title: Epidemiologic Study of Orthodontic Retention Practices in France

acronym: ORIF

summary: The goal of this study is to survey retention procedures used by French orthodontists, and evaluate the needs for practice guidelines. The hypothesis is that there is no consensus among orthodontists, requiring practice homogenization via expert guidelines. Similar studies have been driven in others European countries (such as Swiss, the Netherlands, Lithuania and Norway), but not in France.

ipd_sharing_description: No IPD

lead_sponsor: Nantes University Hospital


title: To Promote Tobacco Free Life in the Dental Practice in France: Feasibility Study

acronym: TOBAFREE-DP

summary:
In France, 34% of the adult population is smoking every day. The links between smoking and the development of several chronic disorders is well established and smoking is directly implicated in most of the oral diseases such as cancers of the oral cavity. Thus, dentists have access to an area of the body that is actively affected and this gives them a central role in dispensing advice and support regarding smoking cessation.

Dentists often cite issues such as lack of time or education as a reason for why they do not offer support for smoking cessation. A brief intervention can increase smoking cessation by 30 to 100% (ie 1-3% in absolute value). The "5A" approach integrates and extends the brief intervention. It consists in Asking about smoking status, Advising smokers of the benefit of stopping, Assessing motivation to quit, Assisting smokers in their quit attempt, Arranging follow-up with stop-smoking services. For practitioners who do not have enough time, a "3A" approach might be acceptable (Ask, Advice and Act) by providing details of local stop smoking services and/or prescribing nicotine replacement therapy (NRT). This very brief advice can be delivered in less than one minute.

To investigators knowledge, the role of dentists in the French national tobacco-free program is not yet documented in France while since 2016, dentists can prescribe NRT with some products taken in charge by the French health insurance.

An intervention taking part in the continuing professional development will be developed so the dentists fell legitimate, motivated and competent to talk with their patients about their tobacco consumption and to assist them in their smoking cessation process. This intervention based on the 5/3A approach and prescription of NRT will include a specific training and provision of management kit, with communication tools and network for appropriate references.

Investigators hypothesize that 5/3A approach is feasible with adequate intervention in dental practices in France (dentists apply the approach to 90% of their patients) and that the format, the conditions, the barriers and the lever actions of its implementation are known.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: University Hospital, Bordeaux

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Out-of Pocket Payments in Patients With Lymphedema in France and Inequities of Access ti Healthcare

acronym: Lymphorac

summary:
Lymphedema is a frequent and chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. Our aim was to analyze the distributive effects of OOPP for lymphedema patients in France.

A prospective, multicenter study will be conducted in France in 2014 on patients with lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. We will combine concentration curves and concentration indices to assess the distributive effects.

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

location_facility: Departement information Medicale CHU Montpellier


title: Impact of the Covid19 Pandemic on the Organization of Healthcare in France

acronym: IRIS

summary:
The 2020 COVID-19 pandemic, which began spreading on January 24, 2020 in France, has required a profound and rapid reorganization of the health system, based in particular on internal hospital reorganizations of front-line establishments, deprogramming of non-urgent activities, and transfers of non-covid19 patients to 2nd line facilities. Beyond the immediate impact on the management of patients infected with COVID-19, this reorganization may have reduced the capacity of management for patients requiring urgent or semi-urgent intervention, or may have postponed some necessary care. The isolation of patients at home may also have resulted in lower compliance to therapy and medical treatments and may have contributed to decompensation.

At the end of this crisis, the different organizational responses in France should be evaluated to identify the consequences and the areas for improvement in order to be prepared for future exceptional health situations. This investigation on healthcare systems confronted to an exceptional health situation thus seeks to determine if the profound reorganizations implemented during this health crisis have indirect effects on the performance of care, in particular if there is a destabilization of the care systems (emergency, semi-emergency and chronic), a loss of chance for the patients and if innovative care paths have emerged.

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

status_simplified: Unknown


title: Management of Venous Thromboembolism in France: a National Survey Among Vascular Medicine Physicians

acronym: Observ-MTEV

summary: In France, venous thromboembolic (VTE) disease is usually managed by vascular medicine physicians (VMP). The national OPTIMEV study, conducted more than 12 years ago among VMP practicing in hospital and in the community described the management of VTE in routine clinical practice. Since then a large number of practice changing studies have been published. This includes trials that have validated the use of direct oral anticoagulants (DOAC), the new standard of care of VTE, as per new national and international guidelines. Management of VTE in 2019 appears to be significantly different from the one that prevailed more than 10 years ago when the last national survey was conducted. It is therefore important to have an update on the routine clinical practice management of VTE by VMP. In this perspective the investigators aim to conduct a national survey among VMP practicing in France

lead_sponsor: Centre Hospitalier Universitaire, Amiens


type: Other Identifier

title: Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort

acronym: CROSS

summary: The purpose of this study is to determine the outcomes of severe osteoporotic fractures hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years.

status: Active, not recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Hospices Civils de Lyon

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: CROSS

titre: Conséquences des fractures sévères ostéoporotiques hospitalisées en France : cohorte française multicentrique CROSS

discipline_principale: rhumatologie

nom_porteur: BRIOT

prenom_porteur: Karine


title: Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes

summary: The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot study in the Department of the Alpes-Maritimes.

study_type: Interventional

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Procedure


title: " 7 Days Survey of Obstetric Analgesia/Anesthesia in France" (EPIDOL)

acronym: Epidol

summary:
Obstetric analgesia is a requirement of our times. The different applicable methods vary in effectiveness. The essential part is represented by epidural analgesia which remains one of the most effective methods. It is important to know other methods to respond to all requests. The applications of these methods, patient satisfaction and psychic experience, complications or incidents remain poorly or partially evaluated in France.

The main objective is to describe the different techniques of anesthesia/analgesia actually used in France for the management of pain during vaginal deliveries and cesarean sections on a representative sample of all maternity hospitals at a given time(7 days per maternity hospital, 63 maternity hospitals (levels I,II,III), so about 2500 births).

Secondary objectives will be multiple :

Describe the results of analgesic methods on the physical pain of patients during labor by a global visual analog scale
Describe the feeling of pregnant women relative to the different anesthesic and analgesic techniques, by an analysis of the questionnaire responses
Describe the frequency of adverse events of birth

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France: Surgical Thresholds, Geographical Distance, Age and Therapeutic Sequence

acronym: Pro-TOCa

summary: Evaluation of the following prognostic factors in France, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,Upfront surgery.

ipd_sharing_description: NC


title: Exploration of Patient Self-medication Practices During and After Cancer in France: Cross-sectional Observational Study With Online Response

acronym: CASEME

summary: The purpose of this study is to assess the patient self-medication practices during and after cancer in France, using an online questionnaire

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand


title: Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France

summary:
The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.

The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this study, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

lead_sponsor_type: industriel


title: A Prospective Cohort of Healthcare Workers in France

acronym: ESPERES

summary: ESPERES is a national prospective e-cohort study providing a resource for collecting information on healthcare workers (HCWs) currently working in France. The overall goal of ESPERES is to develop the infrastructure necessary to create and engage a community of HCWs who may be eligible for participation in future research studies. ESPERES is set up to answer research questions, in the field of prevention for HCWs, prevention for their own health, that of their relatives, their colleagues, and users of the hospital. These research questions will be carried out in the context of specific subsequent studies. The first study that will be carried out is related to prevention against COVID-19, in particular vaccination against COVID-19 and more broadly on the COVID-19 pandemic.

status: Recruiting


title: Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France

summary:
No structured organization for ovarian first line management emerges in France. Management across France seems to depend on regional contexts.

Regions display no specific organization or delineate regional network for the ovarian cancer management or report centralized management revolving around referent centers. These different templates present a major problem in identifying differences, costs and benefit.

