title: Exploration of the Transfer of Barium From Thermal Mud (T2BT Study)

summary: It involves conducting a clinical study on a population of healthy volunteers (age between 18 and 30 years) without direct benefit for the subject to explore a transfer of barium in the blood and urine following applications of thermal mud. The main objective is to highlight an increase in serum barium level of at least twice.

ReferenceCitation: Roques CF, Trèves R, Queneau P, Bontoux D. Avis de l'académie nationale de médecine relatif à l'évaluation des risques sanitaires liés à la présence de baryum dans des argiles constitutives des boues thermales et à l'absence de contrôle sanitaire des boues thermales. Bull Acad Ntle Méd., , 201: 13-38, 2017.

ReferenceCitation: Ainouche R, Tabone W, Bouvier CE, Renaud V. Usage thérapeutique (des boues thermales), panorama du thermalisme français en 2013. Bulletin de l'AFTH (Association Française des Techniques Hydrothermales), 2014, n° 25, Symposium Utilisation des boues en établissement thermal, Enghien les Bains, Novembre 2013, pp. 7-11

ReferenceCitation: Gomes C, Carretero MI, Pozo M, Maraver F, Cantista P et al. Peloids and pelotherapy : historical evolution, classification and glossary. Applied clay science 75-76:28-38, 2013.

ReferenceCitation: Liu H, Zeng C, Gao SG, Yang T, Luo W, Li YS, Xiong YL, Sun JP, Lei GH. The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2013 Oct;41(5):1418-25. doi: 10.1177/0300060513488509. Epub 2013 Sep 5.

ReferenceCitation: Roques CF. Mud Therapy. Data of clinical evidence. Balnea 10:57-62, 2015.

ReferenceCitation: Xiang J, Wu D, Li J. Clinical Efficacy of Mudpack Therapy in Treating Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Studies. Am J Phys Med Rehabil. 2016 Feb;95(2):121-31. doi: 10.1097/PHM.0000000000000354.

ReferenceCitation: Roques CF, Queneau P. [SPA therapy for pain of patients with chronic low back pain, knee osteo-arthritis and fibromyalgia]. Bull Acad Natl Med. 2016 Mar;200(3):575-86; discussion 586-7. Review. French.

ReferenceCitation: World Health Organization (WHO) - 2001 - IPCS (International Programme on Chemical Safety) - Concise international chemical assessment document 33 - barium and barium compounds. 57 pp

ReferenceCitation: Conseil canadien des Ministres de l'environnement - Recommandations canadiennes pour la qualité des sols - environnement et santé humaine. Le baryum. Feuillet d'information 2013, 1 doc 11 pp

ReferenceCitation: Kravchenko J, Darrah TH, Miller RK, Lyerly HK, Vengosh A. A review of the health impacts of barium from natural and anthropogenic exposure. Environ Geochem Health. 2014 Aug;36(4):797-814. doi: 10.1007/s10653-014-9622-7. Epub 2014 May 21. Review.

ReferenceCitation: INRS - base de données de fiches toxicologiques. Baryum et composés. Fiche toxicologique complète n°125. 1 doc 12 pp, 2012

ReferenceCitation: Ding C, Pan Y, Zhang A, Zhu C, Liu D, Xu G, Zheng Y, Yan H. [Distribution of rubidium, cesium, beryllium, strontium, and barium in blood and urine in general Chinese population]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2015 Dec;33(12):894-9. doi: 10.3760/cma.j.issn.1001-9391.2015.12.004. Chinese.

lead_sponsor: Association Francaise pour la Recherche Thermale


title: Realistic Evaluation of Expériences Animées, a School-based Intervention in Nouvelle Aquitaine

acronym: ERIEAS

summary: The study is a realistic evaluation of the Expériences Animées school-based programme. The aim is to precisely characterize i) the effects in terms of alcohol and cannabis consumption, the use of health professionals in case of problematic use of those two substances; ii) the context and underpinning mechanisms triggered by the program in terms of changes of alcohol and cannabis representations and life skills development. This evaluation could allow to produce the key functions of the programme: how the intervention works, in which conditions.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Martin-Fernandez J, Affret A, Martel E, Gallard R, Merchadou L, Moinot L, Termote M, Dejarnac V, Alla F, Cambon L. Realist evaluation of a theory-based life skills programme aiming to prevent addictive behaviours in adolescents: the ERIEAS study protocol. BMJ Open. 2020 Jun 29;10(6):e034530. doi: 10.1136/bmjopen-2019-034530.

family: Martin-Fernandez

full_name: Judith Martin-Fernandez

given: Judith

sequence: first

family: Affret

full_name: Aurelie Affret

given: Aurelie

sequence: additional

family: Martel

full_name: Emma Martel

given: Emma

family: Gallard

full_name: Romain Gallard

given: Romain

family: Merchadou

full_name: Laurence Merchadou

given: Laurence

family: Moinot

full_name: Laetitia Moinot

given: Laetitia

family: Termote

full_name: Monique Termote

given: Monique

family: Dejarnac

full_name: Vincent Dejarnac

given: Vincent

family: Alla

full_name: François Alla

given: François

family: Cambon

full_name: Linda Cambon

given: Linda

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Bordeaux

location_facility: CIC1401-EC - CHU de Bordeaux Centre Inserm U1219

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Preliminary Validation of the Demonstrator of an In Vitro Diagnostic Device for Hepatitis B Screening

acronym: DiVHeB

summary: The principale objective of the study is to perform a first step of technical adjustment and preliminary validation of a diagnostic test for hepatitis B (HBsAntigen, anti-HBs Antibody and anti-HBc Antibody) on capillary blood with the device under study in non-immunized subjects against hepatitis B, in subjects with hepatitis B, in subjects with old or cured hepatitis B and in hepatitis B vaccine recipients, compared with the values obtained with the reference technique of medical biology laboratory on serum. The analysis will be performed on the entire cohort.

study_start_date_type: Actual

status: Unknown status

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Device Feasibility

ipd_sharing: Undecided

lead_sponsor: University Hospital, Grenoble

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Study of PtiO2 Variation by Body Temperature and Capnia in Severe Head Trauma Patients With Intracranial Refractory Hypertension Treated With Targeted Temperature Control

acronym: TODAY

summary:
Serious head trauma is a common and pathology and responsible of high morbidity and mortality. The major challenge, from the very first hours, is to limit cerebral ischemia by controlling secondary brain injury factors.

These parameters must be integrated early in order to guide the better cerebral resuscitation. Brain monitoring is multimodal:transcranial Doppler, intracranial pressure sensor, cerebral tissue pressure in O2.

In the case of refractory intracranial hypertension to well-conducted medical treatment, targeted temperature control showed its efficacy on the control of intracranial pressure.

There are few data in the literature on PbtO2 modifications during therapeutic hypothermia.

PbtO2 monitoring is now commonly used according to literature data, showing the benefit of the latter but the interpretation of its values during the phase of targeted temperature control is not known. Due to the lack of data on the variation of values of PbtO2 during the hypothermia phase, values falsely comfortable or falsely weak could lead respectively to a lack of support of an episode of tissue hypoxia or the introduction of unjustified aggressive therapeutics.

lead_sponsor: University Hospital, Brest


title: Meningiomas and Treatment With CYPROTERONE ACETATE or Progestin: Retrospective Study in Patients Followed at the CHRU of Brest

acronym: MAP

summary: Investigators observe an increase risk of meningioma in patient treated by CYPROTERONE ACETATE or other form of progestin. Investigatorsdiscribe caractéristics of meningioma and treatement of the patients follow up in CHRU of Brest

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Bernat AL, Oyama K, Hamdi S, Mandonnet E, Vexiau D, Pocard M, George B, Froelich S. Growth stabilization and regression of meningiomas after discontinuation of cyproterone acetate: a case series of 12 patients. Acta Neurochir (Wien). 2015 Oct;157(10):1741-6. doi: 10.1007/s00701-015-2532-3. Epub 2015 Aug 12.

ReferenceCitation: S. Froelich, "Does cyproterone acetate promote multiple meningiomas?," 2009.

location_facility: Département de Nutrition - CHRU de Brest

status_simplified: Completed


title: Small-vessel Disease Burden and Early Risk of Stroke After Transient Ischemic Attack

acronym: TIA

summary: Predicting the risk of stroke remains a challenge in the management of transient ischemic attack (TIA). In addition to clinical variables, morphological features such as the presence of a diffusion weighted sequence (DWI) lesion and carotid stenosis of at least 50% improve risk stratification and are considered in the literature. score ABCD3-I1. Several studies have shown that brain microhemorrhages are associated with the risk of early stroke in patients with TIA. Data on white matter hypersignals on the T2-weighted sequence or FLAIR (FLuid Attenuated Inversion Recovery) are more conflicting. The global microangiopathic load, including the gaps, the hypersignals of the white matter, the perivascular spaces visible on MRI in the basal ganglia, especially when they are very numerous (> 20) and the gaps, have recently been described as being associated with stroke risk within 2 to 3 years of TIA or ischemic stroke. To date, the predictive value of global microangiopathic burden on early stroke risk in the course of TIA is not known.

