title: Determination of the Level of Immunity, Neutralization of the SARS-COV-2 Virus and Reinfections in Residents of 2 Migrant Workers' Residences 10 Months Apart

summary:
A previous seroprevalence survey showed very high seroprevalence levels among residents of the two among the residents of the two migrant workers' hostels surveyed, indicating a high level of circulation of the virus SARS-COV-2 during the 1st wave of COVID-19. The constitution of a cohort after the event would be an opportunity to obtain opportunity to obtain answers to crucial questions: duration of immunity, potential reinfections potential reinfections, potential re-clustering. Going back to check the serological status seems feasible, especiallyespecially in the Foyers de Travailleurs Migrants (high probability of finding the participants).

There is an obvious scientific interest around the duration of immunity and reinfections in a population highly exposed during the first wave. Several articles document the decline of IgG antibodies in the months following an infection, but very few infection, but very few evaluate the protective character in the medium term (>=6 months), especially in asymptomatic individuals. We are also concerned about the circulation of We are also concerned about the circulation of new variants and the immunity acquired after infection in residents.

To date, no study on the duration of immunity has been conducted in migrant worker's residences.

ipd_sharing_description:
The research team will develop a range of activities to disseminate the study findings. These dissemination activities will be coordinated by MSF and Epicentre. The results will be presented in an internal report and an external report for the Ministry of Health (MoH), the French National Public Health Agency and Institute Pasteur.

An abstract of the findings will be submitted for presentation at a scientific conference, and at least one manuscript will be submitted for publication in a peer-reviewed scientific journal.

The findings of the survey will also be used for advocacy purposes, in coordination with community leaders of participating communities.

The results of the survey (lay version of the report), and their possible use for advocacy / communication, will be shared with the staff, resident representatives and residents of the MWRs, whether or not they actually participated in the study.

lead_sponsor: Epicentre


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.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: background

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). pii: taw073. Print 2016 Jul.

lead_sponsor: CHU de Reims

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Study of Symptoms Linked to Covid-19 in Residents and Professionals in EHPAD, Associated With a Dual Diagnostic Approach by PCR and Serology: a Cohort in Île-de-France.

acronym: COVID - EHPAD

summary: The main purpose is to study the prevalence of Covid-19 in EHPAD. The primary endpoint will be the combination of PCR results and symptomatology, making it possible to define positive cases in EHPAD, in residents and professionals in contact with them. The prevalence obtained can be compared with the results of serology if these are performed.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Gérond'if

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Specificities of Quality of Life and Influence of Participation on the Quality of Life of the Adult With Spinal Muscular Atrophy in France: a Cross-sectional Study

acronym: QOLSMA

summary:
Spinal muscular atrophy is a hereditary motorneuron disease caused by a mutation of the SMN1 gene, which is at the origin of a progressive limb and axial motor deficiency. It concerns 1200 individuals in France, including 700 adults in 2018. The main objective of this study is to assess the quality of life of SMA patients in France.

The secondary objectives are, in one hand, to compare the quality of life of SMA patients to a population of neuromuscular diseases patients. And on the other hand to evaluate the determinants of participation and the impact of participation on quality of life in adult SMA patients.

study_start_date_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Service L'Escale - Médecine Physique et de Réadaptation Pédiatrique Groupement Hospitalier Est des Hospices Civils de Lyon


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.

status: Unknown status

time_perspective: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: service de Biologie de la Reproduction-CECOS

status_simplified: Unknown


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


type: Other Identifier

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).

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse

intervention_type: Drug


title: Epidemiological Description of the Kaposi's Disease in France's Southeast

summary: The purpose of this study is to evaluate the prevalence of the Kaposi's disease in France's southeast on 10 years (from 2007 to 2017)

ipd_sharing: No

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Multimodal and Longitudinal Assessment of MOBility Disorders in Patients With Mild COGnitive Disorders

acronym: COG-MOB

summary:
Mild cognitive impairment (MCI) is defined by lower performance in one or more cognitive domains with preservation of independence in functional abilities. Sixteen percent of community-dwelling older people (over 65 years) live with MCI. They are both cognitively and physically vulnerable. From a cognitive perspective, they are susceptible to converting to the dementia stage at an annual rate of 10%. From a physical perspective, the proportion of slow gait or neurological gait abnormalities can reach 46% in the population with MCI. Falls in turn increase the risk of accelerated cognitive decline and the risk of institutionalization. In the absence of a curative treatment for dementia, it is essential to have an effective and personalized prevention strategy by identifying the predictive factors for falls in this at-risk population with MCI.

The research goals of this project are 1) to identify specific predictors for falls in clinic attendees with MCI in preparation for a definitive, fully powered study across France, and 2) to demonstrate the feasibility of a pragmatic fall risk assessment in MCs, whatever its setting and location.

We aim to prospectively follow-up people diagnosed with MCI and aged above 65 years old in four MCs in France (three in the North (one community-based MC), and one in the Centre) for one year.

time_perspective: Prospective

lead_sponsor: University Hospital, Lille

location_facility:
Hop Salengro - Hopital B
Les Bateliers Chu Lille

intervention_type: Behavioral


type: Registry Identifier

title: Prevention of HIV in "Île-de-France"

acronym: ANRS-PREVENIR

summary:
Interventional HIV prevention strategy based on pre-exposure prophylaxis (PrEP) with Truvada® for people in the Île-de-France area (or Paris region) who don't have HIV but who are at high risk of becoming infected with HIV (men who have sex with men (MSM), transgender men and women, heterosexual men and women, sex workers, migrants) in combination with overall prevention services (communautary-based or educational counselling; addiction, social and psychological care; condoms and lubricating gel; clean injection equipment; sexually transmitted diseases (STD) screening and treatment; hepatitis A virus (HAV), hepatitis B virus (HBV) and hepatitis C virus (HCV) vaccinations and post-exposure treatment of HIV infection as soon as possible after diagnosis using an antiretroviral combination recommended by the French Guidelines on HIV treatment).

