title: Description of Ophthalmologic Injuries in Intensive Care During the SARS-CoV2 Epidemic - COVID19

acronym: DOCOV

summary:
The management of patients with SARS-CoV2 in respiratory distress can expose to corneal or retinal lesions induced by the stay in intensive care.

Examination by ophthalmologists would make it possible to detect the most of the ophthalmologic problems known in intensive care and to provide an early, preventive or curative therapeutic response when possible, in order to avoid irreversible visual loss.

The object of the research is to assess the presence and the importance of surface ophthalmologic lesions, the presence and the importance of retinal or optic nerve lesions, in order to improve the monitoring and primary prevention of this population

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


type: Other Identifier

title: Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication

acronym: MRIMOP

summary: Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Montpellier

collaborators: Association la Montpellier Reine a du Cœur

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


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

acronym: COVIDBioToul

summary: The spectrum of the COVID-19 disease ranges from benign to asymptomatic to viral pneumopathy that can progress to acute respiratory distress syndrome (ARDS). The host-pathogen relationships and the physiopathological mechanisms underlying the clinical aggravation of COVID-19 patients remain misunderstood. The project aim is to create a prospective cohort of biological samples collected from well characterized COVID-19 patients. This project aims first to identify based on these samples an early immune signature predictive of clinical worsening of COVID-19 patients in order to improve their management, and secondarily to better understand pathophysiological mechanisms underlying the different phases of the disease in order to identify innovative therapeutic targets and vaccine perspectives.

status: Active, not recruiting

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Dimeglio C, Herin F, Da-Silva I, Gernigon C, Porcheron M, Chapuy-Regaud S, Izopet J. Decreased Efficiency of Neutralizing Antibodies from Previously Infected or Vaccinated Individuals against the B.1.617.2 (Delta) SARS-CoV-2 Variant. Microbiol Spectr. 2022 Aug 31;10(4):e0270621. doi: 10.1128/spectrum.02706-21. Epub 2022 Jul 5.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Dimeglio C, Herin F, Da-Silva I, Jougla I, Pradere C, Porcheron M, Martin-Blondel G, Chapuy-Regaud S, Izopet J. Heterologous ChAdOx1-S/BNT162b2 Vaccination: Neutralizing Antibody Response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2022 Apr 9;74(7):1315-1316. doi: 10.1093/cid/ciab705. No abstract available.

oa_colors: green other

evidence: open (via free article)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Kreutmair S, Unger S, Nunez NG, Ingelfinger F, Alberti C, De Feo D, Krishnarajah S, Kauffmann M, Friebel E, Babaei S, Gaborit B, Lutz M, Jurado NP, Malek NP, Goepel S, Rosenberger P, Haberle HA, Ayoub I, Al-Hajj S, Nilsson J, Claassen M, Liblau R, Martin-Blondel G, Bitzer M, Roquilly A, Becher B. Distinct immunological signatures discriminate severe COVID-19 from non-SARS-CoV-2-driven critical pneumonia. Immunity. 2021 Jul 13;54(7):1578-1593.e5. doi: 10.1016/j.immuni.2021.05.002. Epub 2021 May 9. Erratum In: Immunity. 2022 Feb 8;55(2):366-375.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories:
HAL
PubMed Central
www.zora.uzh.ch

repositories_concat: HAL;PubMed Central;www.zora.uzh.ch

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

intervention_type: Biological


title: Randomized Controlled Trial Comparing the Effect of a Parent-guided Speech and Language Therapy Program During the Summer Holidays With an Adapted Holiday Book on the Reading Level of Children With Visual-attentional Dyslexia

acronym: REEDVAC

summary:
"After summer break, the reading performance of dyslexic children declines more than those of non-dyslexic children. Indeed, during the summer, dyslexic children are less inclined to read and their consultations with speech therapist are usually suspended.

Intensive speech therapy programs proved to be efficient during the summer, to maintain reading level of dyslexic children. However these programs are expensive and not easy to generalise. Some other studies tested reading therapy programs applied by parents at home. It proved to be effective and feasible.

Thus, the hypothesis of the present study is: a parent-administered reading therapy program during the summer break could stabilise the reading performance of dyslexic children after the summer. On the contrary the investigators assume the control group reading performance would decrease."

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Kerjean L, Benard P, Peyre H. Parent-implemented intervention for children in third to fifth grade with dyslexia. Encephale. 2023 Dec;49(6):589-595. doi: 10.1016/j.encep.2022.08.016. Epub 2022 Oct 15.

oa_host_type: closed

repositories_concat: closed

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

status_simplified: Completed


type: Registry Identifier

title: Feasibility, Safety and Medico-economic Study of Magnetic-end Double-J Ureteral Stent Use in Children

acronym: EFUJA

summary:
Double-J ureteral stent (DJUS) is one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.

Classically, DJUS are introduced and removed in the operation room, under general anesthesia, using a cystoscope.

The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop.

To remove the magnetic stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip is inserted into the urethra in the outpatient clinic.

The purpose of this study is to demonstrate the feasibility and safety of magnetic-end Double-J ureteral stent use in children and to perform a medico-economic study.

primary_purpose: Other

intervention_type: Device


title: Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients: Role of Androgens

summary: Asthma is more common in females than in males but the difference has not been explained yet. Group 2 innate lymphoid cells (ILC2) have recently emerged as critical players in the initiation of allergic responses but their implications in the difference between males and females in terms of asthma prevalence has not been fully studied. The aim of this project is to compare the proportion of ILC2 in blood between males and females with asthma.

study_type: Observational

time_perspective: Prospective


title: Digestive Events in Duchenne Muscular Dystrophy Patients

acronym: DIGD

summary: Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients

time_perspective: Retrospective

ipd_sharing_description: All clinician and biologist involved in the follow-up of these patients

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

lead_sponsor_type: industriel


title: Newborn Infant Parasympathetic Evaluation (NIPE) Index After Three Standardized Tetanic Stimulations (10, 30 and 60 Miliamps) Performed in a Randomized Sequence Under General Anesthesia in a Pediatric Population

acronym: NIPESTIM

summary: NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.

primary_purpose: Diagnostic

ReferenceCitation: Lebrun S, Boccara J, Cailliau E, Herbet M, Tavernier B, Constant I, Sabourdin N. Quantitative assessment of a pediatric nociception monitor in children under sevoflurane anesthesia. Reg Anesth Pain Med. 2022 Jun 2:rapm-2022-103547. doi: 10.1136/rapm-2022-103547. Online ahead of print.

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Fondation Apicil


title: Projet GonioSEF: Etude de faisabilité d'un Dispositif d'amélioration du défaut de Report d'Appui Pendant la Marche en Phase Portante Chez Des Sujets présentant Une Atteinte du système Nerveux Central

acronym: GONIOSEF

summary: The main hypothesis of the present study is that a safer knee joint is likely to encourage post stroke patients at an early stage to rely on their hemiparetic leg and transfer their weight onto it while walking. The main purpose of the present work is to assess the feasibility of FES-induced muscular control of the hemiplegic knee joint in order to improve stance phase support symmetry recovery in individuals with post stroke hemiplegia. Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb based on the real-time estimation of the knee angle and support phase.

lead_sponsor: Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie

collaborators: Institut National de Recherche en Informatique et en Automatique

location_facility: Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie


title: Lipid Metabolism, Lipotoxicity and Nonalcoholic Fatty Liver Disease: Implication of Postprandial Cytotoxic Lipids

acronym: LITONAS

summary: Nonalcoholic fatty liver disease (NAFLD) is mainly considered a nutrition-related disease and life-style/diet interventions showed some promising results. But in spite of this, there are no available markers to efficiently guide interventions. the hypothesize put farth by the investigators is that NAFLD patients develop postprandial abnormalities of plasma lipids upon "western diet" challenge, more severe in steatohepatitis (NASH) than in pure steatosis (NAFL), promoting liver injury. Our study aims to evaluate the presence of toxic lipids (such as free-fatty acids, ceramides, diacylglycerols, sphingolipids) in postprandial state after ingestion of a "western diet" in NAFLD patients. Consecutive patients (group 1: NAFL patients; group 2: NASH patients) with biopsy-proven NAFLD (liver biopsy < 6 months) will be recruited during a period of 12 month. Blood samples will be drawn at fasting, 2hours, 4hours, 6hours and 8hours after ingestion of a "western diet" meal. Plasma lipid profiles using lipidomics, circulating markers of liver injury and inflammation will be analyzed. the investigators will also assess the hepatotoxicity of plasma from NAFL or NASH patients in-vitro.


title: Appréciation de la Prise en Charge de la Fibrillation Atriale Aux Urgences

acronym: ACFA

summary: Atrial Fibrillation (AF) is the most common disorder of the rhythm disturbance, especially in older adults. The incidence and prevalence of AF increases significantly with age: less than one new case per 1000/year before age 40 to 20/1000 per year after the age of eighty. AF represents 1% of emergency department (ED) visits a third of which are inaugural or recurrent. The causes are varied from cardiac (ischemic cardiac disease, valvular, high blood pressure, heart failure, pericarditis, myocarditis) to extra cardiac etiologies (pulmonary embolism, thyroid disorders, thyrotoxicosis, alcohol, shock, chest trauma, electrolyte disorders, dehydration). While the diagnosis is given quickly by reading the electrocardiogram (ECG), its management both in terms of therapeutic strategy that of choice of care pathway is complex as evidenced by the diversity of possibilities and the difference in practice. Specific recommendations have been published by the French Society of Emergency Medicine in 2015. Our study aims to investigate guidelines implementation in French ED, especially the contribution of diagnostic tests and initiated treatments. Therapeutic strategies are evaluated with a follow up at 3 months, 6 months and 1 year, reporting cardiovascular events and long-term treatment.

lead_sponsor: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône

collaborators:
French Cardiology Society
French Society of Emergency Medicine
Bayer
Boehringer Ingelheim


title: Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

summary:
The management of chronic low back pain is now part of a multi-disciplinary set of proposals with the aim of adapting for each patient orientations of both medicated and non-medicated care.

