title: Tenotomy of Biceps' Long Head by Mini-optics in Consultation (Hyperambulatory): What Advantage Compared to the Operating Room?

acronym: NANOBICEPS

summary:
Mini-optics has been used in orthopedics for a short time. The Nanoscope used in this study is marketed by Arthrex. Its main indications concern knee, elbow, wrist, carp and small joints of long fingers for diagnostic and sometimes therapeutic purposes. Some teams use it to replace expensive radiological examinations and/or difficult to access, in consultation, for diagnostic in the knee, but also for therapeutic for partial meniscectomy with several related publications. The investigators recently published a feasibility study of isolated tenotomy of the biceps with this minimally invasive device in consultation (first indexed article describing this technique).

This project is part of the broader context of "In Office" surgery, for which there are many applications. Through the miniaturisation of optics and access to "portable" technologies, surgical procedures can now be performed in consultation ("In Office"). For example: release of the carpal tunnel or ulnar canal to the elbow under ultrasound, partial meniscectomy, removal of foreign body from the elbow in consultation.

Indeed, in addition to the technical interest of this innovation for a simple and frequent surgical procedure, it should make it possible to transpose anxiety management for the patient, time-consuming and costly for the institution into a heavy technical platform (operating room) towards a simplified, fast and streamlined approach in consultation. In the scientific literature, other equivalent surgical procedures have already been identified and performed in consultation with various tools (carpal tunnel, ulnar nerve in the elbow, meniscectomy in the knee but also in other surgical specialties such as cataract in ophthalmology) with better patient satisfaction, improved patient journey, reduced costs, an increase in the number of patients treated.

The investigators wish to demonstrate the non-inferiority of intraarticular tenotomy of the biceps long head performed in consultation with mini-optics and local anaesthesia compared to the operating room in order to modify practices and optimize the management of patients within the institution while improving their satisfaction.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study

acronym: LIPOPREP

summary: The objective is to show the superiority of the PRP + microfat (MG) mixture compared to microfat alone, in the filling of large subcutaneous depressions of the face and skull. The investigators chose to study the post neurosurgical sequelae after removal and reinstallation of the cranial flap, with, for example, damage to the temporal muscle and asymmetry of the temples or sinking of the cranial flap

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assiatnce Publique Hopitaux de Marseille

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Pilot, Multicenter, Randomized, Non-Comparative, Double-Blind Study of Phage Therapy in Patients With Hip or Knee Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR and Antibiotic Therapy.

acronym: PhagoDAIRI

summary: Pilot non comparative study assessing the clinical control of infection of DAIR + SAT +NaCl and DAIR + SAT + Phages anti-Staphylococcus aureus in patients with Staphylococcus aureus Prosthetic Joint Infection with an indication of DAIR + SAT.

ipd_sharing: No

lead_sponsor: Pherecydes Pharma

intervention_type: Biological

lead_sponsor_type: industriel


title: Carlevale Sutureless Scleral Fixation Intra Ocular Lens : Retrospective Study of Power Calculation Accuracy.

summary: The purpose of this study is to assess the accuracy of intra ocular lens power calculation using the new Carlevale sutureless scleral fixation posterior chamber intra ocular lens.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Refractive data

lead_sponsor: Poitiers University Hospital

intervention_type: Procedure

status_simplified: Completed


title: Evaluation of Plasma Concentrations of Intravenous Lidocaine and Epidural Ropivacaine When Used in Combination in Major Abdominal Surgery

acronym: LARA

summary:
Thoracic epidural analgesia (TEA) is the gold standard analgesia of the laparotomy in major abdominal surgery and can be associated with intravenous lidocaine or subtituted by intravenous lidocaine when TEA is contraindicated and in order to reduce the use of the morphinics in the perioperative period.

Side effects can be paralytic ileus or nausea and vomiting and delay the enhanced recovery after surgery.

Intravenous lidocaine and TEA share several properties like anti hyperalgesia, anti inflammatory effect, intestinal process, anti tumoral effect… which suggests an additive effect of their combination that was not studied yet.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Drug


type: Other Identifier

title: Improving Postural Control Through Innovative Stimulation of the Proprioceptive System

acronym: IMPULSES

summary: Every movement humans make in everyday life is based on a continuous integration of sensory information. A good interaction between sensory processes and motor control, called sensorimotor integration, is necessary for the efficiency of movements. Sensorimotor integration in the context of posture and walking is based on proprioception. Proprioception is the conscious and unconscious perception of the spatial and mechanical state of the musculoskeletal system. Proprioceptive information transmitted through the neuromuscular spindles in particular is suggested to play a role in motor rehabilitation.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: The Contributions of the Multidisciplinary Management of TKA Infections in a Reference Center: A Retrospective Study About 52 Cases.

summary: Acute and chronic infection of knee joint prosthesis can have several outcomes, the most feared of which is trans-femoral amputation. In order to save the limb while maintaining function, the management of these infections involves several specialists. Orthopedic surgeons are on the front line for carrying out bacteriological samples as well as for changing the material when necessary. The infectiologists coordinate this care by supervising each of the interventions by an antibiotic therapy adapted to the germs and by ensuring the occurrence of adverse events related to the treatment. Plastic surgeons intervene when the skin cover of the knee is deemed to be precarious or when there is an identified loss of substance that could affect the prognosis of the prosthesis. The main objective of our study is to evaluate the success rate of skin coverage and functional recovery for patients cured of their infection. The secondary objective is the identification of risk factors for skin coverage in this population.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Undecided

lead_sponsor: Hospices Civils de Lyon


title: Bone Flap Osteomyelitis Following Craniectomy : Retrospective Evaluation of Clinical Presentation, Microbiological Diagnosis and Management

acronym: BoFOC

summary: Osteitis of the cranial flap after craniectomy is an unknown complex osteoarticular infection and there are few data concerning its epidemiology, its risk factors, and its management.


title: Remote Programming of Cardiac Implantable Electronic Device

acronym: REACT

summary: Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full interrogation and changing the CIED parameters is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. We aim to investigate the efficacy and safety of remote programming.

primary_purpose: Prevention

lead_sponsor: University Hospital, Bordeaux


title: Evaluation of the Efficacy of Early Implantation of a Percutaneous Left Ventricular Assist Devices in Acute Coronary Syndrome Complicated by Cardiogenic Shock Compared to Conventional Therapy: a Prospective, Multicenter, Randomized, Controlled and Open-label Clinical Trial

acronym: ULYSS

summary:
The ULYSS study is a randomized, multicenter, interventional and prospective open-label clinical trial. It aims to evaluate the efficacy of the addition of an early IMPELLA CP support on top of optimal medical therapy and culprit lesion PCI compared to optimal medical care and culprit PCI in patients with an ACS complicated by a CS.

A transthoracic echography is required to exclude some non-inclusion criteria as soon as possible and before randomization.

Randomization will be performed after an informed consent is signed by the patient, a family member if he is unable to consent or thanks to the emergent consent procedure if all inclusion criteria are met and there are no non-inclusion criteria. A computer-generated randomization list will be drawn-up using a permuted block design (stratified on center). Each center will have a specific list.

Randomization 1:1 to one of the 2 groups

In all patients, emergent PCI of the culprit lesion will be performed.

Control group: patients will receive IV inotropes associated or not with vasopressors according to the attached protocol and based on the current guidelines (annex 1) (2, 4) in addition to emergent culprit lesion PCI
Experimental group: patients will receive IMPELLA CP before PCI on top of conventional therapy based on the same protocol as the control group and emergent culprit PCI

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Device

appel_a_projets: PHRCN

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

type_etablissement: CHUR

acronyme: ULYSS

titre: Evaluation du bénéfice clinique de l'implantation précoce d'un dispositif d'assistance percutané du ventricule gauche par rapport au traitement conventionnel dans le syndrome coronarien aigu compliqué d'un choc cardiogénique : une étude prospective randomisée contrôlée en ouvert

discipline_principale: cardiologie

nom_porteur: BONELLO

prenom_porteur: Laurent


title: Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Intensive Care Unit Patients Under Mechanical Ventilation. A Pilot Physiological Study

acronym: CHARM-ICU

summary: The objective of this study was to investigate the hemodynamic effects of two alveolar recruitment maneuver strategies in critical care patients with acute respiratory distress syndrome.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effect of the Degree of Energy Turnover on Appetitive Responses in Adolescents With Obesity

acronym: NEXT

summary: The aim of the study is to compare the effect of a low versus moderate versus high energy turnover on energy intake, appetite and food reward, in adolescents with obesity. 18 adolescents with obesity will then complete three experimental sessions in a randomized order: low, high and moderate Energy turnover.

primary_purpose: Basic Science

intervention_type: Behavioral


title: Study of Connected Soles With Pressure Sensors in the Evaluation of Gait Disorders in Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

acronym: ESCAL-PIDC

summary: Chronic Inflammatory Demyelinating Polyneuropathies (CIDP) are acquired, autoimmune and inflammatory neuropathies leading mainly to gait disorders in patients. Assessment of gait disorders is a major component of therapeutic management, but evaluation is sometimes difficult due to the fluctuating nature of the symptoms. The principal objective of this study is to compare the walking speed of patients with a reference method (GAITRITE® walkway) and an innovative one (FEETME® connected soles) with the aim of validating the use of theses connected soles in CIDP gait disorders evaluation.

design_allocation: Non-Randomized

intervention_type: Diagnostic Test


title: An Intervention to Promote Health Students' Well-being : a Protocol of a Quasi-experimental Interventional Study in Le Havre

acronym: IFPDays

summary:
The lack of well-being observed among health students underscores the urgent need of implementing interventions designed to meet their specific need and improving their quality of life.

