: Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouviere O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21.

ReferenceCitation: N. Mottet JB, E. Briers, R.C.N. van den Bergh, M. Bolla, N.J. van Casteren, P. Cornford, S. Culine, S. Joniau, T. Lam, M.D. Mason, V. Matveev, H. van der Poel, T.H. van der Kwast, O. Rouvière, T. Wiegel. Guidelines on prostate cancer. European Association of Urology Web site https://uroweborg/guideline/prostate-cancer/. Accessed May 17, 2016.

ReferenceCitation: Schoots IG, Petrides N, Giganti F, Bokhorst LP, Rannikko A, Klotz L, Villers A, Hugosson J, Moore CM. Magnetic resonance imaging in active surveillance of prostate cancer: a systematic review. Eur Urol. 2015 Apr;67(4):627-36. doi: 10.1016/j.eururo.2014.10.050. Epub 2014 Nov 15.

ReferenceCitation: Le JD, Tan N, Shkolyar E, Lu DY, Kwan L, Marks LS, Huang J, Margolis DJ, Raman SS, Reiter RE. Multifocality and prostate cancer detection by multiparametric magnetic resonance imaging: correlation with whole-mount histopathology. Eur Urol. 2015 Mar;67(3):569-76. doi: 10.1016/j.eururo.2014.08.079. Epub 2014 Sep 23.

ReferenceCitation: Branger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.

ReferenceCitation: Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.

ReferenceCitation: Robertson NL, Hu Y, Ahmed HU, Freeman A, Barratt D, Emberton M. Prostate cancer risk inflation as a consequence of image-targeted biopsy of the prostate: a computer simulation study. Eur Urol. 2014 Mar;65(3):628-34. doi: 10.1016/j.eururo.2012.12.057. Epub 2013 Jan 3.

ReferenceCitation: Wetterauer C, Weibel M, Gsponer JR, Vlajnic T, Zellweger T, Butikofer S, Muller G, Puschel H, Bachmann A, Gasser TC, Bubendorf L, Rentsch CA. Incidental prostate cancer prevalence at radical cystoprostatectomy--importance of the histopathological work-up. Virchows Arch. 2014 Dec;465(6):629-36. doi: 10.1007/s00428-014-1656-9. Epub 2014 Oct 1.

ReferenceCitation: Bains LJ, Studer UE, Froehlich JM, Giannarini G, Triantafyllou M, Fleischmann A, Thoeny HC. Diffusion-weighted magnetic resonance imaging detects significant prostate cancer with high probability. J Urol. 2014 Sep;192(3):737-42. doi: 10.1016/j.juro.2014.03.039. Epub 2014 Mar 15.

ReferenceCitation: Steinberg DM, Fine J, Chappell R. Sample size for positive and negative predictive value in diagnostic research using case-control designs. Biostatistics. 2009 Jan;10(1):94-105. doi: 10.1093/biostatistics/kxn018. Epub 2008 Jun 12.

ReferenceCitation: DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Chu Saint Etienne
Hopital Nord
Institut Mutualiste Montsouris
CHRU Hopital Edouard Herriot
Institut Paoli Calmettes

appel_a_projets: PHRCK

region: Provence-Alpes-Côte d'Azur

nom_etablissement: INSTITUT PAOLI CALMETTES

titre: NPV-MRI-02 : Evaluation multicentrique de la vraie valeur prédictive négative de l'IRM multiparamétrique dans la détection du cancer de prostate chez des patients traités par cystoprostatectomie totale

nom_porteur: WALZ

prenom_porteur: Jochen


title: Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer

summary: This phase II trial is assessing how 64Cu-ATSM (64Cu-copper(II) diacetylbis(N4-methylthiosemicarbazone)) PET/CT scan could predict neo adjuvant treatment response in rectum cancer locally advanced

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Fondation ARC

location_facility: Institut de Cancerologie de l'Ouest (ICO)


title: Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease

acronym: COATS-VEGF

summary:
Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.

