title: Observational Study (and Blood Samples Without Genetics Analysis) Tramadol Clinical Efficiency and Tolerance Correlated to O-desmethyltramadol/Tramadol Ratio (CLINCYTRAM)

acronym: CLINCYTRAM

summary:
Tramadol is a grade II analgesics as World Health Organization definition. It can both be an agonist on mu receptors, which provides it a low opioid action, and also be a Serotonin-norepinephrine reuptake inhibitor, which act on neuropathic pain.

Tramadol is metabolized by P450 2D6 cytochrome (CYP2D6) in O-desmethyltramadol (O-dt) which is the most active form on the pharmacologic side (analgesic effect 2 to 4 times more powerful than tramadol itself).

In caucasian population, 5 to 10% of patients are genetically qualified as "poor metabolizer phenotype"; this status is correlated to a lower analgesic efficiency compared to "rapid metabolizer".

A multicenter study, CYTRAM, is under publication and allowed measurement of blood ratio O-dT/tramadol as a way to know the phenotype of CYP2D6 to detect "poor metabolizer phenotype" status.

Indeed, blood ratio O-dT/tramadol threshold under 0.1 detects " poor metabolizer phenotype " status for postoperative patients treated by tramadol, with a good sensibility (87,5%) and specificity (83.8%).

Which impacts for current practice? The next step is to know if this blood ratio is linked to an analgesic efficiency and a good tolerance for tramadol. A "poor metabolizer phenotype" patient would have no benefit of tramadol posology increasing. Therefore, phenotype detection, thank to blood ratio, could allow to switch quickly tramadol to another analgesic treatment for "poor metabolizer phenotype" patients.

The main objective of the study is to forge a link between O-dT/tramadol ratio and analgesic efficiency. Secondary objectives investigate side effects and frequency related to O-dT/tramadol ratio and pain relief, and also impact of CYP2D6 - inhibitor treatments on the blood ratio.

If there is a correlation between this blood ratio and treatment efficiency and tolerance, O-dT/tramadol ratio's detection will allow a better adaptation for some treatments metabolized by CYP2D6. Therefore, this evolution will contribute to health quality and health safety improvement.

lead_sponsor: University Hospital, Caen


title: Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV) in Healthy Subject and Subject Affected by Glaucoma or Retinal Venous Occlusion

acronym: AO-LDV

summary:
The difficulty to measure blood flow in humans is connected with the necessity of using not invasive, reliable and reproducible techniques.

There is several quantitative approaches to study eye blood flow which do not answer all these specifications. The laser doppler velocimetry allows movement speed measures but not vessel diameter. Optical coherence tomography doppler allows a simultaneous diameter and speed of travel (movement) measures, but presents a limited spatial resolution and thereby not easily reproducible vessel diameter measures.

The investigators propose development of a technique allowing a simultaneous diameter and velocity measure of these vessels.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Diagnostic Assessment Study, Single Site and Prospective, comparing18F-DOPA PET and Multiparametric RMI in Initial Exploration of Diffuse Glial Tumors

acronym: GLIROPA

summary:
For patient having a brain tumor, RMI is the standard exam for tumor characterization and determines initial surgery.

The aim of this study is to assess if PET could provide additional information that could have an impact on surgery (indication and planification)

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Center Eugene Marquis

intervention_type: Diagnostic Test

lead_sponsor_type: industriel

status_simplified: Completed


title: Study of the Association Between Transferrin Saturation and Asthenia in Hemochromatosis

acronym: HEMOSAT

summary: Observational study.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Rennes University Hospital


title: Application de l'oxymétrie Dynamique Pour le Diagnostic Des pièges artériels poplités

acronym: PETRUS

summary: Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of popliteal entrapment syndrome (PES) in 30 patients with suspected PES and 30 asymptomatic control heathy subjects

ipd_sharing: Undecided

lead_sponsor: University Hospital, Angers


type: Other Identifier

title: Magnetic Resonance Imaging Study of the Mechanisms Underlying Irreversible Disability in Multiple Sclerosis

acronym: SEP-MRI

summary: Multiple sclerosis (MS) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. MS is an inflammatory demyelinating and degenerative disease of the central nervous system. Recently, MRI technics have demonstrated their sensibility to the different processes involved in MS. Particularly, MRI has evidenced that the pathological process of MS is not restricted to the macroscopic lesions of the white matter but also involves the normal appearing white and grey matter. In the normal appearing brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced. Moreover, MRI has demonstrated the existence of brain functional reorganization processes that may limit the clinical expression of pathological injuries. Despite these important findings, the pathological underpinnings of irreversible disability are largely unknown. The present project aims to depict the main determinants of physical but also cognitive disability in patients with MS. To do this, a longitudinal study including 70 patients with MS using different MRI markers known to be sensitive to the different pathological aspects of MS will be performed. The relationships between these markers and the progression of disability will be assessed. Identification of the main pathological underpinnings of irreversible disability of MS will provide the most relevant therapeutic targets.

status: Recruiting

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille

intervention_type: Other

status_simplified: Ongoing


type: Registry Identifier

title: Protocol for Evaluating a Planning Algorithm for Gamma Knife Radiosurgery

acronym: SPEED

summary:
The process of developing Gamma Knife radiosurgery treatment plans is today very dependent on the level of human expertise resulting in a great heterogeneity of the intrinsic qualities of the treatment planning and the quality of care delivered in radiosurgery.

The existing reverse planning systems, although they have progressed considerably in recent years, produce results that are still lower than those achieved by an expert.

Conventionally, an experienced dosimetric planner will act mainly on the coordinates of the position of the isocenters, on the size of the collimators, sector by sector, and on the irradiation time of each isocenters. In theory, the combination of these variables provides access to billions of combinatorics whose diversity far exceeds the computational capabilities of the human mind. The dosimetric planner therefore uses a very small part of the spectrum of possible patterns by always reproducing a limited number of empirical solutions.

The company Intuitive Therapeutics has developed a new mathematical algorithm which can automatically test in a very short time all the combinatorial possibilities and converge very quickly to the solution that best meets the clinical, anatomical and dosimetric objectives defined by the neurosurgeon. The quick processing of the system also allows the operator to modify the constraints to refine the proposed result in real time.

The demonstration of the reality of the performances of this algorithm would give the ability to even inexperienced users to develop high performance planning for the benefit of the patient in terms of optimizing the efficacy / toxicity ratio of the radiosurgery treatment results

The primary objective is to evaluate comparatively the quality of the schedules produced by the algorithm developed by the company Innovative Therapeutics to those produced by an expert who carried out more than 15000 dosimetric plannings and radiosurgical interventions.

The main criterion of comparison is the Paddick index.

The secondary criteria for comparison are:

Compliance index
selectivity index
Gradient index
Maximum, minimum, average dose at risk structures
Dose distribution in the target volume
Treatment time (at equal source activity)
Time of realization of the planning

It was chosen to treat patients with vestibular Schwannoma OR multiple brain metastases (> 5) treated in single session by Gamma Knife OR para-optic meningioma in hypo-fractionated treatment on Gamma Knife with restraint mask with inclusion of visual paths in the target volume planning.

The aim of the study is to show at least the non-inferiority of this new method compared to the expert user based on the Paddick Index. This index has continuous values between 0 and 1, 0 being the worst case and 1 being the ideal solution. In order to define the sample size needed for each pathology, a pilot phase is required. This phase can be performed retrospectively using treatments already defined by the expert user. This pilot phase will allow us to identify the difference that can be expected between the index values and the variability of this difference. Based on these values we will be able to determine the size of the sample allowing us to statistically test the non-inferiority, or even the superiority of this new device. The number of cases to be included during the pilot phase should be at least ten cases and a maximum of thirty cases. The choice of the number of cases to be integrated during this pilot phase will depend on the homogeneity of the differences obtained on the first cases. These values will allow us to calculate the size of the samples necessary for the study of non-inferiority as well as for the study of superiority. Depending on the calculated sizes samples we will make a choice to ensure that this study takes place in the expected duration.

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Device


title: Childhood Trauma in Schizophrenia: Exploration of Links Between Gene Expression, Cerebral Morphology and Symptomatology. SCHIZO' TRAUMA

acronym: SCHIZO'TRAUMA

summary:
Childhood trauma is known as a vulnerability factor in schizophrenia. In healthy volunteers, these adversities are linked to a decrease of grey matter of the brain, similar to those observed in schizophrenia.

In a previous study based on Voxel-Based Morphometry (VBM), including 21 schizophrenic patients and 30 healthy volunteers, the investigators shown a negative correlation between emotional neglect (important dimension in childhood trauma) and grey matter decrease. This strong correlation was significantly higher in schizophrenic patients than in healthy volunteers, suggesting a higher genetic predisposition to environmental factors in schizophrenic people.

Currently, interaction between genetic predisposition and environmental stress factors is the major model for understanding in schizophrenia. In order to analyze both effects on human body, particularly on brain, several studies currently focus on the product of genetic expression, the ribonucleic acid (ARN).

The purpose of this study is to provide an explanatory model of links between childhood trauma, candidate gene for schizophrenia expression, cerebral morphology and schizophrenic symptomatology. Using conceptual framework of stress vulnerability, structural equation modeling (SEM) will allow testing causal link between these different variables.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Descriptive Study on the Evaluation of Well-being in Relation to Diet and Nutrition and Comparison Between Three Care Units in the Dijon University Hospital Centre

acronym: ALIMS

summary: The aim of this study is to qualify patient well-being in relation to diet. The notion of dietary well-being is believed to be subjective and we wish to base it on tangible parameters (presentation of meals, variety of menus, social interaction, environment, convenience, pleasure...) in order to establish a score of dietary well-being that we will then correlate to the patient's nutritional status. This tool can then be used more widely as an assessment tool within health institutions.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Cognitive and Emotional Factors in Visual Exploration Among Patients With Post-Traumatic Stress Disorder

summary: Post-traumatic stress disorder (PTSD) is characterized by hypervigilance. In particular, previous works suggest that patients tend to scan constantly the environment for possible threats. The present project aims at investigating such attentional bias in patients with PTSD using the change blindness paradigm that offers the interesting possibility of studying sensitivity to sudden changes using ecological stimuli. More precisely, the investigators will investigate whether patients are more sensitive than matched controls to sudden changes in the visual environment and whether this hypersensitivity is specific or even stronger when visual information has an emotional content. The attentional bias will be measured using motor responses (accuracy and speed to indicate the occurrence of a change by pressing a button) as well as eye movements.

lead_sponsor: University Hospital, Lille


title: Study of Prevalence and Characteristics of Hallucinations in Patients With Borderline Personality Disorder

summary: Hallucinations in borderline personality disorder are a frequent an serious trouble which have an important impact in patients lives. Despite this, they are often ignored by nursing staff, and are not an important criteria in Diagnostic and Statistical Manual (DSM) 5 and Classification Internationale des maladies (CIM-10). The main objective of our study is to assess the prevalence of this trouble in borderline personality disorder (BPD) population, and to characterize the hallucinations in order to compare our results with those of international studies.

