title: Translation and Validation of the French Version of the Postoperative Quality of Recovery Score QoR-15

summary: After a surgery, the recovery of the previous health status of patients, such as walk, body care, sleep, diet, feeling of comfort, is one of the priorities of the perioperative medicine. The QoR-15 was designed to measure quality of recovery after surgery. It provided a valid, extensive and efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into French, and do a full psychometric evaluation of the French version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, orthopedic, […], gynecological surgery, in the University Hospital of Strasbourg. The secondary objectives will be to evaluate the quality of recovery of the patients who undergone surgery at Strasbourg University Hospital, and to evaluate the incidence of postoperative complications occurring within three months postoperatively and a possible association with the QoR-15F.

ReferenceCitation: Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.

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

location_facility: Service D'Anesthesiologie - Reanimation Chirurgicale


title: Characterization of Phenotypes of Occupational Asthma: Descriptive Study

summary: The general objective of this multicenter, international study is to perform a multivariate descriptive analysis of a large population of well-defined subjects with sensitizer-induced OA ascertained by a positive SIC result in order to provide more information on the characteristics of this condition.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de pneumologie, d'allergologie et de pathologie de l'environnement

lead_sponsor_type: academique

status_simplified: Unknown


title: Relevance of Mammary MRI in the Preoperative Assessment of Ductal Carcinoma in Situ (DCIS)

summary: Compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size

ipd_sharing: No


title: Imaging of Facial Neuritis Using T2-weighted Gradient-echo Fast Imaging Employing Steady State Acquisition After Gadolinium Injection

summary: Improved means of positive diagnosis of facial neuritis, the leading cause of peripheral facial palsy


title: Fast and Accurate Diagnosis of an Oval or Round Window Perilymphatic Fistula on CT and MRI, Without Injection, on 101 Patients With Surgical Confirmation

summary: Our objective is to validate the CT / MRI combination of non-injected rock for the rapid positive diagnosis of perilymphatic fistulas.


title: Epidemiology of Merkel Carcinomas in the Bas-Rhin From 1983 to 2011: General Population Study Based on the Bas-Rhin Cancer Registry

summary: The aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower Rhine, thus obtaining the first French data.


title: Duration of Stay for Outpatient Surgery After Tension Free Vaginal Tape (TVT) Urologic Surgery : Neuraxial Versus General Anesthesia

summary:
Outpatient midurethral surgery is a frequent surgery. It is performed either under general anesthesia or neuraxial anesthesia. A frequent complication is postoperative urinary retention requiring urinary catheterization, which implies a higher infectious risk.

The investigators compared the complication rate after TVT surgery depending on the type of anesthesia.


title: Characteristics of Positive Lyme PCR Arthritis, Data From CNR Borrelia 2011-2016

acronym: ArthLyme

summary: Lyme disease is due to Borrelia burgdorferi sensu lato and is transmitted by a tick vector of the genus Ixodes. One of the clinical forms of this disease in the disseminated phase is the appearance of arthritis, classically mono or oligo-arthritis in the large joints.


title: NON-INTERVENTIONAL STUDY, MULTICENTRIC STUDY, AIMING AT CONSTITUTING A BIOLOGICAL SAMPLES COLLECTION FROM CENTENARIAN PEOPLE

acronym: BISCOTE

summary:
The compositional analysis of commensal bacterial populations collected from a variety of clinical samples has been recently made possible with the availability of Next Generation Sequencing (NGS) technologies. The term 'next-generation probiotics' (NGP) is now widely used to describe these commensal species of potential health interest. However, this approach is still hampered by the fact that there are usually few or even no strains available for a number of commensal species. In this context, BIOASTER has developed a specific technological process based on flow cytometry analysis and then sorting under strictly anaerobic conditions to target and cultivate commensal species of interest.

The review of the literature shows that certain species present among centenarians have an interest in maintaining the longevity of these individuals. Numerous studies have shown that the intestinal microbiota of centenarians presents a greater diversity compared to groups of younger subjects as well as an enrichment in certain bacteria such as Akkermansia and Christensenella.

The goal of this observational study is to constitute a biological samples collection from centenarian people, to proceed with the isolation of beneficial commensal strains such as Faecalibacterium prausnitzii, Akkermansia muciniphila and Oscillospiraceae, in a non-limitative way.

Elderly and centenarian people will be recruited in nursing home among the Gerontopole of "Ile de France" network.

Blood (serum + TruCulture tubes) and stools will be collected from each subject.

study_start_date_type: Anticipated

status: Recruiting

time_perspective: Prospective

lead_sponsor: Bioaster

sponsor_collaborators:
Bioaster
Gerond'if (Gerontopole Ile de France)

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Study CARPUS : " Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus "

acronym: CARPUS

summary:
Perilunate dislocation of the carpus is a serious lesion of the wrist which is defined by a total loss of contact of the articular surfaces capito-lunar, scapholunate and lunate-triquetral. Rare by its frequency, it represents 5 to 10% of traumatic injuries of the wrist.

Perilunate wrist dislocation is a rare injury that goes unnoticed in 25% of cases. Even with surgical treatment, 50-100% of patients will develop radiocarpal and/or midcarpal osteoarthritis.

location_facility: Service de Chirurgie de la main - CHU de Strasbourg - France


title: Percutaneous Cryoablation of Central Kidney Tumours With Temporary Renal Artery Occlusion

acronym: CP-Renal

summary: Percutaneous cryoablation is an alternative to urological surgery for T1a tumours, whose oncological efficacy decreases for the most central tumours due to a cold sink effect.

location_facility: Service d'Imagerie Interventionnelle - CHU de Strasbourg - France


type: Other Identifier

type: Other Grant/Funding Number

title: Prévention Des Erreurs médicamenteuses liées Aux Interruptions de tâches Des Soignants Lors de la préparation et de l'Administration Des médicaments : Essai contrôlé randomisé Multicentrique en Clusters

acronym: PERMIS

summary:
Serious medication administration errors are common in hospitals and nurse's interruptions during medication preparation and administration is associated with errors. Various interventions were developed to help prevention of errors such as visual intervention. Investigators aimed to study the effect of a medication safety vest to reduce medication errors. The vest serves as a visible signal to inform others that the nurse is preparing and administering medications and should not be disturbed. Patients and visitors are provided with an informational flyer to inform them about the use of medication safety vests.

The hypothesis is that the vest will reduce nurse's interruptions during medication preparation and administration, and ultimately reduce medication errors.