The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre hospitalier René Dubos (Pontoise)

location_facility: Fondation Ophtalmologique A. de Rothschild

location_facility: Hôpital Universitaire Necker Enfants Malades, APHP

nom_etablissement: HOPITAL FONDATION A DE ROTHSCHILD

type_etablissement: EBNL

acronyme: COATS-VEGF

titre: Étude contrôlée randomisée multicentrique sur l'intérêt des injections intra-vitréennes d'anti-VEGF comme traitement initial puis adjuvant dans la maladie de Coats

nom_porteur: METGE

prenom_porteur: Florence


title: Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS

acronym: COPP-MS

summary:
Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum (PP) period is a critical phase in MS patients, during which a recrudescence of disease activity is expected. Different strategies have been assessed in the prevention of post-partum relapse. High dose methylprednisolone was evaluated in a case control study with historical controls but the positive results have not been confirmed.

In this study, the main objective will be to compare the risk of relapse in the 6 months PP period between patients treated systematically by high dose methylprednisolone after delivery compared to patients who didn't receive a systematic treatment.

The second objective will be focused on the comparison of the disease activity and disability progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery vs patients who haven't.

lead_sponsor: Rennes University Hospital

location_facility:
Hôpital LAENNEC
CHU Rennes
CHU Lyon
Hôpital Pasteur 2 - CHU Nice
CHU Strasbourg


title: Phase Ib Study Evaluating the Safety and Efficacy of Intratumoral Agonistic Anti-CD40 (Selicrelumab) in Combination With Anti-PDL1 (Atezolizumab) in Patients With Refractory or Relapsed B Cell Lymphoma

summary: This is a multicenter, open, dose escalation phase Ib trial of intratumoral agonistic anti-CD40 Ab (Selicrelumab intratumoral every 3 weeks for 3 cycles) in combination with anti-PDL1 Ab (Atezolizumab 1200mg intravenous every 3 weeks) in patients with refractory or relapsed B cell lymphoma

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud


title: Regional Anticoagulation of Dialysis Extra-corporeal Circuits With a Calcium-free Citrate-containing Dialysate : Efficiency and Tolerance

summary: Critically ill patients have a high risk of bleeding but also require prolonged intermittent dialysis. Thus, a heparin-free easy-to-use alternative type of anticoagulation within the dialysis circuit is required. In a non-comparative study, heparin-free regional citrate anticoagulation of the dialysis circuit using a calcium-free citrate-containing dialysate, with calcium reinjected according to ionic dialysance, was considered as safe and efficient. The aim of this study is to confirm the superiority of this approach compared to a anticoagulation based on heparin-grafted membrane.

lead_sponsor: University Hospital, Toulouse

location_facility:
Nimes Hospital
CHU Toulouse
Tenon Hospital
Montpellier Hospital
Pellegrin Hospital

intervention_type: Combination Product

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: C2D study

titre: Evaluation de l'efficacité et de la tolérance d'une anticoagulation régionale des circuits de dialyse par un dialysat au citrate sans calcium

discipline_principale: néphrologie, dialyse, réanimation

nom_porteur: FAGUER

prenom_porteur: Stanislas


title: Microvesicles and Monocytes to Predict Mortality of Patients With Cirrhosis

acronym: PROMICE

summary:
Chronic liver diseases related to viral hepatitis, metabolic syndrome or excessive alcohol consumption can evolve towards cirrhosis. Cirrhosis is responsible for 170 000 deaths per year in Europe. Initially asymptomatic and called "compensated" it can become "decompensated" with the developement of acute complications such as infections, ascites or variceal bleeding. The transition from compensated to decompensated cirrhosis is associated with a reduction in survival from 95 to 55% at 1 year.

The only curative treatment for cirrhosis is liver transplantation (LT). Liver transplants are allocated according to the severity of the patients. Despite a modest prognostic value (area under the ROC curve = 0.7 to predict the risk of death), graft allocation is based on the MELD (Model for End-Stage Liver Disease) score including INR, bilirubin and serum creatinine. In 2014, 11.5% of registered patients died on the liver transplant waiting list, illustrating the need for biomarkers that predict death and improve MELD-based prediction.

Microvesicles are membrane vesicles released in extracellular space during cell activation or apoptosis. Our team showed that circulating levels of hepatocyte microvesicles increase with the severity of cirrhosis and predict survival at 6 months independently of MELD score in a cohort of 242 patients with cirrhosis.