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon


title: Randomised Study of Noninferiority Comparing a TransversusAbdominis Plane Block Surgical (c-TAP Block) to the Ultrasound-guided Abdominis Plane Block Transversus (Us-TAP Block) in Postoperative Analgesia After Laparoscopy or Laparotomy

acronym: CHIRTAP

summary: Interventional, randomised, prospective, multicentric study

status: Recruiting

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Institut Jean-Godinot

intervention_type: Procedure

lead_sponsor_type: industriel


type: Other Identifier

title: Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient

acronym: ULD OSLER

summary:
Hereditary hemorrhagic telangiectasia (HHT) is linked to a dysregulation of angiogenesis leading to the formation of arteriovenous malformations (AVM): cutaneo-mucous telangiectasia and visceral shunts. The diagnosis is clinical and based on Curaçao criteria: recurrent epistaxis, cutaneo-mucous telangiectasia, hereditary signs and presence of visceral AVM.

Pulmonary AVMs (PAVM) expose patients to many potentially life-threatening complications, such as strokes or brain abscesses due to the right-left shunt created and the lack of filtration barrier of the pulmonary capillary within the AVM. These patients should therefore have regular monitoring throughout their life by a chest CT scanner every 5 to 10 years in the absence of PAVM at the initial scan or more often if PAVMs are present. The management of PAVMs is based on their early detection and embolization in interventional radiology during which is set up within the afferent artery of the PAVM an embolizing agent, the coil.

However, the risk of cumulative irradiation exposure from thoracic scanners and repeated thoracic embolizations over time could be reduces by a decrease of X-rays dose.

A new thoracic CT imaging protocol validated in the United States in the primary screening of lung cancer, the ultra-low dose protocol, is a CT scanner acquired at an irradiation dose equivalent to that of a frontal chest x-ray and in profile. The dose reduction is of 40 times the usual dose of a chest CT scanner.

The lung parenchyma has a high natural contrast on thoracic CT images and there are few adjacent attenuating structures allowing a drastic reduction of dose. However, from this dose, the image quality is degraded with an increase of the image noise. The diagnostic performances have to be confirmed with qualitative and quantitative measurements.

Thus, the objective of this study is to compare the sensitivity and the specificity of the current scanner and the ultra-low dose scanner to reduce the exposure to X-rays.

primary_purpose: Diagnostic

location_facility: Hospices Civils de Lyon - Hopital Louis Pradel

intervention_type: Radiation


title: Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorder in Female Adolescents With Anorexia Nervosa: a Randomized, Controlled Superiority Study

acronym: ANO-TERV

summary:
Anorexia nervosa is defined in DSM V as a quantitative and qualitative dietary restriction resulting in significant weight loss, intense fear of weight gain, altered weight and body shape perception (body dysmorphic disorder) and low self-esteem influenced by weight or body shape. Body dysmorphic disorder is the most difficult symptom to manage in anorexia nervosa and its persistence is a factor associated with relapse.

Virtual reality exposure therapy has proven its effectiveness in the management of post-traumatic stress disorder in the military and is a widely used therapy. The effectiveness of this treatment using new technologies has not yet been studied for the treatment of body dysmorphic disorder in anorexia nervosa and is not used routinely. It could represent an interesting alternative to the physical approach in psychomotor therapy, traditionally offered to patients suffering from anorexia nervosa. It is important to evaluate the effectiveness of virtual reality exposure therapy in the management of body dysmorphic disorder in patients with anorexia nervosa by comparing these two care techniques.

primary_purpose: Treatment

lead_sponsor: CHU de Reims

intervention_type: Behavioral


title: Metabolic, Functional and Nutritional Responses to Weight Cycling in Athletes: The WAVE Study

acronym: WAVE

summary:
Many elite athletes are submitted to frequent rapid weight loss periods to meet their competition weight category and then experience weight cycling (lowing and gaining weight regularly). This weight cycling induce severe temporary energetic and metabolic changes and when repeated over time can lead to permanent metabolic adaptations that might favor metabolic disorders, body weight gain and body composition changes (favoring fat mass). The exact effects of this weight cycling are not clear yet, especially in terms of metabolic, energetics, nutritional functional and psychological impacts. Better understand these adaptations and their variations during weight loss and weight gain in regular weight cycler is of main importance to prevent these athletes for future health issues.

The aim of the present project if to assess these metabolic, functional, energetic and nutritional adaptations during weight loss, weight stable and weight gain periods in athletes experiencing regular weight cycling.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Randomized Study of the Effect of Vocal Exercises With Straw on Aerodynamic Parameters of Voice (Pressure, Flow) in Dysodic Singers With Nodules

acronym: DYSODIE

summary:
Singers are over-represented in phoniatric consultations; they present increased risk of developing voice disorders. The most common lesion found in singers is nodule. It comes from vocal straining characterized by the use of a pressed phonation mode, resulting in an increase subglottal pressure and a decrease flow rate. Voice therapy aims to restore a more relaxed phonation. There is a growing interest in semi-occluded vocal tract exercises with a straw in therapy; they have positive effects, particularly in terms of aerodynamic parameters such as subglottal pressure and oral airflow. After these exercises, subglottal pressure decreases and oral airflow increases. In other words, patient adopts a more relaxed phonation mode. Several studies have investigated the effect of these straw exercises on dysphonic patients i.e. on speaking voice; no study to date has explored the effect of these exercises on dysodic subjects i.e. on singing voice.

The aim of this study is to evaluate the impact of straw exercises compared to open-mouth exercises on aerodynamic parameters in dysodic women singers with nodules.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier


title: Data Collection of Therapeutic Compliance in Patients Receiving Corneal Graft Using a Collection Box for Corticosteroid Eye Drops

acronym: KALICORT

summary:
Following corneal graft, local steroids with a gradually decreasing dose for 12 months are prescribed to reduce the graft rejection risk (maximum incidence of 20% for the first 12 months). The validated KaliJAR® device is a box for single-dose eye drops collection. This innovative tool will make it possible to objectify the compliance of patients with a corneal graft.

Unlike the field of glaucoma, no specific compliance data are available for corneal grafts, although it is important because graft rejection is the most important cause of corneal graft failure.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Device


title: Clinical, EEG and Radiological Initial and Evolutive Characterisation of LGI1-antibody Patients

summary:
Autoimmune encephalitis involve autoantibodies targeting central nervous system, and particularly the synapse or its structure like for LGI1 protein. Anti-LGI1 encephalitis is revealed by an inflammation of the limbic system, with mainly temporal lobe, faciobrachial dystonic or generalized seizures, and cognitive disorders.

This disease is rare and its clinical, EEG and radiological characterisation is not sufficiently established. The investigators will evaluate these three aspects for the anti-LGI1 cohort of patients of the National Reference Center of autoimmune encephalitis.

location_facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes


title: Immunogenetic Characteristics in Autoimmune Encephalitis and Related Disorders: HLA Analysis

acronym: ICARE

summary:
Autoimmune encephalitis (AE) are characterized by subacute onset of memory deficits, altered mental status or psychiatric symptoms, frequently associated with seizures, inflammatory cerebrospinal fluid and in cases with prominent limbic involvement, typical magnetic resonance imaging. Several autoantibodies (Ab) may be detected in AE, although its detection is not mandatory to establish a diagnosis. These Ab mainly recognize different synaptic and cell-surface proteins in the central nervous system, and are thought to be pathogenic as they alter the normal location or function of its antigens.