This study aims to evaluate a well-being promotion intervention among paramedic students.

This is a before/after study using a quasi-experimental design. This study aims to compare well-being, resilience, and self-esteem before and after the intervention.

Students' satisfaction will be assessed through a questionnaire.

lead_sponsor: Groupe Hospitalier du Havre


title: Pulmonary Rehabilitation for COPD Patients: Can Performance Predict Exacerbation?

acronym: PREDICT

summary: The aim of pulmonary rehabilitation is to improve exercise capacity and reduce dyspnoea. As well as improving the patient's overall condition, pulmonary rehabilitation provides a means to monitor the patient regularly. During physical exercise, the increased activity of the muscle system increases cardiac and respiratory output. If the patient's respiratory status deteriorates, as occurs, for example, before the onset of an exacerbation, exercise capacity could be reasonably expected to reduce. The investigators hypothesised, therefore, that changes in the physical capacity of patients with COPD during a rehabilitation session could provide a predictive indication regarding the risk of occurrence of exacerbation.

time_perspective: Prospective

ipd_sharing_description: by contact the correspondent author


title: Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients: A Physiological Study

acronym: CHARM-Bloc

summary: The objective of this study is to investigate the hemodynamic effects of two strategies of alveolar recruitment maneuver in patients undergoing major abdominal surgery in the operating room


title: Evaluation of MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis

summary:
The transition from relapsing-remitting multiple sclerosis to secondarily progressive multiple sclerosis (SPMS) is difficult to identify. Typically, SPMS is diagnosed retrospectively, with a significant delay, on the basis of a clinical history of progressive worsening, independent of relapses. Thus, SPMS is often associated with a considerable period of diagnostic uncertainty.

The use of ultra-high field imaging can shed light on the mechanisms of disability progression thanks to its better spatial resolution and advanced imaging techniques.

The new morphological imaging techniques make it possible to visualize chronic inflammatory lesions and to evaluate their evolution. It also allows for the precise measurement of brain atrophy, a reference in the evaluation of neurodegeneration.

Metabolic imaging via proton spectroscopy allows the analysis of several promising cerebral metabolites that can provide information on cellular energy metabolism, mitochondrial function, or oxidative stress, and can help identify tissues at risk of neurodegeneration. Sodium imaging can provide information on axonal energy metabolism before the occurrence of stable and irreversible axonal damage. This technique is promising as an early marker of neurodegeneration.


title: Cross-sectional Pilot Study of the Alveolar and Serum sRAGE Biomarker in Severe Asthma in Children.

acronym: sRAGE

summary:
sRAGE is a recognized marker of alveolar injury in acute respiratory distress syndrome (ARDS). More recently, it seems to be an interesting marker in asthma. It is the soluble form of the pro-inflammatory RAGE receptor overexpressed in the lungs and in particular the bronchi. It acts as a decoy to its ligands, and thus blocks the pro-inflammatory axis of RAGE.

Few studies are available in asthma, especially in children. A local study showed low levels of serum sRAGE in the context of acute bronchiolitis. The same finding emerges from the few studies available in asthma, with rates all the lower when the asthma is poorly controlled. A study carried out in the animal model in 2012 found an absence of inflammatory infiltrate, the absence of increased expression of mucin and the absence of mucus goblet cell hyperplasia within the respiratory epithelium in the absence of RAGE receptor in sensitized mice dust mites, after exposure to their allergen. One could imagine in the long term a potential therapeutic avenue by a substitution in sRAGE in this pathology.

The objective of this study is to study the ability of the alveolar sRAGE level measured on broncho-alveolar lavage for assessment, to discriminate the clinical degrees of control of severe asthma in children.


title: Intragastric Balloon in Obese Patients With Uncontrolled Asthma: a Multicentre Randomized Controlled Study

acronym: BOA

summary: The aim of this project is to study the effect of an intragastric balloon (IGB) on asthma control in obese patients. Obese patients with uncontrolled asthma will be recruited and randomly assigned to two intervention arms : an intragastric balloon combined with diet and exercise versus diet and exercise alone (control group). The primary endpoint will be the proportion of patients with an improvement based on an Asthma Control Questionnaire (ACQ) score ≥ 0.5 at 1 year compared to baseline.

lead_sponsor: University Hospital, Toulouse


title: Biocollection of Patients With ANCA Associated Vasculitis Diagnosed Within the CERAINO Autoimmune Disease Reference Center, Part of the Global BRAISE Project (B-dependent Rare AutoImmune DiseaSES

acronym: ANCA

summary: As rare disease, vasculitis affects a small number of patients, the cohorts available in the literature are few and the pathophysiological mechanisms remain to be elucidated. The collection of standardized data within a patientheque as part of a multi-year follow-up will facilitate the study of the characteristics of these diseases. This may, in particular, address the main objective of identifying predictors of relapse, as well as secondary objectives for predictive factors of mortality, infectious, cardiovascular or neoplastic complications that affect the prognosis of vasculitis in order to establish a more appropriate management of the patients concerned.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity

acronym: RVTOX

summary:
The main objective of the study is to investigate the effect of exposure to a virtual reality session during botulinum toxin injections on injection-induced stress.

The secondary objectives are to study the effect of exposure to a virtual reality session during botulinum toxin injections, on the pain induced by the injection. And study the evolution of the effects of virtual reality with the repetition of the sessions.

status: Active, not recruiting

primary_purpose: Supportive Care

ipd_sharing_description: According to the provisions concerning data confidentiality that are available to those responsible for the quality control of biomedical research, all researchers with direct access to the data will take the necessary precautions to ensure the confidentiality of information (participant identification and results). All data collected will be anonymized. Our study will be continued by the investigator and a second article with the results will be published. Dissemination of the results of this study will be through peer-reviewed publications, and national and international conferences


title: Clinical Study for the Effectiveness of Use of an Injectable Medical Device GANA X® in the Treatment of Buttocks Volume Depression

acronym: PLLA

summary: The purpose of this study is to assess the effectiveness and safety of Gana X, a Poly L-lactic acid filler for the aesthetic treatment of buttocks.

lead_sponsor: GCS Co., Ltd

sponsor_collaborators:
GCS Co., Ltd
Eurofins Dermscan Pharmascan


title: Contra-attitudinal Versus Mindfulness Treatment in Anorexia Nervosa - Randomised Controlled Trial

acronym: CAT-AN

summary: This study propose to compare the effectiveness of two care programs, the CAT and cognitive therapy based on mindfulness (Mindfulness-Based Cognitive Therapy, MBCT) compared to the usual care ("Treated as usual", TAU) in AM and to show their benefit on dimensions specific to EDs such as body dissatisfaction and the internalization of the ideal of thinness, but also on eating symptoms and the anxious and depressive dimensions.

lead_sponsor: University Hospital, Grenoble

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

type_etablissement: CH

acronyme: CAT-AN

titre: Traitement contra-attitudinal versus mindfulness dans l'anorexie mentale  essai contrôlé randomisé

discipline_principale: psychiatrie

nom_porteur: POLOSAN

prenom_porteur: Mircea


title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Cephalomedullary Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series

summary:
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Cephalomedullary Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of trochanteric, sub-trochanteric or shaft femoral fractures and osteotomies.

This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.

lead_sponsor: Zimmer Biomet


title: Performance of the Variation in Arterial Lactatemia During a Spontaneous Breathing Trial (SBT) in the Prediction of Extubation Failure

acronym: PREDILACT

summary:
Extubation failure (EF) is independently associated with excess mortality of critically ill patients. To avoid EF, critically ill patients being weaned from invasive mechanical ventilation (IMV) perform spontaneous breathing trial (SBT), which is the litmus test for determining the ability to breathe without a ventilator.

Thus, the performance of the SBT during weaning from IMV to predict successful extubation is crucial. The investigators hypothesize that patients with EF increase arterial lactate concentration during SBT due to increased work of breathing and hypoxia.

The aim of this study is to evaluate the performance of variation in arterial lactate concentration before and after SBT in predicting successful extubation in critically ill patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Periventricular White Matter Hyperintensities in Cerebral Amyloid Angiopathy and Hypertensive Arteriopathy

acronym: PVWMH

summary:
White matter hyperintensities (WMH) are one of the small vessel disease-related MRI characteristics of both cerebral amyloid angiopathy (CAA) and hypertensive arteriopathy (HA). WMH tend to show a peri-basal ganglia pattern in HA, whereas a multiple subcortical spots pattern can be observed in CAA. Periventricular WMH (PVWMH) have been reported to be posterior predominant using a semiautomated segmentation method and logarithmic transformation, not used in daily clinical practice. In these studies including CAA patients, patients initially presented with haemorrhage-related symptoms. In another study analysing PVWMH and cerebral amyloid evidence in patients with mild cognitive impairment, frontal PVWMH burden was associated with high uptake on florbetapir-PET whereas parietal and occipital PVWMH burden was associated with low CSF-amyloid-beta.