To deal with this issue the Investigators propose a health economic evaluation based on cost-effectiveness analyses, completed with a budget impact analysis. This study will investigate the cost-effective management of patients with initial ovarian cancer using databases representative of different parts of French territories.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Cancer Côte d'or registry
Cancer Calvados registry

location_facility:
Oveval
Côte d'or registry
Calvados registry

appel_a_projets: PRMEK

region: Auvergne-Rhône-Alpes

nom_etablissement: CENTRE LEON BERARD

type_etablissement: CLCC

titre: Optimisation du parcours de soins dans la prise en charge initiale des cancers épithéliaux ovariens en France

discipline_principale: ovarian cancer

nom_porteur: RAY-COQUARD

prenom_porteur: Isabelle


title: Impact of the COVID-19 Pandemic on Online Gambling in France and Sweden

acronym: CONGA

summary:
The coronavirus disease 2019 (COVID-19) pandemic represents a major threat to global health. Since the beginning of the COVID-19 epidemic, all eyes have been focused on the significant somatic complications of COVID-19, but the impact on behaviors, particularly those that can lead to addictive disorders, remains little studied. A set of factors could explain a change in gambling activities, both in number of gamblers and in intensity of practices, due to the pandemic. On the one hand, the reduction or even the interruption of sporting and horse racing competitions may induce a decrease in these activities (both online and offline). Moreover, the closure of certain gambling venues and travel restrictions may also lead to a decrease of offline gambling activities in general. On the other hand, gamblers who can no longer perform their usual gambling activity could refer to available online gambling activities (poker, lotteries, casinos, etc.). Moreover, the threat of a financial crisis, the negative impact on psychological well-being (due to social isolation, stress of being infected, etc.), and increased time spent freely online, could also very largely motivate an initiation or an exacerbation of the gambling activity, especially online and in people in a situation of vulnerability. Both in France and Sweden, the closing of sports and horse race events has led to a sharp decrease in sports and horse-race betting. In both countries, the increase in other gambling types, including illegal gambling, and their potential for gambling problems is a source of concerns for public health authorities. As a consequence, more research is promptly needed in this area.

The use of gambling tracking data, widely acclaimed in recent years in research on online gambling given its ecological nature, could allow observing longitudinally changes in online gambling practices (both the raw gambling activity and risky behaviors) and in the use of responsible gambling (RG) tools due to the pandemic. Moreover, the combination of French and Swedish data will allow comparing two countries with very distinct politics regarding the pandemics, i.e. a lockdown in France in March - May 2020 and then in November - December 2020 compared to no lockdown in Sweden. Finally, gambling in women is on the rise and women display specific gambling behaviors, especially in early stages of the online gambling practice. The project will include the investigation of gender specificities both in the investigation of the impacts of the pandemic and in the comparison of French and Sweden gambling behaviors. Age, type of gambling activity and country (France / Sweden) will also be taken into account.


title: Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.

acronym: CrèchMV

summary: Direct DNA amplification, viral isolation and specific antibody measurement in saliva from children attending nursery in France Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

ReferenceType: derived

ReferenceCitation: Alain S, Garnier-Geoffroy F, Labrunie A, Montane A, Marin B, Gatet M, Grosjean J, Dufour V, Saugeras M, Postil D, Hantz S. Cytomegalovirus (CMV) Shedding in French Day-Care Centers: A Nationwide Study of Epidemiology, Risk Factors, Centers' Practices, and Parents' Awareness of CMV. J Pediatric Infect Dis Soc. 2020 Dec 31;9(6):686-694. doi: 10.1093/jpids/piz097.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Oxford University Press

lead_sponsor: University Hospital, Limoges


title: Survey for the Initial Treatment of Hypothyroidism in France

acronym: ORCHIDEE

summary: This observational survey with prospective and/or retrospective follow-up is designed to study practices for the initial treatment of hypothyroidism in France without modifying subject treatment.

lead_sponsor: Merck KGaA, Darmstadt, Germany


title: Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF

acronym: CCF

summary: The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.

ReferenceCitation: Sutter W, Duceau B, Vignac M, Bonnet G, Carlier A, Roussel R, Trimaille A, Pommier T, Guilleminot P, Sagnard A, Pastier J, Weizman O, Giordano G, Cellier J, Geneste L, Panagides V, Marsou W, Deney A, Karsenty C, Attou S, Delmotte T, Ribeyrolles S, Chemaly P, Gautier A, Fauvel C, Chaumont C, Mika D, Pezel T, Cohen A, Potier L; Critical COVID-19 France Investigators. Association of diabetes and outcomes in patients with COVID-19: Propensity score-matched analyses from a French retrospective cohort. Diabetes Metab. 2021 Jul;47(4):101222. doi: 10.1016/j.diabet.2020.101222. Epub 2020 Dec 31.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

evidence: oa repository (via free pdf)

license: cc-by

license_normalized: cc-by

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

lead_sponsor: French Cardiology Society

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

location_facility: Georges Pompidou European Hospital (AP-HP)

location_facility: Lille Catholic Institute Hospital Group, Lille


title: Are Potentially Avoidable Hospitalizations a Good Measure of Access To Primary Care in France?

acronym: HPE-LR

summary:
Potentially Avoidable Hospitalizations (Pah) Are Studied As An Indirect Measure Of Access To Primary Care And Of The Interface Between Primary And Secondary Care. A Previous Work Unveils Considerable Geographic Variation In The Rate Of Pah In France And Suggest That Primary Care Organization Might Play A Role In This Variation. However, A Limitation Of This Work Lies In The Lack Of Data On Actual Primary Care Utilization.

The Aim Of This Study Is To Analyze The Role Of Primary Care In The Variation Of Potentially Avoidable Hospitalizations At the Zip Code Level, In The French Region Languedoc-Roussillon-Midi-Pyrénées.

The investigator will implement An Ecological Approach In Which The Geographic Variation In The Rate Of Pah Is Analyzed In The French Region Lrmp, Year 2014. Age- And Sex-Adjusted Rate Of Pah By Zip Codes (N=612) Is Modeled Using A Spatial Regression Model.

appel_a_projets: PREPS

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: HPE LR

titre: Déterminants des variations Juridiques des hospitalisations potentiellement évitables (HPE) en Languedoc-Roussillon

discipline_principale: organisation des soins

nom_porteur: MERCIER

prenom_porteur: Grégoire


title: COVID-19 Critically Ill Patients' Evolution After Medical Transport by Train From Paris Intensive Care Units to West of France Intensive Care Units

acronym: TOCCIP

summary: Since early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients admitted in Intensive Care Units (ICU). It led to a saturation of the French health system, especially in some geographic areas such as East of France or Paris region. Therefore, authorities decided to transfer some critically ill patients from these crowded ICUs to less busy regional ICUs. it was done for the first time by medical train transportation. Knowing that the investigators lack experience regarding this type of medical evacuation, regarding the high number of transferred patients, with such a logistic effort, the investigators decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So far, there are no data in the literature regarding this topic.

study_start_date_type: Anticipated

lead_sponsor: Rennes University Hospital

location_facility:
CHU Tours
CHU Poitiers


title: Prospective/Retrospective Multicenter Registry to Examine the Real-world Performance in France of the E-vita OPEN PLUS Stent Graft System

acronym: FEOR

summary: The FEOR registry is undertaken to examine the real-world data of patients that were treated with the E-vita OPEN Plus Stent Graft System under routine care in France. This registry is a requirement of the Haute Autorité de Santé (HAS).

lead_sponsor: JOTEC GmbH

location_facility: Clinique de l'Infirmerie Protestante à Lyon

location_facility: Rennes Pontchaillou University Medical Centre

intervention_type: Device


title: Evaluation of the Vaccination Coverage in a Prospective Cohort of Cirrhotic Patients Followed in the General Hospitals in France in 2021 and in 2022.

acronym: VACCIR

summary: the purpose of this study is to estimate vacinal coverage against hepatitis A and B viruses, pneumococcus, diphtheria/tetanos and poliomyelitis, influenza virus and covid in cirrhotic patients followed in general hospitals of France and to show the

lead_sponsor: Centre Hospitalier Sud Francilien


title: Cabozantinib Real-life Use for Advanced Renal Cell Carcinoma in France: a Retrospective Descriptive Non-interventional Study of 2 Cohorts.

acronym: CABOREAL

summary: The primary objective of the study is to describe the real-life conditions of use and exposure of cabozantinib in France in two cohorts defined by their treatment initiation period.

ReferenceCitation: Albiges L, Flechon A, Chevreau C, Topart D, Gravis G, Oudard S, Tourani JM, Geoffrois L, Meriaux E, Thiery-Vuillemin A, Barthelemy P, Ladoire S, Laguerre B, Perrot V, Billard A, Escudier B, Gross-Goupil M. Real-world evidence of cabozantinib in patients with metastatic renal cell carcinoma: Results from the CABOREAL Early Access Program. Eur J Cancer. 2021 Jan;142:102-111. doi: 10.1016/j.ejca.2020.09.030. Epub 2020 Nov 27.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

lead_sponsor: Ipsen


title: Trans&VIH: National Survey About Trajectory and Life Conditions of HIV Trans People in France

acronym: Trans&VIH

summary: TRANS&VIH is a national survey that will explore condition of vulnerability and trajectory of transgender people living with HIV. To fulfill this purpose, clinical data from medical registry and socio-behavioral information collected through questionnaire, will help to explore this questions about vulnerability and condition of transgender people living with HIV.

