title: Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension

acronym: Evencipor

summary: Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.

lead_sponsor: IHU Strasbourg

location_facility: Service d'Hépato-Gastroentérologie, Hôpitaux Civils


title: Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells

acronym: IMMUNHEMAC

summary:
Acquired hemophilia A is a rare condition of hemostasis secondary to the development of antibodies against factor VIII. This is a potentially serious pathology that can be life-threatening due to the major risk of bleeding caused by the sometimes drastic decrease in the level of circulating factor VIII.

This pathology occurs overwhelmingly in elderly subjects or, more rarely, in young women, during the postpartum period. It appears idiopathic in 50% of cases and associated, for the other cases, with underlying pathologies such as autoimmune pathologies (rheumatoid arthritis and bullous pemphigoid in particular) and neoplasias, or with a particular circumstance represented by the post -partum.

The association between this autoimmune pathology and its association with pathologies of the same type or with circumstances involving the immune system, suggests that common mechanisms could favor its emergence.

This study therefore proposes to study lymphocyte populations and subpopulations as well as Myeloid-Derived Suppressor Cells and the cytokine profile, which are abnormal in a large part of autoimmune pathologies.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
CHU de Nantes
CH de Saint Nazaire

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Secondary Prognostic Index in RefrActory Diffuse Large B Cells Lymphoma

acronym: SPiRAL

summary:
60% of patients with diffuse large B cell lymphoma are healed after first-line treatment which whatever the age. For the remaining 40% of patients (relapses and primary refractories):

38% of patients will be cured with a 2nd line including an autologous haematopoietic cell transplantation for those under 65 years.
for older patients who are not eligible for a autograft: only 70% of patients will be able to receive 2nd line treatment with rates response less than 50%.
the survival rate in patients receiving 3rd line treatment or more is 15% at 2 years. Actually, no standard of chemotherapy is offered to relapsed or refractory patients after 2 therapeutic lines. Subsequent lines lead to hospitalizations for infectious complications or transfusions without clear clinical benefit with often an impacted quality of life.

Palliative care is rarely offered as part of the treatment overall load.

status: Unknown status

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Weprom

location_facility: Clinique Victor Hugo / Centre Jean Bernard

lead_sponsor_type: industriel

status_simplified: Unknown


title: Effects of an Exergame Focused on Cognitive-motor Interference on the Cognitive and Motor Capacities of Older Adults

acronym: INCOME

summary:
Ageing is accompanied by a high risk of developing physical or cognitive impairments, as well as a decrease in abilities to perform two tasks simultaneously, contributing to loss of autonomy.

Interventions based on the performance of cognitive-motor dual tasks show positive effects on cognitive, physical and emotional development on dual-tasking capabilities. Exergames, interactive serious games combining physical activity and technology, are a certain type of cognitive-motor dual task training. These exergames appear to be cognitively effective, discussed on a physical level, not studied on dual task functions. It is likely that a dual task cognitive-motor with the support of a exercise leads to the same benefits as training without the need for special support.

In addition, the exergames benefit from specific features such as a good immersion and a playful aspect that increase the participant's adhesion. Moreover, the level of security of this type of programme has been little studied. It is likely that cognitive-motor dual tasks training supported by an exercise programme leads to few undesirable events and good adherence.

Many of the recommendations specific needs gaming state that it is important to develop systems that respond to the needs specific to the population concerned in order to be effective. Within the laboratory HAVAE has been developed a tool, the "virtual carpet":

association between a video-projected scene and a monitoring system of position of the participants. This system makes it possible to use as a grid of play the cartography and iconography of the City of Limoges. The investigators suppose that this emphasis on local heritage will encourage the participants leaving their homes, thereby increasing their level of physical activity and their quality of life.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: University Hospital, Limoges

location_facility:
Résidence Autonomie DURKHEIM
Résidence Autonomie CASSEAUX

status_simplified: Completed


title: AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE

acronym: APPENDAGE

summary: The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF). The primary objective of the study is to evaluate the efficacy of Aspirin versus Aspirin + Clopidogrel after LAAC by comparing the occurrence of ischemic lesions on cerebrovascular magnetic resonance imaging (MRI) studies.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Bordeaux

location_facility:
Toulouse University Hospital
Bordeaux University Hospital

intervention_type: Drug


type: Other Identifier

title: S100B Kinetic During the Occurrence and Treatment of Delayed Cerebral Ischaemia After a Subarachnoid Haemorrhage.

acronym: SKinDCI

summary:
Nearly half of the survivors of subarachnoid haemorrhage (SAH) retain irreversible neurological damage resulting from the early lesions associated with the initial bleeding, and the occurrence of possible delayed cerebral ischaemia (DCI). The early diagnosis of the occurrence of an DCI is therefore a major challenge in order to optimise management before irreversible lesions are formed. However, the means of diagnosis are often not available, and up to a third of DCI are discovered on follow-up images when the lesions are already present. Among the markers of brain injury, S100 calcium-binding protein B (S100B) is an astrocyte protein released into the bloodstream at the time of the appearance of a brain lesion. Its short half-life makes it a prime candidate for patient follow-up to diagnose a new ischemic lesion and assess the effectiveness of its management.

Among the elements at the origin of DCI, the occurrence of proximal vasospasm is the main element on which we can have a therapeutic action. The strategy implemented in the department consists of performing a mechanical angioplasty when proximal vasospasm is detected with a decrease in downstream cerebral perfusion. Nevertheless the benefit of this therapeutic action is discussed and there is currently no early marker of the effectiveness of this procedure.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hopital Femme Mère Enfant
Hôpital Gabriel Montpied

intervention_type: Biological


title: Interest in "Combo" (a Combination of Dietary Supplements Including Probiotics) in NASH Improvement

acronym: ICAN

summary: The aim of this bicentre, prospective, placebo-controlled, double-blind, randomized, interventional study is to assess for the first time the effects of a Combo with probiotics and dietary supplements compared to placebo for non-alcoholic steatohepatitis (NASH) patients with mild or severe fibrosis.

lead_sponsor: Mativa-Tech SA

location_facility: Centre Hospitalier Intercommunal Créteil

location_facility: Centre Hospitalier Intercommunal de Villeneuve St Georges


title: Caracterisation of SARS-Cov2 Infected Patients Hospitalized in Infectious Disease Department

summary: The main objective of this cohort is to characterize COVID-19 patients hospitalized in infectious disease department. The collection of clinical and biological data from start of hospitalization to long-term follow up will contribute to a better description of the patient care, to the identification of predisposition to complication related to the disease, and to the evaluation of the impact of different therapeutical strategies.

ipd_sharing_description: No data sharing plan is scheduled

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de NICE - Urgences
CHU de NICE - Infectiologie


title: Crossover Comparison of the Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children

summary:
In children with Covid-19, the diagnosis of Kawasaki Disease (KD) and pneumonia should be made very quickly. However, the regional hospitals surrounding Paris don't have the required expertise. The use of MELODY allows the paediatric team to quickly carry out the necessary examinations while avoiding the movement of patients and the risk of contamination.

The MELODY remote system developed by the company AdEchoTech is a CE marking telemedicine technique, allowing an expert to perform an ultrasound scan on a distant patient (several hundred/thousands of kms). The Melody system makes it possible to optimize ultrasound expertise resources wherever they are located (all specialties combined) The feasibility of the clinical use of telerobotic sonography has been demonstrated in adults for abdominal, cardiac and prenatal exam. Thus, the aim of this study is to assess the feasibility of this system in children.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHI Villeneuve-Saint-Georges
CHI Créteil

intervention_type: Device


title: Multicenter, Observational Study of Anti-Sars-Cov2 Vaccine Efficacy in Patients With Malignant Pathologies Treated in the University Hospitals of AP-HP. Nord

acronym: COVIDVAC OH

summary:
In the context of malignant disease, it is likely that vaccine efficacy and immunogenicity depends on the type of pathology, stage of the disease, immunosuppression induced by the treatments, in addition to more classic factors such as age, general condition and possibly the type of vaccine used.

There are very little data on the efficacy and immunogenicity of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with malignant disease in the active phase of treatment.

This multicenter observational study aims to assess the efficacy and the immunogenicity of anti-Sars-CoV-2 vaccines in the cohort of patients treated for malignant pathology (solid or hematological tumors) at Saint Louis Hospital and in thoracic oncology patients at Bichat Hospital.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Saint-Louis Hospital, AP-HP
Bichat Hospital, AP-HP


title: BRAF V600-mutated Lung Carcinoma Treated With the Combination of Dabrafenib-trametinib: a Retrospective Evaluation (Secondary Data Use Study of Dabrafenib-Trametinib in "Real Life" for Non-Small Cell Lung Cancer With a BRAF V600 Mutation)

acronym: BLaDE

summary: BLaDE cohort will evaluate overall survival (OS), real world progression-free survival (PFS), best response and duration of treatment in patients with advanced, metastatic Non-Small Cell Lung Cancer (NSCLC) harboring BRAF V600E or non E mutation who received dabrafeninb-trametinib combination or not. Subsequent or previous treatments (treatments delivered after or before dabrafeninb-trametinib combination will be recorded). Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Créteil - CHI
Lyon - CRLCC


title: L'Étude de la Dysfonction endothéliale Dans la Maladie à COVID-19 Chez Des Patients en Soins Critiques.

acronym: CAUSED

summary:
SARS-CoV-2 enters human cells through the binding of the spike protein with angiotensin converting enzyme-2 (ACE2), a membrane receptor highly expressed in immune or non-immune cells, and in many organs, including lungs and endothelial cells.