The aim of this study is the descriptive comparative analysis of the distribution of PVWMH between CAA and HA patients with radiological tools available in daily practice.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Mean Arterial Pressure After Out-of-hospital Cardiac Arrest: the METAPHORE Randomized Trial

acronym: METAPHORE

summary: Out-of-hospital cardiac arrest is a public health problem for which overall survival is below 10%. Post-cardiac arrest syndrome is the principal cause of death in intensive care units (ICU), due to refractory shock or brain injuries secondary to anoxia. Brain anoxia is responsible for severe neurological sequelae that may be aggravated by cerebral hypoperfusion during the first few hours after the return of spontaneous circulation. Current recommendations are to ensure that arterial blood pressure is sufficient for the perfusion of organs, but no minimum threshold mean arterial pressure (MAP) has been defined. In practice, most teams target a MAP of at least 65 mmHg. Several observational studies have shown a correlation between MAP and neurological prognosis, patients with a higher initial MAP having a better outcome. Recent pilot studies have demonstrated the feasibility of increasing the target MAP after cardiac arrest, but conflicting results have been obtained concerning patient prognosis. These findings may be explained by changes to the autoregulation of the brain after cardiac arrest, with a shift of the curve towards the right, or its abolition. Cerebral blood flow is dependent on MAP, and a target MAP of 65 mmHg for these patients may result in insufficient brain perfusion. Conversely, a too high MAP might cause brain lesions due to vasogenic edema, hemorrhagic complications or excess perfusion in conditions of diminished brain metabolism. An interventional study is required to evaluate the effect of increasing MAP on neurofunctional outcome after cardiac arrest. Given the data available for brain autoregulation, the correlation between MAP and prognosis, and the risks theoretically associated with a higher MAP, investigator plans to compare a standard threshold of MAP (≥ 65 mmHg) with a high threshold of MAP (≥ 90 mmHg). Investigator hypothesizes that a high MAP within the first 24 hours after cardiac arrest will improve neurofunctional outcome.

lead_sponsor: Centre Hospitalier le Mans


title: Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity

acronym: OBEGENE

summary: Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: The Effects of a TENS System (Transcutaneous Electric Nerve Stimulation) on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis (ENNOX Study)

acronym: ENNOX

summary: Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). Sustained contractile activity, such as that observed in spastic muscles, could reduce the capillary density and induce important changes in the muscular microcirculation, leading to oxidative changes within the muscular tissue. Such changes reflect altered aerobic metabolism and impaired mitochondrial function. The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.

lead_sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences


title: IS ElastomEtry Useful in Muscle Lesion evaluaTion-REPROducibility Study

acronym: ISEULT-Repro

summary:
Our objective is to evaluate the inter and intra observer reproducibility of the measure of elasticity using Acoustic Radiation Force Impulse (ARFI) ultrasonography of mucles of patients with and without hamstring injury.

76 patients will be evaluated cross sectionally twice by two ultrasonographists.

time_perspective: Cross-Sectional

ipd_sharing_description:
Yes

All collected data that underlie results in a publication


title: Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Facilities "Outside the Walls" Using the Dual Screening Method TROD (Rapid Diagnostic Tests) and FibroScan

acronym: SCANVIR

summary: The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.

ReferenceType: background

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ReferenceCitation: Tran A, Shili-Masmoudi S, Moga L, Chevaliez S, Luciani A, Ruiz I, Ganne-Carrie N, Bureau C, Bourliere M, de Ledinghen V. Non-invasive diagnosis and follow-up of chronic infection with Hepatitis C Virus. Clin Res Hepatol Gastroenterol. 2022 Jan;46(1):101771. doi: 10.1016/j.clinre.2021.101771. Epub 2021 Jul 28.

ReferenceCitation: Pol S, Lagaye S. The remarkable history of the hepatitis C virus. Genes Immun. 2019 May;20(5):436-446. doi: 10.1038/s41435-019-0066-z. Epub 2019 Apr 25.

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ReferenceCitation: Brouard C, Saboni L, Gautier A, Chevaliez S, Rahib D, Richard JB, Barin F, Larsen C, Sommen C, Pillonel J, Delarocque-Astagneau E, Lydie N, Lot F; 2016 Health Barometer Group. HCV and HBV prevalence based on home blood self-sampling and screening history in the general population in 2016: contribution to the new French screening strategy. BMC Infect Dis. 2019 Oct 28;19(1):896. doi: 10.1186/s12879-019-4493-2.

ReferenceCitation: Bajis S, Grebely J, Hajarizadeh B, Applegate T, Marshall AD, Ellen Harrod M, Byrne J, Bath N, Read P, Edwards M, Gorton C, Hayllar J, Cock V, Peterson S, Thomson C, Weltman M, Jefferies M, Wood W, Haber P, Ezard N, Martinello M, Maher L, Dore GJ; LiveRLife Study Group. Hepatitis C virus testing, liver disease assessment and treatment uptake among people who inject drugs pre- and post-universal access to direct-acting antiviral treatment in Australia: The LiveRLife study. J Viral Hepat. 2020 Mar;27(3):281-293. doi: 10.1111/jvh.13233. Epub 2019 Dec 6.

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ReferenceCitation: Smookler D, Vanderhoff A, Biondi MJ, Valencia J, Ryan P, Karkada J, Hong R, Sattar I, Mandel E, Gjevori M, Casey J, Fletcher D, Shah H, Hansen BE, Capraru C, Janssen HLA, Lazarus JV, Feld JJ. Reducing Read Time of Point-of-Care Test Does Not Affect Detection of Hepatitis C Virus and Reduces Need for Reflex RNA. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1451-1458.e4. doi: 10.1016/j.cgh.2020.07.058. Epub 2020 Aug 4.

lead_sponsor: University Hospital, Limoges


title: Effects of Prone Positioning-induced on the Recruitment-to-inflation Ratio in COVID-19 Patients With Acute Respiratory Distress Syndrome

acronym: SyDRAC-DV

summary: The purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in COVID-19 patients with acute respiratory distress syndrome.

ipd_sharing_description: No sharing data plan is sheduled.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Risk Factors for Recurrence of Thrombosis or Thrombotic Extension, in the Event of Acute Non-cirrhotic Portal Vein Thrombosis Secondary to a Local Cause.

acronym: LOCAPORT

summary: In case of acute portal vein thrombosis (PVT) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. Prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis, angiocholitis, liver abces, diverticulitis, appendicitis, acute/chronic pancreatitis, chronic bowel inflammatory disease, acute hepatitis due to cytomegalovirus, bacteroïdes pylephlebitis, abdominal neoplasia such as adenocarcinoma of the colon, abdominal traumatism or surgery such as cholecystectomy, bariatric surgery or splenectomy). To date the impact of prothrombotic factors associated with local conditions responsible for acute PVT has not been well studied except for acute or chronic pancreatitis. No significant association has been pointed out in this pathology. The aim is to determine what are the risk factors of thrombotic recurrence or extension associated with local conditions responsible for acute non cirrhotic PVT, and to evaluate the rate of secondary long term anticoagulant therapy.

lead_sponsor: University Hospital, Caen


title: Interest of Electroneuromyography in the Diagnosis of Thoracic Outlet Syndrome

acronym: ENMG-AFC

summary: Record the ENMG data carried out systematically in patients treated by rehabilitation for thoracic outlet syndrome in order to assess their characteristics and judge the relevance of these data in the context of the diagnosis and their possible modifications following the rehabilitation treatment.

lead_sponsor: Nantes University Hospital

location_facility: Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)


title: Prediction Of Pulmonary Edema With Müller Maneuver

acronym: PoEM

summary:
The mechanical ventilation weaning must begin as early as possible to limit its complications and requires a spontaneous breathing trial (SBT) before the separation from the ventilator to the patient.

However, some patients fail this test and cannot be extubated. The main causes are pulmonary edema and diaphragmatic dysfunction. Predicting the risk of failure before carrying out the SBT makes it possible to anticipate a failure of the extubation and to adapt the therapies as well as possible. To assess the risk of pulmonary edema, cardiac preload, which corresponds to the end-diastolic filling volume of the ventricle, can be estimated using simple tests as the passive leg raising test before an SBT.

However, this test requires tilting the patient's trunk and raising the lower limbs to 45°, and is not practical, especially in intensive care.

The Müller maneuver, which allows maximum inspiratory pressure measurement via a one-way valve connected to the intubation tube, is currently used in routine care for diaphragmatic assessment. The endothoracic depression induced by this test is likely increasing venous return and cardiac output in patients with a reserve of preload, i.e. in preload-dependent patients. This test would be an easy alternative to the passive leg raising test used in current practice.

The objectif is to assess whether the presence of an independant prelaod state, as detected by the absence of increased cardiac output during the Müller maneuver, is associated with the occurence of pulmonary edema during weaning from mechanical ventilation.

The study consist in the measurement of cardiac output before and after the passive leg raising test and the Müller maneuver, then measurement of cardiac output before and after an SBT.

A transthoracic ultrasound and a blood sample with dosage of proteins and hemoglobin will be carried out initially and then at the end of the SBT as part of routine care.

The investigators hypothesize:

The Müller maneuver induces a greater increase in cardiac output in patients in a state of preload dependancy than in patients in a state of preload independancy.
The absence of documented preload dependancy during a Müller maneuver is associated with the occurrence of pulmonary edema during an SBT.

