type: EudraCT Number

title: Phase Ia/Ib, Randomized, Double Blinded, Dose Escalation Trial to Evaluate the Safety and Immunogenicity in Healthy European and Burkinabe Adults of a Placental Malaria Vaccine Candidate (PRIMVAC) Formulated With Alhydrogel ® or GLA-SE

acronym: PRIMALVAC

summary:
The primary objective of the study is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and Burkinabe adults.

The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions The safety profile will included local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria

ReferenceCitation: Gamain B, Chene A, Viebig NK, Tuikue Ndam N, Nielsen MA. Progress and Insights Toward an Effective Placental Malaria Vaccine. Front Immunol. 2021 Feb 25;12:634508. doi: 10.3389/fimmu.2021.634508. eCollection 2021.

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

publisher_dissemination: Frontiers

ReferenceCitation: Sirima SB, Richert L, Chene A, Konate AT, Campion C, Dechavanne S, Semblat JP, Benhamouda N, Bahuaud M, Loulergue P, Ouedraogo A, Nebie I, Kabore M, Kargougou D, Barry A, Ouattara SM, Boilet V, Allais F, Roguet G, Havelange N, Lopez-Perez E, Kuppers A, Konate E, Roussillon C, Kante M, Belarbi L, Diarra A, Henry N, Soulama I, Ouedraogo A, Esperou H, Leroy O, Batteux F, Tartour E, Viebig NK, Thiebaut R, Launay O, Gamain B. PRIMVAC vaccine adjuvanted with Alhydrogel or GLA-SE to prevent placental malaria: a first-in-human, randomised, double-blind, placebo-controlled study. Lancet Infect Dis. 2020 May;20(5):585-597. doi: 10.1016/S1473-3099(19)30739-X. Epub 2020 Feb 4.

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

collaborators: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

collaborators: Centre national de recherche et de formation sur le paludisme

location_country:
Burkina Faso
France

location_facility:
CNRFP
CIC 1417


title: Feasibility and Safety of Ultrasound Guided Installation Central Subclavian Catheter Through Supraclavicular Way

summary: Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de réanimation néonatale - HOPITAL DE HAUTEPIERRE

lead_sponsor_type: academique

status_simplified: Unknown


title: OPTIMIZATION OF NUTRITIONAL MANAGEMENT OF PATIENTS WAITING FOR LUNG TRANSPLANT INTO Strasbourg University Hospitals

acronym: nONsTOP

summary:
Undernutrition is the result of energy and protein deficiency and / or catabolic. These phenomena are observed daily in patients awaiting lung transplantation.

After lung transplantation that undernutrition is growing (on average 11% weight loss after the first observations in the continuing care of the University Hospital of Strasbourg). In other words the non-malnourished patients become. Hence the importance to reach every patient awaiting transplant, mainly to patients already malnourished before surgery.

Several studies have shown that early nutritional support has a direct effect on reducing comorbidities and the average length of stay. In the course of care of these patients it is necessary to intensify the dietary management to give them the best chance for early rehabilitation.

The main objective of the study is to evaluate the impact of the use of the SFNEP's nutritional care decision-making tree (Société Francophone Nutrition Clinique et Métabolisme) on the implementation of enteral nutrition by gastrostomy tube in patients awaiting for lung transplantation.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

location_facility: Service de pneumologie - Nouvel Hôpital Civil

status_simplified: Completed


acronym: PROBA-PD

summary:
Our hypothesis is that the conventional treatment of Behavioral Addiction in Parkinson's disease is often not effective, and that affects the motor aspects (worsening akinéto-rigid syndrome and / or worsening of dyskinesia due to higher levodopa doses to compensate for the drop in behavioral addictions) and non-motor (withdrawal syndrome dopamine agonist) anxiously including apathy.

Our goal is to describe the natural history of Behavioral Addiction under the effect of the evolution of the disease and adapt treatment according to the prior art, through a study of a larger population of patients than in the few published studies.

status: Terminated


title: Clinical Signs and Symptoms of Anemia in Patients Over 75 Years

summary: Anemia is a common pathology in geriatrics. According to the World Health Organization it affects 23.9% of subjects over 60 years in the world, and 8% of patients over 60 years in Europe. A prevalence that increases with the age and twice in individuals over 85 years.

location_facility: Service de Médecine Interne, diabète et maladies métaboliques - Médicale B


type: Other Identifier

title: Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)

acronym: ANCHOR

summary:
Data from case series and large retrospective trials suggest that the early treatment of cardiogenic shock AMI patients with the association of VA-ECMO and IABP may significantly decrease mortality, which is still unacceptably high nowadays (40-50% at 30 days).

An important benefit for the patients randomized to the ECMO arm is expected and the risk-to-benefit ratio is expected to be in favor of the experimental treatment arm.

status: Suspended

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.

ReferenceCitation: Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

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 OAI-PMH doi match)

host_type: repository

repository_institution: University of Bern - Bern Open Repository and Information System

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Fuernau G, Eitel I, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Jobs A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Hunziker L, Savonitto S, Torremante P, Vrints C, Schneider S, Zeymer U, Desch S; CULPRIT-SHOCK Investigators. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710. doi: 10.1056/NEJMoa1808788. Epub 2018 Aug 25.

ReferenceCitation: Overtchouk P, Pascal J, Lebreton G, Hulot JS, Luyt CE, Combes A, Kerneis M, Silvain J, Barthelemy O, Leprince P, Brechot N, Montalescot G, Collet JP. Outcome after revascularisation of acute myocardial infarction with cardiogenic shock on extracorporeal life support. EuroIntervention. 2018 Apr 6;13(18):e2160-e2168. doi: 10.4244/EIJ-D-17-01014.

ReferenceCitation: Muller G, Flecher E, Lebreton G, Luyt CE, Trouillet JL, Brechot N, Schmidt M, Mastroianni C, Chastre J, Leprince P, Anselmi A, Combes A. The ENCOURAGE mortality risk score and analysis of long-term outcomes after VA-ECMO for acute myocardial infarction with cardiogenic shock. Intensive Care Med. 2016 Mar;42(3):370-378. doi: 10.1007/s00134-016-4223-9. Epub 2016 Jan 29.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: ANCHOR

titre: ECMO veino-artérielle pour la prise en charge des infarctus du myocarde compliqués de choc cardiogénique

discipline_principale: cardiologie

nom_porteur: COMBES

prenom_porteur: Alain


title: Pilot Study Prok-Idm: Interest of Dosage of Prokinecitine in Acute Myocardial Infarction

acronym: Prok-Idm

summary: The study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. The usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.

time_perspective: Prospective


title: Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women Combined With Sending Their General Practitioners a List of Their Nonadherent Patients

acronym: IMPACTGP

summary:
Context:

In France, cervical cancer (CC) screening was opportunistic until recently. The target population includes women aged 25 to 65 years. About 66% of women aged 25-40 years have performed a screening test over the last three years but this figure decreases to 55% in women over 40. The third "Cancer Plan" proposed by the French National Institute for Cancer recommends to achieve an 80% participation in eligible women.

Improving women compliance to CC screening is a major challenge to decrease cancer incidence and mortality.

To improve patient adherence, a CC screening organization will be launched in 2020 at a national scale in France. Women who did not perform a PAP test over the last 3 years will receive an invitation letter from the local public health association in charge of cancer screening organization. The invitation letter will remind women that they should consult a healthcare professional (a general practitioner (GP), a gynecologist or a midwife) to perform a screening test.

Providing GPs with a list of their non-adherent patients could also improve women compliance to CC screening recommendations.

The study objective is to assess whether sending both an invitation letter to non-adherent women and a list of their non-adherent patients to GPs ("invitation letter + GP reminder" group) could increase the proportion of women who perform a screening test, compared to only sending an invitation letter to non-adherent women ("invitation letter" group) or not sending any invitation ("usual care" group).

status: Active, not recruiting

primary_purpose: Screening

lead_sponsor: Nantes University Hospital

intervention_type: Other

status_simplified: Ongoing


title: Characteristics of Cognitive Decline During Parkinson's Disease in the Elderly

summary: Cognitive disorders in Parkinson's disease (PD) are not as obvious as cognitive disorders in Alzheimer disease and their diagnosis tends to be delayed. If neuropsychological assessment of cognitive decline in Parkinson's disease is well established, the thresholds of cognitive testing corresponding to a dementia are unknown. Recently, new diagnosis criteria of dementia associated with PD have been proposed by the movement disorder society. In this study two groups of patients with idiopathic PD will be separated and compared according to their Mini Mental State Examination (MMSE) score (upper or lower than 26). Included patients will have clinically idiopathic PD, will be over 65 years old and will present cognitive complain. Cognitive and mood disorders as well as motor symptoms will be assessed using validated scales and a neuropsychological assessment dispatched in two visits will be performed . Differences in the distribution of data from the two groups of patients will be assessed in statistically analysis with non parametric tests. The purpose of this study is to determine the most effective tests and their threshold value corresponding to a pathological cognitive decline.

location_facility: Service de Gériatrie, Hôpital de la Robertsau, Hôpitaux Universitaires de Strasbourg


title: Evaluation of the Brain Natriuretic Peptide as a Predictor of Morbidity and Mortality in Cardiac Surgery

summary:
Objective: The purpose of the present study is to assess if perioperative variation of Brain Natriuretic Peptide (BNP) levels is a predictor of mortality and morbidity after cardiac surgery.Material and Methods: 500 consecutive patients will be enrolled prospectively in this study before cardiac surgery under cardiopulmonary bypass. BNP levels will be measured prior to surgery and at postoperative day 1. Variations of BNP levels will be analyzed to determine if it is a predictor of mortality and morbidity after cardiac surgery. This dynamic evaluation will be compared to other tools of risk stratification in cardiac surgery as the EuroScore. All patients will be followed 3 years after the procedure.