The study is a randomized controlled trial in 30 care units of four hospitals in France. Each unit will be randomized in either the control group or the experimental group using the medication safety vest. Nurses of the unit will be selected at random to determine who will be observed during the administration rounds.The observation method will be used to evaluate the error rates in the 2 groups. The number of interruptions and error rates will be evaluated.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Berdot S, Sabatier B, Gillaizeau F, Caruba T, Prognon P, Durieux P. Evaluation of drug administration errors in a teaching hospital. BMC Health Serv Res. 2012 Mar 12;12:60. doi: 10.1186/1472-6963-12-60.

ReferenceCitation: Berdot S, Gillaizeau F, Caruba T, Prognon P, Durieux P, Sabatier B. Drug administration errors in hospital inpatients: a systematic review. PLoS One. 2013 Jun 20;8(6):e68856. doi: 10.1371/journal.pone.0068856. Print 2013.

ReferenceCitation: Berdot S, Roudot M, Schramm C, Katsahian S, Durieux P, Sabatier B. Interventions to reduce nurses' medication administration errors in inpatient settings: A systematic review and meta-analysis. Int J Nurs Stud. 2016 Jan;53:342-50. doi: 10.1016/j.ijnurstu.2015.08.012. Epub 2015 Sep 7.

ReferenceCitation: Westbrook JI, Woods A, Rob MI, Dunsmuir WT, Day RO. Association of interruptions with an increased risk and severity of medication administration errors. Arch Intern Med. 2010 Apr 26;170(8):683-90. doi: 10.1001/archinternmed.2010.65.

ReferenceCitation: Relihan E, O'Brien V, O'Hara S, Silke B. The impact of a set of interventions to reduce interruptions and distractions to nurses during medication administration. Qual Saf Health Care. 2010 Oct;19(5):e52. doi: 10.1136/qshc.2009.036871. Epub 2010 May 28.

ReferenceType: derived

ReferenceCitation: Berdot S, Vilfaillot A, Bezie Y, Perrin G, Berge M, Corny J, Thi TTP, Depoisson M, Guihaire C, Valin N, Decelle C, Karras A, Durieux P, Le LMM, Sabatier B. Effectiveness of a 'do not interrupt' vest intervention to reduce medication errors during medication administration: a multicenter cluster randomized controlled trial. BMC Nurs. 2021 Aug 24;20(1):153. doi: 10.1186/s12912-021-00671-7.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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

intervention_type: Device

status_simplified: Completed

appel_a_projets: PREPS

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: PERMIS

titre: Prévention des ERreurs Médicamenteuses liées aux Interruptions de tâches des Soignants

discipline_principale: organisation des soins

nom_porteur: SABATIER

prenom_porteur: Brigitte


title: A French, Multicentric, Randomized, Simple Blind, Superiority Study Comparing the Efficiency and the Safety at 24 Months of the Stent Titan2 Versus Bare Metal Stent in Cobalt-Chrome in All Comers Patients Among Which 40 % Present an ACS.

acronym: EVIDENCE II

summary: The purpose of this study is to compare the effectiveness and safety, at 24 months, of the TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an indication for these stents among 40% of which present an acute coronary syndrome (ACS).

primary_purpose: Treatment

lead_sponsor: Hexacath, France

location_facility:
HCL Croix-Rousse
Hôpital Emile Muller
Centre Hospitalier de Lille
CH Henri Duffaut
Clinique Beauregard
Clinique de l'Europe
Hôpital Claude Galien- ICPS
Hôpital Sud
Polyclinique de Bois Bernard
Clinique Les Fontaines
Clinique Claude Bernard
Ch Sud Francilien
HCL Bron
CHRU Tours
Centre hospitalier Louis Pasteur
CH Cannes
Clinique Alleray Labrouste
CHU Angers
Clinique Saint-Martin
CHU Caremeau
Clinique Saint-Hilaire
Hôpital Albert Schweitzer
HIA Val de Grâce
Hôpital Saint-Joseph
Clinique Saint Laurent
Hôpital Nord
CHU de Grenoble
Clinique Pasteur
Clinique La Fourcade
CHU Côte de Nacre
CHI Toulon La Seyne
Hôpital de Rangueil
Centre Hospitalier de Lagny
Nouvelles Cliniques Nantaises
Hôpital Gabriel Montpied
CH Pau
Centre Hospitalier Laënnec
CH Valence
Centre Hospitalier Départemental
Centre Hospitalier Général
CH Saint-Brieuc
Groupe Hospitalier Mutualiste


title: Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction

summary:
These last years, it has been proven that the solicitation of a muscle using vibration may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition of local vibration training sessions on the quadriceps muscle to the classic readaptation program (i.e. physiotherapist sessions) may allow a better recuperation 2 months after the surgery and the reconstruction of the anterior cruciate ligament.

The aim of the vibration training proposed in the current study is to allow a better recuperation 2 months after the anterior cruciate ligament reconstruction when compared with conventional physiotherapy alone.

ReferenceType: result

ReferenceCitation: Coulondre C, Souron R, Rambaud A, Dalmais E, Espeit L, Neri T, Pinaroli A, Estour G, Millet GY, Rupp T, Feasson L, Edouard P, Lapole T. Local vibration training improves the recovery of quadriceps strength in early rehabilitation after anterior cruciate ligament reconstruction: A feasibility randomised controlled trial. Ann Phys Rehabil Med. 2022 Jun;65(4):101441. doi: 10.1016/j.rehab.2020.08.005. Epub 2021 Nov 13.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (author manuscript)

version: acceptedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CEPART
CHU de SAINT-ETIENNE


title: Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint

acronym: SYNOVITIS

summary:
Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon.

Corticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use.

There are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.

location_facility: Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France


title: REACT AGAINST STROKE

acronym: AVC - REACT

summary:
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region, France (AVC69) the investigators observed that only a small percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of patients reached hospital through an emergency department instead of going directly to a stroke unit. Among those patients, only 8% were finally thrombolysed, because of extended management times.. Our hypothesis was that public awareness campaign designed to improve public's knowledge and skills would consequently reduce prehospital time and favour call to prehospital emergency medical services (EMS).

The investigators will conduct an awareness campaign aimed at the general population, using different communication media, the content will be developed based on the results of a qualitative study with focus groups (Quali-AVC), and using a diffusion plan established with communications professionals. To assess the effects of this campaign, a comparative quasi-experimental before-after study will be conducted. A control region where no awareness stroke program has been set up has been selected, data will be collected in the two regions. The assessment of the impact of the campaign will focus on the comparison of the evolution of indicators between these two regions. Three assessment time will be provided: before starting the program, at 3 months and at the end of the program.