The individual benefit being already demonstrated in clinical trials, the aim is to demonstrate the public health impact of the interventional HIV prevention strategy by reducing the risk of getting HIV-1 infection of at least 15% of new diagnosis of HIV infections among MSM/transgender in the Ile-de-France area after a 3-year period.

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Molina JM, Ghosn J, Assoumou L, Delaugerre C, Algarte-Genin M, Pialoux G, Katlama C, Slama L, Liegeon G, Beniguel L, Ohayon M, Mouhim H, Goldwirt L, Spire B, Loze B, Surgers L, Pavie J, Lourenco J, Ben-Mechlia M, Le Mestre S, Rojas-Castro D, Costagliola D; ANRS PREVENIR Study Group. Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Lancet HIV. 2022 Aug;9(8):e554-e562. doi: 10.1016/S2352-3018(22)00133-3. Epub 2022 Jun 27.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Cochin
Hôpital André Mignot
Hôpital Bichat-Claude-Bernard
Hôpital Avicenne
CHI Poissy Saint Germain en Laye
Hôpital Antoine Béclère
Hôpital Pitié-Salpétrière
Hôpital Saint-Louis
Hôpital Ambroise-Paré
Hôpital Européen Georges Pompidou
Hôpital Tenon
Hôpital Louis Mourier
Hôpital Hôtel Dieu
Hôpital Necker-Enfants Malades
Hôpital Saint-Antoine
Hôpital de Bicêtre
Hôpital Raymond Poincaré
Hôpital Foch
Hôpital Henry Mondor
Hôpital Jean Verdier
Centre Hospitalier Marc Jacquet


title: Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.

acronym: VHENE

summary: The present research aims to collect virological and clinical data on hepatitis E virus (HEV) infections, either in acute or chronic forms of HEV infection in North-Eastern France, with liver- or non liver-related symptoms, plus data on HEV circulation in the outside environment. The purpose of this study is to improve the diagnosis and care of HEV-infected patients, as well as the preventive features to take into account in order to avoid food- and environment-borne infections. At last, we will investigate HEV molecular characteristics, with the hypothesis that some advantageous HEV strains coul be more pathogenic for some tissues and/or organs.

lead_sponsor: Central Hospital, Nancy, 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:
Chu Grenoble
Institut Paoli-Calmettes


title: National Lymphangioleiomyomatosis Registry, France

acronym: RE-LAM-CE

summary:
RE-LAM-CE is a registry of lymphangioleiomyomatosis cases in France. its aim is to determine the incidence and prevalence of lymphangioleiomyomatosis in France, including demographic information and information concerning the timing and modalities of diagnosis.

Based on the registry, we will set up a prospective cohort of patients. The database will include detailed medical information, particularly regarding progression of the respiratory function.

lead_sponsor: Vincent COTTIN


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.

primary_purpose: Treatment

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. Review.

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.

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. Review.

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. Review.

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.

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.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Impact of Yogotherapeutics in Consultation on Chronic Pains' Patients

acronym: YOGADO

summary: In a context where yoga is more and more popularized in France and in Europe, and where Yogatherapy (as complementary medicine) begins to make its place in the care of patients in French hospitals, it seems interesting to study the impact of yoga in the chronic pain patient treated in a specific pain consultation by this non-pharmacological approach, and accessible.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Departement of Chronic Pain Consultation, Hospital René Dubos,


title: Puumala Hantavirus Infection in France: Evaluation of Commercial Assays for the Detection of Antibodies Against This Virus and the Use of Urine Samples for the Molecular Detection of This Infection

acronym: HANTADIAG

summary: Routine Puumala virus (PUUV) infection diagnosis is performed using serological commercial kits of which performances have not been established in real life, which use recombinant protein from strains from Central or North Europe. Molecular diagnostic of these infection is not the rule. Consequently the objectives of the project are to evaluate the performances of the serological commercial assays in real life in France and to assess the use of urine versus plasma for the molecular diagnostic of this infection.

ReferenceCitation: Plyusnin A, Hörling J, Kanerva M, Mustonen J, Cheng Y, Partanen J, Vapalahti O, Kukkonen SK, Niemimaa J, Henttonen H, Niklasson B, Lundkvist A, Vaheri A. Puumala hantavirus genome in patients with nephropathia epidemica: correlation of PCR positivity with HLA haplotype and link to viral sequences in local rodents. J Clin Microbiol. 1997 May;35(5):1090-6.

ReferenceCitation: Prince HE, Lieberman JM. Impact of the Yosemite hantavirus outbreak on hantavirus antibody testing at a national reference laboratory. Clin Vaccine Immunol. 2013 Aug;20(8):1213-6. doi: 10.1128/CVI.00326-13. Epub 2013 Jun 5.

ReferenceCitation: Lederer S, Lattwein E, Hanke M, Sonnenberg K, Stoecker W, Lundkvist Å, Vaheri A, Vapalahti O, Chan PK, Feldmann H, Dick D, Schmidt-Chanasit J, Padula P, Vial PA, Panculescu-Gatej R, Ceianu C, Heyman P, Avšič-Županc T, Niedrig M. Indirect immunofluorescence assay for the simultaneous detection of antibodies against clinically important old and new world hantaviruses. PLoS Negl Trop Dis. 2013 Apr 4;7(4):e2157. doi: 10.1371/journal.pntd.0002157. Print 2013. Erratum in: PLoS Negl Trop Dis. 2020 Nov 9;14(11):e0008864.