In COVID-19 disease, the infection of endothelial might cause an acute endothelial dysfunction.

The objective of this study is to demonstrate that patients COVID19 (+) hospitalized in ICU present an acute endothelial dysfunction (compared with COVID19 (-) also hospitalized in ICU).

This acute endothelial dysfunction could lead to organ failure, systemic immune dysregulation and thrombosis.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Angers

location_facility: Hopital E.Herriot - Hospices Civils de Lyon

intervention_type: Diagnostic Test


title: Circulating Levels of Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and / or Overweight, and / or Obesity

acronym: HOGRID

summary:
A significantly higher proportion of patients with rare diseases (RD) with intellectual disability (ID), present hyperphagia, overweight or obesity, compared to the general population. Prader-Willi syndrome is the only genetic obesity identified to date associated with hyperghrelinemia, while ghrelin levels are lower than in controls in other situations of obesity.

The aim of the study is to find out whether the levels of ghrelin, which are abnormally high in PWS throughout life, are also high in these RD when people have hyperphagia and/or overweight.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre N°1 : 40 Centre de Référence PRADORT Pr Tauber - Toulouse Centre N°2 : 22 Centre de Référence PRADORT Pr Poitou Bernert - Paris La Pitié Salpetrière Centre N°3 : 15 Centre de Référence DI de causes rares Dr Heron - Paris La Pitié Salpêtrière Centr


title: Stress, Personality, Attachment and Coping During the Covid Crisis.

acronym: STERACOVID

summary: Because of containment due to Covid-19, the French High Authority for Health (HAS) recommended reinforced monitoring of patients taken in care in the psychiatric ward, with special attention for people over the age of 65. To meet this recommendation, the geriatrics department of the hospital of Charity of Saint-Etienne hospital and the Vinatier hospital in Lyon organized follow-up of these patients by telephone throughout the containment period, thus allowing continuity of care. This pandemic situation and these measures are unprecedented; it is difficult to anticipate the psychological impact on patients.

ReferenceType: derived

ReferenceCitation: Edjolo A, Dorey JM, Herrmann M, Perrot C, Lebrun-Givois C, Buisson A, El Haouari H, Laurent B, Pongan E, Rouch I. Stress, Personality, Attachment, and Coping Strategies During the COVID-19 Pandemic: The STERACOVID Prospective Cohort Study Protocol. Front Psychiatry. 2022 Jun 27;13:918428. doi: 10.3389/fpsyt.2022.918428. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CH Le Vinatier
Chu Saint-Etienne


title: ASIA Study: French Register of Inflammatory Eye Disease Secondary to Cancer Immunotherapy

acronym: ASIA

summary:
New anticancer therapies based on lifting the inhibition of the immunological synapse are used in the therapeutic arsenal of a growing number of neoplasias (melanoma, lung cancer, hepatocellular carcinoma, etc.). These "immune check points" inhibitors "(ICPI) target molecules that usually allow immunity to destroy malignant cells. At the systemic level, this results in a loss of immune homeostasis and facilitation of the inflammatory response which may be responsible for dysimmune manifestations distant from the neoplastic site. Thus, since their introduction, ICPIs have been of interest to immunologists, rheumatologists and internists who often find themselves in the first line to deal with this type of side effect (immunotherapy-related adverse events, IRAEs). The frequency of these ARIs between 70% and 90%, depending on the immunotherapy used and the severity of these ARIIs (grade 1-2 vs. 3-5). The overall increase in the number of cancers, the multiplication of available molecules and the expansion of their indications should exponentially increase the number of IRAEs to be supported. Little is known about the epidemiology, risk factors and efficacy of treatments.

In these IRAEs, inflammatory ophthalmological manifestations have been described with an estimated prevalence of between 0.4 and 1% of the patients treated. These attacks are rare and protean (uveitis, scleritis, retinitis, inflammatory orbitopathies, Vogt-Koyanagi-Harada -like…) and reported most often in the form of clinical cases.

The Main objective is to describe the inflammatory ophthalmic disorders linked to anti-cancer immunotherapy.

location_facility: CHU Angers - Service de Médecine Interne - Immunologie Clinique

location_facility: Hôpital de la Croix-Rousse - Service de médecine interne - 103 Grande Rue de la Croix-Rousse


title: Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)

summary: Dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. Scarring is pathological with a tendency to retraction. The gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. Likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. The investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. Better knowledge of gynecological semiology in patients with EBD will allow better adaptation of gynecological follow-up, screening for STDs and gynecological cancers, as well as possible specific complications. This study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.

ipd_sharing_description: no data sharing plan is schedule

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility:
Hôpital Saint Louis
CHU de NICE


title: Feasibility Study of a New Immunoglobulin E (IgE) Assay Method in Urine and Blood

acronym: LuLISA

summary: The main objective is to study the feasibility of a new specific IgE assay using a bioluminescence technique in a pediatric and adult allergic population. For this, we will collect blood, and urine during a blood test scheduled for the follow-up of the patient.

location_facility:
Larrey hospital
University Hospital


title: Non-use après Accident Vasculaire cérébral : Influence de la Force et de la précision du Geste à Fournir Lors Des Mouvements du Membre supérieur parétique

acronym: OPTISTROKE

summary: After a stroke, 80% of patients have an upper limb deficit, limiting activity. Some develop a non-use: they can, but do not, use their paretic limb. Non-use is a general phenomenon applied to all situations where the patient applies unnecessary compensation. Several rehabilitation techniques are effective to counter non-use, but there is insufficient knowledge to choose the most suitable technique. Optimal control theory could help guide these choices. It assumes that the chosen coordination satisfies the constraints of the task (force, amplitude, tolerance) while reducing the cost of the movement. This study will assess non-use by anticipating the sensitivity to the constraints of force and precision deduced from the logic of optimal control. The study authors expect to observe a weakness effect: in a reaching task (i.e. when the person has to touch an object placed in front of them), lightening the paretic arm makes it possible to reduce non-use, and a precision effect: in a reaching task, non-use increases with the required spatial precision.

ipd_sharing: Yes

ipd_sharing_description: Anonymised raw datasets and code used for the analysis will be available on reasonable request.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU de Nîmes


title: Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment

acronym: SAPPHYRE

summary: The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.

time_perspective: Other

lead_sponsor: Sophysa

location_facility:
La Timone Children's Hospital
La Pitié Salpétrière Hospital


title: Impact of Side to Side Gastrojejunostomy on the Rate of Delayed Gastric Emptying After Pancreaticoduodenectomy: A Prospective Randomized Study

acronym: IPAD

summary: Prospective bi-centric randomized open-label study comparing side to side and end to side gastrojejunostomy in pancreaticoduodenectomy

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Rennes University Hospital

location_facility:
Institut Paoli Calmettes
CHU de Rennes

intervention_type: Procedure


title: Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education

acronym: APPRO-FSL

summary: Following the proposal to self-monitor by the Freestyle Libre® (FSL) connected object, in diabetic patients in the context of therapeutic education, regarding the appropriation of FSL, what works, for which patients , in what specific contexts and by what mechanisms does it govern? A multicentric observational research will be conducted with mixed method design (follow-up using patient questionnaires) and semi-structured interviews of patients and caregivers.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility:
Hôpital Avicenne
Hopital d'Instruction des Armées Bégin


title: Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.

acronym: VIBRATAC

summary:
In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.

In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.

The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Le Clos Champirol - Service de Médecine Physique et de Réadaptation


title: Exploration of Differences in Metabolite Concentrations by 7Teslas NMR Spectroscopy in Striatum and Subthalamic Nuclei in de Novo Parkinsonian Patients and Control Subjects

summary:
Initially, the exploration of brain metabolism by Nuclear Magnetic Resonance Spectroscopy (MRS) of the high magnetic field proton (1H) (11.7T) applied to acute and chronic animal models of Parkinson's disease (PD) showed glutamatergic hyperactivity within the striatum, one of the components of the basal ganglia. Interestingly, acute administration of L-dopa and acute, subchronic and chronic deep brain stimulation of the subthalamic nucleus (STN) normalizes these neurochemical profiles. Investigators also show an increase in glutamate levels in the STN ipsilateral to the substantia nigra pars compacta (SNpc) damaged by the neurotoxin, expected phenomenon, but also and surprisingly in the STN controlateral to the lesion. A degeneration of dopaminergic neurons is also observed in the controlateral SNpc at the lesion suggesting that the hyperglutamatergy of the controlateral STN to the lesion could promote neuronal death in the SNpc and thus participate in the progression and lateralization of the PD.