Hypothesis: Perioperative BNP variations may be more sensitive than pre- or postoperative BNP levels alone. Furthermore the perioperative homeostasis will be measured to assess its impact on BNP secretion during the perioperative period.

ReferenceType: derived

ReferenceCitation: Kindo M, Minh TH, Perrier S, Petit-Eisenmann H, Bentz J, Cristinar M, Ajob G, Collange O, Mazzucotelli JP. Impact of prosthesis-patient mismatch on early haemodynamic status after aortic valve replacement. Interact Cardiovasc Thorac Surg. 2017 Jan;24(1):48-54. doi: 10.1093/icvts/ivw303. Epub 2016 Sep 13.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

location_facility: Service de Chirurgie Cardio-Vasculaire au NHC, Hôpitaux Universitaires de Strasbourg


type: Registry Identifier

title: Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.

acronym: GB-MOV

summary: This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients .

status: Recruiting

primary_purpose: Basic Science

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

location_facility:
CIC-GHPS
Groupe Hospitalier Pitie-Salpêtrière

intervention_type: Procedure


title: National Investigation in College and High School Among Adolescents on Health and Substances at the FSEF

acronym: EnCLASS-FSEF

summary:
For the clinical component:

Describe the young people hospitalised in residential care at the FSEF, in particular through vulnerability factors and their psychosocial repercussions (school level, repetition, intensity of symptoms, irritability, nervousness, substance use (cannabis, alcohol, tobacco), social relationships, family relationships, well-being, level of health literacy, learning disorders)) and to compare them with young people from the general school population.

For the epidemiological aspect:

To study the construct validity of the EnCLASS questions aiming to characterize handicap situations in the general school population in both a population in situation of psychic handicap and of somatic handicap.

lead_sponsor: Fondation Santé des Étudiants de France

lead_sponsor_type: industriel


title: Poor Knowledge Among French Travelers of the Risk of Acquiring Multidrug-resistant Bacteria During Travel

acronym: MDR bacteria

summary: Since it is not routine practice in France to raise public awareness about the risk of acquiring multidrug resistant Enterobacteriaceae (MRE) during international travel, the investigators aimed to determine, among French travelers attending a consultation for travel medicine, patients level of knowledge about the risk of acquiring MRE.

time_perspective: Cross-Sectional

ReferenceCitation: Migault C, Kanagaratnam L, Nguyen Y, Lebrun D, Giltat A, Hentzien M, Bajolet O, Drame M, Bani-Sadr F. Poor knowledge among French travellers of the risk of acquiring multidrug-resistant bacteria during travel. J Travel Med. 2016 Oct 30;24(1):taw073. doi: 10.1093/jtm/taw073. Print 2016 Jul. No abstract available.

lead_sponsor: CHU de Reims


title: Gamete Donation Conception and Disclosure to Children : Towards an Evaluation of the Practices

acronym: AMP

summary:
Assisted reproductive techniques (ART) is very framed in France by principles initially stated by the french CECOS Federation of (Centre d'Etude et de Conservation des Oeufs et du Sperme) and then included in the bioethic law. Since 1973, more than 50 000 births have been achieved through sperm donation, and the investigators have little knowledge of what information parents pass on to their children about how they have conceived. However, it is accepted that the secrecy about the use of donated gametes has negative consequences.

The investigators propose an original project never initiated in France, to evaluate at the national level the disclosure to the people conceived using donated gametes, thanks to an interdisciplinary research crossing medical approach (biology, psychology) and social sciences (anthropology, sociology). It uses a quantitave and qualitative approach relying on one hand on online questionnaires and on the other hand on semi-structured interviews, aimed at parent who have used ART with donated gametes and people conceived using donated gametes. This dual approach will outline broad trends in sharing information about the use of donated gametes, explore in depth the motivation of parental choices for information, and better understand the family and biographical dynamics associated with information sharing or its absence. Moreover, this project will lead to evaluate the way in which the parents received the messages of the professionnals involved in ART with donation gametes, in terms of disclosure to offspring.

The conclusions will highlight the most important elements that will be useful to the professionnals involved in gamete donation to help them improve their practices upstream, during, and after the completion of the ART with gamete donation.

time_perspective: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: service de Biologie de la Reproduction-CECOS


title: CDK13 Related Disorder : Clinical Phenotype, Neuropsychological Profile, Brain MRI Characteristics and Epigenetic Signature.

summary:
CDK13 related disorder is mainly characterised by developmental delay (DD) and intellectual disability (ID), ranging from mild to severe, and malformation syndrome.

The aims of this study are first to better delineate the clinical phenotype, as well as the neuropsychological profile, and the brain MRI characteristics; and, second, to study the epigenetic signatures in a cohort of individuals with CDK13 intragenic pathogenic variants. This work will conduct to a MD thesis of a clinical resident geneticist in France.

Physician that will participate will fill an Excel sheet regarding the clinical and neuropsychological assessment.

The investigators will be also happy to have either CD-ROM or a link to have access to the brain MRI data as well as a DNA sample with a minimum 0.5ug of peripheral blood genomic DNA. The investigators will gather the DNA in Montpellier genetic lab (Dr Mouna BARAT) and send the batch to the Dr Sadikovic' lab.

Between 2019 and 2020, The investigators have already recruited data from individuals with CDK13 pathogenic variants from France and several European genetic centres.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Genetic


title: Place of Birth and Neonatal Health in Cases of Preterm Birth Between 32 and 36 Weeks of Amenorrhoea: a National Population-based Study

summary:
Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns.

In the case of preterm birth, optimal antenatal, birth and postnatal management is necessary to prevent neonatal complications and mitigate longer-term consequences. However, we lack knowledge about the management of this at-risk population and the factors influencing their health.

This knowledge is needed in the current context of unfavourable trends in neonatal health. Over the last ten years, neonatal and infant mortality has stagnated in France, with France falling behind other European countries. According to the latest European report, France ranks 22nd out of 33 countries. The causes of this stagnation are not well known, but many hypotheses have been put forward, including sub-optimal organisation of care.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of the Analgesic Effect of Orally Administrated Ketamine in Peripheral Neuropathic Pain Disease: Comparison of Three Doses Versus Placebo.

acronym: KETACLUD

summary:
Nowadays, available drugs cannot always produce pain relief in patients with neuropathic pain disease.

It is believed that drugs acting as antagonists of the N-methyl-D-aspartic acid (NMDA) receptor may have been efficient in the treatment of neuropathic pain disorders.

Ketamine is the only NMDA receptor antagonist commercially available in France. Ketamine is usually administered intravenously for surgical anesthesia.

The intravenous administration of ketamine will be difficult to manage in the treatment of chronic neuropathic pain.

Some trials using oral ketamine for the treatment of neuropathic pain were conducted but results were heterogeneous. This may be explained by the different range of ketamine doses tested.

The aim of this clinical trial is to identify a safe and an efficient dose of orally administrated ketamine for the treatment of peripheral neuropathic pain.

The clinical trial will be conducted in Toulouse Hospital, France. This study is a randomized, double-blind, placebo-controlled trial. The study will be conducted using 4 parallel groups (three doses of ketamine versus placebo).

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse

intervention_type: Drug


title: Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations: Study of Principal Inter-individual Variation Factors

acronym: BDD TEP FDG

summary: The purpose of this study is to define a reference population for FDG-PET neurological examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma (tumor in remission, low disabling chronic tumor).

lead_sponsor: Central Hospital, Nancy, France

location_facility: Service de Médecine Nucléaire, Hôpital Central


title: Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program

acronym: NEMO-Nurse

summary:
Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. Although inflammation is predominantly expressed in the GI tract, extra-intestinal manifestations (EIMs) are so frequent that the concept of systemic disease is now widely accepted. Moreover, similar to other chronic diseases, patients with CD can be affected by other unrelated diseases which are called comorbidities.

Although no specific guidelines on comorbidity and EIMs in CD are available, data from other immune-mediated diseases support the use of nurse-led programs to improve the cost-effectiveness for the management of cardiovascular risk factors, increase rates of pneumococcal vaccination in high-risk patients, provide preventive measures against osteoporosis and increased fracture risk in older women.

The investigators believe that such an initiative can be conducted for CD patients by developing a CD-specific nurse-led program. Moreover, it has been shown that CD patients highly appreciate the "communicator role" and "skilled companionship" performed by nurses to fulfill their needs for attention to the "complete picture".

Therefore, the investigators hypothesize that a nurse-led program would increase the number of measures taken to treat or identify EIMs and/or comorbidities in CD patients and thus revolutionize their management.

primary_purpose: Prevention

location_country: Italy France

location_facility:
Nancy University Hospital
San Raffaele Hospital


title: Evaluation of Advanced Practice Nurse's Management of Patients With Chronic Myeloid Leukemia

acronym: IPA-LMC

summary:
Chronic Myeloid Leukemia (CML) affects 820 people per year in France (2018), half of them are older than 60 years old.