ReferenceCitation: Hentzien M, Mestrallet S, Halin P, Pannet LA, Lebrun D, Dramé M, Bani-Sadr F, Galempoix JM, Strady C, Reynes JM, Penalba C, Servettaz A. Bioclinical Test to Predict Nephropathia Epidemica Severity at Hospital Admission. Emerg Infect Dis. 2018 Jun;24(6):1045-1054. doi: 10.3201/eid2406.172160.

lead_sponsor: Centre Hospitalier de Charleville-Mézières

location_facility:
CHU Besançon
CH Charleville Mézières
CH de Laon
CH de Saint Claude
CHP Sud de l'Oise
CH Belfort-Montbéliard
CHU Nancy
CH de Verdun
CHU Reims
CHU Dijon


title: Follow-up of Heart Failure Patients With an Implantable Cardiac Defibrillator Enabled With the HeartLogic Algorithm - HeartLogic France Study

summary:
Heart Failure (HF) is a chronic disease that leads to numerous rehospitalisations and affects more than one million people in France.

The main objective of this prospective multicentric French study is to describe the annual rate of unplanned hospitalisations for heart failure in a cohort of patients managed by a HeartLogic algorithm.

Patients will be included if they fulfill the following requirements 1/Patient implanted with a cardiac defibrillator with or without resynchronisation with the HeartLogic index (RESONATE family, Boston Scientific); 2/History of heart failure (left ventricular ejection fraction ≤40 %; or at least one episode of clinical heart failure with elevated NT pro BNP≥450 ng/L)

If a HeartLogic index ≥16 is noticed, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment.

lead_sponsor: Poitiers University Hospital

location_facility:
Hopital Europeen G Pompidou
Clinique du Confluent
Hospital of Lorient
Clinique Pasteur
University hospital of Brest

intervention_type: Diagnostic Test


title: Assessment of Adults Epidemiological Characteristics of Status Epilepticus in the French West Indies and in French Guiana

acronym: EpiDFA

summary:
The justification of this prospective and multicenter study is based on the absence of published data concerning, status epilepticus (SE), a pathology which seems frequent in the French West Indies (FWI) and French Guiana, and whose etiological and prognostic characteristics are often mentioned or assumed but which remain to be demonstrated. The scientific interest lies both in the knowledge of the epidemiology of this pathology and in the identification of the main etiologies, in particular the underlying brain lesions.

The morbidity of SE is significant, associating neurological disorders with impaired consciousness, respiratory, hemodynamic and cardiac rhythm disorders, as well as metabolic disorders such as acidosis. SE-related mortality in the acute phase ranges from 3-40% across studies and regions, while long-term mortality ranges from 17-80% depending on age, cause of SE, comorbidities and the occurrence of complications.

The prognosis of this pathology has however improved in recent years in developed countries or countries with a high level of health system. On the other hand, the morbidity and mortality of SE in the French overseas departments is not known, even if these territories are supposed to be at an equivalent level in terms of health system to that of mainland France.

lead_sponsor: University Hospital Center of Martinique

location_facility: University Hospital Center of Guadeloupe


title: Impact of Containment and Quarantine During COVID-19 Outbreack on Psychotic Symptoms in the General Population in France

summary: Study the impact of containment related to COVID-19 pandemic on psychotic experiences in the general population in France.


title: Randomized, Cross-over Study Comparing the Efficacy of the 3C60 Knee Against Non-microprocessor Controlled Knees on the Risk of Falling and Locomotor Skills of Moderately Active Persons With Leg Amputation Above Knee or Knee Disarticulation

summary:
Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance criteria associated with being given one. However, these amputees have a very high risk of falling because they use a non microprocessor controlled knee joint (NMPK) and because their physical ability, associated disability and persistent contralateral leg weakness do not allow them to compensate for a balance deficit. These amputees restrict how much they move around and their participation because of their instability and elevated risk of falling.

The objective of the study is to evaluate the effect of the 3C60 knee, a microprocessor-controlled knee joint for external leg prosthesis, on the reduction in the risk of falling after three months in moderately active persons with leg amputation above knee or knee disarticulation.

primary_purpose: Other

ReferenceCitation: Schoppen T, Boonstra A, Groothoff JW, de Vries J, Göeken LN, Eisma WH. The Timed "up and go" test: reliability and validity in persons with unilateral lower limb amputation. Arch Phys Med Rehabil. 1999 Jul;80(7):825-8.

ReferenceCitation: Dite W, Connor HJ, Curtis HC. Clinical identification of multiple fall risk early after unilateral transtibial amputation. Arch Phys Med Rehabil. 2007 Jan;88(1):109-14.

ReferenceCitation: Franchignoni F, Orlandini D, Ferriero G, Moscato TA. Reliability, validity, and responsiveness of the locomotor capabilities index in adults with lower-limb amputation undergoing prosthetic training. Arch Phys Med Rehabil. 2004 May;85(5):743-8.

ReferenceCitation: Gauthier-Gagnon C, Grisé MC, Potvin D. Enabling factors related to prosthetic use by people with transtibial and transfemoral amputation. Arch Phys Med Rehabil. 1999 Jun;80(6):706-13.

ReferenceCitation: Burnfield JM, Eberly VJ, Gronely JK, Perry J, Yule WJ, Mulroy SJ. Impact of stance phase microprocessor-controlled knee prosthesis on ramp negotiation and community walking function in K2 level transfemoral amputees. Prosthet Orthot Int. 2012 Mar;36(1):95-104. doi: 10.1177/0309364611431611. Epub 2012 Jan 5.