Using 3T MRS in PD patients, as in other studies in humans, investigators do not see changes in glutamate and glutamine levels in the putamen of Parkinsonian patients. This difference between animal and human studies can be explained:

by the different rate of progression between PD in humans and animal models with plasticity phenomena limiting glutamatergic hyperactivity,
by the effect of treatment in PD masking changes in glutamate metabolism,
by limiting sensitivity in the detection of metabolites (Glutamate, glutamine, GABA) at 3T.

The 7T 1H MRS improves the dispersion of chemical shifts of the metabolites studied, increases the sensitivity of the measurement, makes it possible to select regions of interest of smaller volumes (1 cm3) and thus limits the magnetic susceptibility effects that degrade the quality of the measured signal. This makes it possible to reliably separate glutamate and glutamine peaks.

In this context, investigators propose to study the metabolic changes in a homogeneous group of de novo Parkinsonian patients, naive to any treatment intended to replace the missing dopamine. The gain in spatial resolution, contrast and signal will allow better characterization of localized anomalies in small-volume structures such as basal ganglia, putamen and STN.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Poitiers
Chu Clermont Ferrand


title: Survenue Des Infections d'Emergence après la Pose d'un catHéter de Dialyse péritonéaLE

acronym: SINEPHILE

summary: Peritoneal dialysis, which appeared at the end of the 1970s, quickly proved its worth both in terms of its effectiveness and of its ease of compliance, which guarantees an improved quality of life. To date there are different modes of application of this technique: Continuous Ambulatory Peritoneal Dialysis, and Automated Peritoneal Dialysis. Whatever the technique used, the placement of a dressing covering the exit site of the catheter is necessary just after the placement of the PD catheter and this so that the site of emergence is kept dry until healing (in general 2 to 4 weeks). Once the emergence site has healed, the technique can be started. Discharge site infections are a major predisposing factor for the development of peritonitis. Numerous studies in different parts of the world have shown that the rates of PD-related infections have steadily declined over the past 10 to 20 years. Several recommendations for the prevention and treatment of emergence site infections have been published by the International Peritoneal Dialysis Society. Several studies nonetheless call into question the recommendations by showing that catheter infection is not linked to the number of risk factors present at the time of catheter insertion, nor to the prescription of antibiotic prophylaxis, nor to the the experience of the caregiver, the antiseptic used or the early dressing change. In addition, only antibiotic prophylaxis at catheter placement is strongly recommended. Regarding the other measures, their relevance is not always demonstrated and their application varies considerably from one center to another. In addition, many authors have sought to establish a definition of catheter infections in order to allow an optimal assessment of their frequency. However, these definitions are not universal and have certain limitations. The objective of this work is on the one hand to better characterize the incidence of infections at the site of emergence in peritoneal dialysis, and on the other hand, in the absence of a definition established according to the recommendations, to use the score de Schaeffer, is in particular the value of this score which would make it possible to define more precisely the presence of an infection.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Service de néphrologie, CHU de Besançon
Besancon University Hospital


title: Early Integration of Supportive Care Into Standard Oncology Care for Metastatic Uveal Melanoma Patients

summary:
The study main objective is to assess whether the early introduction of supportive care demonstrates a benefit on patients' psychological care needs at 6 months (M6), versus oncological standard of care in patients with metastatic UM.

Supportive care in patients with metastatic Uveal Melanoma (UM)

primary_purpose: Supportive Care

lead_sponsor: Institut Curie

location_facility:
Centre Antoine Lacassagne
Institut Curie


type: Registry Identifier

title: A Randomized Prospective Multicenter Study Comparing Fibula Free-flap Mandibular Reconstruction With or Without Preoperative Virtual Planning in Patients With Oral or Oropharyngeal Cancer

acronym: CURVE

summary: This is a national multicenter, randomized, stratified, open label study, aiming to compare mandibular reconstruction (MR) with or without preoperative virtual planning (PVP), in patients with oral/oropharyngeal cancer (OOPC).

lead_sponsor: UNICANCER

location_facility:
Centre Antoine Lacassagne
CHU Groupe Hospitalier Pellegrin

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

acronyme: CURVE

titre: Etude prospective multicentrique randomisée comparant la reconstruction mandibulaire par lambeau libre de fibula avec ou sans planification virtuelle préopératoire chez les patients atteints d'un cancer de la cavité buccale ou de l'oropharynx.

discipline_principale: chirurgie maxillo-faciale / stomatologie

nom_porteur: BOZEC

prenom_porteur: Alexandre


type: Other Grant/Funding Number

title: Interventional Study With Low Risks and Constraints on the Effect of KCNQ1 Mutation (Romano-Ward Syndrome) on Insulin Tolerance and Obsessive Compulsive Features, a Cross-sectional Study With Matched Controls With an Attempt of Linkage to Whole Genome Scanning.

acronym: PRIME

summary: The objectives of the study are to investigate if KCNQ1 mutation in Romano-Ward long QT patients can be associated with changes in insulin regulation and with psychological features of compulsivity, impulsivity and behavioural rigidity.

ReferenceType: background

ReferenceCitation: Torekov SS, Iepsen E, Christiansen M, Linneberg A, Pedersen O, Holst JJ, Kanters JK, Hansen T. KCNQ1 long QT syndrome patients have hyperinsulinemia and symptomatic hypoglycemia. Diabetes. 2014 Apr;63(4):1315-25. doi: 10.2337/db13-1454. Epub 2013 Dec 18.

ReferenceCitation: van de Vondervoort I, Poelmans G, Aschrafi A, Pauls DL, Buitelaar JK, Glennon JC, Franke B. An integrated molecular landscape implicates the regulation of dendritic spine formation through insulin-related signalling in obsessive-compulsive disorder. J Psychiatry Neurosci. 2016 Jun;41(4):280-5. doi: 10.1503/jpn.140327.

ReferenceCitation: van de Vondervoort IIGM, Amiri H, Bruchhage MMK, Oomen CA, Rustogi N, Cooper JD, van Asten JJA, Heerschap A, Bahn S, Williams SCR, Buitelaar JK, Poelmans G, Glennon JC. Converging evidence points towards a role of insulin signaling in regulating compulsive behavior. Transl Psychiatry. 2019 Sep 12;9(1):225. doi: 10.1038/s41398-019-0559-6.

ReferenceCitation: Southgate L, Tchanturia K, Collier D, Treasure J. The development of the childhood retrospective perfectionism questionnaire (CHIRP) in an eating disorder sample. Eur Eat Disord Rev. 2008 Nov;16(6):451-62. doi: 10.1002/erv.870.

ReferenceCitation: Foa EB, Huppert JD, Leiberg S, Langner R, Kichic R, Hajcak G, Salkovskis PM. The Obsessive-Compulsive Inventory: development and validation of a short version. Psychol Assess. 2002 Dec;14(4):485-96.

ReferenceCitation: Lynam, D.R., Smith, G.T., Whiteside, S.P., Cyders, M.A. (2006). The UPPS-P: Assessing five personality pathways to impulsive behavior (Technical Report). West Lafayette: Purdue University.

ReferenceCitation: Zermatten, A., Van der Linden, M., Jermann, F., Ceschi, G. Validation of a French version of the Obsessive-Compulsive Inventory-Revised in a non-clinical sample. (2006). Revue Européenne de Psychologie Appliquée. 56:151-155

ReferenceCitation: Van der Linden, M., d'Acremont, M., Zermatten, A., Jermann, F., Laroi, F., Willems, S., Juillerat, A., Bechara, A. (2006). A French Adaptation of the UPPS Impulsive Behavior Scale: Confirmatory factor analysis in a sample of undergraduate students. Eur J Psychol Assess. 22:38-42.

ReferenceType: result

ReferenceCitation: Fatima SS, Chaudhry B, Khan TA, Farooq S. KCNQ1 rs2237895 polymorphism is associated with Gestational Diabetes in Pakistani Women. Pak J Med Sci. 2016 Nov-Dec;32(6):1380-1385. doi: 10.12669/pjms.326.11052.

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

repository_institution: PubMed Central - Europe PMC

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

repositories_concat: PubMed Central;ecommons.aku.edu

publisher_dissemination: Pakistan Journal of Medical Sciences

ipd_sharing_description: All anonymized individual participant data will be shared within the PRIME consortium collaborators in accordance with the PRIME Consortium Agreement

lead_sponsor: Biotrial

sponsor_collaborators:
Biotrial
European Union
Nantes University Hospital

location_facility:
Biotrial Clinical Unit
L'Institut du Thorax, Nantes Hospital

intervention_type: Genetic


title: Use of a Connected Companion in Children With Cystic Fibrosis - COMPANION-CF

acronym: COMPANION-CF

summary:
The study will be conducted over a 6 months period. For the first three months, the child will be accompagned with a connected companion. After this period, the companion will be removed for three months in oder to prove this companion could improve treatment adherence for children suffering from cytolisis fibrosis.