Tyrosine Kinase Inhibitors (TKI) are new kind of targeted therapy whose efficiency allow for a high rate of complete molecular response, leading to a disruption of treatment under certain conditions.

Optimizing CML treatment is a major concern, particularly for adverse events management, treatment compliance and therapeutic response. Multiple studies demonstrated that grade ≤ II adverse events are most likely to be under reported by patients and clinicians. Although these adverse events are mostly reported by clinical examination, needing minimal treatment. These toxicities could alter daily and domestic living activities, potentially impacting treatment compliance and therapeutic response. Therefore, early detection of these adverse events is a major challenge for the prognosis and care of CML.

The Advanced Practice Nurse (APN), a new health care professional, acquired the skills needed to independently follow, manage and care the patients with medical approvals.

At international level, many studies, in oncology and in others domains, have been done to demonstrate the added value of the APN, particularly in improving patient's quality of life, management, care of drug-induced adverse events and treatment compliance.

In France, because of the recentness of the profession, only few studies were have been conducted. The goal of this study is to demonstrate the benefit of APN in clinical follow-up, quality of life, treatment compliance, and therapeutic response of CML patients. These effects could be managed thanks to early detection and management of ≤ grade II adverse events during consultation, in partnership with the patients, and in collaborative working.

lead_sponsor: Centre Hospitalier Henri Duffaut - Avignon

location_facility: Centre Hospitalier d'Avignon, Hôpital Henri Duffaut


title: Moderators of Online Gambling, How Effective? Experimental, Controlled and Randomized Study.

acronym: MOD&JEU

summary:
Prevalence of problem gambling is estimated about 1-3% of the general adult population. This percentage increases to 5% when talking about online gambling. In France, the market for online gambling was recently opened up to competition and regulation (May 2010), including poker and sports/horse races betting, but excluding for the moment casino games. Recent international studies show that legalizing online gambling led to an increase of practices, including problem gambling.

In France, the law stipulates the establishment of moderators of online gambling, to prevent excessive gambling practices. The Regulatory Authority of Online Games (ARJEL) guarantees the implementation of these moderators. However, no evaluation of the effectiveness of these moderators is planned.

Therefore the investigators propose to conduct an experimental study about online gambling. The objective will be to evaluate the effectiveness of four kinds of moderators, some already legislated, but not evaluated, and others offered by the investigators team. Proposals for amending legislation will be made according the results of this study.

primary_purpose: Other

ReferenceCitation: Caillon J, Grall-Bronnec M, Saillard A, Leboucher J, Pere M, Challet-Bouju G. Impact of Warning Pop-Up Messages on the Gambling Behavior, Craving, and Cognitions of Online Gamblers: A Randomized Controlled Trial. Front Psychiatry. 2021 Jul 23;12:711431. doi: 10.3389/fpsyt.2021.711431. eCollection 2021.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

ReferenceCitation: Challet-Bouju G, Grall-Bronnec M, Saillard A, Leboucher J, Donnio Y, Pere M, Caillon J. Impact of Wagering Inducements on the Gambling Behaviors, Cognitions, and Emotions of Online Gamblers: A Randomized Controlled Study. Front Psychiatry. 2020 Nov 17;11:593789. doi: 10.3389/fpsyt.2020.593789. eCollection 2020.

ReferenceCitation: Caillon J, Grall-Bronnec M, Hardouin JB, Venisse JL, Challet-Bouju G. Online gambling's moderators: how effective? Study protocol for a randomized controlled trial. BMC Public Health. 2015 May 30;15:519. doi: 10.1186/s12889-015-1846-7.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer-Nature


title: National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood

acronym: DENACAPST

summary:
The DENACAPST programme represents an important initiative to provide near nation-wide roll-out of an important cancer surveillance program for childhood cancer survivors. The program is based on internationally recognized standards in cancer surveillance, which were developed by the International Guideline Harmonization Group (IGHG) with support of all relevant stakeholders in cancer survivorship research and clinical work in Europe, Canada and the United States and recognized French recommendations about breast screening for women at high risk of cancer.

With this programme, French centers organized themselves to provide to childhood cancer survivors adequate medical attention, which includes close medical surveillance for breast/thyroid cancer where appropriate, based on adequate risk stratification.

The aim of the study is to analyze if the recommendations about breast and thyroid cancer screening are followed in this population and secondly to provide more informations about these second cancers and about the screening.

study_start_date_type: Anticipated

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


title: Evaluation of a Question Prompt List for Patients With Myelodysplastic Syndromes (QPL-MDS)

acronym: QPL-MDS

summary:
MDS are a diverse group of hematopoietic malignancies, which mainly occur in patients over 75 years of age. Incidence rate in 2012 in France was more than 6 cases per 100 000 person-years. MDS are characterized by ineffective haematopoiesis causing cytopenia, and by leukemic transformation. The disease is heterogeneous, its pathophysiology complex and clinical evolution variable.The few data available on MDS patients show how difficult it is to understand MDS, its prognosis and the reasons for prescribing or not some treatments. In the context of a highly complex potentially lethal disease such as MDS, it is of utmost importance to optimize the information conveyed to patients. Particularly, 70.5% of MDS patients surveyed in our developmental study would have preferred more information about prognosis at diagnosis disclosure.

A simple intervention based on the use of a question prompt list (QPL), would greatly improve the information process by helping patients to express their main concerns at their medical consultations. Cultural differences may exist in the appraisal of QPLs and QPLs have not yet been widely used in France.

However, in line with the previous results available in the literature and in a context a priori favourable to the use of such an instrument, the investigators hypothesise that use of a QPL will increase MDS patients' expressions of concerns and questions at their medical consultations. Particularly the investigators assume that the discussion about prognosis will be facilitated, without increasing anxiety because patients remain free to ask or not for such information. The use of QPLs would also be a way to limit social inequalities related to insufficient information and to encourage patient-doctor communication and meeting of patient preferences which could lead to better health outcomes.

primary_purpose: Health Services Research

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Institut Paoli-Calmettes
Chu Grenoble

intervention_type: Behavioral


title: Effect of the Early Ultrasound-guided Femoral Nerve Block Performed by Emergency Physicians on Pre-operative Opioids Usage in Patients With Proximal Femoral Fractures: a Randomized Controlled Trial

acronym: FORELEG

summary:
In France, approximately 80,000 patients with a fracture of the upper extremity of the femur (femoral neck or trochanter) are admitted in the emergency department. This is a serious disease with a one-year mortality rate of 29% (i.e., 1 of 5 women and 1 of 3 men), and significant consequences on quality of life and autonomy. The morbidity of these fractures is closely related to the occurrence of altered mental status or delirium, before and after surgery. The diagnosis is based on clinical features and x-rays of the hip. These fractures are associated with severe level of pain, before and after the surgery. For emergency physicians, managing appropriately the pain is a common problem at the admission in the emergency room. Proper pain management is essential to ensure patients' comfort before surgery, but also to ensure their return to their previous functional and cognitive state after surgery. For patients, the goal of treatment is to regain walking as quickly as possible, while minimizing surgical and medical complications. However, severe pain induced by the fracture may lead to an acute altered mental status or delirium. In France, the latest guidelines about analgesia in emergency medicine reported that local anesthesia and loco-regional anesthesia (LRA) are useful and should be promoted in emergency medicine. In 2010, these guidelines proposed to perform LRA techniques such as iliofascial block more widely available. In 2016, the largest review of the literature on the use of regional nerve blocks for hip and femoral neck fractures in the emergency department [MEDLINE (1946-2014), EMBASE (1947-2014), CINAHL (1960-2014), and the Cochrane Central Register of Controlled Trials] indicated that the femoral nerve block was likely to be at least as effective as, if not superior to, standard analgesic practices for decreasing pain after ESF fracture.

The authors of the meta-analysis suggested the superiority of ultrasound guidance compared to anatomic techniques or use of neurostimulation for an adequate needle placement. Despite the increasing availability of ultrasound in the emergency department, recent literature supporting the efficacy of ultrasound-guided femoral nerve block, and the improvement of ultrasound skills in routine emergency medicine practice, the literature lacks of data about the effective duration of action, medication influence, and the occurrence of complications when an ultrasound-guided femoral nerve block is used by emergency physicians at the admission.

For patients with hip fractures, it is questioned if ultrasound-guided femoral block used early on admission in the emergency room is in more efficient than intravenous morphine titration in reducing opioid use before surgery? Our hypothesis is that early use of ultrasound-guided femoral nerve block in the emergency room decreases preoperative opioid use (intravenous and/or oral) in patients with proximal femoral fractures.

ReferenceCitation: Haleem S, Lutchman L, Mayahi R, Grice JE, Parker MJ. Mortality following hip fracture: trends and geographical variations over the last 40 years. Injury. 2008 Oct;39(10):1157-63. doi: 10.1016/j.injury.2008.03.022. Epub 2008 Jul 24.

ReferenceCitation: Gerson LW, Emond JA, Camargo CA Jr. US emergency department visits for hip fracture, 1992-2000. Eur J Emerg Med. 2004 Dec;11(6):323-8. doi: 10.1097/00063110-200412000-00005.

