acronym: PROPASPI

summary:
There is actually no consensus in place defining for which patients with suspected inhalation pneumonia antibiotic treatment should be initiated and what the duration of this antibiotic treatment should be.

This absence of recommendations results in excessive use of antibiotics, in emergence of multi-resistant strains and increase of costs. Several studies have been performed investigating antibiotic treatment based on procalcitonin values and have demonstrated a decreased use of antibiotics without change in mortality rates, in duration of hospitalization, in occurrence of super-infections or in infection relapse rate. Of the studies performed in an intensive care setting, none has specifically studied inhalation pneumonia.

The objective of this study is to determine whether use of a decisional algorithm based on procalcitonin values allows reducing antibiotics exposure in patients who are intubated because of coma in comparison with standard care according to actual guidelines and clinical experience with respect to ventilator-acquired pneumonia.

The study has a prospective, multi-centre, comparative, randomized, open design. It is a superiority study, with as primary parameter the duration of antibiotic therapy during the first 15 days after admission in the intensive care unit (ICU).

Patients can be included in this study if they are intubated for coma (Glasgow Coma Scale (GCS) ≤ 8) within 48 hours following admission to the hospital and with a foreseen duration of ventilation exceeding 48 hours.

There will be two treatment groups, stratified by centre and randomised in blocs of 4: one group for which treatment initiation and discontinuation will be guided by a procalcitonin-based decisional algorithm and a control group to whom antibiotics will be administered according to the standard protocols of each participating centre.

Based on an estimated duration of antibiotic treatment of 6.2 days, a risk -significance α level- of 5%, a power of 90% and a reduction of antibiotic treatment duration of 25% in the treatment arm guided by procalcitonin values, the number of patients to be included is 83 per treatment arm. Taking into account a loss of 10% for patients lost to follow-up, 166 patients should be included.

ReferenceCitation: Labro G, Aptel F, Puyraveau M, Paillot J, Pili Floury S, Merdji H, Helms J, Piton G, Ecarnot F, Kuteifan K, Quenot JP, Capellier G; PROPASPI (PROcalcitonin Pneumonia/pneumonitis Associated with ASPIration) trial investigators. Impact on antimicrobial consumption of procalcitonin-guided antibiotic therapy for pneumonia/pneumonitis associated with aspiration in comatose mechanically ventilated patients: a multicenter, randomized controlled study. Ann Intensive Care. 2021 Oct 12;11(1):145. doi: 10.1186/s13613-021-00931-4.

family: Labro

full_name: Guylaine Labro

given: Guylaine

family: Aptel

full_name: François Aptel

given: François

family: Paillot

full_name: Jonathan Paillot

given: Jonathan

family: Pili Floury

full_name: Sébastien Pili Floury

family: Merdji

full_name: Hamid Merdji

given: Hamid

family: Helms

full_name: Julie Helms

given: Julie

family: Piton

full_name: Gaël Piton

given: Gaël

family: Ecarnot

full_name: Fiona Ecarnot

given: Fiona

family: Kuteifan

full_name: Khaldoun Kuteifan

given: Khaldoun

family: Quenot

full_name: Jean Pierre Quenot

given: Jean Pierre

family: Capellier

full_name: Gilles Capellier

given: Gilles

family: Navellou

full_name: Jean-Christophe Navellou

family: Chaignat

full_name: Claire Chaignat

given: Claire

family: Grandperrin

full_name: Mathilde Grandperrin

given: Mathilde

family: Claveau

full_name: Mélanie Claveau

given: Mélanie

family: Belin

full_name: Nicolas Belin

given: Nicolas

family: Patry

full_name: Cyrille Patry

given: Cyrille

family: Claude

full_name: Frédéric Claude

given: Frédéric

family: Belon

full_name: François Belon

family: Barrot

full_name: Loïc Barrot

given: Loïc

family: Colnot

full_name: Marion Colnot

given: Marion

name: for the PROPASPI (PROcalcitonin Pneumonia/pneumonitis Associated with ASPIration) trial investigators


title: Epigenetic Evaluation of HAT/HDAC Activity in Peripheral Blood Mononuclear Cells From Patients With Clinically Isolated Syndrome and Analysis of the Relationship With the Pathophysiology and Disease Activity

acronym: EPIC

summary: The aim of the study is to compare the enzymatic activity of HATs and HDACs in peripheral blood mononuclear cell (PBMC) of patients with a clinically isolated syndrome (CIS group) and healthy controls (control group).

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Unknown


title: Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.

acronym: TherMO

summary: The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

intervention_type: Device

status_simplified: Completed


title: Measuring the Effects of Therapeutic Education Program "Caratif" Patient Under Strong Opioids Versus Standard Taking Charge of Patient Pain Receiving Opioid Therapy in Medical Oncology.

summary:
A first empirical evidence on the difficulties of observance of morphine in cancer patients invited a multidisciplinary team to initiate an innovative quality approach. It shows the lack of transcript of a comprehensive care causing a problem for monitoring actions undertaken for the relief of pain. In addition, two exploratory studies targeting the expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong opioids.

The E.T.P, public health priority, provides a framework for action and improving care. In oncology, the involvement of the patient in pain relief and management of opioids represents an axis of intervention more appropriate. Yet, it is not found in literature. In our department, we conduct an experimental therapeutic education program type "caratif" and a nurse consultation FTE receiving opioids on the model of nursing "care" of J. Watson (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient experience). The ETP folder and its tools have been continuously validated with patients. The heart of the educational process is in the patient's complex path neat oncology and relies on interaction and creativity between patient and caregivers.

design_allocation: Randomized

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille Hôpital de la Timone

intervention_type: Other


title: Réponse à l'Application d'Une Pression Locale en Laser Speckle Imaging Locally Applied Pressure-induced Vasodilatation

acronym: LAV

summary: Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).

study_start_date_type: Actual

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Henni S, Hersant J, Loufrani L, Duval G, Humeau-Heurtier A; SIMS Group, Riou J, Abraham P; SOCOS Group. Painless local pressure application to test microvascular reactivity to ischemia. Microvasc Res. 2019 Mar;122:13-21. doi: 10.1016/j.mvr.2018.10.013. Epub 2018 Nov 3.

family: Henni

full_name: Samir Henni

given: Samir

sequence: first

family: Hersant

full_name: Jeanne Hersant

given: Jeanne

sequence: additional

family: Loufrani

full_name: Laurent Loufrani

given: Laurent

family: Duval

full_name: Guillaume Duval

given: Guillaume

family: Humeau-Heurtier

full_name: Anne Humeau-Heurtier

given: Anne

family: Riou

full_name: Jeremie Riou

given: Jeremie

family: Abraham

full_name: Pierre Abraham

given: Pierre

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Microvascular Research

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Angers


title: Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controlled Clinical Trial

acronym: NEMS and FSHD

summary: Facioscapulohumeral muscular dystrophy (FSHD) is an autosomal dominant disease characterized by progressive weakness and atrophy of specific skeletal muscles. One of the major problems of patients affected by FSHD is the limitation in performing daily activities induced by the progressive muscle weakness. This sedentary lifestyle can cause a "debilitative cycle," and neuromuscular deconditioning can even aggravate the muscular deficiencies. Recent studies have indicated the safety and the effectiveness of moderate aerobic training programs in patients with FSHD. However, these training programs have limited applicability in patients with more severe muscular weakness. Artificial strength training by means of neuromuscular electrical stimulation (NMES) appears to be a promising rehabilitation strategy for FSHD patients suffering from neuromuscular disorders. Therefore we propose to investigate the feasibility, safety, and effectiveness of NMES strength training to counteract quadriceps muscle weakness in patients affected by FSHD.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Montpellier


summary:
This is a first care research focuses on the study of adaptation strategies implemented by cancerous wound patients. Today, advances in treatment generally increases the life expectancy of a patient with cancer. the patients thus live longer with their wound. How to live then? The literature review shows that there is research on adaptation strategies in cancer pathology and that different factors seem to interact with these strategies. However the investigators have not found written on the theme cancerous wound and adaptation strategies.

the investigators conducted a pilot study of this research in medical oncology, Prof. service Duffaud CHU Timone, which allowed us to highlight patient adherence and motivation centers contacted but also areas for improvement. Indeed, the investigators now were doing a study of adaptation strategies implemented by the patient time T of his life. However, adaptation is a process in constant motion, the investigators want to identify two different time patients coping strategies following a specific charge nurse taking.

study_type: Observational

time_perspective: Retrospective

location_facility: Assistance Publique Hôpitaux de Marseille Hôpital de Timone


type: Other Identifier

title: Study of New Determinants of Type 2 Diabetes in Severe Obesity

acronym: COMET

summary:
This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric surgery in obese patients. Three different groups of metabolic status of patients, corresponding to different stages of evolution of the disease, will be constituted: type 2 diabetes, insulin resistance, insulin sensitivity.

The main objective is to compare, between these 3 groups of patients, several biological processes that may be involved in the pathophysiology of type 2 diabetes and disorders associated with obesity, including:

Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma, serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver)
Identification of metabolic signatures, protein and miRNA in plasma
Immunoinflammatory response in adipose tissue
Polymorphisms SNP from whole blood
Histological analysis of tissue sections This main objective will be studied on samples taken at the time of surgery Secondary objectives will be to study the changes in metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of surgery, according to the initial metabolic state.

status: Recruiting

time_perspective: Prospective

status_simplified: Ongoing


type: Registry Identifier

title: Improving the Diagnostic of Tuberculosis

summary:
The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.

Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal.

Secondary

Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely.
Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely.
Beijing genotype prevalence among patients with pulmonary tuberculosis.

location_facility: Assistance Publique Hopitaux de Marseille


summary: Acute erythroid leukemia (AEL) is a morphologically distinct, infrequent (o5%) acute myeloid leukemia (AML) designed as M6 in the French- American-British (FAB) classification. The World Health Organization classification recognizes two subclasses, M6a, a leukemia with myeloid blast cells, and M6b, a very rare, purely erythroid AML. It may be difficult to distinguish between a myelodysplastic syndrome and AEL because of the erythroblastic proliferation, which is increased when dysplasia is present. No recurrent cytogenetic abnormality is specific of AEL and the prognosis is poor with a median survival of 17 months. A study of 14 genes in a series of 92 cases has shown that mutations are frequent in AEL and somewhat differ from the other AMLs by the lower and higher proportion of FLT3-ITD and TP53 mutations, respectively. Only three cases of AEL are reported in the TCGA database. To further characterize AEL, determine whether it constitutes a distinct class of AML and document the reasons for its poor prognosis, the investigators will search for molecular alterations in 40 M6a-AMLs using array comparative genomic hybridization (aCGH) and next-generation sequencing (NGS) of 106 genes known or suspected to have a role in myeloid malignancies or in erythrocyte differentiation.

lead_sponsor: Institut Paoli-Calmettes


title: Study of the Interest of Proprioceptive Therapy as a Complement to Speech Therapy in Children With Reading Difficulties

summary:
Before proposing this observational study protocol, a randomized study was attempted. This consisted in proposing to families of children with difficulties in learning to read, via the speech therapists who were treating them, to take part in a randomized trial that compared speech therapy alone with a combination of speech therapy and proprioceptive therapy. If parents agreed in principle with the study, the child underwent a complementary speech therapy examination and was referred to the nearest investigating doctor for inclusion. However, this study had to be abandoned because of insufficient recruitment (2 patients included in 1 year). Despite the motivation and training of participating speech therapists, proposing a study based on randomization to families often in distress proved to be extremely difficult, as their conviction of the interest of proprioceptive therapy was greater than the available scientific evidence suggested. Direct recruitment by investigating ophthalmologists was not possible because they were consulted directly by the families so as to obtain proprioceptive therapy. The principle of randomization would thus not have been accepted.

In light of the above, we decided to turn towards a non-randomized study comparing outcomes in two groups of children:

children who consulted an ophthalmologist who proposed proprioceptive therapy in Côte d'Or
children managed by one of the four speech therapists who do not propose proprioceptive therapy and who accepted the principle of the study.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Development and Validation of a Prognostic Score for Early Death in Head Injury Patients in the Traumatic Brain Injury Intensive Care Unit of Dijon CHU

acronym: SCORE TC

summary:
Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis.

The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury.

This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death.

We will subsequently test this score in a prospective validation cohort.


title: Ex-vivo Sentinel Lymph Node in Stage I-II Colon Cancer: Kappa Analysis With Immunochemistry and Molecular Biology

acronym: UNMASK

summary: Unmask Trial aims to evaluate the Kappa concordance between immunochemistry and molecular biology to detecting cancer cells in sentinel lymph node in patients undergoing colectomy for non metastatic colon cancer.

intervention_type: Procedure


title: Economic Evaluation of the Use of Plerixafor for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma

acronym: PLERIXAFOR

summary: This study aims to realize an economic evaluation of the introduction of Plerixafor in addition to G-CSF and alternative options, in patients with multiple myeloma (MM) who failed or insufficiently mobilize peripheral blood stem and progenitor cells in response to G-CSF alone.


title: Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection

summary:
It exists recommendations to get an optimal antibiotic treatment for bone and joint infection and prescription of antibiotics in the bone and joint infections on material meets certain obligations: the micro-organism must be known, the antibiotic therapy must be started in association, obtaining high plasma levels, use of molecules having good bone circulation. It is recommended to initially administer treatment with intravenous route and to propose an oral relay, under conditions. It is recommended to administer the antibiotic treatment for at least 6 weeks.

The dosages of antibiotics are adapted to the weight of patients in order to respond to those recommendations. But little is known about the optimal dose of treatment to give to obese patients (BMI>=30) and the frequency of serious adverse events in these patients in which the dosage is then higher can be more important compared to non-obese patients. The aim of the study is then to evaluate the risk of occurrence of serious adverse events in obese patients and to identify risks factors.

This study consists in a retrospective cohort of obese patients treated for a bone or joint infection and having had a serious adverse event. Several data are collected concerning: demographics data, treatment responsible of the serious adverse event (molecules, dosage, route), description of the serious adverse event, residual rate for vancomycin.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de référence des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse,


title: Inflammatory Bowel Disease : Could a Regular Physical Activity Reduce Patients Fatigue ?

acronym: MICI

summary:
The chronic fatigue is observed in approximately 40 % of the patients with a chronic quiet inflammatory bowel disease (IBD) and impacts the quality of life of the patients. The beneficial role of a regular physical activity on the quality of life of patients having an IBD was demonstrated in 5 studies including only 1 controlled one [Bilski, on 2013]. The mechanism by which the physical activity could improve the quality of life of the patients remains unknown (stress decreased, reduction of the inflammatory process) [Bilski, on 2014]. Several studies concerning other chronic pathologies such as fibromyalgia, have demonstrated the beneficial effect of a regular physical exercise to reduce the fatigue of patients. It was recently demonstrated that the chronic fatigue observed in patients with IBD came along with a physical reduction in the performances during the exercise test and a reduction in the physical activity of the patients [Vogelaar, 2015].

Our hypothesis is that a regular moderate physical activity could improve physical performance during an effort et could reduce the chronic fatigue and improve their quality of life.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Rouen


title: Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease

acronym: NASH

summary: The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH

lead_sponsor: Rennes University Hospital

location_facility: Centre hospitalier universitaire de Rennes


title: Use of Infrared Spectroscopy in Septic Arthritis Diagnosis

acronym: SynoFAST

summary: The main objective of this study is to assess the ability of Fiber-optic Evanescent Wave Spectroscopy (FEWS) to discriminate synovial fluids samples of septic arthritis patients from other causes of joint effusion by analyzing ex vivo joint fluid samples collected during routine clinical care.

ReferenceCitation: Albert JD, Le Corvec M, Berthoud O, David C, Guennoc X, Hoppe E, Jousse-Joulin S, Le Goff B, Tariel H, Sire O, Jolivet-Gougeon A, Coiffier G, Loréal O. Ruling out septic arthritis risk in a few minutes using mid-infrared spectroscopy in synovial fluids. Rheumatology (Oxford). 2021 Mar 2;60(3):1158-1165. doi: 10.1093/rheumatology/keaa373.

name: Rheumatology Department, Centre Hospitalier Universitaire de Rennes, Rennes, France

name: INSERM, Université de Rennes, INRAe, UMR 1241, Institut NUMECAN CHU Rennes, Rennes, France

family: Albert

full_name: Jean-David Albert

given: Jean-David

family: Le Corvec

full_name: Maëna Le Corvec

given: Maëna

family: Berthoud

full_name: Olivia Berthoud

given: Olivia

name: Rheumatology Department, Centre Hospitalier de Bretagne Atlantique, Vannes, France

family: David

full_name: Claire David

name: Rheumatology Department, Centre Hospitalier St-Brieuc, St-brieuc, France

family: Guennoc

full_name: Xavier Guennoc

given: Xavier

name: Rheumatology Department, Centre Hospitalier Universitaire Angers, Angers, France

family: Hoppe

full_name: Emmanuel Hoppe

given: Emmanuel

name: Rheumatology Department, Centre Hospitalier Universitaire and Inserm, LBAI, UMR1227, Brest, France

family: Jousse-Joulin

full_name: Sandrine Jousse-Joulin

given: Sandrine

name: Rheumatology Department, Centre Hospitalier Universitaire de Nantes, Nantes, France

family: Le Goff

full_name: Benoît Le Goff

given: Benoît

family: Tariel

full_name: Hugues Tariel

given: Hugues

family: Sire

full_name: Olivier Sire

given: Olivier

family: Jolivet-Gougeon

full_name: Anne Jolivet-Gougeon

family: Coiffier

full_name: Guillaume Coiffier

family: Loréal

full_name: Olivier Loréal

journal_name: Rheumatology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


title: Role of PTK-7 in Acute Myeloid Leukemias: Impact of PTK7 Serum Marker and ex Vivo Studies to Decipher the Role of PTK7

summary:
The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to convey promigratory and antiapoptotic signals into the cell and represents an independent prognosis factor of survival in patients treated with induction chemotherapy. This study aims at:

evaluating the impact of PTK7 expression on primary AML cells ex vivo
evaluating the diagnostic and prognostic value of a soluble form of PTK7


title: Clinical Observatory of the Prescription of Erythropoietin as Treatment of Anemia Induced by Chemotherapy or Allograft Conditioning Among the Patients With a Haematological Malignancy

acronym: EPREX/LAM-ALLO

summary:
Anemia concerns a lot of patients with cancer and affects their quality of life (QOL). Numerous studies in oncology have demonstrated the benefit of erythropoiesis-stimulating agents (ESA) in the treatment of anemia. ESAs allow the improvement of QOL,of the hemoglobin level (Hb) and is a validated alternative to transfusion.

However, in hematology, if there are some specific recommendations for the use of ESAs in lymphoid pathology, there are none for myeloid disorders and in the context of autografts and allogeneic hematopoietic stem-cell transplantation (HSCT). Thus, the investigators are in particular interested in both indications: treatment of anemia in acute myeloid leukemia (AML) patients treated with chemotherapy, and the in patients receiving a myeloablative or a non-myeloablative conditioning before allogeneic HSCT, whatever type of donor and cell source.


acronym: BREAST-HDCT

summary: The objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.


intervention_type: Drug

status: Withdrawn

study_start_date_type: Anticipated

acronym: EVEROST

type: EudraCT Number

source: euctr

title: Topical Everolimus Versus Placebo for the Treatment of Facial Angiofibromas in Patients With Tuberous Sclerosis Complex. A Phase II/III, Multicentre, Randomized, Double-blind, Placebo-controlled Study of 3 Doses of Topical Everolimus.

summary: Tuberous sclerosis complex (TSC) is a rare genetic multisystem disorder characterized by the development of hamartomas in several organs (e.g. brain, heart, kidney, liver, lung), and skin in more than 90% of cases. Facial angiofibromas (FA), present in about 80% of patients, are a stigmatizing hallmark of the disease. Everolimus could be a candidate for use as a topical formulation to treat FA. This adaptive seamless Phase II/III study primary objective is to determine the dose of topical everolimus for treatment of FA and evaluate the efficacy and safety of topical everolimus versus placebo in patients with angiofibromas.


title: Role of Pulse Co-oximetry in Prehospital Emergency Medical Service Management of Suspected Carbon Monoxide Poisoning : A Prospective Multicenter Study.

acronym: CO-OX

summary:
The RAD-57 pulse CO-oximeter is a lightweight device allowing non-invasive measurement of blood carboxyhemoglobin. Previous studies comparing RAD-57 measurements (SpCO) to standard laboratory blood gas analysis (COHb) have reported contradictory results.

the RAD-57 pulse CO-oximeter could be useful as a first-line screening test for acute CO poisoning, enabling rapid detection and management of patients with suspected CO poisoning in the prehospital emergency setting This study assesses the diagnostic value of pulse CO-oximetry, comparing SpCO to standard laboratory blood measurement for prehospital management of patients with suspected carbon monoxide (CO) poisoning.

location_facility: Montpellier University hospital - Emergency department


title: Motor Imagery for Reach-to-grasp Rehabilitation After Tetraplegia

summary: Single center, pilot study, to evaluate the influence of Motor Imagery (MI) on functional rehabilitation and cerebral plasticity through the qualitative and quantitative mental practice approach. For this, the investigators will use magnetoencephalography (MEG) but also physiological and behavioral indicators developed by the Laboratoire de la Performance Motrice, Mentale et du Matériel (P3M) of Université Claude Bernard Lyon 1 and its partners.

ReferenceType: result

ReferenceCitation: Mateo S, Reilly KT, Collet C, Rode G. Descriptive pilot study of vividness and temporal equivalence during motor imagery training after quadriplegia. Ann Phys Rehabil Med. 2018 Sep;61(5):300-308. doi: 10.1016/j.rehab.2018.06.003. Epub 2018 Jun 23.

family: Mateo

full_name: Sébastien Mateo

given: Sébastien

family: Reilly

full_name: Karen T. Reilly

given: Karen T.

family: Collet

full_name: Christian Collet

given: Christian

family: Rode

full_name: Gilles Rode

given: Gilles

journal_name: Annals of Physical and Rehabilitation Medicine

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

location_facility: Hôpital Henry Gabrielle - Médecine physique et Réadaptation, Hospices Civils de Lyon, 20 Route de Vourles,


title: Evaluation of Systemic Leakage When a Heparin or Citrate Lock is Injected and Biological and Clinical Repercussions: Ancillary Study of the VERROU-REA Randomized Controlled Trial

acronym: VERROU HEMOST

summary: In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings will complete safety data already collected in the VERROU REA study.


title: Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke: Effect of Intravenous Fibrinolysis With Rt-PA

acronym: BDNF

summary:
The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.

The analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.


title: Mechanical Characterization of Ascending Aorta in Patients With Acute Type A Dissection and in Healthy Control Group Combined to Structural and Ultrastructural Analysis of Aortic Tissue

summary: Acute type A aortic dissection is a frequent (3 cases per 100 000 people per year) and severe (spontaneous mortality 70%), needing an emergency surgical treatment. Surgical outcomes have improved with the development of surgical techniques, but the postoperative mortality remains high (15-30% at 30 days). Endovascular approach with the deployment of endoprosthesis sealing the proximal intimal tear is an attractive minimally invasive technique, which can represent an alternative to surgical repair especially in high risk patients.

location_facility: Assistance Publique Hôpitaux de Marseille


acronym: FUSE-TM-Duo

summary: The monitoring and prognosis of patients with familial polyposis adenomatous rests on analysis of the transitional mucosa at the anal margin and especially on the tracking, characterization and resection of lesions of dysplasia type of high grade at the duodenal level, after total proctocolectomy. Currently, endoscopes with axial or lateral vision are used. The FUSE technology allows the simplification or even the improvement of patient surveillance with a 245° vision (versus150° in case of classical gastroscope). The use of a second screen to enlarge the field of view may allow both analysis of duodenum and the main and accessory papilla with one single endoscope and to decrease the number of omitted lesions .

ReferenceType: background

ReferenceCitation: Gralnek IM, Segol O, Suissa A, Siersema PD, Carr-Locke DL, Halpern Z, Santo E, Domanov S. A prospective cohort study evaluating a novel colonoscopy platform featuring full-spectrum endoscopy. Endoscopy. 2013 Sep;45(9):697-702. doi: 10.1055/s-0033-1344395. Epub 2013 Aug 12.

ReferenceCitation: Gralnek IM, Siersema PD, Halpern Z, Segol O, Melhem A, Suissa A, Santo E, Sloyer A, Fenster J, Moons LM, Dik VK, D'Agostino RB Jr, Rex DK. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol. 2014 Mar;15(3):353-60. doi: 10.1016/S1470-2045(14)70020-8. Epub 2014 Feb 20.

ReferenceCitation: Moussata D, Napoleon B, Lepilliez V, Klich A, Ecochard R, Lapalus MG, Nancey S, Cenni JC, Ponchon T, Chayvialle JA, Saurin JC. Endoscopic treatment of severe duodenal polyposis as an alternative to surgery for patients with familial adenomatous polyposis. Gastrointest Endosc. 2014 Nov;80(5):817-25. doi: 10.1016/j.gie.2014.03.012. Epub 2014 May 6.


title: Description of the Evolution of a Cohort of Adolescents With Type 1 Diabetes Following Their Participation in Therapeutic Education Program Based on Social Cognitive Theory: Socio-cognitive Profile, Physiological Behaviour of Therapeutic Adherence and Quality of Life

acronym: ETPACAP

summary:
Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary management of type 1 diabetes for adolescents, favoring their adherence and improving their quality of life and metabolic control. Six pediatric diabetes teams have engaged in action research to build a regional ETP program based on social cognitive theory of Bandura, assuming that the learning strategies of theory, applied in ETP program, should strengthen self-efficacy of adolescents with type 1 diabetes, which could induce an improvement behaviors adherence, quality of life and physiological profile of participants about 6 months post-inclusion in the program.

Aims: The main objective is to describe the evolution over 6 months of self-efficacy in a cohort of adolescents with type 1 diabetes who followed a therapeutic education program based on social cognitive theory of Bandura in region PACA (ETPACAP program). Secondary objectives are to describe the evolution of 6 months of glycemic control, behavior of adherence, quality of life and other components of social cognitive theory for this population, to explore the effects of socio-cognitive profile on adherence, quality of life and glycemic control among adolescents with type 1 diabetes followed this program.

Method: A prospective multicenter cohort study of adolescents with type 1 diabetes who participated in ETPACAP program, consisting of three components:

A quantitative component: collection and analysis of changes over 6 months of self-efficacy, adherence, quality of life and HbA1c levels (ANOVA repeated measures);
A qualitative component: interviews with 32 participants at M0, M3 and M6 on the socio-cognitive factors according to Bandura (analysis continues theming);
An integrative component, exploring the effects of the components of social cognitive theory on adherence, glycemic control and quality of life of adolescents with type 1 diabetes cohort.

Expected results: This research is expected to bring new knowledge about the ETP programs and the adolescent cohort studied to make an improvement and adjustment of educational sessions relevant to the needs and expectations of this population.


title: Riluzole in the Treatment of Spasticity in the Traumatic Chronic Spinal Cord Injury Condition: Adaptive, Multicenter, Placebo-controlled, Randomised, Double Blind Trial in a Rare Disorder

acronym: RILUSCI

summary:
The study will be conducted in two steps:

Determination of the Minimal Effective Dose (MED) among the four doses of the panel
Estimation of the probability of response associated to the MED.

Each step has a main objective:

Step 1 Objective: To determine a daily dose of Riluzole that improves spasticity in patients with chronic SCI

Step 2 Objective: To demonstrate, in a phase 2b trial, the efficacy of Riluzole to improve spasticity vs placebo, in patients with chronic SCI.


title: Prospective Randomized Controlled Study Comparing Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy (MCT) Versus Percutaneous Radiofrequency Ablation (RFA) in Patients With Chronic Liver Disease and Hepatocellular Carcinoma

acronym: Thermoablation

summary: To date, the majority of studies that have evaluated the efficacy of microwave ablation (MWA) in the treatment of hepatocellular carcinoma (HCC) lesions in cirrhotic patients and compared its efficacy with that of percutaneous radiofrequency ablation (RFA) for local recurrence and survival have been retrospective. There have been no prospective randomized studies comparing percutaneous microwave ablation (PMWA) with RFA for ablated tumour volume, the response after one session, local recurrence rates in the first year, complication rates and survival at 3 and 5 years for HCC lesions > 2 cm in patients with Child-Pugh A and B cirrhosis. The hypothesis the investigators wish to explore is that though the 2 methods are equivalent for lesions ≤ 2 cm, MWA could show better efficacy with a similar risk for lesions > 2 cm and for lesions close to vessels ≥ 3 mm in diameter, as shown in retrospective studies.

ReferenceCitation: Vietti Violi N, Duran R, Guiu B, Cercueil JP, Aubé C, Digklia A, Pache I, Deltenre P, Knebel JF, Denys A. Efficacy of microwave ablation versus radiofrequency ablation for the treatment of hepatocellular carcinoma in patients with chronic liver disease: a randomised controlled phase 2 trial. Lancet Gastroenterol Hepatol. 2018 May;3(5):317-325. doi: 10.1016/S2468-1253(18)30029-3. Epub 2018 Mar 2.

family: Vietti Violi

full_name: Naïk Vietti Violi

given: Naïk

family: Duran

full_name: Rafael Duran

given: Rafael

family: Guiu

full_name: Boris Guiu

given: Boris

family: Cercueil

full_name: Jean-Pierre Cercueil

given: Jean-Pierre

family: Aubé

full_name: Christophe Aubé

given: Christophe

family: Digklia

full_name: Antonia Digklia

given: Antonia

family: Pache

full_name: Isabelle Pache

given: Isabelle

family: Deltenre

full_name: Pierre Deltenre

family: Knebel

full_name: Jean-François Knebel

given: Jean-François

family: Denys

full_name: Alban Denys

given: Alban

journal_name: The Lancet Gastroenterology & Hepatology


title: Validation of the SIGAM/VF Mobility Grade

acronym: SIGAM

summary: The objective of this study is to demonstrate the validity, the reproducibility and the coherence of the French version of the Special Interest Group in Amputee medicine (SIGAM) mobility scale questionnaire in adults with lower-limb amputations.


title: Detection of Colorectal Adenomas in Côte-d'Or: Impact of Organized Screening on Socio-geographic Disparities

acronym: DACCOR

summary: Previous studies have shown geographic disparities in the detection of colorectal adenomas in Côte-d'Or, with an impact of the distance from the general practitioner and an ecological deprivation index (EDI). On the other hand, the extremely low detection rates for these lesions in everyday practice before the implementation of organized screening for colorectal cancer in the Côte-d'Or were shown. One of the aims of this screening is to reduce socio-geographic inequalities in access to care and prevention. Yet, participation in screening also varies depending on the socio-economic level. In this context, the Côte-d'Or Polyps Registry, the only body to have data for the pre-screening period (before 2003), will make it possible to determine whether the implementation of organized screening led to the elimination of socio-geographic disparities concerning the detection of adenomas.


title: Can Epimutations be Inherited? How to Manage Patients With Imprinting-related Diseases Who Wish to Become Parents

acronym: REPAR

summary:
Like genetic mutations, DNA methylation anomalies or epimutations can disrupt gene expression and lead to human diseases.

However, unlike genetic mutations, epimutations can in theory be reverted through developmental epigenetic re-programing, which should limit their transmission across generations. Following the request for a parental project of a patient diagnosed with Silver-Russell syndrome (SRS), and the availability of both somatic and spermatozoa DNA from the proband and his father, we had the exceptional opportunity to evaluate the question of inheritance of an epimutation. We provide here for the first time evidence for efficient reversion of a constitutive epimutation in the spermatozoa of an SRS patient, which has important implication for genetic counseling.

intervention_type: Genetic


title: Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease

acronym: Smell&Crohn

summary: This study will improve our understanding of the mechanisms underlying anorexia in persons with Crohn's disease flare-ups. The practical spin-off from this research is potentially very important for the management of nutritional disorders associated with the disease by guiding diets towards foods that correspond to patients' preferences and/or to modified tastes. In addition, the results could lead to the identification of sensory markers that herald an inflammatory flare-up of the disease.


title: Gestural Short Term and Working Memory Task

acronym: GeSTWoM

summary:
According to the working memory model, which accounts for the organisation of working memory, the processing of non-meaningful gestures is not clear. Some authors suggest that working memory for non-meaningful gestures has the same characteristics as the phonological loop, made up of a phonological store and of a revival process (articulatory rehearsal). These characteristics are evidenced in memory span tasks, memory span which is itself determined by the duration of the memory trace and the time required to refresh the trace by subvocal rehearsal.

The investigators therefore aim to set up a gestural working memory task, which is specific, simple and reproducible, in the manner of verbal and visuospatial span tasks. It will first be an exploratory and descriptive study with healthy subjects.

ReferenceCitation: Baddeley A. The episodic buffer: a new component of working memory? Trends Cogn Sci. 2000 Nov 1;4(11):417-423.

ReferenceCitation: Baddeley AD, Allen RJ, Hitch GJ. Binding in visual working memory: the role of the episodic buffer. Neuropsychologia. 2011 May;49(6):1393-400. doi: 10.1016/j.neuropsychologia.2010.12.042. Epub 2011 Jan 20. Review.

ReferenceCitation: Wilson M, Fox G. Working memory for language is not special: evidence for an articulatory loop for novel stimuli. Psychon Bull Rev. 2007 Jun;14(3):470-3.

ReferenceCitation: Conway AR, Kane MJ, Bunting MF, Hambrick DZ, Wilhelm O, Engle RW. Working memory span tasks: A methodological review and user's guide. Psychon Bull Rev. 2005 Oct;12(5):769-86. Review.

ReferenceCitation: Cowan N. The magical number 4 in short-term memory: a reconsideration of mental storage capacity. Behav Brain Sci. 2001 Feb;24(1):87-114; discussion 114-85.

ReferenceCitation: CONRAD R, HULL AJ. INFORMATION, ACOUSTIC CONFUSION AND MEMORY SPAN. Br J Psychol. 1964 Nov;55:429-32.

intervention_type: Behavioral


title: Study of Elastographic Properties of the Clot by Technical SWIRE (Shear Wave Induced Resonance Elastography)

acronym: ClotStruct

summary:
Deep vein thrombosis (DVT) is a vascular disease characterized by the formation of a thrombus within the venous system, mainly the lower limbs. The clot structure directly influences both its location, but also its progressive profile expansion material or regression and embolic migration.

Few data are available regarding the evolution of structural properties of thrombus after an acute episode of DVT. Thrombus formation is due to the polymerization of fibrinogen into fibrin. Fibrin is a viscoelastic polymer. Its mechanical properties directly determine how the thrombus responds to forces which it is subjected.

Determining the mechanical properties of the thrombus in vivo and ex vivo is expected to study its evolutionary properties.

lead_sponsor: University Hospital, Grenoble

intervention_type: Radiation


title: Eating Behaviour and Gustatory Sensitivity Before and After Liver Transplant in Cirrhotic Patients

acronym: GREFFE

summary:
Today, we know that olfactogustatory alterations occur in cirrhotic patients before the liver transplant but no study has been conducted to show eventual disturbances after the transplantation able to explain modifications in eating behaviour. In parallel, the metabolic status, itself dependent on liver metabolism, influences food preferences and is modified after the transplantation as the liver recovers its ability to store glycogen, but is not able to inform the brain as the afferent nerve impulses have been suppressed. The innovative aspect of this project is to provide information on the importance of the liver in the regulation of energy homeostasis.

The results of this study will improve our understanding of eating behaviour and olfactogustatory sensitivity and allow us to orient liver transplant patients towards appropriate diets.

primary_purpose: Other


title: Evaluation of the Effect of Saccharomyces Cerevisiae on the Improvement of the Conventional Treatment for Vulvo-vaginal Infection to Candida Spp (Local Administration)

summary: This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study. The administration of yeast will be local (vaginal).

lead_sponsor: Lesaffre International

lead_sponsor_type: industriel


title: Single-centre Study of the Expression of Heat Shock Proteins in the Lymphocytes From the Tonsils of Patients With Various Diseases Requiring Tonsillectomy

acronym: HOTLYMPHO

summary:
It has recently been shown that various HSPs are strongly expressed in B lymphomas. Indeed, HSP90 stabilizes the protein Bcl-6 in diffuse large-cell B lymphomas. Pharmacological inhibition of HSP90 in vitro induced apoptosis in lymphoma cells (Cerchietti et al. Nat. Medicine, 2009, 1369-1376). In addition, HSP110 is strongly expressed in non-Hodgkin lymphomas, and targeting this HSP at the cell surface using specific antibodies could constitute a future therapy (Zappasodi et al. Blood, 2011, 4421-4430). Despite the importance of these proteins in the development of lymphomas, their expression and their role in the activation of normal B lymphocytes and the normal development of germinal centres is not known.

The expression of Heat shock proteins should vary among the different B lymphocyte populations present in the tonsils (naïve B cells, memory B cells, germinal centre B cells).

The aim of this study is to establish an expression profile for heat shock proteins in populations of B lymphocytes in human tonsils


title: Memory, Auditory and Visual Attention in Healthy Children: Neurophysiological and Electrophysiological Aspects

acronym: MASK

summary:
This project studies memory and attention in healthy children aged from 5 to 17 years. The processes investigated are short term memory (auditory and visual) and attention.

To characterize these processes involved in childhood, neuropsychological and neurophysiological assessments will be performed (using Electro-encephalography measures, behavioural responses and questionnaires).


title: Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

summary:
After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. This decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. These information lack sensitivity and specificity.

Therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:

one source to higher health care costs (hospitalization, additional examinations)
Selection of the bacterial ecology of the newborn and neonatal services and
stress for the newborn and parents


title: Structural and Functional Brain Reorganization in Neuropathic Pain. Influences of the Loss of Sensitivity and the Atrophy Cortical on Activations Due to Stimulation Allodynic

acronym: ALLO

summary:
Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).

This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain. It induces a loss of sensitivity and reorganization of brain activity.

Previous studies in functional neuroimaging have focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally.

The objective of this study is to understand the brain dysfunction that induces allodynic pain considering the deafferentation of each patient and possible cortical losses.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Structural and Functional Brain Reorganization in Neuropathic Pain: Basal State of Local Cerebral Blood Flow and Functional Connectivity

acronym: CONNECT

summary:
Neuropathic pain is a medical condition involving allodynia (painful perceptions in response to stimuli that normally are not) and spontaneous pain (occurring at rest, without stimulation).

This pain is secondary to nervous system injury affecting the sensory system. The lesion is either at the nerve endings of the spinal cord or brain.

It induces a loss of sensitivity and likely reorganization of brain activity that are causing pain and which are the subject of this study.

Previous studies in functional neuroimaging has focused on brain areas activated during allodynic stimuli compared to non-painful stimuli. The abnormalities have been reported, but it was not possible to conclude formally. The authors failed to assess the part of the effect of the loss of sensory afferents (deafferentation) and the basal brain function.

Indeed, the operation without any sensory stimulation is not known yet is the initial level of activity which is the benchmark for studying brain function during stimulation. The objective of this study is to understand what are the cortical systems of allodynic dysfunctional in patients compared with controls at baseline.


title: Exploratory Study of Cellular Reservoirs in Blood From HIV Infected Patients: EURECA (ERANET to Unravel New Roads to Eradication and a Cure for AIDS) Study

acronym: EURECA

summary: This study evaluates the impact of highly active antiretroviral therapy on the size of the latent viral reservoirs in resting CD4+ T cells and monocytes in HIV positive patients. The activation state of the cells will be assessed, by measuring the activation of Akt, to determine its influence on the size of the viral reservoirs.

location_facility: Centre Hospitalier Régional Universitaire


acronym: QUALVESTO

summary: The study aims to assess and compare the pain in women suffering from provoked vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18 months after treatment.


summary:
During thoracic surgery, an excessive use of fluid results in pulmonary complications. Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation. The investigators hypothesized that the assessment by transesophageal echocardiography (TEE) of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict fluid responsiveness in patients receiving one-lung ventilation.

This retrospective, observational, single center study was from January 2014 to December 2015. The investigators included 105 patients requiring one lung ventilation lung resection. The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining 400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the VTI above 15% after infusion of 500 ml of crystalloid.

location_facility: hôpital Nord Assistance Publique Hôpitaux de Marseille


title: Evaluation of Infarct Size With 3D Rotational Angiography

acronym: EVATIAR

summary: The size of the infarct is particularly important prognostic marker. It is clearly established that the extent of the infarct is not only correlated to mortality, but also long-term adverse events. The evaluation of the infarct size at the acute phase of the disease is therefore an essential clinical tool to adapt the immediate treatment and follow-up of patients. It is therefore crucial to have techniques that are effective, precise, reproducible, and easily performed during the acute phase to quantify the size of the infarct following angioplasty. Myocardial scintigraphy and cardiac MRI have been the standard examinations for the evaluation of infarct size. However, these exams are difficult to perform during the acute phase of the infarct owing to difficulties in monitoring unstable patients and the limited availability of the apparatus. It is for this reason that the investigators would like to investigate the rotational angiography (RA), which is comparable to a scanner in its mode of action but does not require transfer of patients as performed using the same apparatus that used for diagnostic coronarography and therapeutic angioplasty. RA is a radiological technique that uses the system employed for coronagraph, and consists rotating the fixed C-Arm around the patient and acquisition of a series of images that are then reconstituted. The investigators propose to evaluate the size of the infarct using RA in comparison with cardiac MRI (standard examination) performed as soon as possible after RA and the investigators hope to demonstrated that RA allows the measurement of an infarct as precisely as cardiac MRI.


title: Anti-thymocyte Globulin-induced Immune Senescence

acronym: SIGAL

summary: The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune senescence. Markers of immune senescence expression is assessed in a prospective cohort of renal transplant recipients the day of transplantation and one year after renal transplantation.


title: Identification of the Predisposing Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)

acronym: ATM

summary:
Polypoidal choriodal vasculopathy (PCV) is an ophthalmologic disease, characterized by vascular abnormalities of the walls of small choroidal vessels, reproducing the specific aspect of polyps (cluster aspect). PCV is one of the "boundary-forms" of age related macular degeneration.

These vasculopathies can be idiopathic. Following the radiotherapy treatments of active and occult-typed neovessels in Age-Related Macular Degeneration (ARMD), 10% of the patients would present typical polypoidal vasculopathic lesions. These polypoidal secondary lesions have been induced by radiotherapy treatment and may show an increased sensibility to radiation in these patients.

Such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in relation to the ATM gene mutations. The secondary or idiopathic polypoidal vasculopathic lesions are to be brought closer to telangiectasias in Ataxia Telangiectasia. Considering the iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it seems legitimate to search for predisposing variants to polypoidal vasculopathies in the ATM gene.

Considering the frequency of PCV worldwide, it seems important to identify the predisposing genetic factors of the ATM gene. These biomarkers to the pathology might enable us to offer prevention (reinforced protection against radiations, including light) and to develop therapeutics (recruitment of other kinases, ATM's partners, in the stability and cellular control of DNA).

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rotchschild


title: Effect of Simple Corneal De-epithelization Associated With a Therapeutic Photokeratectomy in Patients With Evolutive Keratoconus

acronym: KERADES

summary:
Keratoconus is a symmetrical, bilateral, non-inflammatory, idiopathic corneal pathology, characterized by a progressive corneal thinning. This disease leads to a bombing of the cornea, inducing a strong corneal astigmatism, responsible for a loss of visual acuity sometimes very important, non-correctable by lens of glasses. Collagen Cross-Linking (CXL) and simple corneal de-epithelization are two common surgical technics aiming to slow the progression of this pathology. They consist in rigidifying the corneal structure in order to stabilize its deformation progression. Even though these technics are commonly performed, none of these strategies has proven their efficiency. The effects of CXL can be due to the superficial scarring reaction as well as the effects of corneal remodeling induced by the de-epithelization phase during a CXL procedure, and not due to the covalent links between collagen and fibrils, formed by the biochemical reaction resulting from the UV-A exposition in the presence of Riboflavine De-epithelization may be an equally effective treatment, when compared to CXL, but without long term secondary effects. Its association with a therapeutic photokeratectomy (PKT, surgical technic used to regulate the corneal surface, and eliminate its opacities in order to recuperate the transparency of the cornea) will aim to improve the regularity of the anterior corneal surface, thus allowing a better epithelial attachment (adhesion) and may allow a stromal inflammatory reaction, favorable to the improvement of corneal biomechanics. PKT is a reliable technic; however it has not yet proven its efficiency in the treatment of keratoconus.

The purpose of this study is to describe the effects of de-epithelization associated with a therapeutic photokeratectomy in patients with evolutive keratoconus, by showing the proportion of patients who lost the evolutivity of their keratoconus, after 6 months and 1 year, after an intervention of de-epithelization associated with therapeutic photokeratectomy.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Study of the Contribution of Confocal Microscopy Dual Band in the Management of Bladder Cancer

acronym: HEXVISIO

summary: Bladder cancer is one of the most common cancer worldwide and the second most frequent urological cancer. The photodynamic diagnosis technique (PDD) currently used (Hexvix®) has improved tumor detection but with a high false positive rate. Indeed, the main limitation of the PDD is its lack of specificity, ranging from 35 to 66%. The association of this technique with new technologies such as the Cellvizio Dual Band featuring simultaneous dual wavelength illumination and detection, could improve the identification of tumoral lesions. The objective of this study is to demonstrate the efficacy of Cellvizio dual band technique for the diagnosis of tumors bladders.

time_perspective: Cross-Sectional

lead_sponsor: Lille Catholic University

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: A Randomized Phase I/II Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in Combination With Intra-venous Nivolumab in Patients With Metastatic Melanoma

acronym: NIVIPIT

summary:
The study aims to evaluate the 6 month-treatment tolerance defined as the immune related grade 3-4 adverse event-free survival of the combination therapy IT ipilimumab + IV nivolumab.

The IV ipilimumab + IV nivolumab (same doses than in Phase I) arm will be used as an internal control to interpret the results obtained in the IT ipilimumab arm.

status: Active, not recruiting

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure Evaluated at the Initiation of Intermittent or Peritoneal Dialysis

acronym: DIALYSOX

summary: The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.


title: Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire

acronym: FRESH COLA

summary:
The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life.

The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. It has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. It has never been validated in French. The Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients.

This tool, validated in a British population, has never been validated in French.


title: Assessment of Frequency of Xerostomia and Their Care Management in Upper Aerodigestive Tract Cancer Patients After the End of Radiotherapy

acronym: XEROSTOMIA

summary:
The aim of this study is the evaluation of the frequency of xerostomia and their management after radiotherapy in head and neck cancer.

The quality of life of these patients is also analysed with European Organization for Research and Treatment of Cancer Quality of life Questionnaire H&N35 (EORTC QLQ H&N35).


title: Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative

acronym: VEPSY

summary: The experimental strategy is to develop a specific device about the anesthetic and surgical acts for a subject with a documented psychiatric condition and to benefit from surgery. This device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative phase. A nurse anesthetist will come into contact with the subject the day before surgery. This contact will be concomitant with the pre-anesthesia visit. She explained about the general organization of the arrival in the operating room. The interview will be a minimum of 15 minutes and beyond if necessary. This will be accompanying this the next day in the operating room in order to optimize its hospitality and installing the block, guide the subject through all the steps before falling asleep. Finally, even accompanying will be present upon awakening the subject in the recovery room.


title: Study of Phenotypic and Functional Characteristics of Regulatory T Lymphocytes in Giant Cell Arteritis (Horton's Disease)

acronym: ACG et TREG

summary:
Giant cell arteritis (GCA) is the most frequent vascularitis after 50 years of age The investigators recently showed that GCA was accompanied by an elevation in Th1 and Th17 response [1]. Even though a quantitative deficit in regulatory TL (Treg) was shown, there are to date no data concerning their precise phenotypic and functional characteristics and notably their ability to inhibit Th1 and Th17 polarisation. The hypothesis of the investigator is that, in GCA, there is quantitative and above all functional deficit of Treg. Recently, progress has been made in the identification of Treg with new markers (CD39), which will make it possible to better identify and to study their specific functions. In this study the phenotypic and functional characteristics of Treg in GCA will be analysed. Better understanding of the role des Treg in GCA should lead to better-targeted treatments for patients with GCA, notably via the blockage of cytokines that inhibit the differentiation and/or function of Treg.

The study is classified interventional because a lot of blood samples are taken.

ReferenceCitation: Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clément O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.

family: Maldiney

full_name: Thomas Maldiney

given: Thomas

family: Greigert

full_name: Hélène Greigert

given: Hélène

family: Martin

full_name: Laurent Martin

given: Laurent

family: Benoit

full_name: Emilie Benoit

given: Emilie

family: Creuzot-Garcher

full_name: Catherine Creuzot-Garcher

given: Catherine

family: Gabrielle

full_name: Pierre-Henry Gabrielle

given: Pierre-Henry

family: Chassot

full_name: Jean-Marie Chassot

given: Jean-Marie

family: Boccara

full_name: Claude Boccara

given: Claude

family: Balvay

full_name: Daniel Balvay

given: Daniel

family: Tavitian

full_name: Bertrand Tavitian

given: Bertrand

family: Clément

full_name: Olivier Clément

family: Audia

full_name: Sylvain Audia

given: Sylvain

family: Bonnotte

full_name: Bernard Bonnotte

given: Bernard

family: Samson

full_name: Maxime Samson

given: Maxime

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

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

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

repository_normalized: bioRxiv

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


title: Prospective Cohort Study Monitoring Patients Undergoing Bariatric Surgery

acronym: BARIASURG

summary: The aim of this cohort study is to collect prospectively clinical data on all the patients admitted in the investigators department for bariatric surgery or for any complication of a bariatric procedure. The investigators goal is not only to improve the follow-up but also to assess and publish the investigators results regarding weight loss and the complication rate.

ReferenceCitation: Iceta S, Tardieu S, Nazare JA, Dougkas A, Robert M, Disse E. An artificial intelligence-derived tool proposal to ease disordered eating screening in people with obesity. Eat Weight Disord. 2021 Oct;26(7):2381-2385. doi: 10.1007/s40519-020-01076-2. Epub 2021 Jan 2.

family: Iceta

full_name: Sylvain Iceta

family: Tardieu

full_name: Solène Tardieu

given: Solène

family: Nazare

full_name: Julie-Anne Nazare

given: Julie-Anne

family: Dougkas

full_name: Anestis Dougkas

given: Anestis

family: Robert

full_name: Maud Robert

given: Maud

family: Disse

full_name: Emmanuel Disse

given: Emmanuel

journal_name: Eating and Weight Disorders - Studies on Anorexia, Bulimia and Obesity

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Department of Digestive Surgery, University Hospital of Edouard Herriot, Hospices Civils de Lyon


acronym: ToucherDétente

summary: Measure the impact of touch relaxation on pain communicative patients suffering from chronic pain of cancer origin inpatient Oncology. measure over three days the effects on pain anxiety welfare and consumption of analgesics

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille


title: The Ratio of Ascites Calprotectin to Total Protein is a Diagnostic and Prognostic Marker for Spontaneous Bacterial Peritonitis in Liver Cirrhosis

acronym: Ca-DRISLA

summary: The prognosis of spontaneous bacterial peritonitis (ISLA) remains a serious complication of cirrhosis. Rapid diagnosis of ISLA is a key issue for improving the prognosis. The determination of calprotectin in ascites, used for the diagnosis of infection of ascitic liquid, could allow the diagnosis in a very short time (about 30 minutes). To date, the determination of calprotectin in ascites was not evaluated properly. The investigators would thus evaluate the interest of the determination of calprotectin in ascites for the rapid diagnosis of ISLA in cirrhotic patients, like you, hospitalized for decompensation of their disease. The main purpose of this pilot study will determine the optimal threshold calprotectin in ascites for diagnosis of ISLA.


title: Study of the Emotional Reactivity to Olfactive and Visual Perception in Depressed Patients

acronym: PERODEP

summary: The study aimed to determine the emotional reactivity of depressed patients to visual and olfactory stimuli in comparison with healthy volunteers.


summary:
Malnutrition affects until 70% of the patients hospitalized in geriatric's units and constitutes an independent risk factor of morbidity and mortality. Malnutrition is also associated with increased length of stay and increased costs, and alters the quality of life. Oral nutritional supplements (ONS) play a key role in the prevention and treatment of malnutrition in older people. ONS are a simple way to offer in a small volume a nutritional supply with a high density of calorie and protein. The clinical efficiency of ONS is well demonstrated whether on nutritional parameters or on clinical outcomes. However, acceptability and consumption of these ONS are frequently suboptimal: in geriatrics, only 50% to 65% of the prescribed volumes of ONS are consumed. The reasons are multiple: anorexia, taste changes, monotony … also partly because patients dislike flavor, taste or texture. The respect of patients' preferences is essential to improve the therapeutic observance to ONS. Generally, ONS are delivered after the patient has told his preferences orally to the dietitian. To date, there is no study evaluating the effect of an alternative strategy based on a preliminary degustation of several products on the effective consumption of ONS in geriatrics.

The study is designed as prospective, randomized, controlled, open study to test this strategy in older undernourished people hospitalized in geriatrics who require prescription of ONS. This study will be performed among 220 older people hospitalized in two departments of geriatrics of the AP-HM (Assistance Publique - Hôpitaux de Marseille).

The main objective is to compare the therapeutic observance to ONS when products are delivered to older people according to the usual way (preferences announced orally and/or dietitian's choice) or according to an alternative strategy based on a preliminary degustation of several products varying for flavor and texture but always in respect of the medical prescription. The secondary objective is to compare the evolution of the nutritional status estimated by routinely used clinical and biological parameters, as well as the main clinical outcomes during the hospital stay. Lastly, the nutritional status of these patients will be reevaluated clinically 3 months after the hospital's discharge.

The hypothesis is that a strategy based on a preliminary degustation, leading to an informed choice, will significantly improve the acceptability and the effective consumption of ONS during the hospital stay, and will also impact positively the nutritional status at hospital's discharge and 3 months after. The validation of this hypothesis could allow recommending the generalization of preliminary degustation of ONS at the time of their prescription to optimize the therapeutic observance in undernourished older people.


title: Rotating Hinge Knee Arthroplasty for Septic Revision After Total Knee Arthroplasty: a Retrospective Cohort About 50 Patients With 2 Years Follow up

summary: Between 2009 and January 2016, the investigators included 49 patients from four hospitals in Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive cohort aims at studying the functional results after 2 years follow up.

location_facility: Centre de reference des infections ostéo-articulaires de Lyon,Groupement Hospitalier Nord - Hôpital de la Croix-Rousse - Bât. B, niveau 3 103 Grande-Rue de la Croix-Rousse


title: Clinical Criteria for Decision Support Regarding Emergency Radiography for Knee Acute Traumatism in Order to Identify Bone Fracture Among Children.

acronym: KID

summary:
At this time, there is no standardization for knee trauma care in children. Each physician is free to resort or not to radiography to verify or dispel bone fracture, depending on radiographic device availability. This decision is based on trauma severity, clinical features, and physician experience.

Knee traumatisms are a common reason of consultation. In emergency departments, radiographic use is widespread for those traumatisms, but not in private practice.

Most of those knee traumatisms includes soft tissue lesion, for which radiography gives no details. Yet, radiography exposes bone fracture which may require a specific orthopaedic care. Then, it seems beneficial to highlight simple and reproducible clinical criteria in order to identify severe knee traumatisms, requiring radiography to assess bone fracture.

Those criteria should have a sensibility close to 1, and the highest specificity. Such criteria could significantly decrease the number of radiography thus irradiation, emergencies waiting time, and consultation expenses without missing bone fracture.

Ottawa knee rules for adults are: age 55 years older, tenderness at head of fibula, isolated tenderness of patella inability to flex to 90°, inability to bear weight on 4 steps both immediately and in the emergency department. Presence of one of those criteria required front and profile radiography to assess bone fracture.

However, few studies have been conducted among children, and they do not confirm the use of those criteria targeting fracture screening. Data are contradictory and they do not allow concluding that such criteria could be of benefit for children. Moreover, studies only consider adults clinical criteria. This study would be the first to implement specific paediatric criteria, which make this study original.

location_facility: Hospices Civils de Lyon, HFME. 32 Avenue Doyen Jean Lépine


title: Determination of Fibrin Activity in Plasma on STA-R® Prototype

acronym: FAST

summary: The purpose of the study is to give the proof of concept of the Fibrin structure assay on STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from the normal population. Secondary objectives are to determine the precision of the assay, to record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation activation assay and in a coagulation-lysis assay.

ReferenceCitation: Yeromonahos C, Polack B, Caton F. Nanostructure of the fibrin clot. Biophys J. 2010 Oct 6;99(7):2018-27. doi: 10.1016/j.bpj.2010.04.059.

ReferenceCitation: Ząbczyk M, Undas A. Plasma fibrin clot structure and thromboembolism: clinical implications. Pol Arch Intern Med. 2017 Dec 22;127(12):873-881. doi: 10.20452/pamw.4165. Epub 2017 Dec 11. Review.

ReferenceCitation: Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15.

lead_sponsor: Diagnostica Stago R&D

location_facility: Hôpital d'Instruction des armées Percy - Laboratoire d'Hématologie


title: Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis

summary:
Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner surface of the heart), which may include one or more heart valves. Epidemiologic pattern has changed during the last 20 years whereas the incidence was unchanged. However, the mortality increase despite recent diagnosis and therapeutic advances.

Only few investigations consider the prognostic and the therapeutic medical care according to the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery, (ii) patients secondary addressed to a referent center with cardiac surgery, (iii) patients for which the totality medical care are performed in non-referent health center. In addition, epidemiologic studies concern only a part of IE, not including most of the time the patients hospitalized in non-referent center.

The aim of the study was to determine the prognosis of threated patients according to the clinical care pathway. Secondary objectives was (i) to evaluate the application of European recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and surgical practice, (ii) to compare the epidemiologic profile according to the type of center.

For this, 300 patients addressed in the 22 French participating centers for a possible or certain IE according to Duke Criteria were prospectively included during 3 years.

Patient data (clinical, demographical, biological, microbiological, echocardiographic and evolutive data) were collected at the admission, during hospitalization, at discharge and one-year follow up.

location_facility: Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone


title: Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis

acronym: ASAP PSO

summary: This study aims to describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks.

ReferenceCitation: Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74.

lead_sponsor: LEO Pharma

location_facility: Cabinet de Dermatologie, Dr. Mathilde Kemula


title: Pharmacogenetic in the Therapeutic Strategy in Depressed Elderly

acronym: Pharmacogeneti

summary:
The study aims to assess the therapeutic benefits of the adaptation of the antidepressant dose to the metabolic capacity (cytochrome P450 2D6) of elderly depressed patients.

Therapeutic benefits are evaluated through the enhancement of efficiency, decrease of the action time and the after effects.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Phase Ib Trial Of Pembrolizumab And Nintedanib

acronym: PEMBIB

summary: Both anti-angiogenesis and anti PD1 immunotherapy have shown beneficial efficacy in solid tumors and in particular in NSCLC. Therefore it is of interest to investigate whether the combination of these two approaches is tolerable. Moreover, comprehensive pre-clinical and clinical rationale sustain the hypothesis that anti-VEGF could synergize with immunotherapy for the benefit of the patients.


title: Long-term Effects of Methadone for Cancer Pain

summary:
The methadone is an useful opioid for the cancer pain treatment, mostly used in second or last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians agree that the methadone could have an effect in neuropathic cancer pain. During a previous study the investigators find that the pain was still improving after the week 2, but they had only a small number of patients still included at this stage and they cannot conclude.

The investigators decide to follow up systematically all the patients undergoing a methadone treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain improvement.

location_facility: Unité de Soins Palliatifs - Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet


acronym: PerLE

summary:
A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL) muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into this muscle have not yet been described in the literature. Based on the results of a previous study, the hypothesis is: this muscle may thus constitute a new therapeutic target for botulinum toxin injections in the early management of spastic equinus in children aged 2 years or older, before the onset of fixed neuro-orthopedic deformity and the midfoot break.

The aim of this retrospective study is to describe in intramuscular BoNT (Dysport) injections into PL based on the results obtained in a cohort of children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) and which have been treated in the service since 2007 until July 2012.

The investigators results are based on clinical, radiological and video evaluations. For this study, data will be collected in medical folder of each children belonging to this cohort.

All children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) which have been treated by BoNT (Dysport) intramuscular injections into PL in the service between 2007 and July 2012 will be screened. Subjects will be selected according to the following defined inclusion and exclusion criteria.

Data will be collected retrospectively (using a specific case report form designed for the study) in medical folder of each included subject for all visit of follow-up after BoNT (Dysport) injection into PL (since the first BoNT (Dysport) injection up to 2012). Then, data will be entered in a database. After that, they will be analysed .

lead_sponsor: Assistance Publique Hopitaux De Marseille


acronym: REDCHO

summary:
The choroid is a richly vascularized conjunctive tissue, providing the nutritive elements to the pigmentary epithelium and the photoreceptors of the retina. It drains 80% of the eye's blood. The choroidal thickness fluctuates according to the state of fullness of its constitutive vessels. The choroid and the neuroretina (separate by the pigmentary epithelium) are intimately linked and are subject to modifications during the ingestion of caffeine and taurine combined. Several authors have shown a significant decrease of the choroidal thickness lasting at least 4 hours after the ingestion of a small coffee. This decrease may be caused by caffeine's vasoconstrictor effect. Taurine is the most abundant amino acid in the retina. Recent studies have shown the importance of this amino acid in the physiology of both, retinal pigmentary epithelium and retinal ganglion cells.

RedBull® is an energizing drink, where one single 25 cl can contains 80 mg of caffeine (the equivalent of a coffee mug) and 1 g of taurine.

This pilot trial aims to study the variations of the choroidal thickness and to describe possible modifications within the pigmentary epithelium, due to the ingestion of caffeine and taurine. The results of this study will act as a reference for an ulterior trial aiming specific choroidal pathologies of young patients, such as the central serous chorioretinitis.

ReferenceCitation: Arej N, Azar G, Salviat F, Alonso AS, Zuber K, Metten MA, Salomon L, Vasseur V, Mauget-Faÿsse M. Study of choroidal thickness variations after ingestion of a taurine and caffeine-containing energy drink. Clin Nutr ESPEN. 2021 Jun;43:245-249. doi: 10.1016/j.clnesp.2021.04.007. Epub 2021 Apr 17.

family: Arej

full_name: Nicolas Arej

given: Nicolas

family: Azar

full_name: Georges Azar

given: Georges

family: Salviat

full_name: Flore Salviat

given: Flore

family: Alonso

full_name: Anne-Sophie Alonso

given: Anne-Sophie

family: Zuber

full_name: Kevin Zuber

given: Kevin

family: Metten

full_name: Marie-Astrid Metten

given: Marie-Astrid

family: Salomon

full_name: Laurence Salomon

given: Laurence

family: Vasseur

full_name: Vivien Vasseur

given: Vivien

family: Mauget-Faÿsse

full_name: Martine Mauget-Faÿsse

given: Martine

journal_name: Clinical Nutrition ESPEN

intervention_type: Dietary Supplement


title: Direct Antiviral Agents for Hepatitis C Virus-associated Cryoglobulinaemia Vasculitis

summary: Cryoglobulinemia are responsible for systemic vasculitis, and the most frequently targeted organs are the skin, joints, kidney and peripheral nervous system. Cryoglobulinemia vasculitides are associated with significant morbidity and mortality, and require therapeutic intervention. With the discovery of hepatitis C virus (HCV) as the etiologic agent for most cases of mixed cryoglobulinemia new opportunities and problems for crafting therapy of HCV mixed cryoglobulinemia (MC) have emerged. A new and major concern was the potential adverse effects that immunosuppressive therapy with glucocorticoids and cytotoxic drugs could have on an underlying chronic viral infection. Alternatively the discovery of HCV provided the opportunity to control HCV-MC with antiviral therapy based on the belief that the underlying infection was driving immune complex formation and resultant vasculitis. Inducing a sustained virologic and clinical response and minimizing the use of immunosuppressive drugs are the main goals in the treatment of patients with HCV-MC vasculitis. Aggressive antiviral therapy has been shown to induce a complete remission of HCV-MC in up to 70% of patients. New antiviral combination, Interferon (IFN)-free regimens have recently proved very high virological response rate and with a very good safety profile and now need to be evaluated in severe and/or refractory HCV-MC patient's population.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prospective Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care

acronym: FACS

summary: The aim of this pilot study is to determine, as exhaustively as possible thanks to the continuous and precise recording of heart rhythm, the frequency of de novo atrial fibrillation in septic shock, which is currently unknown, and to identify specific factors that could be associated with the condition. These will be investigated more precisely in a future study. This constitutes the first step in a reflection on the management of Cardiac Arrhythmia by Atrial fibrillation (ACFA) in septic shock in Medical Intensive Care, known as a major prognostic factor for morbimortality, but for which management is uncertain in the absence of reference data.


title: Prognosis After Revascularization Therapy in the Dijon Ischemic Stroke Evaluation Study

acronym: PARADISE

summary:
The current management of ischemic stroke is based on different strategies that may be combined: intravenous thrombolysis in a stroke ICU, intravenous thrombolysis in a telemedicine procedure, endovascular thrombectomy. Given this now rich therapeutic arsenal, it seems necessary to evaluate practices in local care in the field and the impact of these on the prognosis of ischemic stroke victims. The aim of this observational study is to compare these different care practices without interfering with the choice of strategy.

A blood sample will also be taken at different times to study the value of growth differentiation factors (GDF) 8, 11 and 15, and Brain-derived Neurotrophic Factor as prognostic biomarkers

primary_purpose: Prevention


title: Assessment of the Effect of a Co-treatment With GnRH Analogs on the Ovarian Reserve in Adolescents and Young Women Treated With Alkylating Agents for Cancer

acronym: PRESOV

summary: The purpose of this study is to determine the efficacy of a temporary ovarian suppression obtained by administration of a gonadotropin releasing hormone agonist during alkylating agents containing chemotherapy on ovarian reserve assessed by Anti-Müllerian hormone (AMH) serum levels in adolescents and young women with cancer.


title: Impact of Nutritional Status and Frailty on the Prognosis of Patients Over 75 Years Old Who Suffered a Stroke

acronym: INFRA

summary:
Stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis. Patients older than 75 years also show excess mortality. One of the hypotheses to explain this situation is the high level of frailty in this population. Many tools to measure the concept of frailty have been developed. One important dimension of these tools is the nutritional status. Indeed, protein-energy malnutrition in the elderly, though a frequent situation, is also a complex phenomenon.

The aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects older than 75 years hospitalized in Dijon CHU.


title: Development and Validation of a French Quality Of Life Scale Specific to Patients Who Have Suffered a Stroke

acronym: QUALI STROKE

summary:
The aim of this work is to develop and validate a scale adapted to French cultural characteristics. It will be based on the SS-QoL scale and be simple and quick to use in everyday practice. It is not simply a translation. This transcultural adaptation requires linguistic and psychometric validation, by studying its validity, its reliability and its sensitivity to change, as though it were a new instrument. The investigators will then develop a short version by reducing the items and conduct a psychometric validation.

The translation and validation of a short French version of the SS-QoL scale will generate a reliable and sensitive, easy-to-use tool suitable for use in everyday practice.

The final objective is to use this tool as a principal judgement criterion in future therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic factors that affect quality of life so as to provide better management of this disease.


title: Evaluation of the Prevalence of anomalIes of Glucose Metabolism in Patients Undergoing a Coronary Artery Bypass Graft, Consequences for Morbi/Mortality in the Short and Medium Term

acronym: IMPACT

summary:
The aim of this study is to determine the prevalence of diabetes and non-diabetic glucose metabolism anomalies (glucose intolerance, non-diabetic fasting hyperglycaemia in patients about to undergo coronary artery bypass grafting (CABG).

In addition, the effect of these anomalies on post CABG morbi/mortality in the short term will be evaluated.


title: Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy

acronym: DEGLUTHYR

summary: The scientific interest of this study is to improve post-operative comfort in patients after thyroid surgery using simple, inexpensive techniques. The investigator expects that local applications of ice or cortisone aerosols will reduce swallowing discomfort and control post-operative pain (POP). The investigator hopes that local cryotherapy will decrease post-operative oedema (vasoconstriction) and the volume of liquid drained (action on the serous fluid at the site of the thyroidectomy).


title: Study of the Impact of Implicit Motor Training Using a Virtual Reality System and Serious Games on a Tablet Computer in a Rehabilitation Programme in Frail Elderly Subjects

acronym: MAAMI

summary:
Even though cognitive-motor performances are impaired in frail elderly subjects compared with healthy elderly subjects, exercising cognitive-motor processes in an implicit manner can improve the carrying out of real actions in everyday life.

No training programme using virtual reality and serious games oriented towards the perception/action system has been tested in frail elderly subjects.

The expected results are:

In the short term, greater strengthening of motor and cognitive abilities in subjects trained with the virtual reality and serious games, thanks to stimulation through action and through the underlying processes.
In the long term (+1 and +3 months at the end of the training period) better preservation of motor and cognitive abilities in subjects who took part in the virtual reality and serious games programme.


title: Exercise Training in Patients With Rheumatoid Arthritis and Cryotherapy: Feasibility Study

acronym: RhumatEx

summary: The main objective of this project is to study, in patients with rheumatoid arthritis, the effects of an intermittent type exercise associated with cryotherapy on the level of inflammation during its recovery.


title: Study of the Relative Impact of the Neonatal Fc Receptor (FcRn) and the Therapeutic History on Monoclonal Antibodies Elimination. Proof of the Concept on Patients Treated by Bevacizumab or Trastuzumab in Breast Cancer

acronym: PK-MAB

summary: This Study evaluates covariables being able to potentially influence the elimination of the monoclonal antibodies (trastuzumab, bevacizumab and denosumab).


title: Effectiveness of Positive Psychology in Suicidal Patients: A Randomized Controlled Trial

acronym: POPS

summary: Suicide is a major health concern. Weeks following psychiatric admission are a highly suicide risk period for those having current suicidal ideation or attempt. Recently, a pilot study suggested the feasibility of positive psychology in patients in suicidal crisis. Notably, gratitude exercises suggested improvement in optimism and hopelessness, two dimensions associated to suicide. Moreover, gratitude has been associated to suicidal ideation and attempt, independently from depression. Thus, investigators want to conduct the first randomized controlled study in order to assess effectiveness of gratitude exercises (vs control task) in suicidal inpatients, on 1) psychological pain reduction 2) suicidal ideation, hopelessness, optimism, depressive symptomatology, and anxiety improvement.

lead_sponsor: University Hospital, Montpellier