Type 1 interferons (IFN-1) are mediators of inflammation, which is excessively activated in cirrhosis. Our team has shown that a gene signature (IFN score) measured in the immune cells of 101 patients with cirrhosis is able to predict 6 month-survival independently of the MELD score.

Thus, the investigators hypothesize that a composite score combining the level of circulating hepatocyte microvesicles, the IFN score and the MELD score could improve the prediction of survival in patients with severe cirrhosis.

The aim of this study is to compare the prognostic performance for the cumulative incidence of death at 6 months of a composite score including MELD, hepatocyte microvesicle level and IFN score with that of the MELD score alone, in patients with Child B or C cirrhosis, considering liver transplantation as a competitive risk.

To address this question, peripheral blood from 335 patients with Child B or C cirrhosis will be obtained and hepatocyte microvesicle levels and IFN score will be measured using ELISA/filtration and Real Time-quantitative PCR.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
De La Fontaine hospital
Avicenne Hospital
Beaujon hospital
La Pitié Salpêtrière hospital
Foch hospital

acronyme: PROMICE

titre: Performances des microvésicules et des monocytes pour prédire la mortalité des malades atteints de cirrhose

nom_porteur: WEISS

prenom_porteur: Emmanuel


title: Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening

acronym: RUC EHPAD

summary: The goal of this cross-sectional, multicentric and descriptive epidemiological study is to assess the prevalence of chronic urinary retention (CUR) in elderly living in residential care for dependent elderly people in order to determine if there is an interest in offering them a bladder scan screening.

location_facility: EHPAD du Centre Local Hospitalier de Saint-Joseph


title: Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis

acronym: DIANE

summary: The purpose is to found new biomarker that differentiate septic arthritis and Juvenile Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The results for each data will be compared in function of the disease to search discriminant markers. On behalf with this result specific pathways could be identified .

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
INSERM U1183

location_facility: CHU Toulouse - Pediatric infectious diseases

location_facility: Hospices Civils de Lyon - pediatric rheumatology


title: Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

acronym: PAAF

summary: Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.

location_facility:
Centre Hospitalier Départemental Vendée
CH La Rochelle
CH Cholet
CH Saint Malo
CHU Angers


title: CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)

acronym: COCTAEyl

summary: The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing treatment on OCTA and to correlate OCTA findings with SD-OCT findings.

sponsor_collaborators: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Ophtalmologique d'Imagerie et de Laser,


title: Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients: a Randomized Controlled Trial

acronym: ELECTROPAD

summary:
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life.

Interventions designed to improve walking impairment may have a significant impact on the functional capacity in LEPAD patients. Lower extremity electrical stimulation is an older technique that relies on different types of electrical stimulations with different expected physiological effects on hemodynamics, skeletal muscle functions or pain pathway. The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients.

ReferenceCitation: Jehannin P, Craughwell M, Omarjee L, Donnelly A, Jaquinandi V, Mahe G, Le Faucheur A. A systematic review of lower extremity electrical stimulation for treatment of walking impairment in peripheral artery disease. Vasc Med. 2020 Aug;25(4):354-363. doi: 10.1177/1358863X20902272. Epub 2020 Apr 17.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: SAGE Publications

sponsor_collaborators:
Rennes University Hospital
AD REM TECHNOLOGY
Ecole Normale Supérieure de Rennes

location_facility:
CHU Caen
CHU Brest
CHU de Rennes
Hôpital de Rangueil
CHU Angers

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: Electro-PAD

titre: Effet de l'électrostimulation sur la distance maximale de marche de patients artériopathes : Essai multicentrique randomisé en double aveugle

nom_porteur: MAHE

prenom_porteur: Guillaume


title: National Retrospective Study to Characterize LOng REsponder Under EribuLINE (HALAVEN®) Metastatic Breast Cancer Patients

acronym: Loreline

summary:
There is currently no strict recommendations for the management of patients who have received at least one or two lines of anthracyclines-based chemotherapy and taxane therapy for advanced breast cancer. However, Halaven® can represent a therapeutic alternative at this stage of the disease.