ReferenceCitation: Gauthier-Gagnon, C, grisé, MCL, Lepage Y. The Locomotor Capabilities Index : Content validity. J rehabil OutcomesMeas 2(4) : 40-46, 1998.

ReferenceCitation: Gauthier-Gagnon C, Grisé MC. Prosthetic profile of the amputee questionnaire: validity and reliability. Arch Phys Med Rehabil. 1994 Dec;75(12):1309-14.

ReferenceCitation: Grisé MC, Gauthier-Gagnon C, Martineau GG. Prosthetic profile of people with lower extremity amputation: conception and design of a follow-up questionnaire. Arch Phys Med Rehabil. 1993 Aug;74(8):862-70.

ReferenceCitation: Demers L, Weiss-Lambrou R, Ska B. Development of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST). Assist Technol. 1996;8(1):3-13.

ReferenceCitation: Leplège A, Mesbah M, Marquis P. [Preliminary analysis of the psychometric properties of the French version of an international questionnaire measuring the quality of life: the MOS SF-36 (version 1.1)]. Rev Epidemiol Sante Publique. 1995;43(4):371-9. French.

ReferenceCitation: Leplège, A. (2001). Introduction, enjeux, définitions. In J. Coste et A. Leplège (Eds.), Mesure de la santé perceptuelle et de la qualité de vie : méthodes et applications (pp 15-36). Paris : Editions Estem

ReferenceCitation: Ware JE, Snow KK, Kosinski M, Gandek B (1993). Health survey : manual and interpretation guide. Boston, Massachussets : The Health Institute, New England Medical Center, 1993

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: Loiret I, Paysant J, Martinet N, André JM. [Evaluation of amputees]. Ann Readapt Med Phys. 2005 Jul;48(6):307-16. Epub 2005 Apr 15. Review. French.

lead_sponsor: Otto Bock France SNC

location_country: Austria Germany France

location_facility: Centre Hospitalier de Cornouaille Concarneau

location_facility: Institut Régional de Médecine Physique et de Réadaptation

intervention_type: Device


title: France PCI Registry : National Observatory of Interventional Cardiology

summary:
Rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (IC). A multicentric IC observational study (CRAC), fully integrated to usual coronary activity report software, started in Centre Val de Loire (CVL) region in 2014.

CRAC observatory was conduced on five IC CathLab of CVL region. Quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. This solution could easily be developed in other French regions.

lead_sponsor: Club Régional des Angioplasticiens de la région Centre

location_facility: Centre Hospitalier Henri Mondor d'Aurillac

location_facility: Centre Hospitalier Jacques Coeur de Bourges

location_facility: Groupe Hospitalier du Havre - Hôpital Jacques Monod

location_facility: Pôle Santé Oréliance - Clinique de la Reine Blanche

location_facility: Research Cardiology Unit / Les hopitaux de Chartres

location_facility: CHU Gabriel-Montpied de Clermont-Ferrand


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


title: HCV Care Pathway in Ile-de-France

acronym: ParcoursVHC

summary: The main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick and effective access to diagnosis and treatment of HCV by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Myocardial Infarction Rates Overview During COVID-19 Pandemic In France: MODIF Study

acronym: MODIF

summary: In late December 2019, an emerging disease due to a novel coronavirus (named SARS-CoV-2) rapidly spread in China and outside. France is currently facing the COVID-19 wave with more than 131 863 confirmed cases and almost 25 201 deaths. Systems of care have been reorganized in an effort to preserve hospital bed capacity, resources, and avoid exposure of patients to the hospital environment where COVID-19 may be more prevalent. Therefore, elective procedures of catheterization and programmed hospitalizations have been delayed. However, a significant proportion of procedures within the catheterization laboratory such as ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction or unstable angina are mandatory and cannot be postponed. Surprisingly, invasive cardiologist noticed a drop in STEMI volume without reliable data to confirm this impression. Furthermore, a recent single center report in Hong Kong pointed out longer delays of taking care when compared to patients with STEMI treated with percutaneous intervention the previous year. These data are at major concern because delay in seeking care or not seeking care could have detrimental impact on outcomes.

lead_sponsor: French Cardiology Society


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.


title: BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry

summary: The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

lead_sponsor: Biotronik SE & Co. KG

location_facility:
Hôpital Gabriel Montpied
CH Villefranche Sur Saone
CHRU de Tours, Hopital Trousseau


title: Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

summary: High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules

lead_sponsor: University Hospital, Strasbourg, France


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.

lead_sponsor: University Hospital, Toulouse


title: Use of Methylphenidate in Children and Adolescents in France

summary: The use of methylphenidate in children and adolescents in France from 2010 to 2015


title: Evaluation of Vitamin D Deficiency Distribution in Children With Sickle Cell Disease Followed in Lyon, France

acronym: EVADDREP

summary: Vitamin D deficiency may be under-diagnosed in sickle cell disease French children. Therefore, the investigator need an epidemiologic study about the prevalence of vitamin D deficiency in this specific population. There are not specific guidelines neither testing nor treatment. The investigator propose to test vitamin D status in all children with sickle cell disease who are consulting their referring haematologist doctor or in the emergency ward.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme Mère enfant - Urgences pédiatriques

intervention_type: Biological


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.

lead_sponsor: University Hospital, Montpellier


title: Outpatient Use of Analgesics in Children and Adolescents in France

summary: outpatient use of analgesics in children and adolescents in France from 2012 to 2015