ReferenceCitation: Mora M, Rincon G, Bourrelly M, Maradan G, Freire Maresca A, Michard F, Rouveix E, Pannetier J, Leriche D, Alain T, Yazdanpanah Y, Michels D, Spire B. Living conditions, HIV and gender affirmation care pathways of transgender people living with HIV in France: a nationwide, comprehensive, cross-sectional, community-based research protocol (ANRS Trans&HIV). BMJ Open. 2021 Dec 16;11(12):e052691. doi: 10.1136/bmjopen-2021-052691.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_normalized: HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

lead_sponsor: ANRS, Emerging Infectious Diseases

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


title: APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study

summary: The purpose of this study is to evaluate the APIXABAN use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation in Real-Life Setting in France, data from SNIIRAM (French data base).

lead_sponsor: Bristol-Myers Squibb

intervention_type: Drug


title: Drug Wastage : Observational Study in the Operating Rooms of France

acronym: GAME-OvBLOC

summary:
Environmental awareness is leading medical field to question its responsibility and possibilities for action.

Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice this is not systematic. Moreover, data on drug wastage in the operating rooms by anesthesia department are rare.

The GAME-OvBLOC observational study aim to evaluate drug wastage in the operating rooms by anesthesia department in France and to propose ways of improving health care practices.

ReferenceType: background

ReferenceCitation: McGain F, Muret J, Lawson C, Sherman JD. Environmental sustainability in anaesthesia and critical care. Br J Anaesth. 2020 Nov;125(5):680-692. doi: 10.1016/j.bja.2020.06.055. Epub 2020 Aug 12.

ReferenceCitation: Barbariol F, Deana C, Lucchese F, Cataldi G, Bassi F, Bove T, Vetrugno L, De Monte A. Evaluation of Drug Wastage in the Operating Rooms and Intensive Care Units of a Regional Health Service. Anesth Analg. 2021 May 1;132(5):1450-1456. doi: 10.1213/ANE.0000000000005457.

ReferenceCitation: Mankes RF. Propofol wastage in anesthesia. Anesth Analg. 2012 May;114(5):1091-2. doi: 10.1213/ANE.0b013e31824ea491. Epub 2012 Mar 13.

ReferenceCitation: Ramstrom H, Martini S, Borgendahl J, Agerstrand M, Larfars G, Ovesjo ML. Pharmaceuticals and Environment: a web-based decision support for considering environmental aspects of medicines in use. Eur J Clin Pharmacol. 2020 Aug;76(8):1151-1160. doi: 10.1007/s00228-020-02885-1. Epub 2020 May 9.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_country: Mayotte Guadeloupe Monaco France

location_facility: Centre Hospitalier Intercommunal de Villeneuve Saint Georges

location_facility: CHU de Lille - Hôpital Jeanne de Flandre

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Centre Hospitalier de Brive-la-Gaillarde

location_facility: Centre Hospitalier de Charleville-Mézières

location_facility: CHU de Bordeaux - Groupe hospitalier Pellegrin

location_facility: Centre Hospitalier Intercommunal Castres-Mazamet

location_facility: Centre Hospitalier de l'Agglomération Montargoise

location_facility: Hôpital NOVO - Site de Beaumont-sur-Oise

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

location_facility: Centre Hospitalier Départemental de Vendée


type: Registry Identifier

title: A reTrOspective Study on Patient's Data From the French Cemiplimab Cohort ATU Programs Compared to Standard of Care in France

acronym: TOSCA

summary:
Primary Objective:

-Assess the effectiveness of cemiplimab versus other available systemic therapies in patients up to 2018 or say historical system organ class (SOC) with metastatic or locally advanced cutaneous Squamous Cell Carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, on overall survival (OS).

Secondary Objectives:

Assess Progression Free Survival (PFS)
To assess Duration of Response (DOR)
To assess Objective Response Rate (ORR)
To describe adverse events leading to treatment interruptions and deaths

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals


title: Opinions and Representations of Advanced Practice Nurses (IPA) in Nephrology in France on Clinical Research

acronym: EBIpa

summary: This single-center study will identify the representations and opinions of Advanced Practise Nurses (IPA) in nephrology in the Auvergne Rhône Alpes (AURA) region about clinical research. The study will consist of individual semi-directive interviews with Advanced Practise Nurses (IPA).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Post-Market Study of the Argus® II Retinal Prosthesis System - France

summary: This is a post-market study of the Argus II Retinal Prosthesis System. The study is being conducted in France. The objective of the study is to obtain data to further demonstrate the effectiveness and evaluate the safety of Argus II System in patients with retinitis pigmentosa who have a bare light perception or worse in both eyes.

lead_sponsor: Second Sight Medical Products

location_facility: Centre hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Neuroendocrine Tumors of Patients Aged of 75 y or Over in the West of France

acronym: TANGO

summary:
Neuroendocrine cancer remains a poorly known entity. Comprehensive treatment is multidisciplinary involving surgery, radiological and nuclear medicine, and medical. A national network for the management of sporadic and hereditary malignant neuro-ENdocrine Tumor (RENATEN) is in charged of coordinating this specific care. This is part of the French National Cancer INstitute (INCa) Rare Cancer Plan.

The project is in the form of an analysis of elderly population (75 years or over) with a diagnosis of neuroendocrine cancer in the western part of the France (Brittany, Pays de Loire, Normandy, Center and a part of New Aquitaine areas) representing a population of more than 12 millions of inhabitants. Oncogeriatric evaluations, specialized meetings, ...would be analysed in order to improve the care of rare cancer patients.

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Novartis


title: Causes, Analysis of the Sub-evaluating Coronary Syndromes Acute and Disparities in France in Women

acronym: CASSANDRE

summary:
Despite efforts of learned societies, community cardiology and more generally of most players in the health, cardiovascular diseases continue to be the leading cause of death among women in France and all over the Western world, there where they fell to second place among men. Clinical practice and the disparity between the sexes are still insufficiently known.

Multicenter observational study on a cross-week comparative basis with men

ReferenceCitation: WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available. Erratum In: Circulation. 2010 Mar 30;121(12):e260. Stafford, Randall [corrected to Roger, Veronique L]. Circulation. 2011 Oct 18;124(16):e425.

ReferenceCitation: Stramba-Badiale M, Fox KM, Priori SG, Collins P, Daly C, Graham I, Jonsson B, Schenck-Gustafsson K, Tendera M. Cardiovascular diseases in women: a statement from the policy conference of the European Society of Cardiology. Eur Heart J. 2006 Apr;27(8):994-1005. doi: 10.1093/eurheartj/ehi819. Epub 2006 Mar 7.

ReferenceCitation: Bairey Merz CN, Shaw LJ, Reis SE, Bittner V, Kelsey SF, Olson M, Johnson BD, Pepine CJ, Mankad S, Sharaf BL, Rogers WJ, Pohost GM, Lerman A, Quyyumi AA, Sopko G; WISE Investigators. Insights from the NHLBI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study: Part II: gender differences in presentation, diagnosis, and outcome with regard to gender-based pathophysiology of atherosclerosis and macrovascular and microvascular coronary disease. J Am Coll Cardiol. 2006 Feb 7;47(3 Suppl):S21-9. doi: 10.1016/j.jacc.2004.12.084.

ReferenceCitation: Lerner DJ, Kannel WB. Patterns of coronary heart disease morbidity and mortality in the sexes: a 26-year follow-up of the Framingham population. Am Heart J. 1986 Feb;111(2):383-90. doi: 10.1016/0002-8703(86)90155-9.

ReferenceCitation: Michos ED, Nasir K, Braunstein JB, Rumberger JA, Budoff MJ, Post WS, Blumenthal RS. Framingham risk equation underestimates subclinical atherosclerosis risk in asymptomatic women. Atherosclerosis. 2006 Jan;184(1):201-6. doi: 10.1016/j.atherosclerosis.2005.04.004.

ReferenceCitation: Kwok Y, Kim C, Grady D, Segal M, Redberg R. Meta-analysis of exercise testing to detect coronary artery disease in women. Am J Cardiol. 1999 Mar 1;83(5):660-6. doi: 10.1016/s0002-9149(98)00963-1.

ReferenceCitation: Mieres JH, Shaw LJ, Arai A, Budoff MJ, Flamm SD, Hundley WG, Marwick TH, Mosca L, Patel AR, Quinones MA, Redberg RF, Taubert KA, Taylor AJ, Thomas GS, Wenger NK; Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease: Consensus statement from the Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Circulation. 2005 Feb 8;111(5):682-96. doi: 10.1161/01.CIR.0000155233.67287.60. Epub 2005 Feb 1.

ReferenceCitation: Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. doi: 10.1161/CIRCULATIONAHA.107.688101. No abstract available.

ReferenceCitation: Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, Pollack C, Gibler WB, Ohman EM, Peterson ED; CRUSADE Investigators. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes. JAMA. 2005 Dec 28;294(24):3108-16. doi: 10.1001/jama.294.24.3108. Erratum In: JAMA. 2006 Feb 8;295(6):628.


title: Prospective Cohort of Patients With Hepatocellular Carcinoma in France

acronym: CHIEF

summary:
Hepatocellular carcinoma (HCC) occurs in 90% of cirrhosis primary liver cancers. In France, 8,500 new cases of HCC occur each year, and about 8,000 deaths per year are related to this cancer. The 5-year survival rate is 10%, one of the lowest survival rates of all cancer types. HCC raises a number of major challenges: HCC is discovered at a curable stage in only 25% of cases, reflecting the marked delay in the diagnosis of early stages. The state of knowledge about HCC is well behind that of other cancers (no biomarker, complex carcinogenesis, influence of the aetiology, poorly valorised data, etc.). Rapid technological progress requires large-scale studies to evaluate new diagnostic and therapeutic modalities.

The CHIEF project constitutes a common basis knowledge for research project using prospectively collected data in patients with HCC, regardless of the cause and stage of the cancer.

This project is a Multicentre longitudinal observational study of patients with HCC with prospective data collection on inclusion and patient follow-up. Constitution of a biological resources collection. 5,000 patients will be included over 2 years with a follow-up of patients of 5 years.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators: Société Nationale Française de Gastroentérologie

collaborators: Association Française pour l'Etude du Foie (AFEF)

collaborators: Federation Francophone de Cancerologie Digestive

collaborators: Association Nationale des Hépato-Gastroentérologues des Hôpitaux Généraux (ANGH)

collaborators: Groupe Coopérateur multidisciplinaire en Oncologie (GERCOR)

collaborators: Club de Réflexion des Cabinets et Groupes d'Hépato-Gastroentérologie (CREGG)

collaborators: Association de Chirurgie Hépato-Bilio-Pancréatique et de Transplantation (ACHBT)

collaborators: Societe Francaise de Radiotherapie Oncologique


title: Risk Factors Associated With the Global Burden of Disease in Reunion Island and Comparison With Mainland France and Indian Ocean Countries

summary: The question posed by this project is that of the regional estimate of the relative importance of the risk factors of the main pathologies. Our hypothesis is that these risk factors are of different relative importance in Reunion Island compared to metropolitan France.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France: a Multicentric Randomized Controlled Study

summary: As mental health care shifted from state psychiatric hospitals to the community in France and western countries, the mental health system became inevitably involved in housing as it strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers found themselves unable to find stable living in the community and struggling with addictions, they became a significant subgroup within a larger homeless population, which has received increasing policy attention over the past three decades. There are two distinct service models for adults who have severe mental illness and are homeless: the residential continuum model and the Housing First model.

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Loubiere S, Lemoine C, Boucekine M, Boyer L, Girard V, Tinland A, Auquier P; French Housing First Study Group. Housing First for homeless people with severe mental illness: extended 4-year follow-up and analysis of recovery and housing stability from the randomized Un Chez Soi d'Abord trial. Epidemiol Psychiatr Sci. 2022 Feb 7;31:e14. doi: 10.1017/S2045796022000026.

repositories_concat: PubMed Central

publisher_dissemination: Cambridge University Press

ReferenceCitation: Tinland A, Loubiere S, Cantiello M, Boucekine M, Girard V, Taylor O, Auquier P. Mortality in homeless people enrolled in the French housing first randomized controlled trial: a secondary outcome analysis of predictors and causes of death. BMC Public Health. 2021 Jul 2;21(1):1294. doi: 10.1186/s12889-021-11310-w.

publisher_dissemination: Springer-Nature

ReferenceCitation: Loubiere S, Tinland A, Taylor O, Loundou A, Girard V, Boyer L, Auquier P. Determinants of healthcare use by homeless people with schizophrenia or bipolar disorder: results from the French Housing First Study. Public Health. 2020 Aug;185:224-231. doi: 10.1016/j.puhe.2020.05.019. Epub 2020 Jul 14.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

ReferenceCitation: Fond G, Boyer L, Boucekine M, Girard V, Loubiere S, Lenoir C, Auquier P, Tinland A; French Housing First Study Group. Illness and drug modifiable factors associated with violent behavior in homeless people with severe mental illness: results from the French Housing First (FHF) program. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 2;90:92-96. doi: 10.1016/j.pnpbp.2018.11.006. Epub 2018 Nov 10.

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

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

repositories_concat: HAL

unpaywall_oa_status: green

ReferenceCitation: Rhenter P, Tinland A, Grard J, Laval C, Mantovani J, Moreau D, Vidaud B, Greacen T, Auquier P, Girard V. Problems maintaining collaborative approaches with excluded populations in a randomised control trial: lessons learned implementing Housing First in France. Health Res Policy Syst. 2018 Apr 19;16(1):34. doi: 10.1186/s12961-018-0305-1.

repository_institution: PubMed Central - Europe PMC

license: public-domain

license_normalized: public-domain

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

ReferenceCitation: Tinland A, Zemmour K, Auquier P, Boucekine M, Girard V, Loubiere S, Fond G, Boyer L; French Housing First Study Group. Homeless women with schizophrenia reported lower adherence to their medication than men: results from the French Housing First experience. Soc Psychiatry Psychiatr Epidemiol. 2017 Sep;52(9):1113-1122. doi: 10.1007/s00127-017-1411-z. Epub 2017 Jun 27.

ReferenceCitation: Tinland A, Fortanier C, Girard V, Laval C, Videau B, Rhenter P, Greacen T, Falissard B, Apostolidis T, Lancon C, Boyer L, Auquier P. Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial. Trials. 2013 Sep 24;14:309. doi: 10.1186/1745-6215-14-309.

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

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France

acronym: ARTEMIS

summary: The purpose of this study is to describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis.

lead_sponsor: Chugai Pharma France

sponsor_collaborators:
Chugai Pharma France
ITEC Services


title: Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application: an Observational Study

acronym: SourceCOVID

summary:
A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). This virus causes a pathology ranging from simple flu-like symptoms in 80% of cases to acute respiratory distress syndromes requiring intensive care in 5% of cases and a death rate of 1.4 to 4% of cases.

Viral contamination is airborne and fecal A first epidemic wave crossed France in March / April 2020 then a second in October / November with a source of contamination which began in mid-August 2020. The sources of propagation are not well known (what places, what times, what contacts…? ) In the context of the health crisis linked to the coronavirus, knowledge of the sources of propagation of this 2nd wave is an important issue to guide end of lockdown and second lockdown policies.

ReferenceCitation: Denis F, Septans AL, Le Goff F, Jeanneau S, Lescure FX. Analysis of COVID-19 Transmission Sources in France by Self-Assessment Before and After the Partial Lockdown: Observational Study. J Med Internet Res. 2021 May 4;23(5):e26932. doi: 10.2196/26932.

publisher_dissemination: JMIR Publications

lead_sponsor: Weprom

sponsor_collaborators: Weprom Kelindi


title: Use and Misuse of Domperidone in Parkinson's Disease in France - Observational

acronym: DUMP-obs

summary:
Parkinson disease is the second most frequent neurodegenerative disease after Alzheimer disease and affect 1% of the population over 60 years. The treatment of PD is based on dopamine replacement therapies (DRT). Nausea is the most frequent adverse event whatever the drug, occurring in 30-40% of patients at the initiation of DRT.

Domperidone, a dopamine D2 receptor antagonist with antiemetic properties, does not readily cross the blood-brain barrier, allowing its used in PD. Domperidone may prolong the duration of the QT interval in predisposed patients, and has been associated with proarrhythmia and arrhythmic deaths. Arrhythmias, sudden death and cardiac arrest were reported with high intravenous doses which has led to withdraw of the parenteral form of the drug in 1984. Two case control studies found an increased risk of sudden death associated with domperidone use. In these reports, the increased risk was depending on age, dose, and the use of domperidone in combination with CYP3A4 inhibitors. Following the discussion created by this alert, the PRAC of the EMA has issued recommendations restricting domperidone use to patients younger than 60 years at doses below 30 mg/day and for a short period (7 days).

Because there is no alternative antiemetic drug to be used in PD, domperidone is commonly prescribed as a preventive therapy in most PD patients initiating DRT. In this population, usually older than 60 years, doses of 60 or 80 mg/day are commonly prescribed, for at least 2 months of the DRT escalating dose period or longer. A particular "niche" of domperidone misuse might be patients treated with continuous subcutaneous administration of apomorphine, a second line therapy in PD, inducing severe and prolonged nausea in almost all patients. Little is known about the use of domperidone in PD in France, but misuse of domperidone in PD patients is probably very high. Data collected from two French PD cohorts, COPARK and DIGPD, showed that 8-14% of PD patients were treated with domperidone.