ReferenceCitation: Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

ReferenceCitation: Riddell M, Ospina M, Holroyd-Leduc JM. Use of Femoral Nerve Blocks to Manage Hip Fracture Pain among Older Adults in the Emergency Department: A Systematic Review. CJEM. 2016 Jul;18(4):245-52. doi: 10.1017/cem.2015.94. Epub 2015 Sep 10.

ReferenceCitation: Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19.

ReferenceCitation: Holdgate A, Shepherd SA, Huckson S. Patterns of analgesia for fractured neck of femur in Australian emergency departments. Emerg Med Australas. 2010 Feb;22(1):3-8. doi: 10.1111/j.1742-6723.2009.01246.x. Epub 2009 Dec 14.

ReferenceCitation: Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.

ReferenceCitation: Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.

ReferenceType: result

ReferenceCitation: Gerlier C, Mijahed R, Fels A, Bekka S, Courseau R, Singh AL, Ganansia O, Chatellier G. Effect of early ultrasound-guided femoral nerve block on preoperative opioid consumption in emergency patients with hip fracture: a randomized trial. Eur J Emerg Med. 2024 Feb 1;31(1):18-28. doi: 10.1097/MEJ.0000000000001075. Epub 2023 Aug 24.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Accidental Reactions in a French Cohort of Children With Peanut and/or Tree Nut Allergy.

acronym: ALLERGY

summary:
Food allergy is an immune reaction, triggered by food protein allergens, of varying severity, from mild local reaction to life threatening anaphylaxis and fatalities.

Peanut is a plant from the botanical family of the Fabaceae, more commonly known as legumes. The prevalence of peanut and tree nut allergy is increasing. In France (ELFE cohort), it is estimated to 0.93%. The tree nuts include mainly almond, hazelnut, pistachio, cashew nut, walnut, pecan nut and Brazil nut. Allergy's prevalence is estimated to 0.54% in children up to 5.5 years. Peanut allergy is a main cause of anaphylaxis and deaths due to food allergy.

Recurrence of food allergy is a main concern. The risk has been estimated to 10% per year for peanut.

In France, Data in real-life on the rate of recurrence of allergic reactions and anaphylaxis to peanut/tree-nut as well as risk factors, are lacking.

The objective of this study is to assess the frequency of allergic reaction to peanut and tree-nuts, to describe the reactions' characteristics and risk factors.

lead_sponsor: University Hospital, Lille


title: Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®

acronym: TOFScan

summary:
The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population.

Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:

the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value
the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value
recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)
complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

location_facility: CHRU de NANCY - Hôpitaux de Brabois - Département d'Anesthésie-Réanimation


title: Influence of Social Determinants of Health on the Management of Hepatocellular Carcinoma in the French National Cohort Study CHIEF

acronym: SOCIAL-CHIEF

summary:
With 8,000 related deaths per year, HCC is one of the most dangerous cancers in France. The main reason for the poor prognosis of HCC is most often a diagnosis at an advanced stage ineligible for curative treatment. In the field of oncology, low participation to screening is closely linked to socioeconomic status (e.g. level of education, income, employment). In HCC, the socioeconomic status is linked to incidence, overall survival and treatment allocation in US, UK and Australia. This suggests that the social environment should be taken into account when designing interventions and policies that allows facilitating the medical pathways for patients with HCC with the ultimate goal of improving the overall prognosis. However, the studies assessing the impact of social determinants on the management of HCC in France are limited. Bryère at al. reported that the highest incidence and the worst prognosis of HCC were observed in the most disadvantaged populations in France. To date, there is no available data concerning the influence of social determinants on: implementation of surveillance programs of HCC, stage of disease at the time of diagnosis or treatment allocation. This data is essential for better understanding the geographic disparities observed in France and for developing the strategies to remedy them.

CHIEF is a multicenter longitudinal observational study of patients with HCC (ClinicalTrials.gov Identifier: NCT04348838), that will collect the exhaustive data including patient and tumor characteristics, diagnostic circumstances and modalities, care pathway from diagnostic imaging to referral to expert center, treatment allocation and implementation, and 5-year follow up including recurrent assessment of quality of life.

Social-CHIEF is an ancillary study to the CHIEF cohort (approved by CHIEF scientific committee). The population of this study will consist in a subset of patients from the CHIEF prospectively included or already recruited who accept to participate in this study. The data collected in CHIEF will be retrieved from the CHIEF main database and additional data about social determinants will be specifically investigated by self-administrated questionnaires. The results obtained will provide a better understanding of the influence of social determinants on health trajectories of HCC patients. These data will be essential in recommending new health policies and in designing innovative intervention studies to address social disparities.

ReferenceCitation: Costentin CE, Mourad A, Lahmek P, Causse X, Pariente A, Hagege H, Dobrin AS, Becker C, Marks B, Bader R, Condat B, Heluwaert F, Seitz JF, Lesgourgues B, Denis J, Deuffic-Burban S, Rosa I, Decaens T; CHANGH Study Group. Hepatocellular carcinoma is diagnosed at a later stage in alcoholic patients: Results of a prospective, nationwide study. Cancer. 2018 May 1;124(9):1964-1972. doi: 10.1002/cncr.31215. Epub 2018 Mar 28.

ReferenceCitation: Damiani G, Basso D, Acampora A, Bianchi CB, Silvestrini G, Frisicale EM, Sassi F, Ricciardi W. The impact of level of education on adherence to breast and cervical cancer screening: Evidence from a systematic review and meta-analysis. Prev Med. 2015 Dec;81:281-9. doi: 10.1016/j.ypmed.2015.09.011. Epub 2015 Sep 25.

ReferenceCitation: Herbert C, Launoy G, Gignoux M. Factors affecting compliance with colorectal cancer screening in France: differences between intention to participate and actual participation. Eur J Cancer Prev. 1997 Feb;6(1):44-52. doi: 10.1097/00008469-199702000-00008.

ReferenceCitation: Jembere N, Campitelli MA, Sherman M, Feld JJ, Lou W, Peacock S, Yoshida E, Krahn MD, Earle C, Thein HH. Influence of socioeconomic status on survival of hepatocellular carcinoma in the Ontario population; a population-based study, 1990-2009. PLoS One. 2012;7(7):e40917. doi: 10.1371/journal.pone.0040917. Epub 2012 Jul 13.

ReferenceCitation: Singal AG, Li X, Tiro J, Kandunoori P, Adams-Huet B, Nehra MS, Yopp A. Racial, social, and clinical determinants of hepatocellular carcinoma surveillance. Am J Med. 2015 Jan;128(1):90.e1-7. doi: 10.1016/j.amjmed.2014.07.027. Epub 2014 Aug 10.

ReferenceCitation: Clark PJ, Stuart KA, Leggett BA, Crawford DH, Boyd P, Fawcett J, Whiteman DC, Baade PD. Remoteness, race and social disadvantage: disparities in hepatocellular carcinoma incidence and survival in Queensland, Australia. Liver Int. 2015 Dec;35(12):2584-94. doi: 10.1111/liv.12853. Epub 2015 May 22.

ReferenceCitation: Bryere J, Dejardin O, Bouvier V, Colonna M, Guizard AV, Troussard X, Pornet C, Galateau-Salle F, Bara S, Launay L, Guittet L, Launoy G. Socioeconomic environment and cancer incidence: a French population-based study in Normandy. BMC Cancer. 2014 Feb 13;14:87. doi: 10.1186/1471-2407-14-87.

ReferenceCitation: Tron L, Belot A, Fauvernier M, Remontet L, Bossard N, Launay L, Bryere J, Monnereau A, Dejardin O, Launoy G; French Network of Cancer Registries (FRANCIM). Socioeconomic environment and disparities in cancer survival for 19 solid tumor sites: An analysis of the French Network of Cancer Registries (FRANCIM) data. Int J Cancer. 2019 Mar 15;144(6):1262-1274. doi: 10.1002/ijc.31951. Epub 2018 Dec 3.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
University Grenoble Alps
University Hospital, Caen
Amiens University Hospital
National Cancer Institute, France


title: Design Of WELL Being Monitoring Systems, Application in Autism

acronym: Do Well B

summary: The worldwide prevalence of autism is constantly increasing. People with autisms have difficulties in communication and social interaction resulting from atypical perceptual and information processing, leading to the accumulation of anxiety. Extreme overloading experienced internally may not be visible externally. Identifying stressful situations at an early stage may avoid socially problematic behavior from occurring, such as self-injurious behavior. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of a portable device, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for the non-communicative individuals with autism.

ReferenceCitation: Dutheil F, Chambres P, Hufnagel C, Auxiette C, Chausse P, Ghozi R, Paugam G, Boudet G, Khalfa N, Naughton G, Chamoux A, Mermillod M, Bertrand PR. 'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism. BMJ Open. 2015 Feb 20;5(2):e007716. doi: 10.1136/bmjopen-2015-007716.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repository_normalized: HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: University Hospital of Clermont-Ferrand (CHU), France


title: Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving

acronym: Procrav

summary: The aim of this study is to have a better understanding of the relationship between self-controle difficulties (and more specifically the inhibition deficit in impulsivity), emotional regulation disorders such as alexithymia and craving.This study will be the first in France to specify the interactions between self-regulkation processes dysfunctions and emotional dysfunctions in craving.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
Ramsay santé


title: Qualitative Study Evaluating Opinions Regarding HPV Vaccinnation in Boys' Parents Aged From 11 to 14 Years Old

acronym: QUALIOPIVAC

summary:
The human papilloma virus infection is the most frequent sexually transmitted infection around the world. In the vast majority of cases, these are inapparent infections that disappear spontaneously. In some cases, the HPV infection persists and can generate anogenital warts or cancer.