The primary trigger of the immune response is unknown for most of AE. In addition to acquired susceptibility, genetic predisposition may also be important in the pathogenesis of AE. Human leukocyte antigen (HLA) is the genetic factor most frequently associated with autoimmune diseases, due to its genetic complexity and key role in the adaptive immune response. The aim of the study is to describe HLA profile in three groups of autoimmune encephalitis and related disorders: anti-LGI1, anti-CASPR2 and anti-GAD neurological diseases.


title: Neuromuscular Plasticity in Response to Obesity: Effects of Mechanical Overload, Metabolic Disorders and Age

acronym: PLANEUROB

summary: Obese people suffer from significant functional limitations, which affect their quality of life and limit their physical activity level. Functional abilities are largely determined by neuromuscular properties, i.e the ability to produce a torque or a power, and fatigability, i.e the ability to maintain a high level of torque production during repeated contractions. Our previous studies on "healthy" obese adolescents (i.e without inflammation or metabolic disorder) suggests that obesity has positive effects on the neural and muscular factors responsible for torque production, with chronic overload acting as a strength training . However, this high torque level is associated with higher fatigability. These results are in contrast with the data obtained on adult obese patients (young and elderly), in whom torque production and fatigability appear to be more impaired, probably due to the development of metabolic disorders associated with obesity (inflammation, insulin resistance and lipid infiltration in muscle) and aging. The respective effects of mechanical overload, metabolic disorders (insulin resistance and lipid infiltration) and aging on neural and muscular factors of torque production and neuromuscular fatigue etiology are not currently known in young adult obese of elderly. Their relationship to the clinical symptoms of mobility troubles is also unknown. However, this knowledge is crucial for designing physical activity programs tailored and adapted to the level of metabolic impairment and age of obese patients. The hypothesis is that mechanical overload associated with obesity has positive effects on torque production in the absence of metabolic alteration and the effect of aging but negative effects on fatigability, mainly due to muscular factors; the insulin resistance increases peripheral fatigue (due to an alteration in the excitability of the sarcolemma during fatiguing exercise), central fatigue, and slows recovery; the development of inflammation and lipid infiltration, which are more pronounced in obese subjects, further affect torque production through inhibition of the nervous control and alteration of contractile properties and muscle architecture, all these phenomena leading to a decrease in torque production and increased fatigability, cumulating with the effects of the ageing (sarcopenia).


title: Prevalence, Impact and Reversibility of Acute Diaprhagmatic Dysfunction in Acute Respiratory Detresse Measured by Diaphragmatic Echogaphy

acronym: PIRD-DRA

summary:
The diaphragm is a fine striated muscle with both extra respiratory and respiratory functions. It does most of the breathing work in interaction with the accessory respiratory muscles, the rib cage and the abdomen. Its activity can be measured by the transdiaphragmatic pressure generated by the magnetic stimulation of phrenic nerves (gold standard). It has been shown in the literature that diaphragmatic ultrasound, via the measurement of diaphragmatic excursion and especially the thickening fraction, is an easily accessible, non-invasive, reproducible and relevant technique for evaluating acute diaphragmatic dysfunction in resuscitation patients.

The objective of this project is to evaluate the prevalence of diaphragmatic dysfunction at admission in patients hospitalized in intensive care / respiratory intensive care unit for hypercapnic and/or hypoxic acute respiratory distress and requiring ventilatory support by non-invasive ventilation or high flow oxygen therapy. A subgroup analysis will then be carried out on 3 populations:

Hypercapnic exacerbation of chronic obstructive pulmonary disease
Hypoxic acute respiratory distress on infectious lung disease
Acute pulmonary edema

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: STUDY OF THE EFFECTIVENESS OF TRANSCRANIAL DIRECT CURRENT STIMULATION ON OBSESSIVE COMPULSIVE DISORDER

acronym: EFFI-STOC

summary:
The usual management of Obsessive Compulsive Disorders is based on cognitive-behavioural psychotherapy, as well as the use of serotonergic antidepressants. Nevertheless, a significant proportion of patients (40% to 60%) are non-responders to these conventional therapies, and remain severely handicapped.

transcranial Direct current stimulation (tDCS) has already proven its effectiveness, in addition to drug approaches, in various clinical settings, such as depression or acoustic-verbal hallucinations. This technic appears to be an extremely interesting alternative This is a non-invasive neuromodulation technique (application of a low intensity direct current (1 to 2 mA) between two electrodes positioned on the scalp) that allows the neural activity of different brain areas to be modulated simultaneously. It is a simple and inexpensive technique with excellent tolerance.


title: A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children

acronym: KID SSQ12

summary:
Deafness significantly affects several auditory tasks of everyday life in children: understanding speech in quiet and noisy environments, spatial location of sounds ...

These difficulties in locating sound sources are often ignored by parents and underestimated by children. Nowadays we there is specific tools to evaluate these problems in children. Indeed, there is a validated French questionnaire (Speech and Spatial Questionnaire SSQ) for adults that evaluates auditory abilities, including sound localization, in different tasks of daily life. Although robust, this questionnaire includes 49 questions and is too long for daily use in consultation. For this reason, Moulin et al validated in 2018 a short version of the SSQ questionnaire for adults with only 15 items.

Based on this model, the aim of this study is to develop and test a paediatric questionnaire with 12 items to assess more specifically auditory difficulties in deaf children. This questionnaire will follow the validated frame of the adult SSQ questionnaire and will consist of three subscales: speech hearing (4 items), spatial hearing (4 items), and qualities of hearing (4 items). These 3 subscales are identical to those defined in long and short form pf the adult SSQ questionnaire.

location_facility: ENT departement, Edouard Herriot Hospital


title: Prescription of Hemangiol in the Treatment of Proliferative Infantile Hemangiomas Requiring Systemic Treatment: Post Marketing Surveillance Study

acronym: postHemangiol

summary:
Infantile hemangioma is a benign tumor belonging to the group of vascular tumors in the ISSVA classification (International Society for the Study of Vascular Anomalies). The diagnosis is clinical and radiological. The hemangioma appears during the first weeks of life (70% classically within 2 weeks after birth) but can, when it develops in the subcutaneous tissue, appear until the age of 2 to 3 months .

Its evolution is characteristic and is divided into 3 phases with a proliferative phase characterized by a rapid increase in the size of the tumor (up to 6 to 12 months), a phase of stabilization (from 12 to 36 months) with a stopping of the growth of the hemangioma and a regression of its size and a phase of involution with the disappearance of the lesion which may give way to residual fibroadipose tissue, cutaneous telangiectases, scars … The usual complications of haemangiomas occur during the proliferative phase. It is necrosis, ulcerations that can be complicated by bleeding or infection and eventually indelible scarring. Other complications related to the site of development of hemangiomas (amblyopia, astigmatism, upper respiratory obstruction, nasal obstruction, sphincter disorders, eating disorders), hemangiomas destroying structures noble (breast hypodévelopment, alopecia). The aesthetic prognosis can be seriously compromised for facial locations.

Historically, when drug therapy was required, patient management was based on systemic corticosteroids (at doses of 3 to 5 mg / kg / day) in first-line therapy and vincristine as a second-line failure of corticosteroid therapy or when life-threatening is at stake.

In 2014, the high French health authority (HAS) gave Marketing Authorization for Hemangiol 3.75 mg / ml oral solution for the management of infantile proliferative hemangioma requiring first-line systemic treatment, evaluating the actual benefit as important.

The selected indication concerns children from 5 weeks to 5 months with:

Hemangiomas leading to a vital or functional risk,
Hemangiomas ulcerated painful and / or not responding to simple care,
Hemangiomas with a risk of permanent scarring or disfigurement. The 2014 HAS Transparency Commission wishes in its report "to have follow-up data of prescriptions allowing to describe on a representative sample of patients, the characteristics of the treated patients, the indication, the doses and the durations of treatment of this specialty ".

The objective of our study is to describe the use of Hemangiol in current practice in our hospital from 2014 to 2018.

ReferenceType: result

ReferenceCitation: Socchi F, Bigorre M, Normandin M, Captier G, Bessis D, Mondain M, Blanchet C, Akkari M, Amedro P, Gavotto A. Hemangiol in infantile haemangioma: A paediatric post-marketing surveillance drug study. Br J Clin Pharmacol. 2021 Apr;87(4):1970-1980. doi: 10.1111/bcp.14593. Epub 2020 Nov 16.

name: Department of Paediatric and Congenital Cardiology, M3C Regional Reference Centre, Clinical Investigation Centre Montpellier University Hospital  Montpellier France

family: Socchi

full_name: Floriane Socchi

given: Floriane

name: Department of Paediatric Plastic Surgery Montpellier University Hospital  Montpellier France

family: Bigorre

full_name: Michele Bigorre

given: Michele

name: Department of Clinical Pharmacy Montpellier University Hospital  Montpellier France

family: Normandin

full_name: Marion Normandin

given: Marion

family: Captier

full_name: Guillaume Captier

given: Guillaume

name: Department of Dermatology Montpellier University Hospital  Montpellier France

family: Bessis

full_name: Didier Bessis

given: Didier

name: Department of Paediatric ENT, Head and Neck Surgery Montpellier University Hospital  Montpellier France

family: Mondain

full_name: Michel Mondain

given: Michel

family: Blanchet

full_name: Catherine Blanchet

given: Catherine

family: Akkari

full_name: Mohamed Akkari

given: Mohamed

name: PhyMedExp, INSERM, CNRS University of Montpellier  Montpellier France

family: Amedro

full_name: Pascal Amedro

given: Pascal

family: Gavotto

full_name: Arthur Gavotto

given: Arthur

journal_name: British Journal of Clinical Pharmacology

oa_host_type: repository

version: submittedVersion

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Hemangiol in infantile haemangioma: A paediatric post‐marketing surveillance drug study

ipd_sharing_description: NC


title: Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA

summary:
There are several types of circulating DNA: DNA from patient's existing cells, foetal DNA in the case of pregnant woman, and tumoral DNA in the case of patients with cancer. These circulating tumoral DNA (ctDNA) can be obtained from a blood test called liquid biopsy and be detected by the latest generation of very high throughput sequencers with the Massive Parallel Sequencing technique (MPS).

This study focus on using this technique on breast and colorectal cancers in which no analysis of CNV (tumor origin marker) with this technique has been performed yet. It is a prospective, pilot, monocentric, feasibility study on genomic profile. The study aim is to show the possibility to realize in a reproductive way a molecular karyotype on ctDNA with the MPS approach from a liquid biopsy taken from patients with cancer and to compare this profile with the one obtained by CGH array (Comparative Genomic Hybridization) from primitive tumor.

lead_sponsor: Centre Hospitalier Henri Duffaut - Avignon


title: Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

acronym: OIPN

summary: Impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. In case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. Before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. Persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. In addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with TNF alpha, a pro-inflammatory molecule.

intervention_type: Biological


title: Establishment of a Monocentric and Prospective Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department

acronym: BCB RIV

summary: Development of a prospective clinico-biological database allowing the provision of clinical data and corresponding biological materials to the medical and scientific community.

ReferenceCitation: Pouget JP, Lozza C, Deshayes E, Boudousq V, Navarro-Teulon I. Introduction to radiobiology of targeted radionuclide therapy. Front Med (Lausanne). 2015 Mar 17;2:12. doi: 10.3389/fmed.2015.00012. eCollection 2015. Review.

ReferenceCitation: Kumar C, Shetake N, Desai S, Kumar A, Samuel G, Pandey BN. Relevance of radiobiological concepts in radionuclide therapy of cancer. Int J Radiat Biol. 2016;92(4):173-86. doi: 10.3109/09553002.2016.1144944. Epub 2016 Feb 26. Review.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: Usability Assessment of a Device to Promote Physical Activity for Old Patients Hospitalized

acronym: QUSHION

summary:
Falls are a frequent and serious problem in old people. It is estimated that one-third of subjects over 65 years of age and 50% of those over 85 years of age have at least one fall per year (1). The traumatic and psychological consequences of falls contribute to the loss of functional independence and lead to early institutionalization (2).

All activities of daily living require us to maintain a state of postural balance, whether standing, sitting, static or dynamic. Thus, good coordination is essential to maintain balance, reflecting both peripheral (muscular) and central (cognitive) motor control (3,4). Coordination skills between posture and movement decline during aging without associated disorder, and even more so when this aging is associated by cognitive disorders (5,6).

On the contrary, as part of a balance rehabilitation program, an adapted training allows the partial recovery of the balance management process in elderly subjects who fall (7).

Le Qoos® by LudHealth is technical foam equipment, which can be installed on the wall, to practice various physical exercises. It can therefore be used as a simple support, leaning on with hands, arms, feet or even the head, exerting contact points, pressures or even impacts with more or less force. Le Qoos® is an equipment that allows to perform, on the same object, gentle or tonic exercises, balance, flexibility, sheathing or muscle strengthening while having fun.

We hypothesize that cognitive-physical stimulation workshops based on the use of the device Le Qoos® and is environment are i) adapted to geriatric fall prevention issues, ii) accessible to elderly hospitalized patients and health professionals, and iii) effective and safe to maintain and/or recover postural balance in elderly hospitalized patients.

First step of this work is to assess whether "Le Qoos" is considered as usable par end-users of the device.

status: Withdrawn

lead_sponsor: University Hospital, Angers


title: Interest of Intravenous Cholangiography With Indocyanine Green, Compared to Contrast Cholangiography, in the Context of Laparoscopic Cholecystectomy for Grade 1 and 2 Acute Gallstone Cholecystitis: Prospective, Monocentric, Randomized Study

acronym: VIFCAL

summary:
Acute lithiasis cholecystitis (ALC) is the third most common cause of surgical emergency admission. The initial treatment of ALC associates a medical support and a cholecystectomy, preferentially performed laparoscopically in the first 5 days of evolution. During the surgery, intraoperative cholangiography (CPO) using a contrast product is the "gold standard" to identify the bile ducts. However CPO is performed in approximately 30% of laparoscopic cholecystectomy.

Laparoscopic cholecystectomy for ALC is associated with an increase in the rate of biliary ducts injuries compared with cholecystectomy for symptomatic vesicular lithiasis, evaluated at 0.8 % versus 0.1 %. Its higher rate is related to local inflammation that alters the biliary anatomy and complicates the identification of the bile ducts. Indocyanine green facilitates the visualization of extrahepatic biliary structures, which could reduce the risk of biliary wound and shorten the operating time.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Fatigue in Myelodysplasic Patients : Why Blood Transfusion Does Not Systematically Improve Symptoms? (FITME Study)

acronym: FITME

summary: At present, it is unclear why some myelodysplastic patients (MDS) receiving blood transfusion therapy exhibit an increase in Hemoglobin (Hb) without a concurrent improvement in fatigue. Research is thus required to elucidate on why fatigue persists in some MDS patients in order to devise strategies to alleviate fatigue in "non-responders" to blood transfusion.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv Study

acronym: ENDALGOFIV

summary: 25 to 50% of endometriotic patients are infertile and use medically assisted procreation. In general, the assessment of pain in medically assisted procreation is very little studied. Pain assessment studies in endometriotic patients remain limited to a quantitative assessment of pain symptomatology, without contextualization of painful manifestations. The primary objective of our study is the qualitative and contextualized assessment of pain during In Vitro Fertilization (IVF) protocol in endometriotic and non-endometriotic patients. The secondary objectives of our study are the quantitative study of pain, the measurement of the impact of personal efficiency on painful symptomatology, evaluation of depression, the results of IVF (implantation, pregnancy and live birth rates), and compare pain between endometriotic or non-endometriotic patients and between primary infertility and secondary infertility. According to the results obtained in this study, therapeutic strategies for the management of pain could be proposed, with the aim of improving the quality of life and the results of IVF in these patients.

lead_sponsor: University Hospital, Lille


title: Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal

acronym: TransDiPe

summary:
Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis (PD) often have pathophysiological factors that promote chronic constipation. It affects the quality of life of Patients undergoing PD in a much greater way than for hemodialysis patients because it causes complications, mechanical and infectious associated with the transmural migration of enteral bacteria, with an impact on patient morbidity and survival of the technique. In addition, it should be noted that PD patients often take potentially constipants treatments such as phosphorus chelators, calcium inhibitors, opiates, iron preparation and antidepressants. Taking these drugs decreases gastric acidity, which is associated with an increased prevalence of peritonitis.

In this context, a significant lack of literature, specifically studying the risk factors for constipation in Terminal Chronic Kidney Disease patients treated with DP and the correlation with mechanical and infectious complications, is improvable.

ipd_sharing_description:
Source documents defined as any original document or object to prove the existence or accuracy of a data or fact recorded during the clinical study will be kept for 15 years by the Hospital Center; this is the hospital medical record, original results of the patient's biological examinations.

The protocol data that will be collected in the observation book and which will be considered source data can be found in the attached observation book.

Source data will be collected by the service's investigators and nurses; It will be collected in the CRF by investigators.

The data will then be entered into the Excel database by the clinical research officer and a team member (investigator, intern or IDE) for a double entry.

During or after the research, data collected on the appropriate individuals and transmitted to the sponsor by investigators will be anonymized.

lead_sponsor: Centre Hospitalier de Vichy


title: Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients

acronym: CITIUS

summary:
Cardiac rehabilitation includes aerobic and anaerobic training adapted to cardiovascular pathology for which cardiac rehabilitation is prescribed. It is essential to adapt the content of these cardiac rehabilitation sessions to optimize aerobic and anaerobic performance and quality of life. Improvement of the first ventilatory threshold is one of the main objectives since it illustrates the adaptation of the patient to submaximal exercise, typical of everyday life.

The research laboratory "Autonomous Nervous System - Epidemiology, Physiology, Engineering, Health" (SPA-EPIS) has an international expertise in training optimization in top-athletes. He have shown the importance of the relationship between the power-force-velocity profile and athletes performances.

primary_purpose: Supportive Care


title: Evaluation of a Safe Infusion Device in Reducing Occupational Exposure of Nurses to Antineoplastic Drugs: a Comparative Prospective Study. CONTAMOINS-1

summary: Monocentric comparative before / after study to evaluate the efficacy of Safe Infusion Devices (SIDs) in reducing drug exposure to nurses compared to usual perfusion practices.


title: Assessing Motor Imagery Using the Tongue and Mouth Imagery Questionnaire (TMIQ) in Patients With Temporomandibular Disorder and Healthy Control Subjects: a Reliability and Construct Validity Study

acronym: TMIQ

summary: Temporomandibular disorder (TMD) is the symptomatic expression of a muscular or an articular impairment at the manducatory tract. TMD affects between 30 to 65% of the population with a higher prevalence for young women. The patients with DTM report a decrease of their personal, social and professional quality of life. Treatment usually relies on physical therapy. Among the different technics that can be used in physical therapy, there is growing evidence advocating the efficacy of using motor imagery (i.e. imagining a movement with no concomitant physical execution) during rehabilitation. It has also been shown that the benefits of practicing motor imagery depend on the ability (i.e., the higher the ability, the greater the benefits). However, there is no investigation of the motor imagery ability of the tongue and mouth movements conditioning the use of motor imagery during TMD rehabilitation. The objective of the study is to investigate the ability of imagining tongue and mouth movements using the Tongue and Mouth Imagery Questionnaire (TMIQ) as compare to the gold-standard Kinesthetic and Visual Imagery Questionnaire (KVIQ - Malouin et al., 2007).

lead_sponsor: Cabinet de Kinesitherapie SCM Saint-Alexandre


title: Impact of Perioperative Anemia and Red Blood Cells Transfusion on Post-operative Complications After Oncological Surgery

acronym: IMPACT

summary: Oncologic patients experience anemia and anemia is associated with poor prognosis. Transfusion is associated with adverse events, and equipoise remains on the optimal transfusion strategy in oncologic patients in surgical setting. The primary objective of this study is to determine the impact of anemia and red blood cells (RBC) transfusion on post-operative complications and mortality.

location_facility: CHRU de Brest, hôpital de la Cavale Blanche


title: Rocking Chair Therapy: A Non Pharmacological Intervention in Elderly With Dementia, Its Effects in Agitation, Pharmacological Restraint Use, and Pain

acronym: Rocking

summary:
Patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). Behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit AD patients to institutionalized long-term care.

Among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. Only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. The results were promising, but not sufficiently significant.

We propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. The secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. Cohen Mansfield agitation inventory will be employed for the pre- and post-therapy evaluation.

Included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. The therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. During the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. The total duration of the therapy period will be 6 weeks. The use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy.

The expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.


title: Diagnostic Performance of the Ultrasound Examination of the Antrum to Detect a Full Stomach According to the Position of the Patient

acronym: POSIGAST

summary: Pulmonary aspiration of gastric contents is a complication causing significant morbidity and mortality related to anesthesia. Ultrasound examination of the gastric antrum allows the detection of preoperative gastric contents contributing to the preoperative assessment of pulmonary aspiration risk. In particular, this examination is based on the qualitative analysis of gastric contents performed in the supine and in the right lateral decubitus, using a qualitative score which makes it possible to discriminate a low liquid content of a large liquid volume. This score has been described in patients and volunteers installed on a bed without elevation of the upper section of the bed. However, in several studies, this qualitative score has been achieved in the 45° semirecumbent position, which may have affected the diagnostic performance of the examination thus performed, as suggested by the results of a study recently conducted by the investigating team. This study therefore aims to compare the diagnostic performance of the qualitative analysis of the gastric antrum performed in the supine and the right lateral decubitus for the diagnosis of gastric volumes higher than 50 ml and 100 ml, according to the bed angle: 45 ° elevation or no elevation of the upper section of the bed.

primary_purpose: Basic Science


title: Perioperative and Non-invasive Estimation of Mean Left Atrial Pressure From Transesophageal Echocardiography Measures of Pulmonary Vein Diameter and Collapsibility in Cardiac Surgery: a Prospective Study

acronym: POGETO

summary:
Left atrial pressure (LAP) is a crucial hemodynamic parameter during cardiac surgery. Elevated LAP leads to pulmonary edema and other cardiopulmonary complications. The pulmonary capillary wedge pressure (PCWP) measured by a pulmonary arterial catheter (PAC) is the gold-standard method to estimate LAP. However, the placement of a PAC is an invasive procedure associated with adverse events. Transesophagial echocardiophy (TEE) is a non-invasive method to estimate LAP during cardiac surgery. Pulsed Doppler mitral flow, pulmonary vein flow, tricuspid regurgitation peak flow and left atrial volume are validated parameters to estimate LAP. Nevertheless, these parameters are not always valid in cardiac surgery, mainly because of mitral valve pathology or prothesis.

As the diameter and collapsibility of inferior vena cava is the recommended method for non-invasive right atrial pressure assessment in patients under mechanical ventilation, the investigators made the hypothesis that diameter and collapsibility of the pulmonary veins could be an additional method to estimate LAP during cardiac surgery. This has never been investigated in cardiology or cardiac surgery.

In this prospective study, pulmonary vein diameter and collapsibility will be correlated to invasive PCWP to assess LAP perioperatively in 30 patients undergoing cardiac surgery


title: Evaluation of Lung Volume Under Nasal High Flow With a Time of Flight Camera

acronym: CamOpt

summary:
The effectiveness of Nasal High Flow therapy (NHF), in comparison with conventional oxygen therapy, is based on Positive Expiratory Pressure (PEP) and washout of dead space.

Many authors have shown that peak expiratory pressure, expiratory plateau pressure, mean upper airway pressure and lung volume were significantly increased. It depends mainly on gas flow and mouth closure.

First, "Groves"showed in 2007 that mouth opening could vary nasopharyngeal pressure from 2.7 to 7.4 cmH20 to 60 L / min, like Parke did in 2009, with a pressure of 1.2 at 2.7 cmH2O at 35 L / min.

Then, "Parke" showed in 2011 and 2015, a nasopharyngeal pressure changing from 2.7 to 11.9 cmH20 by varying the flow rate from 30 to 100 L / min. "Bräunlich" also showed concordant results in 2018, from 1.6 to 2.3 cmH2O, changing flow rates from 20 to 40 L / min. "Corley" in 2011 found a pressure from -0.3 to 2.7 by passing from ambient air to high flow. "Okuda and Mauri's" work in 2017 on oesophageal pressures also contributed to this.

In addition, it has been proved that the Tidal Volume (TV) is proportional to the flow delivered. These measurements were carried out by impedancemetry, the results of which were extrapolated to Vt. Thus "Okuda" evaluated it at 685mL in ambient air and 968mL at 50L / min. In 2016, "Fraser" highlighted a TV increasing from 400 to 500 mL by increasing the flow rate to 30 L / min. "Parke" in 2015 described an exponential End Expiratory Lung Impedence (EELI) proportional to the flow rate, as did "Riera" in 2013 with a ratio of 1.26 between ambient air and NHF at 40 L / min, and "Corley" in 2011 (ratio of 1.25).

Actualy, Time-of-Flight (ToF) cameras, such as Kinect v2®, are increasingly used in the medical field, particularly to characterize respiratory movement.

Various authors have shown a good correlation between the values of TV obtained by spirometry (reference method) and those obtained with ToF camera. A study led in 2018, by "S. Nazir" in the Department of "Réanimation Médicale" at the University Hospital of Brest, evaluated the average errors less than 46mL, with 76% of measurements having an error less than 50 mL, which corresponds to the clinical limit.

Now having a non-invasive, safe, simple, reproducible, inexpensive, and allowing evaluation in clinical situations method ; the use of a Time-of-Flight camera to evaluate the breathing and its various parameters, is indicated.

In this innovative study, never performed in different respiratory conditions in vigilant patients with NHF, the lung volume will be evaluated by a Time-of-Flight camera.

Different clinical situations, and the different parameters influencing it, will be observed and compared with the results of previous studies.

These situations will be simulations ranging from a physiological state to an acute respiratory distress.

ReferenceCitation: Le Moigne G, Nazir S, Pateau V, Courtois E, L'Her E. Noninvasive Tidal Volume Measurements, Using a Time-of-Flight Camera, Under High-Flow Nasal Cannula-A Physiological Evaluation, in Healthy Volunteers. Crit Care Med. 2021 Jul 12. doi: 10.1097/CCM.0000000000005183. [Epub ahead of print]

family: Le Moigne

full_name: Guillaume Le Moigne

family: Nazir

full_name: Souha Nazir

given: Souha

family: Pateau

full_name: Victoire Pateau

given: Victoire

family: Courtois

full_name: Emmanuelle Courtois

given: Emmanuelle

family: L’Her

full_name: Erwan L’Her

given: Erwan

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Noninvasive Tidal Volume Measurements, Using a Time-of-Flight Camera, Under High-Flow Nasal Cannula—A Physiological Evaluation, in Healthy Volunteers

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication


title: Determinants, Impact and Adherence Related to the Duration of Performing Self Catheterization on Patient Satisfaction and Quality of Life

summary:
Clean Intermittent Self-Catheterization (CISC) is a procedure of regularly emptying the bladder by introducing a single-use urinary catheter through the urethra. CISC are indicated in several situations in patients with neurological pathologies but also with urological or functional disorders.

The announcement of the indication of CISC is often difficult and the acceptance of this therapy remains complicated, due to the invasive side, the dependence on a material and the time required to perform CISC.

A few studies have assessed patient satisfaction and adherence to self-catheterization through quality of life questionnaires, but none have examined the impact of this technique on daily life through the duration of CISC.

Primary aim is to evaluate the impact of time to perform CISC on patient adherence and satisfaction.

Patients over 18 years old performed CISC for more than 1 month, exclusive or not, are included.

History and treatment, age, professional activity, visuals disorders, technical aids for walking and the history of CISC with the date of initiation, the type of catheter, the carrier, the number of CISC per 24 hours, the position of realization, the use of a mirror and urethral sensitivity are recorded. Cognitive disorders, fatigue, psychological state, impact on quality of life are assessed on the day of the patient's consultation. The grip of the upper limbs is explored by Box and Block and Nine Hole Peg Test. The validated questionnaires,Intermittent Catheterization Satisfaction Questionnaire ( InCaSaQ), Intermittent Catheterization Difficulty Questionnaire (ICDQ), Intermittent Catheterization Adherence Scale (ICAS) are completed.

At home, patients have to complete one calendar on the specific duration of a 24-hour self-catheterization and the next day a second calendar on the total duration of CISC

Primary outcome is specific time of self-catheterization described by the timed duration from the moment when the circumstances of care are combined to carry it out : isolated place, nearby equipment.

Secondary outcome is total time of self-catheterization described by the timed duration from the moment of the intention to self-catheter until the return to the initial activity.

Influence of age, Expanded Disability Status Scale (EDSS), American Spinal Injury Association (ASIA), Montreal Cognitive Assessment (Moca), Fatigue Impact Scale (FIS), Box and Block and Nine Hole Peg Test, Hospital Anxiety and Depression Scale (HADS), Qualiveen Total,Intermittent Catheterization Satisfaction Questionnaire (InCaSaQ), Intermittent Catheterization Difficulty Questionnaire (ICDQ), Intermittent Catheterization Adherence Scale (ICAS) on time of self-catheterization are analysis.

ReferenceCitation: Leroux C, Turmel N, Chesnel C, Grasland M, Le Breton F, Amarenco G, Hentzen C. Determinants and impact of the time to perform clean intermittent self-catheterization on patient adherence and quality of life: A prospective observational study. Neurourol Urodyn. 2021 Apr;40(4):1027-1034. doi: 10.1002/nau.24662. Epub 2021 Mar 26.

name: Sorbonne Université, GRC 01, GREEN Groupe de Recherche Clinique en Neuro‐Urologie, AP‐HP, Hôpital Tenon  Paris France

family: Leroux

full_name: Camille Leroux

given: Camille

family: Turmel

full_name: Nicolas Turmel

given: Nicolas

family: Chesnel

full_name: Camille Chesnel

family: Grasland

full_name: Matthieu Grasland

given: Matthieu

family: Le Breton

full_name: Frédérique Le Breton

given: Frédérique

family: Amarenco

full_name: Gérard Amarenco

given: Gérard

family: Hentzen

full_name: Claire Hentzen

given: Claire

journal_name: Neurourology and Urodynamics

title: Determinants and impact of the time to perform clean intermittent self‐catheterization on patient adherence and quality of life: A prospective observational study

lead_sponsor: Gérard Amarenco

location_facility: Department of Neuro-Urology, Hôpital Tenon


title: Diagnosis of Platelet Dense Granules Anomalies in Unexplained Hemorrhagic Syndromes

acronym: AGRAD

summary:
The study aims to know the overall prevalence of granular deficits and their breakdown by type (anomaly of number, content or secretion) in a population of patients with hemorrhagic symptomatology after exclusion of other known causes.

This study consists also to evaluate the association between the presence of a deficit in dense granules and (1) the intensity of the hemorrhagic phenotype (hemorrhagic score) (2) the nature of hemorrhages (post-operative, spontaneous, atypical...)

-Evaluate the association between the type of deficit in dense granules and (1) the intensity of the hemorrhagic phenotype (hemorrhagic score) (2) the nature of hemorrhages (post-operative, spontaneous, atypical...)

ReferenceCitation: Gresele P, Harrison P, Bury L, Falcinelli E, Gachet C, Hayward CP, Kenny D, Mezzano D, Mumford AD, Nugent D, Nurden AT, Orsini S, Cattaneo M. Diagnosis of suspected inherited platelet function disorders: results of a worldwide survey. J Thromb Haemost. 2014 Sep;12(9):1562-9. doi: 10.1111/jth.12650. Epub 2014 Jul 25.

ReferenceCitation: Quiroga T, Goycoolea M, Panes O, Aranda E, Martínez C, Belmont S, Muñoz B, Zúñiga P, Pereira J, Mezzano D. High prevalence of bleeders of unknown cause among patients with inherited mucocutaneous bleeding. A prospective study of 280 patients and 299 controls. Haematologica. 2007 Mar;92(3):357-65.

ReferenceCitation: Fiore M, Garcia C, Sié P, et al. δ-storage pool disease: an underestimated cause of unexplained bleeding. Hématologie 2017-8; 243-254.

ReferenceCitation: Gresele P; Subcommittee on Platelet Physiology of the International Society on Thrombosis and Hemostasis. Diagnosis of inherited platelet function disorders: guidance from the SSC of the ISTH. J Thromb Haemost. 2015 Feb;13(2):314-22. doi: 10.1111/jth.12792. Epub 2015 Jan 22. Review.

ReferenceCitation: Mumford AD, Frelinger AL 3rd, Gachet C, Gresele P, Noris P, Harrison P, Mezzano D. A review of platelet secretion assays for the diagnosis of inherited platelet secretion disorders. Thromb Haemost. 2015 Jul;114(1):14-25. doi: 10.1160/TH14-11-0999. Epub 2015 Apr 16. Review.

ReferenceCitation: Selle F, James C, Tuffigo M, Pillois X, Viallard JF, Alessi MC, Fiore M. Clinical and Laboratory Findings in Patients with δ-Storage Pool Disease: A Case Series. Semin Thromb Hemost. 2017 Feb;43(1):48-58. doi: 10.1055/s-0036-1584568. Epub 2016 Jun 15.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study Of the Nitrous Oxide Perception in Health Students

acronym: SONOPS

summary: In order to evaluate the perception of the Nantes health students we wish to place an anonymous survey concerning their training, their knowledge of the legislative framework governing the use of EMONO and their personal and professional experience around nitrous oxide.

lead_sponsor: Nantes University Hospital


title: Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability

acronym: SHORT

summary:
Anterior plate osteosynthesis of fractures of the lower extremity of the radius may be accompanied by tendinous complications : tenosynovitis of extensors or even tendon ruptures caused by the end of the epiphyseai screws.

The intraoperative measurements as well as the realization of the scopic pictures make it possible to estimate the length of the screws but the tendinous lesions remain frequent (5 to 15% according to the various series)

location_facility: St Antoine hospital - orthopaedic and traumatic surgery


title: Effect of "Breath of Fresh Air" Flash Activity on Dementia Agitation : Pilot Study

acronym: DEMACTIFLASH

summary:
Non-drug therapies (NDT) constitute a strong axis of the person with dementia behaviour management. Among these NDT, the flash activities constitute a mode of intervention to prevent and control the expression of the most disruptive behavior. These are short-term activities with the objective of decreasing the behavioural disorders intensity in less than 15 minutes.