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.

design_allocation: Non-Randomized


title: Intensive Care Unit Activity in France From the National Database Between 2013 and 2019: More Critically Ill Patients, Shorter Stay and Lower Mortality Rate

summary:
Using data from the French National Uniform Hospital Discharge Database (systematically collecting administrative and medical information related to all hospitalized patients in France for care reimbursement purposes), the present study retrospectively assesses the activity of the French Intensive Care Unit (ICU)(1,594,801 ICU admissions):

In-ICU and in-hospital mortality rates
Length of stay in ICU and hospital
Mortality-associated factors during the study period.
Number of organ failures
Bed occupancy,
Regional variations in previous indicators

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: FErtility, PrEgnancy, contRaceptIon After Breast Cancer in France: the FEERIC Study

acronym: FEERIC

summary: FErtility, PrEgnancy, contRaceptIon after breast Cancer in France

lead_sponsor: Institut Curie


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, Gonçalves 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].


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: Prospective, Multicentric Observational Study Evaluating the Management of Chronic Coronary Occlusions In France

acronym: ENCOCHE

summary:
Data from the literature on the management of Chronic Coronary Occlusions (CTO) in France highlight a lack of epidemiological data on these patients at the national level.

For this reason, it was decided to set up this large-scale survey in order to have a picture of the management of patients with chronic coronary occlusion in France, to study the prevalence of CTOs in France as well as their management (medical, surgical or interventional), and then by analysing more precisely, over a second survey period, CTO angioplasties in terms of success rates, complications, medico-economic impact.

ReferenceCitation: Di Mario C, Werner GS, Sianos G, Galassi AR, Büttner J, Dudek D, Chevalier B, Lefevre T, Schofer J, Koolen J, Sievert H, Reimers B, Fajadet J, Colombo A, Gershlick A, Serruys PW, Reifart N. European perspective in the recanalisation of Chronic Total Occlusions (CTO): consensus document from the EuroCTO Club. EuroIntervention. 2007 May;3(1):30-43.

ReferenceCitation: Kahn JK. Angiographic suitability for catheter revascularization of total coronary occlusions in patients from a community hospital setting. Am Heart J. 1993 Sep;126(3 Pt 1):561-4.

ReferenceCitation: Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.

ReferenceCitation: Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.

ReferenceCitation: Garcia S, Sandoval Y, Roukoz H, Adabag S, Canoniero M, Yannopoulos D, Brilakis ES. Outcomes after complete versus incomplete revascularization of patients with multivessel coronary artery disease: a meta-analysis of 89,883 patients enrolled in randomized clinical trials and observational studies. J Am Coll Cardiol. 2013 Oct 15;62(16):1421-31. doi: 10.1016/j.jacc.2013.05.033. Epub 2013 Jun 7.

ReferenceCitation: Sachdeva R. Effect of revascularization of chronic total occlusion on tandem stenoses in a "donor" artery. Tex Heart Inst J. 2014 Oct 1;41(5):547-50. doi: 10.14503/THIJ-13-3569. eCollection 2014 Oct.

ReferenceCitation: Stone GW, Reifart NJ, Moussa I, Hoye A, Cox DA, Colombo A, Baim DS, Teirstein PS, Strauss BH, Selmon M, Mintz GS, Katoh O, Mitsudo K, Suzuki T, Tamai H, Grube E, Cannon LA, Kandzari DE, Reisman M, Schwartz RS, Bailey S, Dangas G, Mehran R, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part II. Circulation. 2005 Oct 18;112(16):2530-7. Review.

ReferenceCitation: Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum in: N Engl J Med. 2013 Feb 7;368(6):584.

ReferenceCitation: Olivari Z, Rubartelli P, Piscione F, Ettori F, Fontanelli A, Salemme L, Giachero C, Di Mario C, Gabrielli G, Spedicato L, Bedogni F; TOAST-GISE Investigators. Immediate results and one-year clinical outcome after percutaneous coronary interventions in chronic total occlusions: data from a multicenter, prospective, observational study (TOAST-GISE). J Am Coll Cardiol. 2003 May 21;41(10):1672-8.

ReferenceCitation: Srivatsa SS, Edwards WD, Boos CM, Grill DE, Sangiorgi GM, Garratt KN, Schwartz RS, Holmes DR Jr. Histologic correlates of angiographic chronic total coronary artery occlusions: influence of occlusion duration on neovascular channel patterns and intimal plaque composition. J Am Coll Cardiol. 1997 Apr;29(5):955-63.

ReferenceCitation: Katsuragawa M, Fujiwara H, Miyamae M, Sasayama S. Histologic studies in percutaneous transluminal coronary angioplasty for chronic total occlusion: comparison of tapering and abrupt types of occlusion and short and long occluded segments. J Am Coll Cardiol. 1993 Mar 1;21(3):604-11.

ReferenceCitation: Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusions of coronary arteries 2002 to 2008: impact of novel guidewire techniques. JACC Cardiovasc Interv. 2009 Jun;2(6):489-97. doi: 10.1016/j.jcin.2009.04.008.

ReferenceCitation: de Labriolle A, Bonello L, Roy P, Lemesle G, Steinberg DH, Xue Z, Kaneshige K, Suddath WO, Satler LF, Kent KM, Pichard AD, Lindsay J, Waksman R. Comparison of safety, efficacy, and outcome of successful versus unsuccessful percutaneous coronary intervention in "true" chronic total occlusions. Am J Cardiol. 2008 Nov 1;102(9):1175-81. doi: 10.1016/j.amjcard.2008.06.059. Epub 2008 Aug 27.

