title: Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition

summary: Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

intervention_type: Dietary Supplement


type: Other Identifier

title: Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care

acronym: COTUKI

summary:
To make an inventory of the physiotherapeutic care and the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment.

The investigators expect to see a lack of consultation of physiotherapists by patients despite a significant number of complications, impacting the quality of life.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble

lead_sponsor_type: academique

status_simplified: Completed


title: Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis (Acetate Free Biofiltration and Bicarbonate-based Intermittent Dialysis) in Critically Ill Patients

acronym: COOBrA

summary: Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the circulation during IHD (HCO3- <--> CO2 + H2O). Some recent studies showed that acetate free biofiltration (AFB-K), a technique that does not require dialysate acidification, could be associated with better hemodynamic stability and to a lower amount of CO2 delivered to the patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent RRT in critically ill patients.

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Toulouse

intervention_type: Other

status_simplified: Unknown


title: Longitudinal Evaluation of Circadian and Ultradian Rhythmic Fluctuations Measured by Continuous EEG During Coma to Predict the Recovery of Consciousness

summary:
BRIEF SUMMARY :

In the most severe cases of brain injuries, intensive care may allow patients with altered consciousness to survive despite a significant risk of heavy sequelae. Persistent impairments of consciousness are currently categorized according to behavior in three main neurological categories: comatose state, vegetative state (recently named unresponsive wakefulness syndrome) and minimally conscious state. Refining the diagnosis of internal state is a major goal to determine the abilities for an optimal recovery of cognitive deficit. Circadian rhythms are implicated in the regulation of sleep-wake cycles but also in cognitive functions. Their role is actually revaluated in the mechanisms of consciousness impairment. First, it is well known that cognitive performances partially depend on such rhythms as they are more elevated during the day and correlated to the hormonal secretion. In a prognostic point of view, fewer rhythmic perturbations during the initial resuscitation period (with reorganized sleep rhythms and the presence of paradoxical sleep) could be associated to a higher functional outcome.

However, this internal state of alertness could be highly variable during the day as it might be influenced by specific rhythms such as the circadian rhythm. Only a continuous assessment could help defining them properly.

Thus, investigators hypothesize that the circadian restauration, assessed in a dynamic perspective, is associated with the improvement of content and level of awareness. The main challenge of our study is to capture the long-term changes in the evolution of circadian and ultradian rhythms and to keep a part of the natural history of the clinical recovery of these patients.

To achieve this goal, the investigators plan to analyze during more than 2 days both neurophysiological rhythms (EEG) and behavioral rhythms of alertness ("Eyes" scale from of the Glasgow coma scale) in a dataset collected retrospectively from the population of patients continuously monitored by EEG for medical purposes (to identify seizures and prevent status epilepticus) in an intensive care unit of teaching hospital as far as acquisitions last more than 48h and present no prolonged epileptic discharges or artifacts leading to uninterpretable EGG.

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_facility: Lyon teaching hospital, Hospices Civils de Lyon

intervention_type: Combination Product


title: Comparison of the Effectiveness of 3 Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients: Prospective Randomized Controlled Clinical Study

acronym: MAHO

summary:
Orthodontic appliances have been shown to interfere with oral hygiene maneuvers by providing many additional sites for formation and retention of biofilm.

Its accumulation is responsible for undesirable effects such as decays and periodontal pathologies. These lower the benefit / risk ratio of orthodontic treatments. In addition, their management is not negligible at the macroeconomic level.

As such, it is more than necessary for the orthodontist to teach oral hygiene methods adapted to each of his patients fitted to limit the risk of appearance of biofilm.

status: Recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Le Fouler A, Jeanne S, Sorel O, Brézulier D. How effective are three methods of teaching oral hygiene for adolescents undergoing orthodontic treatment? The MAHO protocol: an RCT comparing visual, auditory and kinesthetic methods. Trials. 2021 Feb 15;22(1):144. doi: 10.1186/s13063-021-05093-z.

lead_sponsor: Rennes University Hospital

intervention_type: Behavioral

status_simplified: Ongoing


title: Autophagy/Apoptosis Balance During Pregnancy

acronym: GROSSAUTOP

summary:
The object of this study is to assess the intra- and inter-individual variability of apoptosis and autophagy activities in women during pregnancy: 1 / in women with a normal pregnancy and 2 / in pregnant women particularly at risk of complications.

The study investigators hypothesize that there would be an intra-trophoblastic dialogue between the mechanisms of autophagy and apoptosis, the promotion of one partially inhibiting the other. The increase in trophoblastic autophagy during pregnancy could thus constitute an anti-apoptosis defense phenomenon, the exhaustion of which would lead to cellular apoptosis and to pathogenic consequences when it devastates the syncytiotrophoblast.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: REassessement After Hospitalization for Sars-COV-2 Infection : Standardized Assessment of Sequelae and Comorbidities 3 to 6 Months After Hospitalization

acronym: REHCOVER

summary: Currently, the sequelae and short-term medical and psychological impact of the sars-cov-2 infection ("CoVID-19") remain poorly described. The clinical and functional sequelae that may persist after acute sars-cov-2 ("CoVID-19") infection are essential to explore, in order to ensure the best possible follow-up of patients after discharge from hospital.

ipd_sharing: Yes

ipd_sharing_description: Data will be made available upon a reasonable request

lead_sponsor: University Hospital, Montpellier


title: Relevance of Ultrasound Screening for Foetal Macrosomia and Description of Its Management in Champagne-Ardenne

acronym: USmacro

summary: Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.

study_start_date_type: Anticipated

lead_sponsor: CHU de Reims


type: Registry Identifier

title: Seroprevalence of Anti-SARS-CoV2 Among Children According to Parents' SARS-CoV2 Serological Status. Study in a Hospital Population Assistance Publique-Hôpitaux Paris

acronym: FamilyPEDCOVID

summary: The purpose of this study is to define seroprevalence of anti-SARS-CoV2 among children of Hospital Workers in APHP, particularly exposed population, according to parents' SARS-CoV2 serological status.

primary_purpose: Basic Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'investigation clinique (CIC) Necker Cochin in Necker Children's Hospital

intervention_type: Biological


title: Characteristics in Doppler Ultrasound of the Carotid Diaphragm Responsible for an Ischemic Stroke

acronym: DIADOP

summary:
Carotid diaphragms are a non-atheromatous arterial cause of cerebral infarction, especially in young people (≤65 years old). This anomaly is more common in the African or African-American population, although it is more and more often discovered in young Caucasians. This cause of cerebrovascular accident (CVA), known until the 1970s, was later forgotten until a recent revival of interest, probably in connection with the improvement of imagery but also by the discovery that these lesions have a high rate of recurrence in the absence of interventional care. In a Brazilian study, the carotid diaphragm was reported in 10% of patients under the age of 60.

The carotid diaphragm is a non-atheromatous overgrowth of the intima of the arterial wall. It appears in imagery in the form of an endoluminal web wider than it is tall. Its preferred seat is the carotid bulb. It is a source, by an embologenic mechanism, of cerebral infarction starting from local thrombus developed within large cerebral arteries. In histology, the lesions are different from atherosclerosis and characterized by a thickening of the intima with proliferation of loose and strewed spindle cells mainly involving the intima.

An atheromatous plaque or dissection with detachment of the intima are the two main differential diagnoses of the carotid web. However, the appearance of a diaphragm implanted on a regular wall and the absence of any other localization of atheroma distinguish the lesion of the carotid web from that of a focal atheromatous plate. In addition, the very proximal localization of the carotid web, from the emergence of the internal carotid artery, does not suggest a dissection, the localization of which is usually downstream of the bulb.

The baseline exam to detect a carotid diaphragm is a carotid angiography scan, but the abnormalities are often inconspicuous, making diagnosis difficult. We can be led in case of doubt to perform a conventional arteriography, which remains the "gold standard". The latter, dynamic examination compared to the CT scan, shows above all a stasis of blood flow in the recess created by the diaphragm, stasis at the origin of the formation of thrombi. It has been suspected that the maximum risk of infarction is upon waking, at the time of verticalization, with mobilization of the thrombus.

Therapeutically, the discovery of a symptomatic carotid diaphragm (ischemic swallowing accident) justifies radical treatment. The risk of recurrence of a patient on antithrombotic (antiplatelet or anticoagulant) being too high, it is proposed either surgery, or carotid angioplasty with stent placement. No comparative study of the 2 techniques has been carried out.

Besides radiological examinations, ultrasound is another technique for studying the cervical arteries. It is reputed to be of little contribution in the search for a carotid diaphragm, but few publications exist to date even though the cervical Doppler is often the first arterial examination carried out after an ischemic stroke. Two series reported Doppler ultrasound data in the carotid diaphragm. A recent retrospective study evaluated, in multimodal imaging [Doppler, CT scan of the Supra-Aortic Trunks (ASD) and conventional arteriography], 30 patients (60 carotids) with diaphragm or atherosclerosis. The correlation between conventional arteriography and CT angiography was perfect, but the correlation between Doppler and CT angiography for diaphragm diagnosis was moderate. In another series studying 15 diaphragms diagnosed by CT angiography, the retrospective analysis of doppler reports revealed that 40% were considered normal and 60% mentioned nonspecific hyperechoic lesions, but this work remained in the form of a presentation. at a congress. With the improvement of the technique and the resolution of the Doppler ultrasound as well as the knowledge of the particular ultrasound characteristics, it seems to us that this examination could regain a place in the diagnosis of the pathology. The carotid diaphragm is also largely unknown to vascular doctors practicing cervical Doppler ultrasound.

This descriptive study of the diagnostic contribution of the echo-doppler for a carotid diaphragm has for perspective the establishment of a prospective study of the contribution of a combined expertise angiologist-neurologist in the echo-Doppler for patients <60 years hospitalized for an ischemic stroke.

ReferenceType: result

ReferenceCitation: Haussen DC, Grossberg JA, Bouslama M, Pradilla G, Belagaje S, Bianchi N, Allen JW, Frankel M, Nogueira RG. Carotid Web (Intimal Fibromuscular Dysplasia) Has High Stroke Recurrence Risk and Is Amenable to Stenting. Stroke. 2017 Nov;48(11):3134-3137. doi: 10.1161/STROKEAHA.117.019020. Epub 2017 Oct 10.

ReferenceCitation: Coutinho JM, Derkatch S, Potvin AR, Tomlinson G, Casaubon LK, Silver FL, Mandell DM. Carotid artery web and ischemic stroke: A case-control study. Neurology. 2017 Jan 3;88(1):65-69. doi: 10.1212/WNL.0000000000003464. Epub 2016 Nov 18. Erratum in: Neurology. 2017 Aug 1;89(5):521.

ReferenceCitation: Madaelil TP, Grossberg JA, Nogueira RG, Anderson A, Barreira C, Frankel M, Haussen DC. Multimodality Imaging in Carotid Web. Front Neurol. 2019 Mar 12;10:220. doi: 10.3389/fneur.2019.00220. eCollection 2019.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Ethical and Psychological Support for Health Care Professions in Intensive Care Units in the COVID19 Pandemic Context: Adequacy With Needs and Psychological Impact Crisis and Post-crisis

acronym: PsyCOVID

summary: The intensive care unit occupies a particular place in our health care system. The urgency of the clinical situations, the proportion of deaths encountered, and the daily workload is likely to generate suffering among staff. The health crisis linked to SARS-COV-2 is unprecedented and has leads to the unprecedented mobilisation of care providers, particularly in the ICU. Faced with the massive and growing influx of patients, human, therapeutic and material resources are overwhelmed and the teams are faced with an unusually heavy workload in a context of extreme tension. These professionals are thus exposed to a risk of over-investment, in a context of acute and repetitive stress, over an indeterminate period of time combining workload, emotional intensity with specific ethical issues, simultaneously affecting the professional sphere but also the personal and family sphere (confinement, risk of contamination). Now more than ever, the mental health of caregivers is an important concern, as highlighted by the CCNE. Mental health is understood in the way in which the individual responds specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the issue of mental health in the ICU cannot be considered without taking into account the strategies that professionals put in place to combat stress and to contribute or not to the construction and stabilization of the work collective (collaboration, support). Ethical and/or psychological support systems have been set up in most of the establishments involved in the care of Covid-19 patients. However, the adequacy of these systems relative to the needs of professionals during and after the crisis is not yet known. We hypothesize that the psychological and social repercussions of this pandemic as well as the individual and collective strategies deployed by ICU care providers to deal with it will evolve in view of the progression of the crisis but also of the various types of support, particularly psychological and/or ethical, available to them.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth

acronym: TryPla

summary:
Currently the neonatal serum level of severals proteins can be used as an indicator of subsequent risk. For example, we plan to explore the neonatal kinetics of tryptase and other immune proteins as potential markers for the risk of postnatal complications, particularly in premature babies. However, today no study has shown whether the tryptase level in the newborn is a reflection of fetal synthesis alone, or that of the mother by possible transplacental passage. There is also no database that has defined normal values for tryptase in cord blood.

Our main objective is to determine the correlation between the level of maternal tryptase and that of the newborn in cord blood immediately after birth in order to estimate the transplacental passage of this molecule.

lead_sponsor: University Hospital, Clermont-Ferrand


title: VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness

acronym: VERARE

summary:
After a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to treatments which had to be used. This disease is expected to be similar or even higher in patients suffering from COVID-19 and hospitalized in ICU due to the average length of hospitalization of several weeks in this population. This condition will delay the return-to-walk of these patients, their discharge from hospitalization and may deteriorate their autonomy in daily life activities.

Virtual Reality (VR) environments are already used and have proven their worth for the assessment and rehabilitation of patients with neurological diseases. It therefore seems appropriate to offer the use of virtual environments for this type of population. VR represents a unique opportunity for the rehabilitation care of these patients, and in particular those who have been reached by COVID-19, due to the possible mismatch between the amount of motor rehabilitation to be provided and the fatigability and breathlessness at the slightest effort which seem particularly intense in this population.

The main objective of our project is to improve and to accelerate gait recovery in patients hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual Reality tools. The VR tool will consist of virtual environments presented using a Virtual Reality headset where an avatar (double) of the patient hospitalized in Physical and Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks involving their lower limbs (ex: walking, or kicking a ball) in several different virtual environments (settings). The patient will be asked to observe actions, then to imagine carrying out their actions which will be performed by the avatar in the virtual environment, then they will be able to control the actions of the avatar using their legs thanks to sensors, then feel walking sensations through the use of haptic devices.

status: Withdrawn

primary_purpose: Supportive Care


title: Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial

acronym: COLO-GENIUS

summary:
This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy.

The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).

primary_purpose: Diagnostic

lead_sponsor: Clinique Paris-Bercy

lead_sponsor_type: industriel


title: Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy

acronym: COROSAS

summary: The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of OSAHS for these patients.

lead_sponsor: Poitiers University Hospital


title: O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus

acronym: METABOLUPS

summary: This study aims at defining the role of O-GlcNAcylation is in the physiopathology of systemic lupus erythematosus (SLE). O-GlcNAcylation is a metabolic pathway potentially implicated in SLE with potential for the discovery of new therapeutic strategies.

primary_purpose: Other

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Service d'Immunologie et Immunogénétique


title: Long Term Evaluation of Function and Quality of Life After Pollicisation

acronym: Polliglobal

summary:
The study aims at describing long term functional outcome of patients that underwent pollicisation surgery.

The hypothesis of the study is that there are prognostic factors of good function results of pollicisation (based on T-GAP classification for function) that will be searched on univariate and multivariate analysis.


title: Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

acronym: ABIPULSE

summary:
Continuous Doppler ankle brachial index (ABI) is the gold standard for screening and monitoring of peripheral arterial disease (PAD) but is no longer carried out in clinical practice.

The recommended measurement was gradually replaced by colour or pulsed Doppler without validation of these techniques.

The objective of our study is to compare these two techniques (color Doppler and pulsed Doppler in echodoppler) with respect to the gold standard (continuous Doppler) for ABI measurement.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Caen


title: Monitoring of the Mitochondrial Function of Circulating Myeloid Cells in Patients Hospitalized in the Intensive Care Unit of Dijon University Hospital

acronym: Myelochondria

summary:
Severe infections (sepsis) are a common cause of admission to the intensive care unit. They represent a significant health risk for patients in the short and medium term. They are particularly linked to a change in the function of immune cells. In some patients, a state of pseudo-dormancy of monocyte and macrophage-type immune cells, called immunosuppression of myeloid cells, is observed. This situation leads to a worsening of the infection, so it should be avoided because it represents a danger for the patient even when they ar receiving antibiotics. At present, these events are still very poorly understood. Research is essential to understand how this state of immunosuppression of myeloid cells is established in order to adapt existing treatments or find new ones.

Laboratory studies on animal models of septicaemia have shown that this state of immunosuppression of myeloid cells is closely linked to a change in the production of energy by myeloid cells (monocytes and macrophages). The functioning of the mitochondria ("energy factory" of the cells) in these cells is impaired. Thus, restoring mitochondrial function in myeloid cells could be a therapeutic solution against the immunosuppression of myeloid cells during severe septicaemia.

The objective of this study is to verify whether alterations in mitochondrial function in myeloid cells also occur in patients with bacterial infection compared to patients without bacterial infection.


title: Impact of Body Mass Index on Positive End-Expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anesthesia: A Retrospective Observational Study

acronym: PEPTI

summary:
The induction of general anaesthesia is associated with a fall in lung volume due in particular to a decrease in muscle tone and the formation of denitrogenation atelectasis. Many recent studies insist on the need to apply a so-called "protective" strategy of intraoperative ventilation, which combines the use of recruitment manoeuvres, reduced tidal volume (Vt) (6-8ml/kg) and positive expiratory pressure (PEEP) to prevent these phenomena. However, the setting of PEEP remains debated and several authors agree on the need to individualize ventilatory parameters, particularly in obese patients, without describing the individualization tools.

In the ICU, it has been shown that electrical impedance tomography (EIT) can be used to individualise the PEEP level in a simple and non-invasive way. Therefore, we wish to determine whether the use of this technique during general anaesthesia allows for the individualization of PEEP, and whether the value determined is correlated with the body mass index (BMI).


title: AVASNA : Variability of the Autonomic Nervous System (ANS) During Cluster Headache (CH).

acronym: AVASNA

summary: Cluster Headache (CH) is associated with ipsilateral vegetative signs, related to parasympathetic system hyperactivity and/or signs of sympathetic hypoactivity. The precise mechanism of Cluster Headache (CH) is still unknown. The question is whether these dysautonomic disorders are simply secondary to the Cluster Headache (CH) process or whether they are the triggering factor.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Device


title: INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients

acronym: INSTIGO

summary: The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.

ReferenceCitation: Veyssière H, Lusho S, Molnar I, Kossai M, Bernadach M, Abrial C, Bidet Y, Radosevic-Robin N, Durando X. INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse of Triple Negative Breast Cancer. Front Oncol. 2021 Jun 25;11:653370. doi: 10.3389/fonc.2021.653370. eCollection 2021.

lead_sponsor: Centre Jean Perrin


title: National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.

summary: The SECOND SOUFFLE survey focuses on aspects of care and quality of life in a period when the landscape of severe asthma is changing in the context of biotherapies. Moreover survey on care pathway and quality of life of the asthmatic severe population according to their phenotype have never been done. It is likely to bring results in a relatively fast time, results that can lead to guide the criteria collected in RAMSES a national severe asthma cohort and future research tracks of this cohort.


title: Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study

acronym: DrainICU

summary: This prospective randomized multicenter study is intended to investigate tolerance and effectiveness of thoracic drainage conducted by Seldinger technique with small drains, or by a surgical-like technique with large armed drains, in intensive care units patients.

primary_purpose: Treatment

intervention_type: Procedure


title: Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota

acronym: PROFANE

summary: A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis


title: Impact of Pediatrician Intervention on the Smoking Habits of Parents of Children With Cystic Fibrosis, Type 1 Diabetes or Children Hospitalized for a First Episode of Bronchiolitis.

acronym: MUCODIABTAB

summary: Reducing tobacco consumption is a major public health objective, with the prevalence of active smoking estimated in 2017 at 26.9% of the French population aged 18 to 25. The negative impact of passive smoking on children's health and development has been demonstrated by numerous studies, especially with regard to respiratory pathologies. Parental smoking is also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of 1.72 if at least one of the two parents is a smoker). It has been shown that intervention with parents can reduce the number of children exposed to passive parental smoking by about 5%.


title: Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90

acronym: HSP-HEMATO

summary: NVP-BEP800, a new HSP90 inhibitor, has particularly interesting therapeutic potential and represents hope in cancer pathologies. While it is currently being tested for solid cancers, no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia (ALL). The investigators wish to study the effects of NVP-BEP800 on two different types of ALL (T and B-ALL).


title: Group Program IPS: Body-esteem and Self-esteem in a Psycho-social Rehabilitation Perspective

summary: The body esteem influences the physical appearance, which can be a social brake. To enhance the socio-professional insertion of persons with severe mental disorders, the investigators developed a group program about self-presentation and body esteem. The study's objective is to understand the body esteem impact on socio-professional insertion, and how to improve that with a dedicated group program, for patients in a psychosocial rehabilitation center

lead_sponsor: Hôpital le Vinatier

location_facility: centre de réhabilitation - Hôpital le Vinatier


title: INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors

acronym: CaPaLong

summary: The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.

lead_sponsor: University Hospital, Lille


title: Interest of Clinical Ultrasound in Patients Consulting for Acute Gastrointestinal Bleeding in the Emergency Department: an Observational Monocentric Study

summary: Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department. The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as 10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40% of the total blood volume. Currently, few studies have examined the value of echocardiography in the management of patients presenting for Acute GI Bleeding in the Emergency Department. The main objective of this study is to show whether simple ultrasound parameters can, combined with clinico biological parameters, predict in an early manner the evolution of the patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.

lead_sponsor: SUD Association pour le Développement de la Recherche et de lEnseignement


title: Immunometabolic Effects of Non-drug Strategies in the Clinical Management of Obesity: Translational Study

acronym: PPAR-NAPAS

summary:
Forty women aged between 18 and 75 years-old with a BMI> 30kg/m2 are recruited to participate in the evaluation of their medical management. They participate in an 8-week protocol as part of hospital medical treatment for weight loss at the Oxford Polyclinic in Cannes (IPOCA). The effects of 2 independent variables will be studied: (1) an adapted physical activity program and (2) nutritional supplementation with R-α-Lipoic acid (2x300mg/d) versus placebo (double-blind). The volunteers are randomly assigned to the different groups: Placebo with or without exercise groups and ALA with or without exercise groups. At the start of the protocol (T0), at 4 weeks (T4) and at 8 weeks (T8), various measurements are carried out (physical capacities, nutritional status, body composition, distribution of adipose mass by CT-scan). A venous sample taken for all participants is done at T0, T4 and T8 to investigate the immune profile of circulating T lymphocytes.

This project is part of a translational research project to assess current care and to investigate the immunometabolic effects of a non-drug medical care of obesity (adapted physical activities, nutritional supplementation with α-lipoic acid, quality of food intake).

ReferenceType: background

ReferenceCitation: Gleeson M, Bishop NC, Stensel DJ, Lindley MR, Mastana SS, Nimmo MA. The anti-inflammatory effects of exercise: mechanisms and implications for the prevention and treatment of disease. Nat Rev Immunol. 2011 Aug 5;11(9):607-15. doi: 10.1038/nri3041.

ReferenceCitation: Mothe-Satney I, Murdaca J, Sibille B, Rousseau AS, Squillace R, Le Menn G, Rekima A, Larbret F, Pelé J, Verhasselt V, Grimaldi PA, Neels JG. A role for Peroxisome Proliferator-Activated Receptor Beta in T cell development. Sci Rep. 2016 Sep 29;6:34317. doi: 10.1038/srep34317.

ReferenceCitation: Rousseau AS, Sibille B, Murdaca J, Mothe-Satney I, Grimaldi PA, Neels JG. α-Lipoic acid up-regulates expression of peroxisome proliferator-activated receptor β in skeletal muscle: involvement of the JNK signaling pathway. FASEB J. 2016 Mar;30(3):1287-99. doi: 10.1096/fj.15-280453. Epub 2015 Dec 9.

ReferenceCitation: Le Garf S, Murdaca J, Mothe-Satney I, Sibille B, Le Menn G, Chinetti G, Neels JG, Rousseau AS. Complementary Immunometabolic Effects of Exercise and PPARβ/δ Agonist in the Context of Diet-Induced Weight Loss in Obese Female Mice. Int J Mol Sci. 2019 Oct 19;20(20). pii: E5182. doi: 10.3390/ijms20205182.

ReferenceCitation: Namazi N, Larijani B, Azadbakht L. Alpha-lipoic acid supplement in obesity treatment: A systematic review and meta-analysis of clinical trials. Clin Nutr. 2018 Apr;37(2):419-428. doi: 10.1016/j.clnu.2017.06.002. Epub 2017 Jun 8.

ReferenceCitation: Cui J, Huang D, Zheng Y. Ameliorative effects of α-lipoic acid on high-fat diet-induced oxidative stress and glucose uptake impairment of T cells. Free Radic Res. 2016 Oct;50(10):1106-1115. Epub 2016 Aug 4.

ReferenceCitation: Berod L, Friedrich C, Nandan A, Freitag J, Hagemann S, Harmrolfs K, Sandouk A, Hesse C, Castro CN, Bähre H, Tschirner SK, Gorinski N, Gohmert M, Mayer CT, Huehn J, Ponimaskin E, Abraham WR, Müller R, Lochner M, Sparwasser T. De novo fatty acid synthesis controls the fate between regulatory T and T helper 17 cells. Nat Med. 2014 Nov;20(11):1327-33. doi: 10.1038/nm.3704. Epub 2014 Oct 5. Erratum in: Nat Med. 2015 Apr;21(4):414.

ReferenceCitation: Kempkes RWM, Joosten I, Koenen HJPM, He X. Metabolic Pathways Involved in Regulatory T Cell Functionality. Front Immunol. 2019 Dec 3;10:2839. doi: 10.3389/fimmu.2019.02839. eCollection 2019. Review.

ReferenceCitation: Newton R, Priyadharshini B, Turka LA. Immunometabolism of regulatory T cells. Nat Immunol. 2016 May 19;17(6):618-25. doi: 10.1038/ni.3466. Review.

ReferenceCitation: Zou J, Lai B, Zheng M, Chen Q, Jiang S, Song A, Huang Z, Shi P, Tu X, Wang D, Lu L, Lin Z, Gao X. CD4+ T cells memorize obesity and promote weight regain. Cell Mol Immunol. 2018 Jun;15(6):630-639. doi: 10.1038/cmi.2017.36. Epub 2017 Jun 19.

lead_sponsor: Fauqué


title: Lipid Metabolism in COVID-19 Severe Pneumonia Compared With Severe Pneumonia Caused by Other Pathogen

acronym: COVIDOLIP

summary: SARS-COV 2 infection might be responsible for sever pneumonia. Obesity seems to be a risk factor for severe SARS-COV 2 pneumonia. Lipid metabolism alteration are described with both obesity and sepsis. The aim of the present study was to describe association between lipid metabolism, obesity, sepsis inflammation and clinical outcome in COVID-19 patient with severe pneumonia compared with severe pneumonia caused by other pathogenes.

ReferenceCitation: Nguyen M, Bourredjem A, Piroth L, Bouhemad B, Jalil A, Pallot G, Le Guern N, Thomas C, Pilot T, Bergas V, Choubley H, Quenot JP, Charles PE, Lagrost L, Deckert V, de Barros JP, Guinot PG, Masson D, Binquet C, Gautier T, Blot M; Lymphonie study group. High plasma concentration of non-esterified polyunsaturated fatty acids is a specific feature of severe COVID-19 pneumonia. Sci Rep. 2021 May 24;11(1):10824. doi: 10.1038/s41598-021-90362-9.


title: COvid-19 et VITamine d en EHPAD

acronym: COVIT-EHPAD

summary:
First epidemiological data about COVID-19 pandemic confirm that older adults are likely to experience severe and lethal forms of SARS-CoV-2 infection, in particular frail elderly living in nursing-homes. Vitamin D could be a biological determinant of COVID-19, as indicated by genomic-guided tracing of SARS-CoV-2 targets in human cells. Epidemiological observational data are necessary for better understanding the links between vitamin D supplementation and COVID-19 outcomes, in particular in nursing-homes (in which the risk of hypovitaminosis D is very high).

The investigators had the opportunity to use information collected in a French middle-sized nursing-home affected by COVID-19 in March-April 2020, to determine whether recent vitamin D3 supplementation was associated with the prognosis of COVID-19 in residents infected with SARS-CoV-2. As recommended in French nursing-homes, all residents are systematically and regularly supplemented with bolus vitamin D3 (every single, 2 or 3 months, depending on residents).

The main objective of this study is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in improving survival among frail elderly nursing-home residents infected with COVID-19 compared to those having received supplementation longer ago.

The secondary objective is to determine whether bolus vitamin D3 supplementation taken during or in the month before COVID-19 was effective in limiting the clinical severity of the infection according to the World Health Organization's Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 compared to those having received supplementation longer ago.

lead_sponsor: University Hospital, Angers


title: Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

acronym: TOCAF

summary: This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.

ReferenceCitation: Dubosq M, Gouëffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4.


title: Comparison of Different Refraction Measurements in Adults

acronym: REFRACT

summary:
The combatant is likely to carry out missions any time, any place, day or night. The very strong degradation of natural vision performance in these conditions justifies the use of visual replacement means, based on optronic sensors whose sensitivity is more adapted to these luminous environments than that of the human eye.

The duration and repetition of missions carried out with night vision sensors lead to visual complaints from users.

The literature on night vision binoculars adjustment states that a binocular adjustment of the equipment provides more convex settings. The latter would then limit the strain on the accommodative component, which is one of the possible sources of operator visual fatigue. In order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the refraction (optical defect of the eye) of each operator. Like binocular adjustments, binocular refractive methods would limit accommodative stimulation and thus visual fatigue. However, these methods are little used in favour of conventional methods. It is therefore necessary to evaluate the interest of binocular refraction for the adjustment of night vision binoculars.

The purpose of this study is to compare refraction measurements by procedure in adult subjects free of ophthalmological disorders.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Comparison of the Pharmacokinetic and the Safety of Daptomycin Administered Subcutaneously Compared to the Intravenous Route : a Cross-over Study

acronym: DAPTOSC

summary:
Background:

Multidrug-resistant bacteria are a major public health problem worldwide, notably due to excess mortality and an increase in the length of hospital stay. Antibiotics that can be used to treat these infections are limited. Daptomycin is one of the most widely used antibiotics for the treatment of infections with gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA). However, it is only administered intravenously (IV). It is therefore interesting to find new routes of administration in order to widen the possibilities of using daptomycin, especially in people who have difficulties with the venous approach.

Methods/design:

In a randomized, single blinded, crossover, noninferiority study in the CHU of Caen, the investigators aim to demonstrate the pharmacokinetic bioequivalence between the subcutaneous and the intravenous route of daptomycin in healthy volunteers. They will conclude the bioequivalence if the confidence interval of the area under the curve obtained is entirely within the interval [80% - 125%].

Discussion:

This clinical trial could, if bioequivalence is demonstrated, lead to the completion of a clinical trial in infected patients in order to assess the efficacy and safety of daptomycin by the subcutaneous route.

intervention_type: Drug


title: Study of Prognostic Factors in Patients Admitted to ICU for Stroke

acronym: REAVC

summary:
Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS <10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....).

The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.

time_perspective: Other

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Time to Transit Recovery After Treatment With Naloxegol in Cardiac Surgery Intensive Care Trial

acronym: TRANSIT

summary:
Postoperative ileus, defined as the transient postoperative functional inhibition of propulsive bowel activity, commonly occurs in patients after cardiac surgery and contributes to postoperative morbidity.

Naloxegol is a peripheral opioid receptor antagonist. Recent studies showed that naloxegol is effective in the treatment of chronic opioid-induced constipation but there is no data on its use in the management of postoperative ileus after cardiac surgery.

The main objective of this prospective, double-blind, randomized, placebo-controlled trial is to assess the effectiveness of the perioperative use of naloxegol in reducing the duration of the postoperative ileus in patients undergoing cardiac surgery.

lead_sponsor: CMC Ambroise Paré


title: Evaluation of an Enriched Speech Rehabilitation Program Combining Speech Therapy and Sensory-motor Integration in Aphasic Patients

acronym: SEMO

summary: SEMO is a multidisciplinary project (language sciences, cognitive psychology and neuropsychology, physical medicine and rehabilitation, neurology, speech-language pathology, functional neuroimaging and engineering sciences) that aims first, to test and develop a novel speech rehabilitation program designed for patients with non-fluent aphasia and, second, to better describe neural reorganization after successful recovery. To this end, the investigators will conduct a prospective monocentric cross-over study, including two cohorts of post-stroke aphasic patients and two control groups.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Grenoble


title: Perceptions, Representations and Experiences of Septic Isolation of Hospitalized

summary:
The aim of this study is to analyze the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection.

This analysis could lead to better understanding and communication between the medical profession and patients in septic isolation in hospital. It would also provide patient-specific responses to their expectations, as to their families.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Villeneuve St Georges


title: Descriptive and Evaluation Study of the Use of Pulmonary Ultrasound in the Initial Management of Pregnant Women in the Context of COVID-19

acronym: LUSCOVIDPREG

summary:
Cohort prospective study.