The investigators included patients :

> 18 years old, conscious patient, with health insurance, placed under mechanical ventilation for at least 24 hours ;
In whom it was decided to perform a passive leg raising test and an SBT. The investigators excluded pregnancy, patient with chest tube, particpation in another interventional study, tracheostomy, patient under legal protection.


title: Safety and Performance Study of the MultiSense® Ambulatory Telemonitoring System for Non-critical Patient Management

acronym: TELESENSE

summary: In this clinical investigation, the investigators will assess the safety, performances and clinical added value of the MultiSense® ambulatory telemonitoring solution in real-life situations.

lead_sponsor: IHU Strasbourg

sponsor_collaborators:
IHU Strasbourg
Rhythm Diagnostic Systems

location_facility: Service de Chirurgie Digestive et Endocrinienne


title: Association Between Prescription of Antidepressants and Delirium in the Elderly : Analysis From the World Health Organization Global Database

summary:
Delirium is a frequent reason for hospitalisation of the elderly. Associations between the prescription of some medicines and the risk of delirium have already been demonstrated.

Antidepressants are widely prescribed in the elderly because of the frequency of anxiety-depressive symptoms in this population, where there are high pharmacokinetic and pharmacodynamic variability.

However, the association between antidepressants and the risk of delirium remains poorly understood.

Based on the analysis from the World Health Organization global database, the main objective of this study is to investigate the association between the different classes of antidepressants and the occurrence of the " delirium " event reported in the database.

A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of delirium.

location_facility: Caen University Hospital, Department of Pharmacology


title: Impact of Point in Time of Introducing Paramedical Consultations in Oncological Supportive Care in Outpatients With Multiple Myeloma

acronym: SOSAM

summary:
Multiple myeloma is the second most frequent hematologic malignancy, which incidence augmented between 1995 and 2018, with an annual mean variation of +0.6% to 1.1%. Although treatment improved in the last years, the patients' prognostic is associated with cytogenetic abnormalities.

Oncological supportive care provides patients with a global perspective, in addition to specific medical treatment adapted to pathology and patient profile. It contributes to the improvement of quality of life of patients, throughout their care pathway regarding physical, psychological and social aspects, according to their specific needs as well as their caregivers'.

The aim of this study is to evaluate the quality of life at 6 months after multiple myeloma diagnosis in outpatients receiving paramedical consultations in oncological supportive care from the diagnosis versus outpatients receiving paramedical consultations in oncological supportive care after 6 months after diagnosis.

lead_sponsor: Centre Henri Becquerel


title: Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.

acronym: ATLATEP

summary:
With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons.

Accurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Metabolic Inflexibility of the Heart as a Predictor of Occurrence of Heart Failure in Patients With Type 2 Diabetes

summary:
In the type 2 diabetic population, some patients are particularly at risk of developing early heart failure. Finding markers to identify these at-risk individuals is therefore an important scientific objective in order to avoid/delay the development of heart failure.

The protocol will be proposed to type 2 diabetic patients hospitalized for insulin therapy upon admission to the diabetology department and healthy volunteers.

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: External Evaluation of Vancomycin Population Pharmacokinetic Models and Development of Continuous Infusion Dosing Recommendations

acronym: EOPMV

summary:
All patients treated with vancomycin hospitalized outside of ICU in Brest University Hospital from 1rst january 2019 to 1rst january 2021 will be screened for inclusion. Vancomycin dosage, age, weight and serum creatinin will be recorded.

Seven pharmacokinetic models' predictive performance will be evaluated on this database.

Using the best model, we will perform Monte-Carlo simulation to elaborate dosing nomograms and develop dosing recommandations of continuous infusion of vancomycin.


title: ACCESS : ACtive Catheterization for EndovaScular TreatmentS

acronym: ACCESS

summary: The objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.

ReferenceCitation: Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ; American College of Cardiology Foundation; American Stroke Association; American Association of Neurological Surgeons; American College of Radiology; American Society of Neuroradiology; Congress of Neurological Surgeons; Society of Atherosclerosis Imaging and Prevention; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society of NeuroInterventional Surgery; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation. 2011 Jul 26;124(4):489-532. doi: 10.1161/CIR.0b013e31820d8d78. Epub 2011 Jan 31. No abstract available. Erratum In: Circulation. 2011 Jul 26;124(4):e145. Dosage error in article text.

ReferenceCitation: Lanzino G, Rabinstein AA, Brown RD Jr. Treatment of carotid artery stenosis: medical therapy, surgery, or stenting? Mayo Clin Proc. 2009 Apr;84(4):362-87; quiz 367-8. doi: 10.1016/S0025-6196(11)60546-6.

ReferenceType: result

ReferenceCitation: Jansen O, Szikora I, Causin F, Bruckmann H, Lobotesis K. Standards of practice in interventional neuroradiology. Neuroradiology. 2017 Jun;59(6):541-544. doi: 10.1007/s00234-017-1837-8. Epub 2017 May 19.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

ReferenceCitation: Thompson BG, Brown RD Jr, Amin-Hanjani S, Broderick JP, Cockroft KM, Connolly ES Jr, Duckwiler GR, Harris CC, Howard VJ, Johnston SC, Meyers PM, Molyneux A, Ogilvy CS, Ringer AJ, Torner J; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention; American Heart Association; American Stroke Association. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Aug;46(8):2368-400. doi: 10.1161/STR.0000000000000070. Epub 2015 Jun 18.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Smith TR, Cote DJ, Dasenbrock HH, Hamade YJ, Zammar SG, El Tecle NE, Batjer HH, Bendok BR. Comparison of the Efficacy and Safety of Endovascular Coiling Versus Microsurgical Clipping for Unruptured Middle Cerebral Artery Aneurysms: A Systematic Review and Meta-Analysis. World Neurosurg. 2015 Oct;84(4):942-53. doi: 10.1016/j.wneu.2015.05.073. Epub 2015 Jun 18.

publisher_dissemination: Elsevier

ReferenceCitation: Derdeyn CP, Zipfel GJ, Albuquerque FC, Cooke DL, Feldmann E, Sheehan JP, Torner JC; American Heart Association Stroke Council. Management of Brain Arteriovenous Malformations: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Aug;48(8):e200-e224. doi: 10.1161/STR.0000000000000134. Epub 2017 Jun 22.

ReferenceCitation: Plasencia AR, Santillan A. Embolization and radiosurgery for arteriovenous malformations. Surg Neurol Int. 2012;3(Suppl 2):S90-S104. doi: 10.4103/2152-7806.95420. Epub 2012 Apr 26.

ReferenceCitation: Abbott AL, Paraskevas KI, Kakkos SK, Golledge J, Eckstein HH, Diaz-Sandoval LJ, Cao L, Fu Q, Wijeratne T, Leung TW, Montero-Baker M, Lee BC, Pircher S, Bosch M, Dennekamp M, Ringleb P. Systematic Review of Guidelines for the Management of Asymptomatic and Symptomatic Carotid Stenosis. Stroke. 2015 Nov;46(11):3288-301. doi: 10.1161/STROKEAHA.115.003390. Epub 2015 Oct 8.

oa_colors: green other

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ipd_sharing_description: No plan to share IPD

lead_sponsor: Basecamp Vascular

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Organization of Smoking Cessation in Pregnant Women: Study of the Effectiveness, Transferability, Barriers and Facilitators of the Implementation of the 5A Strategy in French Context. A Cluster Randomized Controlled Trial in New Aquitaine.

summary: The investigators are conducting a pragmatic cluster randomized trial in stepped-wedge of which objectives are to evaluate the effectiveness and the conditions of effectiveness of an organizational strategy for smoking cessation - 5A-QUIT-N - among pregnant women in New Aquitaine (NA), by using and optimizing existing resources

lead_sponsor: University Hospital, Bordeaux

appel_a_projets: PREPS

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

titre: Organisation du sevrage tabagique chez la femme enceinte : étude de l'efficacité, de la transférabilité, des freins et leviers de l'implantation de la démarche 5A en contexte français. Un essai contrôlé randomisé par cluster en Nouvelle-Aquitaine.

discipline_principale: organisation des soins

nom_porteur: Alla

prenom_porteur: François


title: Assessment of Intestinal Inflammatory Activity in the Follow-up of Patients With Crohn's Disease: Diffusion-weighted MR-enterography, Without or With Bowel Cleansing, Compared With Standard MR-enterography

acronym: ENTEDIF

summary:
Since 2009, many studies tend to prove the effectiveness of diffusion-weighted MR-enterography in the assessment of inflammatory activity in IBD compared to standard MR-enterography, with the emergence of new radiological scores such as the Clermont score. Diffusion-weighted MRI (DWI) is a faster technique and does not require the injection of gadoline contrast medium, which is a desirable in view of recent data on their long-term adverse effects (intracerebral deposits, nephrogenic systemic fibrosis).

The advent of 3T MRI, which provides a better signal, a better spatial resolution or the same examination quality in a shorter time, seems promising for the future of DWI.

However, to date, there are still few studies carried out at 3T in this field or even few studies on the possibility of doing away with bowel cleansing, although this is one of the main demands of patients. All patients will undergo a simplified MR-enterography, which includes four sequences, without bowel cleansing or injection. On the same day, the standard MR-enterography will be performed as in clinical practice, after ingestion of the usual oral preparation.