Indeed, since march 2011, Halaven® has been granted Marketing Authorization (MA) for patients with metastatic or locally advanced breast cancer, whose disease has progressed after at least two lines of chemotherapy for advanced disease (3rd line). In these patients, the indication for marketing authorization specifies that the previous treatment must have included an anthracycline and a taxane except in patients who can not receive these treatments.

An extension of indication was obtained on 27/06/2014 with a marketing authorization obtained in the treatment of locally advanced or second-line metastatic breast cancer.

According to the Transparency Commission of the High Authority of Health (HAS dated September 23, 2015), Halaven® (Eribulin), administered as monotherapy, in the third line of treatment and beyond, represents a therapeutic option, because it brings an improvement of medical service rendered compared to Capecitabine (XELODA®) and Vinorelbine (NAVELBINE®).

In addition, Halaven® (Eribuline) administrated as monotherapy in second-line of treatment is an alternative to other monotherapies recommended for the treatment of locally advanced or metastatic relapsed breast cancer, such as Capecitabine (XELODA®). and Vinorelbine (NAVELBINE®). But, no improvement of medical service rendered has been reported in second line of treatment.

According to these results, it would be interesting to have additional data concerning the use of Halaven® (Eribulin), in the second and third lines, but also in the fourth line.

For this purpose, the investigators propose to perform a study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.

In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 and December 2016, to have a sufficient follow-up for the survival data of the patients.

lead_sponsor: Centre Jean Perrin

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Transcultural Validation of MSTS and TESS Questionnaire

acronym: MSTS-TESS

summary:
Reference treatment for soft tissue or bone sarcoma is the Monobloc resection surgery, with a margin of one to many millimeters removing the entire tumor leaving no cancer cells, associated or not with other treatments. Other musculoskeletal malignant tumors, some of them with secondary origins (metastases), are treated the same way. Patients with soft tissue and bone tumor could have heavy sequels of this surgery procedure, depending on the localization and size of the initial tumor. Those functional sequels are evaluated by specific questionnaires: the questionnaire TESS for upper limbs and TESS for lower limbs which are completed by the patient (depending on the localization of the tumor) and the questionnaire MSTS which is completed by the medical doctor.

Those English validated questionnaires are frequently used by French surgeons in standard practice as well as scientific research. The translations done have never been validated by an official methodology.

The aim of this trial is to validate the TESS and MSTS questionnaires linguistically, culturally (questions must be adapted for each target population: occidental adults and adolescents population, male and female population and adapted to the current era), and scientifically (repeatability).

The validation of those questionnaires will permit to have functional and reference questionnaires in French language which could be used for the follow up of operated patient in the context of the care and clinical research.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
University Hospital, Angers

location_facility:
Nantes University Hospital
Marseille University Hospital
Tours University Hospital
Rennes University Hospital
Nantes University hospital


title: Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients

acronym: MAINTAIN

summary: Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the medication adherence in RA are rare. The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.

lead_sponsor: University Hospital, Bordeaux

collaborators: Association Aquitaine de Recherche Clinique en Rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie

intervention_type: Behavioral


title: Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses

acronym: CIRCA-HPV

summary: ctDNA detection in patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up.

lead_sponsor: Institut Curie

location_facility:
Hôpital Tenon
Institut Curie - Saint-Cloud
CHU Pontchaillou
CHU de Besançon
Institut Curie - Paris

nom_etablissement: CLCC  INSTITUT CURIE

acronyme: CirCA-HPV

titre: CirCA-HPV : Détection de l'ADN tumoral circulant pour la détection précoce de rechute de cancers pelviens HPV-positifs

nom_porteur: BIDARD

prenom_porteur: François-Clément


acronym: PREDIRESPUC

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary: Vedolizumab (VDZ) is a monoclonal antibody that binds to the heterodimer α4β7 integrin and which has shown its efficacy in Ulcerative Colitis (UC) by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Ulcerative Colitis in patients in failure with anti-Tumor Necrosis Factor (anti-TNF) agents. In the pivotal study, correlation between drug levels and clinical response during induction and maintenance therapy were reported. Moreover, in 3.7% of cases, anti-vedolizumab antibodies were reported during the time-course and 1% had samples that were persistently positive. Up to now, data on the pharmacologic VDZ parameters are scarce and the relationships as well as the predictive value of the measurement of VDZ concentrations and VDZ monoclonal antibodies (mAbs) during the induction and maintenance phases remains unknown. It could be of paramount interest to early identify UC patients under VDZ who will be responders to VDZ induction and to identify those who will achieve clinical remission under maintenance therapy with VDZ.