Objectives :

Primary objective:

To describe the lung ultrasound lesions in pregnant women in case of suspected or confirmed COVID-19

Secondary objectives:

To compare the lung ultrasound lesions with chest Computed Tomography -scanner (CT-Scan) lesions
To evaluate the performances of the lung ultrasound to diagnose COVID-19 in pregnant women
To evaluate predictive value of different lung ultrasound lesions for intensive care unit admission of pregnant women with suspected or confirmed COVID-19
To describe the pregnancy issues of the study population

Course of the study:

Inclusion of pregnant suspected of having COVID-19 and cared following the service protocol
Performing of lung ultrasound at bedside in labor ward or in COVID unit

Primary outcome:

Lung ultrasound lesions (and corresponding score) at the moment of the initial management of pregnant women suspected or confirmed with COVID-19 (having a nasopharyngeal Reverse Transcription Polymerase Chain Reaction (RT-PCR) SARS-CoV-2 and a chest CT-scan)

status: Terminated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Gut Bacteria and Brain of the Baby: to Link up the Dynamic of Gut Colonization in Preterms Born at Gestational Age of 30-326/7 Weeks and Their Psychomotor Development at 2 Years

acronym: BaBBa

summary: The project is a prospective French population based cohort. A hundred moderate preterms born at GA30-326/7 will be enrolled for a longitudinal follow-up up to 2 years of corrected age. Eligible neonates will be those born at 30-326/7 weeks of gestation admitted to the neonatal intensive care unit of Rennes Hospital, including transferred infants during the first day of life. The infants will be followed up to the corrected age of 2 years by pediatricians.

lead_sponsor: Rennes University Hospital


title: French Cohort of Carotid Web Associated With Cerebral Infarctions

acronym: CAROWEB

summary: Carotid Web located at the bulb level is a rare condition and is often associated with severe cerebral infarction in the carotid territory. This condition has been described predominantly in the black population. However, limited data are available for the epidemiology of carotid web and often result from selected population studies. It has been shown that the carotid web is a focal intimal dysplasia. Rate of ischemic stroke recurrence is high, even in patients treated with antiplatelet therapy. This subtle lesion is often unknown and misdiagnosed including in stroke unit. We assume that the implementation of a multicentric cohort would allow a comprehensive analysis of the carotid web condition.


title: Impact of COVID-19 Lockdown on Severely Obese Patients With or Without Binge Eating Behaviors

acronym: CIO

summary:
COVID-19 lockdown presents particular challenges for people living with obesity. Indeed during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours, home office, take care of child, social distancing... All of these modifications may have led to stress and anxiety. It has been previously demonstrated that high perceived stress levels are correlated with high preference for sweet and fat foods . In this context caution would be exercised in obese patients especially those with binge eating disorders. Indeed binge eating disorder is characterized by compulsive overeating or consuming abnormal amounts of food while feeling unable to stop and a loss of control. And one key trigger of binge eating disorder is stress and anxiety. Thus, patients with binge eating disorders may have been more sensitive to the impact of lockdown and thus urgently would require appropriated care management.

The main objective is to compare the eating behaviour between obese patients with or without binge eating disorders. The second objective is to compare the weight evolution between the two groups before and after the lockdown.

To reach these objectives, the scientific team of the CIO project proposes to contact by phone and e-mail obese patients (with or without binge eating disorders) who have been hospitalized for their obesity disease before the start of the lockdown in the Endocrinology department of the Lyon Hospital. The patients will be asked to fill in several questionnaires (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge eating disorders… during the lockdown. The results of these questionnaires will be compared to those collected during their hospitalisation before the lockdown.

The hypothesis is that participants suffering from binge eating disorder will have more sever eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.

ReferenceCitation: Torres SJ, Nowson CA. Relationship between stress, eating behavior, and obesity. Nutrition. 2007 Nov-Dec;23(11-12):887-94. Epub 2007 Sep 17. Review.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Intégré de l'obésité de Lyon / HCL


title: Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement

acronym: CovImmune 2

summary:
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.

The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.

The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Is the Quad Helix More Efficient to Correct Mandibular Asymmetry Before Age 7? A Retrospective Comparative Study

summary: To compare the effectiveness of the Quad Helix, an orthopaedic conventional appliance, in the correction of skeletal mandibular asymmetry, on frontal x-ray, in subjects treated before or after 7 years.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Registrar Performance in Laparoscopic Distal Pancreatectomy and Its Effect on Postoperative Outcomes

summary: This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes.


title: Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies

acronym: EVEIL

summary:
In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms.

However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age.

The investigators have developed a questionnaire with the aim of quantifying the child's vision so that the decision is most justified. The items of this questionnaire were established based on the literature and were submitted to a panel of experts in ophthalmo-pediatrics. The objective of this study is to determine the internal validity and as far as possible (since there is no equivalent tool) the external validity of the questionnaire developed.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Is Adipose Tissue a Reservoir for SARS-Cov2 Spread?

summary: Resident cells of human adipose tissue express ACE2 and DPP4, receptors for SARS-Cov2. The hypothesis is that the virus may enter and spread in fat depots.


type: EudraCT Number

title: Efficacy of Morphine in Reducing the Rate of Early Non-Invasive Ventilation (NIV) Failure in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD), Phase I/IIa

acronym: MORPHEUS I/IIa

summary:
Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are a major source of morbidity and mortality for patients and cost to the society. In case of acute respiratory failure with hypercapnia and acidosis, Non Invasive Ventilation (NIV) is preferred as a first line treatment.

NIV failures are not uncommon, from 15% in intensive care to 25 - 30% in emergency departments. They most often occur at the start of the NIV or in the hours that follow. There are many reasons for these failure. Among these are; dyspnea, discomfort, the pain related to the exacerbation and also to the NIV are frequently noted.

The use of certain drugs with anxiolytic, hypnotic and/or analgesic properties could also be useful. Some sedatives and opioids have already been studied in this indication but without a therapeutic trial and satisfactory methodology. Among the molecules of interest, Morphine seems interesting . It's administration could reduce the ventilatory rate, intensity of dyspnea, pain and anxiety as well as dynamic hyperinflation.

The investigators believe that morphine administration will decrease the rate of early NIV failure by improving comfort (decreased dyspnea and pain) and ventilation (decreased respiratory rate and increase in tidal volume) in patients with exacerbations of COPD.

However, before considering a randomized phase III efficacy study, it is necessary to determine the optimal dose of morphine in this indication, through a phase I/II dose-finding study taking into accounts both the efficacy and toxicity of morphine.

The main objective of this study, is to determine the optimal dose of morphine administered at the initiation of NIV in patient with acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD), which is defined as the maximum gain function combining the probability of dose-limiting toxicity with PaCO2.Therefore, the impact of morphine administration on the physiological parameters of NIV- COPD exacerbation patients will be assessed.

ReferenceCitation: Wedzicha JA Ers Co-Chair, Miravitlles M, Hurst JR, Calverley PM, Albert RK, Anzueto A, Criner GJ, Papi A, Rabe KF, Rigau D, Sliwinski P, Tonia T, Vestbo J, Wilson KC, Krishnan JA Ats Co-Chair. Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017 Mar 15;49(3). pii: 1600791. doi: 10.1183/13993003.00791-2016. Print 2017 Mar.

ReferenceCitation: Bounes V, Charriton-Dadone B, Levraut J, Delangue C, Carpentier F, Mary-Chalon S, Houze-Cerfon V, Sommet A, Houze-Cerfon CH, Ganetsky M. Predicting morphine related side effects in the ED: An international cohort study. Am J Emerg Med. 2017 Apr;35(4):531-535. doi: 10.1016/j.ajem.2016.11.053. Epub 2016 Nov 30.

ReferenceCitation: Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, López Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agustí A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.

ReferenceCitation: Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. Epub 2006 Apr 12. Review.

ReferenceCitation: Schmidt SA, Johansen MB, Olsen M, Xu X, Parker JM, Molfino NA, Lash TL, Sørensen HT, Christiansen CF. The impact of exacerbation frequency on mortality following acute exacerbations of COPD: a registry-based cohort study. BMJ Open. 2014 Dec 19;4(12):e006720. doi: 10.1136/bmjopen-2014-006720.

ReferenceCitation: Hartl S, Lopez-Campos JL, Pozo-Rodriguez F, Castro-Acosta A, Studnicka M, Kaiser B, Roberts CM. Risk of death and readmission of hospital-admitted COPD exacerbations: European COPD Audit. Eur Respir J. 2016 Jan;47(1):113-21. doi: 10.1183/13993003.01391-2014. Epub 2015 Oct 22.

ReferenceCitation: Mackay AJ, Hurst JR. COPD exacerbations: causes, prevention, and treatment. Med Clin North Am. 2012 Jul;96(4):789-809. doi: 10.1016/j.mcna.2012.02.008. Epub 2012 Mar 16. Review.

ReferenceCitation: Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2). pii: 1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug. Review.

ReferenceCitation: Osadnik CR, Tee VS, Carson-Chahhoud KV, Picot J, Wedzicha JA, Smith BJ. Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 Jul 13;7:CD004104. doi: 10.1002/14651858.CD004104.pub4. Review.