Very classically, analgesic treatment of stage I or II is of use, reinforced by the occasional use of NSAIDs in the absence of contraindication. In this medical attempt of the control of the pain associates a physical care (supervised exercises, physiotherapy care), cognitive and behavioral therapy, multidisciplinary care.

Osteopathic treatment is a specific manual diagnostic and therapeutic procedure.

This study aims to evaluate the relevance of providing osteopathic treatment in combination with classical medical treatment in the management of patients with chronic non-specific low back pain.

lead_sponsor: Clinique Pasteur


title: Interest of Pleuropulmonary Ultrasound Associate With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation in Patients Undergoing Thoracic Surgery

acronym: Echo-Thorax

summary:
Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which is an invasive procedure. Although rare, several complications are known with, among other things, the occurrence of pulmonary infections, pneumothorax associated with increased pressure in the airways, atelectasis or bronchospasm.

Avoid the systematic control by fibroscopy in simple cases which makes it possible to overcome the complications related to its use and its cost.

The investigators want to evaluate the diagnostic value of the echographic strategy in 2 steps (2D and TM) on 3 sections (pulmonary field on the axillary line of the 2 sides and left upper lobe) associated with the clinical examination in preoperative by comparing with the gold standard: fibroscopy. Clinical examination and pleuropulmonary ultrasound should have a positive predictive value of at least 85%.

lead_sponsor: Association Pro-arte

sponsor_collaborators:
Association Pro-arte
University Hospital, Grenoble

intervention_type: Diagnostic Test


acronym: CONFIRM

intervention_type: Combination Product

summary:
The incorporation of proteasome inhibitors and immunomodulatory drugs into the standard of care has improved the outcome for patients with multiple myeloma (MM) over the past 10 years. However, most patients (>85%) still eventually relapse around 3-4 years after diagnosis, and ultimately die of their disease, despite salvage therapies. Relapse can occur even when complete remission is achieved after first-line therapy.

Currently, daratumumab (Dara) is approved by the american FDA and EMA in combination with lenalidomide (Len) and dexamethasone (Dex) or bortezomib and Dex for the treatment of MM patients who have received at least one prior therapy. Therefore, the Dara-Len-Dex combination is likely to become the most widely used standard of care regimen for MM at the time of first relapse.

However, although approval of the latter combination is meant for until disease progression (PD) ("continuous therapy") (CT), the actual optimal duration of relapse treatment is still unknown. Of note, many experts advocate that a "fixed duration" of therapy should be favored, especially if one can show that CT does not translate into a significant overall survival (OS) benefit. As a matter of fact, given the extremely high cost of such novel agents (>100 KEuros/year/patient), the pharmacoeconomic consequences of a "continuous" versus "fixed" duration therapy are also of utmost importance.

Based on this background, the investigator propose to conduct a non-inferiority phase III randomized, multicenter, open label trial for treatment of MM at first relapse, comparing the Dara-Len-Dex combination administered continuously until PD, versus a fixed duration of 24 months. The choice of this duration is justified by the currently available evidence with respect to achievement of a plateau in terms of deep disease response, patients' compliance, and physicians' preference according to different surveys. The primary objective of this study is to estimate the OS rate at 4 years after diagnosis of relapse and initiation of salvage therapy. The primary endpoint is OS at 4 years after randomization. The analysis will be performed on both per-protocol and intent-to-treat sets of patients.

location_facility: Saint Antoine Hospital - Hematology Department

title: A Multi-center Phase III Randomized Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

type: EudraCT Number

source: euctr


title: Use of BRASS in Sedated Critically-ill Patients as a Predictable Mortality Factor

acronym: BRASS-ICU

summary:
Sedation is used for 30 to 70 % of all intensive care unit (ICU) patients. Deep sedation can be used for lot of disease like acute respiratory distress syndrome, septic shock.

Deep sedation was defined by RASS (Richmond Assessment Sedation Scale) below -3.

Deep sedation can be associated with increased mortality, length stay, duration of mechanical ventilation, acute brain dysfunction.

The french exploration neurologic group in ICU developed a score used Brainstem response patterns in patient deeply sedated by midazolam and showed that a high BRASS score is associated with high mortality at day 28.

The investigators think that BRASS score isn't associated with the medication used for sedation.

In this study the investigators included all patients sedated independently of medication used for sedation, we also excluded patient with neurologic disorder.

The main objective is to shown that high BRASS score at admission of patient without neurologic disorder sedated is predictive of 28-day mortality.

ReferenceCitation: Legros V, Mourvillier B, Floch T, Candelier Q, Rosman J, Lafont B, Farkas JC, Bard M, Kanagaratnam L, Mateu P. Use of BRASS in sedated critically-ill patients as a predictable mortality factor: BRASS-ICU. Neurol Res. 2021 Apr;43(4):283-290. doi: 10.1080/01616412.2020.1849901. Epub 2020 Nov 19.

publisher_dissemination: Informa

lead_sponsor: CHU de Reims


title: Medical Imaging of the Musculoskeletal System Before and After Surgery for the Generation of Customized Biomechanical Models

summary: The objective of this study is to design a library of biomechanical musculoskeletal models of patients before and after surgery. These models will be evaluated to analyze the support they can provide for virtual surgical planning in orthopedics.

status: Unknown status

collaborators:
Fondation pour la Recherche Médicale
Fondation Garches
TIMC-IMAG

sponsor_collaborators: Centre d'Investigation Clinique et Technologique 805

status_simplified: Unknown


title: Monitoring of Fetal Lung Elasticity by Elastography Between 24 and 39 Weeks

acronym: ELASTOPULM

summary: The objective of the study is to evaluated the evolution of the LLE ratio (Lung to Liver Elastography ratio) during normal pregnancy

ReferenceCitation: Nallet C, Pazart L, Cochet C, Vidal C, Metz JP, Jacquet E, Gorincour G, Mottet N. Prenatal quantification of human foetal lung and liver elasticities between 24 and 39 weeks of gestation using 2D shear wave elastography. Eur Radiol. 2022 Aug;32(8):5559-5567. doi: 10.1007/s00330-022-08654-1. Epub 2022 Mar 10.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

publisher_dissemination: Springer-Nature

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Improvement of Motivation for Physical Activity in an Institutionalized Geriatric Population Thanks to a Virtual Environment: Comparison of Motivation Between Classic Bike and Bike With Virtual Environment

acronym: Cyclepad Pilot

summary: The purpose of this study is to test the interest of a virtual environment with cycling to increase the motivation of physical activity practice in institutionalized older adults.

lead_sponsor: University Hospital, Caen


title: Comparison of 2 Neurofeedback Protocols in the Treatment of Attention Deficit Hyperactivity Disorder in Children and Adolescents

summary:
Attention Deficit Disorder with or without Hyperactivity (ADD / H) is a public health problem since it has short and long-term consequences, affects about 5% of children of school age but remains unknown and therefore under- diagnostic.

The investigator will performed a controlled and randomized research to compare the effects of two neurofeedback protocols on the repercussions of Attention Deficit AD / Hyperactivity Disorder (HD) symptoms, in particular the hyperactivity on which the improvements reported in the literature are less with usual protocols.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux pédiatriques de Nice CHU Lenval


title: Evaluation of in- Hospital Course of Acute Coronary Syndromes in the Contempory Area

acronym: HACSA

summary:
While international guidelines have indicated that use of a routine invasive strategy was favored for high-risk patients with NSTE-ACS and for all STE- ACS, the lower risk patients successfully reperfused and carrefully selected may perhaps not benefit of this systematic strategy. Evaluation of complications occurring in a contemporary population of ACS may help to evaluate the need of ICU strategy. Coupled with favorable outcomes in many patients, these data may be an opportunity for testing of strategies to refine triage to less costly hospital care units. The investigators thus want to compare, through an observational and prospective study, the event rate of two groups of patients with ACS admitted to ICU . Patients are classified as "high risk" and "low risk" according to specific medical criteria validated in the literature. The study will include all consecutive patients admitted for NSTACS and STACS admitted to the intensive care department of the Montpellier university hospital with the diagnosis of ACS confirmed by coronary angiography.