location_facility:
CHU Kremlin Bicêtre
Chu L'Archet
CHU Saint-Etienne
Ch Lyon Sud
CHU Amiens

title: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Ulcerative Colitis

collaborators: Takeda Theradiag


title: To Demonstrate the Ability of Abatacept in Comparison to Placebo to Obtain a Low Disease Activity [PMR-AS (CRP) Lower or Equal to 10] Without GCs (Prednisone or Prednisolone) at Week 12 in Early Onset PMR Patients.

acronym: ALORS

summary:
Polymyalgia rheumatic (PMR) is a frequent inflammatory disease. It affects the elderly, with peak incidences at the age of 70 to 80 years; an age >50 years or older, is considered a criterion for the diagnosis. Polymyalgia rheumatica occurs at a frequency that is 3 to 10 times that of giant-cell arteritis. Disease risk varies according to race and geographic region. The incidence is highest among whites in northern European populations (about 20 cases per 100,000 persons older than 50 years of age); it is lower in southern European populations (about 10 cases per 100,000).The diagnosis is based on established ACR/EULAR classification criteria.

Long term low-dose glucocorticoid (GCs) (prednisone or prednisolone started at 15 to 20 mg/day progressively tapered) is the mainstay of the treatment.

The activity of PMR is evaluated using the PMR-AS, a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment and pain assessment measured by the patient using VAS, and the C-reactive protein (CRP) level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)..

Comorbidity in PMR are due to GCs and 30% of the patients underwent a relapse when tapering GCs. If the investigators able to start prednisone at a lower dosage (i.e. 8 mg then tapered for 3 to 4 months), the cumulative dosage of steroid would not have major side effects but it is not possible without new therapeutic agents.

The TENOR study (Tolerance and Efficacy of tocilizumab iN pOlymyalgia Rheumatica), a phase 2 study, demonstrated efficacy of tocilizumab as first line treatment in PMR without GCs and its ability to spare GCs. This was the first study demonstrating that a biologic may improve PMR without steroid, and that also showed that a short treatment by biologic followed by a low dose GCs therapy may be a new concept in the treatment of PMR.

Molecular studies in GCA and PMR suggest that dendritic cells initiate the pathogenic cascade and recruit T cells. Two major immune-response networks have been identified related to type 1 helper T-cell (Th1) and to helper T-cell (Th17). Abatacept is comprised of the ligand-binding domain of CTLA4 plus modified Fc domain derived from IgG1. By containing CTLA4, abatacept blocks the engagement of CD28 with its ligand, thereby inhibiting T cell activation. It has recently demonstrated its efficacy in Granulomatosis with polyangiitis (GPA) but also in giant cell arteritis (GCA). Due to its good safety profile in rheumatoid arthritis and its potential to modulate T cell activation and derived cytokines, abatacept is an attractive agent to investigate in patients with PMR.

In this randomized prospective placebo controlled study, the objective is to demonstrate the ability of abatacept to improve alone PMR and then to allow a steroid sparing effect after this induction treatment, in early onset PMR.

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Bristol-Myers Squibb

location_facility:
CH Le Mans
CHRU de Brest
CH St-Malo
CHU Strasbourg
CH de Morlaix


title: Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma

acronym: ISSUE

summary:
After trauma or stress factor like death exposition, serious injuries or sexual violence, some patients may develop stress reaction characterized by the presence of various symptoms among different categories (reviviscence, negative humor, dissociates symptoms, occasion, hypervigilance). In the month following trauma, the investigators speak of acute stress reaction (ASR) when symptoms are present during at least three days. If symptoms are present one month after trauma, then it is a post-traumatic stress disorder (PTSD).

