title: Descriptive Study of Brain Velocity in Transcranial Doppler in Newborns Over 35 Weeks of Gestational Age in the Maternity Ward

acronym: VELOCITE

summary:
There are significant variations in blood circulation at birth with the transition from fetal to permanent circulation. These variations are particularly impacted by the closure of the arterial canal within the first 48 hours of life.

Blood circulation velocity values within the cerebral arteries have been well documented in newborns and infants a few days old. However, the initial values of these velocities and their variations during the first hours of life are not well known.

The objective of this study is to describe the evolution of brain circulation at birth in newborns over 35 weeks of gestational age and to investigate the effect of arterial canal closure on brain circulation.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Constitution of a Clinico-radiological Database and a Biobank for Patients With Lacunar Infarcts at Lariboisière Fernand-Widal and Sainte Anne Hospitals

acronym: DHU-LAC

summary: The aim of this study is to determine in patients with a recent lacunar strokes (<15 days), the natural history of cognitive disturbances and disability.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

lead_sponsor_type: academique

status_simplified: Ongoing


title: Enhanced Recovery After Surgery for Total Knee Arthroplasty, Left Colectomy and Hysterectomy: A Multicenter Study Assessing Care Practice and Prevention

acronym: RAAC-AP

summary: The objective of the study is to assess retrospectively the effect of an awareness-raising phase in favour of Enhanced Recovery After Surgery across the Assistance Publique-Hopitaux Paris institution and to explore the determinants of compliance with modalities of Enhanced Recovery After Surgery. This multicenter study is performed for three types of surgery: total knee arthroplasty, left colectomy and hysterectomy.

status: Unknown status

time_perspective: Retrospective

location_facility: Service d'anesthésie-réanimation chirurgicale, Hopital Ambroise Paré

intervention_type: Procedure

status_simplified: Unknown


title: Evaluation of the Global Auditory Nerve Activity as a New Method of Electrophysiological Exploration of Hearing in Humans - 2

summary: To date, all the electrophysiological methods for auditory testing rely on the measure on synchronous evoked auditory nerve activity. This measure only takes into account the response of the first action potential in every auditory fibber, but provides no information about the neural response during a sustained activity. This can explain why in experimental models, a loss of more of 80% of auditory nerve fibbers cannot be detected by usual electrophysiological measurements. In this study we aim at investigating the global spontaneous and sound evoked auditory nerve activity by recording directly the electrical field by an electrode placed directly on the auditory nerve of subjects during a skull base surgical procedure. We expected to demonstrated differences in the electrical activity between subjects with or without hearing loss.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: University Hospital, Montpellier

collaborators: Institute for Neurosciences of Montpellier U1051

status_simplified: Completed


title: Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis

acronym: IPBio-SeP

summary:
Background: High dose biotin is a therapeutic option for French progressive Multiple Sclerosis (MS) patients, without relapse for at least one year, since June 1, 2016. Despite the inflammatory activity of progressive forms of MS is known to be low, several publications mentioned clinical and/or radiological activity for biotin-treated patients.

Objectives:

To determine if high dose biotin increase the clinical inflammatory activity of patients with a progressive form of MS.
To compare the clinical characteristics of the relapses that occurred with biotin or not.
To describe the characteristics of the patients with a clinical inflammatory activity with biotin.

Methods: This is a national, academic, observational and retrospective study comparing one group of progressive MS patients with high dose biotin to another group without this treatment using a propensity score, in intention to treat. The main judgment criterion is the annualized relapse rate (ARR) from the beginning of the biotin to the last evaluation available before the data extraction. A Student's t test will be used. A negative binomial modelling with relapses counting over a period of exposure and taking into account the inter and intra center variability will be used. The statistical tests will be adapted to the nature of the variables concerning the secondary judgment criteria.

Expected results: This French national study will provide a better knowledge of the inflammatory activity of the progressive forms of MS treated with high dose biotin. If an increased clinical inflammatory activity is highlighted with biotin a prospective study will be necessary to confirm the result before a specific information of the scientific community and the patients about this risk or even an amendment of prescription rules in order to secure the use of the product. On the contrary, the absence of increased risk of clinical inflammatory activity with biotin would help to reassure the prescriber and the patient about the innocuity of the treatment.

study_start_date_type: Anticipated

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: OFSEP (Observatoire Français de la Sclérose en Plaques)

collaborators: SFSEP (Société Francophone de la Sclérose en Plaques)

intervention_type: Drug


title: Retrospective Study of Prescribed Physical Activity in Patients With Overactive Bladder Syndrome Monitored Within the Pelvi-perineology Network in Dijon: Evaluation of Prescription Compliance and Impact on Quality of Life

acronym: HAV-AP

summary:
Overactive bladder (OAB) is a clinical syndrome defined by the International Continence Society (ICS) and the International Urogynecological Association (IUGA) as urinary urgency (sudden and uncontrollable urge to urinate) possibly associated with urinary frequency (urination greater than 8 times per day), nocturia (2 or more urinations per night) or urinary incontinence (UI). In most cases no root cause is found, so it is referred to as idiopathic overactive bladder (iOAB).

The treatment of iOAB is based primarily on hygiene and dietary measures and perineal rehabilitation. If these are insufficient, medical anticholinergic treatment is offered.

Second-line therapies are based on percutaneous neuromodulation of the tibial nerve, neuromodulation of the sacral roots S3 and intra-detrusor injection of botulinum-A toxin.

iOAB has a significant negative impact on patients' quality of life, particularly in cases of associated urinary incontinence. It is at the origin of low self confidence.

A significant proportion of patients with iOAB are not managed or are not satisfied with treatment.

A strong epidemiological correlation between AVH and metabolic syndrome (MS) was demonstrated in a literature review of 119 articles. MS is a clinical-biological syndrome defined by the National Cholesterol Education Program Adut Treatment Panel III (NCEP ATP III). The prevalence of OAB increases with that of obesity but only from a waist circumference of at least 100cm. S. Boudokhane showed in a prospective study of 34 patients with MS defined by the NCEP ATP III criteria that waist circumference, BMI and post prandial glucose were positively correlated with the presence of OAB measured by the PSU score (p<0.05).

Physical activity (PA) is defined as any body movement produced by skeletal muscles resulting in a substantial increase in energy expenditure above rest energy expenditure (WHO). The efficacy of AP on MS has been demonstrated in primary prevention and treatment of MS by the HERITAGE study and the controlled trial established under the Diabetes Prevention Program (DPP). The follow-up was conducted over 3.2 years and showed a significant decrease in the incidence of MS in the PA group by 41% compared to placebo (p<0.001). The action of PA on iOAB has not been directly studied but some studies have shown that PA and pelvic floor muscle strengthening significantly and respectively decrease the number of mixed (p< 0.0001) (14) or urgency (p=0.009) UI episodes. Since March 2017, the prescription of modified PA is possible.

intervention_type: Other


title: World Mosquito Program Noumea - Human Sample Component

summary:
The dengue, Zika and chikungunya arboviruses represent potentially severe infections to which the New Caledonian population is exposed. In the absence of specific treatment or vaccine, vector control remains the method of choice to limit their spread. However, the traditional methods of prevention and vector control measure today face their limits: mosquito resistance to insecticides, difficulty of access and destruction of breeding areas... The World Mosquito Program Noumea project is based on the artificial colonization of the mosquito vector Aedes aegypti by the endosymbiotic bacteria Wolbachia, which reduces its ability to transmit arboviruses. The breeding of mosquitoes carrying the bacterium Wolbachia in the laboratories of the Institut Pasteur of New Caledonia requires the use of human blood samples for mosquito gorging.

The objective of the research is to generate, maintain and amplify Aedes aegypti Caledonian lineages carrying the Wolbachia bacteria for the planned insect release program in Noumea.

lead_sponsor: Institut Pasteur

sponsor_collaborators:
Institut Pasteur
Institut Pasteur of New Caledonia

location_facility: Centre Hospitalier de Nouvelle-Calédonie


title: Tobacco and Sperm Genome: Effects of Smoking Cessation

acronym: TABAGERM

summary: Tobacco is a male infertility risk factor. Many studies comparing smokers to non-smokers have shown effects on spermatogenesis and the quality of the male gamete. In vitro fertilization success rates are decreased in smokers and in natural procreation the time required to conceive (excellent fertility indicator) seems to be lengthened in the smoker. The prospective study that the investigators propose to carry out would make it possible to know the time required for the repair of the sperm abnormalities and in particular the DNA of the gametes generated by the smoking.

primary_purpose: Other

lead_sponsor: University Hospital, Toulouse

location_facility: CHU Toulouse, Service de médecine de la reproduction


type: EudraCT Number

title: Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized Trial

acronym: ID-CLO

summary: Noradrenergic system is involved in impulsivity in the general population and is altered in Parkinson's disease (PD) in the early stages of the disease. Thus, targeting this system could be of interest in impulse control disorder (ICD). Acting on the noradrenergic system is possible using clonidine, an α2 adrenergic agonist largely used in hypertension treatment and that induces a decrease of NADR release. Thus, our aim is to conduct a proof of concept study evaluating the efficacy and safety of clonidine on ICD in PD. This study is a multicenter, randomized, double-blind, placebo-controlled in parallel group clinical trial.

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon


title: Retinal Microvascularization and Cardiovascular Diseases

acronym: NESTOR

summary:
The main objective of this study is to investigate whether there are links between the blood vessels of the retina as a whole and heart and/or vascular diseases (cardiovascular diseases).

The arteries and veins of the retina are, like the large vessels of the human body (aorta, coronary, cerebral arteries), exposed to the complications of hypertension, diabetes, obesity, dyslipidemia (abnormal blood lipid profile) or tobacco. Several studies have shown that changes in retinal vessels (microvascularization) generally occur several years before damage to large peripheral vessels (macrovascularization). The study of the vessels of the retina is now possible thanks to simple and non-invasive examinations of photographs (not creating any lesion). They allow a painless evaluation of the vessels in the retina.

Ultimately, if this study is conclusive, the patient's cardiovascular risk could be evaluated simply by analysis of the vessels of the retina.

The study is being conducted in the ophthalmology and cardiology departments of Dijon University Hospital. In total, the investigators wish to include approximately 510 patients who present cardiovascular risk factors (255 low risk patients recruited in the ophthalmology department and 255 high risk patients hospitalized in the cardiology department).

All patients participating in the study will be asked to visit the ophthalmology department for a complete examination of the retina.

status: Terminated


title: Constitution Of A Biological Collection From Samples From The Gut Microbiota In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine (CARBAMICROBIOTA)

summary:
Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection (PJI)) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way to limit catheter-related complications and facilitate ambulatory care.

However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.

The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.

location_facility: Centre de référence des infections ostéo-articulaires de Lyon - Hôpital de la Croix-Rousse


type: Other Identifier

title: 3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy: A Pilot Study

summary:
Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats. Today, there are no reliable means to identify HCM patients at risk of sudden death. The CardioInsight™ has recently been developed by Medtronic for non-invasive advanced cardiac mapping system. The CardioInsight™ Noninvasive 3D Mapping System is a non-invasive mapping system that collects chest ECG signals and combines these signals with CT scan data to produce and display simultaneous, bi-atrial and biventricular, 3-D cardiac maps.

It is a monocentric, prospective, comparative and analytical study. 20 HCM patients will be recruited in the National Reference Center for inherited cardiac diseases of Lyon. The 3D-propagation maps of 10 well phenotyped and genotyped HCM patients with previous VF (ventricular fibrillation) will be compared to 10 HCM patients without previous VF.

After consent signed, Holter ECG, scanner and CardioInsightTM 3D_ECG mapping will be planned in the month following the inclusion. 12-lead ECG, 24h holter ECG, cardiac scanner will be performed as standard procedure of each center in the current health care of the patient.

The widespread screening of HCM patients with 3D high-density noninvasive mapping should improve the risk-benefit ratio of implantable defibrillator therapy. It is expected that more patients at risk will benefit from this device.

primary_purpose: Diagnostic

ipd_sharing: Undecided

intervention_type: Device


title: Evaluation of the Added Value of an Educational Program Associated With a Conventional Spa Therapy of Knee Osteoarthritis Patients

summary: The main objective of this work is to measure the efficiency of 18 days SPA Therapy in orientation rheumatology associated with an educational intervention in patients with knee osteoarthritis on a priority objective, personalized and determined by the patient, chosen in the list of 5 objectives determined during the educational assessment.

ReferenceType: background

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

ReferenceCitation: Mendelson AD, McCullough C, Chan A. Integrating self-management and exercise for people living with arthritis. Health Educ Res. 2011 Feb;26(1):167-77. doi: 10.1093/her/cyq077. Epub 2010 Dec 1.

ReferenceCitation: Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

ReferenceCitation: Krasny-Pacini A, Evans J, Sohlberg MM, Chevignard M. Proposed Criteria for Appraising Goal Attainment Scales Used as Outcome Measures in Rehabilitation Research. Arch Phys Med Rehabil. 2016 Jan;97(1):157-70. doi: 10.1016/j.apmr.2015.08.424. Epub 2015 Sep 4.

ReferenceCitation: Rockwood K, Joyce B, Stolee P. Use of goal attainment scaling in measuring clinically important change in cognitive rehabilitation patients. J Clin Epidemiol. 1997 May;50(5):581-8. doi: 10.1016/s0895-4356(97)00014-0.

lead_sponsor: Association Francaise pour la Recherche Thermale

lead_sponsor_type: industriel


title: Salt Wasting, Hydro-sodium Balance and Fludrocortisone Requirement in Congenital Adrenal Hyperplasia

acronym: NaCAH

summary:
Congenital adrenal hyperplasia (CAH) in its classic neonatal form with severe salt-wasting represents a challenge for pediatric endocrinologists in order to maintain sodium balance, especially as the physiopathology and optimal therapeutic management of this urinary salt loss remain poorly studied, particularly during the neonatal period.

The human kidney presents the characteristic of being immature at birth with a functional tubulopathy associating sodium wasting and difficulty to concentrate urine, in connection with a transient renal resistance to aldosterone action, which is exacerbated in case of CAH by insufficiency of aldosterone production.

The objective of project is therefore to study the secretion profiles of plasma and urinary steroids in neonates with classical salt-wasting form of CAH before treatment and under treatment with Fludrocortisone and Hydrocortisone during the first months of life, using an advanced technology: LC-MSMS (Liquid chromatography coupled with tandem mass spectrometry). The study of the existence of a correlation between plasma and urinary steroid profiles will also make it possible to subsequently consider simplified medical follow-up for these patients.

This project will lead to a better understanding of sodium handling and steroid secretion and excretion profiles in CAH neonates, in order to improve the therapeutic management of mineralocorticoid replacement in these patients.


title: Muscle Evaluation Using Ultrasound in the Critically Ill : ULTRAMUSCLE Study

acronym: ULTRAMUSCLE

summary:
Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction.

Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients.

The aim of the present study is to constitute an image bank and to describe the muscle mass and function recovery in critically ill patients.

ReferenceType: derived

ReferenceCitation: Aarab Y, Flatres A, Garnier F, Capdevila M, Raynaud F, Lacampagne A, Chapeau D, Klouche K, Etienne P, Jaber S, Molinari N, Gamon L, Matecki S, Jung B. Shear Wave Elastography, a New Tool for Diaphragmatic Qualitative Assessment: A Translational Study. Am J Respir Crit Care Med. 2021 Oct 1;204(7):797-806. doi: 10.1164/rccm.202011-4086OC.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

license: cc-by

license_normalized: cc-by

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

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: American Thoracic Society

ReferenceCitation: Flatres A, Aarab Y, Nougaret S, Garnier F, Larcher R, Amalric M, Klouche K, Etienne P, Subra G, Jaber S, Molinari N, Matecki S, Jung B. Real-time shear wave ultrasound elastography: a new tool for the evaluation of diaphragm and limb muscle stiffness in critically ill patients. Crit Care. 2020 Feb 3;24(1):34. doi: 10.1186/s13054-020-2745-6. Erratum In: Crit Care. 2020 Mar 5;24(1):79.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ipd_sharing_description: NC


title: Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN

summary: The links between low LDL-C levels and psychologic symptoms (psychotic disorders, mood disorders, aggressivity, suicidal risk, etc.) and cognitive deficits (mainly executing functioning) are debated. The PARTITION study aims at estimating the prevalence of hypobetalipoproteinemia (HBL), defined as a LDL-C level ≤ 0,50 g/L, in a psychiatric population.

lead_sponsor: Nantes University Hospital

intervention_type: Diagnostic Test


title: End-of-Life Patient Identification Assistance in Acute GEriatric Medicine: Construction and Validation of a Prognostic Tool

acronym: ARPEGE

summary:
The main objective of this project is to build a tool, adapted to the French geriatric population, that will predict the risk of death at three months after hospitalization in acute geriatric medicine. This tool will be built using selected items via a review of the literature published in 2015.

The 8 items of the CriSTAL tool will be collected prospectively in all patients hospitalized successively in the 2 post-emergency geriatric services (PUG) of the University Hospital of Toulouse, over a period of 9 months, by a dedicated clinical research associate. Patient survival will be assessed by obtaining the vital status of the cohort via CépiDC

ReferenceType: result

ReferenceCitation: Steinmeyer Z, Piau A, Thomazeau J, Kai SHY, Nourhashemi F. Mortality in hospitalised older patients: the WHALES short-term predictive score. BMJ Support Palliat Care. 2021 Nov 25:bmjspcare-2021-003258. doi: 10.1136/bmjspcare-2021-003258. Online ahead of print.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

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

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

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

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal


title: Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.

acronym: POIR

summary: Postoperative pneumonia is one of the most common complications after lung cancer surgery and associated with a morbidity and mortality. Postoperative lymphopenia has been recently identified as one of risk factors for postoperative pneumonia. According to recent studies in polytrauma, cancer or septic shock, T cells dysfunction may be related to high expression of inhibitory receptors on lymphocytes.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Biological


title: Impact of Aluminum on Sperm DeoxyriboNucleic Acid (DNA) Quality

summary:
Between 1950 and 2013, aluminum production was multiplied by thirty in the world. Today, men's exposure to aluminum, including food products, cosmetics, air and water contamination, and a number of drugs (vaccine, gastric bandages, etc.) has never been so high and should continue to increase. At the same time, we are witnessing a decline in male fertility in Western countries.

In this context, several teams, including ours, have studied the impact of aluminum on the fertility of men. These studies have shown that aluminum accumulates in semen and especially in sperm near its DNA.

Aluminum has already shown that it is capable of damaging the DNA of various cells, especially to increase DNA fragmentation. We therefore hypothesize that aluminum could lead to increased sperm DNA fragmentation. This would result in a decrease of men fertility and in higher risk of miscarriage.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Accuracy of Left Subclavian Regurgitation Evaluated by Ultrasound Doppler and 4D Flow MRI as an Indicator of Severe Aortic Regurgitation

acronym: SUBCLAR

summary:
Aortic insufficiency (IA) is defined as an abnormal regurgitation of blood from the aorta to the left ventricle in diastole, due to a lack of tightness of the aortic valves. It represents about 10% of valvular pathologies but the annual mortality of nonoperated patients can be as high as 10% to 20%. The quantification of AI is therefore important as it can remain perfectly asymptomatic for a long time.

Doppler echocardiography is currently the key examination to confirm the presence of valvulopathy, to allow positive diagnosis of valve leakage regardless of location, to specify the etiology and mechanism of regurgitation. The quantification of IA requires, in transthoracic ultrasound, to take into account many parameters that individually have all certain limitations. The recommendations are therefore to have an integrative approach considering a combination of different parameters and an overall interpretation. This makes it possible to evaluate with greater precision the importance of the leak. Thus, there is the difficulty of quantifying moderate and severe AI for lack of a truly unique criterion. One of the evaluation criteria commonly used in transthoracic ultrasound is diastolic regurgitation in the aortic arch but this assessment is sometimes difficult. The left subclavian artery (SCG) is more accessible than the aortic arch in terms of the ultrasound window. The measurements will be easier to record since the vessel is more superficial and there are fewer air interpositions than for the aortic arch. The quantification of the AI based on this new element will be compared to the other previously validated ultrasound criteria. The investigators will use this study to describe the feasibility of collecting coronary flow in the artery (IVA), and they will compare systolic velocity, diastolic rate / systolic rate ratio compared to a control group without severe aortic insufficiency (grades 2 and 3). The flows recorded in the IVA will be compared to the importance of the aortic leakage according to its different modes of quantification (ultrasound and MRI). The aim of the study will be to show that diastolic reflux in the left subclavian artery is a marker of severe AI (grades 2 and 3) by comparing this regurgitation with that measured at the level of the aortic arch and other validated ultrasound criteria and cardiac MRI.

status: Active, not recruiting

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation

acronym: proTENS

summary: Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. Several studies showed that transcutaneous electrical nerve stimulation (TENS) could improve dyspnea and pulmonary function. The aim of this study is to assess the acute effect of TENS on exercise tolerance in post-exacerbation COPD patients

status: Not yet recruiting

lead_sponsor: Groupe Hospitalier du Havre


title: Study on the Mnemic Functioning of Children With Kabuki Syndrome

acronym: MEM-K

summary: Mnesic function has not, at present, been evaluated in patients with Kabuki Syndrome. Some data from the neuroimagery suggest an impairment of memory function. The objective of our study is to assess the mnesic function of children with Kabuki Syndrom.

ReferenceCitation: Lehman N, Mazery AC, Visier A, Baumann C, Lachesnais D, Capri Y, Toutain A, Odent S, Mikaty M, Goizet C, Taupiac E, Jacquemont ML, Sanchez E, Schaefer E, Gatinois V, Faivre L, Minot D, Kayirangwa H, Sang KLQ, Boddaert N, Bayard S, Lacombe D, Moutton S, Touitou I, Rio M, Amiel J, Lyonnet S, Sanlaville D, Picot MC, Genevieve D. Molecular, clinical and neuropsychological study in 31 patients with Kabuki syndrome and KMT2D mutations. Clin Genet. 2017 Sep;92(3):298-305. doi: 10.1111/cge.13010. Epub 2017 May 18.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

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

publisher_dissemination: Wiley

location_facility: Genetic Departement, rare disease, personalized medicine


title: Impact of Treatment of Obstructive Sleep Apnea Syndrome by Continuous Positive Airway Pressure Equipment at Night on the Lower Urinary Tract Symptoms and the Erectile Dysfunction

summary:
To treat lower urinary tract symptoms (LUTS) and erectile dysfunction (ED), we mainly have symptomatic drug treatments. Some patients are resistant to the treatments that we have or are forced to stop treatments because of side effects.

It would be interesting to focus on comorbidities and to evaluate whether it is possible to improve the urological symptoms by taking care the comorbidities, which would consist in an etiological treatment of the urological symptoms.

The aim of the study is to evaluate the evolution of low urinary tract disorders (LUTS) and erectile dysfunction (ED) in patients with obstructive sleep apnea syndrome (OSAS) following by continuous positive airway pressure equipment (CPAP) at night.

Participation in the study will be offered to all patients, men and women, consulting or hospitalized in the sleep unit of the department of pneumology CHU of Reims for a nocturnal ventilatory polygraphy or a polysomnography diagnostic of OSAS.

Men will complete three questionnaires about LUTS and DE, women one questionnaire about LUTS. The questionnaires will be completed twice, the first time when consulting at the sleep unit for nocturnal ventilatory polygraphy or a polysomnography diagnostic of OSAS ; the second time during the pneumology consultation three months later. We will compare the results between the questionnaires to assess whether OSAS equipment with CPAP has improved urologic symptoms.

If the management of OSAS allows an improvement of lower urinary tract disorders and / or an improvement of erectile dysfunction, these results would be interesting for the management of patients resistant to symptomatic drug treatments or to stop them because of iatrogenic side effects.

Etiological rather than symptomatic management would also have long-term benefits, both in improving the overall quality of life of the patient and in the medical and economic field.

It might be interesting to identify in urology consultation among patients consulting for LUTS or ED, patients at risk of presenting OSAS and referring them to a pulmonologist to manage OSAS if it exists, from the beginning of the urological care.

lead_sponsor: CHU de Reims


title: A Prospective Single Center Randomized Interventional Controlled Open Trial Comparing Patient and Staff Safety During Peripheral Endovascular Arterial Revascularisation Using Advanced Imaging Guidance Technology to Control Group Without Imaging Guidance.

acronym: SOFtPERIPHERAL

summary: Study the Patient and staff Safety regarding the radiation exposure during the procedure with and without the fusion imaging guidance technology in treatment of peripheral artery disease.

primary_purpose: Prevention

location_facility: Nantes University Hospital, Vascular surgery, Institut du Thorax


title: Clinical and Echocardiographic Characteristics and Prognosis of trIcuspid regurgiTation (EPIT): Prospective and Retrospective Follow-up of a Cohort of Patients With Moderate or Severe Tricuspid Regurgitation

acronym: EPIT

summary: The tricuspid valve : its evaluation is relatively difficult in echocardiography and the management of tricuspid valve diseases remains poorly codified.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Open, Prospective, Single-center Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma

acronym: PICABAS

summary: Basal cell carcinomas (BCCs) are the most common form of cancer. The treatment of BCC can be surgical or topical for the low-risk subtypes. Topical treatments used for BCC are imiquimod and photodynamic therapy (PDT). Ingenol mebutate could provide a fast and easy topical therapy for BCC. Data regarding the treatment of BCC with ingenol mebutate are still limited. The investigators propose a pilot study to investigate the efficacy of 1 or 2 courses of ingenol mebutate 0,05%, on superficial and nodular BCC

ReferenceCitation: Ramsay JR, Suhrbier A, Aylward JH, Ogbourne S, Cozzi SJ, Poulsen MG, Baumann KC, Welburn P, Redlich GL, Parsons PG. The sap from Euphorbia peplus is effective against human nonmelanoma skin cancers. Br J Dermatol. 2011 Mar;164(3):633-6. doi: 10.1111/j.1365-2133.2010.10184.x. Epub 2011 Jan 27.

ReferenceCitation: McKay KM, Sambrano BL, Fox PS, Bassett RL, Chon S, Prieto VG. Thickness of superficial basal cell carcinoma (sBCC) predicts imiquimod efficacy: a proposal for a thickness-based definition of sBCC. Br J Dermatol. 2013 Sep;169(3):549-54. doi: 10.1111/bjd.12402.

ReferenceCitation: Mogensen M, Nurnberg BM, Forman JL, Thomsen JB, Thrane L, Jemec GB. In vivo thickness measurement of basal cell carcinoma and actinic keratosis with optical coherence tomography and 20-MHz ultrasound. Br J Dermatol. 2009 May;160(5):1026-33. doi: 10.1111/j.1365-2133.2008.09003.x. Epub 2009 Jan 12.

ReferenceCitation: Prieto-Granada C, Rodriguez-Waitkus P. Basal cell carcinoma: Epidemiology, clinical and histologic features, and basic science overview. Curr Probl Cancer. 2015 Jul-Aug;39(4):198-205. doi: 10.1016/j.currproblcancer.2015.07.004. Epub 2015 Jul 8. No abstract available.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

ReferenceCitation: Williams HC, Bath-Hextall F, Ozolins M, Armstrong SJ, Colver GB, Perkins W, Miller PSJ; Surgery Versus Imiquimod for Nodular and Superficial Basal Cell Carcinoma (SINS) Study Group. Surgery Versus 5% Imiquimod for Nodular and Superficial Basal Cell Carcinoma: 5-Year Results of the SINS Randomized Controlled Trial. J Invest Dermatol. 2017 Mar;137(3):614-619. doi: 10.1016/j.jid.2016.10.019. Epub 2016 Dec 5.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repository_institution: University of Nottingham - Repository@Nottingham

ReferenceCitation: Ogbourne SM, Suhrbier A, Jones B, Cozzi SJ, Boyle GM, Morris M, McAlpine D, Johns J, Scott TM, Sutherland KP, Gardner JM, Le TT, Lenarczyk A, Aylward JH, Parsons PG. Antitumor activity of 3-ingenyl angelate: plasma membrane and mitochondrial disruption and necrotic cell death. Cancer Res. 2004 Apr 15;64(8):2833-9. doi: 10.1158/0008-5472.can-03-2837.

ReferenceCitation: Rosen RH, Gupta AK, Tyring SK. Dual mechanism of action of ingenol mebutate gel for topical treatment of actinic keratoses: rapid lesion necrosis followed by lesion-specific immune response. J Am Acad Dermatol. 2012 Mar;66(3):486-93. doi: 10.1016/j.jaad.2010.12.038. Epub 2011 Nov 4.

ReferenceCitation: Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.

ReferenceCitation: Siller G, Rosen R, Freeman M, Welburn P, Katsamas J, Ogbourne SM. PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial. Australas J Dermatol. 2010 May;51(2):99-105. doi: 10.1111/j.1440-0960.2010.00626.x.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Oculometry as an Attentional Mechanism Evaluation Tool and Attention Deficit Hyperactivity Inhibition

acronym: TDAH

summary:
The aim of this study is to analyse thanks to eye tracking experiments ocular movement classical parameters in children with attention deficit hyperactivity (ADH) and to compare them to results obtained in healthy children and to results obtained with neuropsychological tests commonly used in standard health care.

We should then be able to compare eye tracking with neuropsychological parameters.

The final objective is to give to health professional a tool for ADH investigation with which they should be able to do a simple and effective follow up of children with ADH.

primary_purpose: Supportive Care

ReferenceCitation: Malsert J, Guyader N, Chauvin A, Polosan M, Szekely D, Bougerol T, Marendaz C. Saccadic performance and cortical excitability as trait-markers and state-markers in rapid cycling bipolar disorder: a two-case follow-up study. Front Psychiatry. 2013 Jan 4;3:112. doi: 10.3389/fpsyt.2012.00112. eCollection 2012.

lead_sponsor: University Hospital, Grenoble

intervention_type: Behavioral


title: Pharmacokinetics of Rocuronium (1 mg/kg) for Deep Block : a Prospective Observational Study

acronym: DeepRocu

summary:
Rocuronium is a non-depolarising neuromuscular blocking agent. The compound has a rapid onset and an intermediate duration of action.

The rapid onset is of importance in patients at risk for pulmonary aspiration, for elective induction of anesthesia. Clinical studies simulating rapid sequence induction in elective patients indicate that rocuronium 0.9 mg kg-1 may be suitable for crash intubation.Also, rocuronium may be an alternative to succinylcholine for rapid sequence induction when high dose is injected (3x Effective Dose 95 %= 1mg/kg). But, pharmacokinetic of rocuronium at 1 mg/kg is not well establish.

The investigator investigate the onset and recovery of a single dose rocuronium (1 mg/kg) in consecutive patients (>100) using adductor muscle monitoring (Train of Four and Post Tetanic Count)

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Open Non-randomized Study on the Management of Operable T1-N0 or T2-N0 Oral Cavity and Oropharynx Cancer and Sentinel Lymph Node in Outpatient Surgery

acronym: SACO

summary: This is a single-center pilot study of open-label, non-randomized interventional research based on the outpatient management of 30 patients with T1-N0 or T2-N0 cancer in the oral cavity or oropharynx.

ReferenceCitation: Burcia V, Costes V, Faillie JL, Gardiner Q, de Verbizier D, Cartier C, Jouzdani E, Crampette L, Guerrier B, Garrel R. Neck restaging with sentinel node biopsy in T1-T2N0 oral and oropharyngeal cancer: Why and how? Otolaryngol Head Neck Surg. 2010 Apr;142(4):592-7.e1. doi: 10.1016/j.otohns.2009.12.016.

ReferenceCitation: Garrel R, Poissonnet G, Temam S, Dolivet G, Fakhry N, de Raucourt D. Review of sentinel node procedure in cN0 head and neck squamous cell carcinomas. Guidelines from the French evaluation cooperative subgroup of GETTEC. Eur Ann Otorhinolaryngol Head Neck Dis. 2017 Apr;134(2):89-93. doi: 10.1016/j.anorl.2016.10.004. Epub 2016 Nov 11.

oa_host_type: closed

ReferenceCitation: Schilling C, Stoeckli SJ, Haerle SK, Broglie MA, Huber GF, Sorensen JA, Bakholdt V, Krogdahl A, von Buchwald C, Bilde A, Sebbesen LR, Odell E, Gurney B, O'Doherty M, de Bree R, Bloemena E, Flach GB, Villarreal PM, Fresno Forcelledo MF, Junquera Gutierrez LM, Amezaga JA, Barbier L, Santamaria-Zuazua J, Moreira A, Jacome M, Vigili MG, Rahimi S, Tartaglione G, Lawson G, Nollevaux MC, Grandi C, Donner D, Bragantini E, Dequanter D, Lothaire P, Poli T, Silini EM, Sesenna E, Dolivet G, Mastronicola R, Leroux A, Sassoon I, Sloan P, McGurk M. Sentinel European Node Trial (SENT): 3-year results of sentinel node biopsy in oral cancer. Eur J Cancer. 2015 Dec;51(18):2777-84. doi: 10.1016/j.ejca.2015.08.023. Epub 2015 Nov 18.

ReferenceCitation: Lee MK, Nalliah RP, Kim MK, Elangovan S, Allareddy V, Kumar-Gajendrareddy P, Allareddy V. Prevalence and impact of complications on outcomes in patients hospitalized for oral and oropharyngeal cancer treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Nov;112(5):581-91. doi: 10.1016/j.tripleo.2011.06.032.

location_facility: Gui de Chauliac Hospital, ENT Department 80 rue Augustin Fliche


title: Evaluation of the Triage Risk Screening Tool (TRST) as Screening Instrument Elderly Subject Fragility at the Accident and Emergency Department

acronym: TRST-U

summary: This study tried to describe diagnostic properties of TRST completed by an emergency doctor, for screening process for fragility of elderly subjects admitted at the accident and emergency department.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition

acronym: VISSEXPOSITION

summary: Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - service de rhumatologie


title: Observational Multicenter Study of Refractory and/or Relapsing Takayasu Arteritis START: Study of Refractory and/or Relapsing TAkayasu aRTeritis

acronym: START

summary: Takayasu arteritis (TA) is a vasculitis of unknown origin, resulting in progressive thickening and stenosis of large and medium arteries (the aorta and its major branches, and the pulmonary arteries). First line therapy of TA consists of high dose corticosteroids (CS) (Mukhtyar et al, 2009). Between 20 and 50% of cases respond to CS alone, with subsequent resolution of symptoms and stabilization of vascular abnormalities (Shelhamer et al, 1985; Maksimowicz-McKinnon et al, 2007). Although second-line agents (methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide) may result in initial remission, relapses remain common when prednisone is tapered (Maksimowicz-McKinnon et al, 2007). Thus, 50% of CS-resistant or relapsing TA patients may achieve sustained remission with the addition of methotrexate (Hoffman et al, 1994). During the last decade, biologics such as anti-tumor necrosis factor alpha (anti-TNFα) and anti-interleukin-6 (anti-IL-6) have been used as third-line treatment in refractory or relapsing TA. Almost 90% of CS-methotrexate resistant TA cases responded to infliximab, an anti-TNFα, and sustained remission was obtained in 37 to 76% of the cases (Schmidt et al, 2012; Comarmond et al, 2012; Mekinian et al, 2012). Tocilizumab, an anti-IL-6 has given similar results with 68% of sustained remission in refractory TA (Abisror et al, 2013). Irrespective of classical cardiovascular risk factors, the systemic inflammation and CS use play a pivotal role in the occurrence of cardiovascular thrombotic events (CVEs) (Roubille et al, 2015). As CVEs overlap with TA complications it is primordial to drastically taper CS in that vasculitis. We therefore aim to analyses prospectively the long term outcome of refractory/relapsing TA patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Imaging by 4 DFlow in Patients With Tetralogy of Fallot

summary:
Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot.

4D Flow CMR Imaging is a new imaging modality able to assess all of these parameters faster (8 min vs 30 min) and more comfortably.

The aim of this study is to compare conventionnal CMR and 4D Flow CMR for the assessment of these parameters (ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway).

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Data Collection for the Creation of the French Pediatric Helicobacter Pylori Observatory

acronym: GFHPP

summary:
Helicobacter pylori is a major human pathogen associated with significant morbidity. The treatment oriented by the antibiogram or PCR (Polymerase Chain Reaction) should be privileged in children. However, the optimal treatment for the eradication of pediatric H. pylori infection is still not established.

No French consensus conference on the management of H. pylori infection in children taking into account the epidemiological data available for this infection has been published. The description of diagnostic and therapeutic management procedures has not yet been specifically described according to the country of birth of children. The main objective is to collect data enabling the establishment of a French observatory of Helicobacter pylori in children in order to provide a national database.

lead_sponsor: Lille Catholic University


title: Pathophysiological Explorations of Red Blood Cells

acronym: GR-Ex

summary: GR-Ex is a program labelled by Labex (Laboratory of Excellence) by the French Ministry of Higher Education and Research. This program aims to develop the means to improve knowledge in the physiology and pathologies of erythropoiesis, red blood cells and iron metabolism, and to develop new therapeutic protocols capable of providing added value in terms of innovation.

lead_sponsor: Imagine Institute


title: Information and Accompaniment of Siblings Following the Announcement of a Cancer in Pediatric Hematology.

summary: The primary objective is to evaluate the experience with the information received on the disease by the healthy brothers and sisters of childrens with malignant haemopathy at the Centre Hospitalier Régional et Universitaire of Lille

lead_sponsor: University Hospital, Lille


title: Clinical Monitoring, MRI and Neuro-Ophthalmology of a Cohort of Patients With a Clinically Isolated Syndrome

acronym: cinocis

summary: The purpose of this study is to develop tools to detect, measure, monitor and predict axonal damage in the course of CIS and during Multiple sclerosis (MS), in order to be able to consider as early as possible an adaptation of the background treatment in patients with MS. patients with radiological criteria of poor long-term clinical course.


title: Impact de la Carence Martiale et de Son Traitement Sur le métabolisme Mitochondrial du Cardiomyocyte (MitoCardioFer)

acronym: MitoCardioFer

summary:
Iron is involved in essential functions of the body. It allows the transport of oxygen in the blood, via hemoglobin, at the muscular level, via myoglobin, and it is also involved in cellular metabolism in general, in particular for the production of ATP at the mitochondrial level, within the cytochromes and iron-sulfur proteins of the respiratory chain.

Recently, iron deficiency has been identified as an important prognostic factor in heart failure patients. Iron therapy improves symptoms and physical performances of heart failure patients, even in the absence of anemia. As a result, the correction of iron deficiency is now proposed as one of the therapies for heart failure. However, the pathophysiology of the association between cardiac dysfunction and iron deficiency is still poorly understood.

The investigators previously developed a mouse model of iron deficiency without anemia, in which the investigators observed impaired physical performances, a decrease of left ventricular ejection fraction, and a decrease in mitochondrial complex I activity. These abnormalities were normalized after iron injection. These animal data suggest that iron deficiency is responsible for left ventricular dysfunction secondary to mitochondrial I complex abnormalities, and that iron therapy corrects them.

Iron deficiency is very common in the preoperative period of cardiac surgery, affecting 40 to 50% of patients. During this surgery, it is possible to perform a myocardial biopsy without risk to the patient.

The purpose of this study is to verify in patients requiring valvular heart surgery, if iron deficiency is responsible for a decrease in mitochondrial complex I activity and a decrease in cardiac function during the perioperative period, and to verify whether iron treatment improves these abnormalities.

lead_sponsor: University Hospital, Angers

location_facility: CHU Angers - DEPARTEMENT D'ANESTHESIE REANIMATION


title: Maintenance Brentuximab Vedotin (Bv) Following Allogeneic Stem Cell Transplantation for Hodgkin Lymphoma Patient: A Prospective, Multicenter, Phase II Study.

acronym: BV-ALLO

summary:
Despite a high recovery rate with chemotherapy and radiation therapy treatment, 15 to 30% of patients suffering from Hodgkin lymphoma are refractory or relapsed. Standard rescue treatment for these patients is chemotherapy followed by a hematopoietic stem cell auto-SCT. Despite a very good rate of complete sustainable response in 50% of the patients, another 50% of the patients relapse after increased therapy and require additional treatment. Consequently, one option for these patients is to offer a novel rescue therapy, enabling them to have partial or complete response, and offer them a hematopoietic stem cell allo-SCT. In the only prospective phase 2 study published by Sureda et al. assessing this therapeutic approach, the rate of mortality not linked to relapse was 8% at 100 days and 15% at 1 year. The progression-free survival rate was 48% at 1 year and 24% at 4 years. Relapse occurred between 3 and 35 months with a median of 6 months in 51% of the patients out of a total of 78 patients. Cumulative incidence of relapse was 37% at 1 year and 59% at 5 years.

Brentuximab Vedotin (Bv) is an anti-CD30 antibody-drug conjugate. This drug has shown its efficacy with very acceptable toxicity in patients suffering from advanced-stage Hodgkin lymphoma. Bv was consolidatively evaluated after an auto-SCT. 329 patients, at high risk of relapse after auto-SCT, received Bv (n=165) in a dose of 1.8 mg/kg every 3 weeks or a placebo (n=164) for 16 cycles. The progression-free survival median (validated by a panel of independent experts) was 42.9 months (95% CI 30,4-42 ; 9) for patients in the Bv group and 24.1 months (11.5 not reached) in the placebo group.

The purpose of our study is to reduce relapse rate by carrying out maintenance with Bv after allografting hematopoietic stem cells in a population of patients suffering from Hodgkin lymphoma with high risk of relapse after auto-SCT. Fifty eight patients have been slated for inclusion over a period of 2 years.

This is an open-label, prospective, multicenter, phase II trial consisting of post allo-SCT maintenance Bv for Hodgkin lymphoma.

Patients will be recruited over 24 months and be followed for 3 years after allo-SCT.

A total of 58 patients will be included in the study. The duration of the treatment period is approximately 10.7 months for 12 cycles of Bv.

End of study: end of study is defined by the last visit planned by the protocol of the last patient in follow-up, which means 3 years after allo-SCT.

lead_sponsor: University Hospital, Caen


title: Hydroxychloroquine Versus Placebo: Impact on Thrombotic Relapse in Primary Antiphospholipid Syndrome

acronym: PAPIRUS

summary:
Antiphospholipid syndrome (APS) combines thrombotic (venous and/or arterial) and/or obstetrical manifestations, along with biological anomalies related to the presence of antiphospholipid antibodies. Despite actual treatment recommended by international guidelines, the relapse rate in APS is high and survival is 65% at 15 years. Hydroxychloroquine has demonstrated its efficacy and benefits in the treatment of Systemic Lupus Erythematosus, but there is no current consensus concerning the efficacy of this treatment in the secondary prevention of thrombotic events in primary APS, even though several in vitro experimental and animal model data, along with several clinical studies have suggested a beneficial effect of this drug in this indication. Considering the prevalence of primary APS in the general population and of the number of clinical events observed in patients with primary APS and receiving conventional treatment with vitamin K anticoagulants (VKA), the consortium expects a minimum clinically relevant difference of 70%. Considering a prevalence of thrombotic events for the entire studied primary APS population of 10% at 2 years, the consortium expects a 70% decrease in thrombotic events under Hydroxychloroquine treatment administered in addition to VKA treatment in primary APS, i.e. a 3% prevalence in the Hydroxychloroquine group at 2 years. The consortium proposes a drug trial, phase III, national multicentric, comparative, randomized, superiority, double-blind, controlled with 2 compared groups (Hydroxychloroquine versus placebo) study. The enrolment period will be 24 months.

The main aim of this trial is to comparatively assess at 24 months the number of new thrombotic events (venous and arterial) in primary antiphospholipid syndrome in patients treated with VKA plus Hydroxychloroquine versus VKA plus placebo, in a multicentre, prospective randomized, double-blind, versus placebo study.

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHR ANGERS

type_etablissement: CH

acronyme: PAPIRUS

titre: Plaquenil versus Placebo : Incidence sur la Récidive thrombotique dans le SAPL primaire

discipline_principale: médecine interne

nom_porteur: BELIZNA

prenom_porteur: Cristina


title: Case-control Study Evaluating the Impact of p16Ink4a in Bronchopulmonary Dysplasia in Children

summary:
The bronchopulmonary dysplasia (BPD) is a respiratory disease of the premature child which lead to a reduction of gas exchange surface and to a prolonged respiratory failure. This disease has morphologic and functional consequences at adulthood and is today considered to be an early determinant of respiratory diseases at adulthood.

The physiopathology of BPD is not well known. Several mechanisms could be involved especially a reparation failure favored by an increase of cellular senescence which is a permanent stop of cellular proliferation. The transcription factor 16 Ink4a, considered as a marker of aging, is one of the essential markers of senescence. Its increase during prematurity was shown at the blood cells of the cordon, but its involvement in BPD and its evolution in child are not yet studied.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Central Apnea in Patients Receiving Ticagrelor

summary: all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy

ReferenceCitation: Meurin P, Ben Driss A, Defrance C, Dumaine R, Weber H, Renaud N, Bonnevie L, Mouram S, Tabet JY. Central sleep apnea after acute coronary syndrome and association with ticagrelor use. Sleep Med. 2021 Apr;80:39-45. doi: 10.1016/j.sleep.2021.01.026. Epub 2021 Jan 20.

lead_sponsor: Les Grands Prés


title: Airtraq Versus Fiberoptic for Awake Tracheal Intubation : A Randomised Non-inferiority Trial

summary:
The airway management is a vital act in anesthesia. The gold standard technique for planned very difficult intubation is nasotracheal fiberoptic intubation. The success rate with this procedure is 98.8%. However, learning this technique is difficult and it's considered uncomfortable by patients and practitioners.

The Airtraq® videolaryngoscope is commonly used for difficult orotracheal intubation. Cases of awake intubation by Airtraq® have been described.

Furthermore, the French Society of Anesthesia-Resuscitation, in its last formalized expert recommendations (2017) on difficult intubation, proposes the use of video laryngoscopes as an alternative to the fiberoptic bronchoscope.

We propose a non-inferiority study evaluating the use of Airtraq® for the realization of a awake intubation compared to the gold standard (fiberoptic bronchoscope). This prospective randomized study should include 78 patients in two groups. The purpose of this study is to improve the comfort of patient and practitioner during an awake tracheal intubation, to facilitate the learning of the technique.

ReferenceCitation: Collins SR, Blank RS. Fiberoptic intubation: an overview and update. Respir Care. 2014 Jun;59(6):865-78; discussion 878-80. doi: 10.4187/respcare.03012.

evidence: open (via free pdf)

publisher_dissemination: Daedalus Enterprises

ReferenceCitation: Pintaric TS. UPPER AIRWAY BLOCKS FOR AWAKE DIFFICULT AIRWAY MANAGEMENT. Acta Clin Croat. 2016 Mar;55 Suppl 1:85-9.

ReferenceCitation: Law JA, Morris IR, Brousseau PA, de la Ronde S, Milne AD. The incidence, success rate, and complications of awake tracheal intubation in 1,554 patients over 12 years: an historical cohort study. Can J Anaesth. 2015 Jul;62(7):736-44. doi: 10.1007/s12630-015-0387-y. Epub 2015 Apr 24.

ReferenceCitation: Law JA, Morris IR, Milne AD. The complications of awake tracheal intubation. Can J Anaesth. 2015 Sep;62(9):1023. doi: 10.1007/s12630-015-0402-3. Epub 2015 May 12. No abstract available.

ReferenceCitation: Allan AG. Reluctance of anaesthetists to perform awake intubation. Anaesthesia. 2004 Apr;59(4):413. doi: 10.1111/j.1365-2044.2004.03729.x. No abstract available.

ReferenceCitation: Xu YC, Xue FS, Luo MP, Yang QY, Liao X, Liu Y, Zhang YM. Median effective dose of remifentanil for awake laryngoscopy and intubation. Chin Med J (Engl). 2009 Jul 5;122(13):1507-12.

ReferenceCitation: Dawson AJ, Marsland C, Baker P, Anderson BJ. Fibreoptic intubation skills among anaesthetists in New Zealand. Anaesth Intensive Care. 2005 Dec;33(6):777-83. doi: 10.1177/0310057X0503300613.

ReferenceCitation: Dimitriou VK, Zogogiannis ID, Liotiri DG. Awake tracheal intubation using the Airtraq laryngoscope: a case series. Acta Anaesthesiol Scand. 2009 Aug;53(7):964-7. doi: 10.1111/j.1399-6576.2009.02012.x. Epub 2009 Jun 3.

ReferenceCitation: Suzuki A, Toyama Y, Iwasaki H, Henderson J. Airtraq for awake tracheal intubation. Anaesthesia. 2007 Jul;62(7):746-7. doi: 10.1111/j.1365-2044.2007.05155.x. No abstract available.


title: SURAYA : Suicide Re Attempts in Young Adults After First Suicide Attempt : Socio-demographic, Clinical and Biological Correlates

acronym: SURAYA

summary:
Suicide is the second leading cause of death among people aged 15 to 24 (WHO, 2014). After a first suicide attempt, the 18 to 25 years old would be very likely to repeat the act: 25 to 31% would make a new attempt in the following year (Christiansen et al, 2007).

Nevertheless the literature on this subject is not detailed. In this project, we hypothesize that young adults aged 18 to 25 who have made their first suicide attempt will repeat their act more frequently than younger or older populations. In addition, these young people would have identifiable risk factors (sociodemographic, clinical and biological) that differ from young people who do not enter this phenomenon.

Our main objective is to measure the rate of suicidal reiteration in a population of young adults aged 18 to 25 years.

Our secondary objectives are to identify sociodemographic, clinical and biological characteristics of a population of suicidal re attempt young people, to highlight potential risk factors

ReferenceCitation: Abrial E, Chalancon B, Leaune E, Brunelin J, Wallon M, Moll F, Barakat N, Hoestlandt B, Fourier A, Simon L, Magnin C, Hermand M, Poulet E. Investigating Predictive Factors of Suicidal Re-attempts in Adolescents and Young Adults After a First Suicide Attempt, a Prospective Cohort Study. Study Protocol of the SURAYA Project. Front Psychiatry. 2022 Jun 29;13:916640. doi: 10.3389/fpsyt.2022.916640. eCollection 2022.

repositories_concat: PubMed Central

publisher_dissemination: Frontiers

lead_sponsor: Hôpital le Vinatier


title: Patients' Perception on Bone Biomaterials Used in Dentistry : a Multicentric Study

acronym: PEPABIO

summary: The goal of this study is to collect the patients' opinion about the different types of bone graft, to assess which are the most rejected by the patients and if the demographic variables (such as the gender or the age) and the level of education influence their decision.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
University of Barcelona


title: Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes

summary:
Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this study was to identify risk factor of cesarean in this population.

Methods: This study is an observational, retrospective and single-center study from the hospital of Montpellier. All the pregnancies, planned or not, with subcutaneous insulin infusion or multiple daily injections of insulin, in patients with diabetes type 1 between 2009 and 2015, after 24 weeks of gestation were included. All the data were retrospectively collected by the principal investigator with computer and paper files.


title: Evaluation du pré-marquage Par AccuVein® au Cours Des échographies Doppler de repérage saphène.

acronym: ACCUMULATION

summary: Ultrasound marking of saphenous veins before varicose vein surgery or for saphenectomy for vascular or coronary artery bypass grafting is a long, tedious, low-grading examination, generating overconsumption of many consumables including marking markers that may damage the probes, of the modern and expensive ultrasound doppler. Augmented reality devices can visualize the superficial veins and hope to simplify the investigation, improve the comfort of the patient during the examination by significantly reducing the time of the examination. There is few data in the literature on the value of using augmented reality devices of this type. The AccuVein® system is a patient-friendly, non-contact, non-invasive technique that minimizes discomfort due to standing time and thus improves patient comfort.


title: Association Between Proton Pump Inhibitors and the Incidence of Hematologic Toxicity of Pemetrexed: a Prospective, Multicenter, Observational and Longitudinal Study Among Patients Treated by a Pemetrexed-based Chemotherapy

acronym: IPPEM

summary: Pemetrexed is a multi-folate inhibitor approved in the treatment of non-small cell lung cancer (NSCLC) and pleural mesothelioma. Its toxicity profile is mainly hematologic (anemia, neutropenia and thrombopenia) and can be limiting when > grade 2 according to NCI-CTCAE criteria. First clinical trials highlighted hematologic toxicity, especially anemia, which was reduced by decreasing pemetrexed dosage from 600 to 500 mg/m² Q3W and by adding systematic vitamin supplementation (B9/B12). Despite this, incidence of hematological toxicity remains frequent with anemia occurring in more than 20% of patients treated by pemetrexed in combination. Methotrexate, a well-known antineoplastic drugs used in several cancer and non-cancer disease conditions can also induced severe hematologic toxicity in case of methotrexate-reduced elimination and, as a consequence, its accumulation. For example, the elimination of methotrexate is mediated by tubular secretion through type 1 and type 3 organic anion transport (hOAT1 and hOAT3). Association with drugs that inhibits hOATs can induced a hematological toxicity caused by methotrexate accumulation. Among these, proton pump inhibitors (PPIs) are known to inhibit hOATs. The drug interaction that results from their combination with methotrexate is clinically relevant and lead to an increased hematological toxicity. However, hypothetical drug interaction between PPIs and pemetrexed is unknown while pemetrexed seems to be mostly eliminated by hOAT3 (11-fold higher than methotrexate). One study revealed lansoprazole to inhibits in vitro hOAT3. This same study investigates in a retrospective chart patients treated by pemetrexed and the study found a significant association between combination with PPI and hematological toxicity by pemetrexed. Unfortunately this study lacks of relevant methodology and suffered from its retrospective chart. This potential drug interaction must be a real concern for oncologists and clinical pharmacists. The investigators aim to investigate the potential association between PPIs and pemetrexed combination and the incidence of hematological toxicity in a multicenter and prospective study.

ReferenceCitation: Slimano F, Le Bozec A, Cransac A, Foucher P, Lesauvage F, Delclaux B, Dory A, Mennecier B, Bertrand B, Gubeno-Dumon MC, Dukic S, Mongaret C, Bouche O, Hettler D, Boulin M, Dewolf M, Kanagaratnam L. Association between proton pump inhibitors and severe hematological toxicity in patients receiving pemetrexed-based anticancer treatment: The prospective IPPEM study. Lung Cancer. 2022 Apr;166:114-121. doi: 10.1016/j.lungcan.2022.02.007. Epub 2022 Feb 24.

evidence: open (via crossref license, author manuscript)

lead_sponsor: CHU de Reims


title: Relationship Between Noise Level and Patients Satisfaction in Post Anesthesia Care Units

acronym: Post op NOISE

summary: World health organization recommends noise level should be less than 30db in hospital. However many analysis conclude to an average of 67dB in the post anesthesia care unit. No many studies were reported about noise impact in a post-anesthesia care unit. Only one was published by B.Allaouchiche in 2002. However, noise is a complaint reported by patients and it could be responsible for physiological and psychological troubles. In this prospective study, the main objective is to determine patients' satisfaction in the post anesthesia care unit, before and after installation of a noise warning device. Between the two parts, a short training about noise consequences on health will be presented to nurses. Improvement off anti-noise actions on patient's satisfaction will analysed.


title: Analysis of Cytokine Expression Pattern in Systemic Sclerosis: Study of the Role of Interleukine-34

acronym: SCLEROKINE

summary: By contrast to other proinflammatory cytokines which are found up-regulated in the skin of patients with psoriasis, atopic dermatitis or systemic sclerosis, IL-34 is the only cytokine that undergoes down-regulation. This finding is interesting regarding the description of IL-34 as an immunosuppressive cytokine. In this study, the expression and the role of interleukin-34 (IL-34) will be investigated in the physiopathology of systemic sclerosis.

lead_sponsor: Poitiers University Hospital

sponsor_collaborators:
Poitiers University Hospital
University of Poitiers


title: Hypoxic Conditioning Combined With Exercise Training in Heart Failure Patient: a Randomised, Controled, Single Blind Study

acronym: hypoxheart

summary: Heart failure impairs quality of life and exercise capacity, despite an optimal medical therapy. Alternative methods, like hypoxic conditioning coupled to exercise training, must be explored and describe

lead_sponsor: University Hospital, Grenoble


title: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits: the Callsas Study

acronym: CALLSAS

summary: Continuous positive airway pressure (CPAP) treatment improves sleepiness, depression and social activities in patients with obstructive sleep apnea (OSA). This evolution can be captured from changes in phone usage habits coupled with a mobile-based services. The aim of this study is to assess the impact of CPAP treatment on phone usage habits in OSA patients.


title: Use of Inhaled Methoxyflurane (Penthrox®) as an Analgesic in Extra-hospital Traumatology at EMS37

acronym: UPETEH

summary:
In pre-hospital settings, the administration of analgesics is often delayed because of difficult patient access (incarceration), difficulty finding a venous pathway or patient refusal.

An optimization of the management of pain in urgency is therefore still necessary.

A side from nitrousoxide of which usage remains restrictive, methoxyflurane (Penthrox®) is the only volatile analgesic currently available for pre-hospital use.

The purpose of this study is to answer the question: Does the use of the inhaled route with Penthrox add value to the treatment of acute traumatic pain in the pre-hospital stage?

lead_sponsor: University Hospital, Tours

location_facility: Emergency Medical Service, University Hospital, Tours


title: Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic

acronym: Edentpsy

summary: Tooth loss impact on daily living, mood and self-perceived well-being. However, psychological impact of teeth loss has not been evaluated. Present study aims to evaluate the psychological conditions of patients pending complete tooth extraction before and shortly after tooth loss using Hospital Anxiety and Depression scale (HAD) and Geriatric Oral Health Assessment Index (GOHAI).


title: Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System - Model of Non-invasive Kyphosis

acronym: VICON-SPINE

summary: Spinal diseases often induce gait disorders with multifactorial origins such as lumbar pain, radicular pain, neurologic complications, or spinal deformities. However, radiography does not permit an analysis of spinal dynamics; therefore, sagittal balance dynamics during gait remain largely unexplored. This prospective and controlled study try to assess the Vicon system for detecting sagittal spinopelvic imbalance and to determine the modification induced by ant induced anterior sagittal imbalance on the kinetics walking parameters

lead_sponsor: University Hospital, Rouen


title: Impact of Renal Replacement Therapy on Coagulation Profile in Patients With Acute Renal Failure

acronym: HEMOSTIR

summary: Renal failure and high plasmatic level of urea have been associated with an increased risk of hemorrhage in surgical patients. There is only sparse data on the impact of renal replacement therapy on homeostatic parameters. The aim of this study is to describe potential changes in homeostatic parameters before and after renal replacement therapy.

lead_sponsor: University Hospital, Brest


title: Closure of Implant Emergence Profile

acronym: FPEI

summary:
In the case of unitary edentulousness, a dental implant is a prosthetic device fixed in the bone which makes it possible to receive a fixed dental prosthesis (crown). Peri-implant soft tissues (gums) play an essential role in the integration of the crown. Indeed, the implant gingival emergence profile provides an aesthetic integration mimicking that of a natural tooth. This implant emergence profile (EIP) is modeled during the surgical and / or prosthetic phases.

The problem comes from the labile character of the EIP (Emergence Implant Profile). If the literature evokes this problem, the instability of the volume of the EIP during the impression phases has never been measured. Moreover, the three-dimensional behavior of the EIP over time (kinetic) during the acquisition phases is not known.

Objective study of the mobility of gingival tissues of the implant emergence profile (IEP), using an intra-oral optical camera, would scientifically measure the labile aspect of the IEP and improve the procedure of registration of peri-implant soft tissues

lead_sponsor: University Hospital, Toulouse


title: Identification of Risk Factors Parkinson's Disease by Convergence Strategy

acronym: CONVERGENCE

summary: Using this convergence approach from a limited group of subjects with non-diseased controls, patients with Parkinson's disease or related diseases, we will be able to limit the number of potential genes of specific susceptibility to Parkinson disease. These genes will then be studied using a case-control genetic epidemiology approach. The risk of developing the disease will then be evaluated according to clinical, biological and environmental variables collected in Parkinson's subjects and healthy controls in the second group of subjects. The specificity of the genetic associations found will be evaluated in subjects with Parkinson's disease.


title: Effects of a Cocktail XXS-2A/Omega-3 on Insulin Sensitivity and Oxidative Stress During a 20-day Period of Physical Inactivity: a Controlled, Randomized Pilot Study on 20 Healthy Men

summary:
This experiment consists on a 20-day reduction in daily step in free-living active individuals to induce physical inactivity. This will be used to test the efficacy of the anti-oxidant cocktail we aim to test as a new countermeasure in 2016 during the 60-d bed rest planed by ESA/CNES.

The objective of this study is to investigate whether the cocktail of natural antioxidants XXS-2A comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the glucose intolerance and improve oxidative defenses induced by 20 days of physical inactivity through daily step reduction

Although physical inactivity is reported to affect glucose tolerance within days of inactivity, we selected a period of 20 days for the effect of the cocktail to take place and assess secondary molecular mechanisms. The effect of this short period of inactivity on metabolism will moreover be boosted during the last 10 days by taking fructose, a sugar found in abundance in fruits, honey and juices, which is known to quickly trigger metabolic deregulation.

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license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Paris Observatory

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

publisher_dissemination: American Diabetes Association

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

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

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

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

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