Our primary goal is to compare the percentage of patients with at least one serious clinical event between the high and low risk groups. A serious event is defined by the occurrence within 7+/-5 days of one of the following criteria: death all causes, serious neurological or hemorrhagic complications, hemodynamic instability and severe heart failure, rhythm or sustained or poorly tolerated conduction disorders requiring therapeutic intervention, painful recurrence requiring new coronary angiography, secondary transfer to intensive care for any reason.

Our hypothesis is that low-risk patients will have very few events and no fatal events and that they could not require intensive care unit admission .

ipd_sharing_description: NC


title: Assessment of Orality Disorders in Children With Food Allergies

acronym: ALLERGORAL

summary:
Orality disorders are frequent in child. There are complications like growth and psychomotor development disorders.

The aim is to estimate the prevalence of orality disorder for child with one or several food allergy.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Angers


title: Impact of a Strategy Combining Morphine Savings and a Loco-regional Anesthesia Technique on the Quality of Post-operative Rehabilitation of Cesareans Performed Under Peri-spinal Anesthesia

acronym: REHACESAR

summary:
The aim of REHACESAR is to study the impact of an association of a low dose of neuraxial morphine and a locoregional anesthesia (TAP block or catheter for continuous wound infiltration) on quality of recovery after cesarean delivery under regional anesthesia.

To assess the quality of recovery, women complete the self-questionnaire Quality Of Recovery (QOR)15 on D-1 (the day before cesarean, if elective), D+1, +2 and +3 after surgery.

The QOR-15 is a 15 items questionnaire which provides a valid and efficient evaluation of the postoperative quality of recovery.

REHACESAR is a prospective observational study. It takes place in the maternity of the CHR Metz-Thionville hospital.

status: Terminated

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Development of Cellular Models for Osteoblast Response Study to Adipocytic Secretions in an Osteoporosis Context.

acronym: ROSA

summary: The recent studies suggest that secretions from medullary adipocytes are involved in the mechanisms of bone loss in osteoporosis (OP) through their actions on neighbouring osteoforming cells, the osteoblasts. The objective of the research is the development of new cellular models representing the aging skeleton to confirm this hypothesis. To this end, osteoblasts will be isolated from human bone fragments coming from femoral heads discarded during total hip replacement surgery. The osteoblastic response to secreted factors released from medullary adipocytes of commercial origin will be analysed using conditioned media incubations. This phenotypic response will be quantified for each subject through the analysis of gene expression levels. Inter-subject phenotype variations will be related to bone density and microarchitecture data obtained by X-ray microtomography. This will assess the existence of a correlation between the osteoblast response to adipocyte secretions and the degree of osteoporosis of the subject from whom the cells are derived.

sponsor_collaborators:
University Hospital, Lille
Universite du Littoral Cote d'Opale


title: Evaluation of the Improvement of Pigmented Skin Lesions in Patients With Mastocytosis After Performing 2 Sessions of Pigment Laser : Pilot Study Conducted at a Reference Centre Mastocytoses (LaserMasto)

acronym: LaserMasto

summary:
Cutaneous mastocytosis can be isolated or associated with systemic involvement. Urticaria pigmentosa affects around 80 to 85% of adult patients with cutaneous mastocytosis. It is also frequently present in patients with mastocytosis associated with systemic involvement (80% of patients in our experience).

This skin damage is one of the causes of deterioration in quality of life in patients with mastocytosis, through the loss of self-esteem, due to the appearance of lesions. However there are not treatment for urticaria pigmentosa.

Skin involvement in mastocytosis is linked to the accumulation of abnormal mast cells in the dermis. However, the mast cells are not pigmented and the brown-brown color characteristic of Urticaria pigmentosa is explained by melanin pigmentation of the epidermal basal layer.

location_facility: Larrey Hospital - Toulouse University Hospital


title: Developement and Evaluation of Serological Assays for COVID-19

acronym: SEROCOV

summary: The primary objective of the study aims to evaluate serological assays of virus Covid-19.

location_facility: Laboratory of microbiology of hospital hygiene, Ambroise Paré Hospital, APHP


title: Thrombo Embolic Events in Hospitalized Patients With Covid-19 Serious Acute Pneumopathy

summary:
The understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. Complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components.

Elements of the coagulation system such as activated thrombin, fibrinogen or factor Xa may increase inflammation by promoting the production of proinflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. Recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation induced thrombosis.

Patients with infection of COVID-19 and severe pneumoniae seem to have higher risk of thromboembolism. The purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of COVID-19.

Blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in Amiens hospital for COVID-19 infection. Thrombin time, factors V and II, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. Anticardiolipin, anti-beta2 glycoprotein I and anti-annexin A2 antibodies IgG and IgM at day of admission and at fourth week after admission will be assessed. SARS-CoV2 viral load and serodiagnosis will be performed at the same time. At the same time venous ultrasound to diagnose thrombosis will be performed.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Computerized Facial Recognition for Automated Diagnosis of the Facio-Scapulo-Humeral Muscular Dystrophy (FSMHD): Pilot Study

summary:
The clinical diagnosis of Facio-Scapulo-Humeral Muscular Dystrophy (FSHMD) requires the movement of patients to a medical centre and a lengthy examination involving medical personnel, and may be underestimated in the most moderate cases. Thus, it requires costly and burdensome logistics both for patients living in remote areas and having to undertake long and expensive travel, and for clinical staff. This is an obstacle to large-scale diagnosis. The investigators plan to alleviate these limitations through the use of digital facial analysis technology that would enable large-scale diagnosis of patients through telemedicine.

Motivated by the reasons described above and by preliminary results, the goal of this project is to develop methods to automatically detect and monitor the progression of this disease using computer vision algorithms. In order to do this, the investigators will first build up a bank of images and videos of patients with moderate to severe FSHMD, patients with other muscular dystrophies causing facial muscle asymmetry, as well as control subjects without facial involvement. Each of these subjects will be characterized clinically and genetically.

The investigators will then develop computer tools using video and audio sensors capable of detecting facial muscle damage in patients with FSHMD and differentiating them from control subjects on the one hand and patients with other muscular dystrophies on the other hand. The investigators wish to use the most recent advances in terms of "deep-learning" and improve their architecture in order to achieve our objectives.

In addition to this holistic approach, the investigators will study facial recognition approaches capable of accurately identifying different facial areas on images, as well as the relevance of different statistical properties of facial dynamics (duration and intensity). These algorithms will also be useful for monitoring the evolution of facial damage in order to develop a specific measurement tool that could be used in patient follow-up and in clinical trials on early stages of the disease.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Assessment of Extra Vascular Lung Water and Pulmonary Permeability by Transpulmonary Thermodilution in Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

acronym: PiCCOVID

summary:
Acute respiratory distress syndrome (ARDS) is a syndromic definition of an acute lung injury with alteration of biomechanics (lower respiratory system compliance) mostly associated with increased lesional edema. Increase in Pulmonary Vascular Permeability Index (PVPI) accompanied with accumulation of excess Extravascular Lung Water (EVLW) is the hallmark of ARDS. In routine clinical practice, the investigators measure the EVLW and PVPI in ARDS patients, as suggested by expert's recommendations, using a transpulmonary thermodilution (TPTD) technique.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly recognized illness that has spread rapidly throughout Wuhan (Hubei province) to other provinces in China and around the world. Most critically ill patients with SARS-CoV-2 will present the criteria for the definition of ARDS. However, many of these patients have a particular form of ARDS with severe hypoxemia often associated with near normal respiratory system compliance. This combination is almost never seen in severe ARDS. Thus other mechanisms (including probably vascular mechanisms), that are still poorly described, have to be involved in SARS-CoV-2.

EVLW and PVPI have never been assessed in SARS-CoV-2 mechanically ventilated patients. The aim of this study is to evaluate these two parameters in order to best characterize and understand the mechanisms related to SARS-CoV-2.

Based on observation of several cases in intensive care units (ICU), the investigators hypothesize that there are following different SARS-CoV-2 patterns:

Nearly normal compliance, low lung recruitability, normal EVLW and low PVPI.
Low compliance due to increased edema, high lung recruitability, high EVLW and high PVPI.

lead_sponsor: University Hospital, Montpellier


title: Multicentric, Parallel, Randomized, Double Blind Study Under Dermatological Control to Evaluate the Anti-acne Efficacy of a Dermo-cosmetic Product (Fla 688977 33) Associated With the Fixed Combination Adapalene 0.1%/ Benzoyl Peroxide 2.5% Treatment Versus This Treatment Associated With a Standard Moisturizer (Hydréane légère, Cosmétique Active International) During a 12-week Application Period in Male and Female Subjects Presenting With Mild to Moderate Acne

summary:
Study to evaluate the anti-acne efficacy of a dermo-cosmetic associated with the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment and to demonstrate that the dermo-cosmetic product can improve the local tolerance of the fixed combination Adapalene 0.1%/ benzoyl peroxide 2.5% treatment

Multi centre, Randomised, Double blind, Controlled, Parallel (100 subjects per arm), Intra-subject & inter subject comparisons

ReferenceCitation: Bouloc A, Roo E, Imko-Walczuk B, Moga A, Chadoutaud B, Dreno B. A skincare combined with combination of adapalene and benzoyl peroxide provides a significant adjunctive efficacy and local tolerance benefit in adult women with mild acne. J Eur Acad Dermatol Venereol. 2017 Oct;31(10):1727-1731. doi: 10.1111/jdv.14379. Epub 2017 Jul 7.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Wiley

ReferenceCitation: Muguet Guenot L, Vourc'h Jourdain M, Saint-Jean M, Corvec S, Gaultier A, Khammari A, Le Moigne M, Boisrobert A, Paugam C, Dreno B. Confocal microscopy in adult women with acne. Int J Dermatol. 2018 Mar;57(3):278-283. doi: 10.1111/ijd.13910. Epub 2018 Jan 25.