This study will be conducted at the University Hospital Center of Rennes and Hospital Center of Saint-Brieuc.

ReferenceCitation: De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.

ReferenceCitation: Jentzsch NS, Camargos PAM, Colosimo EA, Bousquet J. Monitoring adherence to beclomethasone in asthmatic children and adolescents through four different methods. Allergy. 2009 Oct;64(10):1458-1462. doi: 10.1111/j.1398-9995.2009.02037.x. Epub 2009 Mar 28.

ReferenceCitation: Zindani GN, Streetman DD, Streetman DS, Nasr SZ. Adherence to treatment in children and adolescent patients with cystic fibrosis. J Adolesc Health. 2006 Jan;38(1):13-7. doi: 10.1016/j.jadohealth.2004.09.013.

ReferenceCitation: Conway SP, Pond MN, Hamnett T, Watson A. Compliance with treatment in adult patients with cystic fibrosis. Thorax. 1996 Jan;51(1):29-33. doi: 10.1136/thx.51.1.29.

ReferenceCitation: Arias Llorente RP, Bousono Garcia C, Diaz Martin JJ. Treatment compliance in children and adults with cystic fibrosis. J Cyst Fibros. 2008 Sep;7(5):359-67. doi: 10.1016/j.jcf.2008.01.003. Epub 2008 Mar 4.

ReferenceCitation: Sanchis J, Gich I, Pedersen S; Aerosol Drug Management Improvement Team (ADMIT). Systematic Review of Errors in Inhaler Use: Has Patient Technique Improved Over Time? Chest. 2016 Aug;150(2):394-406. doi: 10.1016/j.chest.2016.03.041. Epub 2016 Apr 7.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: O'Donohoe R, Fullen BM. Adherence of subjects with cystic fibrosis to their home program: a systematic review. Respir Care. 2014 Nov;59(11):1731-46. doi: 10.4187/respcare.02990. Epub 2014 Jul 15.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Daedalus Enterprises

ReferenceCitation: Britto MT, Rohan JM, Dodds CM, Byczkowski TL. A Randomized Trial of User-Controlled Text Messaging to Improve Asthma Outcomes: A Pilot Study. Clin Pediatr (Phila). 2017 Dec;56(14):1336-1344. doi: 10.1177/0009922816684857. Epub 2017 Jan 5.

oa_host_type: closed

publisher_dissemination: SAGE Publications

lead_sponsor: Centre Hospitalier de Saint-Brieuc

sponsor_collaborators:
Centre Hospitalier de Saint-Brieuc
Rennes University Hospital

location_facility:
Chu Rennes
Centre Hospitalier de Saint-Brieuc


title: Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology

acronym: GAGNE

summary: When the digestive tract is functional, learned societies recommend the use of a nutritional support by enteral feeding. Indeed, it has many advantages (maintenance of gut trophicity, reduction of the risk of infection by reducing the incidence of bacterial translocations,...). It has been used for about fifteen years in hematology departments and offers promising results in the context of allogeneic transplantation with prospective trials in progress (NEPHA study). However, its tolerance has not been studied during autologous transplantation. This study aims to assess the success of enteral nutrition in this setting.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CH de la Côte Basque
CHU Bordeaux

intervention_type: Dietary Supplement


title: Experiences, Expectations and Needs of Children Whose Parents Have Cystic Fibrosis - Exploratory Study

acronym: MUCOKIDS

summary:
As more and more patients with cystic fibrosis (CF) become parents, we have studied parenting concerns in this serious chronic disease in a first study (MucoPar) which is ongoing.

The current study (MucoKids) is an extension of the previous MucoPar study and aims to explore and collect the perceptions, expectations and needs of children whose one parent has CF.

This will be done in the context of individual interviews or in several small groups of children led by a psychologist who will encourage them to develop what constitutes to be the child of somebody with CF.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Grégory Lemarchal Association

location_facility:
Foch Hospital
Cochin Hospital

intervention_type: Behavioral


title: Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal

acronym: SOPHCIG

summary: To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: CHI Créteil Equipe de liaison et de soins en addictologie (ELSA)


title: Chronic Intradialytic Exercise: a Cardioprotective Role

acronym: EX-CHRODIAL

summary: The main objective is to assess the effects of chronic intradialytic physical exercise on myocardial remodelling and regional function.

lead_sponsor: University of Avignon

location_facility:
ATIR
Centre Hemodialyse AIDER sante


title: Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented. Prospective, Randomized, Single-center, Multisite Non-inferiority Study.

acronym: MAKO CIMENT

summary:
Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant.

Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population.

Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants.

Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence.

We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.

lead_sponsor: Hospices Civils de Lyon

sponsor_collaborators:
Hospices Civils de Lyon
Stryker Nordic

location_facility: Chirurgie Orthopédique et Traumatologique Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Department of orthopedic surgery, Hopital Nord Croix-Rousse- Hospices Civils de Lyon


title: Effect of Tenofovir/Emtricitabine Short Course on Viral Clearance in Patients Recently Infected With SARS-COV2 (Covid-19) Not Requiring Hospitalization: a Phase IIB/III Multicenter Open-label Randomized Controlled Trial

summary: COVID-19 pandemic is currently affecting the globe. To date, there is no effective oral therapy against SARS-CoV2 infection. The investigators propose to test as a repurposing drug combination, a short course of tenofovir disoproxil and emtricitabine (TDF/FTC), as a proof-of-concept randomized open-label study to test its viral efficacy against SARS-CoV2.

ReferenceCitation: Parienti JJ et al. EClinicalMedicine 2021: https://authors.elsevier.com/sd/article/S2589-5370(21)00273-X

ReferenceCitation: Parienti JJ, Prazuck T, Peyro-Saint-Paul L, Fournier A, Valentin C, Brucato S, Verdon R, Seve A, Colin M, Lesne F, Guinard J, Ar Gouilh M, Dina J, Vabret A, Hocqueloux L. Effect of Tenofovir Disoproxil Fumarate and Emtricitabine on nasopharyngeal SARS-CoV-2 viral load burden amongst outpatients with COVID-19: A pilot, randomized, open-label phase 2 trial. EClinicalMedicine. 2021 Aug;38:100993. doi: 10.1016/j.eclinm.2021.100993. Epub 2021 Jun 27.

ipd_sharing_description: We encourage contact the corresponding author for academic IPD sharing

lead_sponsor: University Hospital, Caen

location_facility:
Regional Hospital
Caen University Hospital


title: Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study

summary: Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.

lead_sponsor: Centre Antoine Lacassagne

location_facility:
Pôle Santé République
Centre Antoine Lacassagne

intervention_type: Radiation


title: Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors

acronym: IMMUNOPARP

summary: This study concerns the creation of a biological collection (blood samples) in patients with Epithelial Ovarian Cancer in in order to describe the immune response with PARP inhibitors.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Georges Francois Leclerc
CHRU Jean Minjoz


title: Randomized, Comparative Pilot Study Evaluating the Effectiveness of autoHYpnosis by Anchoring in the Prevention of Anxiety Related to Wearing the Mask for Radiotherapy of Head and Neck Tumors

acronym: HYMACO

summary:
HYMACO is a monocentric, randomized comparative pilot study with a total duration of 25 months. The purpose of this study is to evaluate the effectiveness of autoHYpnosis by anchoring in the prevention of anxiety related to wearing the mask for radiotherapy of head and neck tumors.

60 patients will be randomized into 3 arms ARM A : Standard care ARM B : Autohypnosis ARM C : Musicotherapy This study is carried out during the first 5 radiotherapy sessions because this is decisive for the good progress of subsequent sessions

lead_sponsor: Institut de Cancérologie de Lorraine


title: Identification of Predictive Immune Biomarkers Based on the Understanding of COVID-19 Pathogenesis to Influence Therapeutic Management

acronym: IMMUNOMARKCOV

summary:
Persons infected with Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2 vary in severity from being asymptomatic to having fever, cough, sore throat, general weakness and fatigue and muscular pain and in the most severe cases, severe pneumonia, acute respiratory distress syndrome and sepsis potentially leading to death. Predictive markers of clinical worsening after admission are lacking. COVID-19 immunopathogenesis and relevant therapeutic strategies are still under investigation.

Although viral shedding peaks during the first week of symptoms, reports show that clinical deterioration often coincides with the development of host antiviral immune responses. The inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses that may enter the pulmonary circulation in large numbers and play an immune damaging role causing lung functional disability resulting in clinical worsening. Therapeutic strategies using corticosteroids or biotherapies targeting IL-6 may be valuable in some patients. Based on a better understanding of COVID-19 immunopathogenesis, the identification of predictive biomarkers early in the disease process would be of outstanding interest to tailor prompt therapeutic interventions.