ReferenceCitation: Suero JA, Marso SP, Jones PG, Laster SB, Huber KC, Giorgi LV, Johnson WL, Rutherford BD. Procedural outcomes and long-term survival among patients undergoing percutaneous coronary intervention of a chronic total occlusion in native coronary arteries: a 20-year experience. J Am Coll Cardiol. 2001 Aug;38(2):409-14.

ReferenceCitation: Hoye A, van Domburg RT, Sonnenschein K, Serruys PW. Percutaneous coronary intervention for chronic total occlusions: the Thoraxcenter experience 1992-2002. Eur Heart J. 2005 Dec;26(24):2630-6. Epub 2005 Sep 23.

ReferenceCitation: Hannan EL, Racz M, Holmes DR, King SB 3rd, Walford G, Ambrose JA, Sharma S, Katz S, Clark LT, Jones RH. Impact of completeness of percutaneous coronary intervention revascularization on long-term outcomes in the stent era. Circulation. 2006 May 23;113(20):2406-12. Epub 2006 May 15.

ReferenceCitation: Farooq V, Serruys PW, Garcia-Garcia HM, Zhang Y, Bourantas CV, Holmes DR, Mack M, Feldman T, Morice MC, Ståhle E, James S, Colombo A, Diletti R, Papafaklis MI, de Vries T, Morel MA, van Es GA, Mohr FW, Dawkins KD, Kappetein AP, Sianos G, Boersma E. The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. J Am Coll Cardiol. 2013 Jan 22;61(3):282-94. doi: 10.1016/j.jacc.2012.10.017. Epub 2012 Dec 19.

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title: Fabry Disease Prevalence in End-stage Renal Disease (ESRD) Patients on Dialysis or Transplant in West of France

acronym: SNOUFY

summary: Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France.

lead_sponsor: Rennes University Hospital


title: Impact of a Consultation Between a Coordinating Physician and a Referring Physician About the Optimization of Drug Prescription for Each Resident Entering in Nursing Home (EHPAD).

acronym: OPTIM-EHPAD

summary:
Elderly people are at high risk of multiple medication which increases drug interactions and side effects. This problem is accentuated in EHPAD due to the multiplication of prescribers (the referring physician, the hospital physician, the specialist, the emergency physician, the coordinating physician). The lack of optimization of drug prescriptions in EHPAD can be responsible for iatrogenic, underuse and overuse of treatment, impacting the autonomy and quality of life of residents in EHPAD in France.

A method for optimizing diagnostic and drug management at the entry of a new EHPAD resident, called OPTIM EHPAD, has been tested in Languedoc-Roussillon (France) and validated. This is a consultation between the referring physician and the EHPAD coordinating physician. Some improvements have been made to this method in order to have an optimized version.

Physician's cooperation seems to promote decision-making and change in therapies. The objective of this study is to assess the theoretical effectiveness and efficiency of this approach.

It is supposed that the provision to the EHPAD coordinating physician of a method for optimizing the diagnostic and drug management of the new EHPAD resident (based on a decision following consultation between the referring doctor and the coordinating doctor) would impact on the resident care process, on their care results and on communication and coordination between the coordinating physician and the referring physician.

status: Active, not recruiting


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

acronym: TOBAFREE-DP

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

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

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

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

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


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

acronym: Lymphorac

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

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

location_facility: Departement information Medicale CHU Montpellier


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

status: Terminated

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


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

acronym: IRIS

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

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Observatory of Unintentional Births Hospital Extras in Hérault

summary:
In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these.

For this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the future of patients and newborns until J7 postpartum.


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

acronym: CROSS

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


title: Evaluation of the Satisfaction and the Quality of Life of Patients After Breast Reconstruction as Part of Breast Cancer. Comparison of Several Technics.

acronym: SQUARE

summary:
Breast cancer is the most common cancer in women in France in term of repercussion, 58 698 people has been diagnosed in 2017. Breast cancer is often with good prognosis. The 5 years disease-free survival rate is 87%. Surgery has a major place in breast cancer treatment. Although the conservative surgery is preferred, it stays the indication of mastectomy for nearly 30% of cases. This radical surgery is often experienced by the patient as a mutilation with the impact that this entails from a psychological point of view but also on the quality of life. Breast reconstruction allows an improvement of quality of life with a better acceptance of the body scheme and the benefits in the psychological and sexual domains. The reconstruction is an integral part of the therapeutic care; however, it is not done systematically. Indeed, in France nearly 35% of patients benefit of breast reconstruction 5 years after the mastectomy.

Nowadays, several surgical technics are available to do the reconstruction: autologous technics and the reconstruction with implants. It can be differed or immediate. The strategy of reconstruction is established in accordance with many parameters: the morphology of the breast and of the patient, the state of the thoracic wall and history of radiotherapy, comorbidities, contraindication and of course the wish of the patient. According to the used technics, the reconstruction can sometimes extend to several months, especially for the exclusive fat reshaping which needs a lot of surgery. The autologous technics seems to give a better satisfaction to the patients in an esthetical point of view but we do not have many data including the fat reshaping.

Among the tests allowing the evaluation of quality of life of patients, the Breast-Q© is a self-questionnaire validated that is specific to the breast surgery and includes a module concerning the breast reconstruction. It allows evaluating the quality of life (physical, psychosocial and sexual well-being) and the satisfaction of patients (based on cosmetic results and the care). The reconstruction module includes 116 items in its post-surgery version and is adapted to different types of reconstruction.