The aim of this pilot study is to test the effect of a flash activity "breath of fresh air" compared to the usual relational care on the short-term decrease (15 min.) of the agitation in hospitalized dementia patients.

lead_sponsor: University Hospital, Toulouse


title: Implementation of Data From Pulmonary Function Tests Supervising a Session of Respiratory Physiotherapy of Cystic Fibrosis Children in the VirtualChest Model

acronym: PHYSIOMOD

summary: "The usefulness of respiratory physiotherapy and its execution modalities remains highly debated even though reviews of the literature show that respiratory physiotherapy is able to improve the drainage of bronchial secretions and pulmonary function tests during cystic fibrosis in periods of stability. Different physiotherapy techniques have been developed but the choice of one or the other facing a patient can not currently be recommended. The VirtualChest project, supported by a grant from the National Agency for Research (ANR), aims to develop and validate a physical model of respiratory physiotherapy (6 stages including model establishment pulmonary: bronchial tree and pulmonary mechanics and parietal [steps 1 and 3], a model of mucus [step 2] and modeling the effect of physiotherapy [step 5]). This project is integrated with stages 3 and 5 of this broad project and aims to get on a limited number of children with cystic fibrosis a proof of concept (prediction of drainage efficiency) and especially to feed the proposed physical models in order to subsequent optimization of the model (step 6). The choice cystic fibrosis of the child was justified by the effect demonstrated respiratory physiotherapy, particularly on respiratory functional criteria, and the fact that the parietal mechanics varies physiologically at this age."


title: Analysis of the Diagnostic Performance of LacryDiag, a New "All-in-one" Non-contact Analyzer of the Ocular Surface in the Dry Eye. Study LACRYMOSA

acronym: LACRYMOSA

summary: LacryDiag is a new Conformity European (CE) marked diagnostic imaging device devoted to the analysis of the ocular surface. It is an "all in one" device that provides 4 data: non-invasive break-up time (Non-Invasive Break-Up-Time (NIBUT) without fluorescein eye drop); height of the Tear Meniscus (TM); an infrared image of the meibomian glands; a picture of the lacrimal film by interferometry. it's performance will be compare between in diagnosing dry eye syndrome with the standard clinical evaluation, in 80 patients suffering from dry eye diseases and followed at the consultation of the Ophthalmology department of the University Hospital of Saint-Etienne.


type: EudraCT Number

title: Heparin Antagonization by Protamine in Cardiac Surgery: Pharmacokinetic/Pharmacodynamic Study

acronym: PICS

summary:
Protamine is currently used during cardiac surgery to neutralize unfractionated heparin (UFH) at the end of extra-corporeal circulation (ECC). The optimal dose of protamine is currently unknown, and the administration of protamine is done empirically.

Protamine and UFH pharmacokinetics are characterized by a large inter-individual variability. A dose of protamine proportional to the amount of UFH administrated during the surgery may be therefore not adapted to most of the patients and exposed them to a risk of under or over dosage.

In this study, research investigators hypothesize that an accurate characterization of the pharmacokinetic/pharmacodynamic (PK/PD) relationship of protamine may help to optimize propose an optimal dosing regimen.


title: Study of the IgA Repertoire During IgA Deposition Nephropathy.

acronym: ERINA

summary:
IgA plays a major role in mucosal and systemic immunity but retains mysterious and ambivalent aspects. They can thus, depending on the situation, prove to be capable of triggering either a protective inflammatory response or, on the contrary, anti-inflammatory and inducing tolerance. Similarly, and for reasons that remain very poorly understood, they can be involved in pathologies where the immune system is itself an aggressor of the body and responsible for immunopathological lesions.

The investigator formulates the hypothesis that an inappropriate response of the mucosal immune system to one or more antigens leads to a synthesis of IgA of bad affinity favoring a deposit at the level of the mesangium. It seems important to verify this point by analyzing the IgA repertory of patients with N-IgA and comparing it to that of a control population.

lead_sponsor: University Hospital, Limoges


title: Pain Quantification Study During a Screening for Retinopathy of Premature Babies by RetCam

acronym: DOLICAM

summary:
It is a single-center prospective observational descriptive study.

studied population is premature infants, hospitalized in the neonatology department of the University Hospital of Grenoble and for whom the RetCam examination is planned for screening for retinopathy of prematurity if they are at risk (prematurity <32 weeks).

To measure their pain during the examination, it will be a matter of filming the face of the child for 15 seconds before the examination, then 2 times 30 seconds at two distinct times. The PIPP (Premature Infant Pain Profile) score includes a percentage of time on these 30 seconds where 3 items are found modified and a monitoring of heart rate and oxygen saturation.This time calculation can not be done live and requires video recording of the child's face during the exam.

The statistical analyzes will be adjusted for sex, gestational age at birth, weight, and pain from birth (determined by the number of doses of level 1 analgesics received by the baby and the number of days (from birth to to the RetCam examination) when the baby received > level 1 analgesics).

ReferenceCitation: Jefferies AL; Canadian Paediatric Society, Fetus and Newborn Committee. Retinopathy of prematurity: An update on screening and management. Paediatr Child Health. 2016 Mar;21(2):101-8. English, French.

ReferenceCitation: Chiang MF, Melia M, Buffenn AN, Lambert SR, Recchia FM, Simpson JL, Yang MB. Detection of clinically significant retinopathy of prematurity using wide-angle digital retinal photography: a report by the American Academy of Ophthalmology. Ophthalmology. 2012 Jun;119(6):1272-80. doi: 10.1016/j.ophtha.2012.01.002. Epub 2012 Apr 27.

family: Chiang

full_name: Michael F. Chiang

given: Michael F.

family: Melia

full_name: Michele Melia

given: Michele

family: Buffenn

full_name: Angela N. Buffenn

given: Angela N.

family: Lambert

full_name: Scott R. Lambert

given: Scott R.

family: Recchia

full_name: Franco M. Recchia

given: Franco M.

family: Simpson

full_name: Jennifer L. Simpson

given: Jennifer L.

family: Yang

full_name: Michael B. Yang

given: Michael B.

journal_name: Ophthalmology

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Detection of Clinically Significant Retinopathy of Prematurity Using Wide-angle Digital Retinal Photography

ReferenceCitation: Ezz El Din ZM, El Sada MA, Ali AA, Al Husseiny K, Yousef AA. Comparison of digital imaging screening and indirect ophthalmoscopy for retinopathy of prematurity. Indian J Pediatr. 2015 Jan;82(1):80-3. doi: 10.1007/s12098-014-1525-1. Epub 2014 Aug 1.

family: Ezz El Din

full_name: Zahraa Mohamed Ezz El Din

given: Zahraa Mohamed

family: El Sada

full_name: Mohamed Ahmed El Sada

given: Mohamed Ahmed

family: Ali

full_name: Aliaa Adel Ali

given: Aliaa Adel

family: Al Husseiny

full_name: Khalid Al Husseiny

given: Khalid

family: Yousef

full_name: Aly Abdel Rahman Yousef

given: Aly Abdel Rahman

journal_name: The Indian Journal of Pediatrics

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Comparison of Digital Imaging Screening and Indirect Ophthalmoscopy for Retinopathy of Prematurity

ReferenceCitation: Disher T, Cameron C, Mitra S, Cathcart K, Campbell-Yeo M. Pain-Relieving Interventions for Retinopathy of Prematurity: A Meta-analysis. Pediatrics. 2018 Jul;142(1). pii: e20180401. doi: 10.1542/peds.2018-0401. Epub 2018 Jun 1.

family: Disher

full_name: Timothy Disher

given: Timothy

family: Cameron

full_name: Chris Cameron

given: Chris

family: Mitra

full_name: Souvik Mitra

ReferenceCitation: Ranger M, Grunau RE. Early repetitive pain in preterm infants in relation to the developing brain. Pain Manag. 2014 Jan;4(1):57-67. doi: 10.2217/pmt.13.61. Review.

name: Developmental Neurosciences & Child Health, Child & Family Research Institute, Vancouver, BC, Canada

name: Nursing & Midwifery, Queen‘s University Belfast, Belfast, UK

name: Pediatrics, University of British Columbia, BC, Canada. .

ReferenceCitation: Vinall J, Grunau RE. Impact of repeated procedural pain-related stress in infants born very preterm. Pediatr Res. 2014 May;75(5):584-7. doi: 10.1038/pr.2014.16. Epub 2014 Feb 5. Review.

ReferenceCitation: Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22.

ReferenceCitation: Stevens B, Johnston C, Taddio A, Gibbins S, Yamada J. The premature infant pain profile: evaluation 13 years after development. Clin J Pain. 2010 Nov-Dec;26(9):813-30. doi: 10.1097/AJP.0b013e3181ed1070. Review.

title: The Premature Infant Pain Profile: Evaluation 13 Years After Development


title: Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders

acronym: NeuropsyTCA

summary: Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).


title: A PHASE II Multicentric Trial Evaluating a High Dose Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer Treated by Adjuvant Chemotherapy

acronym: OPTIVIT

summary:
An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy.