On these bases, the present project aims to unravel, using innovative integrated multimodal immunological approaches, immunologic predictive markers by finely characterizing from their admission innate and adaptive immune responses in two well described cohorts of COVID-19 patients that are being collected in Toulouse (COVID-BioToul) and Bordeaux (COLCOV-19 BX).Those two biological cohorts are connected with two clinical cohorts in Toulouse and Bordeaux in order to have a very well defined population of COVID-19 patients and their clinical outcome. In both cohorts, investigators harvest and cryopreserve biological samples, including plasma and peripheral blood mononuclear cells (PBMCs), on admission and longitudinally from patients evolving or not toward severe forms of the disease in Bordeaux and Toulouse University Hospitals and will allow to investigate primary and secondary objectives. Moreover in the two centers, there are also two clinical outpatients cohorts of healthcare workers attending dedicated clinics in the frame of their surveillance medical program, which constitute groups of patients with benign forms of COVID-19.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital Bordeaux
University Hospital Toulouse


title: Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain

acronym: CovIdeDocS

summary:
The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers.

The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.

sponsor_collaborators: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Treg Cell Therapy in Liver and Kidney Transplantation - Preclinical Validation of Batches of Treg Cells Amplified in Vitro

acronym: PRE-TREG

summary:
Kidney and liver transplantation requires a fine tuning of immune responses in order to achieve long term operational tolerance with immunosuppressants or immune modulators. Numerous experimental findings indicate that CD4+ FOXP3 expressing regulatory T (Treg) cells play a central role in the induction of tolerance to the grafts indicating that the use of Treg cells may be an innovative therapeutic strategy in kidney transplantation that would enable the diminution of immunosuppressive drugs or even their discontinuation, thus decreasing their risk of adverse events.

As human Treg cells represent less than 10% of CD4+ T cells, and because it has been shown in mice that a dose of 2*104 polyclonal Tregs/g was necessary to induce tolerance in animal models of solid organ transplantation, it is mandatory to expand human Treg cells ex vivo, after isolating them from peripheral blood. The investigators previously defined a protocol for Treg cell isolation and expansion in clinical grade conditions (cGMP) that enabled us to obtain the expected number of expanded cells maintaining high levels of FOXP3 (3).

The investigators therefore hypothesize in humans, as it has been already shown in mice, that the infusion of autologous expanded polyclonal Treg cells would lead to the obtaining of operational tolerance in kidney and liver graft in association with classical immunosuppressants and an expectable diminution of those.

To this end, it is necessary to have pre-clinical batches of expanded Treg cells validated by the National Agency for Medicines and Health Products Safety validate (ANSM). The investigators therefore plan to have 4 batches from 2 liver transplant patients and 2 kidney transplant patients validated.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PHRCI

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: THTreg

titre: Thérapie cellulaire Treg en transplantation hépatique

discipline_principale: autre

nom_porteur: MIYARA

prenom_porteur: Makoto

appel_a_projets: PHRCN

acronyme: TRTREG

titre: Thérapie cellulaire Treg en transplantation rénale

discipline_principale: immunologie / allergologie


title: Assessment of Post-traumatic Stress Disorder (PTSD) in Patients Monitored for Cytomegalovirus (CMV) Seroconversion During Pregnancy, Without Ultrasound Signs or With Non-serious Ultrasound Signs of Maternal-fetal CMV Infection.

acronym: PTSD CMV

summary:
Reports of maternal seroconversion to CMV during pregnancy can be extremely stressful. This virus is little known to the general public and searching for information on the Internet quickly leads to a consultation of a site mentioning the risk of severe psychomotor retardation in the event of prenatal cytomegalovirus infection.

The psychological repercussions in the event of prenatal CMV infection with criteria of severity, leading or not to a request for IMG, is undeniable, but no study has investigated the consequences of seroconversion to CMV without transmission of the virus to the patient fetus, or in the case of transmission without criteria of seriousness, on the patient's experience during and after her pregnancy. Such a study would, if necessary, improve the care and support of these future mothers

location_facility: Service de Gynécologie Obstétrique, Hôpital Lyon Sud

location_facility: Service de Gynécologie Obstétrique, Hôpital Mère Enfant


title: Recherche d'un Marqueur Pronostique de l'Atteinte rénale du Purpura Rhumatoïde de l'Enfant. Validation de la méthode de détection Des IgA1 Avec Gradient de la Glycosylation Par spectrométrie de Masse

summary: In this ancillary study on the FoxTreg cohort, the study investigators will select variables to input and thus develop two models (Linear Discriminant Analysis and Decision Tree). The aim of this study is to validate the method in terms of repeatability, reproducibility, control of pre-analytical conditions and sample conservation, to complete the screening of IgA glycosylation in individuals of the FoxTreg cohort and to refine the glycopeptide signature to predict renal involvement.

ReferenceCitation: Ozen S, Pistorio A, Iusan SM, Bakkaloglu A, Herlin T, Brik R, Buoncompagni A, Lazar C, Bilge I, Uziel Y, Rigante D, Cantarini L, Hilario MO, Silva CA, Alegria M, Norambuena X, Belot A, Berkun Y, Estrella AI, Olivieri AN, Alpigiani MG, Rumba I, Sztajnbok F, Tambic-Bukovac L, Breda L, Al-Mayouf S, Mihaylova D, Chasnyk V, Sengler C, Klein-Gitelman M, Djeddi D, Nuno L, Pruunsild C, Brunner J, Kondi A, Pagava K, Pederzoli S, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). EULAR/PRINTO/PRES criteria for Henoch-Schonlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part II: Final classification criteria. Ann Rheum Dis. 2010 May;69(5):798-806. doi: 10.1136/ard.2009.116657.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Nimes
CHRU de Montpellier


title: Evaluation of pupillometrY for External Ventricular Drains Stop

acronym: EYES

summary:
Placement of an external ventricular shunt is one of the most common neurosurgical procedures in neuro-resuscitation. However, the modalities of its withdrawal are not, the subject of recommendations but rather of service habits. It has been recently demonstrated that pupillary monitoring by an electronic pupillometer was more reliable than standard clinical monitoring in brain injury patients. This tool provides access to a rich pupillary semiology at the patient's bed.

So the goal is to study the evolution of the various pupillary parameters analyzed by the electronic pupillometer during the external ventricular shunt weaning tests and to highlight the predictive factors of failure.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility:
Hôpital La Timone
CHU de la Réunion


title: Tight Postoperative Control of Mean Arterial Pressure Using a Closed-loop System for Norepinephrine Administration: A Randomized Controlled Trial in Patients Admitted to the Intensive Care Unit After a Major Surgery.

acronym: COMAP-ICU

summary: The goal of this randomized controlled trial is to compare two different strategies of postoperative mean arterial pressure (MAP) management (manual versus automated) in patients who underwent a major surgery and admitted in the intensive care unit or post-anesthesia care unit for postoperative care. The investigators hypothesis is that the automated group will spend more time in a predetermined target MAP range of 80-90 mmHg compared to the manual group.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
University of California, Irvine
University of California, Los Angeles
Erasme University Hospital

location_facility:
Bicêtre Hospital
Paul Brousse Hospital


title: IMCY-NMO-000 In Vitro Study of the Biological and Immunological Activity of Imotopes® Candidates on Blood Cells of Patients With Stabilized Neuromyelitis Optica (PHASE 0)

summary:
This is a fundamental, prospective, multi-centres, interventional non-comparative study without the administration of a study product to patients.

A phase 0 study is particularly well adapted to early exploration of potential targeted treatments - i.e. treatments whose efficacy can only be hoped for in patients presenting specific biological characteristics in addition to being diagnosed with the targeted disease, Neuromyelitis Optica Spectrum Disorders (NMOSD) in this study. The main goal of the study will be to support the selection of Imotopes® (i.e. synthetic peptides encompassing HLA Class II T epitopes flanked by a thioreductase motif), and (i) capable of binding with class II HLA antigens of each patient and (ii) causing ex vivo the appearance of epitope -specific cytolytic CD4+ T cells.

lead_sponsor: Imcyse SA

location_facility:
Hôpital de Hautepierre
Hôpital Pierre Wertheimer


title: Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children

acronym: EPISODE

summary:
One of the most common infections acquired in hospital, also known as nosocomial infections, is intestinal infections. These infections can lead to the development of nosocomial diarrhea which can have serious consequences in young / very young children. These infections tend to prolong the average length of hospital stay of this fragile population. Conventional treatment of these infections, in the absence of knowledge of the infectious agent, is purely symptomatic. It is therefore necessary to develop new prevention strategies for this type of disease. In this sense, the administration of probiotic strains in order to prevent the onset of nosocomial diarrhea is a promising avenue and the present study aims to validate the preventive effect of this supplement.

The objective of this study is to assess the effect of Babybiane® Imedia or the microbiotic strain Lactobacillus rhamnosus GG LA801 in the preventive nutritional management of nosocomial diarrhea in children aged 1 to 24 months. This evaluation will be made in comparison with a placebo. The tolerance of the product under study will also be assessed.

status: Terminated

lead_sponsor: PiLeJe

collaborators: Clinact Clinfile

sponsor_collaborators: PiLeJe Clinact Clinfile

location_facility:
Hopital Robert Debré
Centre hospitalier d'Auxerre


title: Prevalence of Chronic Pain After an Emergency Department Visit for Severe Acute Pain and Influence of the Analgesia Initially Used

acronym: CHROPAIN

summary: The main objective for investigators is to determine the prevalence of moderate to severe chronic pain in the adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission and defined as greater than or equal to 6/10 by the numerical pain scale.

lead_sponsor: University Hospital, Grenoble

location_facility:
CHU Pellegrin
Grenoble Alpes University Hospital


title: NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants

summary:
Very premature birth and the necessary hospitalization expose to a risk of morbidity and mortality which impacts the neurodevelopmental prognosis. Sleep and behavior monitoring have not been developed in the neonatal units. This has to be improved since it is known from clinical and animal studies that the quality, organization and quantity of sleep in very preterm infants impact neurological development and brain plasticity.

The collection system provide neonatal care nurse with access to motion curves (evaluated by signal processing of live video) and real-time infrared video (also available in low-light conditions).

This new non-invasive technology allows an evaluation of the activity cycles of the newborn by the caregivers which until now was only accessible occasionally by short recordings of actigraphy or polysomnography. The investigators wish to demonstrate that this can contribute to an organization of care that respects the sleep patterns of the newborn, which they know to condition the neurodevelopmental prognosis.

lead_sponsor: Rennes University Hospital

location_facility:
Pôle Femme Mère Enfant
CHU Rennes Hôpital Sud

appel_a_projets: PHRIP

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: NEOVIDEO

titre: Impact du monitoring de l'activité motrice par analyse vidéo sur le sommeil des nouveau-nés grands prématurés.

discipline_principale: néonatalogie

nom_porteur: CITTÉ

prenom_porteur: Céline


title: Determination of Biomarkers for the Prediction of Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia

acronym: CortiCORONA

summary:
The primary objective of this study is to demonstrate (at the time of admission) biomarkers of interest (Human Plasma BAK125 panel + interferon panel) for dexamethasone responders versus non-responders in SARS-CoV-2 hypoxemic pneumonia.

The secondary objectives are to describe and compare between groups:

The number of days without mechanical ventilation
The need for mechanical ventilation
28-day mortality
Progression towards acute respiratory distress syndrome (ARDS)
Change in the qSOFA score
Length of hospitalization
The change in the extent of lesions on thoracic computed tomography scan between inclusion and D7 (or the day of discharge from hospital if <D7)
Change in biomarkers on D0, D2, D4, D7 (NFS, liver tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
Demonstrate other biomarkers of interest from the usual management (NFS, liver function tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
Change in biomarkers evaluated by mass spectrometry (on a blood sample) on D0 and D7 +/- 2 days
The initial viral load (within 48 hours preceding D0) and at D7 of inclusion estimated from the nasopharyngeal SARS-CoV-2 RT-PCR
Initial SARS-CoV-2 serology and on D7 from inclusion
The A38G polymorphism of the gene coding for Club Cell Secretory Protein (CCSP) for each patient
Short-term complications related to corticosteroid therapy
The quantitative and qualitative impact of corticosteroid therapy on lymphocytes from patients with COVID-19.

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel).

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospitals of Montpellier
Clinique du Parc


title: Predictive Score for Non-traumatic Secondary Headache After an Emergency Call

acronym: CEPHAREG

summary: The study objective was to identify predictive criteria of severe non-traumatic secondary headache among the information gathered during telephone interview conducted by the on-call regulating physician at the Centre15.

ReferenceCitation: Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482. Erratum In: Headache. 2015 Feb;55(2):356.

ReferenceCitation: Goldstein JN, Camargo CA Jr, Pelletier AJ, Edlow JA. Headache in United States emergency departments: demographics, work-up and frequency of pathological diagnoses. Cephalalgia. 2006 Jun;26(6):684-90. doi: 10.1111/j.1468-2982.2006.01093.x.

ReferenceCitation: Valade D. The Emergency Headache Center at the Lariboisiere Hospital: 7 years with more than 70,000 patients. Intern Emerg Med. 2008 Oct;3 Suppl 1:S3-7. doi: 10.1007/s11739-008-0191-6.

ReferenceCitation: Perry JJ, Sivilotti MLA, Sutherland J, Hohl CM, Emond M, Calder LA, Vaillancourt C, Thirganasambandamoorthy V, Lesiuk H, Wells GA, Stiell IG. Validation of the Ottawa Subarachnoid Hemorrhage Rule in patients with acute headache. CMAJ. 2017 Nov 13;189(45):E1379-E1385. doi: 10.1503/cmaj.170072. Erratum In: CMAJ. 2018 Feb 12;190(6):E173.

ReferenceCitation: Perry JJ, Stiell IG, Sivilotti ML, Bullard MJ, Hohl CM, Sutherland J, Emond M, Worster A, Lee JS, Mackey D, Pauls M, Lesiuk H, Symington C, Wells GA. Clinical decision rules to rule out subarachnoid hemorrhage for acute headache. JAMA. 2013 Sep 25;310(12):1248-55. doi: 10.1001/jama.2013.278018.

ReferenceCitation: Pari E, Rinaldi F, Gipponi S, Venturelli E, Liberini P, Rao R, Padovani A. Management of headache disorders in the Emergency Department setting. Neurol Sci. 2015 Jul;36(7):1153-60. doi: 10.1007/s10072-015-2148-7. Epub 2015 Mar 10. Erratum In: Neurol Sci. 2015 Jul;36(7):1161.

ReferenceCitation: Chey WY, Kusakcioglu O, Dinoso V, Lorber SH. Gastric secretion in patients with chronic pancreatitis and in chronic alcoholics. Arch Intern Med. 1968 Nov;122(5):399-403. No abstract available.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Regional Hospital center of Orleans
CHRU de Tours


title: Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome

acronym: COVIDEIT

summary:
There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved.

If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19.

However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.

ReferenceCitation: Cardinale M, Boussen S, Cungi PJ, Esnault P, Mathais Q, Bordes J, Meaudre E, Goutorbe P. Lung-Dependent Areas Collapse, Monitored by Electrical Impedance Tomography, May Predict the Oxygenation Response to Prone Ventilation in COVID-19 Acute Respiratory Distress Syndrome. Crit Care Med. 2022 Jul 1;50(7):1093-1102. doi: 10.1097/CCM.0000000000005487. Epub 2022 Feb 11.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study

acronym: KALAN

summary: A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema

location_facility:
Chu Grenoble Alpes
CHU Rouen


title: Assessment of Netosis During COVID-19, Under Treatment With Anakinra, an Interleukin-1 Receptor Antagonist

summary:
During their activation in response to an infectious stimulus or during chronic inflammatory processes, blood and tissue neutrophils modify their functional phenotype and produce numerous toxic mediators. In particular, they rapidly release chromatin filaments covered with numerous granular and cytoplasmic components called "Neutrophil Extracellular Traps" (NETs). This phenomenon, called netosis, has been implicated in many diseases, in particular in viral infections during which this response can be useful for the anti-infectious response at the initial phase, then deleterious when it becomes toxic. for the tissue environment. This has been shown in particular during post-pneumonia acute respiratory distress syndrome.

The intensity of netosis is therefore an early factor in activating neutrophils and inflammation. Given the major biological signs of inflammation observed in patients with COVID-19 as soon as they enter the hospital [C-Reactive protein (CRP), Interleukin-6 (IL-6), D-dimers, etc.), it seems particularly interesting to better document this inflammation.

ReferenceCitation: Twaddell SH, Baines KJ, Grainge C, Gibson PG. The Emerging Role of Neutrophil Extracellular Traps in Respiratory Disease. Chest. 2019 Oct;156(4):774-782. doi: 10.1016/j.chest.2019.06.012. Epub 2019 Jun 29.

ReferenceCitation: Granger V, Peyneau M, Chollet-Martin S, de Chaisemartin L. Neutrophil Extracellular Traps in Autoimmunity and Allergy: Immune Complexes at Work. Front Immunol. 2019 Dec 3;10:2824. doi: 10.3389/fimmu.2019.02824. eCollection 2019.

ReferenceCitation: Bendib I, de Chaisemartin L, Granger V, Schlemmer F, Maitre B, Hue S, Surenaud M, Beldi-Ferchiou A, Carteaux G, Razazi K, Chollet-Martin S, Mekontso Dessap A, de Prost N. Neutrophil Extracellular Traps Are Elevated in Patients with Pneumonia-related Acute Respiratory Distress Syndrome. Anesthesiology. 2019 Apr;130(4):581-591. doi: 10.1097/ALN.0000000000002619.