Three reading sessions of the examination will be organized at intervals of at least one month by two radiologists specialized in digestive imaging, blinded to the clinical and

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Effect of Food and Formulation on the Pharmacokinetics, Safety, and Tolerability of GNS561 After One Single Dose (50 and 200mg) in Healthy Volunteers

summary: GNS561 is a drug used in preliminary phase 1b study for treatment of patients with primary and secondary liver cancer. The formulation used was oral capsule.The objective of this study in healthy volunteers is to compare pharmacokinetics, safety and tolerability of different formulations (tablets and capsules) and dosage (50 and 200mg) of GNS561 after single oral administration in first part and to evaluate the food effect on pharmacokinetics in second part.

lead_sponsor: Genoscience Pharma


title: Resilience and Acute Stress in Simulation : "SimStress"

acronym: SimStress

summary: The objective is to study an association between the resilience developed by anesthesia professionals and the level of acute stress during a simulation session.

lead_sponsor: University Hospital, Grenoble


title: The Psychological Experience of Pathological Pregnancy. Study of the Case of Premature Rupture of Membranes and Evaluation of the Impact of Hypnosis Support

acronym: HYPNOPROM

summary: This research investigates the impact of a hypnosis-based intervention in alleviating state anxiety in Preterm Premature Rupture of Membranes (PPROM). Our main hypothesis is that a two-session intervention can decrease anxiety for pregnant women with PPROM compared to usual care. This research also studies the impact of the experience of a PPROM during a pregnancy on several variables such as perinatal depression, pregnancy-related anxiety, bonding and childbirth experience, as well as control and pain perceived during chilbirth. Our hypotheses are that the experience of PPROM negatively influences these variables, and that this impact is alleviated by the hypnosis-based intervention for the experimental group.

lead_sponsor: University Hospital, Lille

collaborators: Laboratory of Psychopathology and Health Processes, University of Paris


title: A Prospective Monocentric Study to Assess the Concordance of Lung MRI Compared to Chest CT Scan to Assess the Extent and Severity of Bronchial and Parenchymal Pulmonary Lesions in Adult Patients With Primary Immune Deficiency (PID): IRM vs SCANNER

acronym: IRMvsSCANNER

summary:
Currently, there is no official recommendations for the respiratory surveillance of patients with PID.However, it is recommended to perform a chest CT scan each 5 years or before any significant therapeutic change.

The methods of surveillance need to meet two contradictory imperatives:

monitor frequently enough not to diagnose with delay an aggravation of bronchiectasis or interstitial pneumonitis, an infectious complication by a slowly growing pathogen such as a non-tuberculous mycobacterium, or lymphoid proliferation.
do not expose these often young patients to significant irradiation by a considerable number of scans during their life. In addition, some patients with PID have increased radiosensitivity without a safe irradiation threshold having been determined.

To make thoses requirements effective, the solution is to combine radiological monitoring and absence of irradiation. Therefore, it makes sense to study whether chest scans can be replaced by MRI, non-irradiating imaging. But the question that needs to be answered is whether the information provided by the chest MRI is not inferior to that provided by the scanner.

The objective of this study is to assess the ability of MRI performed with ultrashort echo time to analyze the extent and severity of bronchial and pulmonary parenchymal lesions during the follow-up of patients with primary immunodeficiency, comparing them to those of the chest CT scan.

lead_sponsor: Hopital Foch

sponsor_collaborators:
Hopital Foch
Siemens Healthcare QT


title: Adapted Physical Activity and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in Intensive Care unit_APAER_H Protocol

summary: Adapted Physical Activity (APA) is accepted as an effective, recommended and beneficial supportive care for the health of people with cancer during the different phases of the disease. The objective of the project is to analyse the effect of APA programs (Classic, Exergaming and Relaxation) on the state anxiety of people with severe blood diseases admitted to Intensive Care Unit (ICU). Anxiety is a major affect in this context. The interest of the practice of APA for this public is to reduce the level of state anxiety and to limit the decline of functional capacities. The main objective of this work is to identify whether specific and/or complementary effects result from the use of biofeedback and/or Exergaming.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Impact of Discontinuing Contact Precautions for Extended-spectrum β-lactamase Enterobacteriaceae (ESBLE) in a Geriatric Unit: an Interventional Prospective Noninferiority Non-randomized Double-blind Controlled Before and After Study

acronym: Ger-SP

summary:
This is an interventional multicenter prospective noninferiority non-randomized double-blind controlled before and after study.

The aim of this study is to demonstrate that standard precautions alone are not inferior to contact precautions by comparing the incidence density of extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae acquired in geriatric units before and after discontinuing contact precautions.

sponsor_collaborators: Centre Hospitalier Régional Metz-Thionville


title: Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery

acronym: ECHOMAX

summary: Maxillo-mandibular osteotomy is a painful surgery which requires mostly opioïds use. Recent studies on maxillary and mandibular nerve blocks have suggested benefit in maxillo-facial surgery but have been poorly investigated in orthognathic surgery. This study is designed to evaluate analgesic effectiveness, through opioïds consumption, of a bilateral double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of Antibiotherapy Prescribed for Outpatients From Emergency Departments

acronym: EVAPAUR

summary:
French health insurance data indicate that approximately 15% of ambulatory antibiotic consumption is generated by hospital prescriptions. This extra-hospital consumption represents a greater volume than intra-hospital consumption. To date, hospital indicators of good antibiotic use do not include this outpatient dimension. This study will provide a snapshot of the proportion of ambulatory antibiotics generated by emergencies and analyze compliance with management recommendations.This study will serve as a basis for developing indicators of outpatient antibiotic consumption generated by hospital activity and for identifying specific intervention targets aimed at the misuse situations that have been highlighted.

This study will be carried out in the form of a repeated survey on a given day (4 days, one across each season), carried out by the local mobile antibiotic therapy team, using a standardized grid. The survey will concern all the medical records of the patients visiting any emergency department on the days of the survey.

The evaluation of antibiotic therapies prescribed in discharge orders will be carried out in accordance with local management recommendations by the site investigator (infectious disease and/or emergency medicine specialist), who will assess whether the prescription is in accordance with the recommendations or not.

lead_sponsor: Henri Mondor University Hospital


title: Multidisciplinary Care Program to Secure mEdication Therapy for hematoLOgy Patients Receiving Injectable Anticancer Drugs

acronym: Melodia

summary:
Several experiences of multidisciplinary care pathways associating oncologists, pharmacists and nurses have been reported for cancer patients, with positive results on medication management safety, reduction of Drug-Related Problems (DRPs), and re-hospitalizations.

This study aims to evaluate the impact of a multidisciplinary city-hospital follow-up program on medication management safety in haematological oncology patients receiving intravenous chemotherapy in onco-haematology. Additional aspects will be evaluated, such as the impact of the follow-up on the city-hospital link, satisfaction of patients and professionals involved in the follow-up and the use of telecare

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Lyon Sud - Hospices Civils de lyon


title: A Retrospective Patient Registry on the Long-Term Performance of the Dialine II® Vascular Graft Prosthesis Used in Open Vascular Surgery

acronym: Dialine II®

summary: This clinical study will capture clinical data specific to the performance and safety of the LeMaitre® CARDIAL Dialine II. It is a retrospective, monocenter, post-market safety and performance study. Following the new MDR regulation, this study will allow the clinical data of the prosthesis to be completed in order to renew its CE marking.

lead_sponsor: Geprovas

sponsor_collaborators:
Geprovas
LeMaitre Vascular


title: Anatomical Relationship Between Carotid Artery and Hyoid Bone in Stenotic and Non-stenotic Carotids: a Cohort Study of Symptomatic and Asymptomatic Carotid Endarterectomy Patients

acronym: CAROTHYD

summary:
Ischaemic stroke is attributable to thromboembolism caused by carotid atherosclerotic disease in 18-25% of patients. Guidelines for prevention of stroke (especially carotid endarterectomy) in patients with carotid atherosclerotic plaque are based on the quantification of the degree of stenosis.

The hyoid bone, in proximity to the carotid artery, has been implicated in the pathophysiology of carotid artery dissection, atherosclerotic carotid disease, and compressive syndromes. In atherosclerotic carotid disease, pressure on the carotid artery induced by these bone structures has been proposed to play a possible role in plaque formation and rupture, leading to stenosis, occlusion, or artery-to-artery embolism. In a recent ultrasound study, dynamic displacement of the carotid artery with interference of the hyoid bone during swallowing, named as "flip-flop" phenomenon (FFP) has been associated with carotid artery stenosis and stenosis-related stroke. Another study based on CTA assessment observed no association between hyoid-carotid distance and plaque thickness, stenosis, or progression of thickness/stenosis. In that study, in almost two-third of the patients CTA was performed for stroke/transient ischemic attack work-up, including a vast majority of patients with absence of carotid stenosis (median degree of carotid stenosis was 7%), and plaque-related stroke was not assessed.

The objective of this study is to determine the anatomic hyoid-carotid interaction (ie, hyoid-carotid distance, carotid position relative to the hyoid bone, and hyoid morphology) based on CTA and its relation to the degree of carotid stenosis and stenosis-related stroke.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Mid-Term Follow-up Assessment After Exposure to Natural Disaster

acronym: MFAE-ND

summary: The present study proposes to carry out an evaluation of the children of adolescents who were seen by the teams of the Cellules d'Urgence Médico-Psychologique (CUMP) following the Alex storm in October 2020. A clinical child psychiatric and psychological evaluation will be carried out, with collection of socio-demographic data

lead_sponsor: Fondation Lenval

location_facility: Hopitaux Pediatriques de Nice Chu-Lenval


title: Identification of Human Circulating Adipocyte and Muscle Biomarkers Potentially Predictive of Diabetes Remission After Bariatric Surgery in Obese and Type 2 Diabetic Subjects.

acronym: BARIAKINES

summary: This study focuses on identifying potentially predictive human circulating adipocyte and muscle biomarkers of diabetes remission after bariatric surgery in obese type 2 diabetic (T2D) subjects.


title: Immunopathology of Loeys-Dietz Syndrome

acronym: I-LoDiS

summary:
Loeys-Dietz syndrome (LDS) is a rare vascular genetic disorder (estimated prevalence 1/25,000-1/100,000) due primarily to mutations in the Transforming growth factor beta (TGF-β) cytokine receptor 1 and 2 genes. In addition to a common vascular phenotype with Marfan syndrome (dilatation of the ascending aorta, arachnodactyly, lens dislocation), patients present specific malformations (bifid uvula, hypertelorism, tortuous arteries) and immuno-allergic manifestations (asthma, eczema, food allergy, eosinophilic esophagitis, chronic inflammatory bowel disease).

Pathophysiologically, LDS appears to be associated with hyperactivation of the intracellular TGF-β signaling pathway in a manner similar to Marfan syndrome, as evidenced by increased intracellular phosphorylated Smad2/3 (pSmad2/3) in lymphocytes. The immuno-allergic complications appear paradoxical because of the major immunosuppressive role of this cytokine on lymphoid and myeloid immune lineages.

The biological description of immunological abnormalities associated with LDS is based on a single 2013 study that found increased regulatory T (Treg) and Th2 lymphocyte polarizations, as well as increased circulating eosinophil and total IgE levels.

In order to better understand the underlying mechanisms, the investigators propose to perform a descriptive clinical-biological study to identify and study the immune subpopulations most impacted by the causative mutations of LDS.

location_facility: Hôpital Femme-Mère-Enfant / Centre de Compétences pour le syndrome de Marfan et apparentés


title: Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing: a Prospective, Controlled, Open, Randomized Multicentre Study

acronym: HYDRA-B

summary: The management of the local treatment of second-degree burns has an influence on the healing time and thus on the quality of the healing process. Fibrin detersion optimizes epidermization and may reduce the need for skin grafting for moderate fibrinous burns. Optimal treatment at this stage is therefore crucial. Since 1968, silver sulphadiazine ointment dressings have been used in the management of burns to minimize the risk of infection. A recent review of the literature suggests that the use of alternative dressings to silver sulphadiazine ointment, from day 3/4, would have a benefit on wound healing, but highlights the insufficient level of evidence in current studies. This probably explains why the prolonged use of silver sulphadiazine dressings remains the rule in the majority of French centres. In the burns department of Hopital Edouard Herriot, PLASTENAN® ointment was used as a relay to silver sulphadiazine after one week of care to promote the detersion of second-degree fibrinous burns. Following the end of its commercialization in 2014, our nursing team wondered whether an ointment or an equivalent dressing was available. A clinical study on URGOCLEAN® dressing was conducted by another team from our university hospital on the detersion of vascular wounds. Given its positive results,the investigator tested its effectiveness on fibrinous burns. A cohort of 70 patients (2014-2018) was thus set up by our nursing team: this dressing used in fibrinous burns showed a low use of skin grafts (2/70), a median healing time of 20 days and an improvement in the quality of the scar. In 2013, a systematic review by the Cochrane compared seven types of dressings for the treatment of superficial and intermediate burns, but the URGOCLEAN® dressing, marketed in 2013, was not included. Considering these findings, the investigator would like to set up a randomized trial to evaluate a strategy integrating the URGOCLEAN® dressing in the management of second-degree fibrinous burns.

appel_a_projets: PHRIP

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: HYDRa-B

titre: Evaluation d'une stratégie de prise en charge des brûlures fibrineuses du deuxième degré intégrant un pansement hydro-détersif : étude prospective, contrôlée, ouverte, randomisée, multicentrique

discipline_principale: chirurgie plastique et reconstructrice

nom_porteur: Guier

prenom_porteur: Anne


title: Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure: Impact of Intervention

summary:
Electrical impedance tomography (EIT) is a non-invasive, bedside monitoring technique that provides continuous, real-time information about the regional distribution of the ventilation.

There are very few data in children admitted to the PICU (pediatric intensive care unit) and the aim of the study is to describe the distribution of the ventilation in children with acute respiratory failure and to study the impact of the interventions in the PICU (change in ventilatory settings, change in position, suction, respiratory kinesiotherapy,…)


title: Evaluation of the Montreal Cognitive Assessment Test as a Screening Tool for Cognitive Dysfunction in in Adults With Sickle Cell Disease

acronym: EvaCAD

summary: This study will assess the performances of the Montreal Cognitive Assessment (MoCA) to screen for cognitive impairment in adults with sickle cell anemia. The results of the MoCA and its subscores will be compared to a standardized neuropsychological evaluation using validated tests.

primary_purpose: Screening

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Video Consultation and Mitochondrial Myopathies: Study of Efficacy and Tolerance of a Personalized Training Program at Home

acronym: TELE-MIT

summary:
Positive effect of physical activity on health arouses a strong interest at international level and is developped within the scope of national programs. Recommandations exist but must be designed for patients with functional limitations of activities.

Patients with mitochondrial diseases have exercice intolerance with an increase of muscular weakness and fatigue after low exercice volume. Theses patients have functional limitations of activities. In order to establish an appropriate training programme, it will be important to define and consider the physical condition. The Society of Mitochondrial Medecine published recommandations for management of theses patients,However, theses recommandations do not allow them to propose a training program of what can be done. For these vulnerable patients, therapists are responsible fo advising a training programm without guidelines to establish its terms and conditions. In addition, some exercices do not appear to have been the subject of complete assessmeents.

Regarding training programs (aerobic training, muscle reinforcement, miwed training), scientific literature shows a significant genetic and clinical variabilities, as well as a lack of data on clinical severity of included patients. In addition, the lack of informations regarding training effects of heteroplamy level limits our comprehension of mechanisms involved in adaptation of mitochondrial pool during training. Therefore, further reserchs on this subject are essential.

It is necessary to offer these patients a follow-up and personalized training program, which are in adequation with daily life. Some publications call on specifics concepts which are not compatible with day-to-day life. The investigators think it will be useful to investigate training effects in order to have practival conclusions, easily reproducible at home by patients with simple and inexpensive equipment. In this context, video consultation could allow the close follow-up of these patients.

The investigators hypothesize that a mixed training (endurance and muscle reinforcement), personalized, at home and followed by video consultation have positive effects on some physical criteria (such as musclar strength, tolerance to effort, functional abilities) without increasing heteroplasmy and creatine phosphokinase levels.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Three-dimensional Perception of Sounds in Military With Acoustic Trauma

acronym: SPHEAR

summary:
Spatial hearing capacities of soldiers with acoustic trauma are evaluated in ENT consultations with routine tests (i.e. tonal audiometry, voice audiometry). While the results conclude that soldiers with acoustic trauma have sufficient abilities to carry out professional missions, soldiers report recurring complaints of sound localization (spatial hearing), i.e. difficulties in identifying the position of sound sources in their environment. However, there is currently no objective test to identify and objectify these complaints of spatial hearing.

The investigators have developed a new approach (SPHERE) based on virtual reality and 3D motion tracking, allowing us to evaluate and record the spatial hearing performance of subject with hearing deficit. This system allowed us to highlight localization deficits in three-dimensional space.

This project explores and quantifies the spatial hearing impairments of soldiers with acoustic trauma. The quantification of the spatial hearing capacities will allow to define a specific rehabilitation strategy of spatial hearing deficits.


title: Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD

summary:
Study aims at evaluating the therapeutic efficacy and safety of low-dose IL-2 immunomodulatory treatment in patients with early AD, in a phase II, randomized, double blind, placebo-controlled phase II clinical trial. Patients with AD at early stage will be recruited and randomized (2:1) in each treatment group.

The primary endpoint is the rate of decline assessed through CDR change at 18 months between the placebo group and the treated patients.

lead_sponsor: Centre Hospitalier St Anne

sponsor_collaborators:
Centre Hospitalier St Anne
For Drug Consulting


title: Non-Interventional Study on Evaluation of Potential Causes of Nap Modulated Tinnitus

acronym: TinniNap

summary:
The proposed research is a non-interventional study made to evaluate different measurements on 1 group of participants, before and after taking a nap, aiming to potentially guide future investigations on nap-modulated tinnitus to better understand this phenomenon.

The main hypothesis is that sleep apneas could be correlated with an increase of tinnitus intensity.

lead_sponsor: Robin Guillard EIRL

collaborators: Service du sommeil de l'hôpital de l'Hôtel-Dieu


title: Association Between Peripheral Muscle Function and Quality of Life in Obese Subjects.

acronym: OVALIA

summary:
The assessment of health status and physical function is fundamental in patients with obesity, as they play an important role among the various factors influencing the quality of life in this population. Several studies have shown an association between high BMI values and a significant deterioration in quality of life, especially in women. Excess body fat in obese patients seems to be responsible for muscle atrophy. This causal link is probably related to dysfunctions in adipose tissue, leading to a decrease in the expression of proteins responsible for muscle contraction. The recent literature highlights an alteration in quality of life, particularly in obese and elderly subjects, for which changes in muscle function are partly responsible. Changes in muscle function can be assessed by simple, rapid and non-invasive tools. They could be used to identify obese subjects at risk of they could be used to identify obese subjects at risk of muscle atrophy, to stratify the risk, and to propose prophylactic intervention or early management.

The main objective of this study is to evaluate the association between structural alteration of the quadriceps and quality of life in obese patients.

The secondary objectives are to evaluate :

The association between quadriceps thickness and quality of life ;
The association between grip strength and quality of life ;
The association between quadriceps strength and quality of life ;
The association between quadriceps strength and ultrasound measurements of the quadriceps.

This is a prospective, monocenter, observationnal and cohort study.

All outpatients for nutrition assessment will be included.

ReferenceCitation: Toselli S, Campa F, Spiga F, Grigoletto A, Simonelli I, Gualdi-Russo E. The association between body composition and quality of life among elderly Italians. Endocrine. 2020 May;68(2):279-286. doi: 10.1007/s12020-019-02174-7. Epub 2019 Dec 31.

ReferenceCitation: Tamura LS, Cazzo E, Chaim EA, Piedade SR. Influence of morbid obesity on physical capacity, knee-related symptoms and overall quality of life: A cross-sectional study. Rev Assoc Med Bras (1992). 2017 Feb;63(2):142-147. doi: 10.1590/1806-9282.63.02.142.

ReferenceCitation: Kim SR, Kim HN, Song SW. Associations Between Mental Health, Quality of Life, and Obesity/Metabolic Risk Phenotypes. Metab Syndr Relat Disord. 2020 Sep;18(7):347-352. doi: 10.1089/met.2020.0028. Epub 2020 May 19.

ipd_sharing_description: The protocole, the statistical analysis plan and data will be available as supplementary materials with the publication. The other data that support the findings of this study will be available from the corresponding author upon reasonable request.

lead_sponsor: Hopital Forcilles


title: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED

acronym: EuroCOV

summary:
Descriptive study of patients with suspected COVID-19 upon ED arrival of European hospitals between March 09 and April 08 2020.

Justification:

lead_sponsor: University Hospital, Tours


title: Evaluation of Plasma Vitamin C Levels in a Population of Chronic Rheumatism in Immuno-Rheumatology

acronym: VitCRIC

summary:
Scurvy is an almost forgotten carential pathology, caused by a deep vitamin C (or ascorbic acid) deficiency, a priori exceptional in industrialized countries. According to the French National Authority for Health standards, hypovitaminosis C is defined as a plasma vitamin C level of less than 23 μmol/L. This deficiency would affect 5 to 10% of the general population in industrialized countries and from 17% (clinical scurvy) to 47% (biological hypovitaminosis C) of vulnerable populations (malnutrition, hospitalized patients...). Vitamin C is essential for collagen synthesis. It plays a cofactor role in the synthesis of catecholamines precursors and takes action in synthesis of certain amino acids.

In rheumatology, pain is a recurring reason for consultation. In a context of treated chronic inflammatory rheumatism (RIC), while most of patients seem in remission or in reduced activity of their disease, all real-life studies show that 30 to 40% of them complain of residual pain, 70% of chronic fatigue and 20-25% of symptoms similar to secondary fibromyalgia. Currently, authors suggest the interest of vitamin C analgesic properties, especially in musculoskeletal pain, due to the role of ascorbic acid in neurotransmitters. Vitamin C would act as a cofactor for a family of biosynthetic and regulatory metalloenzymes. Thus, the authors suggest the potential of vitamin C in an analgesic mechanism involving the biosynthesis of opioid peptides.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: A Pilot Randomized Trial Comparing the Use of MILTA vs Placebo for the Management of Pain Related to Perineal Scars Following Delivery

acronym: MILTADoIP

summary:
The incidence of perineal scars after a pregnancy is high, either related to an episiotomy or to spontaneous perineal tears. These perineal scars can result in acute pain but also in chronic pain for some women. Medical treatment includes level 1 and 2 analgesics and, even for a few women, level 3 analgesic.

The MILTA® uses photons which are emitted with low intensity in the visible and near infrared combining 5 physical principles to reduce pain : 1- The NPCL (Nano-Pulsed Cold Laser) emissions in coherent infrared light, at 905 nanometers; 2- Non-coherent emissions, pulsed by trichromatic RGB CSM diodes (400 to 650 nm); 3- Continuous non-coherent infrared emission monochromatic diodes at 905 nm; 4- A constant circular magnetic field (200 millitesla) equivalent to the terrestrial magnetic field and 5- The effect of magnetic tunnel which potentiates the light propagation. MILTA® treatment has been shown to be effective in various managements of pain, but has never been used in pain related to perineal scars.

This randomized controlled trial aims at assessing MILTA vs placebo to reduce pain related to perineal scars after pregnancy.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluating the Value of Audio-guided Meditation During Breast Biopsy Procedures

acronym: MAG-BM

summary:
A prospective, non-randomized, single-center cohort study to evaluate the value of audio-guided meditation during breast biopsy procedures.

The main criterion of judgment is based on the evaluation of tolerance, which includes anxiety and pain felt. This is assessed with questionnaires (STAI-ETAT and EN) before and after the procedure.

Secondary endpoints include tolerance of additional physical pain, reduction in the number of per-procedure complications, overall satisfaction of the practitioner with the biopsy procedure, and comparison of the tolerance of the procedure in patients who practice meditation at home before the procedure

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancerologie de L'Ouest (Ico)


title: Evaluation of Postoperative Experience of Two WALANT-type Modes of Anesthesia (Lidocaine Alone or Combined With Ropivacaine) Used in Ambulatory Surgery of the Upper Limb. A Single-center Prospective Randomized, Single-blind Study

acronym: ROPIWA

summary: Distal surgery of the upper limb under local anesthesia using the WALANT technique (Wide Awake Local Anesthesia No Tourniquet) has become the standard care in orthopedic surgery. The principle is that the operator infiltrates the whole surgical area with a 1% lidocaine solution combined with adrenaline (diluted to 1/200,000) so that all distal surgery of the upper limb can be performed without a tourniquet. Thus, the perioperative course and management of the patient in the operating room and the constraints inherent to general anesthesia are largely reduced. Also, the material cost is considerably reduced. However, WALANT often induces significant pain when the patient leaves the operating room to return home. This effect is related to the pharmacological formulation of lidocaine which has a short half-life (< 3h). To reduce this inconvenience of early block removal, adding a local anesthetic with a longer duration of action (ropivacaine) to lidocaine would extend the duration of the analgesic, improving postoperative experience and satisfaction. The main objective of this research is to evaluate the effect of two WALANT anesthesia protocols (with or without the addition of ropivacaine) on the postoperative experience of patients (QoR-40 questionnaire) 48 hours after outpatient hand surgery.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

intervention_type: Combination Product


title: Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity : BioFaSt MAPPA

acronym: BioFaSt

summary: Physical activity is one of the most effective therapeutic interventions for frailty, sarcopenia or dynapenia. The benefits of physical activity processes are already widely documented. Typically, researchers want to understand the average response to an intervention to determine its overall effectiveness. However, sports trainers have understood it for a long time, the response of an athlete or a patient to training is very variable and the standard deviations present in all the scientific studies on the subject confirm it. There is therefore inter-individual variation in the response to exercise, with some subjects showing much greater improvements than others. Thus, one can wonder if this "non-response" following training is specific to the training modality. The effects of physical exercise on the body depend mainly on its type, intensity and duration. Thus, from a practical point of view, the most important perspective is the prediction and, ultimately, the individual optimization of management through physical activity.


title: Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients

acronym: CEAlcool

status: Withdrawn

lead_sponsor: Centre Hospitalier Henri Laborit

status_simplified: Unknown


title: Speech and Voice as Biomarkers of Physiological Status in Patients With Respiratory Diseases: Proof of Concept in Acute Respiratory Disease Managed in a Pulmonary Hospital

acronym: LocuPnée-H

summary:
Breathing is an automatic vital function that has the peculiarity of being controllable voluntary for actions other than breathing. Speech production is a characteristic example of use of the respiratory system for nonrespiratory purposes. A healthy respiratory system is necessary for speech to be adequately produced and modulated. In patients with respiratory diseases, it becomes difficult to interfere with an automatic control of breathing that is intensely active to compensate for the respiratory deficience. Speech production is impeded, and, reciprocally, speech can generate dyspnea. This study explores the hypothesis that longitudinal changes in speech characteristics will parallel the clinical evolution of acute respiratory episodes. The aim is to validate such changes as prognostic indicators, in the perspective of future telemedicine applications. The hypothesis tested is that of an association between :

vocal abnormalities at inclusion (assessed in relation to known data within a normal population (database of holy subjects already constituted) and the initial clinical severity (assessed according to the usual clinical and gasometric criteria):
the evolution of vocal abnormalities during the stay and the clinical evolution.

location_facility: Departement of Respiratory Medicine , Pitié-Salpêtrière Hospital


title: 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erithematosus Study Protocol

summary:
The natural history of Systemic lupus erythematosus (SLE) is characterized by relapses or flares alternated with periods of remission. Flares are associated with accrual of organ damage independently of other risk factors, both contributing to a considerable morbidity. No useful biomarker is currently available to predict which patients with a quiescent disease are at risk of flare.

The 3TR project (funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831434, and supported by European Union's Horizon 2020 research and innovation programme and EFPIA) is a transdisciplinary consortium that primary aims at identifying biosignatures as predictors of response and non-response to therapy in seven different autoimmune, allergic and inflammatory diseases, including SLE. 3TR will perform a longitudinal multi-dimensional molecular analysis in patients with these diseases. A molecular profiling approach is a modern and innovative way to investigate and stratify heterogeneous diseases on the basis of their common biomolecular pathways. The main hypothesis of the 3TR project is that data obtained from multiomic analysis across the seven different diseases will identify shared biological pathways that better predict the response or non-response to therapy despite their differences in terms of clinical phenotypes and pathogenetic mechanisms. Therefore patients from multiple European centers participating in 3TR will be recruited for a longitudinal clinical follow-up and collections of several samples that will be used to perform multi-omic analysis.

lead_sponsor: University Hospital, Brest


title: Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application : a Monocentric Randomized Study

acronym: APAISE

summary:
The main characteristic of PAD is to limit physical activity by the appearance of claudication of the lower limbs which limits the walking distance, or the maximum distance traveled by the patient before the pain forces to stop. In daily practice, the walking distance is rarely measured at the time of treatment.

Walking rehabilitation is the first-line treatment for these patients (class 1 recommendation from the AHA 2005 and the ESC 2017 with level A evidence). According to the recommendation, a walking session must last at least 30 minutes at the rate of 3 sessions per week for a minimum of 6 months.

Walking rehabilitation should be systematically offered to all claudicating patients, whether operated on or not. It is often sufficient for mild claudication with a walking distance of more than 500 meters. Surgery should be reserved for patients in whom rehabilitation has failed and in whom the claudication is severe (walking distance less than 500 meters). Surgical intervention should not replace rehabilitation, but should be complementary.

Supervised rehabilitation in specialized centers is rarely offered because it is not easily available and involves additional expenses and constraints for the patient (transport, fewer work periods for active patients, etc.). In the absence of specialized center, simple advice is most often given to the patient, who then only has to rely on his personal motivation: this is the so-called "go home and walk".

Therefore, access to well-conducted rehabilitation is a fundamental element of the management of patients with intermittent claudication, which is currently lacking. In the age of digital health, it is necessary to develop innovative tools allowing self-rehabilitation of the patient in addition with remote monitoring by the doctor.

Recent studies have validated and highlighted the interest of using GPS technology for the evaluation of walking activity in claudicants. To date, there are 2 published examples of smartphone applications developed specifically for exercise rehabilitation. The main shortcomings of the solutions proposed in these publications are:

The need to buy a specific GPS box
Discomfort for the patient to carry the box either in a backpack or over the shoulder
The lack of means for the patient to indicate the precise moment when the pain appears
And consequently the absence of clinical analysis centered on the symptom "walk induced pain" Consumer smartphone applications for GPS activity tracking are not intended for medical use and do not indicate when pain occurs.

In this study, the University Hospital of REIMS will establish a scientific collaboration with the company VascInnove® for the use of a smartphone application, called E-REVA® which offers:

an assessment of walking activity and claudication parameters (appearance of pain, walking distance, recovery time after pain, total distance travelled, walking speed, etc.)
help with self-rehabilitation
quality of life and walking questionnaires

The main innovation is the presence of a button allowing the patient to indicate when the pain appears. The patient will be able to have access via the smartphone application to his statistics and the evolution of his performance over time. The prescribing practitioner will have access, via a secure website, to the statistics of his patient, to whom he will be able to give personalized advice during follow-up consultations.

The aim of this study is to carry out a single-centre prospective randomized stratified study (depending on whether or not patient has been revascularized) in patients with intermittent claudication who will or will not use the rehabilitation assistance smartphone application, seen in consultation for vascular surgery and vascular medicine at the University Hospital of Reims.

lead_sponsor: CHU de Reims

nom_etablissement: CH DU PUY

acronyme: APAISE

titre: Approche corporelle autour de la danse chez les Personnes Agées Institutionnalisées présentant des Symptômes comportementaux et psychologiques de la démencE.

discipline_principale: médecine d'urgence

nom_porteur: Pottier

prenom_porteur: Adeline


title: Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization

acronym: STOM'HAD

summary:
The goalf of the study is to have a basis about QOL for colo-stoma and ileo-stoma for patients which are hospitalized at home. The QOL measurement is done with a questionnaire of several items made by stomatherapist and also using EQ5D QOL form.

After reviewing of the data, our goal is to create or improve some solutions to improve their QOL during their home hospitalization.

lead_sponsor: Fondation Sante Service


title: Locomotion Strategies of Patients With Chronic Non-Specific Low Back Pain During Aperture Crossing

summary: The biomechanical parameters studied in non-specific chronic low back pain patients in a locomotion task have so far focused on straight line walking. Although locomotion is primarily an automated action composed of repetitive patterns allowing movement from one place to another, walkers must respond to the environmental demands.These modifications show a flexible and adaptive approach to the constraints of the environment. In this study, we are particularly interested in a task of passage through a horizontal opening, similar to a doorway, which is a standardized task that has shown its interest in the study of perceptual-motor co-ordinations. In particular, it allows to consider anthropometric and functional abilities of individuals, reflecting their action capacities.

lead_sponsor: University of Rennes 2


title: Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients..

summary: Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

lead_sponsor: University Hospital, Angers


title: Acceptability and Feasibility of Implementing a Coordinated Hospital/Non-hospital Parenting Support and Prevention Program for Families of Infants at High Neurodevelopmental Risk After Neonatal Intensive Care Hospitalization

acronym: PRéPaR

summary: The PRéPaR project aims to construct, with the help of parents and early care providers, a support program for the families of infants at an increased risk for neurodevelopmental disorders, and to evaluate the acceptability and feasibility of such a program. This program aims to strengthen parenting skills, support infant development and improve the continuity of hospital/non-hospital care, including early identification of neurodevelopmental motor disorders and continuation of the support initiated during neonatal hospitalization.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Phase 3 Therapeutic Interventional Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery - Single-centre Prospective Randomised Controlled Study With Blinded Assessment of the Primary Endpoint

acronym: EPITUBE-HEART

summary:
Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs to enable intubation). This is due to the injection of large doses of anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep sleep to allow intubation to take place for artificial ventilation.

The prevention of hypotension during surgery has been extensively studied. In contrast, the prevention of hypotension following GA induction has been the subject of only two randomised studies in the ICU and three non-randomised studies in the OR with small numbers of patients. The level of evidence for the use of noradrenaline in the operating theatre remains low.

The hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce the incidence of hypotension during induction of general anaesthesia.

lead_sponsor: Nantes University Hospital


title: MORPHEE : Mechanisms of Cell Death Induced by Extracorporeal Photochemotherapy

acronym: MORPHEE

summary: The objective of this study is to describe the type of cell death induced by extracorporeal photochemotherapy, depending on the cell type, using a panel of complementary analysis techniques.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Impact of the Number of Doses of Antenatal Corticosteroid Therapy on the Number of Doses of Surfactants Postnatal in Preterm Infants

acronym: CORISURF

summary: No study has shown that two doses of corticosteroids are more effective than a single dose in lung maturation and prevention of hyaline membrane disease (HMD) The aim of this study is to assess the impact of the number of doses on the severity of HMD.

lead_sponsor: Hôpital NOVO

location_facility: Resuscitation and neonatal medicine department - Centre Hospitalier René Dubos


title: Simultaneous Recording of Cognitive and Motor Functions After Stroke : Dissociation of Motor and Cognitive Deficits

acronym: SACSO

summary:
Aim: To assess whether a cognitively demanding dual-task has greater impact on manual dexterity in chronic stroke patients than in healthy subjects.

Methods: A visuomotor force-tracking task, combining grip force and oculomotor recordings, will be applied in chronic stroke patients with mild-moderate hemiparesis without clinical cognitive impairments and in age-comparable healthy subjects. The dual-task includes avoiding visual distractors and mental addition of numbers. Dual-task effect is calculated as difference in force control accuracy (dual minus single-task) and as difference in saccade rate (addition of numbers minus visual distractors).


title: Perioperative Blood Glucose Variability and Autonomic Nervous System Activity in On-pump Cardiac Surgery Patients: Study Protocol of a Single-center Observational Study.

acronym: CAESAR

summary: On-pump coronary artery bypass graft (CABG) and valve replacement surgeries are high-risk procedures. Among the risk factors for postoperative complications, perioperative hyperglycemia and blood glucose variability have been reported to be associated with increased morbidity and mortality. The treatment of hyperglycemia using intravenous insulin infusion improves the prognosis in cardiac surgery patients. However, the determinants of postoperative blood glucose variability and the mechanisms leading to its deleterious impact are unknown. Thus, to date, there is no therapeutic intervention that could effectively prevent and treat the deleterious impact of glycemic variability on postoperative outcome. The purpose of the study is to evaluate whether perioperative alteration of the autonomic nervous system and preoperative blood glucose variability could be related to perioperative glycemic variability.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility: Post operative intensive care unit of the cardiac surgery department