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Toulouse


title: Vision, Attention and Reading in Neurofibromatosis Type 1 (NF1) Children

summary: The present project will therefore focus upon those processes related to visual attention and perceptual abilities and on their potential to explain reading behavior and reading problems in NF1. The main objective of this study is to clarify the specificity and heterogeneity of reading profiles and the causes of its disturbance in NF1. In particular, this project allow the investigators to study more precisely the relations between perceptual, oculomotor and visuo-attentional skills in NF1 children and reading abilities. In addition, a new oculomotor/perceptual reading aid for NF1 children will be evaluated. The investigators believe that the early intervention for perceptual, visuo-attentional or oculomotor problems may promote academic skill development.

primary_purpose: Other


title: Preoperative Physical Activity Intervention in Patients Before Planned Liver Resection for Cancer

acronym: APACHE

summary: The aim of this study is to assess the impact of preoperative physical activity on physical capacities of patients undergoing liver resection for primary or secondary liver cancer.

design_allocation: Randomized

lead_sponsor: Célia Turco

location_facility: Chirurgie digestive, viscérale et cancérologique


title: Comparison of Two Methods of Adjusting the Mechanical In-Exsuflation in Neuromuscular Adult Patients

acronym: EXSUFLOW

summary:
In the context of neuromuscular diseases, the weakness of the respiratory muscles makes difficult to manage periods of congestion due to a less effective cough. It exposes the patient to bronchial superinfections that may require hospitalization. The use of cough assistance is therefore essential in order to avoid acute situations such as bronchial superinfections. Mechanical Insuflation-Exsufflation (MI / E) is an instrumental technique commonly used by therapists in a hospital or at the patient's home in order to facilitate the airway mucus clearance. The choice of the pressure settings of the IM / E is a decisive point because it conditions the effectiveness of the generated cough. It'is important to take into account the presence of any collapse in the use of IM / E in order to ensure the most effective cough given by the patient. Actually, except the common impression of the physiotherapist and the patient, there is no "simple" way for detecting and objectifying the threshold of collapse in the upper airways.

The aim of this study is to compare two modalities for the regulation of the level of the MI-E exsufflation, taking into account the presence of a collapse: a subjective "S" adjustment based on the clinical judgment of the therapist and the patient and an objective "O" adjustment based on the flow-volume curve generated during the cough.

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Physiology and Functional Explorations, Raymond Poincaré Hospital


title: Searching Biomarkers of Acute Intestinal Ischemic Injuries

acronym: Survibio

summary:
The aim of the SURVIBIO study is to characterize accurate biomarkers for acute mesenteric ischemia, in particular at early stages.

In the study, the development of biomarkers will be based on the analysis of human biological samples from patients and controls that will be conserved in a biological library. Samples will be analysed in the Laboratory for Vascular Translational Sciences (LVTS, Inserm U1148), in the Department of Biochemistry (Pr Puy, Dr Peoc'h), in Paris V university , in Imperial College of London (Pr Dumas), in Jacques Monod Institute and in Maastricht University Medical Center . The candidate markers will be determined according to an a priori method (form markers already described in the literature) and with no a priori strategy using -omics methods.

ipd_sharing: Yes

intervention_type: Biological


title: Induction of Labour for LGA fœtus in Women Without Insulin-treated Diabetes.. Application of DAME Study in Montpellier University Hospital.

summary:
A french study published in 2015 (DAME) showed a decrease of shoulder dystocia and an increase of spontaneous vaginal delivery when the non insulin-treated diabetes patients with large-for-date fetus were induced.

This new protocole was introduced in Montpellier University Hospital delivery room.

The aim of this study is to evaluate the protocole in Montpellier hospital and to compare our results with the DAME results.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Health Related Quality of Life and Multidimensional Evaluations of a Cohort of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy

acronym: PRISME

summary: The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.

lead_sponsor: Ipsen


title: Automatization of Counting Procedures in Children With Dyscalculia

acronym: PROCEDYS

summary: Researchers in numerical cognition usually think that the greatest and most common difficulty in children suffering from dyscalculia is retrieval of arithmetic facts from long-term memory. However, we have recently shown that retrieval might not be the optimum strategy in mental arithmetic. In fact, expert adults would rather solve simple problems such as 3 + 2 by automated and unconscious procedures. Therefore, we hypothesize that children with dyscalculia might not present deficit in retrieval but, instead, in counting procedure automatization. The aim of the current project is to test this challenging position. Through a longitudinal approach, we plan to precisely examine the behavior of children suffering from dyscalculia over a 3-year period. Children will be aged between 8 to 11 years at the beginning of the study and we will precisely observe the evolution of their solution times when they solve simple addition problems involving one-digit numbers. If children with dyscalculia still struggle with simple additions three years, their solution times plotted on the sum of the problems should still follow an exponential function. Indeed, if counting is not automated, difficulties necessarily increase with the progression on the number line or the verbal sequence, hence the exponential function. On the contrary, if counting procedures tend towards automatization, moves along a number line will progressively become as easy at the beginning of the line as at the end, hence the linear function. Importantly, a retrieval model would predict exactly the inverse pattern because, according to this model, the linear function, which is unanimously considered as the hallmark of counting procedures, should progressively be replaced by a non-linear function through practice.

lead_sponsor: Hospices Civils de Lyon

intervention_type: Behavioral


title: Cerebellar Stroke and Mood Disorders

acronym: CERMOOD

summary: Post-stroke mood disorders (PSMD), including depression, anxiety and apathy, are observed in about 30 % of stroke patients at follow-up 3 or 4 months after stroke occurrence. They impair the functional outcome of the patients and their quality of life. Among the different brain structures involved in PSMD the role of the cerebellum has been under-evaluated while it is now well-known to be involved in mood regulation. The aim of this study will be to describe the characteristics of early and late mood disorders following a first acute ischemic cerebellar stroke using face to face interviews and mobile technologies and investigate their pathophysiological mechanisms through advanced brain Magnetic resonance imaging (MRI) evaluation of cortico-cerebello-cortical morphological and functional connectivity.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Bordeaux


title: Intervention Study to Identify Biomarkers of Processed Meat Intake

summary: The intake of processed meat products has been linked to several adverse health outcomes. However, estimation of their intake proves difficult. This study aims at identifying biomarkers of intake for processed meat products in blood and urine. For this, participants of a randomized cross-over dietary intervention will consume highly controlled diets containing non-processed pork, different processed meat products or no meat. Urine and plasma will be collected and analysed to identify sets of metabolites that are specific for the intake of the processed meat products.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Wedekind R, Kiss A, Keski-Rahkonen P, Viallon V, Rothwell JA, Cross AJ, Rostgaard-Hansen AL, Sandanger TM, Jakszyn P, Schmidt JA, Pala V, Vermeulen R, Schulze MB, Kühn T, Johnson T, Trichopoulou A, Peppa E, La Vechia C, Masala G, Tumino R, Sacerdote C, Wittenbecher C, de Magistris MS, Dahm CC, Severi G, Mancini FR, Weiderpass E, Gunter MJ, Huybrechts I, Scalbert A. A metabolomic study of red and processed meat intake and acylcarnitine concentrations in human urine and blood. Am J Clin Nutr. 2020 Aug 1;112(2):381-388. doi: 10.1093/ajcn/nqaa140.

name: Nutrition and Metabolism Section, International Agency for Research on Cancer, Lyon, France

family: Wedekind

full_name: Roland Wedekind

given: Roland

sequence: first

family: Kiss

full_name: Agneta Kiss

given: Agneta

sequence: additional

family: Keski-Rahkonen

full_name: Pekka Keski-Rahkonen

given: Pekka

family: Viallon

full_name: Vivian Viallon

given: Vivian

name: Centre for Research into Epidemiology and Population Health (CESP), Faculté de Medicine, Université Paris-Saclay, Inserm, Villejuif, France

name: Institut Gustave Roussy, Villejuif, France

family: Rothwell

full_name: Joseph A Rothwell

given: Joseph A

name: Department of Epidemiology and Biostatistics, School of Public Health, Imperial College London, London, United Kingdom

family: Cross

full_name: Amanda J Cross

given: Amanda J

name: Danish Cancer Society Research Center, Copenhagen, Denmark

family: Rostgaard-Hansen

full_name: Agnetha Linn Rostgaard-Hansen

given: Agnetha Linn

name: Department of Community Medicine, UiT the Arctic university of Norway, Tromsø, Norway

family: Sandanger

full_name: Torkjel M Sandanger

given: Torkjel M

name: Unit of Nutrition and Cancer, Cancer Epidemiology Research Programme, Catalan Institute of Oncology, Barcelona, Spain

name: Blanquerna School of Health Sciences - Ramon Llull University, Barcelona, Spain

family: Jakszyn

full_name: Paula Jakszyn

given: Paula

name: Cancer Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom

family: Schmidt

full_name: Julie A Schmidt

given: Julie A

name: Epidemiology and Prevention Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano,Italy

family: Pala

full_name: Valeria Pala

given: Valeria

name: Division of Environmental Epidemiology,  Institute for Risk Assessment Sciences, Utrecht University,  Utrecht, The Netherlands

family: Vermeulen

full_name: Roel Vermeulen

given: Roel

name: Department of Molecular Epidemiology, German Institute of Human Nutrition Potsdam-Rehbruecke, Nuthetal, Germany

name: Institute of Nutritional Sciences, University of Potsdam, Nuthetal, Germany

family: Schulze

full_name: Matthias B Schulze

given: Matthias B

name: Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany

family: Kühn

full_name: Tilman Kühn

given: Tilman

family: Johnson

full_name: Theron Johnson

given: Theron

name: Hellenic Health Foundation, Athens, Greece

family: Trichopoulou

full_name: Antonia Trichopoulou

given: Antonia

family: Peppa

full_name: Eleni Peppa

given: Eleni

name: Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy

family: La Vechia

full_name: Carlo La Vechia

given: Carlo

name: Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO) , Florence, Italy

family: Masala

full_name: Giovanna Masala

given: Giovanna

name: Cancer Registry and Histopathology Department, Provincial Health Authority (ASP) Ragusa, Italy

family: Tumino

full_name: Rosario Tumino

given: Rosario

name: Unit of Cancer Epidemiology, Città della Salute e della Scienza University-Hospital and Center for Cancer Prevention (CPO), Turin, Italy

family: Sacerdote

full_name: Carlotta Sacerdote

given: Carlotta

name: Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA

name: German Center for Diabetes Research (DZD), München-Neuherberg, Germany

family: Wittenbecher

full_name: Clemens Wittenbecher

given: Clemens

name: Azienda Ospedialiera Universitaria (A.O.U.) Federico II, Naples, Italy

family: de Magistris

full_name: Maria Santucci de Magistris

given: Maria Santucci

name: Department of Public Health, Aarhus University, Aarhus, Denmark

name: Dipartimento di Statistica, Informatica e Applicazioni “G. Parenti” (DISIA), University of Florence, Italy

name: International Agency for Research on Cancer, WHO, Lyon, France

journal_name: The American Journal of Clinical Nutrition

repository_institution: The Arctic University of Norway - Munin Open Research Archive

ReferenceCitation: Wedekind R, Keski-Rahkonen P, Robinot N, Viallon V, Ferrari P, Engel E, Boutron-Ruault MC, Mahamat-Saleh Y, Mancini FR, Kühn T, Johnson T, Boeing H, Bergmann M, Karakatsani A, Trichopoulou A, Peppa H, Agnoli C, Santucci de Magistris M, Palli D, Sacerdote C, Tumino R, Gunter MJ, Huybrechts I, Scalbert A. Syringol metabolites as new biomarkers for smoked meat intake. Am J Clin Nutr. 2019 Dec 1;110(6):1424-1433. doi: 10.1093/ajcn/nqz222.

name: Micro-contaminants, Aroma and Separative Sciences (MASS) Group, National Institute of Agricultural Research (INRA) UR370 QuaPA, Saint-Genès-Champanelle, France

name: Centre for Research in Epidemiology and Population Health (CESP), Faculty of Medicine, University of Paris-Sud, Faculty of Medicine, Versailles Saint-Quentin-en-Yvelines University, French Institute of Health and Medical Research (INSERM), University of Paris-Saclay, Villejuif, France

name: Department of Epidemiology, German Institute of Human Nutrition, Nuthetal, Germany

name: Pulmonary Medicine Department, School of Medicine, National and Kapodistrian University of Athens, “Attikon” University Hospital, Haidari, Greece

name: Epidemiology and Prevention Unit, IRCCS National Cancer Institute Foundation, Milan, Italy

name: Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Florence, Italy

name: Cancer Registry and Histopathology Department, “Civic-M.P.Arezzo” Hospital, ASP, Ragusa, Italy


title: Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study

acronym: CAROTEP

summary: This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components

intervention_type: Drug


title: Incremental Diagnostic Utility of Systematic Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients

acronym: DTOM

summary: Bone scintigraphy is currently a reference test in the initial staging of cancer. Bone scintigraphy historically consists in a planar whole-body scintigraphy (WBS). SPECT/CT has been shown to dramatically reduce the proportion of inconclusive results and increase the specificity of bone scintigraphy. Therefore, in most of nuclear médicine centers, the usual protocol for staging of bone metastases consists in a whole-body planar acquisition followed, if needed, by a targeted SPECT/CT to characterize suspicious or equivocal uptakes seen on WBS. The aim of this study is to assess the incremental diagnostic utility of a systematic double-bed SPECT/CT acquisition for bone scintigraphy in initial staging of cancer patients compared with the conventional "WBS plus single-bed targeted SPECT/CT" strategy.

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest


title: Study of Sexual Dysfunction and Place of Sexuality in Patients Included in a Cardiac Rehabilitation Program in Champagne-Ardenne

acronym: SexualDysf

summary: Sexual health is an important marker of individual quality of life and well-being of patients. Sexual dysfunction (SD) is common in patients with heart disease. Screening and management are recommended. Cardiac rehabilitation (CR) seems to be a privileged moment to address this problem, but the management is often insufficient. The main objective of the study was to evaluate the prevalence of SD in patients in CR in the Champagne-Ardenne region. Secondary objectives were to describe SD most frequently encountered, to identify risk factors of SD, to compare the feelings of patients about their sex life, before and after an acute cardiac event and to collect an estimate of the need for care by a dedicated sexology workshop. The investigators conducted an observational multicenter prospective study for descriptive and analytical purposes after approval by the Institutional review board. An anonymous questionnaire was distributed from June 1 to September 1, 2017 in patients participating in a cardiac rehabilitation program in the various centers in the region.

time_perspective: Cross-Sectional

lead_sponsor: CHU de Reims


title: Are the Patients Having Pets at Greater Risk of Carrying Multidrug Resistance Bacteriae?

acronym: BRANITRANS

summary:
Introduction : The multidrug resistance (MDR) Bacteriae are growing and are a public health problem. The known risk factors to be expanding of MDR Bacteriae are: taken antibiotics, hospitalization, journey in a country at risk. Other risk factors are emitted in hypothesis as the presence of pets.

Aim : The primary objective is to study the association between the presence of a pet and the presence of a MDR bacteria. Methods : Cross sectional study will be performed in Reims University hospital in internal medicine ward.


title: Diaphragmatic Paralysis After Ultrasound Block of the Suprascapular Nerve for Shoulder Surgery : Incidence and Influence of the Approach

acronym: SSParaDia

summary: Shoulder surgery is a source of intense postoperative pain that justifies the use of opioids. In this context, analgesia provided by locoregional anesthesia (ALR) improves the rehabilitation of patients by reducing the length of hospital stay and morphine consumption. Thus anesthesia of the brachial plexus interscalene (interscalene block or BIS) is considered as the reference technique for the management of post-operative pain after shoulder surgery. It is however provider of hemi-diaphragmatic paralysis (PhD) in nearly 100% of cases. Thus, this technique is usually avoided in patients with respiratory insufficiency. In arthroscopic shoulder surgery, the development of a suprascapular and axillary nerve (SSAX) conjugate block appears to be an effective analgesic alternative in this context.


title: Gastric Assessment in Ambulatory Surgery : a Prospective Study

acronym: GAAS

summary:
The surgical procedures in outpatient surgery are in perpetual increase. However, the peri operative stress can reduce the gastric emptying. A patient's compliance for following the fasting rules cannot be controlled at home. Ambulatory surgery is currently proposed to fragile patients with many comorbidities known to slow gastric emptying. In day case surgery the airway management are often managed with supraglottic device ( laryngeal mask). This device does not protect the respiratory tract and may expose the patient to a risk of inhalation of gastric content (if not empty).

This study aim to mesure the prevalence of full stomachs in outpatient surgery and to observe any changes in anesthetic management secondary to the ultrasound assessment of gastric content. It will confront theoretical full stomach risk factors with ultrasound findings. The practical and clinical relevance of such a technique in the context of outpatient surgery will be assessed in this study. The ultimate goal is to improve the safety of the patient's anesthetic management by controlling the risk of pulmonary aspiration.


title: Identification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and Antibodies

acronym: SAFARI

summary:
Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory bowel disease. Its efficiency to induce and maintain clinical response in patients with anti TNF resistant Crohn's disease has been proved in several clinical trials, and the profile of safety of this treatment was good, but the investigators have few data about biological characteristics of patients treated by Ustekinumab, particularly about ustekinumab through levels and rate of patients developing anti ustekinumab antibodies during the induction and maintenance stages, and no predictive factors of clinical response have been identified yet.

The aim of this study will be to assess the evolution of biological markers of inflammation and ustekinumab trough levels and antibodies, in responders and non responders patients treated by ustekinumab, in order to identify predictive factors of clinical response.

The investigators will perform a prospective observational study, including the patients followed in the University hospital center of Lyon and treated by ustekinumab for a moderate to severe Crohn's disease (with a HBI score≥4 ). All the patients included will have been previously treated by at least one anti TNF and/or Vedolizumab, with specified criteria for a primary non response, a secondary loss of response or unacceptable side effects.

Then, clinical and biological data will be collected for each patient at the inclusion, and then at weeks 4, 8, 16, 24: HBI score, sides effects, extra intestinal manifestations, steroids withdraw, CRP, calprotectin, ustekinumab trough levels and ustekinumab antibodies.

The investigators will compare responding and non responding patients at week 16 (end of the induction period) according to these data.

The hypothesis the investigators state is that an early and significant decrease of the inflammation markers in blood and stools associated with a high ustekinumab through level in blood is associated with a clinical response at week 16 in the patients treated by ustekinumab


title: Evaluation of the Effect of Sensory Imagination on Choice of Food Portion Size in School-aged Children

summary: The objective of this intervention is to evaluate the effect of sensory imagination (i.e., imagining the sensory properties of an object) on the choice of food portion size in school-aged children. Previous research showed that it may help children to choose smaller portion size. The investigators would like to assess whether this effect can be reproduced with two types of food (one with a high energy-density and one with a low energy-density), and in older children.

ReferenceType: background

ReferenceCitation: Cornil Y and Chandon P (2016) Pleasure as a Substitute for Size: How Multisensory Imagery Can Make People Happier with Smaller Food Portions. Journal of Marketing Research: October 2016, Vol. 53, No. 5, pp. 847-864. https://doi.org/10.1509/jmr.14.0299

ReferenceCitation: Lange C, Schwartz C, Hachefa C, Cornil Y, Nicklaus S, Chandon P. Portion size selection in children: Effect of sensory imagery for snacks varying in energy density. Appetite. 2020 Jul 1;150:104656. doi: 10.1016/j.appet.2020.104656. Epub 2020 Mar 9.

family: Lange

full_name: Christine Lange

given: Christine

family: Schwartz

full_name: Camille Schwartz

given: Camille

family: Hachefa

full_name: Célia Hachefa

given: Célia

family: Cornil

full_name: Yann Cornil

given: Yann

family: Nicklaus

full_name: Sophie Nicklaus

given: Sophie

family: Chandon

full_name: Pierre Chandon

given: Pierre

bso_classification: Biology (fond.)

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Appetite

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


title: Observational Prospective Monocentric Study Evaluating "Sweeper" Use During Epiretinal Membrane Surgery

acronym: SWEEPING

summary:
Epiretinal membrane (ERM) is a pathological phenomenon requiring surgery when vision is altered.

ERM surgery requires ERM peeling, then active internal limiting membrane (ILM) peeling if it is not spontaneously peeled with ERM. Initiation of peeling is very delicate and can lead to micro scotoma when realized with microscopic forceps. The Sweeper is a microscopic tool with a soft silicon tip covered with diamond dust which allows peeling initiation without retina prehension. It may reduce retinal trauma and visual sequelae.

Purpose of our study is to evaluate use of sweeper during 20 ERM surgeries. The investigator will compare microperimetry before surgery versus those after 1 month (M1) and 3 months (M3), and measure difference of number and depths of micro scotoma.

The investigator will note: number of forceps uses if sweeper is inefficient and all areas of sweeper use to correlate them with micro scotoma.

The investigator will evaluate visual and optical coherence tomography improvement after surgery.

ReferenceCitation: Azuma K, Ueta T, Eguchi S, Aihara M. EFFECTS OF INTERNAL LIMITING MEMBRANE PEELING COMBINED WITH REMOVAL OF IDIOPATHIC EPIRETINAL MEMBRANE: A Systematic Review of Literature and Meta-Analysis. Retina. 2017 Oct;37(10):1813-1819. doi: 10.1097/IAE.0000000000001537. Review.

ReferenceCitation: Fang XL, Tong Y, Zhou YL, Zhao PQ, Wang ZY. Internal limiting membrane peeling or not: a systematic review and meta-analysis of idiopathic macular pucker surgery. Br J Ophthalmol. 2017 Nov;101(11):1535-1541. doi: 10.1136/bjophthalmol-2016-309768. Epub 2017 Mar 17. Review.

ReferenceCitation: Ripandelli G, Scarinci F, Piaggi P, Guidi G, Pileri M, Cupo G, Sartini MS, Parisi V, Baldanzellu S, Giusti C, Nardi M, Stirpe M, Lazzeri S. Macular pucker: to peel or not to peel the internal limiting membrane? A microperimetric response. Retina. 2015 Mar;35(3):498-507. doi: 10.1097/IAE.0000000000000330.

ReferenceCitation: Deltour JB, Grimbert P, Masse H, Lebreton O, Weber M. DETRIMENTAL EFFECTS OF ACTIVE INTERNAL LIMITING MEMBRANE PEELING DURING EPIRETINAL MEMBRANE SURGERY: Microperimetric Analysis. Retina. 2017 Mar;37(3):544-552. doi: 10.1097/IAE.0000000000001179.

lead_sponsor: Nantes University Hospital


title: Prediction of Risk of Hypotension in Hemodialysis

acronym: IMHOTEP

summary: The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Treatment With Low-Dose Cytarabine in Elderly Patients (Age 70 Years or Older) With Acute Myeloid Leukemia: A Single Institution Experience.

summary:
The treatment of very elderly patients (≥70 years) with acute myeloid leukemia remains controversial. Although the outcome in younger adults has improved because of cytarabine- and anthracycline-based chemotherapy with advanced supportive care and introduction of hematopoietic stem cell transplantation, the benefit associated with standard intensive chemotherapy in older patients remain debatable. Life expectancy in elderly patients is a function of age, disability and comorbidity, performance score, along with leukemia characteristics such as genetic alterations or white blood cell count at diagnosis 'Older' patients are generally considered those aged 60 years or older.

Intensive chemotherapy delivered to the very elderly with AML (patients _70 years of age), may not be beneficial to most and could be harmful to some. However, these patients are often referred to as 'unfit' or ineligible for intensive remission induction therapy. In daily practice, the final decision to treat intensively or not is made by the treating hematologist on a case by case basis according to patient's age, cytogenetics, performance score, concomitant diseases and type of AML (de novo or secondary).

In older patients considered 'unfit' for intensive treatment, LD-AraC has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that may have an improved side effect profile and in some cases bioavailability may offer future improvement for this patient population. The efficacy of hypomethylating agents has been studied in older AML patients with conflicting results. Recent publications refined prognostic information, which not only optimize existing treatments but also could lead to the development of additional targeted therapeutic approaches.

In this study, the investigators focus on patients with AML (_20% blasts) aged 70 or older seen in our institution over a 14-year period. The objectives of the analysis are to describe the demographic, clinical and biological characteristics of this population and to evaluate how these characteristics and the treatment chosen affect


title: Evaluation of the Predictors of Clinical and Radiological Response to Gamma-Knife Radiosurgery in the Treatment of Intermediate Ventral Nucleus of the Thalamus (VIM) Thalamotomy Tremor.

acronym: GARP

summary:
Gamma-Knife radiosurgery of the VIM for patients presenting with severe drug-resistant tremor is now current practice as an alternative to Deep Brain Stimulation (DBS) of the VIM.

Now, around 100 patients are treated annually in our unit (essential tremor or Parkinson tremor).

Clinical and radiological follow-up is demonstrating that 80% of these patients are presenting with a homogenous response complete or subtotal, the disappearance of the tremor mean delay of 6 months after radiosurgery. In neuroradiological responses on the MRI, is appearing roughly at the same time local contrast enhancement surrounding highty to signal no associated with clinical side effects.

In 15 to 20% of the patients, the clinical effets is not obtained and in the vast majority no MRI response or minimal MRI response is observed on images suggesting that these failures are related to specific resistance to radiosurgery of this subgroup.

In roughly 5% of the patients, at the contrary, hyper response is observe on the MRI rating clinically with side effects (hemiparesis or proprioceptive ataxia or dysarthria, hands problems….). The adverse effects are generally reversible either in whole or in part with the resorption of the perilesionnel oedema.

It would be extremely helpfull to be able to identify in advance these 2 groups of hyper and hypo respondeurs.

The capacity to identify in advance these patients at risk to hypo or hyper response would allow us to either contre-indicate radiosurgery or modify radiosurgery technicaly at the time of dose planing.

Sequently, these predictions would allow us to tailor individually mission management and information leading to improvment of the efficacy and tolerance of this kind of intervention.

The parameters suspected to be likely to influence the response are :

genetics
co-morbidities (diabetis, vascular…)
Main aspect of the brain (severe atrophy, vascular, micro-infacts…)
Chronobiological (timing during the day of the radiosurgical procedure)
Associated medication (potential radioprotector or radiosensitizer effect of some drugs)
Radiobiological (dose rate…)

The goal of this study is to collect all of these informations out of genetical one in the cohort of 700 patients having benefited ou will benefit from radiosurgery in the situation for essential tremor and parkinson disease. It will be test the predictive value of these parameters and the capacity to predict hyper or hypo response.

The work on the genetic material will take place in the second stage in the frame of a new different resarch project.


title: Retrospective Study on TACE for HCC by TANDEM and Idarubicin

acronym: TANDEM-IDA

summary:
DcBeads and lipiodol-transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) using doxorubicin result in about 50% objective response rate at 6 months (Precision V study, Lammer et al. CVIR 2010) We previously demonstrated that idarubicin was the most effective drug on 3 HCC cell lines (Boulin et al., Anticancer drugs 2009). We tested idarubicin-loaded beads in a phase I trial (Boulin et al., Aliment Pharmacol Therapy 2012) and more recently in a prospective multicentric phase II trial (IDASPHERE II, Magna Cum Laude CIRSE 2017, B Guiu et al.). This trial was stopped at interim analysis because the endpoint was reached.

Tandem beads are precisely calibrated, of small size, allowing the maximization of ischemic effects together with an optimal efficacy of the drug. We previously published that idarubicin was able to load fastly in Tandem, with minimal modification of bead diameter and a very interesting releasing profile of the drug (Guiu et al., JVIR 2015).

We used TANDEM combined with idarubicin in our practice for the treatment of HCC by TACE (in-label use of beads and the drug).

No clinical study (even retrospective) has been published so far with TANDEM-IDA (except our first paper published in JVIR in 2015, only 4 patients).

Here we propose to collect the retrospective data of patients treated by TANDEM-IDA, to help to design a future multicentric randomized phase II trial


title: Impact of Systematic Pulmonary Follow-up After Hematopoietic Stem Cell Transplantation

summary: Allogeneic hematopoietic stem cell transplantation is the only possible treatment for many malignant and non-malignant hemopathies. The graft-versus-host immunological reaction (GvH) is a frequent and sometimes serious complication. The objective is to study whether a systematic and early follow-up by a lung specialist of allografted patients would allow an earlier diagnosis of GvH with pulmonary complications.

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon


title: Randomized Study Assessing the Benefits of Foot Reflexology in Patients With Gastrointestinal or Thoracic Cancer With Chemotherapy

acronym: REFYO-R

summary: Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors.

ReferenceCitation: Murat-Ringot A, Souquet PJ, Subtil F, Boutitie F, Preau M, Piriou V. The Effect of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients With Digestive or Lung Cancer: Randomized Controlled Trial. JMIR Cancer. 2021 Nov 5;7(4):e25648. doi: 10.2196/25648.

family: Murat-Ringot

full_name: Audrey Murat-Ringot

given: Audrey

family: Souquet

full_name: Pierre Jean Souquet

given: Pierre Jean

family: Subtil

full_name: Fabien Subtil

given: Fabien

family: Boutitie

full_name: Florent Boutitie

given: Florent

family: Preau

full_name: Marie Preau

given: Marie

family: Piriou

full_name: Vincent Piriou

given: Vincent

bso_classification: Medical research

currency_apc_doaj: USD

journal_name: JMIR Cancer

oa_host_type: publisher

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

title: The effect of foot reflexology on chemotherapy-induced nausea and vomiting in digestive or lung cancer patients: a randomized controlled trial (Preprint)

ReferenceCitation: Murat-Ringot A, Souquet PJ, Chauvenet M, Rentler C, Subtil F, Schott AM, Preau M, Piriou V. The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jul 14;9(7):e17232. doi: 10.2196/17232.

apc_source: openAPC

family: Chauvenet

full_name: Marion Chauvenet

given: Marion

family: Rentler

full_name: Charlotte Rentler

given: Charlotte

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

journal_name: JMIR Research Protocols

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central


title: Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis

acronym: MS-EYE

summary: It's a pilot, interventional prospective monocentric study. It aims to compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics.

lead_sponsor: Versailles Hospital


title: Attention and Memory Disorders Related to Acute Morphine

acronym: MEMOMORPH

summary:
The aim of the study is to determine if there are attention disorders related to acute morphine use in single-traumatized patients and after that the investigators will determine whether there are immediate memory problems associated with acute morphine withdrawal in single-traumatized patients.

From a biochemical point of view, the analgesic effects of morphine and the central side effects appear to be two different dimensions of the action of morphine, each related to a metabolite. Regarding acute attention, it is difficult to differentiate attention deficit disorder due to pain or due to morphine.

Two tests have been validated in the literature to evaluate attention and memory: the 15 words of Rey and the Stroop Color Word test. The investigators will use these two tests in this study.


title: Hospital Acquired and Ventilator Associated Pneumonia : Impact of the New French Guidelines on Patients Care and Outcomes.

acronym: PNEUMOCARE

summary: hospital-acquired pneumonia are a common disease in intensive care unit. The prevention, the diagnosis and the treatment of hospital acquired pneumonia are a frequent challenge. Nevertheless it seems that there are great differences in standard of care between hospitals. The investigators hypothesized that medical education and implementation of evidence-base guidelines can reduce the duration of mechanical ventilation in patients presenting of hospital acquired pneumonia

ReferenceCitation: Roquilly A, Chanques G, Lasocki S, Foucrier A, Fermier B, De Courson H, Carrie C, Danguy des Deserts M, Gakuba C, Constantin JM, Lagarde K, Holleville M, Blidi S, Sossou A, Cailliez P, Monard C, Oudotte A, Mathieu C, Bourenne J, Isetta C, Perrigault PF, Lakhal K, Rouhani A, Asehnoune K, Guerci P, Tran Dinh A, Chousterman B, Cupaciu A, Dahyot-Fizelier C, Bellier R, Au Duong J, Mansour A, Morel J, Beauplet G, Vibet MA, Feuillet F, Sébille V, Leone M. Implementation of French Recommendations for the Prevention and the Treatment of Hospital-acquired Pneumonia: A Cluster-randomized Trial. Clin Infect Dis. 2021 Oct 5;73(7):e1601-e1610. doi: 10.1093/cid/ciaa1441.

name: Department of Anesthesiology and Critical Care, Hotel Dieu, Centre Hospitalier Universitaire Nantes, Nantes, France

name: Laboratory EA3826, Faculty of Medicine, University of Nantes, Nantes, France

family: Roquilly

full_name: Antoine Roquilly

given: Antoine

name: Surgical Intensive Care Unit, Centre Hospitalier Universitaire, Montpellier, France

family: Chanques

full_name: Gérald Chanques

given: Gérald

name: Département Anesthésie Réanimation, Centre Hospitalier Universitaire d’Angers, Université d’Angers, Angers, France

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

name: Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Beaujon (Assistance Publique / Hôpitaux de Paris), Beaujon, France

family: Foucrier

full_name: Arnaud Foucrier

given: Arnaud

name: Intensive Care Unit, Simone Veil Hospital, Blois, France

family: Fermier

full_name: Brice Fermier

given: Brice

name: Department of Neuro-Critical Care, Pellegrin Hospital, Bordeaux, France

family: De Courson

full_name: Hugues De Courson

given: Hugues

name: Surgical and Trauma Intensive Care, Pellegrin Hospital, Bordeaux, France

family: Carrie

full_name: Cedric Carrie

given: Cedric

name: Department of Anesthesiology and Critical Care, Hospital Inter-Armée Clermont Tonnerre, Brest, France

family: Danguy des Deserts

full_name: Marc Danguy des Deserts

given: Marc

name: Department of Anesthesiology and Critical Care, Centre Hospitalier Universitaire Caen, Caen, France

family: Gakuba

full_name: Clément Gakuba

given: Clément

name: Department of Anesthesiology and Critical Care, Hôpital Gabriel Montpied, Centre Hospitalier Universitaire Clermont Ferrand, Clermont-Ferrand, France

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

name: Neuroréanimation-Anesthésie Neuroradiologie Interventionnelle, Hôpital Gabriel Montpied, Centre Hospitalier Universitaire Clermont Ferrand, Clermont-Ferrand, France

family: Lagarde

full_name: Kevin Lagarde

given: Kevin

name: Department of Neuro-Critical Care, Assistance Publique/Hôpitaux de Paris, Creteil, France

family: Holleville

full_name: Mathilde Holleville

given: Mathilde

name: Intensive Care Unit, Eaubonne Hospital, Eaubonne, France

family: Blidi

full_name: Sami Blidi

given: Sami

name: Department of Anesthesiology and Critical Care, Emile Roux Hospital, Le Puy en Velay, France

family: Sossou

full_name: Achille Sossou

given: Achille

name: Intensive Care Unit, Lorient Hospital, Lorient, France

family: Cailliez

full_name: Pauline Cailliez

given: Pauline

name: Department of Anesthesiology and Critical Care, Hôpital Édouard Herriot, Hospices Civils de Lyon, Lyon, France

family: Monard

full_name: Celine Monard

given: Celine

name: Department of Neuro-Critical Care, Hospices Civils de Lyon, Lyon, France

family: Oudotte

full_name: Adrien Oudotte

given: Adrien

name: Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Department of Anesthesiology and Critical Care Medicine, Hôpital Nord, Marseille, France

family: Mathieu

full_name: Calypso Mathieu

given: Calypso

name: Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, Emergency Intensive Care Unit, Hopital la Timone, Marseille, France

family: Bourenne

full_name: Jeremy Bourenne

given: Jeremy

name: Department of Anesthesiology and Cardiothoracic Intensive Care, Pierre Zobda-Quitman, Martinique, France

family: Isetta

full_name: Christian Isetta

given: Christian

name: Neuro-Intensive Care Unit, Centre Hospitalier Universitaire, Montpellier, France

family: Perrigault

full_name: Pierre-François Perrigault

given: Pierre-François

name: Department of Anesthesiology and Critical Care, Guillaume and Rene Laennec Hospital, Centre Hospitalier Universitaire Nantes, Nantes, France

family: Lakhal

full_name: Karim Lakhal

given: Karim

name: Severe Burn Intensive Care Unit, Hotel Dieu, Centre Hospitalier Universitaire Nantes, Nantes, France

family: Rouhani

full_name: Armine Rouhani

given: Armine

name: Surgical Intensive Care Unit, Centre Hospitalier Universitaire, Nancy, France

name: Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Bichat (Assistance Publique/Hôpitaux de Paris), Paris, France

name: Department of Anesthesiology and Critical Care, Severe Burn Unit, Centre Hospitalier Universitaire de Lariboisiere (Assistance Publique/Hôpitaux de Paris), Paris, France

name: Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Saint Louis (Assistance Publique/Hôpitaux de Paris), Paris, France

name: Surgical Intensive Care Unit, Centre Hospitalier Universitaire, Poitiers, France

name: Neuro-Intensive Care Unit, Centre Hospitalier Universitaire, Poitiers, France

name: Intensive Care Unit, Department of Anesthesiology and Critical Care, Rangueil Hospital, Centre Hospitalier Universitaire, Toulouse, France

name: Department of Anesthesiology and Critical Care, Pontchaillou Hospital, Centre Hospitalier Universitaire Rennes, Rennes, France

name: Department of Anesthesiology and Critical Care, Centre Hospitalier Universitaire Saint Etienne, Saint Etienne, France

name: Department of Anesthesiology, Intensive Care and Perioperative Medicine, Hautepierre Hospital, Strasbourg, France

name: Microbiotas Hosts Antibiotics Bacterial Resistances, Université de Nantes, Nantes, France

name: Diirection de la Recherche Clinique et Innovation, Plateforme de Méthodologie et de Biostatistique, Centre Hospitalier Universitaire Nantes, Nantes, France

name: Unite Mixte de Recherhce, Institut National de la Santé et de la Recherche Médicale U1246, Method in Patient-Centered Outcomes and Health Research (SPHERE), Université de Nantes, Nantes, France

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

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


title: Evaluation of Desensitization Protocols in HLA-incompatible Kidney-transplant Candidates

summary: Kidney transplantation is the best renal-replacement in the setting of end-stage renal disease. However, some transplant candidates have developed anti-HLA alloantibodies (human leukocyte antigen). When they are numerous and when their strength assessed by mean fluorescence intensity (MFI) is high it is very complicated to find-out a suitable kidney allograft against which the recipient has a negative cross-match. In such a case the only hope for the patient is desensitization therapy, whereby the treatment will decrease anti-HLA alloantibodies below a threshold, i.e. MFI < 3,000, enabling kidney transplantation without risking antibody-mediated rejection. Desensitization relies on i) apheresis technics in order to withdraw circulating anti-HLA antibodies, and ii) immunosuppression, i.e. rituximab or tocilizumab, targeting B-lymphocytes, and tacrolimus/mycophenolic acid/steroids targeting T-cells. The type of apheresis is guided by the pre-desensitization MFI of anti-HLA alloantibodies, e.g. double filtration plasmapheresis or semispecific immunoadsorption. Likely the choice between rituximab and tocilizumab depends also on predesensitization anti-HLA antibody MFIs. At the end of the desensitization process, the patient will be able to get a kidney transplant either from a live-donor or from a deceased donor.