Among patients visiting emergency after latest trauma, quite a few is in acute stress reaction. However, this reaction is often incorrectly identified by healthcare team, due to lack of oriented medical examination, patients visiting about other complaints (pain, insomnia) and not expressing clearly the trauma context. Yet, it is know that acute stress reaction occurrence and existence of dissociate symptoms after trauma confrontation is considerably predictive of the eventual post-traumatic stress disorder occurrence.

The identification of risk population of post-traumatic stress disorder is not the subject of any particular structured procedure in emergency services while early care of these patients may allow limiting post-traumatic stress disorder occurrence and associate consequences. Previous works on the subject having exclusively targeted some trauma subgroups or some predictive factors subtypes, investigators propose here biopsychosocial global approach that can weight the impact of each parameters.

In this study, investigators aim at determining predictive biopsychosocial factors of the post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after latest trauma (less than one month old) and identified as "high-risk" to develop post-traumatic stress disorder (moderate or high).

ReferenceCitation: Wafa MH, Viprey M, Magaud L, Haesebaert J, Leaune E, Poulet E, Bied C, Schott AM. Identification of biopSychoSocial factors predictive of post-traUmatic stress disorder in patients admitted to the Emergency department after a trauma (ISSUE): protocol for a multicenter prospective study. BMC Psychiatry. 2019 May 30;19(1):163. doi: 10.1186/s12888-019-2154-z.

license: cc-by

license_normalized: cc-by

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

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

publisher_dissemination: Springer-Nature

lead_sponsor: Hospices Civils de Lyon

location_facility: CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence

location_facility: Centre Hospitalier Lyon Sud - Urgences psychiatriques

location_facility: CHU St Etienne - Hôpital Nord - Urgences Psychiatriques

location_facility: Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence

location_facility: CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence

acronyme: ISSUE

titre: Identification des facteurs biopsychosociaux prédictifs de la survenue d'un trouble de stress post-traumatique chez les patients admis aux urgences après un traumatisme

discipline_principale: hors cancer

nom_porteur: BIED

prenom_porteur: Clémence


title: Clinical and Genetic Analyzes of Age-related Macular Degeneration

acronym: COLDMLA

summary: The purpose of this collection is to search for susceptibility genes for age-related macular degeneration (AMD) alone or in combination with environmental factors and to look for genes that modulate the AMD phenotype (particularly the response to treatment).

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre ophtalmologique d'imagerie et de laser

intervention_type: Genetic


title: Biological Bank for Studies Related to Atrial Fibrillation and Stroke

acronym: BAFA

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. This arrhythmia is responsible for 15% of strokes and more than 30% of strokes on people over 65 years.

According to studies, 30 to 40% of isolated atrial fibrillations could be familial. Atrial fibrillation has significant genetic heterogeneity. About 40 genes have been identified as potentially involved. Studies have identified genes common to the risk of atrial fibrillation and stroke. Despite the pathophysiology of atrial fibrillation has been intensively and extensively studied for almost a century, there are still many questions. The pathophysiology is not sufficiently understood to allow finding more effective therapies. It is necessary to identify genetic determinants and thus potentially new pharmacological targets more adapted.

The establishment of a biological database will test hypotheses concerning the genetic origin and thromboembolic process of atrial fibrillation and associated stroke.

location_facility: Service d'urgences Neurovasculaires - service de neurologie vasculaire , Hôpital Pierre Wertheimer

location_facility: Service de médecine gériatrique Centre hospitalier Lyon Sud, Groupement hospitalier Sud

location_facility: Service neurologie Centre hospitalier Fleyriat

location_facility: Service de rythmologie, hôpital cardiologique Louis Pradel


title: Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity of Patients in Treatment for a Substance Use Disorder or a Gambling Disorder. A Multicenter Randomized Controlled Trial (AjusT)

acronym: AjusT

summary: The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. The awareness of the craving intensity and its individual cues for each patient will allow the clinician to tailor a better treatment. The aim of this study is to evaluate the efficacy of a program based on an Individually Adjusted Therapy scale added to a treatment as usual for the treatment of addiction.

location_facility: Centre Hospitalier Universitaire La Réunion

location_facility: Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA