title: Pilot Study With the Aim to Quantify a Stress Protein in the Blood and in the Urine for Early Diagnosis of Malgnant Solid Tumors

acronym: EXODIAG

summary:
Recent studies shows that extracellular vesicles (named "exosomes") released by cancer cells exhibit at their membrane the stress protein HSP70, contrary to exosomes released by normal cells. These exosomes ("HSP70-exosomes") have a very important role in intercellular communication and have specific biological functions that can promote tumor progression. They are found in the different biological fluids such as blood and urine.

We have developed a protocol able to isolate exosomes in blood and urine. We also demonstrated that only exosomes derived from cancer cell have HSP70 at their membrane. Those results strongly suggest that we can only identify exosomes with HSP70 at the membrane in patients with cancer.

Detection of HSP70-exosomes in the diagnosis of patients is a promising pathway of research. Because a cancer cell can releases a large amount of exosomes (several billion) and since its appearance, our approach will allow to earlier detect cancer with respect to the use of imaging and circulating tumor cells (CTCs), which remains a rare event (about one CTC of 1 billion cells).

The aim of this study is to demonstrate that HSP70-exosomes could be used for early diagnosis of patients with malignant solid tumor. In order to demonstrate this, the objective of the study is to study blood and urine samples from 60 subjects with a malignant tumor and 20 healthy subjects (witness).

ReferenceCitation: Chanteloup G, Cordonnier M, Isambert N, Bertaut A, Marcion G, Garrido C, Gobbo J. Membrane-bound exosomal HSP70 as a biomarker for detection and monitoring of malignant solid tumours: a pilot study. Pilot Feasibility Stud. 2020 Mar 3;6:35. doi: 10.1186/s40814-020-00577-2. eCollection 2020.

lead_sponsor: Centre Georges Francois Leclerc


title: To Investigate the Impact of Aging on Cytokine and Chemokine Production by Peripheral Blood Immune Cells

acronym: Cytokinage

summary: The main goal of this study is to investigate the impact of aging on the responsiveness of peripheral blood immune cells. To this aim, the investigators will take advantage of a recently described syringe-based assay system that can reproducibly assess induced, innate or adaptive immune responses. Briefly, a total of 50 healthy volunteers will participate to this study: 25 will be older than 18 and younger than 30, and 25 will be older than 55. A total of 14 ml of blood will be drawn including 5 X 1 ml in TruCulture™ tubes containing poly(I:C), R-848, LPS, CpG, or no stimulus, respectively. After 22 hours of incubation at 37°C, cellular supernatants will assessed for levels of 10 different chemokines using a MesoScaleDiscovery multiplexing platform.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice, CRC, Hôpital de l'Archet 151 route de saint-antoine de ginestière

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Assessing the Impact of Different Compression of the Hand (Made to Measure Gloves / Compression Bandaging) Versus Free Hand on the Implementation of the Precision Grip

acronym: EvICoMaB

summary: The purpose of this study is to determine the impact of compressing therapy on the dexterity of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board / Jamar's test)

status: Terminated

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hôpital Léon Bérard

status_simplified: Unknown


title: Infectious Risk of Vaginal Ultrasound Examination: Evaluation and Modeling From Human Papillomavirus (HPV)

acronym: PREEV

summary: Multicenter observational survey of the presence of Human Papilloma Virus (HPV) on trans vaginal ultrasound (TVUS) probes, and of the behavior of professionals during US examination and probe disinfection. This will allow modeling the risk of HPV transmission, and could contribute establishing future guidelines for reducing the risk of transmission of microorganisms and the risk of infection through TVS.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: EudraCT Number

title: Impact of the Choice of 3rd Generation Cephalosporins on the Emergence of Resistance in the Microbiota Intestinal.

acronym: CEREMI

summary: CEREMI is an open, randomised prospective study in parallel groups in healthy volunteers. This study compare the effect of a monotherapy by ceftriaxone or cefotaxime on the emergence of resistance of enterobacteria to 3rd-generation cephalosporins within the intestinal microbiota. Each volunteer will be treated for 3 days by either ceftriaxone (1 gram per day) or cefotaxime (1 gram every 8 hours).

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Burdet C, Grall N, Linard M, Bridier-Nahmias A, Benhayoun M, Bourabha K, Magnan M, Clermont O, d'Humières C, Tenaillon O, Denamur E, Massias L, Tubiana S, Alavoine L, Andremont A, Mentré F, Duval X; CEREMI Group. Ceftriaxone and Cefotaxime Have Similar Effects on the Intestinal Microbiota in Human Volunteers Treated by Standard-Dose Regimens. Antimicrob Agents Chemother. 2019 May 24;63(6). pii: e02244-18. doi: 10.1128/AAC.02244-18. Print 2019 Jun.

ipd_sharing: Undecided

intervention_type: Drug


acronym: TRIGGERFISH

summary:
Glaucoma is a very frequent disease in Brittany. In glaucoma the retinal ganglion cells and their axons slowly die with visible changes at the optic nerve head (cupping). Without early diagnosis and effective treatment or with delayed treatment decrease of visual acuity or blindness become.

In secondary pseudoexfoliation glaucoma grayish-white deposits of abnormal proteins are found on all surfaces of eye irrigated by the aqueous humor. The deposits of PEX material inside the trabecular meshwork decrease aqueous humour outflow and the intraocular pression raise. The exfoliation material is found on the surface of the lens capsule with frequent developement of nuclear cataract . After cataract surgery the intra ocular pressure (IOP) decrease.

Some recent study have found decreasing ocular volume variation associated to IOP fluctuation in night after cataract surgery in normal pressure glaucoma patients. In our study we want see if it's the same thing in pseudoexfoliation glaucoma patients.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: University Hospital, Brest


title: Early and Short Psycho-educational Lifestyle Intervention to Prevent Weight Gain Induced by Psychotropic Drugs in Adults With Severe Mental Illness: a Randomized Controlled Trial

acronym: HYVIE

summary:
People with severe mental illness have an increased risk of somatic comorbidities such as metabolic syndrome, obesity, hypertension, dyslipidemia and diabetes mellitus, which induce an increased risk of early mortality, mainly because of cardiovascular diseases.

These high cardio-metabolic risks result of several factors such as lack of access to medical care, a poor and unbalanced nutrition, physical inactivity and smoking but they are also exacerbated by antipsychotic medications and anti-epileptic mood stabilizers prescribed to treat their psychiatric disorder.

These prevention and awareness interventions in lifestyle are most often implemented in ambulatory stabilized patients. Also weight gain occurs in the early months of treatment. The therapeutic education program evaluated in this study seeks to potentiate the effectiveness of these preventive measures through early awareness in hospitalized patients.

Finally, this study aims to compare the efficacy of two early and short programs on health behavior: first a program inspired by motivational interviewing and behavioral psychotherapy and secondly an exclusively educational program (information, formative assessment).

primary_purpose: Prevention

lead_sponsor: Hôpital le Vinatier

intervention_type: Behavioral


title: EFFECTS OF CARDICHOL, AN HERBAL DIETARY SUPPLEMENT, IN MODERATE HYPERCHOLESTEROLEMIA

acronym: CARDICHOL 1

summary: This research aims to evaluate the effect of CARDICHOL chronic consumption (12 weeks) on lipid metabolism and especially on blood LDL cholesterol in volunteers with moderate hypercholesterolemia.

lead_sponsor: Direct Plantes

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


type: Other Identifier

title: Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR Study

acronym: RICHAR

summary: Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. Few results are available on the use of activated charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). The objective of this study is to evaluate the effect of activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.

ReferenceCitation: Ollier E, Hodin S, Lanoiselée J, Escal J, Accassat S, De Magalhaes E, Basset T, Bertoletti L, Mismetti P, Delavenne X. Effect of Activated Charcoal on Rivaroxaban Complex Absorption. Clin Pharmacokinet. 2017 Jul;56(7):793-801. doi: 10.1007/s40262-016-0485-1.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment

acronym: CoachSAS

summary: Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed. SA can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes & obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.

primary_purpose: Other


title: A Single (Part A) and Multiple (Part B) Dose Study of AMAZ-02, a Food Derived Ingredient to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Profile in Healthy Elderly Subjects

summary:
Part A:

The study is a double-blind, randomized, single ascending doses, study in 24 healthy elderly male and female volunteers. Each subject will be randomized for two subsequent doses in three cohorts.

Part B:

The study is a double-blind, randomized, multiple ascending doses study in 36 healthy elderly male and female volunteers. Subjects will be randomized to receive study product or placebo for 28 days.

ReferenceType: background

ReferenceCitation: Andreux PA, Blanco-Bose W, Ryu D, Burdet F, Ibberson M, Aebischer P, Auwerx J, Singh A, Rinsch C. The mitophagy activator urolithin A is safe and induces a molecular signature of improved mitochondrial and cellular health in humans. Nat Metab. 2019 Jun;1(6):595-603. doi: 10.1038/s42255-019-0073-4. Epub 2019 Jun 14.

lead_sponsor: Amazentis SA


title: Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping

acronym: SALBEXO

summary: This study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise.

lead_sponsor: University Hospital, Toulouse


title: Study on the Links Between Action and Perception in Schizophrenia, " Have a Good Grasp of the World "

acronym: GRASP

summary: Brief Summary: In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible. However, automatic integration between perception and action is the necessary condition to be in "relationship with the world." Affordance is the experimental link between object perception and potentially associated actions (Gibson, 1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. With Tucker & Ellis sensory motor compatibility task (1998), with a modified response device (responses given with grasp), we study the impact of motor activation on these affordance effects. In this study, a group of controls will also be included in order to understand, as precisely as possible, the mechanisms involved (i.e., interference between the perception of the object and the response gesture).


title: Evaluation of the Efficiency of Autologous Bone Marrow no Concentrated to Associate at BMP7 Treatment of Necrosis of the Femoral Head of the Adult

summary: The main objective of the study is to evaluate the effectiveness of the injection of bone marrow unconcentrated more R BMP 7 to repair necrosis of the femoral head with stage I-III classification FICAT.

lead_sponsor: University Hospital, Lille

intervention_type: Biological


title: Variations of the Lung Compliance During Extracorporeal Circulation and Post Operative Pulmonary Complications

acronym: COMPLI

summary: the decrease in thoracopulmonary compliance after cardiac surgery is well known . The investigators hypothesize that the major factor determining pulmonary outcome after cardiac surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and that this alteration is due to CBP itself through pulmonary blood emptying.

ReferenceCitation: Ellison LT, Duke JF 3rd, Ellison RG. Pulmonary compliance following open-heart surgery and its relationship to ventilation and gas exchange. Circulation. 1967 Apr;35(4 Suppl):I217-25.

ReferenceCitation: Suter PM, Fairley HB, Isenberg MD. Effect of tidal volume and positive end-expiratory pressure on compliance during mechanical ventilation. Chest. 1978 Feb;73(2):158-62.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass

acronym: CAPD-CPB

summary:
Central and peripheral arterial pressure decoupling occurs in some clinical conditions like sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as the use of catecholamines.

The aim of this study is to evaluate the pulse wave's speed as a marker of central and peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary bypass during cardiac surgery.

lead_sponsor: Hospices Civils de Lyon

intervention_type: Procedure


title: Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels

acronym: Plasti-Stim

summary: The aim of this study is to investigate the effects of non invasive brain stimulation - NIBS - techniques (Electroconvulsivotherapy - ECT, transcranial Direct Current Stimulation - tDCS, repetitive transcranial magnetic stimulation - rTMS) on serum Brain Derived Neurotrophic factor (BDNF) levels in patients with depression and schizophrenia. Four blood samples will be collected in each participants, one before the NIBS sessions, and 3 after the completion of NIBS protocols: one immediately after the end of the NIBS sessions, a second one week after and a last one month after. Two blood samples separated by one month will also be collected in a a group of healthy volunteers.

primary_purpose: Basic Science

intervention_type: Device


title: Cutaneous Microcirculation and Nervous Sensitivity in Psoriasis

acronym: MicroPso

summary:
Psoriasis is a chronic inflammatory cutaneous disease, affecting 3% of the French population. Among psoriatic patients, 80% feel pain or cutaneous discomfort related to their pathology.

Neurogenic inflammation's role in psoriasis has recently been put forward by a study showing that TRPV1 ion channels are necessary to establish psoriasiform inflammation in mice.

The investigators hypothesize that there is a link between cutaneous sensory neuropathies and altered cutaneous microcirculation during psoriasis.

In order to test this hypothesis, local vasodilators will be delivered to patients by iontophoresis and their skin blood flow in response to these molecules will be followed by laser Doppler recordings. Two recordings will be performed for each patient, both on a psoriasis plaque and on uninvolved skin, in order for the patient to be his own internal control.

location_facility: Hôpital Edouard Herriot - Service de Dermatologie et Vénéréologie


title: Evaluation and Neural Basis of Communication in Patients With Multiple Sclerosis

acronym: COGNISEP

summary:
Multiple sclerosis (MS) progressively leads to an increasing level of disability. That's why individuals faced with this chronic disease whose progression is unpredictable have to mobilize all their available resources. As a result, management of interpersonal relationships appears to be a key issue in adjustment to situations.

Although knowledge on cognitive abnormalities in MS has been growing in recent years, there is a lack of research about social behaviour regulation skills. The few studies conducted in this field are mainly interested in emotional processing (emotional facial recognition and empathy) and skills mentalizing (theory of mind) that appear disturbed in MS.

While some recent studies touch on the issue of the contextual analysis of language (that is to say, the social use of language) in MS, their assessment on a wide range of pragamtic skills has never been studied. However, the pragmatic aspects of language are known to play a major role in social adjustment.

This project has three main objectives : (1) to increase general knowledge of deficits in communication and in social cognition in patients with MS, (2) to propose new leads for the evaluation of these disorders and (3) to contribute to increasing knowledge of neural basis of communication and social cognition.

In order to address those objectives, the assessment will be focused on many various pragmatics skills : conversation, indirect language comprehension (indirect questions, idiomatic expressions, sarcasm) and metapragmatic knowledge in a population of 40 RR-MS patients. Those patients' performances will be compared to a group of healthy matched control subjects, potential relationships between pragmatic abilities, other aspects of social cognition (theory of mind and processing of emotional stimuli), cognitive functioning, psycho-behavioural aspects and the characteristics of the disease will be explore.

Social cognition tasks have been selected for their dynamic and ecologic aspects in order to match natural social interaction.

Finally, communication consideration, cognitive and cerebral skills of patients with MS will contribute to increasing knowledge of the neural basis of social cognition.

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Pôle Saint Hélier


title: Evaluation de la Performance d'Une Nouvelle Plateforme de Tests de dépistage Orthoptique numériques

acronym: ESPPADON

summary: This clinical trials aims to evaluate Tests Performance on a New Digital Orthoptic Platform.


title: Looking for a Link Between Endometriosis and Exposure to Lipophilic Environmental Chemicals Like Brominated Flame Retardant (ENDOTOX Study)

acronym: ENDOTOX

summary: The investigators wish to highlight, in a Case-Control design, if there is an increased concentration of BFRs in omental adipose tissue of cases ( women with severe endometriosis with surgical indication ) versus bioaccumulation recorded in a control cohort ( women recruited in obstetrics and gynecology or visceral surgery showing no sign of endometriosis ) . Pairing will be operate on Age (+/- 5 years compared to the case ) , BMI ( BMI 5 Classes described by the HAS) and previous breastfeeding experience (yes / no , opposite the release expected bioaccumulate contaminants in breast adipose tissue , when the lactation ) .

lead_sponsor: Nantes University Hospital


acronym: COLOSTRUM

summary: Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal circulation to the milk, and especially immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind this work is that the oro pharyngeal administration of colostrum early in preterm infants could help deliver an oral immunotherapy even before the installation of enteral nutrition, through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract. This practice would improve the digestive tolerance and the establishment of enteral feeding, the decrease in mucosal inflammatory phenomena, but also to provide any protection against subsequent infections. Finally, there could be an improvement in the secondary immune tolerance with a decrease in the occurrence of allergic phenomena.


title: Micropulsed Laser in Association With Intravitreal Injections of Anti-VEGF for the Treatment of Macular Edema in Diabetic Patients (LAMED).

acronym: LAMED

summary:
Diabetes is a major cause of blindness in adults in the developed countries. The retinal damages associated with diabetes lead to gradual loss of vision, which is accentuated when the macula is affected. This results in macular edema.

Currently, intravitreal injections of anti-VEGF have demonstrated their effectiveness and are the first line treatment of macular edema.

Subthreshold micropulsed laser photocoagulation is an alternative to conventional grid photocoagulation. By delivering pulsed impacts under the thermal lesion threshold of the pigment epithelium, it would not cause the side effects of conventional photocoagulation. Micropulsed photocoagulation combined to anti-VEGF injections, could be the most effective treatment with a minimum injection number and without epithelial lesions.

The main objective of this study is to show that the subthreshold micropulsed laser photocoagulation, in association with intravitreal injections of anti-VEGF, allows to reduce the number of anti-VEGF injections during the first year of treatment.

In this randomized, double blind study, eligible patients will be randomized between a micropulsed laser photocoagulation arm and a sham micropulsed laser photocoagulation arm.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild

intervention_type: Radiation


title: Efficacy Assessment of CT-guided Hook Wire Localization of Lung Nodes With Medical Device " Fil d'Ariane " Laurane médical Before Thoracoscopy- HARNO Trial

acronym: HARNO

summary:
When patient presents a lung node, there is an important risk that this node was a tumor. For patients who have these nodes, the surgery is the best treatment. When the surgery is possible, the thoracoscopy may be more advantageous compared to thoracothomy (decrease of post surgery pains, decrease of recovery time and decrease of drugs consumption). Nevertheless, thoracoscopy needs specific materiels and nécessite un équipement spécifique and trained physicians.

Moreover, this technic needs that nodes was well localized. For this, radiologists use CT-guided hook wire localization of these lung nodes before surgery.

TThe hook wire laying is delicate. It can lead secondaries effects as pneumothorax, dislodgement of the hook wire before and after surgery. The success rate of hook wire fixation in lung near of the node is primary.

The main objective of our study is to assess the success rate localization of node in surgery piece, that is to verify if the hook wire have allowed to localize the lung node in surgery piece.

status: Withdrawn

lead_sponsor: Centre Jean Perrin


title: A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in Patients With Behçet Disease

acronym: STELABEC

summary: The purpose of this study is to evaluate the proof of concept of efficacy of ustekinumab in subjects with Behçet disease, including patients with oral ulcers (STELABEC-1) and patients with active posterior uveitis or panuveitis (STELABEC-2)

location_facility: Hôpital Cochin, Department of Internal Medicine, National Reference Center for Autoimmune and Systemic Diseases


title: Does Hypnosis Improve Severe Sleepwalking ?

acronym: HYPNOSOM

summary: The aim of the study is to compare the benefit of two cognitive therapies in severe sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric, double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking (defined as at least one epsidoe per week and at least two awakenings in stage N3 on video polysomngraphy) will be included. All patients will have a visit 1 for diagnosis including a medical interview, a video polysomnography, questionnaires on sleepwalking (PADSS and systematized interview), sleep quality (PSQI, MEQ) and sleepiness (Epworth scale) and suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated controls. Randomized patients will receive the therapy on day 1, and be monitored during the subsequent night. They will have a weekly therapy for 4 additional sessions and be monitored again on Month 1, as well as they will complete the sleep and sleepwalking questionnaires. They will also complete the questionnaire by phone on Month 3. The non-randomized controls will complete the questionnaire on month 1, with no therapeutical intervention between Day 1 and Month 1. The main outcome will be the frequency of sleepwalking episodes, as assessed by the PADSS-B. Secondary outcomes include the changes in other subitems of teh PADSS, of the N3 awakenings in v-PSG between night 1 and Night 2 (short term effect) and Night 1 and Night 28 (long term effect), as well as changes in sleep quality and sleepiness scales. A comparison of spectral EEG, as well as respiration, eye movements, muscle tone and heart rate during rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.

ReferenceCitation: Barros A, Uguccioni G, Salkin-Goux V, Leu-Semenescu S, Dodet P, Arnulf I. Simple behavioral criteria for the diagnosis of disorders of arousal. J Clin Sleep Med. 2020 Jan 15;16(1):121-128. doi: 10.5664/jcsm.8136. Epub 2019 Dec 4.

ReferenceCitation: Dubessy AL, Leu-Semenescu S, Attali V, Maranci JB, Arnulf I. Sexsomnia: A Specialized Non-REM Parasomnia? Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw043.


title: Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy

acronym: DYNAMAT

summary:
This project intends to investigate children with idiopathic and cryptogenic localization related epilepsies, using a longitudinal assessment of structural and functional MRI data, in relation to neuropsychological evaluation. The rationale is primarily based on: 1) the frequent observation of selective cognitive dysfunctions in such children, the pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI investigation of brain maturation showing striking age and region dependant patterns.

The primary hypothesis is that some children with localization related epilepsies suffer from altered maturation in the epileptic brain regions, and that this abnormal maturation affects their cognitive abilities. 100 children with localization related epilepsies and 100 matched controls will be prospectively enrolled during the first two years of the disease (for patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation once a year for 5 years. The brain maturation of these children will be longitudinally assessed using structural and functional MRI, and correlated with neuropsychological data. Investigators hope to demonstrate that children with localization related epilepsies and cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the epileptic activity and the altered cognitive processes. The finding could partly bridge the gap between these two abnormalities and help better understand their interaction and respective dynamic. Once validated, the study of regional brain maturation in children with epilepsy might be further used as a reliable surrogate marker or predictor of associated cognitive dysfunction.

location_facility: Hôpital Femme-Mère-Enfant, 59 Boulevard Pinel


title: Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation

summary:
The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation.

After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.

lead_sponsor: Pr Isabelle CONSTANT

location_facility: Departement d'anesthesie Hopital Armand Trousseau


title: Functional Connectivity Measurement After Severe Traumatic Brain Injury

acronym: Connectivite

summary: To compare functional connectivity after severe traumatic brain injury (TBI) between a group of post-comatose TBI with restored consciousness and a group of post-comatose TBI with persistant disorder of consciousness at admission in rehabilitation

ReferenceCitation: Nakase-Richardson R, Whyte J, Giacino JT, Pavawalla S, Barnett SD, Yablon SA, Sherer M, Kalmar K, Hammond FM, Greenwald B, Horn LJ, Seel R, McCarthy M, Tran J, Walker WC. Longitudinal outcome of patients with disordered consciousness in the NIDRR TBI Model Systems Programs. J Neurotrauma. 2012 Jan 1;29(1):59-65. doi: 10.1089/neu.2011.1829. Epub 2011 Aug 4.

ReferenceCitation: Achard S, Delon-Martin C, Vértes PE, Renard F, Schenck M, Schneider F, Heinrich C, Kremer S, Bullmore ET. Hubs of brain functional networks are radically reorganized in comatose patients. Proc Natl Acad Sci U S A. 2012 Dec 11;109(50):20608-13. doi: 10.1073/pnas.1208933109. Epub 2012 Nov 26.

lead_sponsor: University Hospital, Grenoble


acronym: CARRY

summary:
This current care protocol follows the biomedical research protocol entitled "Non-invasive mapping of the heart ECG high amplification" that demonstrated the clinical value of noninvasive Cardioinsight® mapping system.

Guide the management of patients hospitalized for cardiac rhythm radiofrequency ablation of cardiac arrhythmias, implantation or programming of a pacemaker, or assess the risk of serious arrhythmias or sudden death, with the currently used non-invasive mapping routine. The results obtained with non-invasive mapping will be compared with those obtained with the conventional method without non-invasive mapping.

lead_sponsor: University Hospital, Bordeaux


title: Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index

summary: This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.

ReferenceCitation: Sabourdin N, Diarra C, Wolk R, Piat V, Louvet N, Constant I. Pupillary Pain Index Changes After a Standardized Bolus of Alfentanil Under Sevoflurane Anesthesia: First Evaluation of a New Pupillometric Index to Assess the Level of Analgesia During General Anesthesia. Anesth Analg. 2019 Mar;128(3):467-474. doi: 10.1213/ANE.0000000000003681.


acronym: CORIDA

summary:
Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration ([DOAC]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients.

Objectives: To investigate the factors associated with per-procedural [DOAC]. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal perprocedural [DOAC], defined as [DOAC] < 30 ng/mL.

Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in this multicentre, prospective, observational study. [DOAC], will be measured during invasive procedure.

time_perspective: Cross-Sectional

ReferenceCitation: Godier A, Martin AC, Lessire S, Mullier F, Leblanc I, Gouin-Thibault I. Concentrations of direct oral anticoagulants according to guidelines for the periprocedural management of low bleeding risk procedures. Anaesth Crit Care Pain Med. 2020 Feb;39(1):121-122. doi: 10.1016/j.accpm.2019.04.004. Epub 2019 Apr 13.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)


title: Randomized Controlled Trial Comparing the Efficiency of the Bipolar Energy Compared With the Monopolar Energy in Endometrial Ablation in Women Having Menorrhagia

summary:
Since the development a few years ago of bipolar energy in the surgery by operative hysteroscopy, the hysteroscopic treatment of menorrhagia by endometrial ablation can be achieved either by the use of monopolar or bipolar current, in parallel with other techniques labelled as 'second generation' (microwave, radio frequency, thermal destruction ...) treating the uterine cavity.

It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the success rate after bipolar endometrial ablation are poor and there is currently no recommendation as to the choice of technique to use. No prospective assessment exists to date in the literature to compare the difference in efficacy on bleedings when using monopolar or bipolar current. The goal of this study is to compare these two energies, by measuring the amount of bleeding calculated by the Higham score 12 months after the intervention.

ReferenceCitation: Duckitt K. Menorrhagia. BMJ Clin Evid. 2015 Sep 18;2015. pii: 0805. Review.

ReferenceCitation: Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9.

ReferenceCitation: Fergusson RJ, Lethaby A, Shepperd S, Farquhar C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2013 Nov 29;(11):CD000329. doi: 10.1002/14651858.CD000329.pub2. Review. Update in: Cochrane Database Syst Rev. 2019 Aug 29;8:CD000329.

ReferenceCitation: Bøe Engelsen I, Woie K, Hordnes K. Transcervical endometrial resection: long-term results of 390 procedures. Acta Obstet Gynecol Scand. 2006;85(1):82-7.

ReferenceCitation: Brumsted JR, Blackman JA, Badger GJ, Riddick DH. Hysteroscopy versus hysterectomy for the treatment of abnormal uterine bleeding: a comparison of cost. Fertil Steril. 1996 Feb;65(2):310-6.

ReferenceCitation: Mayor S. NICE says hysterectomy must be last option for heavy menstrual bleeding. BMJ. 2007 Jan 27;334(7586):175.

ReferenceCitation: Berg A, Sandvik L, Langebrekke A, Istre O. A randomized trial comparing monopolar electrodes using glycine 1.5% with two different types of bipolar electrodes (TCRis, Versapoint) using saline, in hysteroscopic surgery. Fertil Steril. 2009 Apr;91(4):1273-8. doi: 10.1016/j.fertnstert.2008.01.083. Epub 2008 Apr 18.

lead_sponsor: Brugmann University Hospital


title: New Treatment Modalities in Obese Patients: High Intensity Interval Training and Hypoxic Conditioning

acronym: HYPINT

summary: The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of the interventions will be measured regarding exercise tolerance, blood pressure, body composition, metabolic status.

ReferenceCitation: Verges S, Chacaroun S, Godin-Ribuot D, Baillieul S. Hypoxic Conditioning as a New Therapeutic Modality. Front Pediatr. 2015 Jun 22;3:58. doi: 10.3389/fped.2015.00058. eCollection 2015. Review.

ReferenceCitation: Weston KS, Wisløff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21. Review.


title: A Phase Ib Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer - DOUBLIRI

acronym: DOUBLIRI

summary:
MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan: the liposomal formulation is designed to extend plasma circulation and to increase accumulation in the tumor through the enhanced permeability and retention (EPR) effect.

This study introduces a new concept of combining free and nanoliposomal drugs.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group


title: Cluster Headache (CH), Addictions and Vascular Function

acronym: CHAD

summary: Cluster headache (CH) is one of the most painful primitive headaches. Developments in neuroimaging have demonstrated activation of the ipsilateral hypothalamic and orexinergic system, which is similar in patients with addictions. CH has strong links to the vascular system but there is no study measuring endothelial function in CH sufferers.


title: Impact of Rheumatoid Arthritis on Type 2 Diabetes Mellitus

acronym: INSPIRED

summary: The purpose of this study is to determine whether patients with rheumatoid arthritis and type 2 diabetes experience a more severe disease course compared to control patients with osteoarthritis and type 2 diabetes

status: Suspended

ReferenceCitation: Meune C, Touzé E, Trinquart L, Allanore Y. High risk of clinical cardiovascular events in rheumatoid arthritis: Levels of associations of myocardial infarction and stroke through a systematic review and meta-analysis. Arch Cardiovasc Dis. 2010 Apr;103(4):253-61. doi: 10.1016/j.acvd.2010.03.007. Epub 2010 May 18. Review.

ReferenceCitation: Meune C, Touzé E, Trinquart L, Allanore Y. Trends in cardiovascular mortality in patients with rheumatoid arthritis over 50 years: a systematic review and meta-analysis of cohort studies. Rheumatology (Oxford). 2009 Oct;48(10):1309-13. doi: 10.1093/rheumatology/kep252. Epub 2009 Aug 20. Review.

ReferenceCitation: Liao KP, Solomon DH. Traditional cardiovascular risk factors, inflammation and cardiovascular risk in rheumatoid arthritis. Rheumatology (Oxford). 2013 Jan;52(1):45-52. doi: 10.1093/rheumatology/kes243. Epub 2012 Sep 16. Review.

ReferenceCitation: Reilly MP, Wolfe ML, Rhodes T, Girman C, Mehta N, Rader DJ. Measures of insulin resistance add incremental value to the clinical diagnosis of metabolic syndrome in association with coronary atherosclerosis. Circulation. 2004 Aug 17;110(7):803-9. Epub 2004 Aug 2.

ReferenceCitation: Chung CP, Oeser A, Solus JF, Gebretsadik T, Shintani A, Avalos I, Sokka T, Raggi P, Pincus T, Stein CM. Inflammation-associated insulin resistance: differential effects in rheumatoid arthritis and systemic lupus erythematosus define potential mechanisms. Arthritis Rheum. 2008 Jul;58(7):2105-12. doi: 10.1002/art.23600.

ReferenceCitation: Dessein PH, Joffe BI. Insulin resistance and impaired beta cell function in rheumatoid arthritis. Arthritis Rheum. 2006 Sep;54(9):2765-75.

ReferenceCitation: Ashida R, Ihn H, Mimura Y, Jinnin M, Asano Y, Kubo M, Tamaki K. Clinical features of scleroderma patients with contracture of phalanges. Clin Rheumatol. 2007 Aug;26(8):1275-7. Epub 2006 Dec 15.

ReferenceCitation: Kiortsis DN, Mavridis AK, Vasakos S, Nikas SN, Drosos AA. Effects of infliximab treatment on insulin resistance in patients with rheumatoid arthritis and ankylosing spondylitis. Ann Rheum Dis. 2005 May;64(5):765-6. Epub 2004 Sep 30.

ReferenceCitation: Rosenvinge A, Krogh-Madsen R, Baslund B, Pedersen BK. Insulin resistance in patients with rheumatoid arthritis: effect of anti-TNFalpha therapy. Scand J Rheumatol. 2007 Mar-Apr;36(2):91-6.

ReferenceCitation: Solomon DH, Massarotti E, Garg R, Liu J, Canning C, Schneeweiss S. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011 Jun 22;305(24):2525-31. doi: 10.1001/jama.2011.878.

ReferenceCitation: Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. Epub 2006 Dec 4. Erratum in: N Engl J Med. 2007 Mar 29;356(13):1387-8.

ReferenceCitation: Arrieta F, Piñera M, Iglesias P, Nogales P, Salinero-Fort MA, Abanades JC, Botella-Carretero JI, Calañas A, Balsa JA, Zamarrón I, Rovira A, Vázquez C; ESD2 Group. Metabolic control and chronic complications during a 3-year follow-up period in a cohort of type 2 diabetic patients attended in primary care in the Community of Madrid (Spain). Endocrinol Nutr. 2014 Jan;61(1):11-7. doi: 10.1016/j.endonu.2013.09.002. Epub 2013 Oct 30.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Validation of Molecular Neuroimaging Biomarkers in Huntington's Disease in View of Therapeutic Trials Targeting the Krebs Cycle

acronym: HDeNERGY

summary:
There is no curative treatment available today in Huntington disease (HD) despite the identification of the mutated gene 20 years ago. Nonetheless, safe and promising therapeutic strategies targeting brain energy metabolism are now becoming available.

In view of the small effect sizes of any clinical parameter in HD, robust neuroimaging biomarkers reflecting brain energy metabolism are therefore urgently needed to better assess the potential of therapeutics targeting the mitochondria, and especially the Krebs cycle. Identifying such biomarkers at the presymptomatic phase in HD also provides a unique window for therapeutic intervention, which can be used as a proof-of-concept for the real challenge of tomorrow's medicine: the prevention of neurodegeneration HDeNERGY is an observational study consisting of the transfer of methods from preclinical to clinical studies and their application in HD. HDeNERGY aim at optimizing MRI/MRS methods to study the dynamics of brain energy metabolism. At the CENIR (Centre de neuro-imagerie et de recherche, Paris) the determination of creatine kinase rate will be first validated in healthy volunteers (n=20) and then applied to the selected cohort of early affected HD patients (n=20), presymptomatic individuals (n=20) and controls (n=20) together with the methods previously validated in HD patients (Mochel et al., 2012b) to determine the ratio of inorganic phosphate (Pi)/ phosphocreatine (PCr) during visual stimulation in presymptomatic individuals. The Chemical Exchange Saturation Transfer (CEST) method on the 3T clinical scanner of CENIR will be first validated in healthy volunteers (n=20) and then applied to the selected cohort of early affected HD patients (n=20), presymptomatic individuals (n=20) and controls (n=20).

The cerebral synthesis rate of creatine phosphate and of brain glutamate concentrations and pH values will be compared between controls, HD patients and HD presymptomatic individuals, and correlated with clinical parameters (age, BMI, UHDRS).


title: Evaluation of the Increase of the Driving Speed After the Apparatus by Walkaide® Medical Device in Deficits Levator Foot of Central Origin.

acronym: WALKAIDE

summary: Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.

ReferenceType: result

ReferenceCitation: Stein RB, Everaert DG, Thompson AK, Chong SL, Whittaker M, Robertson J, Kuether G. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair. 2010 Feb;24(2):152-67. doi: 10.1177/1545968309347681. Epub 2009 Oct 21.

ReferenceCitation: Detrembleur C, Dierick F, Stoquart G, Chantraine F, Lejeune T. Energy cost, mechanical work, and efficiency of hemiparetic walking. Gait Posture. 2003 Oct;18(2):47-55.

ReferenceCitation: Kottink AI, Oostendorp LJ, Buurke JH, Nene AV, Hermens HJ, IJzerman MJ. The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review. Artif Organs. 2004 Jun;28(6):577-86. Review.

ReferenceCitation: Everaert DG, Thompson AK, Chong SL, Stein RB. Does functional electrical stimulation for foot drop strengthen corticospinal connections? Neurorehabil Neural Repair. 2010 Feb;24(2):168-77. doi: 10.1177/1545968309349939. Epub 2009 Oct 27.

ReferenceCitation: Sabut SK, Lenka PK, Kumar R, Mahadevappa M. Effect of functional electrical stimulation on the effort and walking speed, surface electromyography activity, and metabolic responses in stroke subjects. J Electromyogr Kinesiol. 2010 Dec;20(6):1170-7. doi: 10.1016/j.jelekin.2010.07.003. Epub 2010 Aug 6.

lead_sponsor: University Hospital, Angers


title: REAnimation Low Immune Status Markers

acronym: REALISM

summary:
The fact that sepsis disrupts immune system homeostasis by inducing an initial cytokine storm, that participates to occurrence of organ failures and early death, followed by a compensatory anti-inflammatory response leading to immunosuppression, is now well established. This immunomodulating response results in a higher risk of secondary infections and is associated to 2/3 of deaths related to septic shocks. Follow up of patients' immune status with time is crucial to guide therapy management. Objective of REALISM project is to demonstrate existence of this immunosuppression phase, by providing strong epidemiologic data for septic shock patients, but also by extension to other situations of inflammatory aggressions like severe severe trauma or burns, or major surgery. This project will provide tools to predict occurrence of secondary infections and guide patient management by comparing innovating immunomonitoring tools to reference tests non already adapted to a routine patient management.

Targeted populations are adult patients hospitalized for septic shock, severe trauma (including severe burn) or major surgery and healthy volunteers, whom blood samples will serve to validate reference intervals of the two reference tests.

ReferenceCitation: Bodinier M, Peronnet E, Brengel-Pesce K, Conti F, Rimmelé T, Textoris J, Vedrine C, Quemeneur L, Griffiths AD, Tan LK, Venet F, Maucort-Boulch D, Monneret G; REALISM study group. Monocyte Trajectories Endotypes Are Associated With Worsening in Septic Patients. Front Immunol. 2021 Nov 29;12:795052. doi: 10.3389/fimmu.2021.795052. eCollection 2021.

ReferenceCitation: Mallet F, Diouf L, Meunier B, Perret M, Reynier F, Leissner P, Quemeneur L, Griffiths AD, Moucadel V, Pachot A, Venet F, Monneret G, Lepape A, Rimmelé T, Tan LK, Brengel-Pesce K, Textoris J. Herpes DNAemia and TTV Viraemia in Intensive Care Unit Critically Ill Patients: A Single-Centre Prospective Longitudinal Study. Front Immunol. 2021 Nov 2;12:698808. doi: 10.3389/fimmu.2021.698808. eCollection 2021.

ReferenceCitation: Venet F, Textoris J, Blein S, Rol ML, Bodinier M, Canard B, Cortez P, Meunier B, Tan LK, Tipple C, Quemeneur L, Reynier F, Leissner P, Védrine C, Bouffard Y, Delwarde B, Martin O, Girardot T, Truc C, Griffiths AD, Moucadel V, Pachot A, Monneret G, Rimmelé T; REALISM study group. Immune Profiling Demonstrates a Common Immune Signature of Delayed Acquired Immunodeficiency in Patients With Various Etiologies of Severe Injury. Crit Care Med. 2022 Apr 1;50(4):565-575. doi: 10.1097/CCM.0000000000005270.

ReferenceCitation: Rol ML, Venet F, Rimmele T, Moucadel V, Cortez P, Quemeneur L, Gardiner D, Griffiths A, Pachot A, Textoris J, Monneret G; REALISM study group. The REAnimation Low Immune Status Markers (REALISM) project: a protocol for broad characterisation and follow-up of injury-induced immunosuppression in intensive care unit (ICU) critically ill patients. BMJ Open. 2017 Jun 21;7(6):e015734. doi: 10.1136/bmjopen-2016-015734.

location_facility: Service d'Anesthésie Réanimation - Hôpital Edouard Herriot


title: Performance Evaluation of Clinical Ultrasound in Management of Acute Pulmonary Edema in Elderly Patient Over 65 Years, Admitted to a Host of Vital Emergency Services

acronym: ECHOP

summary: The main objective is to assess the validation of the diagnosis early acute pulmonary edema in elderly patients with acute respiratory distress, admitted in a host of vital emergency services by lung ultrasound associated with the measurement of the inferior vena cava.

ReferenceCitation: Zannad F, Mebazaa A, Juillière Y, Cohen-Solal A, Guize L, Alla F, Rougé P, Blin P, Barlet MH, Paolozzi L, Vincent C, Desnos M, Samii K; EFICA Investigators. Clinical profile, contemporary management and one-year mortality in patients with severe acute heart failure syndromes: The EFICA study. Eur J Heart Fail. 2006 Nov;8(7):697-705. Epub 2006 Mar 3.

ReferenceCitation: Melniker LA, Leibner E, McKenney MG, Lopez P, Briggs WM, Mancuso CA. Randomized controlled clinical trial of point-of-care, limited ultrasonography for trauma in the emergency department: the first sonography outcomes assessment program trial. Ann Emerg Med. 2006 Sep;48(3):227-35. Epub 2006 Mar 24.

ReferenceCitation: Nielsen LS, Svanegaard J, Wiggers P, Egeblad H. The yield of a diagnostic hospital dyspnoea clinic for the primary health care section. J Intern Med. 2001 Nov;250(5):422-8.

ReferenceCitation: Ray P, Birolleau S, Lefort Y, Becquemin MH, Beigelman C, Isnard R, Teixeira A, Arthaud M, Riou B, Boddaert J. Acute respiratory failure in the elderly: etiology, emergency diagnosis and prognosis. Crit Care. 2006;10(3):R82. Epub 2006 May 24.

ReferenceCitation: McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. Erratum in: Eur Heart J. 2013 Jan;34(2):158.


title: Bispectral Index Under Propofol Anesthesia in Children : a Comparative Randomised Study Between TIVA and TCI

summary:
In children, only a few studies have compared different modes of propofol infusion during a total intravenous anesthesia (TIVA) with propofol and remifentanil. The aim of this study is to compare Bispectral Index (BIS) profiles (percentage of time spent at adequate BIS values) between four modes of propofol infusion: titration of the infusion rate on clinical signs (TIVA0), titration of the infusion rate on the BIS (TIVABIS), target controlled infusion (TCI) guided by the BIS either with the Kataria model (TCI KBIS) or the Schnider model (TCI SBIS).

Methods: Children will be prospectively randomized into the 4 groups. In the TIVA0 group the anesthesiologist is blinded to the BIS. In each group, the percentage of time with adequate BIS values (45-55), the bias and imprecision will be calculated.


type: Registry Identifier

title: Treatment of Opioid-refractory Pain (WHO Level III) by Pituitary Radiosurgery: A Multicenter, Prospective, Randomized Study

acronym: Hyporadoul

summary: 80% of palliative care cancer patients suffer from severe pain. The management of these pain improves the quality of life of these patients. The management of opioid pain refractory to date remains a difficulty for caregivers. Hypophysectomy performed to try to control hormone-dependent neoplasia also help relieve pain associated with lesions secondary cancer. The surgical hypophysialis radio Gamma Knife ® was recently performed on a small number of patients. She would have the advantage of reducing the risk of complications compared to other techniques and achieve similar analgesic effect on diffuse, or mixed nociceptive pain associated with metastases on average in 2 days and would reduce or stop opiates most often responsible for side effects impairing the quality of life. The objective of this clinical trial, multicenter, prospective, randomized controlled is to evaluate the effectiveness of surgical hypophysialis radio for patients in palliative situations with refractory cancer pain in opioid level III. The type of pain "cancer pain" was done in order to optimize the recruitment and homogenization of the study population: patients cared for in palliative care units are mostly patients cancer (70-80%). This study is therefore part of a palliative setting and the results of this test can be extrapolated to other populations of palliative patients with refractory pain.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis

acronym: QALCIMUM

summary:
The main objective of this study is to measure, in patients with MS or Chronic Inflammatory Arthritis (CIA), the correlation between two calcium intake assessment methods: A self assessment questionnaire of calcium intake (QALCIMUM®) versus a food survey serving as a reference (gold standard) and based on data from CIQUAL *.

* CIQUAL Data: Nutritional food composition table available on the website of the ANSES (National Agency for Sanitary Security of Food, Environment and Labour), published by the Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58 nutritional components. The data is integrated into the software (DATAMEAL) for calculating the ingesta parameters at the Nîmes University Hospital.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Non Invasive Methods for Differential Diagnosis Radionecrosis/Recurrence After Radiosurgery of Brain Metastases. CV-METANEC

acronym: CV-METANEC

summary:
The purpose of this multicenter study is to assess a diagnostic strategy concerning differential diagnosis between radiation necrosis and relapse in brain metastases treated with radiosurgery. Two non-invasive tests - positron emission tomography (PET) with 1F-fluoro-ethyl-tyrosine (FET) and magnetic resonance spectroscopy (MRS) - will be compared to histology in a cohort of patients presenting growing lesions 6 months after radiosurgical treatment.

The results of this study should help to earlier diagnosis of recurrences after radiosurgery and to perform an appropriate treatment for patients.

location_facility: CHU Pitié-Salpêtrière - Service de Neurochirurgie du Pr Philippe Cornu - Babinsky


title: Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis

summary:
Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage, cutaneous and visceral fibrosis and a dysimmune condition.

Therapies in this disease remain insufficient and the complications resulting from organs involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved in the vascular damage of the SSc. However mechanisms at the onset of this endothelial cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune populations. The purpose of the project is to define the role displayed by cytotoxic, circulating immune populations of SSc patients in endothelial cytotoxicity as well as the role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune cytotoxic cells and the endothelium.

location_facility: Assistance Publique Hopitaux de Marseille


title: Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos

acronym: EMVOLS

summary: Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function

lead_sponsor: Poitiers University Hospital


title: Assessments and Recommendations for the Implementation of Advance Directives in Oncology

acronym: DA

summary: Legitimized by the Leonetti law of April 22, 2005, advance directives (AD) appear in various places of care that alongside the end of life, and even tend to be generalized to all areas related to health care in general. In this context, a prospective study to assess how the patient will seize the AD and identify the different problems writing these AD will be conducted. From this study, it will establish recommendations for the implementation of AD in the Multidisciplinary Oncology Department and Therapeutic Innovations service and in oncology in general. They will be asked patients if they choose to write their AD, complete and sign the AD pre-written in the book or not to draft their AD. The choice of the patients, but also the reasons they associate thereto and, where appropriate, their AD written will be collected. The patient will also inform its demographic and socio the case report (clinical data) should be completed by the investigator. During the first part of research, the use of AD by patients and will be assessed and analyzed in connection with the characteristics of these patients (history of the disease, course of care, socio-demographic) and the reasons they set out to explain their choice. For those who write their AD, they will, in a second step, subject to thematic content analysis to identify the main aspects that the subject convened to consider its end of life.This research therefore lead to the definition of the contours of a user device AD in oncology in general. This study was qualified biomedical research because of the sensitive nature of the study population and bring the patient to personal preoccupations when filling the questionnaire on the choice of directing advance directives and their contents.

primary_purpose: Health Services Research


title: Interest of Preventive Personalized Treatment in Hemophilia A

acronym: OBTC

summary: The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven prophylaxis in current clinical practice

primary_purpose: Supportive Care


title: Impact of the Duration of Antibiotics on Clinical Events in Patients With Pseudomonas Aeruginosa Ventilator-associated Pneumonia : a Randomized Controlled Study (iDIAPASON)

acronym: iDIAPASON

summary:
Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units (Réseau RAISIN 2012). A short duration (8 days; SD) vs. long duration (15 days; LD) of antibiotic therapy has a comparable clinical efficacy with less antibiotic use and less multidrug-resistant pathogens (MDR) emergence. These results have led the American Thoracic Society to recommend SD therapy for VAP, with the exception of documented VAP of non-fermenting Gram negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA-VAP), due to the absence of studies focusing specifically on PA-VAP. Thus the beneficial effect of SD therapy in PA-VAP is still a matter of debate. In a small (n=127) subgroup analysis, a higher rate of recurrence with SD therapy (n=21, 32.8%) has been observed compared with LD therapy group (n=12, 19.0%). Unfortunately, the definition of recurrence was essentially based on microbiological rather than clinical data, and the higher rate of recurrence observed could rather reflect a higher rate of colonization more than a new infection.

Interestingly, a trend for a lower rate of mortality was also observed in the SD group (n=15, 23.4%) compared with the LD group (n=19, 30.2%), but this study was clearly underpowered to detect a difference of mortality between groups.

The two strategies were considered as not different, for the risk of mortality in a recent meta-analysis, performed on the very few available studies (n=2), that (OR = 1.33, 95% CI [0.33 to 5.26] for SD vs. LD strategies respectively). However, this conclusion remains questionable considering the large confidence interval of the risk and the power of these studies.

Primary objective and assessment criterion: To assess the non-inferiority of a short duration of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in P. aeruginosa ventilator-associated pneumonia (PA-VAP) on a composite end-point combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU.

Study Design :

Randomized, open-labeled non inferiority controlled trial 32 French Intensive Care Units participating to the study

Research period:

Total study duration: 27 months Inclusion period: 24 months Duration of participation for a patient: 90 days

ReferenceCitation: Gaynes R, Edwards JR; National Nosocomial Infections Surveillance System. Overview of nosocomial infections caused by gram-negative bacilli. Clin Infect Dis. 2005 Sep 15;41(6):848-54. Epub 2005 Aug 16.

ReferenceCitation: Neuhauser MM, Weinstein RA, Rydman R, Danziger LH, Karam G, Quinn JP. Antibiotic resistance among gram-negative bacilli in US intensive care units: implications for fluoroquinolone use. JAMA. 2003 Feb 19;289(7):885-8.

ReferenceCitation: Crouch Brewer S, Wunderink RG, Jones CB, Leeper KV Jr. Ventilator-associated pneumonia due to Pseudomonas aeruginosa. Chest. 1996 Apr;109(4):1019-29.

ReferenceCitation: Trouillet JL, Vuagnat A, Combes A, Kassis N, Chastre J, Gibert C. Pseudomonas aeruginosa ventilator-associated pneumonia: comparison of episodes due to piperacillin-resistant versus piperacillin-susceptible organisms. Clin Infect Dis. 2002 Apr 15;34(8):1047-54. Epub 2002 Mar 15.

ReferenceCitation: Garnacho-Montero J, Sa-Borges M, Sole-Violan J, Barcenilla F, Escoresca-Ortega A, Ochoa M, Cayuela A, Rello J. Optimal management therapy for Pseudomonas aeruginosa ventilator-associated pneumonia: an observational, multicenter study comparing monotherapy with combination antibiotic therapy. Crit Care Med. 2007 Aug;35(8):1888-95.

ReferenceCitation: Planquette B, Timsit JF, Misset BY, Schwebel C, Azoulay E, Adrie C, Vesin A, Jamali S, Zahar JR, Allaouchiche B, Souweine B, Darmon M, Dumenil AS, Goldgran-Toledano D, Mourvillier BH, Bédos JP; OUTCOMEREA Study Group. Pseudomonas aeruginosa ventilator-associated pneumonia. predictive factors of treatment failure. Am J Respir Crit Care Med. 2013 Jul 1;188(1):69-76. doi: 10.1164/rccm.201210-1897OC.

ReferenceCitation: Chastre J, Wolff M, Fagon JY, Chevret S, Thomas F, Wermert D, Clementi E, Gonzalez J, Jusserand D, Asfar P, Perrin D, Fieux F, Aubas S; PneumA Trial Group. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98.

ReferenceCitation: Klompas M. Does this patient have ventilator-associated pneumonia? JAMA. 2007 Apr 11;297(14):1583-93. Review.

ReferenceCitation: Pugin J, Auckenthaler R, Mili N, Janssens JP, Lew PD, Suter PM. Diagnosis of ventilator-associated pneumonia by bacteriologic analysis of bronchoscopic and nonbronchoscopic "blind" bronchoalveolar lavage fluid. Am Rev Respir Dis. 1991 May;143(5 Pt 1):1121-9.

ReferenceCitation: Johanson WG Jr, Pierce AK, Sanford JP, Thomas GD. Nosocomial respiratory infections with gram-negative bacilli. The significance of colonization of the respiratory tract. Ann Intern Med. 1972 Nov;77(5):701-6.

ReferenceCitation: Baram D, Hulse G, Palmer LB. Stable patients receiving prolonged mechanical ventilation have a high alveolar burden of bacteria. Chest. 2005 Apr;127(4):1353-7.

ReferenceCitation: El Solh AA, Akinnusi ME, Wiener-Kronish JP, Lynch SV, Pineda LA, Szarpa K. Persistent infection with Pseudomonas aeruginosa in ventilator-associated pneumonia. Am J Respir Crit Care Med. 2008 Sep 1;178(5):513-9. doi: 10.1164/rccm.200802-239OC. Epub 2008 May 8.

ReferenceCitation: Borg MA. Bed occupancy and overcrowding as determinant factors in the incidence of MRSA infections within general ward settings. J Hosp Infect. 2003 Aug;54(4):316-8.

ReferenceCitation: Trouillet JL, Chastre J, Vuagnat A, Joly-Guillou ML, Combaux D, Dombret MC, Gibert C. Ventilator-associated pneumonia caused by potentially drug-resistant bacteria. Am J Respir Crit Care Med. 1998 Feb;157(2):531-9.

ReferenceCitation: Micek ST, Ward S, Fraser VJ, Kollef MH. A randomized controlled trial of an antibiotic discontinuation policy for clinically suspected ventilator-associated pneumonia. Chest. 2004 May;125(5):1791-9.

ReferenceCitation: Kollef MH, Kollef KE. Antibiotic utilization and outcomes for patients with clinically suspected ventilator-associated pneumonia and negative quantitative BAL culture results. Chest. 2005 Oct;128(4):2706-13.

ReferenceCitation: Pugh R, Grant C, Cooke RP, Dempsey G. Short-course versus prolonged-course antibiotic therapy for hospital-acquired pneumonia in critically ill adults. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD007577. doi: 10.1002/14651858.CD007577.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;8:CD007577.

ReferenceCitation: Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Régnier B, Brun-Buisson C, Chastre J, Wolff M; PRORATA trial group. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25.

ReferenceCitation: Stolz D, Smyrnios N, Eggimann P, Pargger H, Thakkar N, Siegemund M, Marsch S, Azzola A, Rakic J, Mueller B, Tamm M. Procalcitonin for reduced antibiotic exposure in ventilator-associated pneumonia: a randomised study. Eur Respir J. 2009 Dec;34(6):1364-75. doi: 10.1183/09031936.00053209. Epub 2009 Sep 24.

ReferenceCitation: Amour J, Birenbaum A, Langeron O, Le Manach Y, Bertrand M, Coriat P, Riou B, Bernard M, Hausfater P. Influence of renal dysfunction on the accuracy of procalcitonin for the diagnosis of postoperative infection after vascular surgery. Crit Care Med. 2008 Apr;36(4):1147-54. doi: 10.1097/CCM.0b013e3181692966.

ReferenceCitation: Schuetz P, Albrich W, Christ-Crain M, Chastre J, Mueller B. Procalcitonin for guidance of antibiotic therapy. Expert Rev Anti Infect Ther. 2010 May;8(5):575-87. doi: 10.1586/eri.10.25. Review.

ReferenceCitation: American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416.

ReferenceCitation: Fekih Hassen M, Ayed S, Ben Sik Ali H, Gharbi R, Marghli S, Elatrous S. [Duration of antibiotic therapy for ventilator-associated pneumonia: comparison of 7 and 10 days. A pilot study]. Ann Fr Anesth Reanim. 2009 Jan;28(1):16-23. doi: 10.1016/j.annfar.2008.10.021. Epub 2008 Dec 18. French.

ReferenceCitation: Capellier G, Mockly H, Charpentier C, Annane D, Blasco G, Desmettre T, Roch A, Faisy C, Cousson J, Limat S, Mercier M, Papazian L. Early-onset ventilator-associated pneumonia in adults randomized clinical trial: comparison of 8 versus 15 days of antibiotic treatment. PLoS One. 2012;7(8):e41290. doi: 10.1371/journal.pone.0041290. Epub 2012 Aug 31.

ReferenceCitation: Kollef MH, Chastre J, Clavel M, Restrepo MI, Michiels B, Kaniga K, Cirillo I, Kimko H, Redman R. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care. 2012 Nov 13;16(6):R218. doi: 10.1186/cc11862.

ReferenceCitation: Dimopoulos G, Poulakou G, Pneumatikos IA, Armaganidis A, Kollef MH, Matthaiou DK. Short- vs long-duration antibiotic regimens for ventilator-associated pneumonia: a systematic review and meta-analysis. Chest. 2013 Dec;144(6):1759-1767. doi: 10.1378/chest.13-0076. Review.

ReferenceCitation: Hanberger H, Garcia-Rodriguez JA, Gobernado M, Goossens H, Nilsson LE, Struelens MJ. Antibiotic susceptibility among aerobic gram-negative bacilli in intensive care units in 5 European countries. French and Portuguese ICU Study Groups. JAMA. 1999 Jan 6;281(1):67-71.

ReferenceCitation: Cosgrove SE. The relationship between antimicrobial resistance and patient outcomes: mortality, length of hospital stay, and health care costs. Clin Infect Dis. 2006 Jan 15;42 Suppl 2:S82-9.

ReferenceCitation: Paterson DL. The epidemiological profile of infections with multidrug-resistant Pseudomonas aeruginosa and Acinetobacter species. Clin Infect Dis. 2006 Sep 1;43 Suppl 2:S43-8. Review.

ReferenceCitation: Kalfon P, Giraudeau B, Ichai C, Guerrini A, Brechot N, Cinotti R, Dequin PF, Riu-Poulenc B, Montravers P, Annane D, Dupont H, Sorine M, Riou B; CGAO-REA Study Group. Tight computerized versus conventional glucose control in the ICU: a randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):171-181. doi: 10.1007/s00134-013-3189-0. Epub 2014 Jan 14.

ReferenceCitation: ProCESS Investigators, Yealy DM, Kellum JA, Huang DT, Barnato AE, Weissfeld LA, Pike F, Terndrup T, Wang HE, Hou PC, LoVecchio F, Filbin MR, Shapiro NI, Angus DC. A randomized trial of protocol-based care for early septic shock. N Engl J Med. 2014 May 1;370(18):1683-93. doi: 10.1056/NEJMoa1401602. Epub 2014 Mar 18.

ReferenceCitation: Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Åneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Køber L, Langørgen J, Lilja G, Møller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33°C versus 36°C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.

ReferenceCitation: Dunnett CW, Gent M. Significance testing to establish equivalence between treatments, with special reference to data in the form of 2X2 tables. Biometrics. 1977 Dec;33(4):593-602.

ReferenceCitation: Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. Erratum in: JAMA 1994 May 4;271(17):1321.

ReferenceCitation: Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10.

ReferenceCitation: Bouglé A, Foucrier A, Dupont H, Montravers P, Ouattara A, Kalfon P, Squara P, Simon T, Amour J; iDIAPASON study group. Impact of the duration of antibiotics on clinical events in patients with Pseudomonas aeruginosa ventilator-associated pneumonia: study protocol for a randomized controlled study. Trials. 2017 Jan 23;18(1):37. doi: 10.1186/s13063-017-1780-3.

location_facility: Anesthesiology and Critical Care Medicine Institut de Cardiologie, Groupe Hospitalier Pitié-Salpêtrière


title: Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension

acronym: RACE

summary:
"Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe form of pulmonary hypertension characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right failure.

In patients deemed operable, pulmonary endarterectomy (PEA) is the gold standard treatment and is the only potentially curative treatment. However, some patients are ineligible for surgery owing to occlusion of distal vessels. The best treatment option for these non-operable CTEPH patients is not yet established.

ReferenceCitation: Jaïs X, Brenot P, Bouvaist H, Jevnikar M, Canuet M, Chabanne C, Chaouat A, Cottin V, De Groote P, Favrolt N, Horeau-Langlard D, Magro P, Savale L, Prévot G, Renard S, Sitbon O, Parent F, Trésorier R, Tromeur C, Piedvache C, Grimaldi L, Fadel E, Montani D, Humbert M, Simonneau G. Balloon pulmonary angioplasty versus riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (RACE): a multicentre, phase 3, open-label, randomised controlled trial and ancillary follow-up study. Lancet Respir Med. 2022 Oct;10(10):961-971. doi: 10.1016/S2213-2600(22)00214-4. Epub 2022 Aug 1.


title: Impact on Quality of Life of an Early Management Supportive Care of Patients With Acute Leukemia in First Relapse.

acronym: Pablo Hemato

summary: Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .


title: Study of the Impact of 18F-FDOPA Positon Emission Tomography on Therapeutic Proposals Made at Neurooncology Multidisciplinary Case Conferences

acronym: POSEIDON

summary: 18F-FDOPA PET is expensive. It is mandatory therefore to assess its impact on the management of patients with high-grade gliomas in order to provide medico-economic justification for its use. The article by the UCLA group showed that 18F-FDOPA modified 41% of management decisions for patients with brain tumors (Walter JNM 2012). However, this study comprised 58 patients, combined primary and recurring tumors, and was based on questionnaires sent out to referring physicians. A targeted study is needed, therefore, to make a prospective multicenter assessment of the contribution of this technique in the context of high-grade glial tumors and neurooncology MCCs.

lead_sponsor: Centre Antoine Lacassagne


title: Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.

summary:
The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation.

This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time.

This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.

ReferenceCitation: European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery, Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. Erratum in: Eur Heart J. 2011 May;32(9):1172.

ReferenceCitation: Rich MW. Epidemiology of atrial fibrillation. J Interv Card Electrophysiol. 2009 Jun;25(1):3-8. doi: 10.1007/s10840-008-9337-8. Epub 2009 Jan 22. Review.

ReferenceCitation: Pison L, Gelsomino S, Lucà F, Parise O, Maessen JG, Crijns HJ, La Meir M. Effectiveness and safety of simultaneous hybrid thoracoscopic and endocardial catheter ablation of lone atrial fibrillation. Ann Cardiothorac Surg. 2014 Jan;3(1):38-44. doi: 10.3978/j.issn.2225-319X.2013.12.10.

ReferenceCitation: Pison L. Breakthroughs in hybrid management of stand-alone AF. Ann Cardiothorac Surg. 2014 Jan;3(1):78-9. doi: 10.3978/j.issn.2225-319X.2013.12.05.

ReferenceCitation: Gelsomino S, Van Breugel HN, Pison L, Parise O, Crijns HJ, Wellens F, Maessen JG, La Meir M. Hybrid thoracoscopic and transvenous catheter ablation of atrial fibrillation. Eur J Cardiothorac Surg. 2014 Mar;45(3):401-7. doi: 10.1093/ejcts/ezt385. Epub 2013 Jul 31. Review.

lead_sponsor: University Hospital, Toulouse


acronym: VNI Versus

summary:
VNI Versus is a clinical, prospective, randomized, cross over study, aiming to compare two mechanical ventilators during non-invasive ventilation for patient suffering from respiratory acidosis.

This study will compare a dedicated ventilator for Non Invasive Ventilation (NIV) functioning with a turbine and with vented mask (exhalation by a calibrated leak) and a dedicated ventilator for Intensive Care Unit (ICU), functioning with non-vented masks and an exhalation valve.

Patient will be randomized before the first NIV session lasting 2 hours. After a two hours wash-out, a second NIV treatment will be delivered with the other ventilator for duration of 2 hours.

Arterial blood samples will be collected at the beginning and the end of each session of NIV. A transcutaneous captor of dioxide carbon pressure (PCO2) will also be used for patient monitoring.

ReferenceCitation: Akada S, Takeda S, Yoshida Y, Nakazato K, Mori M, Hongo T, Tanaka K, Sakamoto A. The efficacy of dexmedetomidine in patients with noninvasive ventilation: a preliminary study. Anesth Analg. 2008 Jul;107(1):167-70. doi: 10.1213/ane.0b013e3181732dc2.

ReferenceCitation: Carteaux G, Lyazidi A, Cordoba-Izquierdo A, Vignaux L, Jolliet P, Thille AW, Richard JM, Brochard L. Patient-ventilator asynchrony during noninvasive ventilation: a bench and clinical study. Chest. 2012 Aug;142(2):367-376. doi: 10.1378/chest.11-2279.

ReferenceCitation: Chiumello D, Chevallard G, Gregoretti C. Non-invasive ventilation in postoperative patients: a systematic review. Intensive Care Med. 2011 Jun;37(6):918-29. doi: 10.1007/s00134-011-2210-8. Epub 2011 Mar 18. Review.

ReferenceCitation: Ferrer M, Sellarés J, Valencia M, Carrillo A, Gonzalez G, Badia JR, Nicolas JM, Torres A. Non-invasive ventilation after extubation in hypercapnic patients with chronic respiratory disorders: randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1082-8. doi: 10.1016/S0140-6736(09)61038-2. Epub 2009 Aug 12.

ReferenceCitation: Girault C, Bubenheim M, Abroug F, Diehl JL, Elatrous S, Beuret P, Richecoeur J, L'Her E, Hilbert G, Capellier G, Rabbat A, Besbes M, Guérin C, Guiot P, Bénichou J, Bonmarchand G; VENISE Trial Group. Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure: a randomized multicenter trial. Am J Respir Crit Care Med. 2011 Sep 15;184(6):672-9. doi: 10.1164/rccm.201101-0035OC.

ReferenceCitation: Janssens JP, Howarth-Frey C, Chevrolet JC, Abajo B, Rochat T. Transcutaneous PCO2 to monitor noninvasive mechanical ventilation in adults: assessment of a new transcutaneous PCO2 device. Chest. 1998 Mar;113(3):768-73.

ReferenceCitation: Peter JV, Moran JL, Phillips-Hughes J, Graham P, Bersten AD. Effect of non-invasive positive pressure ventilation (NIPPV) on mortality in patients with acute cardiogenic pulmonary oedema: a meta-analysis. Lancet. 2006 Apr 8;367(9517):1155-63. Review.


title: Impact of the Perception of Cohesion Within a Relationship (Dyadic Adjustment) on the Quality of Life of Patients With Prostate Cancer With Gonadotropin-releasing Hormone (GnRH) Agonist Therapy Initiated by the Urologist in the Routine Practice. Evaluation by the Patient and the Partner.

acronym: EQUINOXE

summary: The general hypothesis put forward in this study is that the degree of cohesion (agreement) in the relationship, or dyadic adjustment affects a patient's quality of life and clinical course during the first few critical months following diagnosis and the introduction of treatment. The level of cohesion in the relationship is certainly not the only parameter associated with changes in the quality of life. Other factors must also be investigated such as level of education, circumstances surrounding the diagnosis (new diagnosis or relapse), management (single therapy or adjuvant therapy), the level of physical activity, the patient's age and the presence of functional disorders, etc.

lead_sponsor: Ipsen


title: Efficacy of Oral Prednisolone Versus Partial Endodontic Treatment on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis of Mandibular Molars: Non Inferiority Randomized Clinical Trial

acronym: PULPISOLONE

summary: Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, representing one of the main reasons for consulting dental emergency. The recommended emergency care is a partial endodontic treatment under local and/or locoregional anesthesia. The purpose of the emergency partial endodontic treatment is to stop the pain of pulpitis by removing a portion of the pulp. The final endodontic treatment is ideally performed 72 hours after. The literature reports major difficulty in obtaining adequate anesthesia in the mandible to perform partial endodontic treatment, especially for the mandibular molars. This results in a very painful care for the patient. The management of this type of emergency is costly in terms of equipment and time for health facilities. Patient comfort, cost saving and rationalization of the care time justify the search for an alternative to emergency partial endodontic treatment. In current practice, the short course oral corticotherapy is used in the management of oral pain from inflammatory origin. Glucocorticoids, thanks to their anti-inflammatory action, can neutralize the inflammatory mediators and thus pain. The pulp inflammation can be treated with this molecule: the effectiveness of intraosseous local steroid injection for irreversible pulpitis of mandibular molars has already been shown but results in local comorbidities and requires specific device. Oral administration of short-course prednisolone is simple and safe but its effectiveness to manage pain caused by irreversible pulpitis has not yet been demonstrated. Per-os administration of prednisolone has a very high (90%) and rapid (≤ 4 hours) bioavailability. No difference in effectiveness between intravenous and oral administration of this molecule was reported. This oral treatment could limit comorbidities and technical difficulties related to intraosseous injection and could delay the endodontic treatment to 72 hours in optimal conditions of anesthesia for the patient. Despite the difficulties described for the partial endodontic treatment, it is very effective in pain reduction and can reach 100% of success. Therefore a non-inferiority design was chosen to compare the effect of a short-course oral corticotherapy to a partial endodontic treatment for the reduction of pain at the emergency care of the irreversible pulpitis in mandibular molars. The intervention arm will receive an oral dose of prednisolone (1 mg/kg) during the emergency visit followed-up by one morning dose by day during three days and the reference arm will have partial endodontic treatment. Both groups will have planned complete endodontic treatment 72 hours after enrolment.

ReferenceCitation: Kérourédan O, Jallon L, Perez P, Germain C, Péli JF, Oriez D, Fricain JC, Arrivé E, Devillard R. Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial. Trials. 2017 Mar 28;18(1):141. doi: 10.1186/s13063-017-1883-x.


title: Onset and Offset of Von Willebrand Factor Multimemirization Defects in Cardiovascular Disease: the Case of the Molecular Sensor of Blood Flow

acronym: WiTAVi

summary: The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.

ReferenceCitation: Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10.

ReferenceCitation: Vincent F, Spillemaeker H, Kyheng M, Belin-Vincent C, Delhaye C, Piérache A, Denimal T, Verdier B, Debry N, Moussa M, Schurtz G, Porouchani S, Cosenza A, Juthier F, Pamart T, Richardson M, Coisne A, Hertault A, Sobocinski J, Modine T, Pontana F, Duhamel A, Labreuche J, Van Belle E. Ultrasound Guidance to Reduce Vascular and Bleeding Complications of Percutaneous Transfemoral Transcatheter Aortic Valve Replacement: A Propensity Score-Matched Comparison. J Am Heart Assoc. 2020 Mar 17;9(6):e014916. doi: 10.1161/JAHA.119.014916. Epub 2020 Mar 16.

ReferenceCitation: Van Belle E, Rauch A, Vincent F, Robin E, Kibler M, Labreuche J, Jeanpierre E, Levade M, Hurt C, Rousse N, Dally JB, Debry N, Dallongeville J, Vincentelli A, Delhaye C, Auffray JL, Juthier F, Schurtz G, Lemesle G, Caspar T, Morel O, Dumonteil N, Duhamel A, Paris C, Dupont-Prado A, Legendre P, Mouquet F, Marchant B, Hermoire S, Corseaux D, Moussa K, Manchuelle A, Bauchart JJ, Loobuyck V, Caron C, Zawadzki C, Leroy F, Bodart JC, Staels B, Goudemand J, Lenting PJ, Susen S. Von Willebrand Factor Multimers during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2016 Jul 28;375(4):335-44. doi: 10.1056/NEJMoa1505643.

lead_sponsor: University Hospital, Lille


title: Comprehensive Analysis of HIV Reservoirs in Chronically Infected HIV-1 Treated Patients With a Low Total Cell-associated Blood HIV-DNA

acronym: RESACHRON

summary:
HIV infection can be efficiently controlled by antiretroviral therapy (ART), with in 2013 nearly 85 % of patients having a suppressed viremia, but HIV cannot, however, be eradicated with ART alone [1]. Overall, HIV has moved from a fatal to a chronic disease provided treatment is maintained life-long. Despite major improvement in antiretroviral drugs in terms of efficacy, tolerability and simplicity, life-long therapy is still associated with drug toxicity. Several drugs or drug classes, which have historically saved lives since 1996 and are currently widely used such as protease inhibitors and nucleosides analogues, are associated with long-term toxicities and increased incidence of comorbidities.

Currently, worldwide there is an approximated 10 millions of HIV infected patients under cART. This number should increase in the next years, as most recent guidelines recommend earlier therapy given the benefits in terms of disease progression and prevention of transmission. Because of the increasing number of patients who will be under cART in the future, the cumulative ART toxicity, the difficulties to access ART in some areas of the world, the fatigue expressed by patients about ART and the cost issues, there is an urgent need to search for HIV CURE. To date, only two cases of sterilizing HIV cure were reported so far: the famous "Berlin Patient" after two homozygous Delta32-CCR5 bone-marrow grafts for an acute leukemia [2], and the Mississipi baby after very early initiation of cART 31 hours after delivery [3]. However those cases of sterilizing HIV cure remain exceptional and the alternative objective of a functional HIV cure appears to be more realistic, though still described in rare groups of patients like Elite controllers (EC) and post treatment controllers (PTC) patients. In addition new and complex therapeutic strategies are currently proposed to try purging the HIV reservoirs, but none of them proved so far able to reach this goal.

Therefore the objective of finding a Cure to HIV [4] requires first to better understand the basic mechanisms of the persistence of HIV reservoirs in the population of chronically-infected fully-suppressed HIV+ patients in order to define future therapeutic strategies.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Service des Maladies Infectieuses et Tropicales


title: Nephrologic Prognosis 10 Years After Diabetes Cell Therapy

acronym: PRONOCELDIAB

summary:
Islet transplantation for type 1 diabetes results are still improving, and actually Insulin-independence with normal HbA1c is obtained in 50% of patients after 5 years, 80% of c-peptide positive patients. In addition to the need of 2 or 3 surgical or radiological interventions to inject islets, an immunosuppressive regimen is needed, which can be deleterious, particularly on kidneys. Moreover, long term beneficial effects of islet transplantation on stabilization or prevention of macro and micro vascular complications of diabetes has not been evaluated. In a preliminary work, it was observed a stabilisation or improvement of microvascular complications when compared to pre-transplant data.

The aim of this study is to compare the evolution of diabetes complications, especially nephrologic, 10 years after islet transplantation and to compare it to patients with a brittle diabetes, 10 years after evaluation for islet transplantation, finally not performed.

This case-control study will evaluate nephrologic parameters (creatinine, MDRD creatinine clearance, microalbuminuria, proteinuria) and other micro and macro-vascular complications of type 1 diabetes) before islet transplantation and 10 years after the transplantation or after the first evaluation in patients who finally did not underwent islet transplantation for various non nephrologic reasons

time_perspective: Retrospective


title: Cancer Patient Perceptions of the Osteopathy Treatment: a Qualitative Study

summary: For more than seven years an osteopath has been working in the palliative care unit (PCU) and in both palliative care mobile team (PCMT) as a member of the multidisciplinary team. The patients referred to the osteopath by the palliative care physicians present pains related to cancer, but also to the treatment, in particular to surgery or radiotherapy. The osteopath can help with other symptoms such as constipation or dyspnoea. As this approach is provided in complement of the medicinal approach, it is not considered as an alternative medicine but as a complementary medicine associated to a conventional care. It seemed relevant to the investigators to ask the cancer patients undergoing osteopathic sessions for pain how they saw this complementary therapy.

ReferenceCitation: Steel A, Tricou C, Monsarrat T, Ruer M, Deslandes C, Sisoix C, Filbet M. The perceptions and experiences of osteopathic treatment among cancer patients in palliative care: a qualitative study. Support Care Cancer. 2018 Oct;26(10):3627-3633. doi: 10.1007/s00520-018-4233-y. Epub 2018 May 4.

lead_sponsor: Hospices Civils de Lyon

location_facility: Médecine palliative - Groupement Hospitalier Lyon Sud- Hospices Civils de Lyon


title: Prospective Multicenter Randomized Open-label Controlled Trial Assessing Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia

acronym: DAPS-ITP

summary:
Due to its expected efficacy based on the retrospective data available in ITP, its relatively good safety profile and its very low cost , dapsone could be a good steroid-sparing second-line option for adults with ITP.

This study is a phase III prospective multicenter randomized open trial comparing two treatment strategies:

Arm A (experimental arm): prednisone at 1 mg/kg for 3 weeks + dapsone at 100 mg per day up to week 52 if an initial response is achieved.
Arm B (control arm): prednisone alone at 1 mg/kg for 3 weeks followed by monitoring and "standard of care" The aim of the study is to demonstrate the efficacy of dapsone based on the overall response rate (including response and complete response) as a second-line treatment for adults with newly-diagnosed persistent or chronic (modified by amendment 08/11/2016) ITP not achieving a durable response with corticosteroids. The primary endpoint will be the overall response-rate (response or complete response according to standard definitions) in both arms at week 52 (1 year).

The secondary endpoints are the following :

To assess the safety of dapsone over the study period and especially the incidence of cutaneous reactions.
To analyze the overall response rate (platelet count > 30 x 109/L with at least a doubling of the pre-treatment count in the absence of any other ITP treatment) in both treatment arms at week 24.
To compare the rate of complete response and failure in both arms at 24 and 52 weeks.
To compare time to treatment failure (TTF) in both arms
To investigate the mechanisms of action of dapsone in ITP in a subgroup of patients (ancillary study)

ReferenceCitation: Durand JM, Lefèvre P, Hovette P, Mongin M, Soubeyrand J. Dapsone for idiopathic autoimmune thrombocytopenic purpura in elderly patients. Br J Haematol. 1991 Jul;78(3):459-60.

ReferenceCitation: Godeau B, Oksenhendler E, Bierling P. Dapsone for autoimmune thrombocytopenic purpura. Am J Hematol. 1993 Sep;44(1):70-2.

ReferenceCitation: Hernández F, Linares M, Colomina P, Pastor E, Cerveró A, Pérez A, Perella M. Dapsone for refractory chronic idiopathic thrombocytopenic purpura. Br J Haematol. 1995 Jun;90(2):473-5.

ReferenceCitation: Godeau B, Durand JM, Roudot-Thoraval F, Tennezé A, Oksenhendler E, Kaplanski G, Schaeffer A, Bierling P. Dapsone for chronic autoimmune thrombocytopenic purpura: a report of 66 cases. Br J Haematol. 1997 May;97(2):336-9.

ReferenceCitation: Damodar S, Viswabandya A, George B, Mathews V, Chandy M, Srivastava A. Dapsone for chronic idiopathic thrombocytopenic purpura in children and adults--a report on 90 patients. Eur J Haematol. 2005 Oct;75(4):328-31.


title: Study of the Genetic and Environmental Factors of Vulnerability in Bipolar Disorders

acronym: GAN

summary:
Bipolar disorder is a complex, multifactorial disorder with the intervention of genetic vulnerability factors. To help the identification of these genetic factors and to improve genotype-phenotype correlation, the identification of endophenotype through the exploration of vulnerability characteristics in unaffected first degree relatives have been recommended. For this purpose, the investigator include bipolar patients, unaffected first degree relatives and control subjects to perform genetic association studies and subphenotype analyses. In this study the investigator will focus on subgroups defined according to the existence of abnormal circadian rhythm (a major indicator of bipolar vulnerability).

Lithium is the leading treatment of bipolar disorders but prophylactic lithium response is highly variable and difficult to predict due to lack of biomarkers of response. To explore lithium response variability and to identify biomarkers of response, the investigator characterise lithium response using "ALDA" scale to conduct pharmacogenetic studies and pharmacokinetic studies of lithium extended release, in the subpopulation of patients treated with lithium. As lithium is a circadian agent, the investigator will also explore the links between lithium response and circadian phenotypes. Finally, using Li7 magnetic spectroscopy, the investigator will compare lithium brain distribution in a small sample of good and partial responders to lithium.

ReferenceCitation: Loftus J, Scott J, Vorspan F, Icick R, Henry C, Gard S, Kahn JP, Leboyer M, Bellivier F, Etain B. Psychiatric comorbidities in bipolar disorders: An examination of the prevalence and chronology of onset according to sex and bipolar subtype. J Affect Disord. 2020 Apr 15;267:258-263. doi: 10.1016/j.jad.2020.02.035. Epub 2020 Feb 19.

ReferenceCitation: Geoffroy PA, Micoulaud Franchi JA, Maruani J, Philip P, Boudebesse C, Benizri C, Yeim S, Benard V, Brochard H, Leboyer M, Bellivier F, Etain B. Clinical characteristics of obstructive sleep apnea in bipolar disorders. J Affect Disord. 2019 Feb 15;245:1-7. doi: 10.1016/j.jad.2018.10.096. Epub 2018 Oct 9.

ReferenceCitation: Richard-Lepouriel H, Kung AL, Hasler R, Bellivier F, Prada P, Gard S, Ardu S, Kahn JP, Dayer A, Henry C, Aubry JM, Leboyer M, Perroud N, Etain B. Impulsivity and its association with childhood trauma experiences across bipolar disorder, attention deficit hyperactivity disorder and borderline personality disorder. J Affect Disord. 2019 Feb 1;244:33-41. doi: 10.1016/j.jad.2018.07.060. Epub 2018 Aug 6.