ReferenceCitation: Ko BS, Ahn S, Lim KS, Kim WY, Lee YS, Lee JH. Early failure of noninvasive ventilation in chronic obstructive pulmonary disease with acute hypercapnic respiratory failure. Intern Emerg Med. 2015 Oct;10(7):855-60. doi: 10.1007/s11739-015-1293-6. Epub 2015 Sep 4.

ReferenceCitation: Maignan M, Chauny JM, Daoust R, Duc L, Mabiala-Makele P, Collomb-Muret R, Roustit M, Maindet C, Pépin JL, Viglino D. Pain during exacerbation of chronic obstructive pulmonary disease: A prospective cohort study. PLoS One. 2019 May 24;14(5):e0217370. doi: 10.1371/journal.pone.0217370. eCollection 2019.

ReferenceCitation: Yeung WY, Reigner B, Beyer U, Diack C, Sabanés Bové D, Palermo G, Jaki T. Bayesian adaptive dose-escalation designs for simultaneously estimating the optimal and maximum safe dose based on safety and efficacy. Pharm Stat. 2017 Nov;16(6):396-413. doi: 10.1002/pst.1818. Epub 2017 Jul 9.

ReferenceCitation: Jolliet P, Ouanes-Besbes L, Abroug F, Ben Khelil J, Besbes M, Garnero A, Arnal JM, Daviaud F, Chiche JD, Lortat-Jacob B, Diehl JL, Lerolle N, Mercat A, Razazi K, Brun-Buisson C, Durand-Zaleski I, Texereau J, Brochard L; E.C.H.O. ICU Trial Investigators. A Multicenter Randomized Trial Assessing the Efficacy of Helium/Oxygen in Severe Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Apr 1;195(7):871-880. doi: 10.1164/rccm.201601-0083OC. Erratum in: Am J Respir Crit Care Med. 2018 Mar 15;197(6):839-840.

ReferenceCitation: Lightowler JV, Wedzicha JA, Elliott MW, Ram FS. Non-invasive positive pressure ventilation to treat respiratory failure resulting from exacerbations of chronic obstructive pulmonary disease: Cochrane systematic review and meta-analysis. BMJ. 2003 Jan 25;326(7382):185. Review.

ipd_sharing_description:
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.

In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.

location_facility: Emergency Department of Grenoble Alpes University Hospital


title: Study of the Sars-Cov2 Neuroinvasiveness - COVID19

acronym: CORONEVRAXE

summary: Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia, ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can be safely removed from the patient. In this study, COVID-19 patients will be evaluated first, for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.


title: Impact of Barriers and Facilitators to Physical Activity in Patients With Inflammatory Arthritis and Link With Physical Activity Collected by Mobile Phone Apps: a Cross-sectional Study

acronym: ImBAIA

summary:
Background: Patients with inflammatory arthritis (IA), such as spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) are more prone to physical inactivity but derive specific benefits from regular physical activity. Barriers and facilitators to physical activity (B&F-PA) are key elements and knowledge of their correlation to physical activity is essential for developing interventions to promote physical activity that have a greater likelihood of success.

Objectives: primary objective will be to measure the correlation of these B&F-PA to physical activity collected through apps. Secondary objective will be to (I) to quantify physical activity collected through apps in IA patients and (II) to observe the link between physical activity, B&F to physical activity and adherence to treatment.

Patients and methods: This is an international, multicentric, cross-sectional study.

Patients: From the first of September to the first of February 2020, all patients with definite axSpA, RA or PsA, aged above 18 and able to walk, who have a mobile phone compatible with apps that can track steps, who agree to participate and give his oral informed consent and with ability to read and write in the language of the participating country, seen in outpatient visits in the participating centers, will be asked to participate. The planed inclusion was 200 participants.

Data collection: clinical data and information about physical activity and B&F-PA will be entered by rheumatologists during or electronically by patients at the same time point.

Questionnaire for B&F-PA: a patient reported questionnaire was recently developed for this study in 2019 based on a systematic review to identify the main B&F-PA. A list of questions was generated from the systematic review reviewed and tested for face validity by 11 experts and confronted to 20 patients with IA through a cognitive debriefing.

Physical activity: Physical activity will be measured objectively during the last 7 days by apps already installed by default on the mobile phone of participants and subjectively with the International Physical Activity Questionnaire short version (IPAQ-S).

Other outcomes: Stage of exercise behavior change and adherence to treatment will also be collected.

Planned analyses: Perceived B&F-PA will be described using frequencies. A score will be calculated for each participant representing the limitations or facilities to perform physical activity.

Analysis of the physical activity: The distribution of mean number of steps will be assessed visually for outliers. Univariate analysis will be completed between mean number of steps and gender, age, disease and stages of change. Correlation between mean number of steps and IPAQ-S score will be calculated.

Link between physical activity and barriers and facilitators: The link between B&F questionnaire score and mean number of steps will be tested using linear regression. Then multivariate regression including demographic variables, psychological status and disease characteristics will be performed.

Outcomes of the study: The expected outcomes of the ImBAIA study are a better understanding of B&F to physical activity in patients with IA and their impact to limit or to favor physical activity. We also expect to observe the level of physical activity of an IA population objectively measured with apps. Finally, a validation was expected to use questionnaire of B&F.

ReferenceCitation: Davergne T, Tekaya R, Sellam J, Tournadre A, Mitrovic S, Ruyssen-Witrand A, Hudry C, Dadoun S, Avouac J, Fautrel B, Gossec L. Influence of perceived barriers and facilitators for physical activity on physical activity levels in patients with rheumatoid arthritis or spondyloarthritis: a cross-sectional study of 150 patients. BMC Musculoskelet Disord. 2021 Oct 30;22(1):915. doi: 10.1186/s12891-021-04792-7.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants

acronym: CORhum

summary: A retrospective monocentric study with large active files of patients monitored for rheumatoid arthritis, spondyloarthritis and systemic lupus erythematosus with as main endpoint the morbimortality of Covid-19 in these patients (number of patients hospitalized in conventional units and/or in intensive care and/or deceased). The results will be compared with those of the general population based on the epidemiological data of Covid-19.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

ReferenceCitation: Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2.

ReferenceCitation: Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16.

ReferenceCitation: Haberman R, Axelrad J, Chen A, Castillo R, Yan D, Izmirly P, Neimann A, Adhikari S, Hudesman D, Scher JU. Covid-19 in Immune-Mediated Inflammatory Diseases - Case Series from New York. N Engl J Med. 2020 Jul 2;383(1):85-88. doi: 10.1056/NEJMc2009567. Epub 2020 Apr 29.

ReferenceCitation: Michaud K, Wipfler K, Shaw Y, Simon TA, Cornish A, England BR, Ogdie A, Katz P. Experiences of Patients With Rheumatic Diseases in the United States During Early Days of the COVID-19 Pandemic. ACR Open Rheumatol. 2020 Jun;2(6):335-343. doi: 10.1002/acr2.11148. Epub 2020 May 9.

ReferenceCitation: Favalli EG, Ingegnoli F, De Lucia O, Cincinelli G, Cimaz R, Caporali R. COVID-19 infection and rheumatoid arthritis: Faraway, so close! Autoimmun Rev. 2020 May;19(5):102523. doi: 10.1016/j.autrev.2020.102523. Epub 2020 Mar 20. Review.


title: " Brain Changes After Repetitive Head Impacts in Soccer and the Effects of a Protective Device: Biomechanical, Cognitive, Electrophysiological and Multimodal Neuroimaging Study "

acronym: Soccer-BRAIN

summary: Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired

lead_sponsor: University Hospital, Bordeaux


title: Effect of Music Therapy in Pain and Anxiety Management for Patients Treated With Stitches in Emergency Department

acronym: PLAY

summary: The aim of this study is to measure the effect of music therapy on pain and anxiety levels during stitches procedure in an adult emergency department.

ReferenceCitation: Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD004843.

ReferenceCitation: Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L. Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr. 2008 Mar-Apr;8(2):117-28. doi: 10.1016/j.ambp.2007.12.005. Review.