ReferenceCitation: Haesebaert J, Laude C, Termoz A, Bravant E, Perreton N, Bony T, Trehard H, Porthault S, Derex L, Nighoghossian N, Schott AM. Impact of a theory-informed and user-centered stroke information campaign on the public's behaviors, attitudes, and knowledge when facing acute stroke: a controlled before-and-after study. BMC Public Health. 2020 Nov 16;20(1):1712. doi: 10.1186/s12889-020-09795-y.

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

evidence: oa repository (via page says license)

repositories:
HAL
PubMed Central
Research Square

repositories_concat: HAL;PubMed Central;Research Square

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

lead_sponsor: Hospices Civils de Lyon

location_facility: Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne


title: Enquête épidémiologique Sur la prévalence et le Pronostic de l'Histiocytose Langerhansienne Pulmonaire de l'Adulte en France

summary: The long-term outcomes of adult patients with pulmonary Langerhans cell histiocytosis (PLCH), particularly survival, is largely unknown. This is the first prospective study in the field evaluating the long-term outcomes of PLCH patients. This french countrywide registry-based study included a large cohort of PLCH patients followed for a sufficiently long period to address risk factors of long-term outcomes of PLCH patients.

ReferenceCitation: Benattia A, Bugnet E, Walter-Petrich A, de Margerie-Mellon C, Meignin V, Seguin-Givelet A, Lorillon G, Chevret S, Tazi A. Long-term outcomes of adult pulmonary Langerhans cell histiocytosis: a prospective cohort. Eur Respir J. 2022 May 26;59(5):2101017. doi: 10.1183/13993003.01017-2021. Print 2022 May.

oa_host_type: closed

publisher_dissemination: European Respiratory Society

ipd_sharing: Undecided

location_facility: French national reference centre for Histiocytoses


title: Functional Knee Phenotypes of Patients Operated on for Total Knee Arthroplasty. Comparison With a Reference Non Arthritic Population

acronym: FP-Knee

summary: The aim of this study was to analyze the coronal alignment of a large population of patients undergoing total knee arthroplasty using a modern classification of the knee phenotypes found in a population of non-osteoarthritic patients.

location_facility: Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France


title: Frequency of Palpebral Involvement in Adult Atopic Dermatitis, in a Cohort of Patients From Lille and Rouen (France) ; a Multicenter Prospective Study

acronym: PAUPIAD

summary:
Atopic dermatitis is a common inflammatory skin disease, resulting from genetical, immunological and environmental factors. Head and neck are among the most frequent involved areas, almost 50% in adult patients according to most publications. Palpebral involvement is also common and a source of major quality of life impairment for patients.

However, the real frequency of this palpebral involvement is unknown, only estimated about 20% in few studies. The treatment of this location remains difficult, regarding to the thickness of palpebral skin and proximity of the eye.

To our knowledge, no prospective studies about allergological skin tests (such as patch-tests) in atopic patients with palpebral involvement had been conducted.

Finally, atopic dermatitis is frequently associated with ophthalmological diseases such as conjunctivitis, keratoconus or cataract, which belong to the minor criteria of Hanifin and Rakja classification.

A better knowledge of the atopic dermatitis palpebral involvement and the associated factors seems to be needed to improve the treatment and the quality of life of patients

lead_sponsor: University Hospital, Lille

location_facility:
Hop Claude Huriez Chu Lille
Hopital Charles Nicolle Chu Rouen


title: Analysis of ADVerse evENTs in Anesthesia Using ARtificial IntelligencE

acronym: ADVENTURE

summary:
The interest of health databases in anesthesia is no longer to be demonstrated. The aim of this research was to develop a natural language processing approach to establish a classification of adverse events observed during the perioperative period and to facilitate their analysis:

The main objective of the study was to identify what a "naïve" unsupervised model would discover based on Adverse Event (AE) descriptions. Our second goal was to identify apparently unrelated events whose combination could favor the occurrence of an AE

location_facility: Service d'Anesthésie et Réanimation chirurgicale - CHU de Strasbourg - France


title: Immunity and COVID Infections in the Psychiatric Population

acronym: COVIDIMMUNOPSY

summary:
The main objective of this multicenter cohort study is to determine the degree of COVID19 infection immunization of a population of psychiatric patients.

The secondary objective of this cohort follow-up is to:

Clinically characterize COVID patients who are positive for serological testing
Assess the socio-demographic, clinical and psychotropic determinants of a COVID diagnosis
Immunologically characterize COVID patients who are positive for serological testing
Exploring the links between susceptibility to COVID19 and erythrocytic blood groups

primary_purpose: Diagnostic

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

intervention_type: Diagnostic Test


title: Evolution of the State of Health of Patients Undergoing Surgery for Osteoarticular Surgery: Retrospective Study Based on the Point of View of Patients

acronym: EPOPEE

summary: Osteoarticular surgery is frequently associated with the occurrence of moderate to severe postoperative pain. This pain can persist and become chronic post-surgical pain that is often debilitating. The transition between early postoperative pain and chronic pain is poorly understood, which complicates treatment.

location_facility: Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France


title: Understanding the Phenomena of Aging and Rupture of Breast Implants

acronym: CRIMA

summary:
Breast implants, like all implantable medical devices, are subject to wear and tear as they age in the body. In addition to this wear and tear, they are subject to external trauma, whether accidental during daily life, during insertion or during mammography.

The kinetics and mechanisms of aging are poorly studied and the phenomenon of implant rupture is not elucidated. However, studies of older generation implants have shown that implant rupture is correlated with the duration of implantation.

location_facility: Service de Chirurgie Plastique Esthétique et Reconstructrice - CHU de Strasbourg - France


title: Phenotyping and Genotyping of Duffy Antigen

acronym: DARC

summary: Malaria remains the world's leading parasitic endemic. Almost half of the world's population lives in endemic areas. Many at-risk people in African countries remain without access to malaria control. Malaria kills approximately 400,000 people each year, most of whom are children under the age of 5 in Africa. Since 2005, an increasing number of Plasmodium vivax infections have been observed in Duffy-negative populations in South America and Africa, calling into question the essential role of the PvDBP-DARC interaction. The objective of the investigators is therefore to study and understand the invasion pathways used by Plasmodium vivax in Duffy-negative subjects.

location_facility: Service de Laboratoire de Parasitologie et Mycologie Médicale-PTM - CHU de Strasbourg - France


title: An Open-Label Study to Examine the Safety and Efficacy, of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis in France

acronym: PAGELEC

summary: The objectives of the study are to evaluate the safety and efficacy of open label treatment with WR 279,396 (topical paromomycin & gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL).

collaborators: U.S. Army Medical Research and Development Command

location_facility: Centre d'investigations cliniques- Hopital Robert Debré

intervention_type: Drug


title: Pharmacists in Detecting Opioid Misuse Using the Prescription Opioid Misuse Index (POMI): Survey in a Region in the South of France, Occitanie-Est

summary:
Opioid use is increasing in Western countries and is associated with harms as hospitalization, addiction and deaths(1). Community pharmacists interact frequently with patients, giving them the opportunity to identify and prevent the risk of prescribed opioid misuse. The purpose of this study was therefore to assess the risk of prescribed opioids misuse in ambulatory patients with chronic non-cancer pain (CNCP) seen in community pharmacies.

Method: A questionnaire (including the Prescription Opioid Misuse POMI(2)) have been proposed to patients with opioid prescription by pharmacy students, in 86 pharmacies of Occitanie-Est, in April 2019. Eligible patients were adults with CNCP that consented to participate.

A total of 414 patients (62.4% women, mean age 58 ± 16.00) have been included. The main pains were spinal (37.3%) and osteoarticular (33.1%). The median visual analog scale (VAS) was 7 [IQR25-75: 5-8]. The prescribed opioids are mainly weak opioids (73.2%): paracetamol/tramadol (35%), paracetamol/codeine (17.4%), paracetamol/opium (16.8%). Strong opioids (32.6%) were oxycodone (11.95%), fentanyl (9%), and morphine (9%). The median morphine milligram equivalent (MME) was 40 mg/day [IQR25-75: 20-80].

POMI score was superior to 2/6 in 45.4% and superior to 4 in 16%. The main positive question were feel high (40.3%), take the opioid more often (39.3%), take more medication (36.6), and need to early renew opioid medication earlier (30.8%).

Patients with POMI score > 4 were younger (49 years versus 55.9; p<0.01), more urban (78.1% versus 69.2%; p=0.03), had higher VAS (7.3 versus 6.2; p<0.01), received higher median MME (112 mg versus 64.9 mg; p<0.01), and consumed more strong opioid (45.3% versus 27.3%; p=0.04).

time_perspective: Cross-Sectional

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid? : Multicenter Retrospective Study in France and Switzerland

summary:
Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs have been reported for their potential link with the development of PB. Recently, cases of PB associated with dipeptidyl peptidase-IV (DPP4) inhibitors, also known as gliptins, have been reported. DPP4 inhibitors are oral antidiabetic agents prescribed to patients with type 2 diabetes, as monotherapy, in combination with other oral antidiabetic agents or with insulin.

In recent years, an increasing number of cases have been published, describing the potential role of gliptins in PB induction. All these clinical cases and pharmacovigilance analyzes tend to show an increased risk of developing BP in case of gliptin exposure.

The main objective is to evaluate the risk of developing a PB under DPP4 inhibitor treatment, comparing cases of diabetic patients with BP, to matched diabetic controls for sex and age, from French departments. Endocrinology in a retrospective study from 1 January 2014 to 31 July 2016.

The study will be conducted using databases of clinical and histological records. The investigators will perform a retrospective 1: 2 case-control study comparing cases with type 2 diabetes and BP to matched diabetic controls for sex and age, randomly drawn from French endocrinology departments (Marseille La Conception ) and Switzerland (Bern), between January 1, 2014 and July 31, 2016. the investigators will compare gliptin exposure in the case-control group versus the control group, adjusting for potential confounding bias using models. logistic regression.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Qualitative Study on CRIAVS-LR (Resource Centre for Sex Offenders in Languedoc-Roussillon, France) Psychoeducation Group for Juvenile Sex Offenders

summary: Some sexual violence is committed by minors but how to take care of them ? Despite heterogeneous profiles, some characteristics are common in these adolescents and can be used in psychoeducation group. CRIAVS-LR team has therefore decided to create a psychoeducation group on emotional and sexual life specific for this population of young adult/adolescents in order to improve their skills and find alternative solutions to violence, particularly in the area of sexual violence The qualitative aspect of this study would make it possible to provide data in this still little explored field, to try to understand the experience of the young people participating in this group and to improve its structure and content so that it reaches best its goals.


title: Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study.

summary: Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is helpful to better target standard biopsies and reduce the number of biopsies required. CLE necessitates an intravenous injection of a fluorescent marker, e.g. fluorescein, to obtain 'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than 1000 endomicroscopy procedures have been performed in the world and different publications have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication related to IV injection of fluorescein has been reported. However, all these data come from a very limited number of expert centres and need to be confirmed and validated at the multicenter level. The aims of this multicenter trial are: 1) to standardize CLE in all centres equipped in France, 2) to ensure the safety of intravenous fluorescein injection, 3) to test the diagnostic value of CLE in various conditions representative of the large spectrum of different cancerous and non-cancerous digestive diseases.

design_allocation: Non-Randomized

lead_sponsor: Nantes University Hospital

location_facility: Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud

location_facility: Service d'Hépato-Gastroentérologie, CHU Nantes

location_facility: Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes

location_facility: Service d' hépato-gastro-entérologie, CHU de ROUEN

intervention_type: Procedure


title: "Prospective Multicenter Observational Study for the Evaluation of the Efficacy of the Cordis Enterprise(TM) Self-expanding Intracranial Stent: Enterprise Stent Aneurysm Treatment (ESAT) Study

acronym: ESAT

summary: The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.

lead_sponsor: Codman & Shurtleff

location_facility:
Lariboisiere Hospital
Pitie Salpetriere Hospital
La Pitie Salpetiere Hospital
Roger Salengro Hospital
Albert Michallon Hospital
La Pitie Salpetriere Hospital
Jean Minjoz Hospital
Timone Hospital
Rothschild Foundation
Beaujon Hospital
White House Hospital
Purpan Hospital
Pellegrin Hospital
CHU Amiens


title: Use of the French Healthcare Insurance Database to Evaluate How Early Diagnosis of Hepatocellular Carcinomas is Implemented in France: SAMHEPAT Study

acronym: SAMHEPAT

summary: Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: ECR Visant à évaluer l'Effet d'Une Intervention Sur la Diffusion d'Informations (Conduite de la Diversification Alimentaire) Sur le Comportement de Nourrissage Des Parents, le Comportement Alimentaire et le Statut pondéral de l'Enfant

acronym: NUTRIENT

summary: The purpose of this randomized controlled trial is to conduct an intervention aimed at providing first-time parents with information on the conduct of complementary feeding through a paper brochure and a smartphone application, to test the effect of this intervention (compared to usual care, i.e. receiving the paper brochure only), on infant corpulence at 36 and 48 months of age, and parental feeding practices and infant eating behavior up to 36 months of age.

primary_purpose: Basic Science

ReferenceCitation: Asta K, Miller AL, Retzloff L, Rosenblum K, Kaciroti NA, Lumeng JC. Eating in the Absence of Hunger and Weight Gain in Low-income Toddlers. Pediatrics. 2016 May;137(5):e20153786. doi: 10.1542/peds.2015-3786. Epub 2016 Apr 18.

