title: Nasal Ventilation Versus Voluntary Hypoventilation in the Rehabilitation of Hyperventilation Syndrome: a Randomized, Controlled Trial

acronym: RehabSHV

summary: The main objective of this study is to measure the effect (at 3 months) of dyspnea control rehabilitation with nasal ventilation versus standard rehabilitation, in dyspneic patients with hyperventilation syndrome.


title: Influence of Surgeon-anesthesiologist Collaboration on Patient Outcomes After Pheochromocytoma Surgery

acronym: CCAP

summary: Collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. This study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults

acronym: CASSANDRA

summary:
Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.

The collection should be done as soon as possible, in the reception of vital emergencies or in the urgencies. The collection consists of the realization of a Glasgow score and a scale of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is filled by medical personnel trained.

The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended, which will be made during a following consultation or by phone. Additional data will be collected on the folder (ventilation time, days of hospitalization, mortality).

study_start_date_type: Actual

status: Recruiting

time_perspective: Prospective

lead_sponsor: Poitiers University Hospital

status_simplified: Ongoing


title: Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.

acronym: CBT

summary: This study evaluates the performance of "CRYOBEAUTY MAINS", a Cyto-selective Cryotherapy based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one application of "CRYOBEAUTY MAINS" in one hand (right or left hand according to the randomization code).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Cryobeauty

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Peripheral Ischemia Evolution Assessed by Ultra-wide Field Angiography in Patients With Diabetic Macular Edema

summary: Patients with diabetic macular edema treated with aflibercept injections for visual impairment will be observed in standard care during 12 months. They will undergo visual assessments by Ultrawide Field angiography at baseline and at 12 months

ipd_sharing: Undecided

lead_sponsor: Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital


title: Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome

acronym: GASTRO-SGS

summary: the investigators propose to carry out a prospective study consisting of a systematic research of digestive symptoms in patients with SGSp with the validated Global symptom score (GSS) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Parreau S, Jacques J, Dumonteil S, Palat S, Geyl S, Gondran G, Bezanahary H, Liozon E, Azaïs J, Colombie S, Jauberteau MO, Loustaud-Ratti V, Ly KH, Fauchais AL. Abdominal symptoms during Sjogren's syndrome: a pilot study. Adv Rheumatol. 2021 Jan 19;61(1):5. doi: 10.1186/s42358-021-00164-w.

lead_sponsor: University Hospital, Limoges

intervention_type: Other


title: Alternative Splicing and Leukemia Initiating Cells

acronym: ASLIC

summary:
Aberrant RNA splicing and mutations in spliceosome complex in acute myeloid leukaemia (AML) are frequent. It have been shown that some splicing variants had a prognostic value in AML.

AML are characterized by their propensity to relapse because of the persistence of leukaemia initiating cells (LICs).

The aim of this study is to determine the splice variants on AML initiator cells and define a splicing pattern.

location_facility: Service d'hématologie du Centre Hospitalier Lyon Sud


type: Other Identifier

title: High Dosage Buprenorphine as a Drug Strategy Withdrawal Assistance of Analgesics Opioid After Failure of an Opioid Tapering-off Strategy.

acronym: SEVROP

summary:
The prevalence of analgesics opioids addiction in chronic pain patient is very difficult to know. Many studies indicated that the prevalence of addiction varied from 0% up to 50% in chronic non cancer pain patients, and from 0% up to 7.7% in cancer pain patients. Analgesics opioids use have increasingly been increased in chronic pain for 20 years. However, a long use, at least 3 months in this type of pain has not proved a large efficiency and we have noticed a habituation, tolerance and withdrawal when treatment was decreased or stopped. In current practice, patients with chronic pain, often keep their analgesics opioids despite the absence of pain relief and benefits in quality of life.

Nowadays, no withdrawal strategy is the reference in chronic non-cancer pain patients with physical opioid dependence. The most common clinical strategy is progressive decrease of analgesic opioid. But this strategy is often a failure in these patients (no data are available in literature).

It's necessary to make a prospective pilot study to assess benefits from this practice.

The primary objective of this study is to assess a new ambulatory withdrawal strategy, consisting of a temporary opioid rotation with buprenorphine in CNCP patients suffering from physical withdrawal symptoms and who have failed a conventional strategy of progressive withdrawal from their opioid analgesic treatment.

status: Active, not recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug


title: Impacts of the α-fetoprotein (AFP) Score in Real Life for Patient Selection for Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)

acronym: Impact AFP

summary: This is a French multicentric retrospective study on intention-to-treat comparing results of LT for HCC before and after the use of the AFP score. The investigators hypothesis is a better respect of the Biomedicine Agency (the French national transplantation agency) criteria since the general application of this score in March 2013. The aim of this study is to determine if the tumoral characteristics at the time of LT are improved and if it modified the patients'outcome.

ReferenceType: background

ReferenceCitation: Decaens T, Roudot-Thoraval F, Bresson-Hadni S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Boudjema K, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Dhumeaux D, Cherqui D, Duvoux C. Impact of pretransplantation transarterial chemoembolization on survival and recurrence after liver transplantation for hepatocellular carcinoma. Liver Transpl. 2005 Jul;11(7):767-775. doi: 10.1002/lt.20418.

ReferenceCitation: Decaens T, Roudot-Thoraval F, Hadni-Bresson S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Sulpice L, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouilleres O, Cherqui D, Duvoux C. Impact of UCSF criteria according to pre- and post-OLT tumor features: analysis of 479 patients listed for HCC with a short waiting time. Liver Transpl. 2006 Dec;12(12):1761-9.

ReferenceCitation: Decaens T, Roudot-Thoraval F, Bresson-Hadni S, Meyer C, Gugenheim J, Durand F, Bernard PH, Boillot O, Compagnon P, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Dharancy S, Chazouillères O, Cherqui D, Duvoux C. Role of immunosuppression and tumor differentiation in predicting recurrence after liver transplantation for hepatocellular carcinoma: a multicenter study of 412 patients. World J Gastroenterol. 2006 Dec 7;12(45):7319-25.

ReferenceCitation: Decaens T, Roudot-Thoraval F, Badran H, Wolf P, Durand F, Adam R, Boillot O, Vanlemmens C, Gugenheim J, Dharancy S, Bernard PH, Boudjema K, Calmus Y, Hardwigsen J, Ducerf C, Pageaux GP, Hilleret MN, Chazouillères O, Cherqui D, Mallat A, Duvoux C. Impact of tumour differentiation to select patients before liver transplantation for hepatocellular carcinoma. Liver Int. 2011 Jul;31(6):792-801. doi: 10.1111/j.1478-3231.2010.02425.x. Epub 2011 Mar 31.

ReferenceCitation: Duvoux C, Roudot-Thoraval F, Decaens T, Pessione F, Badran H, Piardi T, Francoz C, Compagnon P, Vanlemmens C, Dumortier J, Dharancy S, Gugenheim J, Bernard PH, Adam R, Radenne S, Muscari F, Conti F, Hardwigsen J, Pageaux GP, Chazouillères O, Salame E, Hilleret MN, Lebray P, Abergel A, Debette-Gratien M, Kluger MD, Mallat A, Azoulay D, Cherqui D; Liver Transplantation French Study Group. Liver transplantation for hepatocellular carcinoma: a model including α-fetoprotein improves the performance of Milan criteria. Gastroenterology. 2012 Oct;143(4):986-94.e3; quiz e14-5. doi: 10.1053/j.gastro.2012.05.052. Epub 2012 Jun 29.

ReferenceCitation: Brusset B, Dumortier J, Cherqui D, Pageaux GP, Boleslawski E, Chapron L, Quesada JL, Radenne S, Samuel D, Navarro F, Dharancy S, Decaens T. Liver Transplantation for Hepatocellular Carcinoma: A Real-Life Comparison of Milan Criteria and AFP Model. Cancers (Basel). 2021 May 19;13(10). pii: 2480. doi: 10.3390/cancers13102480.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of the Clinical Performance of Optimized Angiomammography and Comparison With Standard Angiomammography

acronym: OPTIAM

summary:
This study will be proposed consecutively to any patient who angiomammography examination was requested by the clinician in charge of patient. A randomization will be performed between an angiomammography examination Standard (SenoBright®) and an optimized angiomammography examination.

A blinded central re-reading of the acquisition technique will be carried out by 3 radiologists (2 seniors and 1 junior) who will evaluate:

The intensity of lesion enhancement
The presence and type of artefacts on the recombined images.
The quality of low-energy images according to recognized criteria for mammography.

The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for non-biopsied benign lesions

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors

acronym: NEUROSEX

summary: This study aim to ensure that the implementation of a paramedical screening program and counseling in sexual health of patients with neurological pathologies (low-grade gliomas and Multiple Sclerosis) improves their sexual health.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: RITUX-PLUS. A Prospective Open Trial to Assess the Efficacy and Safety of a Treatment Combining Rituximab and Belimumab in Adults With Persistent Immune Thrombocytopenia.

acronym: RITUX PLUS

summary: Previous studies have shown that increase level of BAFF could promote the settlement of long-lived plasma cells in the spleen of ITP patients treated with anti-CD20. This single-center prospective pilot study, currently in phase IIa, will evaluate the efficacy of a rituximab and belimumab sequential combination treatment. Investigators plan to include 15 patients with persistent ITP over a 24-month inclusion period. Each patient will be followed for 1 year

ReferenceCitation: Mahévas M, Azzaoui I, Crickx E, Canoui-Poitrine F, Gobert D, Languille L, Limal N, Guillaud C, Croisille L, Jeljeli M, Batteux F, Baloul S, Fain O, Pirenne F, Weill JC, Reynaud CA, Godeau B, Michel M. Efficacy, safety and immunological profile of combining rituximab with belimumab for adults with persistent or chronic immune thrombocytopenia: results from a prospective phase 2b trial. Haematologica. 2021 Sep 1;106(9):2449-2457. doi: 10.3324/haematol.2020.259481.


title: Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses

summary: Nonstandard time-schedules work are widespread in the world of work. Shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. However, while health consequences of night and shift work are widely recognized and represent a major public health concern (High Authority of Health 2012 Recommendations and National Agency for Public Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system is affected by shift work remain poorly understood. Indeed most of the studies in the fields are cross-sectional, based on few blood or urinary samples in a single work position, in workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few studies have assessed melatonin secretion alterations in relation to objective sleep measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle recording.

primary_purpose: Diagnostic


title: Efficacy And Safety Of High Concentration Capsaicin Patches In Knee Osteoarthritis In Obese Patients: A Randomized Prospective Double Blind Placebo Controlled Study

acronym: CHILI-OB

summary: To assess the efficacy and safety of high concentration capsaicin patches in pain due to osteoarthritis (OA) of the knee in patients with obesity

status: Terminated

primary_purpose: Other

lead_sponsor: Nadine ATTAL

location_facility: Hospital Ambroise Paré, Nutrition Department


title: Assessments of Sarcopenia Prevalence in Chronic Heart Failure Patients and in Subjects Before Transcatheter Aortic Valve Implantation

acronym: PRESAR-HF

summary:
The main objective was to assess the prevalence of sarcopenia in chronic heart failure patients and in patients before the trans aortic valvular implantation.

The loss of muscle mass in chronic heart failure patients is a prognostic factor for sarcopenia. The purpose was to identify in these patients signs of sarcopenia for a better management.

design_allocation: Non-Randomized

ReferenceCitation: Blanquet M, Massoulié G, Boirie Y, Guiguet-Auclair C, Mulliez A, Anker S, Boiteux MD, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Rossignol P, Clerfond G, Eschalier R. Handgrip strength to screen early-onset sarcopenia in heart failure. Clin Nutr ESPEN. 2022 Aug;50:183-190. doi: 10.1016/j.clnesp.2022.05.019. Epub 2022 Jun 6.

ReferenceCitation: Eschalier R, Massoullié G, Boirie Y, Blanquet M, Mulliez A, Tartière PL, Anker S, D'Agrosa Boiteux MC, Richard R, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Stolt P, Rossignol P, Clerfond G. Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact. Clin Nutr. 2021 Jun;40(6):4490-4499. doi: 10.1016/j.clnu.2020.12.033. Epub 2021 Jan 9.

intervention_type: Diagnostic Test


title: Evaluation of the Pharmacokinetic Profile, Pharmacodynamic Effects, Acceptability and Tolerability of an Oral Amiodarone Solution of 15 mg / mL in Children With Supra Ventricular Tachycardia

acronym: Enteramio

summary:
The supra ventricular tachycardia is the most common symptomatic arrhythmia in pediatrics. Amiodarone is an antiarrhythmic drug used in this indication. Pharmacokinetic, efficacy and safety data are not known in the pediatric population due to the lack of a suitable specialty available on the market.

The development of an amiodarone oral solution formulation adapted to this age group should provide a therapeutic alternative and collect data on the pharmacokinetics, efficacy, acceptability and tolerability of the drug.

status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Biological


title: Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône

acronym: OBSTACLE

summary:
The effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. This improvement is accompanied by an increase in the number of stroke survivors. One of the major issues for these ever-increasing survivors is the prevention of recurrence. According to data from the 3 French registries, more than 20% of patients have at least one recurrence. Secondary prevention treatment has demonstrated his efficacy to prevent stroke recurrence.

This evolution justifies identifying factors associated with adherence to secondary prevention treatment, measured at 1 year post-stroke / transient ischemic attack (TIA), in patients included in the STROKE 69 cohort.

location_facility: Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche


title: Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Healthy Volunteers

acronym: MAP-VS

summary: The main objective of the studies that will be carried out on volunteer patients who have given their consent will be the development and optimization of the sequence parameters or the design of the stimulation paradigms in order to optimize the quality and Relevance of the images realized taking into account anatomical, functional or metabolic parameters. These adjustments will be carried out without interfering with the management of voluntary patients

intervention_type: Radiation


title: Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.

acronym: Equil-BPCO

summary:
The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.

The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.


title: Measure of Intracranial Pressure Variations During Migraine Attacks

acronym: MigICP

summary: An increase in intracranial pressure (ICP) during migraine attacks is possible and could contribute to pain initiation and maintenance. From now on, it was not possible to measure ICP in a non-invasive way. The development of a new tool allows non-invasive self-measures of ICP variations. Thus, it is possible for the first time to look for such ICP variations during migraine attacks and to conclude if this mechanism is implied in the pathophysiology of migraine.


title: Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home Continuous Positive Airway Pressure or At-home Non-invasive Ventilation

acronym: APARDetp

summary: The primary objective of this study is to study the effect of therapeutic education on patient adherence for at-home continuous positive airway pressure (CPAP) or at-home non-invasive ventilation. This first study will use data already present in the Association for Home Assistance and Rehabilitation (APARD) database to compare patients who received therapeutic education with a control group who did not.

lead_sponsor: University Hospital, Montpellier


title: Survey About Oral Anticoagulant Peri-procedural Management in Patients Undergoing an Oral Surgery, Implantology or Periodontology

acronym: PRADICO

summary:
Patients receiving long-term oral anticoagulant (defined as duration of treatment of at least 1 month of Direct Oral Anticoagulant (DAOC) or Vitamin K Antagonist (VKA)) and referred for an invasive procedure (oral surgery, implantology or periodontology) to an oral surgeon taking part to the study will be included in this prospective observational study.

The main composite outcome is the occurrence rate of hemorrhagic and/or thromboembolic events during the peri-procedural period (between 5 days before surgery plus 30 days after the invasive procedure).

0. The secondary end-points will consist of identifying risk factors for bleeding during the peri-procedural period, risk factors for thromboembolic events during the peri-procedural period, the peri-procedural management of each treatment (VKA or DOAC), the prescribers involved in the possible change of anticoagulant prescription prior the oral surgery All outcome events will be blindly adjudicated by a central independent adjudication committee.

ReferenceCitation: Radoï L, Hajage D, Giboin C, Maman L, Monnet-Corti V, Descroix V, Mahé I. Perioperative management of oral anticoagulated patients undergoing an oral, implant, or periodontal procedure: a survey of practices of members of two dental scientific societies, the PRADICO study. Clin Oral Investig. 2019 Dec;23(12):4311-4323. doi: 10.1007/s00784-019-02877-1. Epub 2019 Mar 19.


title: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.

acronym: HIBISCUSSTROKE

summary:
Ischemic stroke is the first cause of acquired disability of the adult, the second cause of dementia and the third cause of death in the industrialized countries, what constitutes à major public health issue. Stroke is characterized by a cerebral parenchymal lesion due to an ischemic mechanism (85% of the cases) or hemorrhagic mechanism (15%). For a long time, the only approved treatment was the intravenous thrombolysis (rt-PA). Recently, thrombectomy has proven its superiority in this pathology.

Cohorts of patients with stroke are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.

The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after ischemic stroke.

Secondary objectives of the HIBISCUS-STROKE cohort are to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:

Descriptive epidemiology of ischemic stroke and cerebral reperfusion,
Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs
Assessment of the long-term effect of the treatment on the occurrence of disability, stroke recurrence and death,
Quality of life and personal, familial, professional and social consequences of stroke,
Research of new diagnostic and prognostic biomarkers,
Research projects.

location_facility: Hôpital neurologique Pierre Wertheimer (Lyon)


title: Effects of a Dance Workshop on the Balance Abilities of Hemiparetic Patients

acronym: DanceStudio

summary: The majority of hemiparetic patients have balance disorders, which impact independence in daily living activities and walking. Conventional techniques used in rehabilitation improve balance but have shown no effects on dynamic balance required during walking. Recently dance is proposed to improve dynamic balance in older people and people with Parkinson's disease. Although many studies showed that dance is an effective activity to improve balance in these people, it has never been assessed in hemiparetic patients (except a case report). The aim of this study is to show that a dance program improves the balance of hemiparetic patients, compared to a control group. This randomized controlled study aims to include 40 hemiparetic patients who will perform a dance program (experimental group) or a upper-limb rehabilitation program (control group) for 8 one-hour sessions.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility: Raymond Poincaré Hospital- PMR Unit - Netter


title: Effectiveness of Mirror Therapy in Patients With Amputations of Lower Limbs of Vascular Origin

acronym: MIR-PHAN

summary: The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for patients with amputation after vascular etiology. the secondary aim are to measure the impact of the mirror therapy on quality of life, sleep disorders, and predictive factors for effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric. There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include 40 patients. The length of the study is 20 months.


title: Study of microRNAs in the Evolution of Carotid Plaque. Physiopathological and Therapeutic Interest

summary: Carotid stenosis of atherosclerotic origin may be responsible for stroke, which is one of the most important causes of morbidity and mortality in the Western world


title: Prevalence of Thyroid Function Abnormalities in HIV-infected Patients: State of Play in 2012

acronym: THYVI

summary: Review the evolution of thyroid function in HIV-infected patients, with sufficient follow-up.


title: Multicentric Cohort of HIV-1 (Human Immunodeficiency Virus 1) Primary Infection Cohort ANRS CO6 PRIMO

acronym: PRIMO

summary: Open, prospective, multicenter French cohort study enrolling subjects aged of 15 years or more, during or immediately after HIV-1 primary infection. This cohort was organized from the outset to be highly multidisciplinary, bringing together immunologists, virologists, clinicians and epidemiologists.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Advanced Breast Cancer and Lifestyle Exercise Study

acronym: ABLE

summary: About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.

primary_purpose: Supportive Care

ReferenceCitation: Delrieu L, Touillaud M, Pérol O, Morelle M, Martin A, Friedenreich CM, Mury P, Dufresne A, Bachelot T, Heudel PE, Fervers B, Trédan O, Pialoux V. Impact of Physical Activity on Oxidative Stress Markers in Patients with Metastatic Breast Cancer. Oxid Med Cell Longev. 2021 Jul 16;2021:6694594. doi: 10.1155/2021/6694594. eCollection 2021.

ReferenceCitation: Delrieu L, Pialoux V, Pérol O, Morelle M, Martin A, Friedenreich C, Febvey-Combes O, Pérol D, Belladame E, Clémençon M, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Touillaud M, Trédan O, Fervers B. Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study. JMIR Mhealth Uhealth. 2020 Jan 28;8(1):e12306. doi: 10.2196/12306.

ReferenceCitation: Delrieu L, Vallance JK, Morelle M, Fervers B, Pialoux V, Friedenreich C, Dufresne A, Bachelot T, Heudel PE, Trédan O, Pérol O, Touillaud M. Physical activity preferences before and after participation in a 6-month physical activity intervention among women with metastatic breast cancer. Eur J Cancer Care (Engl). 2020 Jan;29(1):e13169. doi: 10.1111/ecc.13169. Epub 2019 Sep 30.

ReferenceCitation: Delrieu L, Pérol O, Fervers B, Friedenreich C, Vallance J, Febvey-Combes O, Pérol D, Canada B, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Trédan O, Touillaud M, Pialoux V. A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2018 Aug 30;7(8):e10487. doi: 10.2196/10487.

lead_sponsor: Centre Leon Berard


title: BetaLACTA® Test-guided Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections Diagnosed in Intensive Care Unit - BLUE¬-CarbA Study

acronym: BLUE-CarbA

summary:
The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably intensivists, to prescribe more carbapenems, particularly in the most fragile patients such as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of carbapenem resistance mechanisms. Moreover, several preliminary results suggest that carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of carbapenem exposure is widely desired both by national and international antibiotic plans. Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce inappropriate exposure to carbapenems could be a relevant solution. Due to its good diagnostic performance, the betaLACTA® test could meet these objectives.

Experimental plan :

Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic medical device (close to a phase III study), comparing two parallel groups:

Experimental group: early carbapenems de-escalation since the second dose, guided by results of the betaLACTA® test performed directly on the bacterial pellet from the microbiological sample positive on direct examination.
Control group: carbapenems de-escalation guided by definitive results of the antibiotic susceptibility test obtained 48 to 72h after microbiological sampling (reference strategy).

ReferenceCitation: Garnier M, Gallah S, Vimont S, Benzerara Y, Labbe V, Constant AL, Siami S, Guerot E, Compain F, Mainardi JL, Montil M, Quesnel C; BLUE-CarbA study group. Multicentre randomised controlled trial to investigate usefulness of the rapid diagnostic βLACTA test performed directly on bacterial cell pellets from respiratory, urinary or blood samples for the early de-escalation of carbapenems in septic intensive care unit patients: the BLUE-CarbA protocol. BMJ Open. 2019 Feb 19;9(2):e024561. doi: 10.1136/bmjopen-2018-024561.

location_facility: Anesthesiology and Critical Care Medicine Department


title: Search for Restenosis Markers in Lower Limb Arteritis

acronym: FEMIA

summary:
The initial hypothesis of this work is that the genesis and the evolution of the atheromatous plaque are partly controlled at the molecular level and in particular by the microRNAs through their role as regulator of the genes.

The study of the tissue and serum profile over time of specific microRNAs involved in the regulation of atheromatous plaque correlated with clinical data and restenosis imaging will allow to define biological markers of restenosis in the patient with an arteritis of the lower limbs .

This study is a pioneer in the field and it would be imprudent to conclude that a biomarker would be used clinically at the end of this work alone. Nevertheless this study will make a major advance in this topic, in vivo intervention studies with inhibition or over-expression of microRNA will obviously be necessary to confirm the use of these as biomarkers of arteritis of the lower limbs.

Regular assay of reliable biomarkers in arterial patients will ultimately suggest early management to best adapt surgical and medical treatment.


title: Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease

acronym: NoISE-PD

summary: Impulse control disorders encountered in Parkinson's disease (PD) are induced by dopaminergic medications and their frequency is estimated to be nearly 20%, mainly under dopaminergic agonists (AD).


title: Diagnosis Accuracy of Abdominal Compression and Hemoconcentration to Detect Diuretic Induced Fluid Removal Intolerance.

summary: Fluid overload increases morbidity and mortality of pediatrics patients in intensive care unit (ICU). It could be interesting to predict the decrease in stroke volume when diuretics are prescribed. Nevertheless, no test predict a decrease of stroke volume in a context of a diuretics induced depletion. Abdominal compression (AC) coupled with echocardiographic measurement of the stroke volume can predict fluid responsiveness and is a good tool to assess preload dependency. Another point is that during depletion refilling can occur. We aim to assess the diagnostic accuracy of abdominal compression to predict a decrease of the stroke volume of 15 % during diuretic-induced depletion of 10 ml/kg of diuresis. Secondary outcome will assess the hemoconcentration during depletion to diagnose a decrease of stroke volume during diuretic induced depletion

ReferenceType: result

ReferenceCitation: Foland JA, Fortenberry JD, Warshaw BL, Pettignano R, Merritt RK, Heard ML, Rogers K, Reid C, Tanner AJ, Easley KA. Fluid overload before continuous hemofiltration and survival in critically ill children: a retrospective analysis. Crit Care Med. 2004 Aug;32(8):1771-6.

ReferenceCitation: Sinitsky L, Walls D, Nadel S, Inwald DP. Fluid overload at 48 hours is associated with respiratory morbidity but not mortality in a general PICU: retrospective cohort study. Pediatr Crit Care Med. 2015 Mar;16(3):205-9. doi: 10.1097/PCC.0000000000000318.

ReferenceCitation: Li Y, Wang J, Bai Z, Chen J, Wang X, Pan J, Li X, Feng X. Early fluid overload is associated with acute kidney injury and PICU mortality in critically ill children. Eur J Pediatr. 2016 Jan;175(1):39-48. doi: 10.1007/s00431-015-2592-7. Epub 2015 Jul 24.

ReferenceCitation: Monnet X, Cipriani F, Camous L, Sentenac P, Dres M, Krastinova E, Anguel N, Richard C, Teboul JL. The passive leg raising test to guide fluid removal in critically ill patients. Ann Intensive Care. 2016 Dec;6(1):46. doi: 10.1186/s13613-016-0149-1. Epub 2016 May 20.

lead_sponsor: Hopital Louis Pradel


title: Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

summary:
Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial thromboembolic events. The incidence of symptomatic venous thromboembolic events is particularly high in myeloma, linked to the usual risk factors for venous thromboembolic disease, biological risk factors specific to myeloma, and especially to its treatments.

The prevalence of asymptomatic venous thromboembolic events and arterial events are not known to date and remain important data for planning a possible randomized study to determine the most suitable thromboprophylaxis in these patients.


title: Objective Markers of Pain Perception in Pediatric Emergency

acronym: TAMALOU

summary: Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief rests on the oral communication of the young patient, who does not always able to it (difficult to verbalize, fear of the hospital, problem mental development ...). There is no way in which pain can be apprehended objectively, immediately and effectively. To advance our knowledge of this problem, several approaches have been studied as from functional magnetic resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters. However, all these approaches have their limitations: although fMRI presents interesting performances, it allows only a retrospective analysis, and cannot adapt to the clinical context of the young patient for example. EEG-based approaches and autonomic parameters show interesting results but suffer from perfectible sensitivity to muscle activation for EEG whereas the vegetative parameters to stress. In this context, our working hypothesis considers that the search for markers of painful perception must be based on a neurophysiological approach, based on the combined analysis of the EEG and autonomic responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic (cardiovascular, skin, pupillary) responses induced by sutures in children who can communicate their pain according to whether they cause pain or not.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prospective, Randomized, Cross-over, Multicenter, Trial Comparing the Efficacy and Tolerability of Nasal Irrigation With Respimer® Netiflow® Mineral Salts Solution Versus Saline Among Patients With Cystic Fibrosis and Suffering From Chronic Rhinosinusitis

acronym: Respire

summary: Prospective, randomized, cross-over, multicenter, trial comparing the efficacy and tolerability of nasal irrigation with Respimer® mineral salts solution versus saline solution both administered with Respimer® Netiflow® medical device among patients aged ≥ 11 years and older with cystic fibrosis and suffering from chronic rhinosinusitis.

lead_sponsor: Laboratoire de la Mer

location_facility: ORL et Chirurgie Cervico-faciale Centre Hospitalier Intercommunal (CHI) de Créteil


title: Arterial Catheterization by Ultrasound: Impact on Success Rates and Complications in Patients Hospitalized in Resuscitation

acronym: ACTIVE

summary: Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended

ReferenceCitation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10:CD013585. doi: 10.1002/14651858.CD013585.pub2. Review.


title: Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy

acronym: SPECTROBEVA

summary:
No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment.

These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients


title: Behavior of Various Galenic Forms of a Probiotic in the Digestive Tract

acronym: PROBIOSIN

summary:
The aim of this study is to assess the behavior of a model probiotic strain, Lactobacillus salivarius, in the digestive tract of healthy volunteers and of ileostomized patients, depending on its galenic form.

Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested.


title: Evaluation of 4 MRI Methods (PDFF 3, 6 and 11 Gradient Echoes and Spectroscopy) Compared to the Reference Method (Liver Biopsy) in Quantification of Hepatic Steatosis

acronym: STEA-MRI

summary: Evaluation of 4 MRI methods (PDFF 3, 6 and 11 gradient echoes and Spectroscopy) compared to the reference method (liver biopsy) in quantification of hepatic steatosis


title: Hypermetabolism in the Elderly Lung Cancer Patient

acronym: HELP

summary: Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer.

time_perspective: Cross-Sectional

ReferenceCitation: Ulmann G, Jouinot A, Tlemsani C, Curis E, Kousignian I, Neveux N, Durand JP, Goldwasser F, Cynober L, De Bandt JP. Lean Body Mass and Endocrine Status But Not Age Are Determinants of Resting Energy Expenditure in Patients with Non-Small Cell Lung Cancer. Ann Nutr Metab. 2019;75(4):223-230. doi: 10.1159/000504874. Epub 2019 Dec 19.

lead_sponsor: University of Paris 5 - Rene Descartes


title: Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation

summary: Intraabdominal fungal infections with Candida are constantly increasing. Their diagnosis and treatment is difficult. Morbidity and mortality are high. Β-D-Glucan has been proposed as a marker of systemic fungal infection in candidemia. Moreover, its kinetics is associated with therapeutic success. On the other hand, there are no data on intraabdominal infections that are much more frequent. The objective of the study is to evaluate the initial levels of β-D-glucan and its daily kinetics during the treatment of fungal peritonitis in resuscitation compared to a control group with a yeast-free peritonitis.

primary_purpose: Screening


title: Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis

acronym: VOPRABIO

summary: Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. The purpose of this study is to find a link between arterial stiffness and degenerative aortic stenosis. If this link is established, arterial stiffness may become a medical therapeutic target in order to delay the evolution of the disease.


title: SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis

acronym: SARCOLOWDOSE

summary: The goal of this study is to evaluate the diagnostic agreement between, on the one hand, ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan, to quantify lung parenchyma patterns in thoracic sarcoidosis.

lead_sponsor: Rennes University Hospital


title: Evaluation of the Emergence of the Resistance to Linezolid in Staphylococcus Epidermidis and Risk Factors Analysis : a Mono-centric Case-control Study

acronym: ELiCSIR

summary:
Understanding the emergence of linezolid-resistance in Staphylococci has been allowed in the past years through the discovery of the clonal dissemination of a chromosomal cassette carrying a modified crf gene. New mutations have even been described. Though, clinical evidences are still lacking, especially concerning the factors associated to this emergence. It could seriously become quite problematic to eliminate one of the last therapeutic weapon at our disposal for the treatment of severe or complicated infections caused by resistant strains of Staphylococci and Enterococci.

We aim to describe the mechanisms that permitted to this resistance to become clinically significant, concerning meticillin-resistant Staphyloccocus epidermidis strains causing blood stream infections in ICU patients, and show the clinical risk factors associated with it through a case-control study on patients hospitalized in two ICUs of our hospital between 2011 and 2016.

time_perspective: Other

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib.

acronym: HCC-CTPerf

summary:
Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response should be performed with mRECIST criteria that are significantly better correlated with survival. These criteria take into account the tumor size and also the modification of the tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate tumor control rather than tumor response since sorafenib is more stable than tumor response.

This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months. The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected patients, and with undesirable effects and a significant cost. Predictive biological criteria have already been studied, such as alpha foeto-protein (AFP), whose early decrease with sorafenib is associated with better overall survival. The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 1.1 criteria. The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs. On the other hand, an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival.

Therefore, the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC.


title: Impact of a Feedback Device, CPRmeter®, on Chest Compression Quality Preservation During Cardio-pulmonary Resuscitation: A Manikin Study

acronym: CILICA-QS

summary:
Context: Chest compressions quality is known to be essential in cardiopulmonary resuscitation. Despite a known harmful effect of chest compressions interruptions, current guidelines still recommend provider switch every 2 minutes. Feedback impact on chest compressions quality preservation during cardiopulmonary resuscitation remains to be assessed.

Study design: simulated prospective monocentric randomized crossover trial.

Participants and methods: Sixty five professionals rescuers of the pre-hospital care unit of University Hospital of Caen (doctors, nurses and ambulance drivers) are enrolled to performed continuous chest compression on manikin (ResusciAnne®, Laerdal), twice, with and without a feedback device (CPRmeter®). Correct compression score (the main criterion) is defined by reached target of rate, depth and leaning at the same time (recorded continuously).

Hypothesis: Feedback device preserve chest compression quality above the 2 minutes recommended switch over during cardiopulmonary resuscitation.

lead_sponsor: University Hospital, Caen


title: Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children.

acronym: DIABSPORT

summary: The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand


title: Connectivity and Social Cognition in Adolescent Girls With Borderline Personality Disorder, a Pilot Study

acronym: EEG-NIRS

summary: The disruption of social cognition associated with borderline personality disorder (BPD), and more specifically categorization of facial emotions, remains largely under-studied, despite the high frequency of this pathology in the clinical population. The first results differ from the observations made in adults and this confirms the relevance of studying this theme specifically in adolescence. On the cognitive level, there is a disturbance of the detection and the categorization of the facial emotions in the TPL. The characteristics of this disturbance and its possible association with an attack on the connectivity of the brain remain unknown in adolescence. No functional imaging studies are published in adolescent TPL. This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and feasibility data to support a response to upcoming PHRC competitions and eventually offer a science thesis opportunity.


title: Prospective Follow-up of a Cohort of Patients With Aortic Valve Bicuspidia: Multicentre Study

summary: The aortic valve bicuspidia (BVA) is a congenital condition corresponding to the presence of 2 sigmoids instead of 3. This is the most common cardiac congenital anomaly affecting 0.5 to 2% of the population The general rule. BVA may be associated with structural damage to the ascending aorta, which exposes BVA patients to a risk of developing ascending aortic aneurysm and acute aortic accidents. Recent data from the literature have revealed that the natural history of BVA is marked by a possible development towards significant valvulopathy and / or an ascending aortic aneurysm often requiring surgical treatment. However, the natural history of bicuspid disease remains poorly understood and the prognostic factors for progression to severe valvulopathy and / or aneurysmal dilatation of the ascending aorta remain to be determined.


title: Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy

acronym: PRELOAD-CRRT

summary:
Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. New diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.

The aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in Intensive Care Unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de réanimation médicale- Hôpital de la Croix-Rousse


title: Prevalence of Liver Fibrosis and Cirrhosis in Patients With Squamous Cell Carcinoma of the Head and Neck

acronym: fibr'HOM

summary: Tobacco and alcohol are the two major risk factors for upper respiratory tract cancer (VADS).


title: Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics

acronym: VeinGER

summary: Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. There is little data from the literature that highlights the difficulties of venipuncture in the context of old age. New venous visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV) have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV) route.


title: Place of Endoscopic Rectal Ultrasound With Elastosonography and Contrast in Diagnosis and Supported of Deep Pelvic Endometriosis With Bowel Involvement

summary: The aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (Sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.

lead_sponsor: Société Française d'Endoscopie Digestive


title: The Potential Impact of Aging Stereotypes in the Assessment of Memory Deficits and Screening for Prodromal State of Alzheimer's Disease

acronym: AGING

summary: Because of the lengthening of life expectancy, more and more people are concerned with the effects of aging on their mental faculties (e.g., memory decline) and with the possibility of getting Alzheimer's Disease (AD) or other forms of dementia. This increasing awareness of AD has already resulted in a growing demand for neuropsychological testing. AD's research also emphasizes the need for early screening to improve the prediction of the disease progression and the efficacy of any future therapy. Such a drive to screen for pre-dementia raises the challenging issue of frontline identification of individuals in the preclinical or early clinical stages of AD. Mild Cognitive Impairment (MCI) is typically considered to be the prodromal state of AD, and is therefore at the core of the drive for early screening. Moreover, Pre-MCI so called SCI (Subjective Cognitive Impairment) can precede AD for 15 years. However, many individuals diagnosed with MCI do not convert to AD, some remaining stable and others even reversing back to normal (with rates of reversion to normal varying from 4.5% to as high as 53%). This over-diagnosis bias, which has been largely overlooked, is at the core of the present project at the interface of human and life sciences. Here, we argue that an important source of overdiagnosis in the prodromal state of AD comes from negative aging stereotypes (e.g., the culturally shared beliefs that aging inescapably causes severe cognitive decline and diseases such as AD) that permeate neuropsychological screening. There is ample evidence in the laboratory that such stereotypes contribute to the differences observed in the healthy population between younger and older adults in explicit memory tasks. Additionally, three pilot (lab) studies specifically conducted for the present ANR project showed that the threat of being judged stereotypically undermines the controlled use of memory of healthy older adults and simultaneously intensifies their automatic response tendencies, resulting in impaired memory performance. The present proposal goes several steps further by examining for the first time whether aging stereotypes are powerful enough to implicitly permeate the clinical neuropsychological testing and thus inflate memory deficits in older adults judged "at risk" (based on either epidemiological criteria or memory complaints), resulting in false-positive detection of SCI and MCI. This provocative hypothesis will be tested while 1) using biomarkers of neurodegeneration to distinguish false-positives from true MCI, and 2) using biomarkers of stress to examine whether and how aging stereotypes can lead to acute physiological stress during neuropsychological testing. This innovative project has the potential to offer new recommendations to improve the diagnosis accuracy of prodromal state of AD, with positive consequences for older people's wellbeing.

ReferenceCitation: Gauthier K, Morand A, Dutheil F, Alescio-Lautier B, Boucraut J, Clarys D, Eustache F, Girard N, Guedj E, Mazerolle M, Paccalin M, de la Sayette V, Zaréa A, Huguet P, Michel BF, Desgranges B; AGING consortium, Régner I. Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study. BMJ Open. 2019 Oct 7;9(10):e032265. doi: 10.1136/bmjopen-2019-032265.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Optimizing Access to Care Through New Technologies: a Randomized Study Evaluating the Impact of Telephone Contact and the Sending by the General Practitioner of Suspicious Lesions Melanoma Photographs Taken With a Smartphone, on the Time Limit to the Consultation With a Dermatologist

acronym: OASE Melanome

summary:
Early detection of melanoma showed an impact on the thickness of the lesions at the time of diagnosis. One challenge is to improve the modalities.

Decrease the rate of non-compliant patients among patients referred to the dermatologist for a suspicious lesion (patients who will never go to the consultation), and reduce the time interval between the first identification of the lesion and the excision allowing the diagnosis are major issues.

Direct contact between the general practitioner (GP) and the dermatologist would probably make it possible to shorten the care pathway of patients with lesions justifying excision.

The objective is to evaluate whether contacting the dermatologist directly by telephone and e-mailing the photograph of a suspicious melanoma lesion can significantly reduce the time required for access to the consultation for the following patients: (a) referred for a suspicious lesion of melanoma by the GP (b) and having a sufficiently suspicious lesion of melanoma so that the dermatologist conclude at the need for excision (true positives).

Expected results: The procedure should shorten the care pathway for patients with melanoma and decrease the proportion of patients who do not consult the dermatologist when they were referred ("non-observing patients").

This should facilitate the identification of thinner lesions. The benefit for the patient is then direct with a survival at 5 years higher.

In public health terms, it is expected a benefit as better optimization of resources. In a situation of shortage of professionals, access to the dermatologist should be optimized by optimizing emergency access for patients who require it.

lead_sponsor: Nantes University Hospital


title: Characterization of Proteins and Forms of Albumin Removal Capacities of the Theranova Membrane by Innovating Proteomic Investigations

acronym: DIALOMIC

summary:
Hemodialysis is the major technique of renal suppleance and membrane improvements allow an efficient depuration. During the past fifty years, improving the architecture of the membranes increased constantly the clearance of uremic toxins. Online-hemodiafiltration allowed a potential interest for decreasing morbi-mortality, but this technique is not available in all hemodialysis centers yet. Theranova membrane, by its innovating architecture, could be a valuable option for the enhancement of toxin removal in patients who are not eligible for online-hemodiafiltration techniques. Interestingly, many works pointed adsorptive capacities of dialysis membranes and these observations suggest that adsorption cannot be considered as an epiphenomenon. However, there is a lack of knowledge about the extent of its benefits in hemodialysis. The efficiency of a session of hemodialysis is routinely based on the clearance of only few generic toxins (urea, ß2-microglobulin, myoglobin). The eKT/V formula permitted to link a good depuration of urea with a better survival. EuTox described in a recent review, a large panel of middle molecules considered as uremic toxins. As there are many involved toxins, modern evaluation of hemodialysis efficiency can't be still based on the only description of ß2-microglobulin and urea removals. Inflammation status is routinely measured with blood levels of CRP. However, its accumulation is not leading to a toxicity. Many others inflammatory markers have been linked with morbidity and atherosclerosis, the main cause of mortality in ESRD patients. Obviously, removal of inflammatory markers by different dialyzers needs to be assess concomitantly but single conventional dosages are time-consuming.

A minimal albumin loss is considered as another important factor for a safe hemodialysis. Due to its multiple biological functions, albumin may be one of the most important protein for the maintenance of body homeostasis. Recent works were interested in the potential toxicity of some isoforms of the albumin and especially in chronic kidney disease. Modified forms of albumin have been linked with toxic properties and the removal of modified forms could be beneficial. Furthermore, albumin oxidation can lead to an under-estimation of albumin levels with the routinely used assay. A modern evaluation of the capacities of depuration of dialyzers clearly needs to integrate the evaluation of the clearance and generation of modified forms of albumin and proteins.

Proteomic techniques allow an interesting non-selective integrative approach. This exhaustive view would be particularly adequate for building a snapshot of blood uremic toxins, permeative and adsorptive capacities of each membrane. Due to a high sensitiveness, proteomic techniques can improve dramatically the characterization of the depuration capacities of different hemodialysis membranes considering a large range of uremic toxins especially with middle molecular weight, a large panel of inflammatory markers and modified forms of albumin. Furthermore, proteomic approach can help to build a quasi-exhaustive description of all the proteins removed by a membrane.

This project aims to compare the removal capacities of each membrane on a large range of proteins and forms of albumin (native and modified) with a highly-sensitive LC-MS/MS proteomic approach. We will also build the complete proteome of depuration of each tested membrane.

location_facility: Service de Néphrologie -Hypertension - Hémodialyse, Hôpital Edouard Herriot


title: New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

acronym: SkinTher

summary:
The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1) is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib).

Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. There are currently no predictive biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. The cutaneous metastases are chosen in the model because of easy access to collect tumor tissue.

The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells

summary:
Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem cell transplantation (HSC), and is responsible for significant early mortality despite prophylactic strategies developed in recent decades, Especially since it is resistant to first-line treatment.

The present diagnosis is difficult, non-specific and is based on the combination of an evocative clinical context (CSH allograft, time to appearance before J100, characteristic clinical manifestations), suggestive anatomo-pathological analysis (predominantly inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the exclusion of any differential diagnosis (in particular serology / negative viral PCR).

However, to date there is no molecular characterization of this manifestation, and therefore no specific treatment.

The nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous expression of a group of genes (up to 800 on the same sample), from a very small amount of RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and included in paraffin. It allows the detection of a "molecular signature" of the tissue analyzed.

No transcriptomic analysis has ever been performed on human tissues with GVHD.


title: Prospective Study With Biological Assessment: Evolution of Coagulation Activity in Non Valvular Atrial Fibrillation Patients Under Apixaban

acronym: ECAN

summary: Apixaban is a potent, oral, selective reversible direct inhibitor of factor Xa with a favorable efficacy and safety profile in the prevention of non valvular (NV) atrial fibrillation (AF). It has been shown, including by our group, that D-dimers levels (molecular marker of coagulation activity) are predictive of the events (including mortality) in patient with AF independently of the antithrombotic treatment. The aim of the study is to evaluate the changes in plasma levels of biomarkers of coagulation activation: D-dimers, prothrombin fragments F1+2, von Willebrand factor (vWF) and thrombin-antithrombin complexes (TAT) in response to apixaban treatment in patients with NVAF.

lead_sponsor: Hopital Lariboisière

location_facility: Department of Cardiology Lariboisiere Hospital


title: IMMUNOCANDIDA Candida Host Defense Response After Septic Shock in the Critically Ill

acronym: IMMUNOCANDIDA

summary: Septic shock is associated with acquired immunoparalysis which is associated with a high risk of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of mortality but is difficult to diagnose. The use of colonization indexes and risk factors on the other hand expose to unnecessary use of antifungals. The aim of the present study is to evaluate whether the host response to infection associated with candida biomarkers would help to anticipate the candidiasis onset.

lead_sponsor: University Hospital, Montpellier


title: Retrospective Analysis of Lymphomas and Cancers Synchronous Occurrence in Picardy From 2007 to 2012

acronym: LYMPHOSYNCHRO

summary:
Cancer is the leading cause of death in man and the second leading cause in women with 85,000 and 63,000 deaths, respectively, in 2012. A working group led by Holly L. Howe, PhD, in 2002 defined primary neoplasia Such as the occurrence and diagnosis of two or more independent neoplasms of different histology in the same patient. The occurrence of a new cancer has become more frequent in recent years: the prevalence of multiple primary neoplasia (NPM) is estimated between 0.73% and 11.7%. According to the French data, the risk of second cancer in people who have already had a first cancer is increased by 36% compared to the general population. Several studies have reported an increase in the risk of cancer after treatment of lymphoma but there are currently no studies on the occurrence of lymphoma and cancer of synchronous occurrence.

In our department, 19 patients presented cancer and lymphoma synchronously, that is to say 6 months between 2007 and 2012.

The main objective is to show that there is an increase in the incidence of cancers in patients diagnosed for lymphoma synchronously. Secondary objectives are to describe the clinical and biological characteristics of the patients concerned and to formulate hypotheses on the physiopathological mechanisms involved: peri-tumoral B-cell lymphoproliferation, alteration of the immune system or rearrangement of the BCR.

In a second step, the investigator could propose a multicenter epidemiological study using data from the different Cancer Registries. If results are confirmed in a larger cohort, recommendations could be made.


title: Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia

acronym: HYPER-III

summary:
Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of consultation in ophthalmology.

It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In the usual clinical practice, the investigators noticed in several patients unusual areas of high-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the investigators, has never been reported in the literature and could confirm the nerve impairment.

In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be systematically included in the usual MRI protocol.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation

summary:
Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach.

To date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.

Two recent studies have demonstrated a sustained improvement in endothelial function with TAVI. On the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (CEC) could be the result of the interaction between pre-existing endothelial dysfunction And the "operative" aggression associated with the CEC.

Thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to CEC. This phenomenon would not exist in TAVI, and would explain the absence of so-called vascular dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).


title: Evaluation of Adherence to Guidelines, and of the Risk to Benefit Ratio, in the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases. Study on the French National PMSI Database

acronym: EVASION

summary: : Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes [1]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of the Contribution of the Ultrasound Tracking and the Positioning of the Distal End During the Implantation of Implantable Chamber or Long-lasting Venous Catheter

acronym: EchoPAC

summary:
Given the increase in the number of PAC implants or long-term catheters, and the ease of access to cardiac ultrasound in the operating theaters, the investigator thought to use ultrasound to PAC or long-term catheters.

The investigator considers cardiac echocardiography through its costal pathway to locate the correct positioning of the distal end of the catheter in a manner equivalent to the scopic locating with all the side effects of the irradiation and with Equivalent efficiency


title: Aortitis and Retroperitoneal Fibrosis: Evaluation of Diagnostic Criteria

summary:
Inflammatory aortitis probably represents a heterogeneous group, and the clinical experience accumulated over the last ten years, shared by the experts of the subject, is that the initial clinical, biological or radiological characteristics should make it possible to differentiate them and dismember the Nosological field.

This will be an essential first step before studying prognosis, risk factors, and therapeutic options.

The search for diagnostic criteria on a large series, similar to the study of classification of vascularites of the ACR in 1990, should make it possible to homogenize the diagnoses for the different teams working on the subject, and to begin work Collaborations, which alone can improve patient care in the future.


title: Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia

summary:
Dysfunctional chronic diffuse pain syndrome, concerning 2% of the French population, Fibromyalgia (FM) is classified either as a psychological disease or as a somatic disease. This dichotomous reasoning does not lead to a better understanding and does not allow the use or development of new psychological tools of care.

The issue of the proximity between FM and depression highlighted by some authors and the presence of anxious comorbidities may arise at a different level, that of the transdiagnostic approach. Rumination is one of these transdiagnostic processes that are the subject of recent studies and one of the dimensions of which (abstract analytical rumination) is at work in depression and a number of psychopathologies. The investigator therefore wishes to explore the process of rumination and its abstract analytical dimension in FM and to explore its link with the depressive and anxious manifestations frequently associated with this disorder.


title: Deficits, Adaptation and Cerebral Functional Reorganization of Visual Retinotopic Treatments During Normal and Pathological Aging (Age-related Macular Degeneration and Glaucoma)

acronym: VISIOPERICENT

summary: The main objective of this research is to study the cognitive and cerebral mechanisms of the integration of central and peripheral visual information during normal and pathological aging (ophthalmological patients with AMD and glaucoma) through fMRI studies. To assess the effect of normal aging, research will be conducted on a group of young participants with normal vision and a group of elderly participants with normal vision. Each participant will be assessed once during an MRI (during which the brain activity and behavioral performance will be measured). In order to evaluate the effect of pathological aging, research will be conducted on AMD patients, glaucomatous patients, and age-matched controls (normal vision), evaluated only once during an MRI examination.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinique Ophtalmologique Universitaire de Grenoble


title: Attitudes and Feelings of Doctors Caring for Their Colleagues: a Qualitative Study in Picardy

acronym: ATTRESMED

summary: The sick doctor is a patient apart. His right of prescription and his knowledge of semiology easily lead him to self-medication.


title: Evolution of Indications for Transbronchial Ganglionic Ultrasound in the Picardie Region Over the Period 2008 - 2013

acronym: EBUSPicardie

summary: New indications for bronchial echo-endoscopies with transbronchial needle aspiration (EBUS-PTBA) have appeared since the first French centers with this technique were fitted. Evaluate the respective share of each indication of EBUS-AWPB over time over the period 2008 - 2013


title: Predictive Diagnostic Criteria for Diagnosis of Transbronchial Biopsies, Echo-guided by Mini-probe in Peripheral Lung Lesions

acronym: EBUS-R-PTB

summary:
The diagnosis of nodules and peripheral lung masses (lesions not accessible in classical bronchial endoscopy) is a challenge for the pulmonologist especially when these lesions are not accessible to the transparietal aspirate under scanner. The overall sensitivity of flexible fibroscopy for peripheral lesions is 69% (bronchial brushing, transbronchial biopsies, bronchoalveolar lavage and blind trans-mucosal aspiration). This sensitivity varies from 33% when the lesion is less than 2 cm, to 62% when it is greater than 2 cm. The puncture under scan of these lesions remains the gold standard. In the meta-analysis of Schreiber G et al., The diagnostic sensitivity of transparietal aspirate for peripheral lung lesions is 90%. On the other hand, the complication rate of this technique is not negligible, with in the study of Boskovic et al, a pneumothorax rate varying from 8 to 64%. In the literature, the only risk factor actually found is the existence of emphysema. However, thoracic drainage is rarely necessary.

Bronchial echo-endoscopy using a radial mini-probe was developed in 1992 by Thomas Hürter and Peter Hanrath to produce ultrasound guided specimens of these peripheral lung lesions. In the meta-analysis of Steinfort et al., The overall sensitivity of this mini-probe technique is 73% for the histological diagnosis. From the same author, a randomized trial compared the diagnostic sensitivity of transparietal aspirate undergoing ultrasound-guided transbronchial biopsy with a radial mini-probe: this was 93.3% versus 87.5% with no significant difference (p = 1 ), Whereas post-procedure complications are less frequent in the ultrasound procedure (27% versus 3%, p = 0.03). Steinfort also showed that the economic cost of bronchial echo-endoscopy by radial mini-probe and transthoracic puncture under CT was similar both to the success or failure of the first procedure requiring further investigations . Mini-probe-guided specimens are therefore an efficient diagnostic alternative to obtain a histological diagnosis of these peripheral lung lesions


title: Influence of the Operative Day on the Average Duration of Stay in Primary Hip and Knee Replacements

acronym: JourOpDMS

summary: Reducing the length of stay (LOS) after primary arthroplasty is a relatively new target that arouses the attention of orthopedic surgeons in order to return home early through the fast recovery protocols but this goal is also wanted in public health for the sake of overall decline health spending in public costs.


title: Impact of the Assumption in Charge of Medical Aid to the Procreation With Donation of Gametes on the Sexuality of the Couple

acronym: SEXODON

summary: Sexual disorders associated with medical aid for procreation have already been demonstrated in several studies. However, few of them are interested in the problem of patients in charge of donating gametes, and if studied, it is often restricted to donating sperm to a small number of patients. For this reason, it would be interesting to study the impact of the intake and in charge and the treatments of the Medical Aid to the Procreation on this population of patients (including the patients treated in donation of sperm but also Those supported in oocyte donation)


title: Interest of MRI in Preoperative Staging for the Laryngeal and Hypopharyngeal Cancer

acronym: Larynx MRI

summary: To determine if MRI can detect preoperative invasion of cartilage by laryngeal and hypopharyngeal carcinoma, and to compare it to CT imaging and histopathology in excised larynges and/or hypopharynges.

location_facility: Service ORL et chirurgie cervico-faciale, Hôpital de la Croix rousse


title: Neurophysiological Correlates of Sleep Motor Consolidation Following Motor Imagery Practice

summary: This study is designed to determine the neural networks underlying the sleep-related motor consolidation process following motor imagery practice. While beneficial effects of sleep are expected for sequential movement but not for adaptation motor tasks, the corresponding neuroanatomical correlates have not yet been investigated when participants acquired the motor tasks through mental practice. Data should substantially promote how designing motor imagery interventions targeting (re)learning and/or motor recovery in patients suffering from motor disorders.


title: Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults

acronym: COGFRAIL

summary: The current study seeks to examine the prevalence of amyloid pathology, among patients referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We also aim to fully characterize the clinical progression of frail cognitively impaired patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive impairment but do not have AD pathology.

ReferenceCitation: Robertson DA, Savva GM, Kenny RA. Frailty and cognitive impairment--a review of the evidence and causal mechanisms. Ageing Res Rev. 2013 Sep;12(4):840-51. doi: 10.1016/j.arr.2013.06.004. Epub 2013 Jul 4. Review.

ReferenceCitation: Panza F, Solfrizzi V, Barulli MR, Santamato A, Seripa D, Pilotto A, Logroscino G. Cognitive Frailty: A Systematic Review of Epidemiological and Neurobiological Evidence of an Age-Related Clinical Condition. Rejuvenation Res. 2015 Oct;18(5):389-412. doi: 10.1089/rej.2014.1637. Epub 2015 Aug 20. Review.

ReferenceCitation: Kojima G, Taniguchi Y, Iliffe S, Walters K. Frailty as a Predictor of Alzheimer Disease, Vascular Dementia, and All Dementia Among Community-Dwelling Older People: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Oct 1;17(10):881-8. doi: 10.1016/j.jamda.2016.05.013. Epub 2016 Jun 17. Review.

ReferenceCitation: Buchman AS, Schneider JA, Leurgans S, Bennett DA. Physical frailty in older persons is associated with Alzheimer disease pathology. Neurology. 2008 Aug 12;71(7):499-504. doi: 10.1212/01.wnl.0000324864.81179.6a.

ReferenceCitation: Buchman AS, Yu L, Wilson RS, Schneider JA, Bennett DA. Association of brain pathology with the progression of frailty in older adults. Neurology. 2013 May 28;80(22):2055-61. doi: 10.1212/WNL.0b013e318294b462. Epub 2013 May 1.

ReferenceCitation: Tavassoli N, Guyonnet S, Abellan Van Kan G, Sourdet S, Krams T, Soto ME, Subra J, Chicoulaa B, Ghisolfi A, Balardy L, Cestac P, Rolland Y, Andrieu S, Nourhashemi F, Oustric S, Cesari M, Vellas B; Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability Team. Description of 1,108 older patients referred by their physician to the "Geriatric Frailty Clinic (G.F.C) for Assessment of Frailty and Prevention of Disability" at the gerontopole. J Nutr Health Aging. 2014 May;18(5):457-64. doi: 10.1007/s12603-014-0462-z.

lead_sponsor: University Hospital, Toulouse

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: Study of Gesture and Executive Functions in Children With High Intellectual Potential

acronym: MOHPI

summary: The main objective of this study is to determine whether children with high intellectual potential have gestural and / or executive difficulties compared to control children.

lead_sponsor: University Hospital, Brest


title: High Intensity Focused Ultrasound Guided by MRI as Thermic Destruction in Primitive Small Size Breast Cancer. Phase II Pilot Study : Effectiveness and Procedures Standardization

acronym: MRHEATBREAST

summary: This is a non-randomized, prospective phase II trial evaluating an innovative treatment, focused MRI-guided ultrasound, as thermic destruction in primitive small size breast cancer.

lead_sponsor: Centre Antoine Lacassagne


title: Assessment of Efficacy, Tolerance and Acceptability of Urgo 310 3166 Dressing in the Treatment of Local Venous or Mixed Leg Ulcers

acronym: CASSIOPEE

summary: Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.

lead_sponsor: Laboratoires URGO


title: Characterization of Inflammatory Muscle Involvement in Patients With Primary Sjögren's Syndrome

acronym: AMISS

summary: The AMISS study will characterize the features of muscle disease in patients with primary Sjogren's syndrome (pSS).


title: Assessment of the Predictive Value of the Acetic Acid Test in Surgery Condition for the Detection of Dysplastic Lesions in Patients With Anal Condylomatosis

summary:
Anal condylomatosis is an anal canal mucosa pathology caused by HPV infection (Human Papilloma Virus). This condition is common, especially in immunodepressed patients.

These lesions are not accessible to topical medical treatment because of their location. They should be treated surgically because they may degenerate into squamous cell carcinoma.

In the operating room, lesions are identified by a complete proctologic examination, more or less supplemented by an acetic acid test. Acetic acid allows to detect mucous degeneration (dysplasia) in the form of intense bleaching. The interpretation of this test may nevertheless be difficult in case of local inflammation or scarring. These false positives may lead to unnecessary surgical gestures. The surgical procedure consists of a mucosectomy or destruction of the condylomatosis by electrocoagulation.

The acetic acid test is used at the discretion of the surgeon. However, there is little data on its performance or consensus on its use.


title: Therapeutic Effects of Motor Imagery Practice Following Lower-limb Amputation

acronym: MIPA

summary: Motor imagery practice (MIP), which is the repeated internal representation of a movement without engaging its physical execution and which shares a neurofunctional equivalence with physical practice, has been show to contribute to promote motor recovery and pain alleviation. Despite the extensive body of evidence concerning MIP therapeutic effects, the impact of mental training during lower-limb amputees' rehabilitation process remains to be investigated. This study was designed to assess MIP effects on the relearning of walking and the frequency and intensity of phantom-limb pain among acute lower-limb amputees. Data should contribute to scale up the tools made available to therapists and extend the scope of MIP application. Moreover, results may contribute to directly provide patients recovering from a lower-limb amputation with a cost-effective and adaptable technique that could considerably improve their quality of life.

primary_purpose: Health Services Research

lead_sponsor: Laboratoire Interuniversitaire de Biologie de la Motricité

location_facility: Centre Médico-Chirirgical de Réadaptation des Massues


title: A Nursing Strategy to Prevent Pressure Sores in the Prone Position in ARDS Patients. A Multicenter Controlled Prospective Stepped Wedge Trial

acronym: PSA

summary: A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.

location_facility: Hospices Civils de Lyon - Hopital Croix Rousse


title: Role of Inflammation in Psychiatric Disorders in Patients With Cutaneous Lupus

acronym: RIP-LC

summary:
The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders.

Investigator therefore want to compare inflammation and neurotransmitter synthesis in SRL patients according to the presence or absence of psychiatric disorders.

Investigator expect a decrease in neurotransmitter synthesis and activation of the kynurenin pathway in patients with a psychiatric disorder.


title: Relationship Between Neuromuscular Fatigue, Perceived Tiredness and Level Of Physical Activity of Patients Living With HIV

acronym: ACT PHY HIV

summary:
Fatigue is a common symptom in people living with HIV (PHAs) that affects all aspects of life . This would include physical deconditioning, a reduction in motor skills . Numerous studies show that physical activity brings benefits for the quality of life of PHAs . However, due to the predominantly reported fatigue, many PHAs are not physically active enough in relation to these recommendations. While it is recognized that fatigue is predominant in PHAs, this complaint has mainly been subjectively quantified and has rarely been physically objectified a better understanding of the relationship between neuromuscular fatigue, perceived fatigue and the level of physical activity of PHAs is needed in line with current work on integrating fatigue.

OBJECTIVES This project, based on an integrative (eg, neurophysiological and psychological) approach to fatigue, aims to better explain and prevent the vicious circle of physical deconditioning in PHAs by examining the relationships between neuromuscular fatigue, perceived fatigue, Physical activity of patients.

The main objective of the study will be to compare the characteristics of neuromuscular fatigue in physically active or inactive PHAs.

The secondary objective will be to examine the relationship between neuromuscular fatigue, level of physical activity and perceived physical fatigue of PHAs.

CONDUCT OF THE STUDY Cross-sectional comparative study without individual benefit for the patient. Monocentric test to quantify and relate neuromuscular fatigue, perceived physical fatigue, and physical activity level. The main inclusion criteria for this study are: PLHIV aged between 40 and 60; Diagnosed and treated with antivirals after 1996, irrespective of the value of the viral load and CD4 lymphocyte level at the last assessment; The physical activity level of the patients will be evaluated before the start of the study in order to constitute two distinct groups

Principal evaluation criterion: Investigation of the neurophysiological characteristics of fatigue will be done by recording the capacity to produce force at the level of the extensor muscles of the knee under conditions of voluntary contractions and evoked by magnetic stimulation at the level of Femoral nerve.
Secondary evaluation criteria: the investigation of the perceived fatigue will be done by a valid psychometric questionnaire.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Cognitive Control of Language and Frontal Cortex

acronym: LANGUAGE

summary: The cognitive control of speech is central to human social communication. Two frontal brain regions seem to have a critical role: 1) Broca's area (BA) and 2) the mid-cingulate cortex (MCC). Current rehabilitation strategy is clearly based on therapies promoting language performance. However, there is few evidence that rehabilitation strategies based on nonlinguistic aspects of brain function may enhance recovery. Such strategies may benefit from knowledge about the primary -nonlinguistic- function of the BA-MCC network. The aim of LANGUAGE is to identify this primary function. One hypothesis is that, in non-speaking primates, this network is involved in cognitive control of voluntary vocal/orofacial production. Specifically, whereas BA may be responsible for the high-level selection of orofacial and vocal responses during learning, the face motor representation within the MCC may be responsible for performance monitoring, a process inherently required in learning. LANGUAGE aims to test this hypothesis by determining in human the anatomo-functional organization of the BA-MCC network thanks to functional magnetic resonance imaging (fMRI).

ReferenceCitation: Hillis AE. Magnetic resonance perfusion imaging in the study of language. Brain Lang. 2007 Aug;102(2):165-75. Epub 2006 Jun 6. Review.


acronym: FABRY-Image

summary:
Anderson-Fabry disease is a genetic lysosomal storage disease, linked to chromosome X (gene GLA), responsible of enzyme synthesis deficit in α-galactosidase A with intracellular sphingolipids accumulation and multiorganic achievement.

If renal complication is principally responsible of the pejorative evolution of the disease, it may also exist a cardiac achievement, symptomatic or not (heart failure symptoms including dyspnea, conduction abnormalities, supra-ventricular and ventricular arrhythmias), with or without left ventricular hypertrophy (LVH).

Administration of agalsidase-α or ß, a genetic engineering synthetic equivalent of the deficient enzyme, should significantly slow disease evolution indeed reduce LVH.

Some patients with Fabry disease without LVH should present, compared to healthy subjects, indirect early markers of intramyocyte lipid overload:

in echocardiography, longitudinal myocardial deformation (strain) should be altered while ejection fraction is preserved, and
in cardiac MRI, T1 mapping should be reduced1. This was also previously demonstrated in Fabry patients with LVH2. However, are these abnormalities of longitudinal deformation in echocardiography and of T1 mapping in MRI correlated to the presence of pejorative cardiac markers (such as clinical and functional tolerances, Brain Natriuretic Peptide (BNP) level and electrical complications)?

lead_sponsor: University Hospital, Bordeaux


title: Assessment of Quality of Life of Children With Chronic Idiopathic Thrombocytopenic Purpura

acronym: KIT

summary: Assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment

lead_sponsor: University Hospital, Angers


title: High-flow Nasal Cannula Oxygen Therapy With or Without Non-invasive Ventilation (NIV) During the Weaning Period: a Multicenter Randomized Controlled Trial

acronym: HIGH-WEAN

summary: Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.

ReferenceCitation: Thille AW, Coudroy R, Nay MA, Gacouin A, Decavèle M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouzé A, Vivier E, Lascarrou JB, Ricard JD, Mekontso-Dessap A, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Frat JP, Ragot S; HIGH-WEAN Study Group and the REVA Research Network. Beneficial Effects of Noninvasive Ventilation after Extubation in Obese or Overweight Patients: A Post Hoc Analysis of a Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Feb 15;205(4):440-449. doi: 10.1164/rccm.202106-1452OC.

ReferenceCitation: Thille AW, Monseau G, Coudroy R, Nay MA, Gacouin A, Decavèle M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouzé A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA research network. Non-invasive ventilation versus high-flow nasal oxygen for postextubation respiratory failure in ICU: a post-hoc analysis of a randomized clinical trial. Crit Care. 2021 Jun 28;25(1):221. doi: 10.1186/s13054-021-03621-6.

ReferenceCitation: Thille AW, Coudroy R, Nay MA, Gacouin A, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Levrat Q, Rouze A, Vivier E, Lascarrou JB, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Massri A, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group, for the REVA Research Network. Non-invasive ventilation alternating with high-flow nasal oxygen versus high-flow nasal oxygen alone after extubation in COPD patients: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Feb 9;11(1):30. doi: 10.1186/s13613-021-00823-7.

ReferenceCitation: Thille AW, Muller G, Gacouin A, Coudroy R, Decavèle M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouzé A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PÉ, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901. Erratum in: JAMA. 2020 Feb 25;323(8):793.

ReferenceCitation: Thille AW, Muller G, Gacouin A, Coudroy R, Demoule A, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouzé A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Picard W, Bourenne J, Pradel G, Bailly P, Terzi N, Buscot M, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Ragot S, Frat JP; REVA research network. High-flow nasal cannula oxygen therapy alone or with non-invasive ventilation during the weaning period after extubation in ICU: the prospective randomised controlled HIGH-WEAN protocol. BMJ Open. 2018 Sep 5;8(9):e023772. doi: 10.1136/bmjopen-2018-023772.

lead_sponsor: Poitiers University Hospital


title: Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer

acronym: RPOS+

summary: Phase 1/2 study, open, monocenter, non-randomized