ReferenceCitation: Kühlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Emergency Department Saint Antoine Hospital (AP-HP)


title: Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - PRO-SERO-COV

acronym: PRO-SERO-COV

summary: The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.

status: Active, not recruiting

lead_sponsor: Institut Bergonié


title: The Effect of Nonverbal Vocalisations on Pain Tolerance

acronym: VOCPAIN

summary:
Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in various contexts that are likely to perform biological functions.

and important social issues. Yet despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal vocalizations remain little studied and poorly understood including in humans. In this context, the investigators wish to examine how the production of vocalizations non-verbal communication influences pain tolerance in healthy adults.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire Saint-Etienne

intervention_type: Diagnostic Test


title: Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)

acronym: SALOME

summary: Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.

primary_purpose: Health Services Research

lead_sponsor: Institut Curie


title: Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy

acronym: DEMOGRAFT

summary: Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

ReferenceCitation: Perone JM, Goetz C, Zevering Y, Derumigny A, Bloch F, Vermion JC, Lhuillier L. Graft Thickness at 6 Months Postoperatively Predicts Long-Term Visual Acuity Outcomes of Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Dystrophy and Moderate Phakic Bullous Keratopathy: A Cohort Study. Cornea. 2022 Nov 1;41(11):1362-1371. doi: 10.1097/ICO.0000000000002872. Epub 2021 Oct 22.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Evaluation of an Opioid Decrease Strategy in Chronic Pain Patients at the Pain Assessment and Treatment Center in Montpellier: Prospective Study Over 6 Months.

acronym: EODSCPP

summary:
Increase in the consumption of analgesics observed in many countries with a mediatic crisis resulting in an increasingly frequent wish of patients to wean themselves from opiates. A recent update (B. Rolland 2017) suggests that upon initiation of an opioid analgesic treatment, the patient should be informed of the risk of opioid dependence and misuse. There is no clearly validated decay scheme in the event of dependence in patients with Chronic Non-Cancer Pain.

Hypotheses:

Possibility of a rapid decrease in opioid analgesic treatments at DCNC sensitized to the risk of DOP and MOP. (Protocol implemented: Multidisciplinary assessment, workshops and information sheet on chronic pain, treatments and risk of DOP, pharmacological and nonpharmacological adaptation)
Highlight the need for additional information from patients and prescribers on the risk of DOP and MOP in DCNC.


title: Deformation of the Diaphragm Zone of Apposition During the Loading of the Respiratory System in the Healthy Volunteer. Evaluation of a New Index Measured by Speckle Tracking

acronym: ZADSPECTRA

summary:
The assessment of the work of the respiratory muscles is a fundamental clinical data in intensive care, especially to guide the management of patients requiring ventilatory support. This data is difficult to access in current practice. The reference technique to estimate the work of breathing (transdiaphragmatic pressure) is not feasible in clinical routine and evaluates only the respiratory work of the diaphragm, not that of the accessory muscles. The ultrasound technique of speckle tracking allows a fine and multidimensional analysis of the deformation of the respiratory muscles during the respiratory cycle.

The investigators hypothesize that the analysis of the multidimensional deformation of the diaphragm at the level of the apposition zone can produce a robust and reproducible index, which is correlated with the work of breathing. The performance of this index will be compared to that of the thickening fraction of the diaphragm. On the other hand, the investigators will evaluate the feasibility of measuring the thickening of the accessory respiratory muscles (scalene and intercostal).

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon


title: An Open Randomized Therapeutic Trial Using ANAKINRA, TOCILIZUMAB Alone or in Association With RUXOLITINIB in Severe Stage 2b and 3 of COVID19-associated Disease

acronym: INFLAMMACOV

summary:
COVID19-associated disease may have different clinical aspects classified in 3 stages. Some patients initially presenting with a non-hypoxemic viral pneumonia (stage 2a) may evolve toward a more severe stage 2b or 3 (acute respiratory distress syndrome, ARDS) around the 7th or 10th day of evolution, with a severe biological inflammatory syndrome (CRP>200 mg/l), and some times more severe complications such as acute renal insufficiency, consumptive coagulopathy or shock, requiring increasing oxygen therapy, ICU admission, invasive mechanical ventilation and possibly leading to death. This detrimental evolution is due to a host-derived "cytokine storm" with a great excess of circulating inflammatory cytokines. In animal models of ARDS complicating coronavirus or influenza virus infection, the cytokine storm has been linked to hyperactivation of the NLRP3 inflammasome. NLRP3 constitutes an intracellular protein platform which is responsible for caspase1 activation and processing of interleukin (IL)-1beta and IL-18 . IL-1b is a major proinflammatory cytokine which induces IL-6, whereas IL-18 is an inducer of interferon gamma (IFNg) production by Th-1 lymphocytes. A blood IL-1/IL-6 signature can be defined by increased neutrophilia and CRP concentrations, whereas an IL-18/IFNg signature is characterized by severe hyperferritinemia, consumptive coagulopathy and cytopenia. A majority of patients with COVID-19 infections seems to have an IL-1/IL-6 signature, evolving in the more severe forms toward an IL-18/IFNg signature, mimicking cytokine profiles observed in other inflammatory diseases such as Still's disease or hemophagocytic syndromes. In Still's disease, therapeutic inhibition of IL-1 or IL-6 has proven to be very efficient strategies. During hemophagocytic syndromes, inhibition of IFNg is effective in humans notably through blockade of its receptor signalization, using the JAK kinase inhibitor ruxolitinib.

Following this strategy, we propose to use biological drugs currently available for inhibition of IL-1 (anakinra), IL-6 (tocilizumab) or IFNg signaling (ruxolitinib) in the severe forms of COVID19-associated disease. Our hypothesis is that IL-1, IL-6 or JAK kinase inhibition will allow:

to prevent stage 2b worsening and the need to be admitted in ICU, by decreasing oxygen-requirement and systemic inflammation
to improve stage 3 and extremely severe stage 3, allowing invasive mechanical ventilation weaning, improving multi-system organ dysfunction, leading to a faster ICU exit.

We propose an open randomized therapeutic trial (1/1/1) on 216 patients with severe stage 2b and 3 of the disease


title: Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR

summary:
The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs.

The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is gladly recurrent.

The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments.

The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media.

The objective of this study is to translate and validate the test in French in children.


status: Not yet recruiting

acronym: CAPEMCHAR

title: Evaluation of the Safety, Tolerability, Distribution and Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients at a High Risk of Recurrence Before Radical Prostatectomy: A Phase IIa Study

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

source: euctr

summary:
Our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy.

The primary objective of this Phase IIa pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads according to different loading doses. Four dose levels will be tested: doxorubicin-free beads to test the effect of embolization alone, 2.5 mg of doxorubicin (1/20 of the dose administered for liver cancers), 5 mg and 10 mg of doxorubicin.

The secondary objectives of the study are to evaluate the tolerance (functionnal questionaries at D0, D14 M1 and M3; collection of complications at D1, D5, D14, M1, M3; MRI at D14), evaluate the systemic diffusion of doxorubicin (doxorubinemia at D1), evaluate an early anti-tumor effect of the treatment (via a prostate-specific antigen test at D14 M1, M3 and magnetic resonance imaging at D14), describe the distribution of beads observed on the surgical specimen and evaluate the dose effect at 1 month and 3 months after surgery (via a prostate-specific antigen test at D14, M1, M3 and magnetic resonance imaging at D14).


title: The Effect of Exposure to Aversive Non-verbal Vocalizations on Pain Tolerance

acronym: CRYPAIN

summary:
Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in various contexts that are likely to perform biological functions.

and important social issues. Yet despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal vocalizations remain little studied and poorly understood including in humans.

In this context, the investigators wish to examine how the perception of vocalizations non-verbal aversive behaviours influence pain tolerance in healthy adults.

location_facility: Centre Hospitalier Universitaire SAINT-ETIENNE


title: Contributions and Limitations of the Stress Test on the Prediction of Cardiovascular Events in a High-risk Firefighter Population

acronym: FIRE-PREV

summary: If the risk of myocardial infarction in activity is widely demonstrated to date for firefighters, and the realization of a stress test in those at high cardiovascular risk included in the practice habits, no study has evaluated the contributions and limits of the realization of a stress test in this specific population of firefighters at high cardiovascular risk for the prediction of cardiovascular events.


title: Clinical and Economic Evaluation of Outpatient Bariatric Surgery

acronym: Bariatric Ambu

summary: This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient). Then, the study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences.

ReferenceCitation: Cobourn C, Mumford D, Chapman MA, Wells L. Laparoscopic gastric banding is safe in outpatient surgical centers. Obes Surg. 2010 Apr;20(4):415-22. doi: 10.1007/s11695-009-0065-7.

ReferenceCitation: McCarty TM, Arnold DT, Lamont JP, Fisher TL, Kuhn JA. Optimizing outcomes in bariatric surgery: outpatient laparoscopic gastric bypass. Ann Surg. 2005 Oct;242(4):494-8; discussion 498-501.

ReferenceCitation: Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.