The aim of this proposal is to conduct a cross sectional observational study performed in consecutive patients followed by the 24 PD expert centers of the NS Park network, general hospitals and private practice neurologists, to describe the actual use of domperidone in PD patients.

status: Terminated

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Characteristics of Health Insurance Beneficiaries With a Triptan Prescription in the Grand Est Region, France, in 2018-2019 - PASENREGE Study

acronym: PASENREGE

summary:
The high frequency of migraine contrasts with the disparity of its management. The FRAMIG 3 study, carried out in France on the basis of the definition criteria of migraine of the IHS 2004 classification, identified, on the basis of a questionnaire of a representative sample of the general population of 10532 people, 11.2% of the people meeting the criteria of defined migraine and 10.1% of the criteria of probable migraine. Only 40.2% knew they had migraine. 50% used self-medication. Although available since the late 1990s as an effective and specific treatment for migraine attacks, 7.5% of migraineurs in the FRAMIG 3 study used a triptan. In 2003-4, 1.5% of the 1,793,000 inhabitants of Alsace had received at least one prescription for triptans over a one-year period. 1.9% of them were considered overconsumers (greater than or equal to 144 doses/year). More than 10 years later, another population-based study, using data from the French national health agency, identified 1.8% of insured persons receiving a triptan. Several migraine prophylactic treatments have been shown to be effective in patients with frequent or severe migraine attacks, or who do not respond to crisis treatment, or who claim poor quality of life due to migraine, but only 50% of candidates for such prophylactic treatment were receiving it. Only 1.5% of migraine patients in the FRAMIG 3 study were taking prophylaxis. Quality of life was impaired in 57% of migraineurs in the USA and in 28% of French migraineurs. In Ali's study (Ali 2017), 6.9% of migraineurs had used a neurologist. A Brazilian study shows that the average delay of patients accessing a tertiary center was 17 years. As promising new prophylactic treatments become available, we wanted to study a population of migraineurs identified on the basis of a triptan prescription, in order to try to better identify the characteristics of this population, particularly in terms of analgesic consumption and use of specialized care.

The objective of this study was to describe the quantity of triptans dispensed to residents of the Grand Est region aged 12 years and older, between June 1, 2018, and June 1, 2019, based on health insurance data. The secondary objectives were to compare the characteristics of insured persons who had at least one triptan dispensing with those of other insured persons, and to compare the characteristics of insured persons by quantity of triptans dispensed.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Prevalence of Pathologic Gambling in the Workforce: a Cross-sectional Study in Brittany, France

acronym: PJPAP

summary:
Introduction: To date, very few studies about links between work and addictive disorders concern behavioral addictive disorders such as gambling. Such behaviours may be adaptative strategy for unsatisfied workers. The common physiopathology of addictive disorders allows us to hypothesize that it is possible that such troubles at work could promote gambling. Our aim was to evaluate the prevalence of gambling among workers and its links with work.

Patients and methods: We performed a descriptive cross-sectional monocentric study among all workers who consulted one physician between November 2016 and April 2017, from an occupational health service in Brittany, France. The first step was to ask whether they have gambled during the last year and if it was related to their occupation. The second step was a screening for risky gamblers (using the "Lie or Bet" questionnaire) among these and then to assess more precisely the severity (using the Indice Canadien du Jeu Excessif, ICJE questionnaire).


title: Use and Misuse of Domperidone in Parkinson's Disease in France - Dump Investigation

acronym: DUMP-invest

summary:
Parkinson disease is the second most frequent neurodegenerative disease after Alzheimer disease and affect 1% of the population over 60 years. The treatment of PD is based on dopamine replacement therapies (DRT). Nausea is the most frequent adverse event whatever the drug, occurring in 30-40% of patients at the initiation of DRT.

Domperidone, a dopamine D2 receptor antagonist with antiemetic properties, does not readily cross the blood-brain barrier, allowing its used in PD. Domperidone may prolong the duration of the QT interval in predisposed patients, and has been associated with proarrhythmia and arrhythmic deaths. Arrhythmias, sudden death and cardiac arrest were reported with high intravenous doses which has led to withdraw of the parenteral form of the drug in 1984. Two case control studies found an increased risk of sudden death associated with domperidone use. In these reports, the increased risk was depending on age, dose, and the use of domperidone in combination with CYP3A4 inhibitors. Following the discussion created by this alert, the PRAC of the EMA has issued recommendations restricting domperidone use to patients younger than 60 years at doses below 30 mg/day and for a short period (7 days).

Because there is no alternative antiemetic drug to be used in PD, domperidone is commonly prescribed as a preventive therapy in most PD patients initiating DRT. In this population, usually older than 60 years, doses of 60 or 80 mg/day are commonly prescribed, for at least 2 months of the DRT escalating dose period or longer. A particular "niche" of domperidone misuse might be patients treated with continuous subcutaneous administration of apomorphine, a second line therapy in PD, inducing severe and prolonged nausea in almost all patients. Little is known about the use of domperidone in PD in France, but misuse of domperidone in PD patients is probably very high. Data collected from two French PD cohorts, COPARK and DIGPD, showed that 8-14% of PD patients were treated with domperidone.

The aim of this proposal is to investigate the practices and beliefs of French neurologists regarding use and misuse of domperidone in PD, by a qualitative approach.


title: Gynecology Beyond Gender: Exploration and Identification of Potential Obstacles and Levers in France for Cervical Cancer Screening in Transgender Men, by Conducting an Opinion Survey in a Specific Population

acronym: GYDECAT

summary:
In France, cervical cancer screening is the subject of a national screening programme organized for all asymptomatic individuals aged 25 to 65 years with a cervix. The latter contributes greatly to the prevention and early treatment of this disease, whose public health challenge is recognized worldwide.

One of the objectives of this programme is to reduce inequalities in access. Transgender men, i.e. individuals assigned to the female gender at birth but identifying with the male gender, are concerned by this screening as long as they still have a cervix, according to the same modalities as for cisgender women.

However, they are often excluded from health care, including organized screening programs. Gender change in civil status is one of the obstacles.

The provision of gynaecological care is sometimes inadequate. The lack of knowledge of health professionals and the problems of discrimination that transgender people may face reduce the chances of having equitable access.

This survey aims to explore the perception that transgender men have of cervical cancer screening and to identify the challenges they face, the obstacles and the levers to access this prevention program.

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Drug Wastage : Observational Study in Intensive Care Units in France

acronym: GAME-OVER

summary:
Environmental awareness leads medical field to question its responsibility and possibilities for action.

Drug residues can have a major environmental impact as per their bioaccumulation, toxicity and persistence characteristics, depending on where they are discarded. In France, drug residues should be disposed of by incineration, but in practice, this is not systematic. Moreover, data on drug wastage in Intensive Care Units (ICU) are rare.

GAME-OVER observational study aims to evaluate drug wastage in ICU in France and to suggest ways to improve health care practices.

sponsor_collaborators: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_country: Mayotte Monaco France

location_facility: Centre Hospitalier de Charleville-Mezieres

location_facility: Centre Hospitalier Bretagne Atlantique de Vannes


title: Study of People's Profile Living in France Who Could be Interested in the Use of a Nanohydroxyapatite Toothpaste

summary:
Nano-hydroxyapatite is an interesting candidate to be a substitute for fluor in toothpastes or a complement to fluorides in order to prevent caries. The objective of this transversal descriptive study is to evaluate the profiles of people living in France who could be interested in using a nano-hydroxyapatite based toothpaste.

Participants in this transversal descriptive study have been chosen by a self-administered method. Before answering 16 questions, the participants were asked to watch a short video describing the main concepts to know about fluoridated toothpastes and nano-hydoxyapatite toothpastes. Pros and cons of each one them were mentioned. In order to compare the answers, pivot tables have been produced.

time_perspective: Other

lead_sponsor: University Hospital, Montpellier


title: Leisure Physical Activity and Barriers to Physical Activity Among Members and Users of APF France Handicap

summary:
People with disabilities are less physically active than the general population. Currently, the level of leisure physical activity of people who are members or users of APF France handicap and their barriers to physical activity are unknown. The APF France handicap association is a national movement for the defense and representation of people with disabilities and their families. It represents all types and severities of disability.

The objective of this study is to describe the level of leisure physical activity of people who are members or users of APF France handicap and their barriers to physical activity.

lead_sponsor: Institut de Sante Parasport Connecte Synergies

collaborators: Association des Paralysees de France (APF)


title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in France

acronym: OPALE

summary: This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.