In France, the papillomavirus is responsible for 6000 new cases of cancer/year with several possible localizations : cervical, anal, penile, oropharyngeal, vulvar or vaginal. Among them, 4580 new cases of cancer/year occur in women, and half of them are diagnosis of cervical cancer. A quarter of cancers caused by papillomavirus occur in men.

In France, the commercialization of anti-HPV vaccine in 2007 was addressed only to girls, in order to gain a group immunity that would therefore protect the boys. This vaccination did not achieve the cover immunization target that were announced: the objective was fixed at 60% of vaccination coverage and at the end of 2018, only 24% was achieved on the complete vaccination schedule. In December 2019, the French National Authority for Health recommended the anti-HPV vaccinations in girls and boys.

lead_sponsor: Centre Hospitalier Eure-Seine


title: Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.

acronym: OXYREA

summary: In France, the most used humidifying system during oxygen therapy is a non heated device with weak efficiency and non-proven clinical benefits. This study aims to assess the lack of benefits of non-heated humidification compared to no humidification, as regards to the comfort of the patient receiving oxygen therapy.

lead_sponsor: University Hospital, Angers


title: Evaluation of the Efficiency of a Cognitive Remedial Program (PROCOG-SEP) Designed for Multiple Sclerosis Patients. A Double Blind Randomized Multicenter Trial.

acronym: PROCOG-SEP

summary:
Cognitive disorders are well-known in multiple sclerosis (MS), even in earlier stages of the disease. They effect personal life. Their management may be overlooked. The evidence-based program proposes exercises to both stimulate preserved functions and develop new abilities compensating for cognitive disabilities.

Aim of the study is to evaluate the efficiency of the remedial program (PROCOG-SEP) designed for MS patients, compared to an interactive discussion program(DISINT) 140 multiple sclerosis patients will be randomly assigned in one the program for 13 sessions over a 6-month period.

Main outcome criteria is evolution of SRT-LIST before and after program.

collaborators: Centre Hospitalier Universitaire de Besancon


acronym: REVOLMUCO

summary:
The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Standard respiratory function criteria for older children and adults is forced expiratory volume/second.

This technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second.

For preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic measure of specific resistance (sRaw), functional residual capacity by Helium dilution technique (CRF He), arterial blood gas measurement, pulmonary clearance index.

All these methods have a better success rate and can be used in alternative or with forced spirometry. However, each of them gives only a part of information on airway and lung damage of detected children. It is necessary to combine them for a better information on overall respiratory damage.

In France, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment.

So, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers.

A referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. And, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.

location_facility: University Hospital of Montpellier, Arnaud de Villeneuve


title: Primary Dependence to Analgesic Drugs: Development of a Predictive Approach Based on Early Modifications of Drug Use in the Ambulatory Care Setting

acronym: NEO-ADDICT

summary: Abuse of analgesics represents an important part of prescription drug abuse. The consequences in terms of morbidity and mortality at the population level could reach worryingly high levels, as illustrated by the US context. This issue should not focus only on opioid analgesics, but must also account for some antiepileptics or antidepressants with abuse potential (for example, pregabalin or gabapentin). In France, reports related to tramadol abuse are increasing, in particular since dextropropoxyphene withdrawal. Trends of growing abuse are also reported for other analgesics. Patients with no history of primary dependence constituted a significant proportion of those developing a tramadol abuse. There is therefore a need for early identification of these patients and to raise awareness of health professionals on this issue, in particular in primary care. Given the extensive use of analgesic drugs in France, the problem of primary dependence should not be neglected. Since it will affect people who have no history of drug abuse, strategies for identification and prevention are differing from a population already using psychotropic products for example.

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

acronyme: NEO ADDICT

titre: Addiction et dépendance primaire aux médicaments analgésiques: développement d'outils prédictifs à partir des modifications précoces des comportements d'utilisation identifiés en médecine ambulatoire

discipline_principale: médecine générale

nom_porteur: LAPEYRE MESTRE

prenom_porteur: Maryse


title: Evaluation of the Patient's Autonomy Vis-à-vis the Therapeutic Project Proposed in a Chronic Pain Structure

acronym: DoulEthic

summary:
Patient autonomy is recognized throughout the world, by caregivers, as a value. The idea of autonomy has been the keystone of the changes accomplished in the contemporary history of health law. It is about respect for everyone to have their own health and to choose the options that correspond to their wishes, their values or their life projects. The recently revised definition of pain specifies that it is "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage". In this, pain is always a personal experience that is influenced to varying degrees by biological, psychological and social factors. The High Authority of Health considers pain as chronic is considered when it is persistent or recurrent beyond what is usual for its presumed initial cause (most often beyond 3 months), that it responds harm to treatment and that they induce a significant and progressive deterioration of functional and relational capacities. Chronic pain confines patients on a psychosocial level. It is no longer just a symptom, it is even a disease in its own right since 2019 with the new classification of diseases proposed by the World Health Organization.In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state". In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state".In France, chronic pain concerns 31.7% of French people regardless of its intensity, and 19.9% of French people for moderate to severe pain, which represents 13 million people in total. As with any chronic disease, the patient suffering from persistent pain must develop the ability to adapt to cope with the new situation with which he is confronted. He must be able to acquire knowledge and new know-how related to his pathology and thus finally find a new homeostasis, a new state of health having integrated "the pathological state".

In current practice, this skill is assessed in case of doubt (generally when there is uncertainty about the patient's understanding of the issues and his involvement in the therapeutic project) intuitively, by following a Socratic questioning or from grids like the MacCAT-T. In the pain center, investigators use the MacCAT-T but investigators have not yet systematically measured the benefit and the cost of using this questionnaire in everyday practice. In particular, investigators want to know if the skill is not overestimated by the doctor in charge of the patient.

ReferenceCitation: Raja SN, Carr DB, Cohen M, Finnerup NB, Flor H, Gibson S, Keefe FJ, Mogil JS, Ringkamp M, Sluka KA, Song XJ, Stevens B, Sullivan MD, Tutelman PR, Ushida T, Vader K. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020 Sep 1;161(9):1976-1982. doi: 10.1097/j.pain.0000000000001939.

ReferenceCitation: Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.

ReferenceCitation: Bouhassira D, Lanteri-Minet M, Attal N, Laurent B, Touboul C. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008 Jun;136(3):380-387. doi: 10.1016/j.pain.2007.08.013. Epub 2007 Sep 20.

ReferenceCitation: Engel GL. The need for a new medical model: a challenge for biomedicine. Science. 1977 Apr 8;196(4286):129-36. doi: 10.1126/science.847460.

ReferenceCitation: Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997 Nov;48(11):1415-9. doi: 10.1176/ps.48.11.1415.

ReferenceCitation: Raffard S, Lebrun C, Laraki Y, Capdevielle D. Validation of the French Version of the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) in a French Sample of Individuals with Schizophrenia: Validation de la version francaise de l'instrument d'evaluation des competences MacArthur-traitement (MacCAT-T) dans un echantillon francais de personnes souffrant de schizophrenie. Can J Psychiatry. 2021 Apr;66(4):395-405. doi: 10.1177/0706743720966443. Epub 2020 Oct 16.

ReferenceCitation: Etchells E, Darzins P, Silberfeld M, Singer PA, McKenny J, Naglie G, Katz M, Guyatt GH, Molloy DW, Strang D. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999 Jan;14(1):27-34. doi: 10.1046/j.1525-1497.1999.00277.x.


title: Qualitative and Functional Investigation of Lipids in Patients With SARS-CoV2 Infection - In Search of Atherogenic Sequelae

acronym: COVI-LIPI-D

summary:
Currently, the world is facing a SARS-CoV2 coronavirus epidemic, which is responsible for COVID-19. In France, this virus has already infected several million people and is responsible for the death of more than 127,000.

Infection is associated with a higher number of cardiovascular events (myocardial infarction, stroke, cardiac arrhythmia, thrombosis ...) in the short and medium term after infection. The long-term complications of this infection are not yet known and are the subject of research in France and in the world.

In order to investigate the possible long term sequelae of this virus infection, this research aims to evaluate the potential cholesterol abnormalities caused by COVID-19, which could play a significant role in the increase of cardiovascular risk in affected patients.

A total of 180 analysable participants will be recruited in this study. They will be divided into four groups of participants that will be compared to one another:

30 participants who were infected with SARS-CoV2 with no or few signs and did not require hospitalization.
30 participants who were infected with SARS-CoV2 and whose severity of illness required hospitalization in a COVID unit
30 participants who were infected with SARS-CoV2 and required intensive care hospitalization due to severity of illness.
90 participants who were not infected with SARS-CoV2.

For each participant, the study will last approximately 1 hour, the time to fill out the consent forms, to answer a few questions about their current medical history and finally to take a blood sample for lipid measurements.

intervention_type: Biological


title: Heart Failure Educational and Follow up Platform

acronym: HELP

summary: Heart failure is a serious and common disease. HF is marked by a high rate of preventable hospitalizations through proper care. As such, it is a key target for telemedicine programs. However, currently published data are inconclusive. Investigators propose a multicenter randomized study of innovative telemedicine involving the usual patient monitoring daily weight monitoring, clinical signs and in one of three groups in our study of BNP testing in the patient's home all associated with a regular education reinforcement. The objective is to identify early cardiac decompensation to allow to treat ambulatory and thus prevent the occurrence of more serious events such as death or rehospitalization.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

lead_sponsor: Hôpital NOVO

location_facility:
Henri-Mondor Hospital
Sainte Marie Clinic
Georges Pompidou University Hospital
Centre Hospitalier René DUBOS
Meaux Hospital
Mutualiste Montsouris Institute
Gonesse Hospital
Victor Dupouy Hospital
Orsay Hospital
Sud francilien Hospital
Poissy-Saint-Germain-en-Laye Hospital
Versailles Hospital
Simone Veil Hospital
Bernard Clinic
Turin Clinic


title: Evaluating Effectiveness of Barrier Measures to Limit Nosocomial Transmission: Covid-19 Prevalence Survey Among Caregivers With Various Exposures

acronym: EMBELLIE

summary:
Use lay language. The Covid-19 pandemic hit France in March 2020 and stage 3 of the epidemic justified the introduction of national and unprecedented containment measures from March 17, 2020. The Montpellier CHU experienced peak hospitalizations of Covid-19 infections in late March. The estimate of the proportion of infected people in Occitania, South of France, for the 11th of May 2020 is 3.1% (95% CI: 1.9-5.9) for the Occitania region, to which Montpellier belongs.

In the context of the Covid-19 epidemic, notably due to the absence of pharmacological or vaccine prophylaxis, barrier measures were of crucial importance, especially for exposed caregivers. These measures include an adaptation of individual behavior, the creation of a so-called "Covid" hospital, the wearing of specific equipment in all departments, the use in the rooms of Covid-19 patients of a gown, an apron, gloves, and a FFP2 type mask in the event of contact and sampling, protocolized and standardized bio-cleaning measures, a reorganization of the premises and the definition of specific circuits.

In view of the second wave of the epidemic, estimating the effectiveness of the barrier measures is of major importance. The investigators therefore propose an evaluation of the effectiveness of these measures, by comparing the serological prevalence of infection among caregivers working directly in COVID units compared to caregivers working in services excluding the management of Covid-19 patients.

Systematic evaluation in COVID-19 units of Sarc-Co-V2 infection will also be assessed, with naso-pharyngeal swabs.


acronym: TRANSTEP

summary:
Breast cancer is a major public health problem. In France, it is the leading cause of cancer death in women. According to the National Cancer Institute (INCA), approximately 49,000 new cases were diagnosed in 2012 in France.

It is an heterogeneous disease, comprising a plurality of entities whose clinical behavior, biological and prognosis differ. Amongst these entities, the breast cancer triple negative (TN) is defined by the absence of expression of estrogen receptor and progesterone and the absence of overexpression of HER2 oncoprotein. It represents about 15% of breast cancers and occurs more frequently in young women. This is a very proliferative tumor phenotype with metastatic potential. Because of its genomic heterogeneity and lack of recurrent identified molecular target, no targeted therapy has today shown benefit in terms of survival compared to conventional cytotoxic chemotherapy, which partly explains the very poor prognosis of this tumor phenotype. The positron emission tomography (PET) with 18Fluoro-deoxy-glucose (FDG) is a molecular imaging test that can identify from the first or second neoadjuvant chemotherapy treatment non-responder patients to treatment with low probability of pathologic complete response (pCR) after neoadjuvant chemotherapy. For this two FDG-PET examinations should be performed; a) a pretreatment PET b) a control PET after one or two treatments. The objective of this pilot, single-center, prospective study is a preliminary identification of recurrent genomic alterations among triple-negative tumors with early chemoresistance, identified by PET in the first cycle of neoadjuvant therapy.

lead_sponsor: Centre Georges Francois Leclerc


title: Defect in Cell Stimulation and Unexplained hemorrhagesMarkers Related to Membrane Remodelling in the Prognosis Scott-like Syndormes

summary: Purpose: Identification of the gene(s) involved in plasma membrane remodelling. Identification of the circulating markers affected by the defective membrane remodelling in a collection of families with unexplained provoked hemorrhages and evaluation of their prognosis value in the assessment of the hemostatic cellular response.Hypothesis: Scott syndrome is rare a familial disorder characterized by provoked haemorrages in homozygous-type patients due to isolated membrane remodelling deficiency. Membrane remodelling is necessary for cellular hemostatic responses.

lead_sponsor: University Hospital, Strasbourg, France

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

location_country: Martinique France

location_facility: Hôpital Antoine Béclère, Service d'Hématologie Biologique

location_facility: Laboratoire d'Hémostase et d'Immunologie, Centre Hospitalier

location_facility: Laboratoire d'Hématologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service d'Hématologie Biologique, Hôpital Pierre Zobda Quitman

location_facility: Laboratoire d'Hématologie, Hôpital Robert Debré


title: Comparison of Cytokine Profiles in Aqueous Humor of Patients With Age Related Macular Degeneration (AMD)

summary: Age-related macular degeneration (AMD) affects 2 million people in France. It characterized by progressive degeneration of the central area of the retina allowing detailed vision. It is the main cause of irreversible blindness in France. All patients initially present an early form, the latter can evolve in two different ways: the atrophic form, which progresses slowly, and the exudative or neovascular form, of more rapid evolution. While the treatment of exudative AMD has improved dramatically in recent years, there is currently no therapy for atrophic AMD. Recently, it has been demonstrated in atrophic AMD, an accumulation of inflammatory cells, macrophages, in the sub-retinal space. This space is located between the pigment epithelium (PE) and the photoreceptors. It is physiologically devoid of immune cells (immune privilege). Macrophages will secrete many pro-inflammatory molecules, such as cytokines. It has been shown in mouse models that some cytokines (IL-1beta, IL6 et TNFalpha) have a deleterious role on (PE) and photoreceptors. The identification of specific cytokines in the aqueous humor of patients with atrophic AMD would help to better understand this disease and consider potential targeted therapies. This study will be conducted in the ophthalmology department of the Croix-Rousse Hospital in Lyon. 80 patients will be recruited and divided into 4 groups: three experimental groups of 20 patients with : Early / Intermediate AMD, atrophic AMD or exudative AMD, and one control group of 20 patients without signs of AMD. Assays of the markers will be performed using the Luminex® technique on aqueous humor and blood samples collected for all patients during cataract surgery. The concentrations obtained in the aqueous humor will be normalized on their respective blood levels in order to confirm the intraocular secretion of these markers,. The identification of particular cytokine profiles in atrophic AMD compared to other forms of AMD would support emerging hypotheses of involvement of specific inflammatory cells in this pathology. There is currently no treatment available for atrophic AMD. If molecular screening identifies one or more specific biomarkers, targeted therapy may be considered.

lead_sponsor: Hospices Civils de Lyon


title: 3-year Follow-up of Patients Treated With Jetstream Combined With Ranger for Calcified Femoropopliteal Lesions

acronym: FIDJI

summary: The goal of this non interventional study is to evaluate the long-term clinical effects (3-year follow-up after the procedure) of Jetstream atherectomy combined with a paclitaxel-eluting balloon (Ranger) in all patients who were treated for calcified femoropopliteal lesions (de novo, single or multiple, mono- or bilateral) between December 1, 2016 and December 31, 2020 at the Clinique Rhône-Durance, Avignon, France

lead_sponsor: Association de Provence pour la Promotion de l'Enseignement et la Recherche Cardiologique


title: Prevalence of Deep Sedation in Terminal Palliative Phase

summary: This nation-wide, multicentric, prospective and cross-sectional study aims to estimate the prevalence of deep sedations (i.e. with a -4 or -5 score at the Richmond scale at the induction time) for patients in terminal phase and receiving cares from a specialized palliative care facility (palliative care units, dedicated beds in acute units, mobile teams for inpatient or outpatients or home-based structures) in France.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux - St André


title: Predictive Value Analysis of Messenger Ribonucleic Acid (mRNA) Urinary Expression of Foxp3 and Vimentin on Graft Outcome in Renal Transplant Recipient: National Prospective Study

acronym: TUFEV

summary: This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.

ReferenceCitation: Aquino-Dias EC, Joelsons G, da Silva DM, Berdichevski RH, Ribeiro AR, Veronese FJ, Goncalves LF, Manfro RC. Non-invasive diagnosis of acute rejection in kidney transplants with delayed graft function. Kidney Int. 2008 Apr;73(7):877-84. doi: 10.1038/sj.ki.5002795. Epub 2008 Jan 23. Erratum In: Kidney Int. 2008 Aug;74(3):393. Veronose, F J V [corrected to Veronese, F J V]; Berdichewski, R H [corrected to Berdichevski, R H].

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Tele-education in Patients With a Moderate Depressive Episode in Primary Care

acronym: TE-DSP

summary:
Considering that one out of five people may experience depression during the course of their life, and that compliance to anti-depression medication is often not optimal.

Psycho-educational interventions are recommended in international clinical practice guidelines for the management of depression. They are the first step in the treatment protocol.

Psychoeducation in the treatment of depressive episodes has been shown to be an effective intervention because it reduces depressive symptoms, the risk of relapse or recurrence and improves adherence to treatment.