The objective of our project is to evaluate the quality of life and the satisfaction of patients having an immediate or differed breast reconstruction according to the technics used, with the help of the validated questionnaire Breast-Q© and the additional questionnaires.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Multicentre, Randomised Study to Determine the Relative Efficacy of Two Therapeutic Strategies in the Treatment of Children With Congenital Toxoplasmosis

acronym: TOSCANE

summary: Toxoplasmosis is a benign disease in healthy adults, but can be serious in the case of contamination during pregnancy: the parasite can pass through the placental barrier and infect the foetus. The severity of congenital infection varies, but in France, where maternal seroconversions during pregnancy are treated, the manifestations of the disease are often infraclinical at birth and only appear during the first years of life in the form of retinochoroiditis. In order to prevent long-term sequellae, children with confirmed congenital toxoplasmosis (TC) are treated with pyrimethamine combined with either sulfadiazine or sulfadoxine (Fansidar®). The relative efficacy of these two combinations has not yet been evaluated. Moreover, there is no consensus about the duration of the treatment, which varies, in France, from 12 to 24 months depending on the centre. Compared with the duration of parasitaemia in non-treated children, which can persist for up to 4 weeks, these treatments are very long. They are also far longer than the 3 months of treatment, which is in accordance with the World Health Organization (WHO) recommendations, given in Denmark to infants identified as being infected with the parasite during neonatal screening. A one-year treatment was developed in the United States, but it mainly concerns only symptomatic children, given the absence of generalised screening in the United States of America (USA). We have no arguments to justify the use of treatments lasting one year or more in children with asymptomatic or mildly-symptomatic TC. As these treatments carry certain risks, which may be severe, notably with regard to haematological or skin conditions, they have to be supervised closely with biological tests, which adds further constraints for both the children and their parents and increases the cost to health care systems.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Procedure


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

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

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Non-comparative Prospective Study Evaluating the Long-term Efficacy, Tolerance and Compliance of the Panthera D-SAD Mandibular Advancement Orthosis in the Management of Obstructive Sleep Apnea Hypopnea Syndrome (PANTHERA Study)

acronym: PANTHERA

summary:
PANTHERA D-SAD® is a bi-block, custom-made, computer-aided designed and manufactured Mandibular Advancement Orthosis (MAO), by Panthera Dental inc. (Canada). The MAO is equivalent to the NARVAL CC® orthosis, whose efficacy, tolerance and long-term compliance are studied in the "ORCADES" observational study currently being conducted in France. The first results showed a 50% reduction in Apnea Hypopnea Index (AHI) in 76.2% of patients after 3 to 6 months of follow-up, then 67% of patients followed up at 2 years.

Panthera D-SAD® has obtained reimbursement in France since July 2020 and for a period of 5 years: the reimbursement authority (CNEDiMTS) considers that PANTHERA D-SAD® has an interest in the care strategy for OSAHS, in second intention in the event of refusal or intolerance to treatment with Continuous Positive Airway Pressure (CPAP) and as first intention in patients with OSAHS with AHI between 15 and 30 and without associated signs of severity. Nevertheless, in the absence of clinical data specific to PANTHERA D-SAD®, the CNEDiMTS ruled for an absence of Improvement in Expected Service (ASA V) compared to the other reimbursed mandibular advancement orthoses.

CNEDiMTS recommends reimbursement renewal to be conditioned by confirmation of efficacy, tolerance and long-term compliance (at least 5 years) by carrying out a study, the intermediate results of which should be communicated on the occasion of the first renewal.

The present observational prospective and multicenter post-registration study is part of this objective. The effectiveness of the PANTHERA D-SAD® orthosis on reducing AHI and OSAHS symptoms, as well as compliance and tolerance will be evaluated over 5 years.

Around 10 sites composed of a specialist in sleep disorders and a practitioner with knowledge of both sleep and the manducatory apparatus will recruit 337 patients and follow them for 5 years, at the following visits:

Specialist in sleep disorders : Inclusion, 3 months, 2 years, 5 years
Specialist in manducatory apparatus: Inclusion, orthosis set-up and titration, 6 months, 1, 2, 3, 4 and 5 years

lead_sponsor: Panthera Dental Inc.

location_facility:
CHU Angers
Cabinet Dr Le Balc'h


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

acronym: Pro-TOCa

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


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

acronym: CASEME

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

lead_sponsor: University Hospital, Clermont-Ferrand


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

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

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

lead_sponsor: Eli Lilly and Company

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


title: A Prospective Cohort of Healthcare Workers in France

acronym: ESPERES

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris


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

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

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

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

lead_sponsor: Centre Leon Berard

location_facility:
Côte d'or registry
Calvados registry
Oveval


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

acronym: CrèchMV

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

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

lead_sponsor: University Hospital, Limoges


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

acronym: CONGA

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

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

lead_sponsor: Nantes University Hospital


title: Sentinel Lymph Node Identification in Case of Breast Cancer. Clinical Evaluation of a New Intra-operative Probe and a Mini Gamma Camera

summary: This project consists on the realization followed by the clinical validation of two medical instruments dedicated to the precise sentinel lymph nodes identification and localization in the case of breast cancer: an intra operative probe and an operative mini gamma camera. The sentinel lymph node technique, based on the propagation of cancer cells in the lymphatic system, allows a better evaluation of tumor staging, prognosis and therapeutic strategy determination. The goal of these instruments designed by physicians and physicists is to significantly improve the detection efficiency of the technique in order to reduce the false negative rate and then the recurrence risk, as well as the operative morbidity.Clinical oncologist surgeons and fundamental physics applied to medical imaging researchers are involved in this project. The clinical validation of the medical instruments will be organized in the Gynaecologic and Obstetric department of the Hospices Civils de Strasbourg with a series of 25 patients in the framework of a regular french protocol of clinical research.