status: Terminated

ReferenceType: result

ReferenceCitation: Orandi BJ, Montgomery RA, Segev DL. Kidney Transplants from HLA-Incompatible Live Donors and Survival. N Engl J Med. 2016 Jul 21;375(3):288-9. doi: 10.1056/NEJMc1604523.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Montgomery RA, Lonze BE, King KE, Kraus ES, Kucirka LM, Locke JE, Warren DS, Simpkins CE, Dagher NN, Singer AL, Zachary AA, Segev DL. Desensitization in HLA-incompatible kidney recipients and survival. N Engl J Med. 2011 Jul 28;365(4):318-26. doi: 10.1056/NEJMoa1012376.

family: Montgomery

full_name: Robert A. Montgomery

given: Robert A.

family: Lonze

full_name: Bonnie E. Lonze

given: Bonnie E.

family: King

full_name: Karen E. King

given: Karen E.

family: Kraus

full_name: Edward S. Kraus

given: Edward S.

family: Kucirka

full_name: Lauren M. Kucirka

given: Lauren M.

family: Locke

full_name: Jayme E. Locke

given: Jayme E.

family: Warren

full_name: Daniel S. Warren

given: Daniel S.

family: Simpkins

full_name: Christopher E. Simpkins

given: Christopher E.

family: Dagher

full_name: Nabil N. Dagher

given: Nabil N.

family: Singer

full_name: Andrew L. Singer

given: Andrew L.

family: Zachary

full_name: Andrea A. Zachary

given: Andrea A.

family: Segev

full_name: Dorry L. Segev

given: Dorry L.

title: Desensitization in HLA-Incompatible Kidney Recipients and Survival

ReferenceCitation: Vo AA, Choi J, Cisneros K, Reinsmoen N, Haas M, Ge S, Toyoda M, Kahwaji J, Peng A, Villicana R, Jordan SC. Benefits of rituximab combined with intravenous immunoglobulin for desensitization in kidney transplant recipients. Transplantation. 2014 Aug 15;98(3):312-9. doi: 10.1097/TP.0000000000000064.

family: Vo

full_name: Ashley A. Vo

given: Ashley A.

family: Choi

full_name: Jua Choi

given: Jua

family: Cisneros

full_name: Kristen Cisneros

given: Kristen

family: Reinsmoen

full_name: Nancy Reinsmoen

given: Nancy

family: Haas

full_name: Mark Haas

given: Mark

family: Ge

full_name: Shili Ge

given: Shili

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Benefits of Rituximab Combined With Intravenous Immunoglobulin for Desensitization in Kidney Transplant Recipients

ReferenceCitation: Kahwaji J, Jordan SC, Najjar R, Wongsaroj P, Choi J, Peng A, Villicana R, Vo A. Six-year outcomes in broadly HLA-sensitized living donor transplant recipients desensitized with intravenous immunoglobulin and rituximab. Transpl Int. 2016 Dec;29(12):1276-1285. doi: 10.1111/tri.12832. Epub 2016 Oct 24.

name: Cedars-Sinai Medical Center; Comprehensive Transplant Center; Los Angeles CA USA

ReferenceCitation: Klein K, Süsal C, Schäfer SM, Becker LE, Beimler J, Schwenger V, Zeier M, Schemmer P, Macher-Goeppinger S, Scherer S, Opelz G, Morath C. Living donor kidney transplantation in patients with donor-specific HLA antibodies enabled by anti-CD20 therapy and peritransplant apheresis. Atheroscler Suppl. 2013 Jan;14(1):199-202. doi: 10.1016/j.atherosclerosissup.2012.10.030.

ReferenceCitation: Rostaing L, Maggioni S, Hecht C, Hermelin M, Faudel E, Kamar N, Sallusto F, Doumerc N, Allal A. Efficacy and safety of tandem hemodialysis and immunoadsorption to desensitize kidney transplant candidates. Exp Clin Transplant. 2015 Apr;13 Suppl 1:165-9.

ReferenceCitation: Kauke T, Klimaschewski S, Schoenermarck U, Fischereder M, Dick A, Guba M, Stangl M, Werner J, Meiser B, Habicht A. Outcome after Desensitization in HLA or ABO-Incompatible Kidney Transplant Recipients: A Single Center Experience. PLoS One. 2016 Jan 5;11(1):e0146075. doi: 10.1371/journal.pone.0146075. eCollection 2016.


title: Biliary and Intestinal Microbiota Study in Liver Transplanted Patients

acronym: BIM-LT

summary:
Many studies describe the relationship between microbiota alteration and the occurrence of metabolic, alcoholic or inflammatory liver diseases. Nevertheless, the modifications of microbiota during liver transplantation (LT) as well as its implication are poorly studied. Similarly, only the intestinal microbiota is studied in this context, and no data are available on the biliary microbiota, even if it is known that bile microbiota can interfere with hepatobiliary diseases.

This study proposes a clinical and biological in-depth follow-up with multiple sampling of liver transplanted patients to study biliary and intestinal microbiota alterations along LT, as well as bile acids metabolism in corresponding fluids.

Indeed, in recipient samples as saliva, blood, urine, and feces can be taken before LT, and surgeons can easily perform bile sampling during LT. In donors all samples can be taken during liver removal. This offers the opportunity to have a microbiotic landscape of individuals without liver disease (donor), and patients suffering from a chronic liver disease or a liver cancer before and after transplantation.

Also, in Grenoble University hospital, in case of biliary anastomotic incongruence, a biliary stent is placed during LT in 60% of recipients. This stent is removed by endoscopic retrograde cholangiopancreatography (ERCP) within 6 months after LT, offering a second opportunity to obtain bile samples in transplanted patients, after the early post-LT period. Patients who do not require a biliary stent will also be included for the study of secondary objectives, as intestinal microbiota is very poorly characterized in liver transplanted patients too. A portion of the patients without biliary stent, may also develop an anastomotic biliary stricture requiring an ERCP. If this ERCP is realized within the follow-up period of the study, the patient will also be included in the primary objective of the study.

These multiple and sequential samples will allow a complete analysis of microbiota changes in LT patients and aim to answer to 3 questions:

What are the modifications of intestinal and biliary microbiomes during LT?
What is the influence of bile acids' composition on intestinal and biliary microbiota?
What are the relationships between microbiome alterations and the emergence of LT complications?

lead_sponsor: University Hospital, Grenoble


title: Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes (APT1)

summary:
Obstructive sleep apnea (OSA) and Type 2 diabetes are two frequent diseases that occur in adult population. The prevalence of OSA is higher in people with Type 2 diabetes compared with the general population7 ; in addition, the OSA syndrome is almost assessed in obese type 2 diabetes. The relationship between OSA and Type 2 diabetes has been well characterized: the OSA can contribute to increased insulin resistance or glucose intolerance; and, diabetes may worsen sleep-disordered breathing because of autonomic neuropathy8,9. The main link between OSA and Type 2 diabetes is central obesity, which triggers glucose intolerance/insulin resistance and is also an independent risk factor for OSA. Type 1 diabetes is generally not related to obesity; however, sleep-disordered breathing in these patients was described in few reports early as 1985 by pioneers such as Guilleminault5 and the prevalence of OSA is estimated at range 10 to 40% in type 1 diabetes patients. Few studies had evaluated the prevalence of sleep disorders in particular the sleep apnea syndrome in patients with type 1 diabetes and even less their influence on the glycemic control.

This study will take place at the CHU of Amiens-Picardie during a one-night hospitalization. The investigators will study in 44 type 1 diabetes mellitus (IAH apnea hypopnea index ≥15) who underwent polysomnography and continuous glucose monitoring of blood glucose

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Study of Visual-spatial Attention by Oculomotor Recording (Eye Tracking) as a Function of Central or Peripheral Visual Impairment

acronym: BEHAVE

summary: The objective of this pilot work is to determine the role of central and peripheral visions in explicit attention processes (saccade planning) in the case of visual impairment.


title: Evaluation of a Functional Lymphocyte Test (QuantiFERON Monitor®) as a Prognostic Marker for Acute Community-acquired Pneumonia

acronym: LYMPHONIE

summary:
Lower respiratory infections, or pneumonia, remain the third leading cause of death worldwide, despite progress in vaccinating at-risk populations and improved resuscitation techniques.

Research shows that immune defences are weakened during severe infections. This immune weakening could alter resistance to bacterial infection and facilitate death, but also facilitate the onset of secondary infections.

Through this study, investigators wish to evaluate a biomedical test (derived from a blood sample - Quantiferon Monitor test), aimed at measuring the immune response of certain immune cells (lymphocytes).

The objective of the study is to determine whether this test can predict the occurrence of death during pneumonia.

If this hypothesis is verified, it would make it possible to use this test as a marker to identify patients at risk of death, and would open up new therapeutic prospects in order to provide patients with severe pneumonia with a treatment that stimulates their immune defences.