In France, there are only one approved psycho-education programme, but it concerns a population of patients under psychiatric care.

No psycho-education programme has yet been carried out or evaluated in France on depressed patients followed up in primary care by their General Practitioner.

Recent changes in our healthcare practices, which have required adaptation to the pandemic context, have led to the development of the use of telemedicine.

This study aims to evaluate a new and 100% remote educational program adapted to patients ongoing moderate depression and focused on medication adherence, economic gain and patients and professional satisfaction.

status: Not yet recruiting

lead_sponsor: University Hospital, Toulouse


title: Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA Study)

acronym: EMOA

summary: Describe the proportion of patients who underwent cardiac surgery in France and benefiting from a monitoring cardiac output, describe the use of positive inotropic and vasoactive agents for cardiac surgery patients operated (type of catecholamines, their duration), describe the fluid replacement and transfusions of first 24 hours, describe the incidence of postoperative complications in patients undergoing cardiac surgery.

lead_sponsor: University Hospital, Caen


title: Vitamin D Status in Pregnant Women With Preeclampsia

acronym: FEPED

summary: Hypothesis : Vitamin D serum concentration is decreased in the first trimester in pregnant women who will develop preeclampsia in the second or third trimester compare to a control group Primary purpose : To determine the vitamin D status in the first trimester in a large population of french pregnant women in order to evaluate the importance of the vitamin D deficiency in France and correlate this deficiency with preeclampsia

ReferenceCitation: Salakos E, Rabeony T, Courbebaisse M, Taieb J, Tsatsaris V, Guibourdenche J, Senat MV, Haidar H, Jani JC, Barglazan D, Maisonneuve E, Haguet MC, Winer N, Masson D, Elie C, Souberbielle JC, Benachi A. Relationship between vitamin D status in the first trimester of pregnancy and gestational diabetes mellitus - A nested case-control study. Clin Nutr. 2021 Jan;40(1):79-86. doi: 10.1016/j.clnu.2020.04.028. Epub 2020 Apr 25.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier


title: Effects of Stabilization Shoes on Balance and Walking. A Cross-over, Controlled, Randomized Single Blind Study.

acronym: BALAGE

summary:
Movement during everyday activities most often requires stable posture. Postural control corresponds to a complex motor ability to maintain / re-establish balance and orient one's body in the environment. Postural stability and equilibrium deteriorate with age. More than 30% of people over 65 years old fall per year. Falls represent 90% of hip fractures and sometimes result in lasting psychological effects. Shoes are our direct link between the ground and our feet. Wearing shoes plays a major role in postural control. The characteristics of shoes usually worn by elderly people are identified with those of shoes known to be 'dangerous'. In order to improve stability and reduce the risk of falling for the elderly, Axis-Comfort Development® has developed "experimental balance shoes". Their shoes have technical characteristics presented in the scientific literature as beneficial for postural stability.

Therefore, the aim of this study was to investigate the effects of wearing experimental balance shoes on postural balance compared with the people's own shoes. We assumed that postural balance would be improved by experimental balance shoes in an acute way and improved by a familiarization phase.

This was a controlled, randomized, blind and cross-over study. three sessions were held in our center, each time interspersed with a phase of familiarization at home (7 to 10 days) during which the people had to wear either the experimental balance shoes or their own personal shoes. 21 volunteers in total participated in this study, all between 65 and 75 years old. Five tests were presented randomly for each session and all tests were carried out on a Huber 360 ® (LPG System, France) stabilometric platform. The mains criteria were static equilibrium on one foot and two feet (with eyes open and closed) and secondary criteria were stride frequency during the walk on the spot and stability limits.

An improvement of these multiple criteria during the different sessions would be proof of the positive effect of experimental balance shoes on postural balance in the elderly.

lead_sponsor: University of Burgundy

location_facility: Centre d'Expertise de la Performance - Université de Bourgogne


title: Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants With Isolated Congenital Diaphragmatic Hernia (CDH)

acronym: CHIC

summary:
Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20 to 50% according to different hospitals in France and abroad.

Several studies already showed the benefice of late cord clamping at birth on biological and physiological adaptation of newborns to life. Previous works also suggest a possible benefit of this procedure for babies with CDH.

This multicenter randomized clinical study aims to investigate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in full term newborn infants with isolated CDH.

sponsor_collaborators:
University Hospital, Lille
Ministry of Health, France

location_facility:
Hop Jeanne de Flandre Chu Lille
Chu Amiens Picardie
Chu de Nantes -

region: Hauts-de-France

nom_etablissement: CHR LILLE

acronyme: CHIC

titre: Efficacité de la réanimation à cordon intact comparée au clampage immédiat du cordon sur l'adaptation cardiorespiratoire des nouveau-nés porteurs de hernie diaphragmatique congénitale isolée

discipline_principale: neonatology

nom_porteur: STORME

prenom_porteur: Laurent


title: Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -

summary: Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects

location_facility:
CHU Grenoble
CHU Reims
CHU Brest
CHU Strasbourg
CH Cannes
CHU Angers


title: French National Registry of Rare Peritoneal Surface Malignancies (RENAPE Registry)

acronym: RENAPE

summary:
Despite advances in the management of and changes in clinical practice, little is known about the epidemiology, patterns of care and outcomes of rare peritoneal surface malignancies patients in France.

In order to better understand the characteristics of rare peritoneal surface malignancies and to evaluate treatment strategies, the RENAPE registry aims at the collection of data from patients presenting with a rare peritoneal surface malignancy in France. Data will be entered prospectively in a specifically designed and secured web database.

All RENAPE's centres and physicians are invited to register patients with a rare peritoneal surface malignancy diagnosis and to participate to the registry. Data will be evaluated within regular time frames, focusing on types of rare peritoneal surface malignancies, treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing to the better understanding of these rare cancers.

ReferenceCitation: Villeneuve L, Passot G, Glehen O, Isaac S, Bibeau F, Rousset P, Gilly FN; RENAPE Network. The RENAPE observational registry: rationale and framework of the rare peritoneal tumors French patient registry. Orphanet J Rare Dis. 2017 Feb 17;12(1):37. doi: 10.1186/s13023-017-0571-y.

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

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

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

location_facility: Institut Cancérologie de l'Ouest - René Gauducheau

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service de Chirurgie Générale et Digestive - 165 chemin du grand Revoyet,

location_facility: Institut de Cancérologie de l'Ouest - Paul Papin


title: Development of Medication Reconciliation Using Electronic Pharmaceutical Record: a National Multicenter, Cluster-randomized, Two-period Crossover Study in Elderly Hospitalized in Geriatrics, Internal Medicine and Orthopedic Surgery

acronym: CONCIPAGE

summary:
Context Adverse drug events (ADEs) may occur in hospitalized patients and may result from discrepancies between patient's current medications and the drugs prescribed at admission (omission,, dosing errors….).

Consequences of these discrepancies may be mild (e.g. isolated biological abnormalities), but may also lead to severe clinical outcomes. Medication reconciliation is a process of creating the most accurate list of patient's current medication in order to decrease discrepancies and eventually ADEs.

Information technology and electronic health records are of great interest in this process. In France, medications dispensed in community pharmacies during the past 4 months are registered in a patient's electronic pharmaceutical record. The impact of this record, together with pharmacist medication reconciliation, will be tested in the CONCIPAGE study.

Design The CONCIPAGE study is a national, multicenter, cluster-randomized, two-period cross-over study. It will estimate the impact of medication reconciliation, made by a pharmacist, using the patient pharmaceutical record, on the occurrence of ADEs during the hospitalization of patients aged 65 years and over.

appel_a_projets: PREPS

acronyme: CONCIPAGE

titre: Développement de la conciliation médicamenteuse à l'aide du dossier pharmaceutique. Etude multicentrique nationale chez le sujet âgé hospitalisé en service de gériatrie, médecine interne et chirurgie orthopédique.

discipline_principale: médecine interne

nom_porteur: FERNANDEZ

prenom_porteur: Christine


lead_sponsor: Piramal Imaging Limited

summary:
This phase 4 study will explore, in the context of the present French clinical practice, the impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for etiologic determination of the cognitive and functional impairment, but in whom:

lumbar puncture was not feasible for medical conditions
results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians
lumbar puncture (LP) was refused by the patient

ReferenceCitation: Ceccaldi M, Jonveaux T, Verger A, Krolak-Salmon P, Houzard C, Godefroy O, Shields T, Perrotin A, Gismondi R, Bullich S, Jovalekic A, Raffa N, Pasquier F, Semah F, Dubois B, Habert MO, Wallon D, Chastan M, Payoux P; NEUUS in AD study group; Stephens A, Guedj E. Added value of 18F-florbetaben amyloid PET in the diagnostic workup of most complex patients with dementia in France: A naturalistic study. Alzheimers Dement. 2018 Mar;14(3):293-305. doi: 10.1016/j.jalz.2017.09.009. Epub 2017 Nov 4.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

publisher_dissemination: Wiley

location_facility: Coordinating center (Hôpital de La Timone) and 18 associated centers in France

title: Multicenter Study to Explore the Impact of Florbetaben (FBB) in Change of Diagnosis in Patients Who Are Evaluated for AD and in Whom Lumbar Puncture is Contraindicated or CSF Results Are Ambiguous

source: euctr


title: Assessment of Nurses Internal Contamination by Antineoplastic Drugs in Hospital Centers.

acronym: CACIES

summary: CACIES is a descriptive study conducted in two hospital centers in France to assess nurses internal contamination by antineoplastic drugs.