ReferenceCitation: Gollnick HP, Bettoli V, Lambert J, Araviiskaia E, Binic I, Dessinioti C, Galadari I, Ganceviciene R, Ilter N, Kaegi M, Kemeny L, Lopez-Estebaranz JL, Massa A, Oprica C, Sinclair W, Szepietowski JC, Dreno B. A consensus-based practical and daily guide for the treatment of acne patients. J Eur Acad Dermatol Venereol. 2016 Sep;30(9):1480-90. doi: 10.1111/jdv.13675. Epub 2016 May 14.

ReferenceCitation: Nast A, Dreno B, Bettoli V, Bukvic Mokos Z, Degitz K, Dressler C, Finlay AY, Haedersdal M, Lambert J, Layton A, Lomholt HB, Lopez-Estebaranz JL, Ochsendorf F, Oprica C, Rosumeck S, Simonart T, Werner RN, Gollnick H. European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol. 2016 Aug;30(8):1261-8. doi: 10.1111/jdv.13776. No abstract available.

repository_institution: Cardiff University - ORCA Online Research @Cardiff

version: acceptedVersion

ReferenceCitation: Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17. Erratum In: J Am Acad Dermatol. 2020 Jun;82(6):1576.

oa_host_type: publisher

lead_sponsor: Vichy Laboratoires

intervention_type: Drug


title: Prognostic of Annexin Imaging in Dissection of the Descending Aorta

acronym: PAIDDA

summary: The relationship between the presence of a partial thrombus and aortic dilation after type B dissection has recently been reported. The originality lies in the idea of imaging thrombus activity to predict dilation after type B dissection. The innovative character is based on the use of annexin scintigraphy.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Cardiologie - Hôpital Bichat Claude Bernard

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: PAIDDA

titre: Valeur pronostique de la scintigraphie à l'Annexine dans les dissections chroniques de l'aorte thoracique descendante

discipline_principale: autre

nom_porteur: MILLERON

prenom_porteur: Olivier


title: Preoperative Evaluation of Neurogenic Myositis Ossificans or Neurogenic Para-osteo-arthritis: Comparison Between Computed Tomography and Magnetic Resonance Imaging in Preoperative Evaluation

acronym: MON-IRM

summary:
The principal objective of the study is to compare between CT and MRI diagnostic performance (sensibility and specificity) in the preoperative assessment of neurogenic para-osteo-arthritis.

The second objectives of the study are:

besides the diagnostic performance (sensibility and specificity), to evaluate the imaging par MRI in visual and descriptive manner heterotopic ossification and connection with vascular and nervous structures.
to study the concordance (two by two) of results of preoperative obtained by MRI and by CT and operative reports.
to study the characteristics of patients with discordant findings (two by two) by MRI, CT scan and operative report.

ReferenceCitation: Amar R, Thiry T, Salga M, Safa D, Chetrit A, Gatin L, Carlier RY. Comparison of magnetic resonance imaging and computed tomography for bone assessment of neurogenic heterotopic ossification of the hip: a preliminary study. J Orthop Surg Res. 2021 Dec 20;16(1):725. doi: 10.1186/s13018-021-02869-6.

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

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

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

location_facility: Service d'Imagerie médicale, Hôpital Raymond Poincaré


title: Executive Function Disorders and Anxio-depressive Symptomatology in Children and Adolescents With Mitochondrial Pathologies

acronym: MITOPSY

summary:
The major steps forward of the neurosciences in recent years have linked psychiatric diseases, neuropsychological symptoms and brain dysfunctions. The cerebral functioning requiring a big quantity of energy, mitochondria, essential organelles in the cellular energy processes, are at present considered as a way of research for big interest in neurology and in psychiatry. Thus, an increasing number of studies describe potential links between mitochondrial dysfunction and psychiatric symptomatology. The clinical symptomatology of children with mitochondrial cytopathy is varied. Well described neurologically and somatically, it is significantly less in its psychiatric aspects. However, psychiatric symptoms are frequently associated and this symptom has already been described in adult patients. The symptoms mainly include depressive and anxiety disorders, or even tables suggestive of psychotic disorders, which would precede the diagnosis of mitochondrial disease of 13 years on average.

Neuropsychological disorders refer to disorders of the higher functions following a cerebral anomaly (language, praxis, motricity, gnosis, visual spatial processing, memory, attention, intelligence, executive functions ...). Tests validated in French and adapted to children and adolescents can identify neuropsychological disorders in these populations.


title: Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy

acronym: PRURIGAMMA

summary:
Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. The causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when no cause is found.

Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this pruritus. So the aim of this study is to compare the frequency of pruritus between patients with monoclonal gammapathy and controls

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Contribution of Pre-hospital Blood Lactate Level for Pre-hospital Orientation of Septic Shock

acronym: LAPHSUS

summary:
In the pre-hospital setting, the severity assessment of septic shock is essential to decide the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a need for an additional element in order to enhance the severity assessment and to decide in-hospital admission in the intensive care unit (ICU) or in the emergency department (ED). Point of care medical device yielding blood lactate levels since the pre-hospital setting may give an easy and valuable element for the severity assessment and the decision-making.

The aim of this study is to provide clinical evidence that the pre-hospital blood lactate level predicts the 30-day mortality of patients with septic shock.

ReferenceType: background

ReferenceCitation: Marecaux G, Pinsky MR, Dupont E, Kahn RJ, Vincent JL. Blood lactate levels are better prognostic indicators than TNF and IL-6 levels in patients with septic shock. Intensive Care Med. 1996 May;22(5):404-8. doi: 10.1007/BF01712155.

ReferenceCitation: Bakker J, Coffernils M, Leon M, Gris P, Vincent JL. Blood lactate levels are superior to oxygen-derived variables in predicting outcome in human septic shock. Chest. 1991 Apr;99(4):956-62. doi: 10.1378/chest.99.4.956.

ReferenceCitation: Cicarelli DD, Vieira JE, Bensenor FE. [Lactate as a predictor of mortality and multiple organ failure in patients with the systemic inflammatory response syndrome.]. Rev Bras Anestesiol. 2007 Dec;57(6):630-8. doi: 10.1590/s0034-70942007000600005. Portuguese.

ReferenceCitation: Gaieski DF, Goyal M. Serum lactate as a predictor of mortality in emergency department patients with infection: does the lactate level tell the whole story? Ann Emerg Med. 2005 Dec;46(6):561-2; author reply 562. doi: 10.1016/j.annemergmed.2005.07.021. No abstract available.

ReferenceCitation: Mikkelsen ME, Miltiades AN, Gaieski DF, Goyal M, Fuchs BD, Shah CV, Bellamy SL, Christie JD. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009 May;37(5):1670-7. doi: 10.1097/CCM.0b013e31819fcf68.

ReferenceCitation: Shapiro NI, Howell MD, Talmor D, Nathanson LA, Lisbon A, Wolfe RE, Weiss JW. Serum lactate as a predictor of mortality in emergency department patients with infection. Ann Emerg Med. 2005 May;45(5):524-8. doi: 10.1016/j.annemergmed.2004.12.006.

ReferenceCitation: Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, Parrillo JE, Dellinger RP, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009 Jul;32(1):35-9. doi: 10.1097/shk.0b013e3181971d47.

lead_sponsor: Hôpital Necker-Enfants Malades

collaborators: Fire Brigade Of Paris Emergency Medicine Dept

collaborators: University Hospital Center of Martinique


title: Prevalence of Migraine in Infertile Women and Evolution During in Vitro Fertilization (IVF)

acronym: FERTIMIG

summary: The purpose of this study is to determine the prevalence of migraine in infertile women and during in Vitro Fertilization protocol. Migraine is two to three times as common in women as in men. Migraine has considerable impact on quality of life. In Vitro Fertilization has become a common therapeutic modality in modern fertility medicines. Treatment protocols are associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely linked to migraine and its fluctuations have been considered to trigger migrainous headaches.


title: Study of Arithmetic Abilities of Children With 22q11.2 Deletion Syndrome Aged From 4 to 11 Years Old

summary: The study ARITH22 will investigate the role of visuo-spatial attention on arithmetic abilities of children with 22q11.2 deletion syndrome.

lead_sponsor: Hôpital le Vinatier

intervention_type: Behavioral


title: Human Ab Response & immunoMONItoring of COVID-19 Patients

acronym: HARMONICOV

summary: Prospective, mono centric study on COVID-19 patients with or without acute respiratory distress syndrome (ARDS) to analyse the dynamics of the immune response and to search for biomarkers of evolution

ReferenceCitation: Pascal V, Dupont M, de Rouault P, Rizzo D, Rossille D, Jeannet R, Daix T, Francois B, Genebrier S, Cornic M, Monneret G, Venet F, Ferrant J, Roussel M, Reizine F, Le Souhaitier M, Tadie JM, Tarte K, Feuillard J, Cogne M. Demultiplexing Ig repertoires by parallel mRNA/DNA sequencing shows major differential alterations in severe COVID-19. iScience. 2023 Mar 17;26(3):106260. doi: 10.1016/j.isci.2023.106260. Epub 2023 Feb 21.