ReferenceCitation: Blot M, de Maistre E, Bourredjem A, Quenot JP, Nguyen M, Bouhemad B, Charles PE, Binquet C, Piroth L. Specific Features of the Coagulopathy Signature in Severe COVID-19 Pneumonia. Front Med (Lausanne). 2021 Aug 4;8:675191. doi: 10.3389/fmed.2021.675191. eCollection 2021.

family: Blot

full_name: Mathieu Blot

given: Mathieu

family: de Maistre

full_name: Emmanuel de Maistre

given: Emmanuel

family: Bourredjem

full_name: Abderrahmane Bourredjem

given: Abderrahmane

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Nguyen

full_name: Maxime Nguyen

given: Maxime

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

family: Charles

full_name: Pierre-Emmanuel Charles

given: Pierre-Emmanuel

family: Binquet

full_name: Christine Binquet

given: Christine

family: Piroth

full_name: Lionel Piroth

given: Lionel

journal_name: Frontiers in Medicine

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Blot M, David Masson, Nguyen M, Bourredjem A; LYMPHONIE Study Group, Binquet C, Piroth L. Are adipokines the missing link between obesity, immune response, and outcomes in severe COVID-19? Int J Obes (Lond). 2021 Sep;45(9):2126-2131. doi: 10.1038/s41366-021-00868-5. Epub 2021 May 31.

family: David Masson

full_name: David Masson

family: Andreu

full_name: Pascal Andreu

given: Pascal

family: Aptel

full_name: François Aptel

given: François

family: Barben

full_name: Jeremy Barben

given: Jeremy

family: Beltramo

full_name: Guillaume Beltramo

given: Guillaume

family: Bielefeld

full_name: Philip Bielefeld

ReferenceCitation: Blot M, Bour JB, Quenot JP, Bourredjem A, Nguyen M, Guy J, Monier S, Georges M, Large A, Dargent A, Guilhem A, Mouries-Martin S, Barben J, Bouhemad B, Charles PE, Chavanet P, Binquet C, Piroth L; LYMPHONIE study group. The dysregulated innate immune response in severe COVID-19 pneumonia that could drive poorer outcome. J Transl Med. 2020 Dec 3;18(1):457. doi: 10.1186/s12967-020-02646-9. Erratum in: J Transl Med. 2021 Mar 8;19(1):100.


lead_sponsor: Bioprojet

location_facility: Clinical Neurophysiology Department - Hôpital Pellegrin

type: EudraCT Number

source: euctr

title: Randomized Double Blind Parallel Groups Sequential, Placebo Controlled, Trial Assessing the Efficacy and Safety of BP1.4979 in Restless Legs Syndrome (RLS)

summary: This is a Group Sequential Test multicenter, randomized, double blind, placebo controlled phase II proof of concept trial with parallel groups to evaluate the efficacy and the safety of BP1.4979 15mg BID compared to placebo in RLS patients during 2 weeks double blind treatment.


title: Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PLAMD)

acronym: PL-AMD

summary:
The rationale of this research is to determine if patients with lupus and presenting retinal "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD patients.

Based on the results obtained, this study could lead to future research that could better target the treatment of patients with lupus or patients with AMD (Age related Macular Degeneration).

The primary objective is to check if patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits have a different complement profile (functional exploration of complement, complement factors, genetic complement polymorphisms involved in AMD) compared to patients without "pseudo-drusen-like" deposits.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmologique Adolphe de Rothschild


title: Effect of Alirocumab on Postprandial Hyperlipemia in Patients With Type 2 Diabetes : a Randomized, Double-blind, Placebo-controlled, Cross-over Trial"

acronym: EUTERPE

summary:
Proprotein convertase subtilisin/kexin type 9 (PCSK9) has emerged over the past decade as a post-transcriptional regulator of the LDL receptor (LDL-R). PCSK9 acts as an endogenous natural inhibitor of the LDL-R pathway. Monoclonal antibodies (mAb) directed against PCSK9, such as Alirocumab, are the most common method of PCSK9 inhibition.

The goal of the present study is to assess, in the context of type 2 diabetes, a situation associated with an increased post-prandial hyperlipemia, whether PCSK9 inhibition with Alirocumab affects postprandial intestinal lipoprotein metabolism.


title: Evaluation of the Prevalence, Intensity and Consequences of Bortezomib-induced Neuropathic Disorders: Monocentric Observational and Cross-sectional Study.

acronym: PREVIB

summary:
Cancer-induced peripheral neuropathies (CIPN) remain a real problem in oncology (Balayssac et al., 2011). These CIPN are induced by certain classes of anticancer drugs such as taxanes (paclitaxel and docetaxel), platinum salts (cisplatin and oxaliplatin), alkaloids of Madagascar periwinkle (vincristine), bortezomib, thalidomide and eribulin (Balayssac et al., 2011; Vahdat et al., 2013). These CIPN essentially translate into sensory disorders such as paresthesia, dysesthetics or numbness. More rarely, these CIPN may be associated with motor or vegetative disorders (Balayssac et al., 2011). According to the recent meta-analysis by Hershman et al., no treatment can be proposed as a "gold standard" for preventing or treating CIPN (Hershman et al., 2014). As a result, oncologists reduce or stop doses of neurotoxic anticancer drugs because patients with CIPN have a marked deterioration in quality of life and co-morbidities such as anxiety, depression and sleep disorders (Hong et al., 2014; Mols et al., 2014). Therefore, understanding the pathophysiology of CIPN is essential to propose new therapeutic strategies.

Among neurotoxic anticancer drugs, bortezomib remains relatively little studied in terms of pathophysiology compared to platinum salts or taxanes, while the neurotoxicity of bortezomib remains a limiting factor in treatment. Since 2012, the FDA and EMA have validated the administration of bortezomib subcutaneously instead of intravenously in order to limit the neurotoxicity of bortezomib (Minarik et al., 2015). Indeed, a large study (N=222) reported that subcutaneous administration of bortezomib allowed the same therapeutic efficacy to be maintained while improving the safety profile and in particular limiting peripheral neuropathies (CIPN all grades: 38% vs. 53%, p=0.044, grade> 2: 24% vs. 41%, p=0.012 and grade> 3: 6% vs. 16%, p=0.026) However, a recent retrospective study (N=446) reports that the prevalence of bortezomib-induced peripheral neuropathies after subcutaneous administration remains relatively high: all grade: 41%, grade> 2: 18%, grade> 3: 4%, and above all that this prevalence is not different between subcutaneous and intravenous routes (Minarik et al., 2015).

ReferenceCitation: Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.

family: Engelhardt

full_name: Monika Engelhardt

given: Monika

family: Ihorst

full_name: Gabriele Ihorst

given: Gabriele

family: Singh

full_name: Moushmi Singh

given: Moushmi

family: Rieth

full_name: Achim Rieth

given: Achim

family: Saba

full_name: Grèce Saba

given: Grèce

family: Pellan

full_name: Marine Pellan

given: Marine

family: Lebioda

full_name: Andrea Lebioda

given: Andrea

journal_name: Clinical Lymphoma Myeloma and Leukemia

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd


title: Metabolic Signatures Resulting From Acute (Postprandial) Ingestion of Yoghurt or Milk in Humans: Effect of Age

acronym: FermentoMilk

summary:
Despite the fact that dairy products are greatly consumed, it remains today very difficult to determine with a classical blood biochemical test whether a person has ingested a fresh fermented dairy product or just milk, while their biological, metabolic and health impacts may be different.

The metabolic footprint left by the consumption of these products could be modified by the age of the consumer. Indeed, in the elderly, the processes of digestion, assimilation and metabolism are known to be altered /different compared to healthy adults. Thus, different metabolic signatures in the elderly could appear as the result of a less effective use and metabolism of the nutrients ingested. This could further also result in different or altered biological effects on dairy products.

ipd_sharing_description: The identified individual participant data for all outcome measures will be made available, only after joined consent of promotor and investigator. Data use and transfer to a third party will be performed according to the agreement signed as part of the grant funded by CNIEL.

lead_sponsor: Sergio Polakof

location_facility: Centre de Recherche en Nutrition Humaine d'Auvergne


title: Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.

acronym: CEPRIVA

summary:
The World Health Organization (WHO) ranks headache among the top 20 causes of disability in the world.

Primary headaches (with no known organic cause) account for 90% of these conditions. INSERM estimates that 15% of the general population is concerned. WHO estimates that 1.7-4% of the global adult population is affected by headache for at least 15 days a month. Headaches are disabling, for patients (pain, suffering, fatigue, unavailability ...) but also for society (socio-economic cost as frequent work stoppages and drug costs). They are a public health problem.

In 2002, the High Authority of Health published its recommendations for the diagnosis and management of migraine patients. In addition, the French Society for Migraine and Headache Studies updated these recommendations in 2013. They are focused on the medical management offered by doctors and pharmacists. However, the professionals in daily contact with the subjects know that the dimension psychic plays an important role in the etiology of headaches.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Description of Chronic Pain in Emergencies Room and Medical Care Modalities

acronym: CHRODOLURG

summary: The rate of patients with chronic pain (CP) is 40% in patients with acute pain in emergency department (ED). Patients with CP come more frequently to ED than patients without CP. Reasons for their visit to ED are often in relation with this CP. Few studies have been interested to management modalities of these patients in ED. The investigators are going to realize a prospective observational study in one center. The hypothesis is that patients with chronic pain are less satisfied of ED management that patients without CP.

location_facility: Hôpital Pellegrin - Service des urgences adultes


title: Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use

acronym: MONIDOL-ANI

summary: This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau


title: Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly

acronym: EVQ

summary: The Balance and Daily Life questionnaire (EVQ) observes the adaption of the patient in six scenarios of daily life; it is a measurement of falls, but also an evaluation of the modifications taken to prevent future falls. This study will analyze the robustness of this questionnaire.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Study of the Relationship Between the Strength of Ankle Movement Muscles and Postural Parameters in Elderly Fallers: Towards New Strategies for Screening and Management

summary: The quality of life of elderly citizens is to a great extent related to the maintenance of independence. The risk of falling and the loss of autonomy are two frequent problems associated with ageing. Although the impact of falls on functional outcomes and morbi-mortality in the elderly is well-established, the pathophysiological mechanisms underlying these falls are poorly understood. To better assess the risk of falling, numerous studies have investigated the use of dynamic and static posturography. These studies sought to characterise populations of fallers and non-fallers using parameters from postural analysis. Nonetheless, a new concept may emerge: weakening of the ankle movement muscles may be implicated in the age-related deterioration of posture. Even though it has been shown that this decrease occurs earlier and is more severe in fallers, the direct relationship between the strength of ankle movement muscles and balance parameters in elderly fallers has not yet been established. The existence of such a relationship would make it possible on the one hand to facilitate screening for those with a risk of falling, and on the other hand to enrich our understanding of the pathophysiology of the risk of falling. The perspective would therefore be to propose programmes focused on the strengthening of these deficient muscles.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.

acronym: AlgoPGx

summary: The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.

status: Not yet recruiting


title: Effects of LIraglutide on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging

acronym: LICAS-MR

summary: Type II diabetes is a known risk factor for heart failure, particularly through the progressive development of diabetic cardiomyopathy. Cardiac metabolic parameters, including myocardial steatosis and epicardial fat, are altered in diabetic patients. The development of new anti-diabetics (incretins) has demonstrated protective cardiovascular effects independent of effects on glycemic control for the first time in the history of these therapies. Thus Glucagon-Like Peptide 1 (GLP-1) agonists improve the recovery of cardiac function after a heart attack and decrease atheromatous processes. It has also been demonstrated in a diabetic rat model that the administration of Liraglutide, a GLP-1 agonist, leads to normalization of myocardial steatosis associated with beneficial cardiac molecular remodeling involving pro-apoptotic, oxidative and metabolic processes. These beneficial cardiovascular effects were observed in the absence of any changes in blood glucose, insulin levels or body weight.


title: Optical Frequency Domain Imaging-Quantified Intracoronary Thrombus Mass During Primary Percutaneous Coronary Intervention, Its Relationship With Antiplatelet Pretreatment Effect And Its Impact On Myocardial Reperfusion

acronym: ODIPP

summary:
The management of ST-elevation myocardial infarction in the acute phase requires an optimal antiaggregation combining aspirin and a P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor). Primary percutaneous coronary intervention must be performed within 2 hours of first medical contact. However, even with the new P2Y12 inhibitors, effective platelet inhibition which is required to inhibit the progression of intracoronary thrombus, is present only in half of the patients at 2 hours.

Optical coherence tomography (OCT) is the reference method for visualizing and quantifying intracoronary thrombus. The post-stenting intracoronary residual mass evaluated in OCT was associated with altered myocardial reperfusion indices, which were themselves associated with the prognosis of the patient. However, the determinants of this post-stenting residual mass -mostly thrombotic- remain unknown.

Measurement of platelet reactivity (expressed as P2Y12 Reaction Unit and Aspirin Reaction Unit) by simple turbidimetric tests (VerifyNow) is available in the cathlab. Enhanced platelet reactivity is reported in patients with acute coronary syndrome and represents a high-risk situation for recurrent coronary events in this setting.

The study aims to:

to evaluate the relationship between the post-stenting residual intracoronary mass evaluated in OCT and the platelet response at the time of the PCI evaluated by Verify Now
to confirm the impact of the residual mass measured by OCT on the EKG and angiographic myocardial reperfusion indices
identify patients with high thrombotic risk who may require more intensive antithrombotic therapy
identify simple biological markers associated with the residual mass measured by OCT

lead_sponsor: University Hospital, Caen


title: Lexical Priming by Music in Alzheimer's Disease and Healthy Aging

acronym: PriMus

summary: While verbal memory is quickly reached in the wake of Alzheimer's disease, the musical memory remains preserved until a late stage of the disease. This observation encouraged the development of music-based therapies in the management of neurocognitive and behavioral disorders that characterize Alzheimer's disease. In order to develop rehabilitation programs that effectively target cognitive functions to stimulate, it is necessary to understand the mechanisms underlying this beneficial effect of music on cognition.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Benefit of Direct-acting Antiviral Therapy in Hepatitis C Virus (HCV) Monoinfected and HIV-HCV Coinfected Patients With Mixed Cryoglobulinemia

summary: Mixed cryoglobulinemia (MC) is common in patients with chronic hepatitis C virus (HCV) infection. Direct-acting antiviral (DAA) regimens are today very effective with sustained virological response rates (SVR12) above 90%. The objective of this study was to investigate the impact of DAA therapy on cryoglobulin clearance in patients with HCV-associated MC.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Croix-Rousse Hospital


title: Feasability Study on the Use of Botulinum Toxin A in Primary Adductor Tendinopathies Refractory to Medical Treatment

acronym: PETRA

summary:
Pubalgia is a pain syndrome located in the groin area. This syndrome is mainly described in young male athletes and typically affect the superficial muscles defining the boundaries of the femoral triangle, i.e. gracilis, pectineus, adductor brevis and especially adductor longus, and less commonly the deep muscles.

Clinically, the pain is located in the inner aspect of the thigh, where the tendons attach onto the pubic symphysis. It is usually unilateral, and sometimes associated with neuropathic pain suggestive of obturator nerve irritation.

There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement.

The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a controlled study on a larger cohort could be conducted.

The major potential impact is a great effective pain relief for patients with neurological diseases.

ipd_sharing_description: Any exploitation of the data by Ipsen or for another research will be submitted to the preliminary agreement of CHU de Bordeaux and, in case of agreement, of a negotiated contract between the parties.

lead_sponsor: University Hospital, Bordeaux


title: Influence of ABO Blood Group on the Risk of Complications in Alcoholic or Viral C Cirrhosis? Analysis From Two French Prospectives National Cohorts CIRRAL and CIRVIR of Patients With Alcoholic or Viral Cirrhosis Child Pugh A

acronym: ABOCIRRALVIR

summary:
The non-O blood group is a risk factor of deep vein thrombosis and recurrence of thromboembolic events, especially when associated with Factor 5 Leiden or prothrombin G20210A mutations. A recent study suggests that non-O blood group may promote portal vein thrombosis in non cirrhotic patients.

In addition, in general population and chronic hepatitis C, non-O blood group combined with one or the other of the above genetic abnormalities is associated with an increased risk of liver fibrosis and accelerated fibrogenesis. The suspected mechanism could be an increased procoagulant factor VIII and an increased Willebrand plasma level, due to a low ADAMTS 13 activity, the result of which is an hypercoagulable state and a microthrombotic process.

In cirrhotic patients procoagulant factors and ADAMTS 13 which are respectively increased and decreased, have be shown to be prognostic markers of hepatocellular function and portal hypertension. It has been hypothesized that the hypercoagulable state and the microthrombotic process could contribute to the worsening of the disease and enoxaparin has been shown to positively modify the prognosis of cirrhosis.

The role of non-O blood group in decompensation of cirrhosis and occurrence of complications including non-tumor portal vein thrombosis has never been studied. The investigators plan a longitudinal observational study to determine the incidence of complications in alcoholic and viral cirrhosis in case of non-O blood group compared to O blood group. The aim of this study is to determine whether ABO blood group may promote complications in alcoholic or viral cirrhosis. This is an ancillary study of two national cohorts assessing natural history and hepatocellular carcinoma risk factors in alcoholic (CIRRAL) and viral (CIRVIR) cirrhosis.

intervention_type: Genetic


title: Rebond d'adiposité précoce Chez l'Enfant de 4 Ans et Risque de Surpoids Chez l'Enfant de 11 Ans : troisième Temps d'Une Cohorte Franc-comtoise.

acronym: CoOP

summary: This study aims to assess different methods for early adiposity rebound determination at the age of 4/5 years old according to current medical screening criteria in schools, and to assess their prognostic value for obesity amongst 11 years old pre-adolescents according to the known risk factors.


title: Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

acronym: PRAPI

summary:
Retrospective reports from literature have shown a lower rate of infections for transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion.

The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal versus transrectal approach.

primary_purpose: Prevention

lead_sponsor: Institut Mutualiste Montsouris


title: BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

acronym: BIVOLUTX

summary: Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.

ReferenceCitation: Tchetche D, de Biase C, van Gils L, Parma R, Ochala A, Lefevre T, Hovasse T, De Backer O, Sondergaard L, Bleiziffer S, Lange R, Kornowski R, Landes U, Norgaard BL, Biasco L, Philippart R, Molina-Martin de Nicolas J, Mylotte D, Lemee C, Dumonteil N, Van Mieghem NM. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. doi: 10.1161/CIRCINTERVENTIONS.118.007107.

name: Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France (D.T., C.d.B., R.P., J.M.-M.d.N., N.D.).

family: Tchetche

full_name: Didier Tchetche

given: Didier

family: de Biase

full_name: Chiara de Biase

given: Chiara

name: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (L.v.G., N.M.V.M.).

family: van Gils

full_name: Lennart van Gils

given: Lennart

family: Parma

full_name: Radoslaw Parma

given: Radoslaw

name: 3rd Department of Cardiology, Medical University of Silesia, Katowice, Poland (R.P., A.O.).

family: Ochala

full_name: Andrzej Ochala

given: Andrzej

name: Institut cardiovasculaire Paris sud, Hôspital prive Jacques Cartier, Massy, France (T.L., T.H.).

family: Lefevre

full_name: Thierry Lefevre

given: Thierry

family: Hovasse

full_name: Thomas Hovasse

given: Thomas

name: The Heart Center-Rigshospitalet, Copenhagen, Denmark (O.D.B., L.S.).

family: De Backer

full_name: Ole De Backer

given: Ole

family: Sondergaard

full_name: Lars Sondergaard

given: Lars

name: German Heart Center, Munich (S.B., R.L.).

family: Bleiziffer

full_name: Sabine Bleiziffer

given: Sabine

family: Lange

full_name: Rudiger Lange

given: Rudiger

name: Cardiology Department, Rabin Medical Center, Petach Tikva, Tel-Aviv University, Israel (R.K., U.L.).

family: Kornowski

full_name: Ran Kornowski

given: Ran

family: Landes

full_name: Uri Landes

given: Uri

name: Department Cardiology, Aarhus University Hospital, Denmark (B.L.N.).

family: Norgaard

full_name: Bjarne Linde Norgaard

given: Bjarne Linde

name: Centro Cardiotoracico TICINO, Lugano, Switzerland (L.B.).

family: Biasco

full_name: Luigi Biasco

given: Luigi

family: Philippart

full_name: Raphaël Philippart

given: Raphaël

family: Molina-Martin de Nicolas

full_name: Javier Molina-Martin de Nicolas

given: Javier

name: Department of Cardiology, University Hospital Galway, Ireland (D.M.).

family: Mylotte

full_name: Darren Mylotte

given: Darren

name: Independent biostatistician, Toulouse, France (C.L.).

family: Lemee

full_name: Caroline Lemee

given: Caroline

family: Dumonteil

full_name: Nicolas Dumonteil

given: Nicolas

family: Van Mieghem

full_name: Nicolas M. Van Mieghem

given: Nicolas M.

evidence: open (via free pdf)

ipd_sharing_description: Mutual ananymized database. Substudies anticipated.