ReferenceCitation: Mathelin C, Salvador S, Bekaert V, Croce S, Andriamisandratsoa N, Liégeois P, Prados E, Guyonnet JL, Grucker D, Brasse D. A new intraoperative gamma camera for the sentinel lymph node procedure in breast cancer. Anticancer Res. 2008 Sep-Oct;28(5B):2859-64.

ReferenceCitation: Mathelin C, Salvador S, Croce S, Andriamisandratsoa N, Huss D, Guyonnet JL. Optimization of sentinel lymph node biopsy in breast cancer using an operative gamma camera. World J Surg Oncol. 2007 Nov 17;5:132.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Gyynécologie-Obstétrique -Hôpital Civil


title: Study of Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects From Various Origins

summary: The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as traumatic and benign tumoral causes.

lead_sponsor: Biomatlante

location_facility: Service de Chirurgie Orthopédique et Traumatologique - CHU de la Pitié Salpétrière

location_facility: CH des Broussailes - Service de Chirurgie Orthopédique et Traumatologique

location_facility: CHU de Fort de France - Hôpital Pierre ZODBA-QUITMAN - Service d'Orthopédie et Traumatologie

location_facility: CHU de Bordeaux - Hôpital PELLEGRIN -Service d'Orthopédie - Traumatologie C


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

acronym: HPE-LR

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

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

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

lead_sponsor: University Hospital, Montpellier


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

acronym: TOCCIP

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

location_facility:
CHU Tours
CHU Poitiers


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

acronym: FEOR

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

lead_sponsor: JOTEC GmbH

location_facility: Rennes Pontchaillou University Medical Centre

location_facility: Clinique de l'Infirmerie Protestante à Lyon


title: National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units

acronym: VACOVID-SENIOR

summary:
The COVID-19 pandemic is a challenge for the French healthcare system, particularly among the elderly due to their particular vulnerability to the serious consequences of the disease, with an estimated mortality rate of around 30-35% among the frail elderly. The management of the health crisis could take a new turn in 2021 with the arrival in France of vaccines against the SARS-CoV-2 virus.

The objectives of this vaccination campaign are to reduce the morbi-mortality attributable to COVID-19 on the one hand, and to maintain essential activities related to the functioning of the country on the other hand and in particular the health system.

However, the distrust of vaccination, traditionally strong in France, could have a negative impact on this strategy. While the President of the Republic announced on November 24, 2020 that vaccination against SARS-CoV-2 would not be made compulsory, almost one French person in two declared in several surveys that they did not want to be vaccinated; the main criterion for acceptance of vaccination being advanced age (the older they are, the more French people declare accepting to be vaccinated).

In view of the gradual vaccine supply schedule for the year 2021, the French National Authority for Health established at the end of 2020 a prioritization by vaccine availability phases. The critical initial supply phase,which is currently taking place, is the one during which residents of retirement home and long-term care units are prioritized because of their particular vulnerability (age and co-morbidities) and their increased exposure to SARS-CoV-2.

For these reasons, and in order to carry out the current vaccination campaign in the most optimal way possible, this national survey is launching to evaluate the acceptance rate of the SARS-CoV-2 vaccine among people living in retirement homes and long-term care units, to understand the mechanisms of acceptance or rejection, and to draw up an initial large-scale inventory of the symptoms observed following vaccination.

lead_sponsor: University Hospital, Angers


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

acronym: CABOREAL

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

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

lead_sponsor: Ipsen


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

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

lead_sponsor: Bristol-Myers Squibb


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

acronym: Trans&VIH

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

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

lead_sponsor: ANRS, Emerging Infectious Diseases


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

acronym: TOSCA

summary:
Primary Objective:

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

Secondary Objectives:

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

ipd_sharing: Yes

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

lead_sponsor: Sanofi


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

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

lead_sponsor: Second Sight Medical Products

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

location_facility: Centre Hospitalier Universitaire de Bordeaux


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

acronym: TANGO

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

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

lead_sponsor: University Hospital, Brest


title: Long Term Evaluation of Young Adults Born to HIV-infected Mothers. A Cohort of Young Adults Infected With HIV Since Birth or During Childhood

acronym: CO19 COVERTE

summary:
Background: With the improvement of the prognosis for HIV-infected infants, thanks to the availability of antiretroviral therapies, young adults infected with HIV since birth are becoming an emerging group among the HIV-infected population. Morbidity, mortality and immunovirological evolution in these young adults need to be studied in a large population and compared to patients infected with HIV later in adulthood or to the general population in terms of mortality. Moreover, the study of accelerated or premature ageing, linked to HIV and/or antiretroviral therapy, is particularly interesting in this population.

Objectives: To study the transition to adulthood and the further evolution of HIV-1 or -2 perinatally infected young adults: 1) To study the teenager to adult transition in terms of clinical and immunovirological status, schooling and professional integration, sexuality and reproductive life, transition from paediatrics to adult departments; 2) To study prognosis, morbidity and mortality according to age, infection stage at the time of antiretroviral initiation and therapeutic history; 3) To study the incidence and expression of adverse events and the potential link to antiretroviral therapies; 4) To study the markers of a potential premature ageing, from the metabolic, cardiovascular and immunological points of view.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


title: Effects of Gastrostomy on Quality of Life and Survival in Patients With Amyotrophic Lateral Sclerosis

summary: Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

lead_sponsor: University Hospital, Clermont-Ferrand


title: Prospective Cohort of Patients With Hepatocellular Carcinoma in France

acronym: CHIEF

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

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

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

lead_sponsor: Centre Hospitalier Universitaire, Amiens