ReferenceCitation: Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.

oa_colors: green hybrid

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

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

publisher_dissemination: Wiley

lead_sponsor: AbbVie

location_facility: Hopital Bichat-Claude Bernard /ID# 149246

location_facility: Centre Hospitalier D'Avignon /ID# 151098

location_facility: CHU de Besancon - Jean Minjoz /ID# 145884

location_facility: Hopital Universitaire Purpan /ID# 150141

location_facility: Centre Hospitalier D'Avignon /ID# 151343

location_facility: Hopital Bichat Claude Bernard /ID# 145886

location_facility: Centre Hospitalier Universitai /ID# 147568

location_facility: Centre Hospitalier de Libourne /ID# 145564

location_facility: Charles Nicolle Hosp chu rouen /ID# 145557

location_facility: Ctr Consultations La Sauvegard /ID# 147236

location_facility: Cabinet Medical, Dr. Verdier, /ID# 145575

location_facility: Hopital Universitaire Purpan /ID# 145869

location_facility: CH Des Deux Vallees Longumeau /ID# 149336

location_facility: Cabinet Medical, Dr. Constant, /ID# 145561

location_facility: CHU Strasbourg Hautepierre Hos /ID# 147246

location_facility: Centre Hospitalier Victor Dupo /ID# 147241

location_facility: Cabinet Medical, Boyer Darrigr /ID# 145562

location_facility: Ctre Hospitalier de Tourcoing /ID# 145568

location_facility: CHR Orleans - Hopital de la Source /ID# 147250

location_facility: CHU de Grenoble - Albet Michal /ID# 145881


title: Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic

summary: Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.

collaborators:
Centre Hospitalier de Beauvais
Central Hospital Saint Quentin
Centre Hospitalier Compiègne

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: The ESPERES Prospective Cohort of Healthcare Workers in France: Study on COVID-19 Vaccine and the COVID-19 Pandemic

summary:
This is the first study performed within the ESPERES cohort, related to prevention against COVID-19, in particular vaccination against COVID-19 and more broadly on the COVID-19 pandemic.

ESPERES is a national prospective e-cohort study providing a resource for collecting information on healthcare workers (HCWs) currently working in France. The overall goal of ESPERES is to develop the infrastructure necessary to create and engage a community of HCWs who may be eligible for participation in future research studies. ESPERES is set up to answer research questions, in the field of prevention for HCWs, prevention for their own health, that of their relatives, their colleagues, and users of the hospital. These research questions will be carried out in the context of specific subsequent studies.


title: Retrospective Study to Describe Carfilzomib Use on Patients With Relapsed Multiple Myeloma in France in the Context of Carfilzomib Nominative Expanded Access and Compassionate Use

acronym: CARMYN

summary: This retrospective multicenter observational study will provide real-life efficacy and tolerance data for patients with relapsed multiple myeloma (RMM) treated with carfilzomib in the context of nominative expanded access and compassionate use in France, and will allow to evaluate healthcare practices from data obtained during the use of carfilzomib for routine care. Nominative expanded access was open in February 2014 and stopped in march 2016, then relayed by the compassionate program (march 2016- February 2017).

lead_sponsor: Centre Hospitalier le Mans


title: Apixaban in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France - Cross-sectional Study

summary:
The present study will be conducted to assess the following research questions in real-life conditions in France:

What are the patient and disease characteristics, comorbidities and treatment history in NVAF patients initiating a new Anticoagulant (AC) treatment, according to treatment currently available and prescribed (apixaban, other NOACs, VKAs), and are the AC-naive patient profiles different from one treatment pattern to another when initiating a new AC treatment?

What are the HCP's reasons for discontinuing the previous AC strategy for initiating and choosing the newly initiated AC treatment in NVAF patients?

What are the conditions of newly-initiated apixaban prescriptions in NVAF patients: prescriber, proportion of naïve/experienced patients, daily dosage and number of daily doses?

lead_sponsor: Bristol-Myers Squibb


title: Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France

acronym: FAST

summary: Evaluation of antiretroviral treatment adherence using determination of Bictegravir, Emtricitabine and Tenofovir with new HIV patients in France

primary_purpose: Treatment

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses

location_facility: Hôpital Henri Mondor - Service d'Immunologie Clinique

location_facility: Hôpital Gui de Chauliac - Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Côte de Nacre - Service des Maladies Infectieuses


title: Clinical Characteristics of Patients Referred to a Substance Abuse Liaison Department in an Academic Hospital, France

acronym: AddictUrge

summary: The Coalition on Psychiatric Emergencies (CPE) stressed in 2016 that emergency providers were increasingly recognizing the important role of the Emergency Department (ED) in reducing adverse outcomes associated with untreated with substance abuse liaison department (SUDs). Additional research is required to close identified knowledge gaps and improve care of ED patients with SUD. Of the more than 4.5 million ED visits in 2009 in US for drug-related causes,34-32% involved alcohol use alone or in combination with other drugs. Few studies investigated the clinical characteristics of patients referred to an addiction liaison department in a general hospital. The present study will be retrospective in a sample of 700 patients consecutively admitted for addictive behaviors in the emergency department and in the Medicine or Surgery departments of the Amiens University Hospital Center, France.


title: Parental Compliance After Telephone Triage Advice During and After Confinement During the COVID-19 Epidemic in France

acronym: COVIDTEL

summary:
Novel Coronavirus disease 2019 (COVID-19) outbreak seriously challenges worldwide health care systems. The current climate of anxiety due to COVID-19 and home confinement limiting access to emergency departments (ED) have induced an increase of phone calls to the emergency call center "15" medical advices.

To determine if a pediatric telephone triage protocol may improve patient's pathways during COVID-19 outbreak, parental compliance is assessed after telephone advice, during and after home confinement (the end of home confinement in France was on May 11th 2020).

From 14th April 2020 to 7th June 2020, all calls received by the platform of telephone calls at Children's Lenval Hospital during open hours and open days are collected. For each call, symptoms are recorded by trained physicians and trained residents using a telephonic triage tool through a directed interview. A medical orientation is recommended to parents at the end of their call. Follow-up are conducted 2 to 4 days after with their consent by telephone interview in order to evaluate their compliance

status: Withdrawn

lead_sponsor: Fondation Lenval


title: Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease

acronym: COVCALL

summary: This epidemiological, transversal, cohort study aims to determine the potential influence of an active long-term hydroxychloroquine intake over the prevalence of a history of symptoms evocative of a COVID-19 infection in patients with a history of systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome or psoriatic arthritis, during the epidemic period in France. The information is gathered using a standardized questionnaire, by phone call.

ReferenceCitation: Guillaume D, Magalie B, Sina E, Imene SM, Frederic V, Mathieu D, Aurore M, Yoni G, Emma E, Charlotte B, Laura F, Alain S, Steven N, Pierre Z, Jean-Luc F, Romain C, Alice GD, Adrien M, Wassim G, Pierre-Emmanuel R, Christophe P, Catherine C, Kevin B, Thomas S, Damien G. Antirheumatic Drug Intake Influence on Occurrence of COVID-19 Infection in Ambulatory Patients with Immune-Mediated Inflammatory Diseases: A Cohort Study. Rheumatol Ther. 2021 Dec;8(4):1887-1895. doi: 10.1007/s40744-021-00373-1. Epub 2021 Sep 16.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Multicenter Retrospective Study From 5 Hemostasis Treatment Centers in Western France: Severe Hemorrhagic Treated Occurrences' Patterns and Global Substitutive COagulation Factors THerapy in the Inherited Von WILLebrand Disease

summary:
Von Willebrand disease (VWD) is the most common constitutional bleeding disorder in the world, caused by missing or defective von Willebrand factor (VWF). In France, VWD affects approximatively 7,000 patients.

There are many types of VWD. The severest forms are characterized by the occurrence of extremely serious bleedings, requiring in-stays with clotting factors (CF) treatments in specialized hospital units and/or an ambulatory substitutive therapy; both of them are highly expensive.

In France, Hemostasis Treatment Centers (HTC) have the opportunity to record these kinds of data in a database called NHEMO (Net-Hemostasis = care database for constitutional bleeding disorders). Further ahead, the data can be coded, dumped into and extracted from the research database BERHLINGO and analyzed.

The HOPSCOTcH-WILL study will be a retrospective, non-interventional, multicenter (national) cohort study & will provide an overview of the real-life management of patients with VWD in western France requiring a substitutive treatment with VWF, as well as a description of the characteristics of their hemorrhagic events.