ReferenceCitation: Chen G, Wu D, Guo W, Cao Y, Huang D, Wang H, Wang T, Zhang X, Chen H, Yu H, Zhang X, Zhang M, Wu S, Song J, Chen T, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical and immunological features of severe and moderate coronavirus disease 2019. J Clin Invest. 2020 May 1;130(5):2620-2629. doi: 10.1172/JCI137244.

ReferenceCitation: Ruan Q, Yang K, Wang W, Jiang L, Song J. Correction to: Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Jun;46(6):1294-1297. doi: 10.1007/s00134-020-06028-z.

ReferenceCitation: Sarzi-Puttini P, Giorgi V, Sirotti S, Marotto D, Ardizzone S, Rizzardini G, Antinori S, Galli M. COVID-19, cytokines and immunosuppression: what can we learn from severe acute respiratory syndrome? Clin Exp Rheumatol. 2020 Mar-Apr;38(2):337-342. doi: 10.55563/clinexprheumatol/xcdary. Epub 2020 Mar 22.

ReferenceCitation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

oa_colors: green other

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Kupferschmidt K, Cohen J. Race to find COVID-19 treatments accelerates. Science. 2020 Mar 27;367(6485):1412-1413. doi: 10.1126/science.367.6485.1412. No abstract available.

ReferenceCitation: Mahase E. Covid-19: what treatments are being investigated? BMJ. 2020 Mar 26;368:m1252. doi: 10.1136/bmj.m1252. No abstract available.

ReferenceCitation: Li G, De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nat Rev Drug Discov. 2020 Mar;19(3):149-150. doi: 10.1038/d41573-020-00016-0. No abstract available.

ReferenceCitation: Granger V, Fels A, Huet T, Laplanche JL, Laplanche S, Chatellier G, Beaussier H, Chollet-Martin S, de Chaisemartin L, Hayem G. Circulating IL-6 but not neutrophil extracellular traps levels can predict anakinra effectiveness in patients with severe COVID-19. J Leukoc Biol. 2022 Dec;112(6):1365-1367. doi: 10.1002/JLB.4LT0122-018RR. Epub 2022 Jun 15.

evidence: open (via free article)

publisher_dissemination: Oxford University Press

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Groupe Hospitalier Paris Saint-Joseph
CHU Bichat Claude Bernard


title: French Cohort of covid19 Patients With Post-intensive Care Syndrome : Rehabilitation From Intensive Care Unit to Home Return - Spatio-temporal Analysis of Walking Compared to Asymptomatic Participants

acronym: COREADOM

summary: The purpose of this study is to describe post-intensive care syndrome (PICS) of patients surviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recovery process from hospital to home return

location_facility: Department of Rehabilitation, Institute of Rheumatology Cochin

location_facility: Department of Physical Medicine and Rehabilitation


title: Detection of Postoperative Complications and Particularly Hemodynamic Ones Through Continuous Monitoring Using the Biobeat Patch

acronym: Biobeat-Postop

summary:
Brief Summary: Post-operative morbidity remains a reality as shown by the International Surgical Outcomes Study published in 2016 and 2019 and by several recent publications which focus mainly on hypotension and cardio-vascular complications. Other complications, such as respiratory depression, are less often studied. The hypothesis is that this connected patch could be used in surgical departments to detect a postoperative complication.

Biobeat Technologies Ltd has developed a sensor which continuously records the photoplethysmographic waveform and allows the calculation of several physiological parameters: heart rate (HR), oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), stroke volume (SV), cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), respiratory rate (RR), and temperature.

The objective of this study is the quantification of hemodynamic, respiratory and temperature abnormalities detected by routine monitoring (routine nursing follow-up) and continuous monitoring by the Biobeat patch during the first 72 postoperative hours.

ReferenceCitation: Liem VGB, Hoeks SE, Mol KHJM, Potters JW, Grune F, Stolker RJ, van Lier F. Postoperative Hypotension after Noncardiac Surgery and the Association with Myocardial Injury. Anesthesiology. 2020 Sep;133(3):510-522. doi: 10.1097/ALN.0000000000003368.

ReferenceCitation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

ReferenceCitation: International Surgical Outcomes Study (ISOS) group. Prospective observational cohort study on grading the severity of postoperative complications in global surgery research. Br J Surg. 2019 Jan;106(2):e73-e80. doi: 10.1002/bjs.11025.

ReferenceCitation: Turan A, Chang C, Cohen B, Saasouh W, Essber H, Yang D, Ma C, Hovsepyan K, Khanna AK, Vitale J, Shah A, Ruetzler K, Maheshwari K, Sessler DI. Incidence, Severity, and Detection of Blood Pressure Perturbations after Abdominal Surgery: A Prospective Blinded Observational Study. Anesthesiology. 2019 Apr;130(4):550-559. doi: 10.1097/ALN.0000000000002626.

ReferenceCitation: Paternot A, Aegerter P, Martin A, Ouattara J, Ma S, Adjavon S, Trillat B, Alfonsi P, Fischler M, Le Guen M. Screening for postoperative vital signs abnormalities, and particularly hemodynamic ones, by continuous monitoring: protocol for the Biobeat-Postop cohort study. F1000Res. 2021 Jul 21;10:622. doi: 10.12688/f1000research.54781.2. eCollection 2021.

publisher_dissemination: Informa

ipd_sharing_description: Dryad Repository

lead_sponsor: Hopital Foch

location_facility:
Groupe hospitalier Paris Saint-Joseph
Hopital Foch


title: Detection of Viable CTCs Using the EPIDROP Technology in Metastatic Prostate Cancer

acronym: EPIDROP

summary: The use of liquid biopsy could be the key for precision medicine. Circulating tumor cells (CTCs) are the most studied circulating biomarkers used to assess the metastatic process and they have shown their clinical validity and utility in cancer patients. However, their detection and capture are still a challenge as they are very rare in the bloodstream. In this clinical trial named "EPIDROP", the investigators will use an innovative device called EPIDROP (for EPIspot in a DROP) in metastatic prostate cancer. EPIDROP is a completely new technology answering to biological and clinical questions by proposing a procedure detecting the functional subset of prostatic CTCs at the single cell level. The investigators will stain cells in the sample for EpCAM, PSMA, CD45 before to encapsulate them one by one in microdroplets and measure the PSA secretion by only the viable CTCs. This study aims to demonstrate the non-inferiority of the EPIDROP compared to the CellSearch system.

location_facility:
University Center, Hospital
University Hospital Center


title: Study of Balance Reactions in a Virtual Environment Compared to a Real Environment

acronym: EQUIVIRT

summary: Validate a virtual environment by demonstrating a non modification of the characteristics of postural reaction and displacement of the body's center of pressure between a real environment and the same environment in immersive virtual reality.

primary_purpose: Screening

lead_sponsor: Pôle Saint Hélier

sponsor_collaborators:
Pôle Saint Hélier
Hopital La Musse

location_facility:
Pole Saint-Hélier
Hôpital la Musse


title: Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)

summary:
Tobacco use is one of the world's leading preventable causes of disease and premature death, and the physician has a central role in detecting smokers and helping them to quit.

Tobacco use in the military undermines fitness, readiness and performance, and increases health care costs.

A study conducted on a French Army contingent on external operations in Afghanistan have shown an increase in tobacco use in situation of operational constraints (stress, shift work, etc.). However, another study conducted in Ivory Coast on a mobile gendarmerie squadron showed no significant difference.

Among the American firefighters who have been exposed to the 9/11 World Trade Center attacks, smoking have been shown to play an aggravating role in the recovery of lung function.

This study is aimed at assessing smoking prevalence in the Paris Fire Brigade, which is composed of young and healthy sportsmen and women who are exposed to strong operational constraints.

location_facility:
Centre Médical de Champerret
Antenne médicale de Ménilmontant


title: Bronchial REmodeling in Severe Preschool Wheezing chIldren and Risk of Exacerbation

acronym: RESPIRE

summary: Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components that characterizes severe asthma which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. We identified using latent class analysis two classes of patients. Compared to the second class, the first class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, mucus gland mass and bronchial fibrosis. We then hypothesized that this first latent class identified children at risk of asthma exacerbations.