ReferenceCitation: Brugailleres P, Chabanet C, Issanchou S, Schwartz C. Caloric compensation ability around the age of 1 year: Interplay with the caregiver-infant mealtime interaction and infant appetitive traits. Appetite. 2019 Nov 1;142:104382. doi: 10.1016/j.appet.2019.104382. Epub 2019 Jul 23.

ReferenceCitation: Brugailleres P, Issanchou S, Nicklaus S, Chabanet C, Schwartz C. Caloric compensation in infants: developmental changes around the age of 1 year and associations with anthropometric measurements up to 2 years. Am J Clin Nutr. 2019 May 1;109(5):1344-1352. doi: 10.1093/ajcn/nqy357.

ReferenceCitation: de Lauzon-Guillain B, Musher-Eizenman D, Leporc E, Holub S, Charles MA. Parental feeding practices in the United States and in France: relationships with child's characteristics and parent's eating behavior. J Am Diet Assoc. 2009 Jun;109(6):1064-9. doi: 10.1016/j.jada.2009.03.008.

ReferenceCitation: Jansen E, Williams KE, Mallan KM, Nicholson JM, Daniels LA. The Feeding Practices and Structure Questionnaire (FPSQ-28): A parsimonious version validated for longitudinal use from 2 to 5 years. Appetite. 2016 May 1;100:172-80. doi: 10.1016/j.appet.2016.02.031. Epub 2016 Feb 18.

ReferenceCitation: McCurdy K, Gorman KS. Measuring family food environments in diverse families with young children. Appetite. 2010 Jun;54(3):615-8. doi: 10.1016/j.appet.2010.03.004. Epub 2010 Mar 20.

ReferenceCitation: Monnery-Patris S, Rigal N, Peteuil A, Chabanet C, Issanchou S. Development of a new questionnaire to assess the links between children's self-regulation of eating and related parental feeding practices. Appetite. 2019 Jul 1;138:174-183. doi: 10.1016/j.appet.2019.03.029. Epub 2019 Mar 26.

ReferenceCitation: Musher-Eizenman D, Holub S. Comprehensive Feeding Practices Questionnaire: validation of a new measure of parental feeding practices. J Pediatr Psychol. 2007 Sep;32(8):960-72. doi: 10.1093/jpepsy/jsm037. Epub 2007 May 28.

ReferenceCitation: Sall NS, Begin F, Dupuis JB, Bourque J, Menasria L, Main B, Vong L, Hun V, Raminashvili D, Chea C, Chiasson L, Blaney S. A measurement scale to assess responsive feeding among Cambodian young children. Matern Child Nutr. 2020 Jul;16(3):e12956. doi: 10.1111/mcn.12956. Epub 2020 Jan 30.

ReferenceCitation: Tournier C, Demonteil L, Ksiazek E, Marduel A, Weenen H, Nicklaus S. Factors Associated With Food Texture Acceptance in 4- to 36-Month-Old French Children: Findings From a Survey Study. Front Nutr. 2021 Feb 1;7:616484. doi: 10.3389/fnut.2020.616484. eCollection 2020.

ReferenceCitation: van der Veek SMC, de Graaf C, de Vries JHM, Jager G, Vereijken CMJL, Weenen H, van Winden N, van Vliet MS, Schultink JM, de Wild VWT, Janssen S, Mesman J. Baby's first bites: a randomized controlled trial to assess the effects of vegetable-exposure and sensitive feeding on vegetable acceptance, eating behavior and weight gain in infants and toddlers. BMC Pediatr. 2019 Aug 1;19(1):266. doi: 10.1186/s12887-019-1627-z.

ReferenceCitation: Ventura AK, Hupp M, Alvarez Gutierrez S, Almeida R. Development and validation of the Maternal Distraction Questionnaire. Heliyon. 2020 Feb 1;6(2):e03276. doi: 10.1016/j.heliyon.2020.e03276. eCollection 2020 Feb.

ipd_sharing: Yes

ipd_sharing_description: all IPD that underlie results in a publication will be shared

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation

collaborators: Institut de Recherche en Santé Publique, France

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

intervention_type: Behavioral


title: Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy, an Open Smart Digital Platform for Personalized Prevention and Patient Management - QUALITOP -

summary:
An increasing number of cancer patients are eligible to receive immunotherapy. Efficacy and tolerance have been demonstrated in multicentre randomized clinical trials with positive results. However, real-life experience differs from clinical trial results, especially regarding the management of potential adverse events. HR-QoL (Health Related Quality of Life) is one of the components of QoL (Quality of Life) in its broad acceptation and is certainly the only one usually collected in trials while little is known about QoL in cancer patients treated in the 'real-world'. QUALITOP partners intend to bring together all relevant longitudinal information present in large heterogeneous data (big data) to estimate patient QoL and find surrogate markers of QoL and its evolution. Within the QUALITOP consortium, 5 countries will collect prospective clinical and QoL data and also retrospective clinical data, and share it. This project will enable collecting, managing, sharing, modelling, processing, and exploiting big data on QoL. Furthermore, beyond the description of QoL, analytical tools (including causal inference methods and machine learning) are needed to understand the determinants of QoL and their complex relationships with irAEs (immune related Adverse Events) in a big-data context where standard statistical techniques would be limited. Artificial intelligence and causal models may be applied and developed to empower the patient, prevent adverse medical conditions, and promote QoL. The created knowledge will enable proposing guidelines for promoting better QoL.

QUALITOP aims at identifying the determinants of health status regarding immunotherapy-related adverse events (IR-AEs, such as toxicities) depending on the patient's profile in a real-world context.

The richness of QUALITOP is in the diversity of the experts who will collaborate in it. Clinicians involved in the care (thus the health status of the patients) will collaborate with psychologists and sociologists to understand and integrate complementary dimensions of QoL related to immunotherapy. Experts in pharmacovigilance and pharmacists will investigate the IR-AEs and their associations with patient behaviour and non-drug consumption. Epidemiologists, data scientists (including bioinformaticians and biostatisticians) and economists will extract information from the data and develop simulation models to produce knowledge. The project will take place in close relation with patient associations that will interact with experts to design the analyses, interpret their results, and proceed to their dissemination.

The main objective is to collect data of patients receiving immunotherapy in order to describe its impact in their quality of life.

