title: Randomized, Double Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics After Single Ascending Doses or Multiple Ascending Doses of OSCN-, bLF or ALX-009 in Healthy Male and CF and Non-CF Bronchiectasis Patients

summary: This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple ascending doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their combination (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis (CF) and non-CF bronchiectasis (NCFBE).

lead_sponsor: Alaxia SAS


type: Registry Identifier

title: Evaluation of the Effectiveness of Self Management Program on Changes in Physical Activity Level of Knee Osteoarthritis Patients in Spa Therapy

acronym: GEET One

summary: The primary purpose is to evaluate the benefit of an education action of exercise on the level of physical activity in patients with knee osteoarthritis with the waning of a spa treatment for three weeks, three months after the start of the cure.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gay C, Guiguet-Auclair C, Pereira B, Goldstein A, Bareyre L, Coste N, Coudeyre E. Efficacy of self-management exercise program with spa therapy for behavioral management of knee osteoarthritis: research protocol for a quasi-randomized controlled trial (GEET one). BMC Complement Altern Med. 2018 Oct 16;18(1):279. doi: 10.1186/s12906-018-2339-x.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_normalized: HAL

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators:
Clermont Communauté
Innovatherm

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Clermont Communauté
Innovatherm

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Premature Labour Screening by Cervical Ultrasound for Asymptomatic Pregnant Women in the PACA Region. Various Treatment Strategies : 1. Progesterone 200mg (Vaginal Way) 2. Pessary 3. Vaginal Stitching 4. Rest

acronym: Echo-col

summary:
State of the question and research objective: International trials have shown that ultrasound measurement of the cervix identifies a population at high risk of preterm delivery. In case of short neck several types of treatments can be recommended: progesterone, the establishment of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There is no French study.

The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by introducing a routine ultrasound screening strategy asymptomatic short necks.

Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA are eligible to ultrasound of the cervix.

Primary endpoint: delivery rate before 37 weeks.
Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality morbidity.

Expected result: a prematurity of 50%

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceCitation: Figarella A, Chau C, Loundou A, d'Ercole C, Bretelle F. The introduction of a universal transvaginal cervical length screening program is associated with a reduced preterm birth rate. Am J Obstet Gynecol. 2023 Feb;228(2):219.e1-219.e14. doi: 10.1016/j.ajog.2022.07.046. Epub 2022 Aug 4.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Assistance Publique Hopitaux De Marseille

intervention_type: Device

status_simplified: Unknown


type: Other Identifier

title: Evaluation of the Metrological Characteristics of the Inertial Unit FOX HiKoB© in Comparison With the Reference System for the Adaptive Trigger System "Functional Electrical Stimulation" of Foot Elevators in Hemiplegic Post-stroke Patients

acronym: MASEA 2

summary: The main objective of this study is to evaluate the metrological characteristics of the data processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of a step and in the middle of the oscillating phase.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Comparative Evaluation of Two Techniques for the Treatment of Per-operative Bacteriological Samples Associated With Osteo-articular Sepsis: Grinding (Ultra Turrax) Versus Standard Methods

acronym: IOAP Turrax

summary: The main objective of this study was to compare the diagnostic capability (sensitivity and specificity) of standard bacteriological analysis made from one or other of the two sampling processing techniques and perioperative management of samples : the Ultra Turrax method that uses grinding versus the standard method.

primary_purpose: Diagnostic

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

intervention_type: Biological


title: Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study

acronym: RPM-Eval

summary: The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue.

intervention_type: Procedure


title: Exploration du système Des Neurones-miroirs Par Enregistrement EEG du Rythme mu Chez l'Enfant Atteint de lésion cérébrale unilatérale Lors d'Action, d'Observation et d'Imagination d'Action du Membre supérieur. " Action-Observation-EEG "

acronym: AOE

summary: To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.

status: Recruiting

primary_purpose: Basic Science

lead_sponsor: University Hospital, Angers

status_simplified: Ongoing


title: Curative Potential of Liver Transplantation in Patients With Definitively Unresectable Colorectal Liver Metastases (CLM) Treated by Chemotherapy: a Prospective Multicentric Randomized Trial

acronym: TRANSMET

summary: This is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern imaging techniques. The primary objective of the trial is to validate in a large multicentric cohort of selected patients the possibility to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around 10% with chemotherapy alone.

status: Active, not recruiting

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Non Invasive IDentification of Gliomas With IDH1/2 Mutation by Analysis of Circulating Plasmatic DNA, D-2-hydroxyglutarate Dosage in Biological Liquids and Detection by Brain SPEctro-MRI: Impact for Diagnosis and Follow-up

acronym: IDASPE

summary:
This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI.

In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG.

In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.


title: An Open-label, Non-randomized, Multicenter, Two Stage Designed Phase II Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)

acronym: AXIPAN

summary:
Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in phase II study in cytokine-refractory metastatic renal-cell cancer patients.

Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with large organ confined tumors to benefit from NSS.

The Objective is to determine the efficacy of Axitinib administered prior to surgery in patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for shifting from a radical nephrectomy indication to a nephron sparing procedure.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Pfizer

intervention_type: Drug


title: Study of Cortical Excitability in Healthy Subjects With Transcranial Magnetic Stimulation (TMS) and a Neuronavigation Device

acronym: RC-TMS

summary:
This study has two main goals :

to investigate the impact of aging on cortical excitability (CE)
to investigate the impact of "state dependency" on CE, using a cognitive task and an emotional one.

A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic response are recorded.

lead_sponsor: University Hospital, Grenoble

location_facility: Department of Psychiatry & Neurology - University Hospital Grenoble


title: WittyFit - Live Your Work Differently

acronym: WittyFit

summary: Individuals spend one third of their life working. Age of retirement is regularly pushed back. The main challenge in the nearest future will be to maintain workers health to deal with their work till retirement. Morbidity before retirement has a huge cost, both in public health and economically for companies. Numerous factors increase morbidity such as stress at work, sedentary and low physical activity, and poor nutrition habits. Nowadays, digital world wildly invades lives and offer a no-limit possibility to interact with individuals, everywhere. Thus, a software able to understand an individual in its globality seems to address this challenge. Moreover, managers need to understand the actions needed within their company. The objective of WittyFit is to increase life expectancy and well-being. WittyFit will constitute a powerful database to build strong evidence and new knowledge on the relationships between work, behavior, and health, based on a large amount of epidemiological data.

ReferenceCitation: Dutheil F, Pereira B, Bouillon-Minois JB, Clinchamps M, Brousses G, Dewavrin S, Cornet T, Mermillod M, Mondillon L, Baker JS, Schmidt J, Moustafa F, Lanhers C. Validation of Visual Analogue Scales of job demand and job control at the workplace: a cross-sectional study. BMJ Open. 2022 Mar 17;12(3):e046403. doi: 10.1136/bmjopen-2020-046403.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: British Medical Journal

ReferenceCitation: Colin-Chevalier R, Pereira B, Benson AC, Dewavrin S, Cornet T, Dutheil F. The Protective Role of Job Control/Autonomy on Mental Strain of Managers: A Cross-Sectional Study among Wittyfit's Users. Int J Environ Res Public Health. 2022 Feb 14;19(4):2153. doi: 10.3390/ijerph19042153.

evidence: open (via page says license)

publisher_dissemination: MDPI

ReferenceCitation: Serole C, Auclair C, Prunet D, Charkhabi M, Lesage FX, Baker JS, Mermillod M, Gerbaud L, Dutheil F. The Forgotten Health-Care Occupations at Risk of Burnout-A Burnout, Job Demand-Control-Support, and Effort-Reward Imbalance Survey. J Occup Environ Med. 2021 Jul 1;63(7):e416-e425. doi: 10.1097/JOM.0000000000002235.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Clinchamps M, Auclair C, Prunet D, Pfabigan D, Lesage FX, Baker JS, Parreira L, Mermillod M, Gerbaud L, Dutheil F. Burnout Among Hospital Non-Healthcare Staff: Influence of Job Demand-Control-Support, and Effort-Reward Imbalance. J Occup Environ Med. 2021 Jan 1;63(1):e13-e20. doi: 10.1097/JOM.0000000000002072.

ReferenceCitation: Dutheil F, Duclos M, Naughton G, Dewavrin S, Cornet T, Huguet P, Chatard JC, Pereira B. WittyFit-Live Your Work Differently: Study Protocol for a Workplace-Delivered Health Promotion. JMIR Res Protoc. 2017 Apr 13;6(4):e58. doi: 10.2196/resprot.6267.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

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

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher_dissemination: JMIR Publications

collaborators:
WittyFit
Australian Catholic University

sponsor_collaborators:
University Hospital, Clermont-Ferrand
WittyFit
Australian Catholic University

intervention_type: Behavioral


title: Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers

acronym: Hydex

summary: The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.


title: The Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus Under Steady-state Remifentanil Analgesia

summary: A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.

ReferenceCitation: Sabourdin N, Peretout JB, Khalil E, Guye ML, Louvet N, Constant I. Influence of Depth of Hypnosis on Pupillary Reactivity to a Standardized Tetanic Stimulus in Patients Under Propofol-Remifentanil Target-Controlled Infusion: A Crossover Randomized Pilot Study. Anesth Analg. 2018 Jan;126(1):70-77. doi: 10.1213/ANE.0000000000001802.

lead_sponsor: Hôpital Armand Trousseau

location_facility: Departement d'anesthesie Hopital Armand Trousseau


title: Efficiency of Hydroxychloroquine on the Endothelial Dysfunction in Antiphospholipid Syndrome (APLAQUINE)

acronym: APLAQUINE

summary:
This study evaluates the benefits of hydroxychloroquine on arterial function in antiphospholipid syndrome.

Briefly, the patients will be randomized in two groups, one will receive hydroxychloroquine and standard treatment, the other will receive placebo in addition of standard treatment.

lead_sponsor: University Hospital, Rouen


title: Comparative Study, Prospective, Randomized , Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique. A Monocentric Study

acronym: DIRECTE

summary: Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Several medical means were studied without evidence of their efficacy in pain related to IUD insertion. In order to remove this brake, it's important to find another way to act against this pain. The direct technique is one of the techniques described by health professionals. It seems trusted by its users as a more reliable technique but also less painful for patients. However, there is no study available on its evaluation. The aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery. A Monocentric Study

summary: Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium. Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. This study is aimed at evaluating the relationship between Staphylococcus aureus strains colonizing the vestibulum nasi, the sphenoethmoidal recess and the nasopharynx.

primary_purpose: Screening

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study

acronym: IPOD

summary:
The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay.

The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.

primary_purpose: Supportive Care

ReferenceCitation: Bergeat D, Merdrignac A, Robin F, Gaignard E, Rayar M, Meunier B, Beloeil H, Boudjema K, Laviolle B, Sulpice L. Nasogastric Decompression vs No Decompression After Pancreaticoduodenectomy: The Randomized Clinical IPOD Trial. JAMA Surg. 2020 Sep 1;155(9):e202291. doi: 10.1001/jamasurg.2020.2291. Epub 2020 Sep 16.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire Rennes Pontchaillou


summary:
Chronic Obstructive Pulmonary Disease (COPD) had systemic repercussion and lead to peripheral muscular dysfunction. Muscular atrophy limits aerobic capacity and is a major limitation of daily activity and quality of life. Technologies likes' neuromuscular electrical stimulation (NMES) are currently being adapted and tested to support exercise training.

The investigators hypothesized that functional electrical stimulation cycling improves VO2 and aerobic capacities during exercise compared to endurance training.

ReferenceCitation: Medrinal C, Prieur G, Combret Y, Quesada AR, Debeaumont D, Bonnevie T, Gravier FE, Dupuis Lozeron E, Quieffin J, Contal O, Lamia B. Functional Electrical Stimulation-A New Therapeutic Approach to Enhance Exercise Intensity in Chronic Obstructive Pulmonary Disease Patients: A Randomized, Controlled Crossover Trial. Arch Phys Med Rehabil. 2018 Aug;99(8):1454-1461. doi: 10.1016/j.apmr.2018.02.002. Epub 2018 Mar 7.

ReferenceCitation: Medrinal C, Prieur G, Debeaumont D, Robledo Quesada A, Combret Y, Quieffin J, Contal O, Lamia B. Comparison of oxygen uptake during cycle ergometry with and without functional electrical stimulation in patients with COPD: protocol for a randomised, single-blind, placebo-controlled, cross-over trial. BMJ Open Respir Res. 2016 Apr 12;3(1):e000130. doi: 10.1136/bmjresp-2016-000130. eCollection 2016.


title: Pedal Rate Influence on Oxygen Consumption in Eccentric

acronym: PRIOx

summary:
Nowadays, ECC exercise can be realized using various modalities that target small or large muscle masses in a segmentary or dynamic way. The training program proposed in this study is realised on an handmade ergocycle which allows eccentric contractions.

With this type of ergometer, O2 consumption (VO2) is three to five fold lower than during an exercise realised at the same power output with a concentric ergocycle. Due to this later propertie, which origins are not yet fully identified, there is an increasing interest to embed ECC in rehabilitation programs.

The investigators hypothesis that a higher pedal rate will induce a lower oxygen consumption, with the same benefits.

This study aims to compare oxygen consumption at two pedal rates : 50 and 80 rotation per minute (rpm).

The ultimate goal is to assess efficacy and tolerance of eccentric training on ergocycle and to enhance comprehension of the physiological mecanisms involved in the lower O2 consumption observed.


title: A Prospective, Single-center, Randomized, Two-arm, Interventional Study to Evaluate the Implantation Rate of Embryos Selected on the Basis of Morphology and Granulocyte-Colony Stimulating Factor (G-CSF) Concentration in the Ovarian Follicular Fluid (FF) - FF G-CSF - Compared to the Implantation Rate of Embryos Selected on the Basis of Morphology Alone When Elective Single Embryo Transfer (SET) of a Fresh Embryo is Performed on Day 2/3 After Oocyte Retrieval

acronym: DESTINy

summary: Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.

lead_sponsor: Forest Laboratories

location_facility: Centre D'Assistance Médicale À La Procréation

lead_sponsor_type: industriel


summary:
The ventilation of the patient under general anesthesia is an old problem and extensively studied, especially in visceral surgery, higher risk of postoperative complications. Studies have recently shown the impact of a lung-protective ventilation in visceral surgery, however obese patients are often excluded, and alveolar recruitment maneuver has never been studied independently.

The investigators are conducting a randomized controlled prospective study to investigate the clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing bariatric surgery.

The objective is to show the reduction in dyspnea, oxygen dependency: reflection of atelectasis and the incidence of postoperative complications.

ReferenceCitation: Severac M, Chiali W, Severac F, Perus O, Orban JC, Iannelli A, Debs T, Gugenheim J, Raucoules-Aime M. Alveolar recruitment manoeuvre results in improved pulmonary function in obese patients undergoing bariatric surgery: a randomised trial. Anaesth Crit Care Pain Med. 2021 Jun;40(3):100775. doi: 10.1016/j.accpm.2020.09.011. Epub 2020 Nov 1.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

unpaywall_oa_status: hybrid

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Stress and Insomnia: Investigating a Bidirectional Relation

acronym: StresSleep

summary:
Insomnia is characterized by rumination and worry over stressful events affecting nighttime sleep. Emotional reactions while stressful events are ongoing have not often been investigated in insomnia. In the current study stress reactions will be measured during a real-life simulation experiment with stressful events and investigate not only how previous sleep patterns affect emotional reactivity to the event but also how the emotional events affect sleep patterns the following night.

Thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with insomnia (n=18) will enroll in a interventional study measuring the reaction to and effects of either neutral or stressful events during driving. Through questionaires and intake polysomnography, clinical levels of depression and anxiety will be excluded as well as sleep medication use and alternative sleep disorders than insomnia. Stress levels will be measured through skin conductance and heart rate variability during events and through nighttime polysomnography (PSG). Effects on sleep architecture and arousal levels will be measured through nighttime PSG.

Investigators hypothesize that subjects with insomnia, compared to subjects without sleep complaints, show stronger emotional reactions to stressful events and stronger effects of stress on sleep quality the following night. Results will facilitate a model for emotional reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption converting into chronic insomnia and aid in developing customized insomnia treatment.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Labex Brain


title: Vagus Nerve Stimulation in Patients With Chronic Consciousness Disorders

acronym: SNV

summary: Minimally Conscious (MCS) or Vegetative State (VS) are disorders of consciousness which often occur following traumatic brain injury or ischemia. These alterations result most of the time in patients' loss of autonomy and require long years of special care. No efficient therapy to improve patients' consciousness has been found so far. Investigators propose to use vagal nerve stimulation (VNS) to restore cortical activity and patients' embodied self. The investigators' main hypothesis is that VNS will reestablish the thalamo-cortical connectivity leading to an improvement of the consciousness state. To test this hypothesis, investigators will use behavioral measures as well as fMRI, PET scan and EEG to assess brain activity. Patients will be evaluated before and during eight months following implantation of the stimulation device.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Neurologique de Lyon Pierre Wertheimer


acronym: Light-CARMIDO

summary: Hypertrophic cardiomyopathy (HCM) is the most frequent genetic cardiac disease characterized by an asymmetric hypertrophic. In two third of patients, an obstruction to blood ejection is observed within the left ventricle which is named left ventricular outflow tract obstruction (LVOTO). This phenomenon can occur at rest or during exercise and is associated with symptoms such as dyspnea, dizziness or chest pain that can significantly limit day life adaptation. To now, medical or interventional treatments such as betablocacker, calcium blockers or septal alcoholisation or surgery present with a limited efficiency. Recent studies from investigators group revealed new concepts about the role of venous return to the LVOTO. Therefore the investigators hypothesis that BX1514M generating a venous vascular constriction, could improve symptoms of HCM patients by reducing LVOTO.


acronym: PREV-DEMALS

summary:
The project focuses on C9orf72, the most frequent genetic form of frontotemporal dementias (FTD, or frontotemporal lobar degeneration, FTLD) and amyotrophic lateral sclerosis (ALS). FTD is the second commonest cause of degenerative dementia in presenium after Alzheimer's disease. Behavioural and cognitive impairments progressively lead to dementia. ALS produces progressive muscle weakness leading to the death in 2 to 4 years. Since 2006, major discoveries have linked FTLD and ALS:

TDP-43 aggregates in neurons and
C9orf72 mutations is a major genetic cause in both disorders.

Two major pathological subtypes are now defined in FTD, FTD-TDP and FTD-TAU. C9orf72 mutations (associated to FTD-TDP) are the most frequent genetic causes of FTD (15%), FTD-ALS (65%) and ALS (40%).

FTD is difficult at an early stage; and no clinical, biological or imaging features can predict the underlying pathology in living patients. Therapeutic perspectives emerged against tau aggregation, progranulin deficit and C9orf72 expansion (antisense). Presymptomatic carriers of genetic FTD would benefit, before onset of symptoms, from these therapeutic that would delay or prevent the disease. At this step, it becomes crucial to develop markers to know how many years before symptoms, does the pathological progress begin, to treat the patients at the most early stage of the disease. Markers are also needed to predict the pathology (FTD-TDP/FTD-tau) in patients that will be eligible for trials targeting specific pathological lesion.

ReferenceCitation: Saracino D, Dorgham K, Camuzat A, Rinaldi D, Rametti-Lacroux A, Houot M, Clot F, Martin-Hardy P, Jornea L, Azuar C, Migliaccio R, Pasquier F, Couratier P, Auriacombe S, Sauvee M, Boutoleau-Bretonniere C, Pariente J, Didic M, Hannequin D, Wallon D; French Research Network on FTD/FTD-ALS; PREV-DEMALS and Predict-PGRN study groups; Colliot O, Dubois B, Brice A, Levy R, Forlani S, Le Ber I. Plasma NfL levels and longitudinal change rates in C9orf72 and GRN-associated diseases: from tailored references to clinical applications. J Neurol Neurosurg Psychiatry. 2021 Dec;92(12):1278-1288. doi: 10.1136/jnnp-2021-326914. Epub 2021 Aug 4.

oa_colors: green hybrid

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

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

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

ReferenceCitation: Kmetzsch V, Anquetil V, Saracino D, Rinaldi D, Camuzat A, Gareau T, Jornea L, Forlani S, Couratier P, Wallon D, Pasquier F, Robil N, de la Grange P, Moszer I, Le Ber I, Colliot O, Becker E; PREV-DEMALS study group. Plasma microRNA signature in presymptomatic and symptomatic subjects with C9orf72-associated frontotemporal dementia and amyotrophic lateral sclerosis. J Neurol Neurosurg Psychiatry. 2021 May;92(5):485-493. doi: 10.1136/jnnp-2020-324647. Epub 2020 Nov 25.

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

ReferenceCitation: Querin G, Bede P, El Mendili MM, Li M, Pelegrini-Issac M, Rinaldi D, Catala M, Saracino D, Salachas F, Camuzat A, Marchand-Pauvert V, Cohen-Adad J, Colliot O, Le Ber I, Pradat PF; Predict to Prevent Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis Study Group. Presymptomatic spinal cord pathology in c9orf72 mutation carriers: A longitudinal neuroimaging study. Ann Neurol. 2019 Aug;86(2):158-167. doi: 10.1002/ana.25520. Epub 2019 Jun 27.

oa_host_type: repository

ReferenceCitation: Wen J, Zhang H, Alexander DC, Durrleman S, Routier A, Rinaldi D, Houot M, Couratier P, Hannequin D, Pasquier F, Zhang J, Colliot O, Le Ber I, Bertrand A; Predict to Prevent Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis (PREV-DEMALS) Study Group. Neurite density is reduced in the presymptomatic phase of C9orf72 disease. J Neurol Neurosurg Psychiatry. 2019 Apr;90(4):387-394. doi: 10.1136/jnnp-2018-318994. Epub 2018 Oct 24.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

ReferenceCitation: Bertrand A, Wen J, Rinaldi D, Houot M, Sayah S, Camuzat A, Fournier C, Fontanella S, Routier A, Couratier P, Pasquier F, Habert MO, Hannequin D, Martinaud O, Caroppo P, Levy R, Dubois B, Brice A, Durrleman S, Colliot O, Le Ber I; Predict to Prevent Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis (PREV-DEMALS) Study Group. Early Cognitive, Structural, and Microstructural Changes in Presymptomatic C9orf72 Carriers Younger Than 40 Years. JAMA Neurol. 2018 Feb 1;75(2):236-245. doi: 10.1001/jamaneurol.2017.4266. Erratum In: JAMA Neurol. 2019 May 13;:

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

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

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Charles Foix

titre: Prédire pour prévenir les démences frontotemporales (DFT) et la sclérose latérale amyotrophique (SLA)


title: Poker, Skills and Associated Problems (PERHAPS). Controlled Experimental Single Centre Study of Poker Players: Study of the Cognitive Mechanisms Underlying Poker Skills and of the Specificity of Poker-related Problems

acronym: PERHAPS

summary: The PERHAPS project aims to fill two gaps in the scientific literature: on the one hand, studying the clinical and cognitive particularities of poker-related problems, and on the other hand, studying poker skill as a combination of multiple cognitive and emotional abilities. The underlying clinical aim is to develop a cognitive remediation therapy program dedicated to pathological gamblers.

lead_sponsor: Nantes University Hospital


title: Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique

acronym: PEPS

summary: The purpose of this study is to evaluate amino acid absorption with two different type of proteins.

lead_sponsor: Société des Produits Nestlé (SPN)

intervention_type: Dietary Supplement


title: REFIT Hearing: Remote Fitting of Hearing Aids

acronym: REFITHEARING

summary:
Currently, the fitting of hearing aids is using a computer interface that allows to adjust the gain and compression of acoustic amplification. This adjustment is made face to face, patient and audiologist being located in a soundproof space to test the effectiveness of the hearing aid.

However, advances in telemedicine in this context, let consider the possibility of addressing these hearing aids fitting via the same computer interface, but remotely controlled by the hearing care professional. The purpose of this study is to assess the ability to perform these tests no longer in front of the patient settings, but away from it, and without visual and sound contact other than through a computer interface.

At the end, this project wants to show that a remote fitting is an acceptable procedure that provides comparable results to-face fitting in terms of speech perception, speech in noise audiometry, hearing loss related quality of life in order to be able to offer this type of strategy.

primary_purpose: Health Services Research

ReferenceCitation: Venail F, Picot MC, Marin G, Falinower S, Samson J, Cizeron G, Balcon M, Blanc D, Bricaud J, Lorenzi A, Ceccato JC, Puel JL. Speech perception, real-ear measurements and self-perceived hearing impairment after remote and face-to-face programming of hearing aids: A randomized single-blind agreement study. J Telemed Telecare. 2021 Aug;27(7):409-423. doi: 10.1177/1357633X19883543. Epub 2019 Nov 6.

publisher_dissemination: SAGE Publications

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
AudioPro Connect
Alliance Audition Montpellier
Audition Conseil Perpignan
Audition Conseil à Nîmes


title: Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients

acronym: COMETIQUE

summary: The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome

acronym: OBESOMAC

summary: The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.

ReferenceCitation: Roche J, Corgosinho FC, Damaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Tulio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.

ReferenceCitation: Roche J, Gillet V, Perret F, Mougin F. Obstructive Sleep Apnea and Sleep Architecture in Adolescents With Severe Obesity: Effects of a 9-Month Lifestyle Modification Program Based on Regular Exercise and a Balanced Diet. J Clin Sleep Med. 2018 Jun 15;14(6):967-976. doi: 10.5664/jcsm.7162.

publisher_dissemination: American Academy of Sleep Medicine (AASM)

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility: Centre de soins de suite et de réadaptation La Beline


title: The Effect and Tolerance of a Ketamine Subcutaneous Bolus, During Painful Care of Refractory Bed Sores, Ulcers and Vascular Wounds in a Palliative Care Unit

acronym: KETAREF

summary:
Pain is one of the major symptoms in palliative care units and often is very difficult to treat, being considered as a refractory pain.

There are different causes of refractory pain: pain due to bed sores and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain due to traumatological injuries, pain associated with a long-term bed confinement, etc.

The investigators propose a prospective study to estimate the effect and the tolerance to a subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care units.

lead_sponsor: Lille Catholic University


type: EudraCT Number

title: Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis

acronym: FRA-IIT-UPA

summary: Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Gedeon Richter Ltd.


title: Study of the Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi

acronym: EPITRANS

summary: The purpose of this study is to identify the abnormalities of bronchial trans-epithelial transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the bronchi.


title: Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment

acronym: DysArt

summary: This is a prospective multicenter study based on the validation of diagnostic criteria and predictive factors of treatment efficacy for renal artery stenosis in renal artery dysplasia. This is considered as a rare disease and patients are usually treated in specialized centers involved in a national network. Marseille is a center specialized in FMD and a member of the network that is very active across the country. In order to rapidly recruit patients the investigators propose a multicenter study. All patients included will benefit from an invasive angiography with trans stenotic gradient assessment at rest. In case of bilateral stenosis the investigators will randomly omit data from one side and consider the data from the contralateral artery for further analysis, to avoid statistical interdependency. Patients who require angioplasty and who have unilateral stenosis (unilateral FMD lesion or bilateral but with one non significant stenosis based on duplex ultrasound European recommendations for atherosclerotic renal artery stenosis) will be included in the second part of the study. These patients will in addition benefit from a trans stenotic pressure assessment under vasodilation and intravascular renal artery ultrasound. Patients with severe bilateral renal artery stenosis will not be included in the analysis to assess predictive criteria for treatment efficacy on hypertension, treatment of these patients will followed the current best clinical practice. These patients will be followed during 6 to 8 month to assess potential complication of the pressure assessment renal artery stenosis, but their data will be included to assess the value of FFR and IVUS to guide the procedure. Patients with unilateral stenosis will be followed up 6 month after angioplasty in order to assess hypertension and to look for potential complications.

ReferenceCitation: Cadour F, Silhol F, Iline N, Giorgi R, Lorthioir A, Amar L, Sapoval M, Rousseau H, Sarlon G, Thony F, Jacquier A. Insights from intravascular pressure measurement of renal artery revascularization in patients with fibromuscular dysplasia: The DYSART study. J Vasc Surg. 2022 Mar;75(3):939-949.e1. doi: 10.1016/j.jvs.2021.09.023. Epub 2021 Sep 30.

repositories_concat: HAL

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

unpaywall_oa_status: green

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

appel_a_projets: PHRCN

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

type_etablissement: CHUR

acronyme: DysArt

titre: Quantification des sténoses rénale dysplasique : définition des critères échodoppler et anatomique avec la mesure des gradients de pression trans sténostique comme technique de référence

discipline_principale: médecine vasculaire

nom_porteur: JACQUIER

prenom_porteur: Alexis


title: Cluster Headache and SPINK-1 Gene

summary:
Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has been suggested by family and twin studies, but the mode of transmission seems to vary and the amount of heritability is unclear.

The number of genetic association studies investigating variants implicated in the pathophysiology of CH is limited. The HCRTR2 1246G > A and the ADH4 925A > G polymorphisms have been associated with CH. The former has been confirmed and may affect the hypothalamic hypocretin system. The aim of the present study was to investigate the possible link between SPINK 1 gene and cluster headache.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

intervention_type: Genetic


title: Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma

acronym: ETAFIRM

summary:
Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an incidence of 500 000 cases per year. HCC most commonly appears in a context of liver chronic disease (patient with chronic viral hepatitis (hepatitis B or hepatitis C) or with cirrhosis). Surgical resection and liver transplantation concern patients with early stage and are the only curative treatments. Transcatheter arterial chemoembolization, Radiation Therapy and antiangiogenics treatments concern patients with inoperable lesions (palliative treatments).

Antiangiogenic treatments enable to inhibit the angiogenesis process and thus interrupt the blood supply to the tumor. In clinical practice, the efficacy of anti-angiogenic agents is usually assessed by methods based on morphological medical imaging. The measures of each target lesion are obtained by Response Evaluation Criteria In Solid Tumor (RECIST) criteria and WHO.

However, these morphological measures are not fully evaluated. An alternative to these is the functional medical imaging which assess changes before that a diminution of tumor size is detectable. Since these treatments induce generally necrosis without modification of initial tumor size, the new technologies of functional medical imaging are particularly adapted to an early evaluation of the response to treatments which may improve patient management.

In this context, liver Perfusion MRI needs to be assessed in its capacities to early predict the response of antiangiogenic treatments.

Positive results will enable to adapt therapy in order to improve overall survival of patients and avoid expensive treatments which may turn out to be inefficient and generating important side-effects.

location_facility: Service d'Imagerie, MédicaleHôpital Croix-Rousse


title: Ambulatory Prolapse Surgery: Feasibility Study

acronym: PROLAMBU

summary:
Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction. Progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized.

Day-care surgery for prolapse has been little studied. The present study is intended to help extend its future implementation, the primary objective being to assess the feasibility of the day-care approach in prolapse surgery. The secondary objectives are to study criteria of non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of failure, predictive factors for failure, patient satisfaction, postoperative complications, 2-year anatomic and functional results, pain, quality of life and sexuality, and postoperative onset of dyspareunia and urinary incontinence.

The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites managed by the Lyon hospitals board (Hospices Civils de Lyon).


title: A Multicentric Randomised Trial to Evaluate Efficacy, Morbidity and Functional Outcome of Endoscopic TranAnal Proctectomy Versus Standard Transabdominal Laparoscopic Proctectomy for Low Lying Rectal Cancer (ETAP-GRECCAR 11)

acronym: ETAP

summary:
Standard surgical treatment of mid and low rectal cancer is total mesorectal excision (TME). Originally performed by open surgery, TME demonstrated improved local control and reduced urogenital morbidity. Laparoscopic approach has been validated by several randomised controlled trials: laparoscopic approach offers to the patient a better post-operative recovery, a lower risk of wound hernia and comparable oncological results. However, the risk of conversion to open procedure remains significant.

Endoscopic Transanal Proctectomy allows retrograd mesorectal excision, performing the whole pelvic dissection via a specific-moderate cost device. The procedure is then completed by a briefer transabdominal laparoscopic step to mobilise the colon and perform inferior mesenteric vessels ligation, prior to low coloanal anastomosis. The originality of this approach is to perform a surgical dissection via an extra peritoneal route, without peritoneal and abdominal wound trauma. This focuses on new technical improvement in the area of mini-invasive pelviabdominal surgery using natural orifice as surgical access. This approach offer closer and better exposure of pelvic dissection plane and could improve oncological quality and pelvic nerve preservation. It could be profitable to postoperative patient outcome. However rates and type of cancer-recurrences as well as functional results have to be assessed in a controlled study. This technique has shown to be feasible and reproducible through early clinical series. Conversion rates appear to be lower than published rates of laparoscopic approach, markedly inferior to 10%. Compiled rates of morbidity (27.8%), R1 resection* (6%), mesorectum macroscopic integrity (100%) appear to be comparable to laparoscopic approach results. However functional results as well as urologic morbidity have to be evaluated in comparative studies. In a preliminary retrospective comparative (n=72) we founded comparable oncological quality criteria (R1 resection 5.9% vs 10.5% p 0.74, Grade 3 mesorectal integrity 57.5 vs 56.2 p 0.99), lower conversion rate to open procedure (2.9% vs 23.6% p 0.011), shorter in-hospital stay (8 vs 9 days p 0.038). Comparable morbidity rates (Dindo 1-4 27% vs 34% p 0.52) and functional results (Kirwan 1/2 80.3% vs 80.6% p 0.94) were also founded. These data need to be confirmed. To this date, Endoscopic Transanal Proctectomy has been evaluated through preliminary studies including several short series demonstrating the feasibility of the technique and showing low morbidity. For some authors the benefit of transanal approach is significant in difficult cases such as male patient and narrow pelvis. Very recently, two non randomised comparative studies were published with conclusions close to those in our study.

Investigators propose, with the support of the GRECCAR group, to conduct a national, multicenter, open-label randomized study based on oncological non-inferiority (R1 resection rate) for the main objective, comparing Endoscopic Transanal Proctectomy to Standard Transabdominal Laparoscopic Proctectomy, for low lying rectal cancer requiring manual colo-anal anastomosis. There is a clear expected benefit expected for the patients through the ETAP procedure in term of post operative short term outcome, risk of conversion to open procedure, risk of wound hernia.This trial could also show significant advantages in terms of quality of dissection, quality of the specimen, quality of nerve preservation.

ReferenceCitation: Lelong B, de Chaisemartin C, Meillat H, Cournier S, Boher JM, Genre D, Karoui M, Tuech JJ, Delpero JR; French Research Group of Rectal Cancer Surgery (GRECCAR). A multicentre randomised controlled trial to evaluate the efficacy, morbidity and functional outcome of endoscopic transanal proctectomy versus laparoscopic proctectomy for low-lying rectal cancer (ETAP-GRECCAR 11 TRIAL): rationale and design. BMC Cancer. 2017 Apr 11;17(1):253. doi: 10.1186/s12885-017-3200-1.

endpoint_id: HAL

repository_institution: HAL

lead_sponsor: Institut Paoli-Calmettes

appel_a_projets: PHRCK

nom_etablissement: INSTITUT PAOLI CALMETTES

type_etablissement: CLCC

acronyme: ETAP-GRECCAR 11

titre: Etude multicentrique randomisée évaluant l'efficacité, la morbidité et l'impact fonctionnel de la proctectomie endoscopique transanale versus proctectomie standard laparosopique transabdominale dans le cancer du bas rectum.

discipline_principale: digestive surgery / colorectal

nom_porteur: LELONG

prenom_porteur: Bernard


title: Ultrasound Assessment of Gastric Contents : the Way to Best Induce Children for Emergency Surgery

acronym: ECHOGASTRO

summary:
Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric contents. It has been previously reported that bedside two-dimensional ultrasonography can be a useful tool for anesthesiologists to determine gastric contents and volume in adults and children.

In this prospective study, preoperative qualitative ultrasound assessment of gastric contents is performed for each children admitted for emergency surgery, in order to plane in case of empty stomach an intravenous or inhalation technique induction rather than an rapid sequence induction.


title: Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia

acronym: ESTEBAN

summary: This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.

lead_sponsor: Hôpital Cochin

collaborators: Centre Hospitalier Universitaire de Nice


title: Assessment of Magnetic Resonance Imaging Neurography and Tractography for Preoperative Mapping of Pelvic Nerves

acronym: Neuro-Tracto

summary: This project aims at assessing two MRI acquisition methods, neurography and tractography, for the visualization of pelvic nerves. The goal is to optimize both methods and to test them on a pool of volunteers to assess if nerves can be delineated, so as to provide an individualized mapping of nerves to surgeons before an intervention and avoid postoperative complications.

ReferenceType: background

ReferenceCitation: Porter GA, Soskolne CL, Yakimets WW, Newman SC. Surgeon-related factors and outcome in rectal cancer. Ann Surg. 1998 Feb;227(2):157-67. doi: 10.1097/00000658-199802000-00001.

ReferenceCitation: Baader B, Herrmann M. Topography of the pelvic autonomic nervous system and its potential impact on surgical intervention in the pelvis. Clin Anat. 2003 Mar;16(2):119-30. doi: 10.1002/ca.10105.

ReferenceCitation: Lange MM, Marijnen CA, Maas CP, Putter H, Rutten HJ, Stiggelbout AM, Meershoek-Klein Kranenbarg E, van de Velde CJ; Cooperative clinical investigators of the Dutch. Risk factors for sexual dysfunction after rectal cancer treatment. Eur J Cancer. 2009 Jun;45(9):1578-88. doi: 10.1016/j.ejca.2008.12.014. Epub 2009 Jan 13.

ReferenceCitation: Lim KS, Tan CH. Diffusion-weighted MRI of adult male pelvic cancers. Clin Radiol. 2012 Sep;67(9):899-908. doi: 10.1016/j.crad.2012.01.016. Epub 2012 Apr 11.

ReferenceCitation: Shihab OC, Heald RJ, Rullier E, Brown G, Holm T, Quirke P, Moran BJ. Defining the surgical planes on MRI improves surgery for cancer of the low rectum. Lancet Oncol. 2009 Dec;10(12):1207-11. doi: 10.1016/S1470-2045(09)70084-1.

ReferenceCitation: Filler AG, Howe FA, Hayes CE, Kliot M, Winn HR, Bell BA, Griffiths JR, Tsuruda JS. Magnetic resonance neurography. Lancet. 1993 Mar 13;341(8846):659-61. doi: 10.1016/0140-6736(93)90422-d.

ReferenceCitation: Takahara T, Hendrikse J, Yamashita T, Mali WP, Kwee TC, Imai Y, Luijten PR. Diffusion-weighted MR neurography of the brachial plexus: feasibility study. Radiology. 2008 Nov;249(2):653-60. doi: 10.1148/radiol.2492071826. Epub 2008 Sep 16.

ReferenceCitation: van der Jagt PK, Dik P, Froeling M, Kwee TC, Nievelstein RA, ten Haken B, Leemans A. Architectural configuration and microstructural properties of the sacral plexus: a diffusion tensor MRI and fiber tractography study. Neuroimage. 2012 Sep;62(3):1792-9. doi: 10.1016/j.neuroimage.2012.06.001. Epub 2012 Jun 13.

ReferenceCitation: Bertrand MM, Macri F, Mazars R, Droupy S, Beregi JP, Prudhomme M. MRI-based 3D pelvic autonomous innervation: a first step towards image-guided pelvic surgery. Eur Radiol. 2014 Aug;24(8):1989-97. doi: 10.1007/s00330-014-3211-0. Epub 2014 May 17.

ReferenceCitation: Soler L, Nicolau S, Pessaux P, Mutter D, Marescaux J. Real-time 3D image reconstruction guidance in liver resection surgery. Hepatobiliary Surg Nutr. 2014 Apr;3(2):73-81. doi: 10.3978/j.issn.2304-3881.2014.02.03.

ReferenceCitation: Chang KJ, Kamel IR, Macura KJ, Bluemke DA. 3.0-T MR imaging of the abdomen: comparison with 1.5 T. Radiographics. 2008 Nov-Dec;28(7):1983-98. doi: 10.1148/rg.287075154.

ReferenceType: result

ReferenceCitation: Wijsmuller AR, Giraudeau C, Leroy J, Kleinrensink GJ, Rociu E, Romagnolo LG, Melani AGF, Agnus V, Diana M, Soler L, Dallemagne B, Marescaux J, Mutter D. A step towards stereotactic navigation during pelvic surgery: 3D nerve topography. Surg Endosc. 2018 Aug;32(8):3582-3591. doi: 10.1007/s00464-018-6086-3. Epub 2018 Feb 12.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl

lead_sponsor: IHU Strasbourg

location_facility: Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS


title: Algorithm for the Early Diagnosis and Treatment of Patients With Eosinophilia

acronym: EOSINOPHILIM

summary:
Eosinophilia, defined by a blood eosinophil granulocytes rate greater than 500 / mm3, is frequently encountered in internal medicine.

Its causes are varied: atopy, drug allergies, parasitic infections, autoimmune diseases and solid neoplasias. Over 200 etiologies have been reported, some difficult to diagnose and can be life-threatening Eosinophilia can be a diagnostic dilemma, as the etiologies are extensive and varied.

The aim of this study is to assess the feasibility of a diagnostic approach based on a decision algorithm in a group of patients with eosinophilia.

We assume that a procedure with a hierarchy of additional tests would increase the frequency of diagnosed cases while decreasing the time to diagnosis.

This procedure defined by an algorithm would even reduce the number of tests necessary to reach a diagnosis.

lead_sponsor: University Hospital, Limoges


title: A Prospective, Randomized, Double-blind, Placebo Controlled, Multi-national Study of Therapeutic Anticoagulation Strategy for Acute Chest Syndrome in Adults

acronym: TASC

summary:
Acute Chest Syndrome (ACS) is a pulmonary complication of sickle cell disease (SCD) representing the leading cause of death and the second cause of hospitalization among adult patients. Pulmonary vaso-occlusion is one of the main pathophysiologic hypotheses during ACS. Our hypothesis is that therapeutic anticoagulation may reduce the severity of ACS via the alleviation of pulmonary thrombosis. The main objective of this prospective, randomized, double-blind study is to test the efficacy and safety of a curative anticoagulation strategy during ACS. The main efficacy endpoint is time to ACS resolution. The main safety endpoint is number of major bleedings.

A thoracic CT scan will be performed to check for pulmonary artery thrombosis. If the CT scan is positive (thrombosis within a large elastic artery), the patient will not be randomized and will be treated with a curative anticoagulation. If the CT scan is negative, the patient will be randomized to receive subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) either at a curative dose (175 Unit International (UI)/kg/day for 7 days) or at a prophylactic dose (4500 UI/day).

ReferenceCitation: Qari MH, Aljaouni SK, Alardawi MS, Fatani H, Alsayes FM, Zografos P, Alsaigh M, Alalfi A, Alamin M, Gadi A, Mousa SA. Reduction of painful vaso-occlusive crisis of sickle cell anaemia by tinzaparin in a double-blind randomized trial. Thromb Haemost. 2007 Aug;98(2):392-6.

ReferenceCitation: Mekontso Dessap A, Deux JF, Abidi N, Lavenu-Bombled C, Melica G, Renaud B, Godeau B, Adnot S, Brochard L, Brun-Buisson C, Galacteros F, Rahmouni A, Habibi A, Maitre B. Pulmonary artery thrombosis during acute chest syndrome in sickle cell disease. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1022-9. doi: 10.1164/rccm.201105-0783OC.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
LEO Pharma


title: Circulating Silicone After Cosmetic Silicone Injection in Transgender Patients

acronym: TSBS

summary:
This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.

The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.

The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).

time_perspective: Cross-Sectional

location_facility: Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat


title: Study by Magnetic Resonance Imaging of the Modifications of the Vasoreactivity and Cerebral Connectivity in the Progressive Forms of Multiple Sclerosis

acronym: VASOSEP

summary: The goal of this study is to show pattern differences of vasoreactivity and connectivity between Progressive Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, by the use of methods of advanced brain MRIs and the Diffusion Tensor Imaging , and correlate these differences with Clinical disability and cognitive disorder results.

sponsor_collaborators:
University Hospital, Montpellier
Genzyme, a Sanofi Company

location_facility: Hopital Gui de Chauliac -Service de Neurologie


title: Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations

acronym: VAAPS

summary:
Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep. OSA patients often report cognitive complaints.

About 25% of the elderly population is affected by this syndrome with a drastic increase of this rate among dementia patients. OSAS is considered to be an important risk factor for the development of hypertension, heart disease and stroke.

lead_sponsor: Central Hospital Saint Quentin


acronym: ICA Langage

summary: Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

lead_sponsor: University Hospital, Angers


title: Hippocampal Sclerosis and Amnesia Not Due to Alzheimer's Disease

summary: Hippocampal Sclerosis (HS) leads to anterograde amnesia mimicking early Alzheimer's disease (AD) (so called HSA-nonAD). Recent studies showed that (a) the deficit of episodic memory as well as the level of hippocampal atrophy in bvFTD may be of similar severity to that observed in AD, even at initial presentation, leading to misdiagnosis in 22% of cases with post mortem diagnosis; (b) amnesia with HS due to microvascular lesion and microinfarcts can also cause impairment of episodic memory mimicking AD, without subcortical cognitive profile. Because these diseases involve distinct pathophysiological processes, they require different specific care and treatment. In consequence, it is very important to improve our knowledge about HS in order to identify its mechanism and improve the diagnosis.

lead_sponsor: Centre Hospitalier St Anne

location_facility: Neurologie de la mémoire et du langage, Service de Neurologie, Centre Hospitalier Sainte-Anne

region: Île-de-France

nom_etablissement: GHU PARIS PSY ET NEUROSCIENCES

type_etablissement: EPSM

acronyme: HSA nonAD

titre: Caractéristique de la sclérose hippocampique non Alzheimer avec amnésie progressive

discipline_principale: neurologie

nom_porteur: SARAZIN

prenom_porteur: Marie


title: Prognostic Value of Myocardial Perfusion Heterogeneity in Normal Dual Isotope High Speed Myocardial Perfusion Imaging With a Semi Conductor Gamma Camera.

acronym: PROMETHE

summary:
Myocardial perfusion imaging is an efficient tool to assess the risk of major cardiac events for patients with known or suspected coronary artery disease. If the test is normal, or if the abnormalities of perfusion represent less than 10% of the left ventricle myocardium, the patient is considered at low risk and should be managed with optimal medical treatment only.

Recently, new gamma cameras using semi-conductor detectors have been developed. Their diagnostic performances have been demonstrated and confronted with various anatomical and functional reference techniques, such as coronary angiography and FFR. The prognostic value of a normal SPECT MPI has not been specifically assessed yet.

Coronary microvascular dysfunction (CMVD) has been demonstrated to be an early marker of coronary artery disease (CAD). Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive and independent prognostic value over the presence of myocardial ischemia remain unknown.

Accordingly, the purpose of this study is :

To assess the prognostic value of a normal myocardial perfusion stress imaging using a semiconductor gamma camera with a dual isotope high speed protocol,
To evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method, in normal SPECT MPIs.

The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD.

ReferenceCitation: Verma S, Buchanan MR, Anderson TJ. Endothelial function testing as a biomarker of vascular disease. Circulation. 2003 Oct 28;108(17):2054-9. doi: 10.1161/01.CIR.0000089191.72957.ED. No abstract available.

ReferenceCitation: Schindler TH, Nitzsche EU, Schelbert HR, Olschewski M, Sayre J, Mix M, Brink I, Zhang XL, Kreissl M, Magosaki N, Just H, Solzbach U. Positron emission tomography-measured abnormal responses of myocardial blood flow to sympathetic stimulation are associated with the risk of developing cardiovascular events. J Am Coll Cardiol. 2005 May 3;45(9):1505-12. doi: 10.1016/j.jacc.2005.01.040.

ReferenceCitation: Johnson NP, Gould KL. Clinical evaluation of a new concept: resting myocardial perfusion heterogeneity quantified by markovian analysis of PET identifies coronary microvascular dysfunction and early atherosclerosis in 1,034 subjects. J Nucl Med. 2005 Sep;46(9):1427-37.

ReferenceCitation: Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Comparison of the short-term survival benefit associated with revascularization compared with medical therapy in patients with no prior coronary artery disease undergoing stress myocardial perfusion single photon emission computed tomography. Circulation. 2003 Jun 17;107(23):2900-7. doi: 10.1161/01.CIR.0000072790.23090.41. Epub 2003 May 27.

ReferenceCitation: Barone-Rochette G, Leclere M, Calizzano A, Vautrin E, Celine GC, Broisat A, Ghezzi C, Baguet JP, Machecourt J, Vanzetto G, Fagret D. Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography. J Nucl Cardiol. 2015 Jun;22(3):513-22. doi: 10.1007/s12350-014-0016-0. Epub 2014 Nov 8.

publisher_dissemination: Springer

lead_sponsor: University Hospital, Grenoble


title: Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption

summary: The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.

lead_sponsor: Pr Isabelle CONSTANT


title: Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial

acronym: MEMBO

summary: This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

location_facility: Service de Chirurgie Colorectale - Hôpital Beaujon

appel_a_projets: PHRCI

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: MEMBO

titre: Etude randomisée évaluant l'efficacité et la tolérance d'une prothèse pariétale implantée lors de la fermeture d'une iléostomie temporaire après chirurgie du rectum par laparoscopie

discipline_principale: autre

nom_porteur: MAGGIORI

prenom_porteur: Léon


title: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

summary:
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.

The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.

On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.

lead_sponsor: Centre Leon Berard


title: Prevention of HYPOthermia Before Admission in TRAUMa Patients - Hypotraum 2 Study

acronym: HYPOTRAUM 2

summary: The purpose of this study is to demonstrate that the specific management will increase the number of alive trauma patient arriving with a temperature > 35°C.

ReferenceCitation: Lapostolle F, Sebbah JL, Couvreur J, Koch FX, Savary D, Tazarourte K, Egman G, Mzabi L, Galinski M, Adnet F. Risk factors for onset of hypothermia in trauma victims: the HypoTraum study. Crit Care. 2012 Jul 31;16(4):R142. doi: 10.1186/cc11449.

location_facility: SAMU 93, AP-HP, Urgences - SAMU 93, Unité Recherche-Enseignement-Qualité, Hôpital Avicenne

appel_a_projets: PHRIP

acronyme: HYPOTRAUM 2

titre: Prévention de l'hypothermie chez les victimes de traumatismes : Etude HYPOTRAUM 2

discipline_principale: médecine d'urgence

nom_porteur: ROCH

prenom_porteur: Stéphane


acronym: VINTAGE VHC

summary: The study consists to Identify viral variants involved in the transmission of hepatitis C and characterize the antigenic and functional properties of their envelope glycoproteins at very early stage of infection (before seroconversion).

lead_sponsor: University Hospital, Tours


title: Characterization of Ascending and Descending Auditory Processing Involved in the Encoding of Speech Sounds in Adult and Children: Variability Related to Changes in Sensory Input or a Neurodevelopmental Disorder or Targeted Remediation

acronym: PRODIPRICIDE

summary: The ability to encode the speech signal is determined by ascending and descending auditory processing. Difficulties in processing these speech signals are well described at the behavioral level in a specific language disorder. However, little is known about the underlying pathophysiological mechanisms. The assumption is that we should observe a degradation of the signal provided by the ear in the deaf subject while in case of specific language impairment it would be a phonemic disorder (possibly linked to a processing disorder auditory). The two population groups should therefore have different abnormalities of their central auditory process - which could be modified by the target remediation for each group.

lead_sponsor: Hospices Civils de Lyon

location_facility: Sercive d'Audiologie et d'Exploration Orofaciales, Hôpital Edouard Herriot, Hospices Civils de Lyon


title: Influence of Apelin Levels on Postoperative Cognitive Disorders After Orthopedic Surgery in Elderlies

acronym: APOCOGNIT

summary: No successful strategy is proposed to patients submitted to important surgery to reduce the incidence of postoperative cognitive disorders (POCD) onset. This project propose to measure plasma levels of apelin in wide population submitted to orthopedic surgery. Apelin could be involved in anti-inflammatory processes. Apelin levels before and after surgery correlated to postoperative cognitive disorders symptom measured by PET-Scan could be an important predictive or diagnostic marker to adapt therapeutic strategy to fight against postoperative cognitive disorders.

ReferenceCitation: Silverstein JH, Timberger M, Reich DL, Uysal S. Central nervous system dysfunction after noncardiac surgery and anesthesia in the elderly. Anesthesiology. 2007 Mar;106(3):622-8. doi: 10.1097/00000542-200703000-00026. No abstract available.

ReferenceCitation: Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.

ReferenceCitation: Price CC, Garvan CW, Monk TG. Type and severity of cognitive decline in older adults after noncardiac surgery. Anesthesiology. 2008 Jan;108(1):8-17. doi: 10.1097/01.anes.0000296072.02527.18.

ReferenceCitation: Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.

ReferenceCitation: Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.

lead_sponsor: University Hospital, Toulouse

location_facility: CHU Toulouse, service d'orthopédie et traumatologie


title: Walking, Brain and Functional Magnetic Resonance Imaging Study of Motor Representations in Healthy Subjects and Amnestic MCI

acronym: IRMARCHE

summary: Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in healthy subjects and amnesic MCI.

ReferenceCitation: Dinomais M, Minassian AT, Tuilier T, Delion M, Wilke M, N'Guyen S, Richard I, Aube C, Menei P. Functional MRI comparison of passive and active movement: possible inhibitory role of supplementary motor area. Neuroreport. 2009 Oct 7;20(15):1351-5. doi: 10.1097/WNR.0b013e328330cd43.

ReferenceCitation: Beauchet O, Allali G, Berrut G, Hommet C, Dubost V, Assal F. Gait analysis in demented subjects: Interests and perspectives. Neuropsychiatr Dis Treat. 2008 Feb;4(1):155-60. doi: 10.2147/ndt.s2070.

ReferenceCitation: Rimmer E, Wojciechowska M, Stave C, Sganga A, O'Connell B. Implications of the Facing Dementia Survey for the general population, patients and caregivers across Europe. Int J Clin Pract Suppl. 2005 Mar;(146):17-24. doi: 10.1111/j.1368-504x.2005.00482.x.

ReferenceCitation: Ogawa S, Lee TM, Nayak AS, Glynn P. Oxygenation-sensitive contrast in magnetic resonance image of rodent brain at high magnetic fields. Magn Reson Med. 1990 Apr;14(1):68-78. doi: 10.1002/mrm.1910140108.

ReferenceCitation: Beauchet O, Allali G, Launay C, Herrmann FR, Annweiler C. Gait variability at fast-pace walking speed: a biomarker of mild cognitive impairment? J Nutr Health Aging. 2013 Mar;17(3):235-9. doi: 10.1007/s12603-012-0394-4.

intervention_type: Radiation


title: MagnetoEncephaloGraphy Study of Cerebral Activations Induced by Psychomotor Tasks for Target Localisation in View of BCI Clinical Trial

acronym: TAPFINGER

summary: The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal volunteers by tapping the finger .

sponsor_collaborators:
University Hospital, Grenoble
Commissariat A L'energie Atomique


title: Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

acronym: METERMUCADIG

summary: Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.

ReferenceCitation: Dolly A, Lecomte T, Tabchouri N, Caulet M, Michot N, Anon B, Chautard R, Desvignes Y, Ouaissi M, Fromont-Hankard G, Dumas JF, Servais S. Pectoralis major muscle atrophy is associated with mitochondrial energy wasting in cachectic patients with gastrointestinal cancer. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1837-1849. doi: 10.1002/jcsm.12984. Epub 2022 Mar 22.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wiley

collaborators: Inserm U1069 - Team Nutrition, Growth and Cancer

location_facility: Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS


title: Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea

acronym: EndothSAS

summary: Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2 (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.

lead_sponsor: Hopital Foch


title: Study of Predictor of Mood Relapse in Bipolar Disorders : Prospective, Clinical, Neuropsychological, Biological and Genetic Study

acronym: RechuteBP

summary:
Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal objective of this research is to test the predictive value of core vulnerability dimensions such as affective instability and emotional reactivity, measured by validated questionnaires (AIM and ALS) on recurrence of affective major episode (depressed, hypomanic or manic) during a 24 months prospective follow-up.

In addition, several arguments suggest that inter-individual variability in the risk of relapse is influenced by genetic factors. In particular, the implication of such factors have been demonstrated in rapid cycling or antidepressants induced mania. However, this has never been tested in cohorts followed prospectively. Finally, the existence of neuropsychological deficits in bipolar disorder is well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and evolutionary course remain poorly investigated. In summary, the secondary objectives of this research are the study of the influence of these other clinical, neuropsychological and genetic factors on the risk of relapse.

• Scientific rationale The dimensions of affective instability and emotional reactivity, are considered core psychological and temperamental vulnerability dimensions to bipolar disorder. Differences in levels of instability and reactivity may account for the inter-individual variability observed in bipolar disorder in terms of risk of relapse. These dimensions are measured using validated questionnaires (Affective Instability Measure (AIM) and Affective Lability Scale (ALS)). Relapsing is defined as the occurrence of a depressive episode, hypomanic, manic or mixed episode (DSMIV criteria).

Other factors that may influence the risk of relapse have been suggested in the literature but have not been formally tested in prospective studies:

cognitive deficits: the existence of neuropsychological deficits in bipolar disorder are well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and their course remain poorly investigated. Indeed, some appear to be related to the neurotoxicity of the episodes themselves, the other being related to the vulnerability to bipolar disorder
The involvement of genetic vulnerability factors in bipolar disorder is widely demonstrated. Several arguments suggest the implication of genetic factors in the risk of relapse. This is the case for some outcome patterns such as rapid cycling or antidepressants induced mania. Again, this has never been tested in cohorts followed prospectively.

The role of certain inflammatory and infectious factors in the etiology of bipolar disorder has been suggested but it is clear whether these biomarkers are "state" or "traits". Thus, the role of neurotoxic inflammatory or infectious factors in relapse mood has never been tested in a prospective follow up studies.

Main objective of the project To determine if the scores of AIM and ALS, assessed at baseline in euthymic bipolar patients is associated with relapse in patients during a 2 years follow-up period.
Secondary objectives of the project Determine if the neuropsychological performance at T0, measured in euthymic patients predict relapse during a 2 years follow-up period.

Determine whether the neuropsychological deficits observed in euthymic bipolar patients that contribute to functional impairment worsen with time.

DNA collection to test the involvement of candidate genes Serum collection to study the biological and infectious biomarkers

• Methodology Prospective follow up studies. Multicenter.


title: Pharmacokinetic Study of the Amoxicillin / Clavulanic Acid Association to Optimize Dosage Among Obese Adults (PHACO)

acronym: PHACO

summary:
Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration Determination of the pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic concentrations of intravenous injection (IV) and oral administrations. The criterion of evaluation allowing to answer our main objective corresponds to the parameters estimated by the pharmacokinetic model of the concentrations obtained from the data IV and by the pharmacokinetic model of the concentrations obtained from the oral data. The following pharmacokinetic parameters will be considered at every obese volunteer's for both molecules (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of population.

The main evaluation criteria are PK parameters of amoxicillin / clavulanic:

Cl, systematic plasmatic clearance
Vd, volume of distribution
ASC 0-oo, area under the curve time - concentration
T1/2, half-life time
F, bioavailability after oral administration
Ka, constant of speed of absorption

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba


title: Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation

acronym: Relax-TAG

summary:
The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the rise of quality of life when using methods of relaxation combined with virtual reality with patients suffering from generalized anxiety disorder in comparison of the effect of traditional relaxation therapy. Observe and evaluate the effect of perceived presence in synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment of generalized anxiety disorder.

It is a comparative, randomized, two groups study (29 in each group):

Relaxation optimized virtual reality
Classical relaxation (without Virtual Reality). The protocol comprised for each groups 7 relaxing sessions (with or without virtual reality epending on the group). Each session lasted for approximately 30 to 35 minutes, including a 5-minute pause between immersive trials, in order to avoid cyber sickness in the virtual reality group.

Expected results: a measurable therapeutic improvement produced by the combination of relaxation and virtual and its additional effect when compared to the traditional treatment.

Measurements of variables and therapeutic effects will be carried out with psychometric measures.

The creation process of the relaxing virtual environments has already been completed. The virtual environments are ready for use.

The apparatus needed and in our possession include:

A laptop for generating virtual environments
A stereoscopic display
Apparatus for physiological measurements

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Evaluation of Screening for Visual Disorders of the Old Subject in Consultation Memory

acronym: EVAM

summary: Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. The main objective of the study is to evaluate the prevalence of visual disorders among elderly patients at consultant outpatient center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary objectives are to describe ophthalmological diseases detected and taken into the proposed ophthalmic load, to determine if there are associations between eye diseases and cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation to determine the cognitive profiles and geriatric evaluation and ocular pathological, depending on the assessment of arterial stiffness. The results of this study will build a testing strategy to promote access of older patients with cognitive impairment to vision care.

lead_sponsor: Nantes University Hospital


title: A Bioequivalence Study of the Reference Clinical Fexinidazole Tablet vs Proposed Market Formulation in Healthy Male Volunteers of African Sub-Saharan Origin:an Open-label,Randomized,Two-treatment,Single Dose,Replicate Design,Fed Condition

summary:
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition.

The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate crossover study under fed condition. The 4-period sequences for the replicate design will be TRTR and RTRT, where R designates the reference formulation and T the test formulation. Subject will be allocated randomly to one of the two sequences of treatments according to the randomization list.

lead_sponsor: Drugs for Neglected Diseases


title: MELA Study - Hedonic Study on the Taste of Drugs Crushed in Food: Observational Study Involving 16 Healthy Volunteers

acronym: MELA

summary: Elderly people often suffer from chronic pathologies and they are given polypharmacy. In case of swallowing problems, the drugs are crushed and mixed in food, which alters the taste of food and is a cause of anorexia and malnutrition. Gustative side-effects of crushed drugs have nether been investigated. The MELA study is a one session hedonic test involving 16 healthy volunteers. They will score in a blind manner the taste of 10 drugs commonly prescribed in nursing homes, crushed in jelly or apple compote. These volunteers will be 8 food professionals and 8 geriatric care professionals. Thanks to the MELA protocol, they will have a unique opportunity to communicate and propose solutions to this neglected aspect of malnutrition in elderly populations.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Center for Clinical Research - Archet 1 Hospital Nice Hospital


title: Efficacy of Fluoxetine Against Seizure-induced Central Apneas : a Randomized Placebo-controled Double-blind Trial.

acronym: FLUOXETINE

summary:
Sudden unexpected death in epilepsy (SUDEP) is a tragic outcome of seizure disorders that primarily affect young adults suffering from refractory epilepsy. In this population, SUDEP incidence is estimated at 0.5%. While the mechanisms of SUDEP are not completely understood, it appears that the majority of such death occurs in the immediate aftermath of a general tonic-clonic seizure.

There is currently no validated preventive treatment for SUDEP. Some evidence suggest that modulation of the serotoninergic tone, and more specifically selective serotonin recapture inhibitor (SSRI) such as fluoxetine, might prevent SUDEP. Indeed, fluoxetine prevents seizure-induced lethal central apneas in DBA/2 and DBA/1 mice, one of the few animal models of SUDEP. Furthermore, serotoninergic bulbar nuclei are known to play a major role in the control of breathing, especially during sleep and in response to repeated hypoxia.

In patients with epilepsy undergoing in-hospital video-EEG monitoring, about one third of seizures are associated with decrease in SpO2 <90%, an abnormality suspected to represent a risk factor of SUDEP. In a retrospective uncontrolled study, patients treated with SSRIs displayed less frequent ictal/post-ictal hypoxemia than patients not taking SSRIs.

The investigators project aimed at testing whether fluoxetine can reduce the risk of ictal/post-ictal hypoxemia by performing a double-blind, randomized, placebo-controlled trial in patients undergoing video-EEG monitoring as part of the pre-surgical evaluation of their focal drug-resistant epilepsy.

location_facility: Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique


title: The Impact of Surgical Outcomes Monitoring Using Control Chart on Surgical Performance: A Cluster Randomized Trial

acronym: SHEWHART

summary: This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.

ReferenceCitation: Duclos A, Chollet F, Pascal L, Ormando H, Carty MJ, Polazzi S, Lifante JC; SHEWHART Trial Group. Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial. BMJ. 2020 Nov 4;371:m3840. doi: 10.1136/bmj.m3840.

appel_a_projets: PREPS

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: SHEWHART

titre: Impact d'un Suivi Prospectif de la Performance des Equipes Chirurgicales par Carte de Contrôle

discipline_principale: chirurgie viscérale et digestive

nom_porteur: LIFANTE

prenom_porteur: Jean Christophe


title: Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study

acronym: PEEPUS

summary:
There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.

In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.

The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease

acronym: COMPLICUSHING

summary: This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Epilepsy and Mood Regulation Disorders: a Prospective and Longitudinal Study in Children With Newly Diagnosed Epilepsy

acronym: EPILETRE

summary:
Epilepsy is a multifaceted disorder and a major public health problem. In addition to recurrent and unpredictable seizures, abnormalities in psychiatric status, cognition and social-adaptive behaviors are potential major sources of disability in children and adults with epilepsy disorders. Recent studies have unequivocally documented raised psychiatric comorbidities in children with epilepsy, particularly emotional regulation disorders such as depression and anxiety, as compared to both the general population and the children with other medical disorders, neurological and non-neurological. A prevalence of 12% to 35% has been reported, compared to 3-8% in the general population.

Major advances have begun to uncover the potential mediators of emotional regulation disorders and social comorbidities in epilepsy, but important gaps remain in the early detection, treatment and prevention of these disorders. A very small number of investigations have examined children with epilepsy at or near the time of diagnosis. This is a time during which the effects of chronic epilepsy, potential averse social effects of epilepsy, and other complicating aetiological effects are minimized.

Epilepsy syndromes provide a useful framework for considering the risk and type of emotional dysregulation comorbidities. But variability within and across syndromes needs to be taken into account thus requiring a strict phenotyping by specialists in the filed of pediatric epileptology. Retrospective studies, usually including patients with chronic epilepsies and suffering from a mixed spectrum of epilepsy syndromes introduce biases leading to rather disparate findings.

Are such disorders the result of common physiopathological mechanisms, which precede the development of the epilepsy? The link between an underlying brain disorder and psychiatric comorbidities has emerged in recent literature, with evidence based on studies in adults, suggesting bidirectional relations between epilepsy and neurobehavioural comorbidities. Emotional regulation disorders can follow the onset of epilepsy, but they can also precede it, thus serving as a possible risk factor. The clinical implication of such a bidirectional association is that neurobehavioural comorbidities might be present at diagnosis and even before epilepsy onset. There is a need for greater understanding of the causes of these conditions in younger people.

The degree to which specific epilepsy syndromes are associated with the relative risk of emotional dysregulation disorders in children with new- or recent-onset (within six months prior to enrolment) has rarely been comprehensively examined and represents the focus of the current investigation.

The investigators study will be based on a prospectively recruited cohort of 280 children/adolescents with recently diagnosed epilepsy. All participating centres dispose of the necessary competences for a precise diagnosis of the epilepsy syndromes and the tools for a per case appropriate aetiology screening. Following a first seizure children are usually first examined at hospital based emergency departments. Prompt referral to the epilepsy teams participating at the present study will significantly reduce the population biases and shortcuts encountered in studies that recruited patients with chronic epilepsy followed in tertiary care epilepsy units.

The investigators expect their results to provide a greater understanding of both the shared and the unique features of emotional regulation disorders, in relation to specific epilepsy categories defined on the basis of the underlying physiopathological mechanisms.

Such knowledge will also assist clinicians and families in the planning of both diagnosis and management resources.


title: Identification of Cognitive and Emotional Factors in Relation to Auditory Hallucinations in Non-psychotic Children

summary: The aim of this study is to show presence of cognitive and emotional factors on the beginning and persistence of auditory hallucinations in non-psychotic children. Investigators will describe a significant link between this factors and hallucinations in a sample of non-psychotic children. The results of this sample will be comparing to another group of children of the same age, sex and diagnosis, but without hallucination. Finally, investigators will control the persistence of hallucination on the first group after a six month period.

ReferenceCitation: Dumas LE, Bonnard-Couton V, Golse B, Askenazy F. [Identifying cognitive and emotional markers in relation to auditory-verbal hallucinations in pediatric population: Physalis study]. Encephale. 2022 Oct;48(5):546-554. doi: 10.1016/j.encep.2021.06.010. Epub 2021 Oct 5. French.

lead_sponsor: Fondation Lenval


title: Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa

acronym: DIBLAN

summary:
The drastic reduction of nutritional intake in anorexia nervosa(AN) alters many hormonal factors that regulate the activity of bone cells. This alteration of bone remodeling is characterized by increased bone resorption and decreased bone formation, leading to a marked reduction of bone mineral density, osteoporosis and an increased risk of fracture.

To date, there is a paucity of studies and no consensus on the management of bone loss in patients with AN. The few previous studies were performed with small samples and using short follow-up periods.

Denosumab is a fully human monoclonal antibody that binds with high specificity to human RANKL (6, 7), thereby reducing the number and activity of osteoclasts and therefore decreasing bone resorption that was found increased in patients AN.

Denosumab may transiently protect bone whilst psychonutritional management will induce a weight restoration

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
University Hospital, Lille
Nantes University Hospital
University Hospital, Paris
University Hospital, Rouen

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: DIBLAN

titre: Impact du Denosumab dans la prévention de la perte osseuse chez des femmes non ménopausées souffrant d'anorexie

discipline_principale: psychiatrie / addictologie

nom_porteur: GUILLAUME

prenom_porteur: Sébastien