ReferenceCitation: Fayon M, Beaufils F, Esteves P, Campagnac M, Maurat E, Michelet M, Siao-Him-Fa V, Lavrand F, Simon G, Begueret H, Berger P; P'tit Asthme Study Group. Bronchial Remodeling-based Latent Class Analysis Predicts Exacerbations in Severe Preschool Wheezers. Am J Respir Crit Care Med. 2023 Feb 15;207(4):416-426. doi: 10.1164/rccm.202205-0913OC.

publisher_dissemination: American Thoracic Society

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Bordeaux
CHU de Toulouse


title: Study of the Periodontal Microbiota in Gingival Cicatricial Pemphigoid Patients. Bicentric Pilot Study .

summary: In patients with gingival cicatricial pemphigoid (CP), clinical experience has shown that periodontal treatment is beneficial in addition to medical treatment, because the latter does not always allow optimal gingival healing. However in practice, the basic periodontal treatment, combining subgingival scaling and debridement, may be insufficient especially for severe forms of erosive gingivitis. Therefore, a better knowledge of the periopathogenic flora in such patients would facilitate the implementation of a more appropriate and efficient periodontal therapy. In order to meet this objective, we propose a qualitative analysis of the periodontal microbiota in case of gingival CP via a bi-centric observational microbiological pilot study.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
HEnry Mondor


title: Analgesic Efficiency of the Type 3 Quadratum Lumborum Block in Patients Undergoing Total Hip Arthroplasty : a Randomized Double Blinded Trial

summary:
Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA.

Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.

location_facility:
Institut Arnaut Tzanck
CHU de nice - Anesthésie Réanimation


title: Medico-economic Evaluation of Therapeutic Adaptation Guided by the Soluble Suppression of Tumorigenicity 2 (sST-2) Biomarker in the Management of Patients With Acute Heart Failure

acronym: ICAME

summary: Management of patients with heart Failure remains a major health concern because of the high rate of rehospitalization, mortality and induced-cost. Biomarkers could help to guide the management of patients with heart failure (HF). Soluble suppression of tumorigenicity 2 (sST2) appears as a promising biomarker. As a working hypothesis, we postulate that sST2 values monitoring could be an helpful guide for medical management in an attempt to reduce hospital readmission.

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available to persons who address a reasonable request to the study director and fulfil the requirements stipulated by the French CNIL (Commission National Informatic Liberty).

sponsor_collaborators:
University Hospital, Montpellier
EURO BIO Scientific

location_facility:
Arnaud de Villeneuve Hospital
Lapeyronie Hospital

appel_a_projets: PRME

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

titre: Évaluation médico-économique de l'adaptation thérapeutique guidée par le biomarqueur "Soluble Suppression of Tumorigenicity 2" (sST-2) dans la prise en charge des patients en Insuffisance Cardiaque Aigue.

discipline_principale: biologie

nom_porteur: Cristol

prenom_porteur: Jean-Paul


title: Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain

summary: Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients. The study aims to evaluate the immediate effect of thigh muscles stretching in patients with chronic low back pain. The investigation team suppose that flexibility improvement could be detected by instrumented clinical measurements and such difference could be related to psycho-social factors evaluated by questionnaires.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
University Hospital, Clermont Ferrand
CHu de Nîmes


title: Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients

acronym: m-Rehab COPD

summary:
Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.

In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.

In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

ReferenceCitation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

repository_institution: University of Oslo - Duo Research Archive

repositories_concat: PubMed Central;munin.uit.no

publisher_dissemination: Wiley

location_facility: Centre hopsitalier universitaire de Montpellier


title: Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST

acronym: REAVIST

summary:
Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.

Observational, prospective, randomized, open-label, monocentric study.


title: Quantitative Analysis of Myocardial Uptake of 99mTclabeled Bone Radiopharmaceuticals Using New Whole-body CZT-based SPECT-CT Cameras, at Baseline and During Medical Treatment With Tafamidis in Patients With Cardiac Transthyretin Amyloidosis

acronym: REMOD-TTR

summary:
Introduction: Transthyretin cardiac amyloidosis (ATTR) is an important cause of heart failure. Cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is used as a noninvasive diagnostic criterion in patients without detectable monoclonal protein. The visual assessment remains the main noninvasive criterion for the diagnosis. Medical therapy using tafamidis meglumine that binds to transthyretin and prevents amyloidogenesis, recently demonstrated a reduction in all-cause mortality and cardiovascular-related hospitalizations. As a consequence, there is a need for quantitative approaches that would be useful for diagnosis and prognosis assessment but also for the evaluation of patient therapeutic response.

Materials and methods: The investigators aim to include 35 patients with a suspected diagnosis of cardiac ATTR amyloidosis in whom a cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is planned as part of routine noninvasive diagnosis work-up. Using a test-retest approach, the aim is to compare a quantitative method vs. conventional semi-quantitative approaches for the assessment of cardiac uptake of bone radiopharmaceuticals using new 3D CZT-based SPECT-CT cameras in patients with suspected cardiac ATTR amyloidosis. The investigators estimated that 20 patients will have a diagnosis of cardiac ATTR amyloidosis. In the latter patients, the aim is to evaluate the impact of 6-month therapy using tafamidis on quantitative and semi-quantitative assessment of cardiac uptake of bone radiopharmaceuticals Perspectives: This new non invasive imaging techniques for the quantitative assessment of the amyloid burden in patients with cardiac ATTR amyloidosis may help identify the responders and the patients who should benefit from dose intensification.

lead_sponsor: University Hospital, Caen

sponsor_collaborators:
University Hospital, Caen
Pfizer

location_facility:
Clinique du Bois
CHU de Caen


title: Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients

acronym: ATOMIC

summary: The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.

lead_sponsor: University Hospital, Lille

location_facility:
Hop Salengro - Hopital B
Hop Claude Huriez Chu Lille


title: Brainstem Dysfunction in Ventilated and Deeply Sedated COVID-19 Critically Ill Patients: a Prospective Observational Study

acronym: BRAINSTEM-COV

summary: The purpose of this study is to determine the prevalence of brainstem dysfunction in critically ill ventilated and deeply sedated patients hospitalized in the Intensive Care Unit (ICU) for a SARS-CoV-s2 infection.

ReferenceCitation: Rohaut B, Porcher R, Hissem T, Heming N, Chillet P, Djedaini K, Moneger G, Kandelman S, Allary J, Cariou A, Sonneville R, Polito A, Antona M, Azabou E, Annane D, Siami S, Chretien F, Mantz J, Sharshar T; Groupe d'Exploration Neurologique en Reanimation (GENER). Brainstem response patterns in deeply-sedated critically-ill patients predict 28-day mortality. PLoS One. 2017 Apr 25;12(4):e0176012. doi: 10.1371/journal.pone.0176012. eCollection 2017.

ReferenceCitation: Benghanem S, Cariou A, Diehl JL, Marchi A, Charpentier J, Augy JL, Hauw-Berlemont C, Gavaret M, Pene F, Mira JP, Sharshar T, Hermann B. Early Clinical and Electrophysiological Brain Dysfunction Is Associated With ICU Outcomes in COVID-19 Critically Ill Patients With Acute Respiratory Distress Syndrome: A Prospective Bicentric Observational Study. Crit Care Med. 2022 Jul 1;50(7):1103-1115. doi: 10.1097/CCM.0000000000005491. Epub 2022 Feb 9.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
HEGP
Hôpital Cochin


title: Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C/D Ratio

acronym: TIPS

summary:
This prospective study will investigate the concentrations of tacrolimus metabolites (M-I and M-III) over the four first years post-transplantation.

A differential metabolism might result in different metabolites' concentration and explain a kidney survival difference between "high rate metabolism" (defined as a concentration/dose ratio, C/D ratio, lower than 1.04 µg/l/mg) and other patients.

The primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either < or >= 1.04 µg/l/mg, in order to detect differences in tacrolimus metabolization between these groups.

ReferenceCitation: Jouve T, Fonrose X, Noble J, Janbon B, Fiard G, Malvezzi P, Stanke-Labesque F, Rostaing L. The TOMATO Study (Tacrolimus Metabolization in Kidney Transplantation): Impact of the Concentration-Dose Ratio on Death-censored Graft Survival. Transplantation. 2020 Jun;104(6):1263-1271. doi: 10.1097/TP.0000000000002920.

ReferenceCitation: Jouve T, Noble J, Rostaing L, Malvezzi P. An update on the safety of tacrolimus in kidney transplant recipients, with a focus on tacrolimus minimization. Expert Opin Drug Saf. 2019 Apr;18(4):285-294. doi: 10.1080/14740338.2019.1599858. Epub 2019 Apr 1.

ReferenceCitation: Tholking G, Fortmann C, Koch R, Gerth HU, Pabst D, Pavenstadt H, Kabar I, Husing A, Wolters H, Reuter S, Suwelack B. The tacrolimus metabolism rate influences renal function after kidney transplantation. PLoS One. 2014 Oct 23;9(10):e111128. doi: 10.1371/journal.pone.0111128. eCollection 2014.

ReferenceCitation: Egeland EJ, Robertsen I, Hermann M, Midtvedt K, Storset E, Gustavsen MT, Reisaeter AV, Klaasen R, Bergan S, Holdaas H, Hartmann A, Asberg A. High Tacrolimus Clearance Is a Risk Factor for Acute Rejection in the Early Phase After Renal Transplantation. Transplantation. 2017 Aug;101(8):e273-e279. doi: 10.1097/TP.0000000000001796.

sponsor_collaborators:
University Hospital, Grenoble
Chiesi SA/NV

location_facility:
Grenoble University Hospital
Saint Etienne University Hospital