Create the first real-life cohort of cancer patients treated with immunotherapy within a context of multidimensional management (with data on clinical information, health-related QoL (HR-QoL), IR-AEs, drug consumption, lifestyle, and administrative data).
Accelerate knowledge directed to different stakeholders (patients, relatives, clinicians, pharmacists, health authorities, and the general public) for a better understanding of the determinants of QoL and its optimization after immunotherapy through the development of innovative analytic tools (artificial intelligence and causal models).
Produce policies and recommendations to improve patients QoL and participate in the implementation of the SDGs (Sustainable Development Goals) for 4P medicine (Predictive, Preventive, Personalized, Participative) in immunotherapy for cancer patients.

time_perspective: Other

location_country: Spain Netherlands Portugal France

location_facility: Hospital Clinic de Barcelona - Consorci Institut d'Investigacions Biomediques August Pi i Sunyer

location_facility: Medical Clinical Research Platform, Cancer Institute of the Hospices Civils de Lyon


title: Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort

acronym: DREPADENSE

summary: Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort.

status: Terminated

ReferenceCitation: Miller ST, Sleeper LA, Pegelow CH, Enos LE, Wang WC, Weiner SJ, Wethers DL, Smith J, Kinney TR. Prediction of adverse outcomes in children with sickle cell disease. N Engl J Med. 2000 Jan 13;342(2):83-9. doi: 10.1056/NEJM200001133420203.

ReferenceCitation: Benkerrou M, Alberti C, Couque N, Haouari Z, Ba A, Missud F, Boizeau P, Holvoet L, Ithier G, Elion J, Baruchel A, Ducrocq R. Impact of glucose-6-phosphate dehydrogenase deficiency on sickle cell anaemia expression in infancy and early childhood: a prospective study. Br J Haematol. 2013 Dec;163(5):646-54. doi: 10.1111/bjh.12590. Epub 2013 Oct 10.

ReferenceCitation: Quinn CT, Shull EP, Ahmad N, Lee NJ, Rogers ZR, Buchanan GR. Prognostic significance of early vaso-occlusive complications in children with sickle cell anemia. Blood. 2007 Jan 1;109(1):40-5. doi: 10.1182/blood-2006-02-005082. Epub 2006 Aug 29.

ReferenceCitation: Bernaudin F, Verlhac S, Arnaud C, Kamdem A, Chevret S, Hau I, Coic L, Leveille E, Lemarchand E, Lesprit E, Abadie I, Medejel N, Madhi F, Lemerle S, Biscardi S, Bardakdjian J, Galacteros F, Torres M, Kuentz M, Ferry C, Socie G, Reinert P, Delacourt C. Impact of early transcranial Doppler screening and intensive therapy on cerebral vasculopathy outcome in a newborn sickle cell anemia cohort. Blood. 2011 Jan 27;117(4):1130-40; quiz 1436. doi: 10.1182/blood-2010-06-293514. Epub 2010 Nov 10.

ReferenceCitation: Bartolucci P, Brugnara C, Teixeira-Pinto A, Pissard S, Moradkhani K, Jouault H, Galacteros F. Erythrocyte density in sickle cell syndromes is associated with specific clinical manifestations and hemolysis. Blood. 2012 Oct 11;120(15):3136-41. doi: 10.1182/blood-2012-04-424184. Epub 2012 Aug 23. Erratum In: Blood. 2014 Mar 20;123(12):1972.

ReferenceCitation: Thornburg CD, Files BA, Luo Z, Miller ST, Kalpatthi R, Iyer R, Seaman P, Lebensburger J, Alvarez O, Thompson B, Ware RE, Wang WC; BABY HUG Investigators. Impact of hydroxyurea on clinical events in the BABY HUG trial. Blood. 2012 Nov 22;120(22):4304-10; quiz 4448. doi: 10.1182/blood-2012-03-419879. Epub 2012 Aug 22. Erratum In: Blood. 2016 Dec 15;128(24):2869.

ReferenceCitation: Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517. Erratum In: JAMA. 2014 Nov 12;312(18):1932. JAMA. 2015 Feb 17;313(7):729.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors

acronym: ReSiPaTNE

summary:
The indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature.

The reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic resection (up to 40%). The benefit in terms of survival remains to be evaluated. The ReSiPaTNE study proposes to create a retrospective cohort of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors in order to evaluate the short and long term results of this type of resection. The evaluation of the results of this type of resection may be useful for the selection of patients for treatment.

location_facility: Service de Chirurgie Générale, Hépatique, Endocrinienne et Transplantation - CHU de Strasbourg - France


title: Determination of the Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes in Franche-Comté (France).

acronym: R'EHPAD

summary: This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist

acronym: CHECKLISTPEP

summary:
Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care.

The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP.

A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions.

Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Obtaining Reliable Linguistic and Cultural Validation of the Questionnaires Cargier Bruden Inventony (CBI) and Zarit-12, Translate From English for Use in France

acronym: VALI-CBIZ

summary:
To validate the 2 questionnaires ZARIT-12 and CBI it is important to go through several stages:

translation stage : during this stage there will be a meeting of experts to Validate the test version in French by 4 Bilingual translators of the French and English mother tongue.
pilot stage : recruit a number of 30 neurological patients' caregivers, in order to validate the comprehension, thus obtaining the final version of the questionnaire.

Validation stage : the two questionnaires have been validated, in this stage there should be a recruitment of 264 participants for the CBI questionnaire and 120 participants for the ZARIT-12 questionnaire, and these 2 questionnaires will be deliver to the participant on the same day.

The first questionnary will have to be filled the day they get the questionnary (day 1).
The second one must be completed and sent fourteen days later (day 14).

lead_sponsor: Centre Hospitalier de Saint-Denis


title: Analysis of the Outcome of Patients With Suspected Upper GI Bleeding Managed in Emergency Departments in Ile de France and External Validation of Prognostic Scores

acronym: UGIB-ED

summary:
More than 80% of patients with upper gastrointestinal bleeding (UGIB) are hospitalized after their visit to the emergency department (ED). However, some of these hospitalizations do not seem justified. Several clinical scores have been developed to classify patients according to their risk of death or need for therapeutic intervention.