Model : Observationnal, real world evidence study. Time Horizon : 2015-2018. HTC (France): Western University Hospitals (BERHLINGO network) = Nantes University Hospital (promotion), Angers University Hospital, Brest University Hospital, Le Mans Regional Hospital & Rennes University Hospital

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
CHU de Brest
University Hospital, Angers
CH Le Mans
Rennes University Hospital

location_facility:
Nantes University Hospital
Angers University Hospital
Le Mans Regional Hospital
Brest University Hospital
Rennes University Hospital


title: Identification of the Most Suitable Questionnaire to Assess the Sexual Function of Women Living in France After Colorectal Cancer Surgery

acronym: EVAS-CCR

summary:
Sexual quality of life is rarely mentioned by physicians during follow-up consultations, even though it is the source of a significant deterioration in quality of life (QOL).

The assessment of female sexual function is based on self-administered questionnaires. Four questionnaires have been translated and validated in French: FSFI, PISQ-IR, PISQ-12, BISF.

The objective of this project is to determine which questionnaire is acceptable and adapted to a cohort of women living in France who have undergone treatment for rectal cancer

lead_sponsor: University Hospital, Limoges


title: Medical Treatment of Solid Tumors at the Lyon University Hospital Cancer Institute During the First Wave of COVID-19 in France: A Conservative Approach

acronym: COCA

summary:
An article to present how cancer patients were taken in charge at Lyon University Hospital Cancer Institute (France) during the first peak of the COVID-19 pandemic between March and May 2020 is under writing.

It will present strategies that were set-up to avoid cross-contamination between patients and caregivers, patients treatment adaptation (timing, dosage,..) and how consultations, multidisciplinary team meetings, surgical procedures and clinical trials were impacted.

Part of this article will also illustrate the characteristics of patients with a solid tumor(s) that have been hospitalized during this timeframe for the COVID-19. How cancer type and stage affect Covid severity and mortality.will be described for a small sample of patients (44). These qualitative figures will be compared to literature current state of the art.

lead_sponsor: Hospices Civils de Lyon


title: Current Incidence and Treatments Performed of Fractures of the Acetabulum and Pelvis in France in 2013

acronym: ACETABULUM

summary: Fractures of the acetabulum and pelvis are serious injuries to vital prognostic can play in cases of severe bleeding. In all cases the functional is a major issue with a potential reach of walking ability and maintaining the seated and standing positions. The treatment of such lesions requires management to a specialist, or the ability to use such centers for advice or transferring patients. This organization was recommended after the symposium of the French Society of Orthopedic Surgery (SOFCOT) in 2009. With the aging population, the incidence and clinical features of these fractures have evolved to worsening the functional prognosis. Club Basin acetabulum, body SOFCOT, wants to achieve an observational study assessing needs and practices at national and regional level. The long-term objective is to propose a regional organization of care of these patients in order to reduce morbidity and mortality associated.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Feasibility Study on Estimating the Prevalence and Management of Stage 4 Chronic Kidney Disease in Adults Via Laboratories and Nephrologists in the Gard, France

acronym: MRC-Gard

summary: The main objective of this study is to evaluate the feasibility of estimating the prevalence of stage 4 and 5 chronic kidney disease in the Gard department of France from data obtained via laboratory databases. To verifiy if the demand for care thus authenticated by laboratory tests is adapted to nephrology care delivery, as recommended by the French High Authority of Health (HAS), laboratory data will be compared with those of patients seen by nephrologists in the department.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: AIDER - Unité de Dialyse de Nîmes, CHU Carémeau


title: CIRSE Registry for SIR-Spheres in France (CIRT-FR)

acronym: CIRT-FR

summary: Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

ReferenceCitation: Loffroy R, Ronot M, Greget M, Bouvier A, Mastier C, Sengel C, Tselikas L, Arnold D, Maleux G, Pelage JP, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, Urdaniz M, Kaufmann N, Bilbao JI, Helmberger T, Vilgrain V; CIRT-FR Principal Investigators. Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France. Cardiovasc Intervent Radiol. 2021 Jan;44(1):36-49. doi: 10.1007/s00270-020-02643-x. Epub 2020 Sep 25.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Université de Lausanne - SERVAL

repositories:
LIRIAS (KU Leuven)
PubMed Central
serval.unil.ch

repositories_concat: LIRIAS (KU Leuven);PubMed Central;serval.unil.ch

repositories_institution:
KU Leuven - Lirias
Université de Lausanne - SERVAL

lead_sponsor: Cardiovascular and Interventional Radiological Society of Europe

location_facility:
Centre Léon Bérard
Hôpital Henri Mondor
CHU de Grenoble Alpes
CHU de Lyon
Institut Paoli-Calmettes
CHU de Poitiers
CHRU de Strasbourg
CHU de Nimes
CHU d'Angers
Hôpital Beaujon
Chu de Dijon
Institut Gustave Roussy
CHU de Bordeaux


title: Evaluation of the Evolution of the Patient Care Pathway in the Context of the Implementation of the DOuBLE EMIcizumab Dispensing Circuit in France

summary:
Haemophilia A (HA) is a rare constitutional haemorrhagic disease whose drug management is based on the use of chronic lifelong replacement therapy. The occurrence of an inhibitor is a dreaded complication that impacts conventional management, consisting in using factor VIII (FVIII)-based replacement therapy, most often for prophylaxis. Although effective, these treatments can only be administered intravenously, leading to accessibility constraints and significant mental burden for patients and their relatives.

Before June 15, 2021 in France, the emicizumab (HEMLIBRA®) was available only in hospital pharmacies for the prevention or reduction of bleedings. The introduction of the dual dispensing circuit in hospital or community pharmacies, left to patient's choice, is effective from this date. These changes have important organizational consequences for patients and health professionals alongside the pathway of care. Therefore, the effectiveness of this new organization requires to be evaluated with a national French study, called PASO DOBLE DEMI. The aims of this study are twofold :

I. To evaluate the direct impact of the training programs provided to the new placeholders of the dispensing circuit ; the community pharmacists, II. To evaluate satisfaction of patients or their relatives regarding the emicizumab treatment whether they chose dispensing in the community pharmacy, or kept the dispensing at the hospital pharmacy.

The methodology was based on the 4-level of the Kirkpatrick's evaluation model; 1) the immediate reaction of community pharmacists following the trainings (Reaction), 2) their knowledge acquisition (Learning), 3) their professional practice (Behavior) and 4 ) the patients' satisfaction related to their treatment whether dispensing in hospital or in community pharmacies (Results).

The PASO DOBLE DEMI I was based on the first three levels of the evaluation model.


title: The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19

acronym: NeurochirCOVID

summary:
During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies and their limits, ethical reflection, and, how to pursue a distributive and quality medicine.

The restriction of conventional medical resources to our care activity (resuscitation, personnel, operating theatre, constraints linked to the risk of contamination...) is leading to a new medical organisation imposing new Covid-19 standards, the description of which seems essential to us.

A knowledge of the strategies to be adopted during a disaster health situation in order to continue providing care to the civilian population. How can we prevent the setting up of health care systems outside the cause of the health crisis? n triage medicine, Avoiding the "burn-out" of doctors struck by the health crisis.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Department of Neurosurgery - Strasbourg University Hospitals


title: Study of the Seroprevalence of SARS-CoV-2 in Hospital Staff in Strasbourg University Hospital, Strasbourg, France

acronym: SeroCoV-HUS

summary:
COVID-19 is a new emerging disease caused by infection with the SARS-CoV-2 coronavirus, with no specific therapeutic options.

Since the end of February 2020, the Strasbourg University Hospital (HUS) had faced a sudden increase of patients with COVID-19 resulted from a SARS-CoV-2 superspreading event (religious meeting). Infected individuals went to regional hospitals, and this led to a cluster of infected healthcare workers at the Strasbourg University Hospitals from the first week of March. To date, several hundred Strasbourg hospital workers have presented a SARS-CoV-2 infection confirmed by the RT-PCR test from a nasopharyngeal sample. Most of them developed a mild form of COVID-19.

It is important to understand how far the infection has spread in the hospital staff, and to which extent the individuals who have been infected develop antibodies against SARS-CoV-2.

design_allocation: Non-Randomized

ReferenceCitation: Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

publisher_dissemination: MDPI

location_facility: Hôpitaux Universitaires de Strasbourg - Centre d'Investigation Clinique - Nouvel Hôpital Civil et Hautepierre

intervention_type: Diagnostic Test


summary:
Haemophilia A (HA) is a rare constitutional haemorrhagic disease whose drug management is based on the use of chronic lifelong replacement therapy. The occurrence of an inhibitor is a dreaded complication that impacts conventional management, consisting in using factor VIII (FVIII)-based replacement therapy, most often for prophylaxis. Although effective, these treatments can only be administered intravenously, leading to accessibility constraints and significant mental burden for patients and their relatives.

Before June 15, 2021 in France, the emicizumab (HEMLIBRA®) was available only in hospital pharmacies for the prevention or reduction of bleedings. The introduction of the dual dispensing circuit in hospital or community pharmacies, left to patient's choice, is effective from this date. These changes have important organizational consequences for patients and health professionals alongside the pathway of care. Therefore, the effectiveness of this new organization requires to be evaluated with a national French study, called PASO DOBLE DEMI. The aims of this study are twofold :

I. To evaluate the direct impact of the training programs provided to the new placeholders of the dispensing circuit ; the community pharmacists, II. To evaluate satisfaction of patients or their relatives regarding the emicizumab treatment whether they chose dispensing in the community pharmacy, or kept the dispensing at the hospital pharmacy.

The methodology was based on the 4-level of the Kirkpatrick's evaluation model; 1) the immediate reaction of community pharmacists following the trainings (Reaction), 2) their knowledge acquisition (Learning), 3) their professional practice (Behavior) and 4 ) the patients' satisfaction related to their treatment whether dispensing in hospital or in community pharmacies (Results).

The PASO DOBLE DEMI II study was based on the fourth level of the evaluation model and particularly to evaluate to what extent the dispensing of Emicizumab (HEMLIBRA ®) treatment in community pharmacies has contributed to the improvement of the satisfaction of patients with HA.

The availability of the treatment in community pharmacy assumes an improvement of the treatment accessibility for the patient at several levels :

Global accessibility: what choice has the patient expressed to access his treatment from a practical point of view?
Adaptation: Has the patient adapted to the new treatment delivery organization?
Availability of resources: are the special needs of the patients taken into consideration?
Social acceptability: is the patient willing to follow the proposed care pathway? The issue of treatment cost is not considered in this study because the cost of antihemophilic treatments is totally covered by the French government for all patients regardless of their insurance coverage


title: A Multi-Center, Longitudinal, Prospective, Observational, Multi-Cohort Study of Patients With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment (LIST, Lung Initiative on Sequence Therapy)

acronym: LIST

summary:
The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:

The characteristics and treatment sequence of patients treated with nivolumab
The effectiveness of nivolumab treatment
The safety profile of nivolumab
Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab
The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L


title: Real-life Data of Constitutional Von Willebrand Disease in Western France: Treatment Outcomes With the Recombinant Von Willebrand Factor

acronym: HOPSCOTCH-II

summary:
The objective of this observational study HOPSCOTcH-WILL II is to provide an accurate and detailed account of current Von Willebrand Disease (VWD) therapeutic management by collecting real-life data on hemorrhagic treated events in the 5 Western French Hemophilia Treatment Center.

The HOPSCOTCH-WILL II study aims to describe therapeutic management of patients with VWD, following the provision of a recombinant drug in France; It will also permit to carry out a budget impact analysis to quantify the economic significance of this new era.

location_facility:
CH Le Mans
CHU Rennes
CHR de Brest
CHU de Nantes
CHU Angers


title: A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years

acronym: PARROTFISH

summary: An observational study to describe the effectiveness, safety, and patient-reported outcomes (PROs) in participants with moderate to severe active rheumatoid arthritis (RA) in France receiving filgotinib in real-world setting.

lead_sponsor: Galapagos NV

location_facility: Clinique de l'Infirmerie Protestante de Lyon

location_facility: Centre Hospitalier Universitaire de Saint Etienne


title: An Exploratory Study to Evaluate the Acceptability of PKU Explore, a Food for Special Medical Purposes, for Use in the Dietary Management of Phenylketonuria in Infants From 6 Months to 3 Years of Age With Regard to Product-acceptability, Tolerance, Phe Levels and Growth

summary: PKU explore France is an exploratory study to evaluate the acceptability of PKU explore, a food for special medical purposes, for use in the dietary management of phenylketonuria in infants from 6 months to 3 years of age, assessing participant adherence, GI tolerance, phe levels, growth and product palatability.

primary_purpose: Supportive Care

lead_sponsor: Vitaflo International, Ltd

intervention_type: Dietary Supplement


title: Proposal of a Method Using the PMSI and SNIIRAM National Databases to Estimate the Frequency of Physical Abuse and to Identify th Eassociated At-risk Situations and Consequences in Children Aged 0 to 5 Years in France

acronym: MENFIS

summary: The epidemiological data currently available on child abuse in France are very inadequate. They do not make it possible to know the number of child victims, nor the precise context and impact of this violence. Very often, the figures put forward are underestimated. Improving the knowledge of these situations would make it possible to develop targeted primary and secondary prevention programs. In this study, is proposed an innovative method of exploiting existing national databases, the PMSI and SNIIRAM, with the aim of 1) approaching an order of magnitude of the frequency of physical abuse in children and 2) evaluating its contexts and consequences. The PMSI is a high-quality database that has been used for many years for medical research purposes. It provides a large amount of epidemiological information and can be used to create cohorts large enough to detect rare events. The SNIIRAM/EGB data allows the recovery of all data on reimbursed consumption, such as drug treatments, biological examinations carried out or consultations (with general practitioners or specialists).

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Acceptability of Expanded Newborn Screening to Parents in France With or Without Genetics in the First Line

summary:
The recent modifications of the French bioethics law, the therapeutic progress and the massive development of advanced genetic techniques (such Next-Generation Sequencing (NGS)) with a rapid decrease in costs imply to question the extension of Newborn Screening (NBS) to new actionable pathologies and the acceptable and relevant methods for its possible expansion. International studies are beginning to determine the potential place of NGS in NBS. In this perspective, the SeDeN project aims to fully assess the social acceptability of these issues by measuring the diversity and consistency of expectations of French health professionals, parents and public policy makers.

The SeDeN-p3 Study focuses on the opinions of parents. It aims to analyze the perception of parents in different situations: birth, early childhood, child screened in the framework of the national neonatal screening program, etc. The objective of this part is to study the understanding and expectations of parents in France regarding the extension of newborn screening as well as their preferences regarding its conditions (information, types of pathologies, screening methods, etc.).

location_facility:
Groupe Hospitalier de La Haute-Saône
Hopital Antoine Beclere - Aphp
Hôpital Necker - Enfants Malades
Chu Dijon Bourgogne


title: A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed FLT3 Mutated Acute MyEloid Leukemia Patients Treated With Gilteritinib in FrANCE

acronym: ELEGANCE

summary:
Gilteritinib is available in early access in France through Temporary Authorisation of Use (or ATU program) since March 2019. The ATU program reflects a real-life treatment situation and the related clinical data would help to better understand the benefit/risk profile of gilteritinib and to better document gilteritinib efficacy and safety in patients who received midostaurine in First Line (1L) setting.

The main objective is to describe gilteritinib effectiveness in FLT3 (Fms Related Tyrosine Kinase 3) -mutated AML patients in Refractory/Relapsed(R/R) situation treated in the context of early access program to gilteritinib in France through Temporary Authorisation of Use, the so-called ATU program, and the post ATU period from marketing authorisation to launch when reimbursement and price are published.

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Acute Leukemia French Association

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie


title: Syndrome Fibromyalgique en France : Place de l'évaluation et de la Prise en Charge Des Troubles du Sommeil

acronym: FIBOBS

summary: The FIBOBS study is a multi-centered, observational, prospective study carried out within specialized chronic pain structures (CPS) in France. It will estimate the prevalence of sleep disorders, divided into three categories (poor quality of sleep in general, sleep apnea syndrome, restless legs syndrome), using self-questionnaires in patients with Fibromyalgia Syndrome (FMS) consulting within a CPS. The interaction between these sleep disorders and other symptoms of FMS will also be analyzed using self-administered questionnaires. Based on the hypothesis that sleep disorders associated with FMS are only imperfectly assessed and/or treated in CPS, the FIBOBS study will also interview pain physician in order to know both the diagnostic tools used and the recommended management when sleep disorders are suspected in the context of FMS. In addition, this study will provide a better understanding of the symptoms of FMS, their impact and how patients feel.

ReferenceCitation: Andre G, Petitjean P, Haas V, Geraud E, Fantini ML, Creac'h C, Perez C, Bonnefoi M, Gadea E. Screening and management of sleep disorders in patients with fibromyalgia syndrome: a French multicentred, prospective, observational study protocol (FIBOBS). BMJ Open. 2022 Sep 30;12(9):e062549. doi: 10.1136/bmjopen-2022-062549.

lead_sponsor: Centre Hospitalier Emile Roux

sponsor_collaborators:
Centre Hospitalier Emile Roux
Walisco
University Hospital, Clermont-Ferrand

location_facility: CHU Dupuytren 2 - Centre de la douleur chronique

location_facility: Hôpital Nord Ouest - Site Villefranche-sur-Saône

location_facility: Hôpital Pierre Paul Riquet - CHU Toulouse

location_facility: Clinique Mutualiste de la Porte de Lorient