ReferenceCitation: Villa A, Molimard M, Bignon E, Martinez B, Rouyer M, Mathoulin-Pelissier S, Baldi I, Verdun-Esquer C, Canal-Raffin M. Study protocol for the assessment of nurses internal contamination by antineoplastic drugs in hospital centres: a cross-sectional multicentre descriptive study. BMJ Open. 2019 Nov 10;9(11):e033040. doi: 10.1136/bmjopen-2019-033040.

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

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

sponsor_collaborators:
University Hospital, Bordeaux
Bordeaux PharmacoEpi

location_facility:
Hôpital Pellegrin
CHU de Toulouse
IUCT-Oncopole

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: CACIES

titre: Evaluation de la contamination interne par les médicaments anticancéreux du personnel infirmier en Etablissement de soins

discipline_principale: médecine du travail

nom_porteur: VERDUN ESQUER

prenom_porteur: Catherine


title: Initiative in LYon for Lung cAncer Screening Development - Prevalence Study

summary:
Screening at-risk subjects with low-dose computed tomography (CT) efficiently reduces lung cancer specific mortality. However screening efficiency relies on the at-risk population's criteria definition and its participation rate to the screening. In France, there are concerns regarding the participation rates to national cancer screening that are quite low (around 50% and 32% of the eligible population for breast cancer and colorectal cancer respectively). Before organizing national lung cancer screening it is then crucial to determine the factors impacting the at-risk subjects willingness to participate in lung cancer screening.

The Lyon University Hospital is the second biggest hospital in France with more than 23,000 employees distributed among more than 160 professions representing every level of education or working conditions. Its population is heterogeneous and wide enough to perform a prevalence study assessing the willingness to participate among the at-risk population.

ILYAD is a prospective study performed by anonymous questionnaires that will be submitted to the 23,000 employees of the Lyon University Hospital. The study main objective is to evaluate the at-risk population presence in the Lyon University Hospital population, as defined by NELSON criteria and selection criteria for lung cancer screening (PLCOm2012 scoring), and its willingness to participate to a lung-cancer screening with low-dose CT. This might help further efficient national lung cancer screening campaign organization.


title: Seroprevalence of Chikungunya at the End of the First Chikungunya Outbreak in the French Antilles Within a Sample of Patients Treated for a HIV Infection

acronym: ChikVIH

summary:
Late 2013, the first indigenous cases of chikungunya have been observed in the French Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by the outbreak.

During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack rate was 38%. The most active period was three months.

In this context, knowledge of the attack rate and the epidemic in the Caribbean is an important issue for outbreak management and modeling work.

As the chikungunya virus had never circulated in the Caribbean, determining the seroconversion rate can be achieved by realizing a seroprevalence survey among the general population at the end of the outbreak. Another simple method is to estimate the rate in a cohort of patients followed regularly and whose habitat is distributed throughout the territory studied.

The follow up of patients infected by the human immunodeficiency virus (HIV) in the French West Indies is almost exclusively performed in hospitals in department of Infectious and Tropical Diseases.The high prevalence of HIV and homogeneous distribution of infected patients on all of our territories, allow to hypothesize that the risk of transmission of arboviruses by exposure to mosquito bites is comparable to the general population. This patient cohort is well suited to study the emergence of Chikungunya in the French West Indie .

Primary objective :

To estimate the cumulative incidence at the end of the first Chikungunya outbreak in the French West Indies by estimating the prevalence of specific antibodies of chikungunya virus in a sample (randomly constituted) from patients infected by HIV and representative of the general population of Martinique and Guadeloupe

Secondary objective :

To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied population To estimate the frequency of chronic forms of chikungunya in the studied population

ReferenceCitation: Pialoux G, Gauzere BA, Jaureguiberry S, Strobel M. Chikungunya, an epidemic arbovirosis. Lancet Infect Dis. 2007 May;7(5):319-27. doi: 10.1016/S1473-3099(07)70107-X.

ReferenceCitation: Farnon EC, Sejvar JJ, Staples JE. Severe disease manifestations associated with acute chikungunya virus infection. Crit Care Med. 2008 Sep;36(9):2682-3. doi: 10.1097/CCM.0b013e3181843d94. No abstract available.

ReferenceCitation: Brouard C, Bernillon P, Quatresous I, Pillonel J, Assal A, De Valk H, Desenclos JC; workgroup "Quantitative Estimation of the Risk of Blood Donation Contamination by Infectious Agents". Estimated risk of Chikungunya viremic blood donation during an epidemic on Reunion Island in the Indian Ocean, 2005 to 2007. Transfusion. 2008 Jul;48(7):1333-41. doi: 10.1111/j.1537-2995.2008.01646.x. Epub 2008 Feb 22.

ReferenceCitation: Liumbruno GM, Calteri D, Petropulacos K, Mattivi A, Po C, Macini P, Tomasini I, Zucchelli P, Silvestri AR, Sambri V, Pupella S, Catalano L, Piccinini V, Calizzani G, Grazzini G. The Chikungunya epidemic in Italy and its repercussion on the blood system. Blood Transfus. 2008 Oct;6(4):199-210. doi: 10.2450/2008.0016-08.

ReferenceCitation: Sissoko D, Moendandze A, Malvy D, Giry C, Ezzedine K, Solet JL, Pierre V. Seroprevalence and risk factors of chikungunya virus infection in Mayotte, Indian Ocean, 2005-2006: a population-based survey. PLoS One. 2008 Aug 26;3(8):e3066. doi: 10.1371/journal.pone.0003066.

ReferenceCitation: Appassakij H, Khuntikij P, Kemapunmanus M, Wutthanarungsan R, Silpapojakul K. Viremic profiles in asymptomatic and symptomatic chikungunya fever: a blood transfusion threat? Transfusion. 2013 Oct;53(10 Pt 2):2567-74. doi: 10.1111/j.1537-2995.2012.03960.x. Epub 2012 Nov 26.

ReferenceCitation: Bianco C. Dengue and Chikungunya viruses in blood donations: risks to the blood supply? Transfusion. 2008 Jul;48(7):1279-81. doi: 10.1111/j.1537-2995.2008.01806.x. No abstract available.

ReferenceCitation: Ramful D, Carbonnier M, Pasquet M, Bouhmani B, Ghazouani J, Noormahomed T, Beullier G, Attali T, Samperiz S, Fourmaintraux A, Alessandri JL. Mother-to-child transmission of Chikungunya virus infection. Pediatr Infect Dis J. 2007 Sep;26(9):811-5. doi: 10.1097/INF.0b013e3180616d4f.

ReferenceCitation: Gerardin P, Barau G, Michault A, Bintner M, Randrianaivo H, Choker G, Lenglet Y, Touret Y, Bouveret A, Grivard P, Le Roux K, Blanc S, Schuffenecker I, Couderc T, Arenzana-Seisdedos F, Lecuit M, Robillard PY. Multidisciplinary prospective study of mother-to-child chikungunya virus infections on the island of La Reunion. PLoS Med. 2008 Mar 18;5(3):e60. doi: 10.1371/journal.pmed.0050060.

ReferenceCitation: Gerardin P, Guernier V, Perrau J, Fianu A, Le Roux K, Grivard P, Michault A, de Lamballerie X, Flahault A, Favier F. Estimating Chikungunya prevalence in La Reunion Island outbreak by serosurveys: two methods for two critical times of the epidemic. BMC Infect Dis. 2008 Jul 28;8:99. doi: 10.1186/1471-2334-8-99.

ReferenceCitation: Van Bortel W, Dorleans F, Rosine J, Blateau A, Rousset D, Matheus S, Leparc-Goffart I, Flusin O, Prat C, Cesaire R, Najioullah F, Ardillon V, Balleydier E, Carvalho L, Lemaitre A, Noel H, Servas V, Six C, Zurbaran M, Leon L, Guinard A, van den Kerkhof J, Henry M, Fanoy E, Braks M, Reimerink J, Swaan C, Georges R, Brooks L, Freedman J, Sudre B, Zeller H. Chikungunya outbreak in the Caribbean region, December 2013 to March 2014, and the significance for Europe. Euro Surveill. 2014 Apr 3;19(13):20759. doi: 10.2807/1560-7917.es2014.19.13.20759. No abstract available. Erratum In: Euro Surveill. 2014;19(14):pii/20764. Rousset, D [added].

ReferenceCitation: Curlier E, Fagour L, Herrmann-Storck C, Staelen A, Vingadassalom I, Breurec S, Abel S, Pierre-Francois S, Jean-Marie J, Laouenan C, Cesaire R, Hoen B, Cabie A. Seroprevalence of chikungunya virus infection among HIV-infected adults in French Caribbean Islands of Martinique and Guadeloupe in 2015: A cross-sectional study. PLoS Negl Trop Dis. 2021 Apr 9;15(4):e0009267. doi: 10.1371/journal.pntd.0009267. eCollection 2021 Apr.

publisher_dissemination: Public Library of Science

lead_sponsor: University Hospital Center of Martinique

location_facility: Centre Hospitalier Universitaire de Fort-de-France