ReferenceCitation: Roussel M, Ferrant J, Reizine F, Le Gallou S, Dulong J, Carl S, Lesouhaitier M, Gregoire M, Bescher N, Verdy C, Latour M, Bezier I, Cornic M, Vinit A, Monvoisin C, Sawitzki B, Leonard S, Paul S, Feuillard J, Jeannet R, Daix T, Tiwari VK, Tadie JM, Cogne M, Tarte K. Comparative immune profiling of acute respiratory distress syndrome patients with or without SARS-CoV-2 infection. Cell Rep Med. 2021 Jun 15;2(6):100291. doi: 10.1016/j.xcrm.2021.100291. Epub 2021 May 6.

repository_institution: Queen's University Belfast - Research Portal

evidence: oa repository (via free pdf)

repository_normalized: bioRxiv

version: submittedVersion

repositories:
HAL
PubMed Central
bioRxiv
pure.qub.ac.uk/portal

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

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

ReferenceCitation: Hamzeh-Cognasse H, Mansour A, Reizine F, Mismetti P, Gouin-Thibault I, Cognasse F. Platelet-derived sCD40L: specific inflammatory marker for early-stage severe acute respiratory syndrome coronavirus 2 infection. Virol J. 2021 Oct 29;18(1):211. doi: 10.1186/s12985-021-01680-3.

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

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


title: Descriptive Study of Acute Spontaneous Spinal Cord Infarction : EDMIAS

acronym: EDMIAS

summary:
Acute spontaneous Spinal Cord Infarctions (SCI) are an uncommon cause of myelopathy (5%), but their prognostic is heterogeneous and frequently severe. Positive diagnosis is difficult, one quarter of initial MRIs are normal. Differential diagnosis with other transverse myelopathy causes is a common issue. As in cerebral stroke, there are multiple causes and mechanisms in spontaneous SCI, often difficult to clearly establish. There are also clinical and radiological patterns, sometimes misleading, according to vascular territory and its expanse.

Due to its scarcity and heterogeneity, improving knowledge and medical care remains difficult. Medical care is still badly codified in medical literature. Recently, diagnostic criteria have been proposed to better identify SCI, provide earlier care and homogenize future research. External validity and reproduction of these new criteria among acute myelopathies are still to be validated.

While there is no established medical treatment in the initial care of spontaneous SCI, some case reports show successful treatment with IV thrombolysis. Given the severe prognosis, conventional treatment of strokes (thrombolysis, anticoagulant and antiplatelet), could be considered on an individual scale, in a specific protocol. A better knowledge of radio-clinical and security factors are necessary to support this approach.

In order to respond to these difficulties, a retrospective cohort will allow us to better define epidemiological, clinico-radiological and prognostic features of spontaneous SCI. It lays the foundation of a possible prospective multicentric cohort, necessary for specific therapeutic studies.

collaborators: Centre Hospitalier Universitaire de Nīmes


title: Pilot Study Evaluating the Safety of Electroducer Sleeve Medical Device for Temporary Cardiac Stimulation During Percutaneous Cardiovascular Interventions, in All Kind of Patients

summary:
During percutaneous cardiovascular intervention, temporary cardiac stimulation may be required. Usually this stimulation is generated via a temporary pacing catheter. In order to reduce the complexity of the procedure, a new stimulation strategy has been developed: the "Direct Wire Pacing technique".In this approach, the cardiac stimulation is provided via the guidewire connected to an external pacemaker.

Previous study demonstrated the superiority of the new technique compared to the former. However this technique is likely to generate electrical pain, risk of bleeding for the patient and risk of blood exposure accident for the operators. This is why the medical device ELECTRODUCER SLEEVE has been developed. This device integrates a pacing function to the introducer and the guidewire used. The "Direct Wire Pacing technique" is simplified, secured and more reproducible.

lead_sponsor: Electroducer


title: Medical Hypnosis Against Anxiety and Pain in Electro-neuro-myography

acronym: HYPNOMADE

summary: Electroneuromyography (ENMG) is a regular neurological investigation that might be painful or unpleasant. Medical hypnosis can avoid these sensations, and is more and more performed during other medico-technical procedures (radiology, biopsies for example). This study aims at evaluate the effect of medical hypnosis on pain and anxiety during ENMG, in patients presenting with anxiety. Our hypothesis is that the anxiety and pain during ENMG will be lower in patients with hypnosis compared to patients with standard care. This will allow us to help patients with this tool during most ENMG procedures, and extend it to other electrophysiological procedures in the future.

lead_sponsor: University Hospital, Lille


title: Predicting Risk Factors of Postoperative Hypocalcemia After Total Thyroidectomy: is Safe Discharge Without Supplementation Possible?

summary:
With increasing economic pressures to shorten the length of hospital stay, there has been much recent interest in studying risk factors for the development of postoperative hypocalcemia.

The aim of this study was to investigate in patients undergoing total thyroidectomy whether serum calcium and/or PTH levels can predict hypoparathyroidism.

ReferenceCitation: Paladino NC, Guerin C, Graziani J, Morange I, Loundou A, Taieb D, Sebag F. Predicting risk factors of postoperative hypocalcemia after total thyroidectomy: is safe discharge without supplementation possible? A large cohort study. Langenbecks Arch Surg. 2021 Nov;406(7):2425-2431. doi: 10.1007/s00423-021-02237-2. Epub 2021 Aug 10.

ipd_sharing_description: the data are confidential

lead_sponsor: Aix Marseille Université


title: Androcur® (Cyproterone Acetate) and Meningioma Development: a Genotype-environment Association Study

acronym: ANDROMEDE-F

summary:
The primary objective of the study is to create a biobank of oral smears permitting to identify the genetic locus/loci associated with an increased risk to develop meningiomas after cyproterone acetate (CPA) (Androcur®) treatment, using a GWAS approach.

As the secondary objectives, the study aims:

to evaluate the importance of the genetic susceptibility.
to record the frequence of homonodependant cancers occuring in female patients with Androcur® associated meningioma and in their first-degree relatives.
to describe clinical, radiological, histological characteristics of the patients who have developed meningioma after cyproterone acetate exposure.

location_facility: Endocrinology Nutrition Department, Ambroise Paré Hospital, APHP


title: Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital

acronym: Voix Chantée

summary:
As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. This examination seeks to establish whether the infant has retinopathy of prematurity. This disease affects the vessels of the retina of the eye, especially in prematurely born children, and can lead to serious complications such as blindness if it is not treated in time.

The purpose of this study is to assess the discomfort caused by the screening in order to improve practices. To do this, the investigators would like to evaluate whether soft auditory stimulation, more precisely a person singing, would improve the children's level of comfort during the examination.

To do this, the participating children will be divided into 2 groups:

The "Singing" group will receive the usual comfort treatments (placed in a 'nest', pacifier and sugar water) and a trained professional will sing a lullaby or nursery rhyme at the same time
control group will receive the usual comfort care (placed in a 'nest', pacifier and sugar water) The child's head and entire body will be filmed, which will allow an evaluator to assess the child's comfort.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of Cooking Education and Adapted Physical Activity on Nutritional Status and Quality of Life of Patients Treated by Allo Stem Cell Transplantation

acronym: NUTRITION

summary: Majority of patients after allo stem cell transplantation have malnutrition and decrease of physical activities. This state impacts on quality of life and on outcome of some complications like infections, graft versus host disease and could decrease the overall survival. In this study, the investigators propose cooking education and adapted physical activity to improve that. Cooking education and adapted physical activity at home will be performed by two famous chefs for the first one and by a sportive coach for the second every twice week.

primary_purpose: Prevention

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Decrease of Post-operative Complications by SCVO2 Monitoring an Optimisation of Cardiac Flow : Multicentric Randomized Control in Single Blind Study

summary: In operating theater, one of the bigger purpose of anesthetist-resuscitator is to optimize vascular filling (VF) because of a failure or an excess of filling is deleterious for the patient. Several studies have assessed the traditionnal VF based on the clinic and the VF guided by quantitative critereas. Thus studies have showed a decrease of morbidity and duration of patients' stay whose the VF was guided even on the long term. So, formal recommandations of experts (FRE) on the perioperative filling strategy of the SFAR ( Anesthesia and Resuscitation Francophone Society) advise to titrate the perioperative vascular filling of high risk patients guiding on a mesure of end-systolic volume (ESV). The inscrease of ESV answering to filling confirmed the VF realized is relevant and authorized its pursuite while the absence of an increase of the ESV after a filling test signifies the useless and deleterious character of this one. The optimization of perioperative hemodynamics consists in adapting the patient's cardiac output to his metabolic needs. ETO, Swan-Ganz: limit of its application to the routine. The central venous oxygen saturation (ScvO2) is simple and safe, the evaluation of the adjustment of O2 inputs compared to the needs. The industry has developed continuous monitoring systems by reflection spectrophotometry using optical fibers installed in the central venous pathways. In daily practice, the stricto sensu application of FRE leads to administering an VF up to the limit of the preload dependence without evaluating the adequacy of the cardiac output, which is not a physiological situation. This filling is therefore sometimes performed solely on the criteria of preload dependence while it is potentially deleterious for the patient. No study has compared a strategy based on the use of ScvO2 and preload dependence with current recommendations based solely on preload dependence. Our hypothesis is that the continuous monitoring of the ScvO2 in the superior cave territory in intraoperative would allow to detect the patients with an inadequacy of the cardiac output and thus to select the only ones requiring a vascular filling. This would reduce postoperative complications related to overfilling, without exposing the patient to episodes of tissue hypoperfusion.

lead_sponsor: Assistance Publique Hopitaux De Marseille

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

titre: Diminution des complications postopératoires par le monitorage continu de la ScvO2 et optimisation du débit cardiaque : étude contrôlée, randomisée, en simple aveugle

discipline_principale: anesthésie-réanimation hors cancer

nom_porteur: ZIELESKIEWICZ

prenom_porteur: Laurent


title: Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.

acronym: VECUREA

summary:
Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close.

A stay in PICU often leaves a painful memory to the child and family, and can lead to psychological morbidity such as post-traumatic stress disease.

This study aims to assess parents' experience during their child hospitalization in PICU, and the impact of this stay on the entire family in the following month.

lead_sponsor: Hospices Civils de Lyon

location_facility: Pediatric intensive care unit of Women-Mother-Children Hospital


title: Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

acronym: WILL-COPE

summary: Patients with Williams-Beuren syndrome are eight times more likely to suffer from anxiety compared to the general population. Few therapeutic solutions are proposed to these patients. The objective of this research is to validate a cognitive and behavioral therapy anxiety protocol for patients with this syndrome.

ReferenceCitation: Vereenooghe L, Langdon PE. Psychological therapies for people with intellectual disabilities: a systematic review and meta-analysis. Res Dev Disabil. 2013 Nov;34(11):4085-102. doi: 10.1016/j.ridd.2013.08.030. Epub 2013 Sep 18.

ReferenceCitation: Royston R, Howlin P, Waite J, Oliver C. Anxiety Disorders in Williams Syndrome Contrasted with Intellectual Disability and the General Population: A Systematic Review and Meta-Analysis. J Autism Dev Disord. 2017 Dec;47(12):3765-3777. doi: 10.1007/s10803-016-2909-z.

ReferenceCitation: Unwin G, Tsimopoulou I, Kroese BS, Azmi S. Effectiveness of cognitive behavioural therapy (CBT) programmes for anxiety or depression in adults with intellectual disabilities: A review of the literature. Res Dev Disabil. 2016 Apr-May;51-52:60-75. doi: 10.1016/j.ridd.2015.12.010. Epub 2016 Jan 22.

sponsor_collaborators:
University Hospital, Montpellier
Fondation Jérôme Lejeune
association autour des Williams
réseau de santé Maladies Rares


title: Assessment of Professional Practices - Arterial Doppler Waveforms Analysis in PAD

acronym: APP-Wave-PAD

summary:
The main objective is to evaluate the differences of terminology used when describing arterial doppler waveforms.

To assess the impact of an educational process

time_perspective: Cross-Sectional

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
French Society of Vascular Medicine

location_facility: Centre Hospitalier Universitaire de Rennes


title: Transcranius : Junior Emergency Physician Learning Curve to Perform Transcranial Doppler on Brain-damage Patients

acronym: Transcranius

summary: Transcranial Doppler is a noninvasive tool. Using velocity measurements and pulsatility index it allows the evaluation of cerebral haemodynamics. In patients presenting brain injury cerebral perfusion may be impaired. Indirect cerebral blood flow can be monitored and risk of neurological worsening can be detected using transcranial Doppler. Education and performance of emergency physicians must be evaluated on brain-injured patients because this tool is operator dependent. The main objective of this study is to estimate the average number of exams required to learn transcranial Doppler within junior emergency physicians with the achievement of their learning curve. We will perform a prospective, monocentric, observational study within the neurosurgical resuscitation department of Grenoble Alpes University Hospital.

lead_sponsor: University Hospital, Grenoble


title: Identification of Respiratory Stability Mechanisms During Skin-to-skin Care in Premature Infants in the Neonatal Intensive Care Unit: Infant-parent Vegetative Functions Coupling

acronym: PO-A-PO-PREMA

summary: The main purpose of this study is to identify and to determine the involvement of cardio-respiratory coordination mechanisms during SSC between the preterm infant and his (her) parent.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia

acronym: FORCE

summary: The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).

ReferenceCitation: Carvelli J, Meziani F, Dellamonica J, Cordier PY, Allardet-Servent J, Fraisse M, Velly L, Barbar SD, Lehingue S, Guervilly C, Desgrouas M, Camou F, Piperoglou C, Vely F, Demaria O, Karakunnel J, Fares J, Batista L, Rotolo F, Viotti J, Boyer-Chammard A, Lacombe K, Le Dault E, Carles M, Schleinitz N, Vivier E; FOR COVID Elimination (FORCE) Study Group. Avdoralimab (Anti-C5aR1 mAb) Versus Placebo in Patients With Severe COVID-19: Results From a Randomized Controlled Trial (FOR COVID Elimination [FORCE]). Crit Care Med. 2022 Dec 1;50(12):1788-1798. doi: 10.1097/CCM.0000000000005683. Epub 2022 Oct 10.

evidence: open (via page says license)

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

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

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

oa_host_type: repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk;pure.eur.nl

unpaywall_oa_status: green

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Proactive Care of Ambulatory COVID19 Patients: Open-labeled Randomized Trial

acronym: AMBU-COVID

summary:
On January 9, 2020, a new emerging virus was identified by WHO as being responsible for grouped cases of pneumonia in China. It is a coronavirus, SARS-CoV-2, responsible for the disease COVID-19 (Coronavirus disease). The disease is mild in 85% of cases but the proportion of serious cases requiring hospitalization or intensive care (15%) puts stress on health structures and systems around the world.

To limit the influx of patients and avoid overstretching Health systems, containment and social distancing strategies are widely adopted.

It appears crucial to propose the easiest possible therapeutic strategy taking into account the ambulatory nature of the patients. Therefore azithromycin (AZM) is an antibiotic known to have an antiviral effect but also which has anti-inflammatory activity in addition to its antimicrobial effect. Azithromycin targets preferentially pulmonary cells (and particularly of the lines apparently affected in COVID-19 positive cases). The aim of this study is to demonstrate that AZM decreases symptom duration in COVID19 patients and diminishes the viral carriage.

status: Suspended


title: Evaluation of the microDTTect Device (Heraeus) in the Diagnosis of Low-grade Chronic

summary:
Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.

In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.


title: Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS

acronym: COVISLEEP

summary: Most patients in intensive care units (ICUs) experience severe sleep disruption. Sleep disruption and sleep alteration may have an influence on the ability to breathe spontaneously. But, the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Therefore, the aim of this study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).

lead_sponsor: University Hospital, Bordeaux


title: Pulmonary and Ventilatory Effects of Bed Verticalization in Patients With Acute Respiratory Distress Syndrome: An Exploratory and Pathophysiology Study

acronym: ERECTION

summary:
Acute respiratory distress syndrome (ARDS) is defined using the clinical criteria of bilateral pulmonary opacities on a chest radiograph, arterial hypoxemia (partial pressure of arterial oxygen [PaO2] to fraction of inspired oxygen [FiO2] ratio ≤ 300 mmHg with positive end-expiratory pressure [PEEP] ≥ 5 cmH2O) within one week of a clinical insult or new or worsening respiratory symptoms, and the exclusion of cardiac failure as the primary cause. ARDS is a fatal condition for intensive care unit (ICU) patients with a mortality between 30 and 40%, and a frequently under-recognized challenge for clinicians. Patients with severe symptoms may retain sequelae that have recently been reported in the literature. These sequelae may include chronic respiratory failure, disabling neuro-muscular disorders, and post-traumatic stress disorder identical to that observed in soldiers returning from war.

The management of a patient with ARDS requires first of all an optimization of oxygenation, which relies primarily on mechanical ventilation, whether invasive or non-invasive (for less severe patients). Since the ARDS network study published in 2000 in the New England Journal of Medicine, it has been internationally accepted that tidal volumes must be reduced in order to limit the risk of alveolar over-distension and ventilator-induced lung injury (VILI). A tidal volume of approximately 6 mL.kg-1 ideal body weight (IBW) should be applied. Routine neuromuscular blockade of the most severe patients (PaO2/FiO2 < 120 mmHg) is usually the rule, although it is increasingly being questioned. Comprehensive ventilatory management is based on the concepts of baby lung and open lung, introduced respectively by Gattinoni and Lachmann. According to these concepts, it must be considered that the lung volume available for mechanical ventilation is very small compared to the healthy lung for a given patient (baby lung) and that the reduction in tidal volume must be associated with the use of sufficient PEEP and alveolar recruitment maneuvers to keep the lung "open" and limit the formation of atelectasis.

In addition to this optimization of mechanical ventilation, it is possible to reduce the impact of mechanical stress on the lung. The prone position, for example, makes it possible to free from certain visceral and mediastinal constraints, to optimize the distribution of ventilation as well as the ventilation to perfusion ratios.

Thanks to the technological progress of intensive care beds, it is now possible to verticalize ventilated and sedated patients in complete safety. Verticalization could reduce the constraints imposed to the lungs, by reproducing the more physiological vertical station, and thus modifying the distribution of ventilation.

Indeed, in two physiological studies published in 2006 and 2013 in Intensive Care Medicine, 30 to 40% of patients with ARDS appeared to respond to partial body verticalization at 45° and 60° (in a semi-seated or seated position). In addition to improving arterial oxygenation, verticalization appeared to decrease ventilatory stress, related to supine position, and increase alveolar recruitment, with improved lung compliance and end-expiratory lung volume (EELV) over time. Nevertheless, 90° verticalization has never been studied, nor have positions without body flexion (seated or semi-seated). In these studies, only patients with the highest lung compliance appeared to respond. These data support the current hypothesis of subgroups of patients with ARDS with different pathophysiological characteristics (morphological and phenotypic) and therapeutic responses.

The investigators hypothesize that verticalization of patients with ARDS improves ventilatory mechanics by reducing the constraints imposed on the lung (transpulmonary pressure), pulmonary aeration, arterial oxygenation and ventilatory parameters.

The first objective is to study the influence of the bed position of the patient with early ARDS on the variations in respiratory mechanics represented by the transpulmonary driving pressure (ΔPtp). The second objective is to evaluate changes in ventilatory physiology, tolerance and feasibility of verticalization in patients with early ARDS.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Medical Treatment of Peyronie's Disease With Collagenase Clostridium Histolyticum (CCH or Xiapex®): Sexual and Psychological Impact and Results From 156 Patients' Questionnaires Data

summary:
Peyronie's disease is the appearance of a fibrosis plaque on the albuginea of the corpora cavernosa, which produces mechanical traction at the time of erection, inducing a deformation/curvature of the erect penis. The physiopathology is largely unknown.

There is a significant sexual and psychological impact on patients. Historically, the only possible treatment was surgical. The only drug treatment that was FDA approved for this disease was Collagenase from Clostridium Histolyticum marketed under the name Xiapex® until 31/12/2019 by Sobi laboratory. Marketing was stopped on that date for economic reasons and restricted to the US market only.

The investigators propose a retrospective evaluation of the largest French monocentric series of this treatment from the perspective of the sexual and psychological evaluation of patients.


title: Discovery of Soluble Biomarkers for Pancreatic Cancer Using Innovative All-Patient Inclusive Methodology (PanEXPEL2)

summary:
Pancreatic ductal adenocarcinoma (PDAC) remains among cancers with a very poor prognosis (1-year survival <20%). Endoscopic ultrasound with fine needle aspiration (EUS/FNA) is the common examination for all patients with suspicious pancreatic mass. A method was recently developed : it preserves the sanitary sample, named EXPEL, which allows standard pathology examination and OMICS analyzes from the "rinse" liquid. After EUS/FNA in clinical practice, the content of the needle is rinsed in CytoLyt® preservative solution. After cytofiltration, this liquid is systematically discarded.

Based on the EXPEL concept, we hypothesise that this all-patients inclusive approach ("Modified EXPEL" procedure) combined with the methodology to access proteomic and metabolomics information in these original samples will allow us to identify a series of clinically useful marker signatures that will ultimately be measurable, non-invasively, in the patient blood.


title: Sleep Quality During COVID-19 Containment in Children 7 to 12 Years Old, Whether or Not Usually Followed in Child Psychiatry

acronym: CONFIDODO

summary: The purpose of this study is to determine whether sleep disturbances in children aged 7 to 12 during COVID-19 containment are more prevalent in children who received routine psychiatric care before containment compared to children who don't have any psychiatric care.

lead_sponsor: Hôpital NOVO


title: Segment IV Hypertrophy After Liver Venous Deprivation Compared to Portal Embolization in Patient Before Major Hepatectomy

summary:
before major hepatectomy, in case of insufisant future liver remanent volume or function, portal embolization is a routinely used method to enable growth of the future liver remnant. Recently liver venous deprivation has been described in some pioneer centre. The results are processing with greater and faster hypertrophy allowing probably less drop out from the embolization to surgery compared to portal embolization.

In major hepatectomy, and specially in right or extended right hepatectomy the segment IV plays an important role in the proportion of future liver remnant.

Despite the growing interest in the scientific community for liver venous deprivation many aspects concerning the liver hypertrophy remains unexplored. In particular the the degree of hypertrophy of segment IV after liver venous deprivation compared to portal embolization.

lead_sponsor: University Hospital, Montpellier


title: Risk Factors for Thrombosis in Immune Thrombocytopenia

acronym: RiFT-ITP

summary:
Immune thrombocytopenia (ITP) is a rare autoimmune disease (annual incidence: 3-4/105 inhabitants) leading to an increased risk of spontaneous bleeding. ITP is said "primary" when not associated to other systemic disease (lymphoma, systemic autoimmune disease, chronic infectious disease…). First-line treatment is based on corticosteroids. Intravenous immunoglobulin (IVIg) is added in case of serious bleeding. In about 70% of adult cases, ITP becomes persistent or chronic (lasting >3 months and >12 months, respectively). Second-line treatments are then indicated. Among them, thrombopoietin-receptor agonists (TPO-RAs), romiplostim and eltrombopag are increasingly used. Splenectomy is used as ultimate treatment.

Paradoxically, the risk of thrombosis is higher in ITP patients in comparison with the general population, due to the release of young hyperactive platelets from bone marrow. The incidence of thrombosis in ITP patients has been estimated between 0.5 and 3/100 patients-years. However, risk factors for thrombosis in ITP are not known, except splenectomy that is used in very few patients now. The role of other ITP treatments in thrombosis occurrence has been evoked, particularly for corticosteroids and IVIg. TPO-RAs have been associated with a risk of thrombosis in clinical trials and pharmacovigilance studies, even in case of low or normal platelet count. However, this risk has not been measured in the real-life practice, adjusted for other risk factors for thrombosis.

ReferenceCitation: Lafaurie M, Maquet J, Baricault B, Ekstrand C, Christiansen CF, Linder M, Bahmanyar S, Norgaard M, Sailler L, Lapeyre-Mestre M, Sommet A, Moulis G. Risk factors of hospitalisation for thrombosis in adults with primary immune thrombocytopenia, including disease-specific treatments: a French nationwide cohort study. Br J Haematol. 2021 Nov;195(3):456-465. doi: 10.1111/bjh.17709. Epub 2021 Aug 12.

lead_sponsor: University Hospital, Toulouse


title: Impact of Art Therapy on Brain Connectivity in Recent Post-Stroke Aphasia (ART-CONNECT)

acronym: ART-CONNECT

summary: A stroke located in the left parieto-temporal junction is associated, in aphasic right-handed patients, with a poor prognosis for language recovery. The role of the right hemisphere in recovering post-stroke aphasia is still controversial. Our hypothesis, based on recent work in imaging, is that early activation of the right hemisphere linked to the practice of the visual arts could facilitate language recovery in extended posterior left strokes that completely disrupt language areas.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Soins de Suite et Réadaptation


title: External Validation of the RESAS (REnnes Septic Arthritis Score) Septic Arthritis Prognosis Score in an Acute Arthritis Cohort of Less Than 30 Days

acronym: SYNOLACTATES +

summary: Observational study


title: Identification of Predictive Blood Biomarkers of Recurrent Urinary Tract Infections

acronym: Predict-UTI

summary: Urinary tract infections affect more than 130 million people worldwide each year. Almost 50% of women will have at least one urinary tract infection during their lifetime, usually cystitis. Half of them will have recurrent cystitis. Antibiotics are the first-line treatment for cystitis, but their effectiveness is decreasing due to the rapid spread of multi-resistant uro-pathogenic bacteria. The objective of this study is to identify blood biomarkers associated with a high risk of recurrent cystitis. Immune system cells, and more specifically innate immunity cells, play a key role in controlling urinary tract infections. In addition, clinical studies have shown that there is a high inter-individual variability in the ability of innate immune cells to respond to different stimuli. We therefore hypothesized that there was an association between the risk of recurrent cystitis and a deficiency of certain immune cell types in producing certain pro-inflammatory cytokines, including TNF-α, in response to one or more bacterial stimuli, particularly flagellin.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital de l'Archet 1 - CHU de Nice - Service d'Infectiologie


title: Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography

acronym: Elastogreffe

summary:
Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III). It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This exam is systematic on M3 of the transplantation.

Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of fibrosed tissue rigidity.

Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.

The purpose is the validation of elastograhpy, innovative and non -invasive technique, and more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve intra-operator variability and estimate fibrosis' degree of kidney's graft.

lead_sponsor: University Hospital, Tours


title: Efficacy of Transvaginal Ultrasound-guided Aspiration for Treatment of Tubo-ovarian Abscess Compared With Laparoscopy

acronym: Pactol

summary:
"Tubo-ovarian abscess (TOA) include pyosalpinx, ovarian abscess, tubo-ovarian abscess and Douglas abscess. The only randomized study evaluating TOA treatment reported a higher cure rate (90 versus 65%) when antibiotic therapy is associated with abscess evacuation.

TOA evacuation can be performed by surgery or by drainage. No studies have compared success rates between those two methods.

Concerning surgery, current practices recommend performing laparoscopy which allows a shorter hospital stay, a lower complication rate and high success rates.

The majority of published studies reporting radiological drainage concern ultrasound-guided transvaginal drainage. The reported success rates range from 77 to 100%. The PACTOL trial is a randomized, prospective, controlled, open, parallel, non-inferiority, multicenter trial comparing the efficacy of transvaginal drainage versus laparoscopy in both arms with antibiotic therapy in the treatment of TOA.

acronyme: PACTOL

titre: Efficacité de la ponction transvaginale pour le traitement des abcès tubo-ovariens par rapport à la laparoscopie : Etude prospective comparative randomisée contrôlée de non infériorité

nom_porteur: KOSKAS

prenom_porteur: Martin


title: Qualitative Assessment of Emergency Dental Treatments in the Pitie Salpetriere Hospital

acronym: URGDENT

summary:
The objective of the study is to evaluate the efficiency of emergency procedures and patient satisfaction within the GHPS (Groupe Hospitalier Pitié Salpêtrière) Dental Emergency Department.

Pain is the main reason of consultation at dental emergency.

The investigators evaluate the pain felt before and after the intervention of the emergency with questionnaires at the day of the consultation (D0), then with phone interviews at D1, D3 and D7.

The investigators also evaluate the quality of the reception and care provided in the GHPS service using a satisfaction questionnaire completed by the patients at D0.


title: Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

acronym: ERICA

summary:
Alcohol is a major public health problem and its neurotoxic effects are, among other things, responsible for altering the functioning of cerebral neurotransmission pathways.

The retina is an anatomical and developmental extension of the central nervous system. It is composed of several layers of retinal neurons that share similar anatomical and functional properties with brain neurons. Retinal neurons are notably equipped with a complex system of neurotransmission constituted by the main neurotransmitters that are involved in the central effects of alcohol: glutamate, dopamine, serotonin ... The retina is used here as a site of indirect investigation for abnormal central neurotransmission pathways following regular alcohol use. It is recognized to date as a good site for investigating central abnormalities in neuropsychiatric and addictive disorders.

The objective of this project is to study the retinal function using electroretinogram (ERG) in regular alcohol users to isolate potential markers of cerebral neurotransmission abnormalities.

lead_sponsor: Centre Psychothérapique de Nancy


title: Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia

acronym: Calprotect

summary: To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology.


title: Impact of Marketing of Alcohol Products on Young People

acronym: IMAJ

summary: Impact of marketing of alcohol products on young people

collaborators: Ecole des Hautes Etudes en Santé Publique (EHESP)


title: Circadian Character of Food Compulsions and Impulses Control Disorders in Parkinsonian Patients With and Without Resting Leg Syndrome

acronym: RLS nighfood

summary:
Investigator have recently shown that Parkinson disease patients' with restless leg Syndrome have more frequent impulse control behavior in particular compulsive feeding that patients without Restless Leg Syndrome (RLS).

Investigator hypothesized that presence of RLS in parkinsonian patients could be a risk factor for the emergence of TCI or associated behaviors, occurring preferentially at night.

The main objective of this study is to evaluate in patients with idiopathic Parkinson's disease (IPD) the effect of the presence of a RLS on the evening compulsive eating behavior by studying the circadian modulation of food intake of patients with RLS and impulse control disorders.

For this investigator conduct a prospective study, with 2 groups of Parkinson disease patients (with and without restless leg syndrome), to which investigator have to fill an agenda to know the schedule of the behaviors during the day and the night.


title: Performance of Lung Ultrasonography for Endotracheal Tube Positioning in Neonates

acronym: ECHOSI

summary: Lung Ultrasonography (US) has been shown to be effective for verifying endotracheal tube (ETT) position in adults and children but has been less studied in neonates. The aim of this study is to evaluate the performance of lung US in determining correct ETT position in neonates, in comparison with X Ray

lead_sponsor: University Hospital, Limoges


title: Effect of Music on the Reduction of the Sedative Dose During Coronary Angioplasty: A Control-case Comparison Clinical Study

summary: This is a non-blinded, non-randomized controlled pilot study with no follow-up. Patients will be recruited from the coronary angiography patient pool of the American Hospital of Paris and assigned to one of 2 groups in a non-randomized manner.

ReferenceCitation: Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.

ReferenceCitation: Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.

ReferenceCitation: Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guetin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.

ReferenceCitation: Guetin S, Brun L, Deniaud M, Clerc JM, Thayer JF, Koenig J. Smartphone-based Music Listening to Reduce Pain and Anxiety Before Coronarography: A Focus on Sex Differences. Altern Ther Health Med. 2016 Jul;22(4):60-3.

lead_sponsor: Association de Musicothérapie Applications et Recherches Cliniques


title: Respiratory Polygraphy in Children : Feasibility in Every Day Pratice in an ENT Department and Value of the Automatic Detection of Respiratory Events

summary: The use of respiratory polygraphy (RP) in children for the diagnosis of obstructive sleep apnea hypopnea syndrome (OSAHS) can be challenging: device acceptance, sensors displacement. The automatic analysis of respiratory events has never been evaluated in a pediatric population. The primary objective of this study was to determine the feasibility of pediatric RP in an ENT department routine practice. The second objective was to evaluate the reliability of the automatic signal analysis in children.


title: Correlation Study Between Socio-economical Deprivation and Oral Health in in French Children of 9 Years of Age in 2017. A Nationwide Database Retrospective Observational Cohort Study

summary:
Retrospective, observational cohort study.

Objectives :

To search for correlations between socio-economical deprivation and oral health in french children of 9 years of age.

To study the annual use of oral and dental care of children from 6 to 9 years of age depending on their geographical and socio-economical environment, and the medical demography ; To identify and study the share of the cohort not using oral and dental care, and the socio-economical and geographical factors implicated in this non-use of care.

The study will use data from the french nationwide healthcare systems database (SNDS) and data from the french national institute of statistics and economic studies (INSEE).


title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas

acronym: OFACAR 1

summary: Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, sympathetic reaction and inflammatory reaction can be controlled by therapeutic classes other than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption and on a post-operative composite endpoint. Lidocaine was only studied in the context of cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in postoperative cognitive functions, but all these studies were performed during opioid anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine consumption and an improvement in the patient's post-operative well-being (complications, confusion, vigilance, length of stay).

ReferenceCitation: Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square


title: Role of Blood and Tissue Eosinophils in the Fibrogenesis of Systemic Sclerosis

acronym: EOFIB-SSC

summary: Eosinophils are involved in tissue remodeling and fibrosis in many inflammatory diseases. Systemic sclerosis (SSc) is an autoimmune disease with fibrotic skin and lung complications. The profibrosing properties and data from the SSc literature suggest a possible role of the eosinophils in the process of fibrogenesis of SSc.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
GlaxoSmithKline


title: Analgesia Quality and Quality of Deambulation of the Plantar Compartment Block After Hallux Valgus Ambulatory Surgery.

acronym: Observationnal

summary:
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.

Popliteal sciatic nerve block is widely used despite the risk of falling due to prolonged motor blockade.

Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.

The purpose of this study is to describe the analgesic effect of the plantar compartment block following hallux valgus surgery.

time_perspective: Other


title: Feasibility Study to Evaluate the Observance Rehabilitation of Upper Limbs by Visual-motor Simulation Associated at Transcranial Direct Current Stimulation (tDCS) in Hemiparetic Patient Post-stroke.

acronym: SIMSTIM

summary: Although the mirror therapy is recognized as effective, its practice is difficult, especially with hemiplegic patients. It is difficult for them to understand, control the movements and carry out a double task with the two upper limbs. The implementation of a Computerized Mirror Therapy (CMT) with the Intensive Visual Simulation 3 (IVS3) device makes it possible to limit these problems by proposing pre-recorded sessions, not limited to the right or left hemi-space, and proposing a work on proximal motricity. Since the functional prognosis of the upper hemiplegic limb remains mostly unfavourable, a wide range of interventions should be proposed. There is currently a consensus to consider the use of transcranial Direct Current Stimulation (tDCS) stimulation in functional recovery after stroke as a method to enhance the effectiveness of training techniques. Although all motor therapies can theoretically benefit from increased effectiveness by the addition of transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT) has a high potential for sensitivity to transcranial Direct Current Stimulation (tDCS) due to the intensity of the motor training of the upper limb applied.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne