title: Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin

acronym: CIMHBaDD

summary: Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.


title: Non-Violent Resistance Parental Training Versus Treatment as Usual for Children and Adolescents With Severe Tyrannical Behaviour: a Randomized Controlled Trial

acronym: REACT

summary: This was a randomized controlled trial that compared the NVR intervention group with a TAU group during a four-months period in reducing stress in parents of children aged 6-20 years and displaying severe tyrannical behaviour (STB).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


title: L5-S1 Disc Fate in Thoracolumbar Arthrodesis Stopping at L5

summary:
Spinal deformity in adults is one of the most frequently treated pathologies in spinal surgery. Their surgical treatment remains a challenge. In particular, the choice of the borderline vertebrae for thoracolumbar fusion correction remains controversial, including the choice between an instrumented last vertebra at L5 and an arthrodesis extending to the pelvis. Studies and meta-analyses show that an ilio-sacral socket provides better correction of pelvic parameters and avoids the development of distal junctional syndrome. On the other hand, there is more proximal junctional syndrome in patients fixed to the sacrum, and the sacral socket exposes patients to the risk of pseudarthrosis of the L5-S1 level and failure of the fixation hardware. Moreover, although this factor is not described in the studies, it would seem that an ilio-sacral socket is more stiffening. Overall, no study has shown a statistically significant difference in clinical scores between patients whose last instrumented vertebra is L5 and those with pelvic fixation.

One of the theoretical risks of an extended fixation with a proximal thoracic grasp is to observe a premature disc degeneration of the L5-S1 disc since it would be subjected to more stress. This degeneration could be the cause of distal junctional syndrome and lumbo-radiculalgia due to inflammatory disc disease and disco-radicular impingement. However, to Investigator's knowledge, no clinical study has yet investigated the medium- and long-term fate of the L5-S1 disc in patients with extended fusion correction of a thoracic vertebra to L5.

Investigator's team has sometimes favored a final instrumented vertebra at L5 when possible, i.e., when the L5-S1 disc was considered to be minimally or not degenerative and when its horizontality could be obtained after correction of the underlying curvature. Investigators therefore have a cohort of patients who have undergone this technique. The usual follow-up of these patients includes a consultation appointment every 2 to 5 years and a control MRI at a distance of more than 5 years: investigators thus have a control MRI and the clinical score of the patients.

Investigator's objective is to determine whether there is degeneration of the L5-S1 disc, using MRI imaging data, which has never been published to investigator's knowledge.

status: Active, not recruiting

study_completion_date_type: Anticipated

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Yao YC, Kim HJ, Bannwarth M, Smith J, Bess S, Klineberg E, Ames CP, Shaffrey CI, Burton D, Gupta M, Mundis GM, Hostin R, Schwab F, Lafage V. Lowest Instrumented Vertebra Selection to S1 or Ilium Versus L4 or L5 in Adult Spinal Deformity: Factors for Consideration in 349 Patients With a Mean 46-Month Follow-Up. Global Spine J. 2023 May;13(4):932-939. doi: 10.1177/21925682211009178. Epub 2021 Apr 28.

ReferenceCitation: Taneichi H, Inami S, Moridaira H, Takeuchi D, Sorimachi T, Ueda H, Aoki H, Iimura T. Can we stop the long fusion at L5 for selected adult spinal deformity patients with less severe disability and less complex deformity? Clin Neurol Neurosurg. 2020 Jul;194:105917. doi: 10.1016/j.clineuro.2020.105917. Epub 2020 May 19.

ReferenceCitation: Sardar ZM, Ouellet JA, Fischer DJ, Skelly AC. Outcomes in adult scoliosis patients who undergo spinal fusion stopping at L5 compared with extension to the sacrum. Evid Based Spine Care J. 2013 Oct;4(2):96-104. doi: 10.1055/s-0033-1357360.

ReferenceCitation: Jia F, Wang G, Liu X, Li T, Sun J. Comparison of long fusion terminating at L5 versus the sacrum in treating adult spinal deformity: a meta-analysis. Eur Spine J. 2020 Jan;29(1):24-35. doi: 10.1007/s00586-019-06187-8. Epub 2019 Oct 17.

lead_sponsor: Fondation Hôpital Saint-Joseph

status_simplified: Ongoing


title: Relationship Between Self-compassion and Treatment Adherence in Schizophrenic Spectrum Disorders

acronym: CompaSchizo

summary:
Treatment adherence is defined by the World Health Organisation (WHO) as the extent to which the patient's history of therapeutic drug-taking coincides with the prescribed treatment. In patients suffering from psychiatrical diseases, especially in those who are suffering from schizophrenic spectrum disorders, the quality of treatment adherence has to be improved. Indeed, non adherance to anti-psychotic treatment increases the risk of hospitalization, of substance use, violent behaviour and of functionnal and cognitif impairment. Selfcompassion, which involves being touched by and open to one's own suffering and to heal oneself with kindness and without judgement and self-criticism has never beed studied as a possible factor infuencing treatment adherence.

This study aims to evaluate if a link between selfcompassion and treatment adherence exists in patients suffering from schizophrenic spectrum disorders.

status: Withdrawn

study_type: Interventional

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators:
Crysalid center Clermont de l'Oise
CMP de Montataire
CMP de Chambly
CMP de Clermont de l'Oise
CMP de st Just en Chaussée
CMP de Senlis
CMP de Crepy en Valois
CMP de Pont St Maxence
CMP de Chantilly
CMP de Creil

intervention_type: Other

status_simplified: Unknown


title: Search for BIO Diagnostic and Prognostic Markers in Adult VAScularitis

acronym: BIOVAS

summary:
To date, there are no reliable diagnostic blood markers of adult vasculitis. To date, the diagnosis of vasculitis is based on invasive procedure, biopsy of affected tissues potentially at risk of complication . In addition, there are no reliable biomarkers to predict the evolution of vasculitis (relapse, refractory form ...) necessary for the management of patients (type of treatment, duration ..)

Prospective study, monocentric (CHU de Tours), non-interventional, aimed at finding diagnostic and prognostic biomarkers (both metabolomic and immunologic) in adult vasculitis patients.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: University Hospital, Tours


title: Left Atrial Appendage Closure Registry of Henri Mondor Hospital

summary:
Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.

Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.

Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.

acronym: CATS-AF

summary:
Atrial The treatment of atrial fibrillation (AF) includes 2 axes: the prevention of the cardio-embolic risk and rhythm control. The possibilities for this control are antiarrhythmic drugs and, above all, catheter ablation, an interventional cardiology technique which consists in treating the areas responsible for the initiation and perpetuation of AF by applying radiofrequency energy or cryotherapy to the myocardial tissue.

Limited research has been done on the combination of different parameters to manage AF, especially during the initial stage of the disease. A translational and multimodal approach could make it possible to better characterize this pathology and thus, help to adjust the therapeutic management for the patients.

The combined analysis of regional electrophysiological, morphological, and functional parameters of the left atrium could make it possible to better detect early atrial cardiomyopathy and predict recurrences of atrial fibrillation.

primary_purpose: Prevention

ipd_sharing: Yes

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.

location_facility: Institut de Cardiologie de la Pitié-Salpêtrière

intervention_type: Diagnostic Test


title: Flapless Zygomatic Implants Robot-assisted Placement

acronym: ROSA-ZYGOMA

summary:
Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome.

However, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable.

This approach is technically difficult, and is performed by an experienced surgeon.

The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess.

Path planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

intervention_type: Procedure


title: Brain Hemorrhage on 24h-CT and Functional Outcome in Stroke Patients With Cerebral Amyloid Angiopathy Features on Pre-thrombolysis MRI Treated With Intravenous Thrombolysis

acronym: Thromb in CAA

summary:
Background: In stroke patients treated with intravenous thrombolysis (IVT), presence and high number of strictly lobar cerebral microbleeds (compatible with cerebral amyloid angiopathy, CAA) seems to be associated with increased risk of hemorrhagic transformation, symptomatic hemorrhagic transformation, remote hemorrhage, and poor functional outcome. Some of these reported CAA patients with cerebral microbleeds also had chronic lobar intracerebral haemorrhage. Few data is available on IVT-treated CAA patients showing cortical superficial siderosis. There are no reports studying factors associated with brain hemorrhagic complication or functional outcome inside a group of IVT-treated CAA patients. Our aim was to evaluate brain hemorrhagic complications on 24h-CT and functional outcome after IVT in stroke patients with CAA features on pre-IVT MRI.

Methods: In our stroke center, IVT decision in patients with CAA MRI features is left at the discretion of the treating physician. We retrospectively screened pre-IVT imaging of 959 consecutive IVT-treated stroke patients (between January 2015 and July 2022) without ongoing anticoagulation therapy for probable CAA MRI features defined by modified Boston criteria. After exclusion of 119 patients with lacking MRI (n=47), with MRI showing motion artefacts (n=49) or with alternative chronic brain hemorrhage cause on MRI (n=23), 15 IVT-treated patients with probable CAA on pre-IVT MRI were identified. In these 15 patients, clinical, biological and MRI characteristics were compared between patients with vs. without post-IVT hemorrhage and between patients with poor (MRS 3-6) vs. good (MRS 0-2) functional outcome at discharge.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


type: EudraCT Number

title: A Phase I, Open-Label, Randomised, Balanced, Single-Dose, Two-Period, Two-Sequence Crossover-Design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-marketed Tablet Formulation After Single Oral Administration in Healthy Adult Participants

summary:
This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability).

The test drug, elafibranor (IPN60190), is in development for the treatment of primary biliary cholangitis (PBC).

PBC is a rare, long-term autoimmune disease of the liver. An autoimmune disease occurs when the immune (defence) system treats healthy parts of the body as if they were foreign and attacks them.

This study will be in healthy volunteers, so this trial is not to test if the drug helps to improve health.

design_allocation: Randomized

lead_sponsor: Ipsen

intervention_type: Drug

lead_sponsor_type: industriel


title: Atrial Fibrillation and Cancer: a Nationwide French Cohort Study

summary:
Atrial fibrillation (AF) is a common complication associated with cancer but the risk of AF according to the cancer localization and status as well as the risk of thromboembolisms, bleedings and mortality are poorly known.

The objective of this study is to use a very large French nationwide cohort to adress thèses questions.

lead_sponsor: University Hospital, Caen

sponsor_collaborators:
University Hospital, Caen
University Hospital, Tours

location_facility: Service de Cardiologie, Centre Hospitalier Universitaire Trousseau


type: Other Identifier

title: Effect of Acute Sleep Restriction on Responses to Hypoxia

acronym: HypSom

summary:
At altitude, humans are exposed to environmental hypoxia induced by the decrease in barometric pressure. On duty or in training, mountain troops, paratroopers or aircrew are regularly exposed to altitude. The effects of altitude on humans occur gradually from 1500 m and depend on both the duration of exposure and the altitude level. Cognitive disorders can occur from 3500 m (threshold of disorders) but there is a very large inter-individual variability.

The countermeasure to altitude hypoxia is oxygen but its use is not systematic between 3000 and 4000 m. Its use depends on the duration of exposure, without clearly established standards. Incapacitating effects on the operational capacity and health of soldiers can therefore occur as early as 3500 m.

In operations or during training, altitude exposure is often associated with a significant sleep debt (particularly during night or early morning missions), jet lag or precarious rest conditions in overseas operations. These sleep restrictions promote the degradation of mental performance with effects similar to those observed in hypoxia.

The combination of these constraints induces a physiological stress which can favour alterations in mental performance, an increase in incapacity, intolerance to altitude or the occurrence of altitude-related pathologies in military personnel. This could occur in particular in the operational zone around the threshold of disorders (3500 m) where the indication of oxygen is discussed.

The objective of this study is to assess the impact of acute sleep restriction on hypoxia tolerance.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants

acronym: Exposition

summary: Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 28 and 40 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy

primary_purpose: Screening


title: Evaluation of a Connected Interface (Rheumatologist, Physiotherapist, Patient) to Improve the Quality of Life and the Disability of Patients With Rheumatic Diseases

acronym: RHUMATO-APP

summary:
Musculoskeletal pathologies constitute a major public health problem. Rheumatologists, whether they practice in private or hospital settings, play a major role in the management of responsible for these ailments.

Due to the increase in life expectancy, an increase in the number of consultations can be expected. It is therefore imperative that the latter be more efficient, without losing quality.

Communication between doctor and patient is bound to evolve due to the multiplicity of IT tools available and those that are emerging, which are increasingly essential, including many smartphone applications. Each targeting a specific pathology (rheumatoid arthritis, ankylosing spondylitis, osteoporosis osteoarthritis, they will allow the patient to self-assess, thus becoming an actor in his own care.

A "facilitated" exchange between caregivers and patients would be relevant and would provide added value for all. This is the reason why there is a real need for an application listing precise information on the patient, in a sufficiently succinct way to optimize their transmission to the physiotherapist.

primary_purpose: Supportive Care

location_facility: Centre Hospitalier Universitaire de Montpellier

intervention_type: Device


title: Oxidative Stress in the Patient With Peroperative Analgesia by Intravenous Lidocaine

acronym: OSPAIL

summary:
Depending on the anesthesiologist's habits, injection or not of a 1.5 mg/kg bolus of lidocaine at induction of anesthesia followed by a continuous infusion of 1.5 mg/kg/h.

Additional blood sample at 3 different times without additional puncture compared to usual management: 1) during the placement of the venous line before induction (Reactive Oxygen Species), 2) 1h after the end of induction at the time of blood gas to adapt ventilation (Reactive Oxygen Species), 3) at 24h of the beginning of the intervention (Reactive Oxygen Species and antioxidant molecular profile).

ReferenceCitation: Vignon C, Lachot S, Foucault A, Ravalet N, Gyan E, Picou F, Herault B, Le Nail LR, Bene MC, Herault O. Reactive oxygen species levels differentiate CD34+ human progenitors based on CD38 expression. Cytometry B Clin Cytom. 2020 Nov;98(6):516-521. doi: 10.1002/cyto.b.21948. Epub 2020 Sep 4.

ReferenceCitation: Picou F, Vignon C, Debeissat C, Lachot S, Kosmider O, Gallay N, Foucault A, Estienne MH, Ravalet N, Bene MC, Domenech J, Gyan E, Fontenay M, Herault O. Bone marrow oxidative stress and specific antioxidant signatures in myelodysplastic syndromes. Blood Adv. 2019 Dec 23;3(24):4271-4279. doi: 10.1182/bloodadvances.2019000677.

intervention_type: Biological


title: Proteomic Study of Tears From Patients With a PAX6 Mutation

summary:
This is a single-center prospective pilot study involving the ophthalmology and medical genetics departments of the Montpellier University Hospital, and the proteomics platform of the Montpellier University Hospital.

5 patients with PAX6 pathogenic variation will be included in order to determine the proteomic profile in a tear sample associated with different pathogenic variations of the PAX6 gene.

Participation in the study for the patients consists of a single visit with an ophthalmological examination and a tear collection.


title: Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant

acronym: ANTICOLA

summary: The aim is to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the Technical Feasibility of Testing Circulating Tumour DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.

acronym: PROMECI

summary: Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer.


title: Combined Deep Brain Stimulation of the Substantia Nigra Pars Reticulata and of the Subthalamic Nucleus for Unresponsive Freezing of Gait in Parkinson's Disease: a Pilot Cross-over Study

acronym: SCP-FOG

summary: The study is a pilot study on Parkinson's disease patients to evaluate Combined deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus for unresponsive freezing of gait.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of the Satisfaction and Relevance of Leadership Training for Residents - START Study

acronym: START

summary:
Health students are the future actors of the health system. They are exposed to many stressors in their journey. The quality of life of medical students is alarming worldwide: 11.1% of undergraduate and postgraduate residents reportedly have suicidal ideation and 27.2% have depressive symptoms. In addition, 44.2% suffer from burn-out syndrome. In the third cycle, 28.8% suffer from depressive symptoms and 35.1% from burn-out syndrome. This finding is shared internationally among medical residents. Health professionals are facing a global problem which it is crucial to act.

At national level, a survey on the mental health of young doctors carried out in 2017 found, among the 7603 residents who responded a prevalence: 22.8% of depressive symptoms, 59.7% of anxiety symptoms, 23.4% of suicidal thoughts, including 5.0% in the month prior to the survey. In 2018, a French report on the quality of life of health by Dr Donata Marra highlighted a real malaise affecting residents and the need to intervene "for residents, for carers and for patients", through the implementation of specific recommendations. The proposal 6 of the report emphasises the prevention of psychosocial risks through educational interventions such as training in collaborative management. On a personal level, the aim is to the leadership of each individual, in terms of stress management, communication, cross-disciplinary skills or even the introduction of relational simulations in the teaching of an awareness of deviant behaviour and harassment. The stress factors are indeed multiple during health studies confrontation with death, competition, increasing responsibilities… Perceived stress has a negative impact on the quality of life and burnout. Effective stress management strategies could therefore help to improve the quality of life of residents.

In this context, the analysis of the literature highlights three main areas of intervention that could contribute to resident leadership in favour of their quality of life: stress management, healthy living and the construction of a professional identity.

The Junior Leadership programme for residents from the beginning of their professional formation designed to provide basic knowledge and skills in healthcare leadership and to develop cross-disciplinary skills. The aim is to provide the necessary support for the success of the resident's professional project by participating in the improvement of their quality of life and the prevention of psycho-social risks.

The study therefore propose to evaluate the feasibility of training in leadership and meditation on the satisfaction of resident.

lead_sponsor: Hospices Civils de Lyon

location_facility: Pôle de simulation en Santé de Lyon Sud (PL3S)


title: Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects

acronym: LUNGSTRAIN

summary: In the critical patient, lung ultrasound is routinely performed for acute respiratory distress, adult respiratory distress syndrome and for hemodynamic evaluation. Its diagnostic performance is superior to that of chest radiography in the context of pleuropulmonary parenchymal pathologies. The search for lung sliding is performed to diagnose a pneumothorax or to search for the correct placement of the endotracheal intubation tube. However, this analysis is qualitative and is sometimes difficult to interpret. At present, there is no global evaluation technique at the patient's bed allowing to analyze simultaneously the alveolar recruitment, the pulmonary over-distension and the quality of the lung sliding, whereas the pulmonary damage is most often heterogeneous. The justification of our research project is based on the need to develop and validate a means of global and regional quantification of the mechanical and aeration properties of the lung parenchyma by the analysis of the acoustic markers of the pleura (pleural strain) by the ultrasound technique of speckle tracking. The aim is to establish the normal values of the pleural strain in healthy volunteers, in spontaneous ventilation and then in non-invasive mechanical ventilation, in order to vary the lung volume.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes, Hôpital Universitaire Carémeau


title: Changes in the Quality of Life and Experience of Young Women With Utero-vaginal Aplasia (MRKHPSY)

acronym: MRKHPSY

summary: This study aims to evaluate the global evolution of the quality of life on patients diagnosed with MRKH syndrome (Mayer-Rokitansky-Kuster-Hauser), 8 to 10 years after the first research.

collaborators: Laboratory of Clinical Psychology, Psychopathology and Psychoanalysis


title: Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management

acronym: OPTIMOVA

summary: Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.

lead_sponsor: Institut Bergonié


title: Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients

acronym: RE PAR EX

summary:
he aim of the "RE PAR EX" research is to evaluate the feasibility of the instrumented examination of the effects of eccentric muscle strengthening in paralytic patients. This project is part of the research axis of the movement analysis laboratory.

Following a stroke or spinal cord injury, patients develop a spastic paresis syndrome, which is characterized by the appearance of paresis, musculo-tendinous retractions and muscular hyperactivities.

If the traditional treatments proposed (stretching, motor work) show limits, the use of eccentric muscle strengthening in paresis patients has been developing for about ten years, with results superior to the usual treatments. The results of the studies evaluating it are focused on clinical evaluations and do not make it possible to identify the precise origin of the observed responses.

A pathophysiological understanding of the therapeutic effects of eccentric strengthening would be possible through instrumented examination of muscle structure and function, combining dynamometry, ultrasound, elastrography and electromyography (EMG). However, the feasibility of this quantified instrumental examination in paretic patients during a strengthening protocol has not been evaluated.

The feasibility of a quantified instrumented examination in this setting is the aim of this research, a necessary prerequisite for a larger interventional study to evaluate the biomechanical and neurophysiological effects of eccentric muscle strengthening in paretic patients.

lead_sponsor: Nantes University Hospital


title: Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life

acronym: REALSOCOG

summary: It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).


title: Metabolomic Approach During Exercise Testing in Myalgia Induced by eXercise

acronym: Matmix

summary:
Metabolic myopathies form a group of pathologies related to a deficit of muscle energy production (enzymatic deficit) by disorder of the metabolism of carbohydrates, lipids, purines, or mitochondrial involvement related to dysfunction of complex respiratory chain. Most often, the symptomatology may include signs of "muscular" calling with cramps, contractures or exercise myalgia, more or less associated with exercise intolerance with early fatigability and rhabdomyolysis. In practice, the clinical signs are not specific and not pathognomonic, or sometimes absent with only an isolated elevation of the CPK. The diagnosis of certainty is usually based on the realization of a muscle biopsy (invasive). Unfortunately, the performance of the biopsy (definitive diagnosis of myopathy) in front of myalgia is low, hence the interest of functional explorations upstream to better specify its indication.

Given the considerable increase in muscle metabolism to physical effort, resting investigations may not uncover myo-metabolic deficit. The muscle enzymatic deficit, is therefore most often "silent" at rest and its highlighting requires to explore the patient with effort, asking him to perform an exercise test on cycloergometer and/or an isometric contraction of the forearm ('handgrip test'). Currently, only a few metabolites are dosed before and after exertion such as lactate, pyruvic acid and ammonium. Several studies in normal subjects showed the effect of physical exercise on the metabolomic signature of plasma. Our aim is to apply modern metabolomic techniques to plasma and urinary samples collected as part of the care pathway in patients referred to in the Department of Sports Medicine-Functional Explorations of the CHU in comparison with healthy volunteers).


title: Description of Physical Activity Effect on Neuromuscular Fatigue of Older People

acronym: ACTIFS-AGE

summary: There is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance with advancing age. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. The aim of this project is to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations

acronym: PASS

summary: Considering that self-exclusion from gambling on a particular website is an intervention for and by individuals who have developed a gambling disorder, it is currently exclusively a behavioural intervention in the sense that it prevents the behaviour Resumption of commercial solicitations only in the period when gambling is not accessible in the corresponding website , through voluntary self-exclusion (where the gambler prevents himself or herself from gambling), does not appear to be sufficient to prevent relapse. Early commercial solicitations, in the immediate intercourse after the end of the self-exlcusion period may precipitate relapse in gamblers whose behaviour change is by definition recent, and who have only received a behavioural measure. The investigators hypothesize an improved efficacy as measured by reduced gambling after a self-exclusion optimized by a period of suspension of commercial solicitations extended to 9 months, compared to self-exclusion with the standard procedure. Gamblers will be randomized according to an a priori randomization list.


title: Contribution of Lower Limb Venous Colour Doppler Ultrasound in the Diagnosis of Pulmonary Embolism Recurrence

acronym: RECHOPE

summary:
Venous thromboembolic disease is a clinical entity including pulmonary embolism (PE) and deep vein thrombosis (DVT). It is a chronic disease with 30% recurrence rate at 10 years. In patients with recurrent PE clinical suspicion, an objective and accurate diagnostic method/strategy is warranted to exclude or confirm a PE new episode diagnosis and to decide on treatment initiation.

Recurrent PE diagnosis raises several issues related to the limitations of clinical scores, D-dimer testing, and diagnostic imaging used for a first episode diagnosis. Most importantly, residual obstruction on chest imaging reported in more than 50% of cases at 6 months can make it difficult to distinguish between an old and a new thrombosis in the absence of possible comparison with a previous imaging carried out under the same modalities.

There are currently few recommendations about the diagnostic strategy for patients with a recurrent PE clinical suspicion and these recommendations are not very consistent due to the lack of a validated strategy. None of current guidelines have included imaging-detectable lower-limb DVT within the strategies despite a reported high prevalence of PE-associated DVT. In one study using venography, 82% (95% CI 76.5 - 86.9) of angiographically-proven PE patients had an associated proximal or distal deep vein thrombosis, of which 42% were asymptomatic. In another study using lower-limb venous ultrasound, a proximal or distal DVT was detected in 93% (95% CI 85-97) of patients with PE.

time_perspective: Other

ReferenceCitation: Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):3-14. doi: 10.1007/s11239-015-1311-6.

ReferenceCitation: Patel P, Patel P, Bhatt M, Braun C, Begum H, Wiercioch W, Varghese J, Wooldridge D, Alturkmani H, Thomas M, Baig M, Bahaj W, Khatib R, Kehar R, Ponnapureddy R, Sethi A, Mustafa A, Lim W, Le Gal G, Bates SM, Haramati LB, Kline J, Lang E, Righini M, Kalot MA, Husainat NM, Jabiri YNA, Schunemann HJ, Mustafa RA. Systematic review and meta-analysis of test accuracy for the diagnosis of suspected pulmonary embolism. Blood Adv. 2020 Sep 22;4(18):4296-4311. doi: 10.1182/bloodadvances.2019001052.

ReferenceCitation: Nijkeuter M, Hovens MM, Davidson BL, Huisman MV. Resolution of thromboemboli in patients with acute pulmonary embolism: a systematic review. Chest. 2006 Jan;129(1):192-7. doi: 10.1378/chest.129.1.192.

ReferenceCitation: Meysman M, Everaert H, Vincken W. Factors determining altered perfusion after acute pulmonary embolism assessed by quantified single-photon emission computed tomography-perfusion scan. Ann Thorac Med. 2017 Jan-Mar;12(1):30-35. doi: 10.4103/1817-1737.197772.

ReferenceCitation: Sanchez O, Benhamou Y, Bertoletti L, Constans J, Couturaud F, Delluc A, Elias A, Fischer AM, Frappe P, Gendron N, Girard P, Godier A, Gut-Gobert C, Laporte S, Mahe I, Mauge L, Meneveau N, Meyer G, Mismetti P, Parent F, Pernod G, Quere I, Revel MP, Roy PM, Salaun PY, Smadja DM, Sevestre MA. [Recommendations for best practice in the management of venous thromboembolic disease in adults. Long version]. Rev Mal Respir. 2021 Apr;38 Suppl 1:e1-e6. doi: 10.1016/j.rmr.2019.05.038. Epub 2019 Jul 4. No abstract available. French.

ReferenceCitation: Lim W, Le Gal G, Bates SM, Righini M, Haramati LB, Lang E, Kline JA, Chasteen S, Snyder M, Patel P, Bhatt M, Patel P, Braun C, Begum H, Wiercioch W, Schunemann HJ, Mustafa RA. American Society of Hematology 2018 guidelines for management of venous thromboembolism: diagnosis of venous thromboembolism. Blood Adv. 2018 Nov 27;2(22):3226-3256. doi: 10.1182/bloodadvances.2018024828.

ReferenceCitation: Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.

ReferenceCitation: Girard P, Musset D, Parent F, Maitre S, Phlippoteau C, Simonneau G. High prevalence of detectable deep venous thrombosis in patients with acute pulmonary embolism. Chest. 1999 Oct;116(4):903-8. doi: 10.1378/chest.116.4.903.

ReferenceCitation: Elias A, Colombier D, Victor G, Elias M, Arnaud C, Juchet H, Ducasse JL, Didier A, Colin C, Rousseau H, Nguyen F, Joffre F. Diagnostic performance of complete lower limb venous ultrasound in patients with clinically suspected acute pulmonary embolism. Thromb Haemost. 2004 Jan;91(1):187-95. doi: 10.1160/TH03-05-0278. Erratum In: Thromb Haemost. 2004 Mar;91(3):635.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Contribution of Hypnosis in Guided Hepatic Biopsy

acronym: Ap-Hy-PBH

summary:
The purpose of this study is to evaluate the contribution of hypnosis on the level of pain felt by the patient during ultrasound-guided hepatic biopsy, by comparing an intervention group (hypnosis) to a control group (routine and benevolent care).

Single-center randomized controlled trial.

ReferenceCitation: Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17.

ReferenceCitation: Bertrand AS, Iannessi A, Buteau S, Jiang XY, Beaumont H, Grondin B, Baudin G. Effects of relaxing therapies on patient's pain during percutaneous interventional radiology procedures. Ann Palliat Med. 2018 Oct;7(4):455-462. doi: 10.21037/apm.2018.07.02. Epub 2018 Jul 20.

ReferenceCitation: Adams PC, Stenn PG. Liver biopsy under hypnosis. J Clin Gastroenterol. 1992 Sep;15(2):122-4. doi: 10.1097/00004836-199209000-00008.

ReferenceCitation: Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405.

ReferenceCitation: Hauser W, Hagl M, Schmierer A, Hansen E. The Efficacy, Safety and Applications of Medical Hypnosis. Dtsch Arztebl Int. 2016 Apr 29;113(17):289-96. doi: 10.3238/arztebl.2016.0289.

ReferenceCitation: Lindor KD, Bru C, Jorgensen RA, Rakela J, Bordas JM, Gross JB, Rodes J, McGill DB, Reading CC, James EM, Charboneau JW, Ludwig J, Batts KP, Zinsmeister AR. The role of ultrasonography and automatic-needle biopsy in outpatient percutaneous liver biopsy. Hepatology. 1996 May;23(5):1079-83. doi: 10.1002/hep.510230522.

ReferenceCitation: Cadranel JF, Rufat P, Degos F. [Practices of transcutaneous liver biopsies in France. Results of a retrospective nationwide study]. Gastroenterol Clin Biol. 2001 Jan;25(1):77-80. French.

ReferenceCitation: Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897.

ReferenceCitation: Castera L, Negre I, Samii K, Buffet C. Patient-administered nitrous oxide/oxygen inhalation provides safe and effective analgesia for percutaneous liver biopsy: a randomized placebo-controlled trial. Am J Gastroenterol. 2001 May;96(5):1553-7. doi: 10.1111/j.1572-0241.2001.03776.x.

ReferenceCitation: Froehlich F, Lamy O, Fried M, Gonvers JJ. Practice and complications of liver biopsy. Results of a nationwide survey in Switzerland. Dig Dis Sci. 1993 Aug;38(8):1480-4. doi: 10.1007/BF01308607.

ReferenceCitation: Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, Lamy M, Maquet P. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000 May;92(5):1257-67. doi: 10.1097/00000542-200005000-00013.


title: Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients

acronym: IASAAC

summary:
During treatment, cancer patients may experience side effects related to their disease but also to the different treatments they receive.

Currently, adverse effects and toxicities are well codified in the oncology community, notably via the NCI CTCAE criteria.

Unlike objective data such as a blood sample or a CTscan, a major bias in patient assessment is the subjective assessment of the physician or its team at a given time, which may not reflect the overall situation (for better or worse). Several studies had already highlighted the discrepancies between medical and patient data collection.

Self-assessment of symptoms is one way to overcome this bias. Moreover, there are now a large number of solutions that allow to perform these self-assessments at home.

Thanks to these tools, there are now two situations, the scheduled evaluation (before a chemotherapy treatment, or after a surgical procedure for instance) and the unscheduled situations, where it is the patient himself who can trigger an evaluation form.

These new evaluation methods also allow to take a quality of life approach. Patient-reported outcomes (PROs) is now a valid evidence-based assay to detect patient's symptoms and therefore provide helpful clinical information to healthcare providers.

The goal of this study is to go one step further than the previous PROs studies and evaluate the ability to train a machine learning algorithm to detect at-risk situations and lay the foundation for a viable solution for future prospective and randomized trials.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.

acronym: ECMOVIS

summary:
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Currently, there is no consensus about the best timing for implantation and initiation of VA-ECMO in this setting. Some publications have suggested that VIS score could be used to determine the necessity of VA-ECMO in cardiologic area. It was demonstrated that a VIS score between 20 and 40 may be a cut-off value to discuss the implantation of VA-ECMO. Post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area.

Based on the well-established ability of VIS Score in predicting mortality, we will investigate the role of the VIS Score as a determinant for early VA-ECMO implantation in patients suffering of post-cardiotomy cardiogenic shock.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Prospective Evaluation of Complications of MidLine Catheters in the ICU

acronym: COMIDREA

summary:
Midline catheters (MCs) are peripheral catheters inserted into a vein in the arm above the elbow crease, with the tip in the axillary vein. As such, they do not enter the central venous circulation and are therefore not considered central venous catheters.

The main complications associated with CM are accidental removal, leakage, subcutaneous diffusion and occlusion. Severe complications include deep vein thrombosis (DVT) and catheter-related bacteremia (CRB). There is very little data on the use of CMs in intensive care units (ICU).

Resuscitation patients are more likely to develop severe catheter-related complications such as deep vein thrombosis and catheter-related infections. While the use of CMs in patients appears to be associated with a low risk of complications, this may not be the case in resuscitation patients.

Investigator therefore proposes to conduct a prospective observational study to determine the frequency and type of complications associated with CMs when they are implanted and used in ICU. In addition, investigator will attempt to determine whether risk factors predictive of complications can be identified. In addition, this study will evaluate whether the use of CMs can reduce the duration of central venous catheter maintenance in the ICU and the risk of central venous catheter-related infections.

lead_sponsor: Centre Hospitalier le Mans


title: Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Reducing Auditory Verbal Hallucinations (AVH) With High Frequency and Neuronavigation Guidance: A Double-blind, Randomized and Multicentric Study

acronym: MAINSTIM

summary: Repetitive transcranial magnetic stimulation (rTMS) can alleviate persistent auditory verbal hallucinations (AVH) in schizophrenic patients, but the classical procedure with low-frequency stimulation for several weeks upon the left temporoparietal junction have shown modest therapeutic effects, and there is currently no robust predictive factor to the response of the treatment. In a previous multicentric, randomized, and double-blind controlled study, it has been demonstrated that a high-frequency rTMS over an anatomical target can rapidly affect AVHs. Moreover, an intensification of the classical procedure delivering 20-Hz rTMS over a 2-day period was used in addition to a personalized anatomical stimulation target and neuronavigation guidance. Besides the significant efficacy of the procedure, the efficacy was maximal at two weeks after the end of the treatment. In this project, the hypothesis is that the two-day cure could benefit from maintenance rTMS sessions every week for one month and then every two weeks for 3 months to provide an optimal strategy for a long-lasting AVH reduction. This has for now never been tested. Predictive factors to the response of the treatment are also investigated.

primary_purpose: Treatment


title: Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery

acronym: OREV

summary: Patients at high risk of preterm birth are hospitalized with an high stress for their child's future. In order to better prepare the patient to a possible preterm delivery we use to propose her a visit of the neonatology unit. However, as a result of their obstetrical condition and of the pediatric staff disponibility, this visit is not always possible. Virtual Reality (VR) is well known to provide an immersive experience while staying in a unique place. Our project is to propose a virtual visit of the delivery room, neonatology unit and intensive care unit to all hospitalized patients at risk of preterm delivery in order to prepare and decompress them.

lead_sponsor: University Hospital, Limoges


acronym: FLUO

summary:
Obesity has been considered as a risk factor for mortality and development of complications during infection with the influenza virus. Several case studies of severe and fatal infections have identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, and they experience poor recovery from the disease leading to an increased susceptibility to secondary bacterial infections and poor healing of the lung epithelium. Furthermore, in obese people, influenza virus may exploit the lack of antiviral pressure, generate a more virulent population and increase disease severity Due to the growing prevalence of obesity worldwide (500 million subjects in 2017), it is important to be able to offer vaccines that provide the highest protection for this at-risk population. The quadrivalent recombinant high-dose influenza vaccine has been shown to have greater immunogenicity and efficacy than standard influenza vaccine in non-obese adults older than 50 years. However, this vaccine has never been evaluated in obese subjects.

Investigators thus planned this trial to assess whether the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Sanofi Pasteur, a Sanofi Company
Hospices Civils de Lyon

title: Multicenter, Randomized, Open, Phase III, Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients

source: euctr

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.

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: FLUO

titre: Essai randomisé, multicentrique, en double aveugle, de phase III, comparant l'immunogénicité et la tolérance de deux stratégies vaccinales contre la grippe chez les personnes adultes avec une obésité sévère.

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: LAUNAY

prenom_porteur: Odile


title: Feasibility of End-tidal Oxygen Concentration Monitoring During Preoxygenation for Intubation in the Intensive Care Unit. First Part, Preliminary Study of the IMPROVE Global Project

acronym: IMPROVE-Pre

summary:
Intubation is a common procedure in the intensive care unit. Hypoxemia is the most frequent complication of this procedure.

Monitoring the end-tidal of oxygen is recommended in operating room (OR). End-tidal of oxygen (EtO2) >90% is an indication of a correct preoxygenation.

This monitoring is not used in routine in intensive care unit (ICU). There is no recommendation on the monitoring of end-tidal of oxygen in intensive care unit. In practice, clinicians use pulsed oxygen saturation (SpO2) to determine whether the patient is sufficiently preoxygenated. However, this parameter is not a good indicator of a correct preoxygenation.

In the OR, patients are compliant during the preoxygenation period and the measure of EtO2 with the face mask monitor is considered reliable because i) mask leakage is minimal and ii) the patient can breathe slowly and regularly.

Theses conditions are not available in critical ill patients requiring emergency intubation. EtO2 measured on the facemask may not reflect true EtO2.

This concern about the reliability of EtO2 measurement via the facemask justifies that we conduct a study to compare EtO2 measured on a facemask (facemask EtO2) to EtO2 measured in pharynx (via e nasopharyngeal catheter).

The aim of this study is to determine whether the measurement of EtO2 on facemask is reliable in patients in ICU.

ReferenceCitation: Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.

ReferenceCitation: Thille AW, Frat JP, Brun-Buisson C. Trends in use and benefits of non-invasive ventilation as first-line therapy in acute respiratory failure. Intensive Care Med. 2014 Aug;40(8):1179-80. doi: 10.1007/s00134-014-3370-0. Epub 2014 Jun 25. No abstract available.

ReferenceCitation: Ozsancak Ugurlu A, Sidhom SS, Khodabandeh A, Ieong M, Mohr C, Lin DY, Buchwald I, Bahhady I, Wengryn J, Maheshwari V, Hill NS. Use and outcomes of noninvasive positive pressure ventilation in acute care hospitals in Massachusetts. Chest. 2014 May;145(5):964-971. doi: 10.1378/chest.13-1707.

ReferenceCitation: Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via crossref license, author manuscript)

host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

version: publishedVersion

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61. doi: 10.1097/01.CCM.0000233879.58720.87.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

acronym: AmbATO

summary:
Pelvic inflammatory diseases (PID) require antibiotic treatment. Among PID, the investigators distinguish: pelvi-peritonitis and pelvic collections such as Douglas abscess and/or tubo-ovarian abscess (TOA).

Recent recommendations published in December 2018 by the National College of French Gynecologists and Obstetricians (CNGOF) suggest that it is preferable to drain TOA when their size is greater than 3-4 cm. Ultrasound-guided transvaginal drainage is recommended as first-line treatment because of its ease of performance and its effectiveness. In the literature, many authors have demonstrated the feasibility and efficacy of transvaginal drainage associated with antibiotics in the treatment of TOA. Since ultrasound-guided transvaginal drainage is a less invasive alternative therapeutic procedure than laparoscopy for the drainage of TOA, it would be compatible with outpatient management. This mode of management can be carried out in a dedicated outpatient or functional exploration room with the help of a nurse but without an anesthetic team present. This gesture is simple and short-lived. In addition, the antibiotics used have pharmacological properties allowing oral intake from their initiation.

The investigators have proposed a new service protocol to treat TOA in this outpatient mode. The investigators therefore wish to analyze this new protocol from these three angles: 1/ the feasibility of this care, 2/ the quality of life of the patients through questionnaires given throughout the care and 3/ an evaluation of the 'efficiency.


title: Evaluate E-Care Acceptability for Older People Undergoing Chemotherapy at Home

acronym: ONCO-CHATBOT

summary: The main objective of this pilot study is to evaluate the acceptability of clinical data collection using a semi-automated e-solution based on the use of text messaging among older adults undergoing chemotherapy treatment at home.


title: "ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease"

summary: To describe change in ACR and eGFR during study follow-up, and assesss the association of baseline and change in ACR and eGFR, with progression of kidney failure and/or all-cause mortality.

lead_sponsor: Soutien aux Actions contre les Maladies du Globule Rouge


title: An Observational Study Describing Diagnosis and Treatment Patterns in Adults With Metastatic Non-small Cell Lung Cancer With BRAF V600E Mutation in Clinical Practice, to Assess Treatment Effectiveness and Quality of Life (OCTOPUS)

summary: This study aims to describe the treatment patterns in clinical practice in adult patients with mNSCLC with a BRAF V600E mutation. This study will also describe Real-World Progression-Free Survival (rwPFS) and Overall Survival (OS) for treatments prescribed in routine practice for mNSCLC with BRAF V600E mutation. Adverse events (AEs) related to treatment management will also be described.

lead_sponsor: Pierre Fabre Medicament

sponsor_collaborators:
Pierre Fabre Medicament
Iqvia Pty Ltd

location_facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel


title: Study Investigating the Association of NP137 With Atezolizumab-Bevacizumab Combination in First Line in Unresectable Hepatocellular Carcinoma

summary: The study will assess the safety of the association of NP137 with the standard of care Atezolizumab-Bevacizumab in first line setting in patients with unresectable hepatocellular carcinoma.The study drug which is tested is the NP137 in association with Atezolizumab-Bevacizumab to allow a better tumor response as well as better survival outcomes with an acceptable safety.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
NETRIS Pharma


title: Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome

acronym: UDiPPP

summary: The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.

lead_sponsor: University Hospital, Bordeaux


title: Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of HLA-DR Molecules by Flow Cytometry

acronym: CHEX-DR

summary:
The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Nevertheless, pre-analytical constraints (storage of samples at +4°C before analysis) limit the wide use of mHLA-DR in clinical practice (problem of transporting samples to sites with a flow cytometer). Recent studies have shown that samples taken on Cyto-Chex Blood Collection Tubes (BCT) (containing a cell membrane stabilizer) were, for mHLA-DR, stable at room temperature during 72 hours after sampling. The main objective of this study is to compare the expression of mHLA-DR from samples taken simultaneously from standard tubes (EDTA) and new generation Cyto-Chex BCT tubes, to validate using Cyto Chex BCT tube in the clinical practice.

The investigators think that mHLA-DR quantification performed from Cyto-Chex BCT tubes is reliable and similar to quantification performed from EDTA tubes.


title: Df-Life : Quality of Life in Patients With Fibrous Dysplasia

acronym: Df-Life

summary:
Fibrous dysplasia (FD) is a congenital skeletal disorder with multiple complications such as bone pain, fractures, deformities and nerve compression. Few quantitative studies have demonstrated its physical, mental and social negative impacts on patients but none have qualitatively evaluated their global quality of life. Our hypothesis is that a better knowledge of the quality of life of FD patients should allow to target the actions to be implemented to improve patients'care.

The main objective of this qualitative research is therefore to investigate the quality of life of FD patients through 2 approaches: a qualitative study with focus groups interviews addressing several themes: self-image, psychological and emotional well-being, difficulties and adaptative strategies; and a quantitative study to measure the impact of FD on quality of life and on olfaction (sometimes affected by nerve compression due to the disease) using standardized questionnaires Short Form 36 (SF36) and Self-reported Mini Olfactory Questionnaire (SELF-MOQ).


title: Development of a Proactive Health Care Pathway When Initiating Continuous Subcutaneous Apomorphine Infusion in Patients With Parkinson Disease : Impact on Their Autonomy

acronym: AUTAP

summary:
Continuous subcutaneous apomorphine infusion (CSAI) has proven to be effective in advaced Parkinson's disease patients with motor fluctuations not controlled by oral or transdermal medication. After initiation of this therapy, most of the patients need nurse services at home for the entire duration of treatment. Some patients are reluctant about this dependence and thus may refuse or delay the initiation of CSAI. To date, there is no guideline to promote patients' autonomy in managing CSAI treatment. Thus we developed a program focusing on early autonomy during CSAI intitiation, through empowering the patient or their carer, and promoting primary and tertiary care.

The hypothesis is that implementing the program will lead patients to autonomy. This will have beneficial effects on clinical and heath-related outcomes and may be cost-effective.

lead_sponsor: Assistance Publique Hopitaux De Marseille

appel_a_projets: PREPS

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

acronyme: AUTAP

titre: Impact d'un parcours de soins proactif sur l'autonomie des patients atteints de la maladie de Parkinson nécessitant la mise en place d'une pompe à Apomorphine

discipline_principale: neurologie

nom_porteur: Hache

prenom_porteur: Guillaume


title: Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers (SEQUOIA)

acronym: SEQUOIA

summary: The main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic biomarkers.

primary_purpose: Basic Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler (SAVE)

acronym: SAVE

summary:
Dialysis vascular accesses called arteriovenous fistulas ( AVF) are essential to ensure extra-renal purification by hemodialysis for patients with chronic end-stage renal disease. Complications of dialysis AVF cause significant morbidity and hospitalization. Dialysis AVF angioplasties are frequently used to treat stenosis, the 1st complication concerning them and which announces the complete thrombosis which may be the definitive loss of the AVF. Historically performed under X-ray, the progression in the quality of ultrasound scanners allows today to perform this procedure under echo-Doppler guidance and thus to avoid both radiation and the injection of iodinated contrast products and their complications. It is thus possible to preserve residual renal function, a situation with a better prognosis, or to help the maturation of the AVF without precipitating the patient towards dialysis. The procedure can then be less costly, requiring a much lighter infrastructure.

The complication rates of ultrasound angioplasty remain poorly known because only a few series have been published. In addition, the evolution of the echo-Doppler parameters of the AVF is unknown during angioplasty and it is difficult to know which are the most reliable to distinguish during the procedure a "good angioplasty gesture" from an incomplete angioplasty to be continued. The proposed study would provide initial insight into the question posed.

ipd_sharing_description: All of the individual participant data collected during the trial, after deidentification.

lead_sponsor: Centre Hospitalier de Vichy


title: Interchangeability of Right Ventricle Longitudinal Shortening Fraction Measurements Performed by Trans-thoracic and Trans-esophageal Echocardiography in the Operating Room

acronym: RVLSBO

summary:
RV longitudinal shortening fraction (RV-SLF) is based on the analysis of the tricuspid annulus displacement (TAD) and can be performed in transthoracic (TTE) or transoesophageal echocardiography (TEE). Having an 2D-STE interchangeable parameter would allow accurate measurement of RV systolic function before, during and after cardiac surgery. However, to date, there are no data on the interchangeability of RV-LSF measurements performed in TTE and TEE.

The aim of the study is to evaluate the interchangeability of TTE and TEE measurements of RV-LSF during cardiopulmonary bypass surgery.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Non-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation

acronym: NIEPCE

summary: Photography teletransmission allow a better and optimized dispatching of patients calling an Emergency Medical Call Center (EMCC) for a mild traumatic injury. It has previously been studied for patients to whom an ambulance was sent and therefore presumed to be older or with co-morbidities. The present trial aim to evaluate in the general population, the effect of a smartphone-mediated visioconference in the dispatching of patients calling an EMCC for mild traumatic injury.

lead_sponsor: Poitiers University Hospital


title: Establishment of an ex Vivo Tumor Collection of Triple-negative Breast Cancers in Order to Validate the Interest of Innovative Therapies and the Search for Predictive Biomarkers of Response to Treatment

acronym: TRIPLEX

summary:
Initially described in 2009 on LGR5 positive stem cells from intestine, organoids correspond to a 3D cell culture that preserves the organization and part of the initial function of the organ from which the cells were derived. They use the proliferation and differentiation properties of stem cells cultured in a three-dimensional matrix.

These principles have been adapted to many human organs, including the breast. These culture conditions have thus allowed the establishment of cancer organoid lines that have the advantages of rapid amplification, a high rate of establishment success and unlimited proliferation potential. They are transfectable and cryopreservable. They are very close morphologically and genetically to the tumor from which they derive. Very recently, the in vivo response of orthotopic xenograft models of breast cancer organoids has been correlated to the in vitro response of these same organoids. In addition, the in vitro response of various of these models to PARP inhibitors was linked to the presence of the BRCA1/2 mutant signature, highlighting the potential of these models to predict patient response to these treatments.

Furthermore, one study demonstrated the value of using organoids derived from metastatic gastrointestinal tumors to predict patient response to cancer treatments (100% sensitivity, 93% specificity, 88% positive predictive value, and 100% negative predictive value.

lead_sponsor: Centre Francois Baclesse


title: Interest of a Weekly Consultation by a Medical Electro Radiology Manipulator (MERM) in Addition to the Follow-up by the Radiotherapist to Improve the Collection of Radio-induced Toxicities in Patients Undergoing Proton Therapy: Randomized Controlled Trial

acronym: MERMOSE

summary:
To our knowledge, the investigators have not found any scientific article dealing with cooperation between radiation oncologists and medical radiation technologists in the context of monitoring patients undergoing radiotherapy. Cooperation protocols between health professionals are in progress but concern mainly technical procedures (ultrasound, laserthermal sessions).

This study aims to evaluate whether MERMs, after training by physicians, can monitor clinical signs (for usual well-described toxicities) during treatment via a dedicated consultation.

This approach participates in the development of new professions and cooperation protocols between health professionals. This mission of accompaniment on a dedicated time would make it possible to develop the caring role of the medical electroradiology manipulator.


title: Perioperative Individualized Optimization of Mean Arterial Pressure in Cardiac Surgery

acronym: OPTIPAM

summary:
Neurologic and renal complications frequently occur after cardiac surgery. Acute renal failure following cardiac surgery increase the risk of chronic kidney disease, while postoperative neurological complications increased the risk of chronic cognitive dysfunction. Many cardiac surgical patients suffer from systemic hypertension, but the goal in clinical practice is to maintain the mean arterial pressure (MAP) above 65 mmHg. The investigators test the hypothesis that an individualized MAP optimization during the per-operative and the 24 hours postoperative period should decrease the renal and neurological complications following cardiac surgery.

The investigators propose a randomized controlled study conducted in 21 French cardiac surgical centers. Patients scheduled for aortic or coronary by-pass without neurological or renal dysfunction could be allocated to either individualized MAP group (individualized (+/- 10% of the resting MAP measured during the preoperative anesthesiology consultation) or control group (MAP ≥ 65mmHg). In each group, the first hemodynamic time follows fluid optimization and goal directed perfusion during cardio-pulmonary by-pass to test only the MAP as objective during the peroperative and first 24 hours following surgery. The vasopressors used will be carefully protocolized using norepinephrine to objectively test the clinical interest of MAP value more than vasopressor type.

The primary objective is to assess if an individualized MAP strategy (+/- 10% of the resting MAP) conducted in per and postoperative cardiac surgery decrease a composite endpoint (mortality, neurological and/or renal complications following surgery), in comparison with a control group corresponding to the clinical routine (MAP ≥ 65 mmHg).

lead_sponsor: University Hospital, Caen

region: Normandie

nom_etablissement: CHU DE CAEN NORMANDIE

type_etablissement: CH

acronyme: OPTIPAM

titre: Optimisation individualisée de la pression artérielle moyenne en péri-opératoire de chirurgie cardiaque

discipline_principale: anesthésiologie / réanimation

nom_porteur: FISCHER

prenom_porteur: Marc-Olivier


title: Impact of an Enhanced Focused Cardiac Ultrasound on Treatment Modifications in a Population of Internal Medicine Patients: Retrospective Study

acronym: eFOCUS

summary:
Retrospective observational study performed in a internal medicine ward of a French university hospital. Included patients were hospitalized for acute shortness of breath who have benefited from a eFOCUS which was defined as a focused cardiac Ultrasound with utilization of Doppler measurements.

The objectives were the therapeutic and diagnosis changes induced by eFoCUS. The primary endpoint was defined by the pooled introduction or discontinuation of diuretics, antibiotics or anticoagulants associated with eFoCUS results.

lead_sponsor: Nantes University Hospital


title: Study of the Biological Function of Muscle Satellite Cells From Patients With Obstetric Brachial Plexus Palsy Satellite Cell Obstetrical PlExus (SCOPE)

acronym: SCOPE

summary: The purpose of this prospective work is to study the consequences of obstetrical brachial plexus paralysis on the rotator muscles of the shoulder. The hypothesis is that shoulder stiffness of these children is due to an impairment of the shoulder rotator muscles. The investigators want to test the regenerative capacities of these muscles. The development of a cellular model of this pathology will allow to test new therapeutic perspectives and to validate our hypothesis.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
PhyMedExp Inserm U1046


title: Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Effect of Rhubarb Extract Supplementation on Stool Frequency and Biological Markers of Intestinal Function in Seniors With a Low Number of Defecations Per Week

summary: Randomized double-blind clinical study versus placebo evaluating the effect of supplementation with rhubarb extract on stool frequency and biological markers of intestinal function in seniors with a low number of defecations per week

lead_sponsor: ortis

sponsor_collaborators:
ortis
CEN Biotech

intervention_type: Dietary Supplement


title: Longitudinal Study of the Natural History of Two Autosomal Recessive Non Syndromic Deafness (DFNB1A and DFNB9) in Children up to 10 Years of Age

acronym: Otoconex

summary: The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 10 years of age.

lead_sponsor: Sensorion


title: ACTA2 and Familial Aortopathies: Creation and Validation of an Exploratory Cellular Model

acronym: FACE

summary: The prevalence of hereditary aortic disease (HTAD), responsible for aneurysm or dissection, is estimated at 25%. Mutations in the ACTA2 gene represent the main cause of non-syndromic forms (10-21%). ACTA2 is expressed in vascular wall smooth muscle cells (VSMC) and encodes alpha actin (α-SMA). This actin isoform is in the majority in VSMCs and plays a key role in their contractile properties. The mutations are dominant-negative and lead, in a fibroblast model, to defects in the organisation of the actin cytoskeleton and to an increase in the migratory and proliferative potential of the cells. In vivo, VSCMs exist in a phenotypic continuum ranging from a quiescent differentiated contractile state to a so-called synthetic state in which cells are proliferative, synthesise extracellular matrix elements and exhibit enhanced migratory capabilities. To understand how ACTA2 mutations deregulate VSMC functions and steer them towards a synthetic phenotype, it is necessary to have a cellular model as close as possible to the affected tissue..

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients

acronym: CICASAND

summary:
Keratopathy of patients with aniridia leads to epithelial scarring disorders and a progressive clouding of the cornea linked to this abnormal healing (fibrosis). Treatment with autologous serum is usually undertaken to promote epithelial healing.

However, autologous serum does not prevent the formation of fibrosis, whereas growth factor-rich plasma appears to be associated with a reduction in the in vitro expression of fibrosis markers. This study seeks to compare the in vitro healing and anti-fibrotic properties of autologous serum and growth factor rich plasma from aniridia patients and healthy controls.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Prospective Multicenter Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean

acronym: FAUCS

summary: The main objective of this study is to compare the time taken to obtain "street fitness" status for women after extraperitoneal cesarean section compared to women after a classic cesarean section.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
European Clinical Trial Experts Network


title: VALIDITY AND RELIABILITY OF THE 6-MINUTES WALKING TEST EVALUATED BY FEETME® INSOLES

summary:
Currently, the guidelines for performing the 6MWT established by the American Thoracic Society and the European Respiratory Society (ATS/ERS) recommend the use of an indoor or outdoor corridor with a 30 m flat surface (6MWT30) for patients with respiratory diseases, which is also a recommendation for healthy adults. However, not all hospitals, nursing homes or clinics have a corridor of sufficient length to properly perform the 6MWT. A simple way to make the test available to more health care professionals would be to reduce the length of the hallway.

In times when access to the hospital is difficult, the ability to assess functional abilities at a distance becomes essential. Today, this is becoming possible with tools such as connected watches, accelerometers, connected shoes and insoles. They give access to a quantitative analysis of walking without necessarily requiring large spaces, specialized personnel or even being in a hospital environment. The FeetMe® Evaluation device consists of connected insoles as well as a mobile application allowing the evaluation of standard clinical walking tests.

This device allows a better understanding of patients' walking and is transposable in real life.

The objective of the present study is to demonstrate the validity and reliability of the measurement of the distance walked during a 6-minute test with connected insoles in standard conditions (6MW30), degraded conditions (6MW10) in a clinic and at home in a healthy population divided into age subgroups.

In addition, this study will investigate whether there is a relationship between 6 minutes of uncontrolled walking from real-life walking data and a standard 6-minute test.

status: Terminated

lead_sponsor: FeetMe


title: Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain

summary:
Number of centres planned : 1 (CHU Nantes)

Design : Randomized, Prospective

Planning of the study :

Total duration: 34 months
Recruitment period: 24 months.
Follow-up time per patients : 7-10 months

Expected number of cases : 12

Treatment, procedure, combination of procedures under consideration :

During the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.

There will be a random draw on the order of the stimulation program:

the tonic stimulation "LF": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias
burst stimulation (or "burst")
high frequency" stimulation (1000 Hz) "High frequency: HF".
combined tonic + burst stimulation
combined tonic + high frequency stimulation


title: A Prospective Study About Global, Psychological and Visual Quality of Life After an Eye Surgical Removal (Enucleation or Evisceration)

acronym: QOLAE

summary:
Studies have shown that health-related quality of life (HRQOL) was worse among patients who underwent surgical eye removal compared to the general population in Denmark.

A third of eye amputated patients suffered from anxiety and depression. Most of the available evidence on the subject is based on retrospective studies that interviewed patients several years after surgery, which can potentially introduce biases.

Moreover, in the literature, there are no data concerning postoperative psychological and visual impact.

ReferenceCitation: Rasmussen ML, Ekholm O, Prause JU, Toft PB. Quality of life of eye amputated patients. Acta Ophthalmol. 2012 Aug;90(5):435-40. doi: 10.1111/j.1755-3768.2010.02092.x. Epub 2011 Feb 10.

ReferenceCitation: Ahn JM, Lee SY, Yoon JS. Health-related quality of life and emotional status of anophthalmic patients in Korea. Am J Ophthalmol. 2010 Jun;149(6):1005-1011.e1. doi: 10.1016/j.ajo.2009.12.036. Epub 2010 Mar 15.

ReferenceCitation: Damato B. Improving the quality of life of patients undergoing enucleation. Eye (Lond). 2022 Aug;36(8):1711. doi: 10.1038/s41433-021-01783-9. Epub 2021 Oct 13. No abstract available.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family

summary: The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.

lead_sponsor: Arthesys


title: Reproducibility of the Functional Movement Screen Test in the Normandy Amateur Rugby Player

summary:
The main objective of the study is to determine the inter-evaluator and intra-evaluator reproducibility of the FMS test as an evaluation tool in amateur rugby players.

The secondary objective of the study is to evaluate the abilities of the FMS test as a predictive tool for detecting possible injuries during a sports season in amateur rugby players.

lead_sponsor: Pole Sante Grace de Dieu


title: Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer

summary: Standard care for locally advanced rectal cancer consists in a neoadjuvant therapy followed by surgery. Morbidity and mortality remain high after rectal surgery, and often linked with quality of life impairment. 10 to 30% present a pathological complete response after neoadjuvant therapy. Some surgical teams propose "watch and wait" approach for patients selected with clinical complete responses criterion. The problem is to be sur the response is complete. MRI seems to be accurate to select complete responders. We will try to find MRI criterion of complete responses.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Risk Factors for the Occurrence of Post Intensive Care Syndrome (PICS) at 3 Months After a Stay in the Rangueil Multipurpose Resuscitation Unit of the Toulouse University Hospital

summary: Monocentric, observational, descriptive RIPH3 study with prospective data collection.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis

acronym: TEDITUB

summary: The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with that of standard quadruple therapy (reference treatment of drug susceptible tuberculosis).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Bacteriology department- Hôpital Saint-Antoine

appel_a_projets: PHRCI

acronyme: TEDITUB

titre: Evaluation de l'activité bactéricide précoce du tédizolide contre Mycobacterium tuberculosis

discipline_principale: autre

nom_porteur: VEZIRIS

prenom_porteur: Nicolas


title: Comparative STudy of the ARGos Biometer Compared to UltraSound Biometer in B-mode in Case of Measure Failure With a the Conventional Biometer

acronym: STARGUS

summary:
Biometry has become one of the most important steps in modern cataract surgery. The axial length of the eye may be measured by ultrasound (either contact or immersion) or by optical means.

Non-contact optical biometry has become the gold-standard because of its ease of use, accuracy, and reproducibility. However, the main disadvantage of the optical methods is their inability to obtain axial length measurements in approximately 10% of eyes, typically those with dense posterior subcapsular cataracts.

By Using SS-OCT device, it has been reported that the AL measurements cannot be made in 0.6 to 7.4% of cases . Therefore, measurement by US biometer is still necessary for advanced cataract. The ultrasound measure the LA between the corneal epithelium and the vitreomacular interface. Ultrasound in B mode (or Brilliance) with the help of the control vector allows a 2-dimensional control of the plan used for measurement. This method is used in current practice in our centers when LA measurements is not possible with our optical SS-biometer.

Recently Alcon has integrated the ARGOS® biometer's diagnostic testing with Alcon's Cataract Refractive Suite technologies. ARGOS® is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS® measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White-to-White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool. ARGOS® includes an operation mode for when the retina is hardly or not visible at all denominated the "Enhanced Retinal Visualization mode" (ERV) that allows, in most cases, visualization of the retina. This signal in the retinal region is enhanced by shifting the coherence function (Argos Users manual).

In a prospective observational study conducted in 2 centers in USA involving 107 eyes, they have evaluated the repeatability and reproducibility of ARGOS® measurements in comparison with IOLMaster®500 and LENSTAR LS 900. They have shown that the AL acquisition rate was higher with ARGOS® (96%) compared with both LENSTAR LS 900 (79%) and IOLMaster®500 (77%). The reason was that ARGOS® was more successful at measuring AL in eyes with dense cataract.


title: Tenecteplase Treatment in Ischemic Stroke Registry

acronym: TETRIS

summary: The Tenecteplase Treatment in Acute Ischemic Stroke (TETRIS) Registry is multicenter ambispective observational study of patients with acute ischemic stroke who received intravenous thrombolysis with Tenecteplase

location_facility: Service des Urgences Cérébro-Vasculaires, Hôpitaux Universitaires Pitié-Salpêtrière et Saint-Antoine


title: Angiogenic Inflammatory Biomarkers in Juvenile Idiopathic Arthritis

acronym: MAJIC

summary: The aim of the study is to determine whether serum inflammatory angiogenic markers (eg, semaphorins, CCN1) predict severity of juvenile idiopathic arthritis defined by structural progression and/or therapeutic escalation.

location_facility: Rheumatology Department, Cochin Hospital