The aims of this study are:

to describe the characteristics of patients hospitalized for UGIB after their visit to the ED
to assess the predictive factors of hospital intervention or death
to assess the accuracy of existing prognostic scores to classify patients according their risk of death or need for therapeutic intervention (external validation) and to identify low-risk patients not requiring intervention.
Depending on the results, a new score could be derived to identify patients at low risk for intervention or death.


type: Registry Identifier

title: Rôle de la SMA Dans la préparation Des Mouvements Uni et Bi-manuels: le Paradigme Des Mouvements en Miroir

summary:
The aim of the project is to study the role of secondary motor area (more precisely the supplementary motor area, or SMA) during unimanual and bimanual voluntary movements externally (cue) or internally (subject's choice) triggered. In that view, we will study 3 experimental groups :

a group of healthy volunteers (control group)
the same group of healthy volunteers after a transient inactivation of the SMA (by the aim of repetitive trans cranial magnetic stimulation or TMS)
a group of patients suffering from congenital mirror movements who are suspected to present a dysfunction of the SMA (according to our previous results) In each of these groups, by the aim of a serial reaction time task, we will study the influence of a SMA stimulation on the excitability of the primary motor cortex (M1) during the preparation of a voluntary movement (unimanual or bimanual). This will allow us to assess the communication between the SMA and M1 during movement preparation. Using the same task in functional imagery, we will study the activation's pattern of primary and secondary motor areas during movement preparation. This multimodal approach should allow us to better understand the synergistic functioning of these different structures involved in movement preparation. An other interesting aspect will be to determine the role of these structures in movement lateralization. Eventually, our results might allow us to precise to role of the motor preparation's dysfunction in the genesis of congenital mirror movements.

In the first place, this study aims at a better understanding of the cerebral physiology of movement preparation (which is not well known) using the mirror movements paradigm as a dysfunction model (according to our previous results). According to our hypothesis, there is a strong link between the SMA and M1 during movement preparation. This hypothesis will be assessed by the use of the same experimental task with combined neurophysiological and neuroimaging approaches, thus increasing the validity of the results obtained.

A secondary aim of this protocol is to precise the role of motor planning dysfunction in patients with congenital mirror movements. A better understanding of the mechanisms responsible for this condition is necessary in a medium-term therapeutic prospect.

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

location_facility: Fédération des Maladies du Système Nerveux, Hôpital Pitié Salpétrière Paris, France 75013


title: Parasympathetic Activity Evaluation by Newborn Infant Parasympathetic Evaluation (NIPE) Monitor (MDMSTM, Loos, France) During Routine General Anesthesia in Children

acronym: OMNIPED

summary: Description of the standard values and fluctuations of the new NIPE index during routine pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous value ranging from 0 to 100. NIPE values described at different time points during anesthesia: beginning of induction, intubation, extubation, skin incision, opioid administration, vasopressors or atropine administration, transfusion, volume expansion. In addition, NIPE values during hemodynamic events (heart rate or blood pressure increase greater than 20%) will be recorded.

sponsor_collaborators:
University Hospital, Lille
Fondation Apicil


title: PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship, a Randomized Control Study in France (PRESTO-F)

acronym: PRESTO-F

summary:
Background: The outcome of ischemic stroke is related to the brain lesion volume and this volume of infarction is directly related to the time to reperfusion, which therefore depends on the time to initiation of therapy. Acute ischemic stroke is treated medically with the administration of intravenous rtPA, but recent randomized controlled trials have shown the efficacy of mechanical thrombectomy and is now the new gold standard in ischemic stroke. This new therapeutic strategy has created two possibilities for pre-hospital decision-making: i/ transport the patient directly to the nearest stroke unit to receive alteplase and then if indicated perform a thrombectomy (drip and ship) or ii/ bypassing thrombolysis centres in favour of endovascular thrombectomy (mothership).

Objective: To compare cost/effectiveness of transfer to the closest local stroke centre or telemedicine hub to direct transfer to the comprehensive stroke cent(CSC) in patients acute stroke with suspected large vessel occlusion.

Medical and economic expected impact: We hypothesize that direct transportation to CSC is associated with better clinical outcome in case of acute ischaemic stroke due to intracranial large vessel occlusion. However, we have to demonstrate that this approach is not associated with time from onset harm in patients not eligible to mechanical thrombectomy.

lead_sponsor: University Hospital, Caen


intervention_type: Biological

lead_sponsor: Sanofi Pasteur, a Sanofi Company

summary:
Primary Objective:

To demonstrate that Purified Vero Rabies Vaccine - Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection.

Secondary Objective:

To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection.
To demonstrate that the proportion of participants in the VRVg-2 + HRIG group achieving an RVNA titer >= 0.5 IU/mL at Day 28 was at least 95 percent (%).
To describe the immune response induced by VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that induced by VRVg-2, at Day 14 (7 days after the third injection), at Day 28 (14 days after the fourth injection) and at Day 42 (14 days after the last injection).

location_facility:
Investigational Site Number 2500001
Investigational Site Number 2500002

title: Immunogenicity and Safety of a Purified Vero Rabies Vaccine - Serum Free in Comparison With Verorab® and Imovax® Rabies, in a Simulated Rabies Post-exposure Regimen in Healthy Adults in France

primary_purpose: Prevention

type: EudraCT Number

source: euctr

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


title: Prognostic Value of the Immunoscore® Colon Test for Disease Free Survival Stratification in Stage III Patients Under Oxaliplatin Treatment: an Ancillary Study of IDEA France Study

summary:
The primary objective is to validate that the Immunoscore® test (IS0 to IS4) is able to identify patients with high risk (IS 0-1) of relapse or death whichever occurs first among Stage III patients under oxaliplatin-based adjuvant therapy.

Then the prognostic value of Immunoscore® Colon to predict disease free survival (DFS) will be assessed in Stage III patients under Oxaliplatin treatment in each arm of the IDEA trial (6- months and 3-months treatment).

Finally, the additive value of the Immunoscore® test to stratify the DFS will be evaluated among standard clinical and biological parameters and tumor features.

ReferenceCitation: Pages F, Andre T, Taieb J, Vernerey D, Henriques J, Borg C, Marliot F, Ben Jannet R, Louvet C, Mineur L, Bennouna J, Desrame J, Faroux R, Kirilovsky A, Duval A, Laurent-Puig P, Svrcek M, Hermitte F, Catteau A, Galon J, Emile JF. Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France PRODIGE-GERCOR cohort study. Ann Oncol. 2020 Jul;31(7):921-929. doi: 10.1016/j.annonc.2020.03.310. Epub 2020 Apr 12. Erratum In: Ann Oncol. 2020 Sep;31(9):1276.

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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

repositories_concat: HAL

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

collaborators: Methodology and quality of life unit in oncology, University hospital of Besancon


title: Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France

acronym: IPASTAPH

summary: S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.


title: Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population. The Paris Prospective Study III

acronym: PPSIII

summary: The aim of the present PPS3 study is (1) to assess the determinants of the regulation of heart rate and blood pressure variations and carotid properties (under different physiologic stimulations) and (2) to evaluate the respective contribution of heart rate, blood pressure variations and carotid properties to cardiovascular morbidity and mortality including sudden death during 10 years at least in healthy considered subjects.

ReferenceCitation: Jouven X, Empana JP, Schwartz PJ, Desnos M, Courbon D, Ducimetiere P. Heart-rate profile during exercise as a predictor of sudden death. N Engl J Med. 2005 May 12;352(19):1951-8. doi: 10.1056/NEJMoa043012.

ReferenceCitation: Jouven X, Zureik M, Desnos M, Courbon D, Ducimetiere P. Long-term outcome in asymptomatic men with exercise-induced premature ventricular depolarizations. N Engl J Med. 2000 Sep 21;343(12):826-33. doi: 10.1056/NEJM200009213431201.

ReferenceCitation: Briet M, Bozec E, Laurent S, Fassot C, London GM, Jacquot C, Froissart M, Houillier P, Boutouyrie P. Arterial stiffness and enlargement in mild-to-moderate chronic kidney disease. Kidney Int. 2006 Jan;69(2):350-7. doi: 10.1038/sj.ki.5000047.

ReferenceCitation: Kornet L, Hoeks AP, Janssen BJ, Houben AJ, De Leeuw PW, Reneman RS. Neural activity of the cardiac baroreflex decreases with age in normotensive and hypertensive subjects. J Hypertens. 2005 Apr;23(4):815-23. doi: 10.1097/01.hjh.0000163151.50825.e2.

ReferenceCitation: Empana JP, Sykes DH, Luc G, Juhan-Vague I, Arveiler D, Ferrieres J, Amouyel P, Bingham A, Montaye M, Ruidavets JB, Haas B, Evans A, Jouven X, Ducimetiere P; PRIME Study Group. Contributions of depressive mood and circulating inflammatory markers to coronary heart disease in healthy European men: the Prospective Epidemiological Study of Myocardial Infarction (PRIME). Circulation. 2005 May 10;111(18):2299-305. doi: 10.1161/01.CIR.0000164203.54111.AE. Epub 2005 May 2.

ReferenceCitation: Deraz O, Range H, Boutouyrie P, Chatzopoulou E, Asselin A, Guibout C, Van Sloten T, Bougouin W, Andrieu M, Vedie B, Thomas F, Danchin N, Jouven X, Bouchard P, Empana JP. Oral Condition and Incident Coronary Heart Disease: A Clustering Analysis. J Dent Res. 2022 May;101(5):526-533. doi: 10.1177/00220345211052507. Epub 2021 Dec 7.

oa_host_type: repository

repository_institution: Maastricht University - Research Publications

unpaywall_oa_status: green

publisher_dissemination: SAGE Publications

ReferenceCitation: Lisan Q, Tafflet M, Charles MA, Thomas F, Boutouyrie P, Guibout C, Haba-Rubio J, Perier MC, Pannier B, Marques-Vidal P, Jouven X, Empana JP. Self-reported body silhouette trajectories across the lifespan and excessive daytime sleepiness in adulthood: a retrospective analysis. The Paris Prospective Study III. BMJ Open. 2018 Mar 27;8(3):e020851. doi: 10.1136/bmjopen-2017-020851.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Université de Lausanne - SERVAL

repositories_concat: PubMed Central;serval.unil.ch

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

publisher_dissemination: British Medical Journal

ReferenceCitation: Simon M, Boutouyrie P, Narayanan K, Gaye B, Tafflet M, Thomas F, Guibout C, Perier MC, Pannier B, Jouven X, Empana JP. Sex disparities in ideal cardiovascular health. Heart. 2017 Oct;103(20):1595-1601. doi: 10.1136/heartjnl-2017-311311. Epub 2017 Jul 28.

ReferenceCitation: Empana JP, Perier MC, Singh-Manoux A, Gaye B, Thomas F, Prugger C, Plichart M, Wiernik E, Guibout C, Lemogne C, Pannier B, Boutouyrie P, Jouven X. Cross-sectional analysis of deprivation and ideal cardiovascular health in the Paris Prospective Study 3. Heart. 2016 Dec 1;102(23):1890-1897. doi: 10.1136/heartjnl-2016-309502. Epub 2016 Jun 27.

location_facility: Investigations Pré cliniques et Preventives de Paris


title: Nutritional Status on Admission to Pediatric Intensive Care: A French Multicentric Study

acronym: NUTRI-REAPED

summary:
Study rationale: Children admitted to intensive care are often chronically ill and the intensive care setting may upset the balance between nutritional intakes and needs.

As malnutrition is a key factor in the morbidity/mortality on pediatric intensive care units (PICUs), screening for malnutrition and the individualized adaptation of nutritional support are important elements of patient care. Yet no recent study has evaluated the nutritional status of children admitted to PICUs in France.

Primary Objective: Determine the prevalence of malnutrition in the population of children admitted to intensive care.

Secondary objectives:

Determine the children's nutritional status on admission.
Characterize the profile of malnourished patients compared with those not malnourished (sex, age, history, chronic disease, usual dietary habits, reason for admission, scheduled/unscheduled admission, surgery/medication, seriousness, seasonality).
Describe the practices regarding nutritional care in each center.

Population: All children (1 month to 18 years) admitted to all PICUs in France during three one-week periods (February, June, October) in the course of a year.


title: Constitution of a Centralized Biological Resources Collection and Associated With a Clinical Database for Childhood Liver Tumors Diagnosed in France (Retrospective Collection From 1990 and Prospective)

acronym: HEPATOBIO

summary: Centralized biological collection of multicentric origin, retrospective and prospective of biological samples (tissues and fluids) taken within the framework of the diagnostic and therapeutic management of children and adolescents with liver tumor, and supported in the centers of French Society for Childhood Cancers (SFCE) with associated clinical database.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Cohorte Française Des Patients Implantés de Micra AV

acronym: AV-CESAR

summary: Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous pacemakers. The absence of atrial pacing has restricted their uses mainly for cases of paroxysmal atrioventricular block (AVB) or AVB with atrial fibrillation. The Micra AV contains an embedded accelerometer that senses the atrial contraction waveform, allowing the ventricle to be paced once the atrial contraction is complete. This atrioventricular synchronization is intended to extend the use of the device to cases of permanent complete AVB with normal sinus function. Two randomized clinicals trials have been proven it's efficacy. However, with AV-CESAR cohort, we aim to evaluate the real word effectiveness of Micra AV, in the first 1000 patients implanted by the device in France.

lead_sponsor: Paris Sudden Death Expertise Center

collaborators: Centre Hospitalier Universitaire, Amiens

collaborators: Centre Hospitalier Régional et Universitaire de Brest

collaborators: Centre Hospitalier Universitaire de Besancon

collaborators: Centre Hospitalier Régional Metz-Thionville

location_facility: Paris Cardiovascular Research Centre (AV-CESAR Investigators)