ReferenceCitation: Ignat M, Ansiaux J, Osailan S, D'Urso A, Morainvillers-Sigwalt L, Vix M, Mutter D. A Cost Analysis of Healthcare Episodes Including Day-Case Bariatric Surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy) Versus Inpatient Surgery. Obes Surg. 2022 Aug;32(8):2504-2511. doi: 10.1007/s11695-022-06144-3. Epub 2022 Jun 10.

lead_sponsor: IHU Strasbourg

location_facility: University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery


title: Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)

summary: The investigators have previously reported that cardiac surgery with CPB ( cardiopulmonary bypass) in young infants induced a drastic reduction in mHLA-DR ( Human Leucocyte Antigen) expression, which represents one of innate immune mediator. Danger-Associated Molecular Patterns (DAMPs) can elicit immune response and may subsequentely induce an immune-suppressed state. The investigators hypothesize that CPB causes excessive DAMP release, leading to the development of immune suppression. Thus, DAMPs release will be assessed in patients undergoing CBP, and consequences on immune suppression will be evaluated.

lead_sponsor: Nantes University Hospital


title: Pilot Study Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical Devices and the Economic Repercussions

acronym: OPTIBLOC

summary: assess the impact of the intervention of a clinical pharmacist expert in sterile medical devices


title: Foci of Tumor Heterogeneity in IDH1-mutated Diffuse Low-Grade Gliomas Reveal STAT3 Activation and Downregulation of the Phosphoethanolamine Enzyme ETNPPL Acting as a Negative Regulator of Glioma Growth

acronym: FDLGG

summary:
Background:

Diffuse low-grade gliomas (DLGG) are slow-growing primary-cancer of the brain and spinal cord. They represent up to 15% of the developing tumors in those organs with fatal outcome for the patients because of their evolution. The reasons for this transformation towards more malignant tumors still remain ill defined. Previously, the research team in neuro oncology at Montpellier University Hospital found foci of tumor heterogeneity within 20 to 30 % of the patients developing a DLGG and published their results. The investigators assumed that those foci represent the early beginning of the transformation from a diffuse low-grade glioma to a glioblastoma, tumor with highly malignant cells and a life expectancy of two years in average for the patient.

Methods:

The investigators selected adult patients with no prior surgery nor neuro oncology treatment when enrolled. They presented a specific mutation for an enzyme of the metabolism named IDH1, standing for Isocitrate Dehydrogenase 1, found in 70% of DLGG. Patients were also selected because they presented foci of tumor heterogeneity. After obtaining their consent, the investigators studied by immunohistochemistry the pathways deregulated between the DLGG and the foci. The investigators also extracted RNAs, molecules expressing the life and metabolism of tumor cells, and compared them to know what genes were differentially expressed between the DLGG and the foci. All RNAs were tested for quality control prior to be processed further. The investigators then studied 8 patients with compliance with ethics, authorizations and institutional guidelines. Genes of interest were studied in vitro to assess their functions. The investigators found a barely described enzyme of the catabolism of the phosphoethanolamines and discovered a new anti-proliferative tumor-role for it.

•Discussion: The investigators first showed that foci have a higher percentage of p-STAT3+ cells which indicates STAT3 pathway activation in these cells. Phosphorylated STAT3 translocates to the cell nucleus to regulate many genes involved in proliferation, apoptosis and angiogenesis. As such, phosphorylation of STAT proteins, notably STAT3, is involved in the pathogenesis of many cancers, including GBM, by promoting cell cycle progression, stimulating angiogenesis, and impairing tumor immune surveillance.

The investigators found that ETNPPL RNA and protein are reduced in foci cells and absent in glioblastomas. This is consistent with glioma database analyses showing that ETNPLL expression is inversely correlated to STAT3 and MKI67 whose expression are higher in foci and glioblastomas. In addition, Kaplan-Meier analysis shows that patients with low expression of ETNPPL have lower overall survival These observations suggested that this enzyme may oppose glioma cells proliferation. The investigators demonstrated this hypothesis by overexpressing ETNPPL in 3 glioblastoma cell cultures. Two were sensitive to ETNPPL overexpression which reduced their growth while no effect was detected in Gli4 cells. These glioblastoma-derived cultures have different types of mutations.


title: Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) Self-questionnaire Assessing Women's Feelings About the Onset of Childbirth

acronym: EXIT

summary: The objective of the study is to cross-culturally adapt and validate the French version of the EXIT scale: an assessment tool on induction of labor.

lead_sponsor: University Hospital, Clermont-Ferrand


title: New Tools for Predicting Capillary Leak Shock During Dengue Fever

acronym: PrediDengue

summary: Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.

ReferenceCitation: Djossou F, Vesin G, Elenga N, Demar M, Epelboin L, Walter G, Abboud P, Le-Guen T, Rousset D, Moreau B, Mahamat A, Malvy D, Nacher M. A predictive score for hypotension in patients with confirmed dengue fever in Cayenne Hospital, French Guiana. Trans R Soc Trop Med Hyg. 2016 Dec 1;110(12):705-713. doi: 10.1093/trstmh/trx004.

lead_sponsor: Centre Hospitalier de Cayenne


title: Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case

summary: Evaluation of psychological impact of patients after pancreatectomy because of cancer diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3 control groups will be used to compare de psychological impact.

lead_sponsor: Institut Paoli-Calmettes


title: Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

summary:
Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which conditions the prognosis of the disease.

Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day as a result of possible hyperinflammatory response, the respiratory impairment of COVID is unique and many questions remain unanswered concerning its evolution once the acute phase has passed. Knowledge of the evolution of pulmonary involvement, particularly in patients requiring hospitalization, can help reduce the morbidity linked to the persistent abnormalities identified by establishing early therapeutic management. It can also provide a better understanding of the mechanisms of pulmonary involvement in the acute phase. Current data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain distant from this infection at all levels of the respiratory system: gas exchange, perfusion, ventilatory mechanics, and interstitial lung disease.

The main objective is to characterize persistent gas exchange anomalies 4 months after documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring hospitalization.

lead_sponsor: University Hospital, Toulouse


title: COVID 19 Serology in Pulmonologists : Pneumo Sero Cov

acronym: Pneumoserocov

summary: Respiratory physicians are highly exposed workers to Covid-19 as they perform spirometry, endoscopy, and manage Covid-19 in first line for most of them. Moreover, none reported to have apply increased levels of protection for performing these acts in the most active period of viral circulation, until the lockdown. Whether they were most frequently immunized against SARS-CoV-2 at the end of the first wave than the general population is of utmost importance individually but also worldwide

lead_sponsor: University Hospital, Montpellier


title: A 12-month Real Life Study of IBD Patients Under Stable Steroid Free Clinical and Biological Remission Switched From Adalimumab Originator Humira® to One of Its Biosimilar: Amgevita®,Hulio®,Hyrimoz® or Imraldi®.

acronym: Rhoneswitch

summary:
Biosimilars represent great potential in cost saving and reinvestment opportunities in healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference product in patients with rheumatoid arthritis and psoriasis. No data are currently available in IBD patients. Real-life data are needed.

Minimizing the switch back is another clinical challenge in the current area of biosimilars. The primary objective of Rhoneswitch is to describe the magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.

The primary endpoint is to assess the percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.

lead_sponsor: University Hospital, Grenoble


title: Retrospective Observational Study of Posterior Keratometry Measured by IOLMaster 700 in Patients With Keratoconus

summary:
Keratoconus is a progressive bilateral disease leading to an apical stromal thinning and an irregular astigmatism by a steepening of the cornea, causing visual impairment. The causes are not yet well known, but it seems to be linked to several comorbidities. Keratoconus is a rare and for a long-time asymptomatic condition and its diagnosis needs meticulous screening for the early stages. Detecting it as soon as possible is a goal as it could lead to earlier avoiding of contributing factors such as eye rubbing and earlier treatment if needed.

The gold standard for keratoconus screening and staging is computerized videotography. It gives information about anterior and posterior corneal bulging, steepening, and thinning. It can be completed by anterior segment optical coherence tomography, which can show corneal scarring. Since recently, some biometry devices can give some information about the posterior corneal keratometry trough swept source optical coherence tomography measures. The measurement of the total corneal power instead of an extrapolation lead to better precision in refractive results after cataract surgery in some cases. It also helped to increase our knowledge about posterior corneal astigmatism. In normal eyes, average posterior corneal astigmatism is 0.37 diopters and against the rule in 91 percent of eyes. There is a correlation between the magnitude of anterior and posterior astigmatism.

In keratoconus eyes, several studies have shown that there is an alignment between axes of the anterior and posterior corneal astigmatism. These studies have been performed on computerized videotopography devices.

The goal of this study was to confirm or deny previous observations about posterior astigmatism in keratoconus eyes, and to assess if the rotation of axis between anterior and posterior astigmatism measured by IOL Master 700® can be a good sign for detection of early stages and fruste keratoconus.