A calcium supplementation will be prescribed in parallel.

An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy

ReferenceCitation: Cavalier E, Delanaye P, Chapelle JP, Souberbielle JC. Vitamin D: current status and perspectives. Clin Chem Lab Med. 2009;47(2):120-7. doi: 10.1515/CCLM.2009.036. Review.

family: Cavalier

full_name: Etienne Cavalier

given: Etienne

family: Delanaye

full_name: Pierre Delanaye

given: Pierre

family: Chapelle

full_name: Jean-Paul Chapelle

given: Jean-Paul

family: Souberbielle

full_name: Jean-Claude Souberbielle

given: Jean-Claude

journal_name: Clinical Chemistry and Laboratory Medicine

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

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

publisher: Walter de Gruyter GmbH

publisher_dissemination: De Gruyter

publisher_group: De Gruyter

publisher_normalized: De Gruyter

ReferenceCitation: Sinotte M, Diorio C, Bérubé S, Pollak M, Brisson J. Genetic polymorphisms of the vitamin D binding protein and plasma concentrations of 25-hydroxyvitamin D in premenopausal women. Am J Clin Nutr. 2009 Feb;89(2):634-40. doi: 10.3945/ajcn.2008.26445. Epub 2008 Dec 30.

family: Sinotte

full_name: Marc Sinotte

given: Marc

family: Diorio

full_name: Caroline Diorio

given: Caroline

family: Bérubé

full_name: Sylvie Bérubé

given: Sylvie

family: Pollak

full_name: Michael Pollak

given: Michael

family: Brisson

full_name: Jacques Brisson

given: Jacques

journal_name: The American Journal of Clinical Nutrition

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. Review.

ReferenceCitation: Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. 2005 May 11;293(18):2257-64. Review.

ReferenceCitation: Tang BM, Eslick GD, Nowson C, Smith C, Bensoussan A. Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis. Lancet. 2007 Aug 25;370(9588):657-66. Review. Erratum in: Lancet. 2012 Sep 1;380(9844):806.

ReferenceCitation: Roux C, Bischoff-Ferrari HA, Papapoulos SE, de Papp AE, West JA, Bouillon R. New insights into the role of vitamin D and calcium in osteoporosis management: an expert roundtable discussion. Curr Med Res Opin. 2008 May;24(5):1363-70. doi: 10.1185/030079908X301857 . Epub 2008 Apr 2. Review.

name: Cochin Hospital, Rheumatology DepartmentParis-Descartes University ParisFrance

family: Roux

full_name: C. Roux

given: C.

name: Department of RheumatologyInstitute for Physical Medicine, University Hospital ZurichSwitzerland

family: Bischoff-Ferrari

full_name: H. A. Bischoff-Ferrari

given: H. A.

name: Department of Endocrinology and Metabolic DiseasesLeiden University Medical Center LeidenThe Netherlands

family: Papapoulos

full_name: S. E. Papapoulos

given: S. E.

name: Merck & Co., Inc. Whitehouse Station, NJUSA

family: de Papp

full_name: A. E. de Papp

given: A. E.

family: West

full_name: J. A. West

given: J. A.

name: Laboratory of Experimental Medicine and Endocrinology, Katholieke Universiteit Leuven LeuvenBelgium

family: Bouillon

full_name: R. Bouillon

given: R.

ReferenceCitation: Bischoff-Ferrari HA, Dawson-Hughes B, Willett WC, Staehelin HB, Bazemore MG, Zee RY, Wong JB. Effect of Vitamin D on falls: a meta-analysis. JAMA. 2004 Apr 28;291(16):1999-2006. Review.

ReferenceCitation: Abbas S, Nieters A, Linseisen J, Slanger T, Kropp S, Mutschelknauss EJ, Flesch-Janys D, Chang-Claude J. Vitamin D receptor gene polymorphisms and haplotypes and postmenopausal breast cancer risk. Breast Cancer Res. 2008;10(2):R31. doi: 10.1186/bcr1994. Epub 2008 Apr 17.

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

ReferenceCitation: Abbas S, Linseisen J, Slanger T, Kropp S, Mutschelknauss EJ, Flesch-Janys D, Chang-Claude J. Serum 25-hydroxyvitamin D and risk of post-menopausal breast cancer--results of a large case-control study. Carcinogenesis. 2008 Jan;29(1):93-9. Epub 2007 Oct 31.

ReferenceCitation: Khan QJ, Reddy PS, Kimler BF, Sharma P, Baxa SE, O'Dea AP, Klemp JR, Fabian CJ. Effect of vitamin D supplementation on serum 25-hydroxy vitamin D levels, joint pain, and fatigue in women starting adjuvant letrozole treatment for breast cancer. Breast Cancer Res Treat. 2010 Jan;119(1):111-8. doi: 10.1007/s10549-009-0495-x. Epub 2009 Aug 5.

ReferenceCitation: Peppone LJ, Huston AJ, Reid ME, Rosier RN, Zakharia Y, Trump DL, Mustian KM, Janelsins MC, Purnell JQ, Morrow GR. The effect of various vitamin D supplementation regimens in breast cancer patients. Breast Cancer Res Treat. 2011 May;127(1):171-7. doi: 10.1007/s10549-011-1415-4. Epub 2011 Mar 8.

ReferenceCitation: Mann GB, Kang YC, Brand C, Ebeling PR, Miller JA. Secondary causes of low bone mass in patients with breast cancer: a need for greater vigilance. J Clin Oncol. 2009 Aug 1;27(22):3605-10. doi: 10.1200/JCO.2008.20.2549. Epub 2009 Jun 22.

name: From Royal Melbourne Hospital; Royal Women's Hospital; University of Melbourne; Western Hospital; and Centre for Research Excellence in Patient Safety, Monash University, Melbourne, Australia.

publisher: American Society of Clinical Oncology (ASCO)

title: Secondary Causes of Low Bone Mass in Patients With Breast Cancer: A Need for Greater Vigilance


title: Usability Assessment of a Tablet PC Designed for Old Patients: the "Ardoiz" Tikeasy Tablet.

acronym: TikTac

summary:
In the last ten years, gerontechnology is becoming an increasing topic in geriatric medicine. Nevertheless, there are still few studies assessing the usability of technologies in old patients, especially when they are hospitalized. Moreover, it has been shown that new technologies could be a source of ageism, thence the importance of involving the old people in the development of these technologies.

Tik easy is a subsidiary of La Poste Company. Tik easy as designed a new tablet PC for old people. Research tends to show that the use of tablet PC can promote health and well-aging, and delay cognitive decline. In this study, we want to give a free access to "Ardoiz", the tablet PC designed by Tik easy, for old patients hospitalized in a geriatric acute care unit. The "Ardoiz" tablet PC allows to:

Maintain the family and social bond (send and receive messages, share photos and videos, call remotely between the patient and his family)
Discovering the Internet at his own pace (browse the Internet with daily updated contents such as news, content on cooking, music, etc.).
Prevent cognitive aging (stimulate cognitive abilities with the DYNSEO games).
Facilitate online administrative procedures.


title: Ffects of A Dual-Task Intervention in Postural Control in Multiple Sclerosis Patients With Low Level of Disability

acronym: MOCOGSEP

summary:
Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease affecting the central nervous system. It is the leading cause of severe non-traumatic disability in young adults (20-40 years). It affects more than 540,000 individuals in Europe and around 2.8 million people worldwide. The etiology of MS remains unknown to date, but probably results from a genetic predisposition associated with environmental factors (vitamin D deficiency, tobacco, vaccines, stress, diet, ...). MS is a neurological disease in which demyelination and axonal loss lead to many symptoms such as fatigue, spasticity, decreased sensitivity, muscle weakness, balance disorders, oculomotor visuals.

The Expanded Disability Status Scale (EDSS), which is used to rate functional disorders in MS patients, tends to underestimate these neurological disorders, which are often present in the early stages of the disease and are an important issue. major in the management and evolution of the disease.

Recently, it has been shown that motor and cognitive disorders appear in the early stages of the disease, yet these functions are not systematically evaluated in the early stages of the disease. These isolated or associated disorders often lead to real difficulties in realizing everyday activities. Since this disease affects young people who still have a professional activity, it is important not to underestimate the presence of these functional and cognitive disorders.

It is therefore necessary to seek more precise means of evaluation to detect certain neurological disorders.

Thus, the evaluation of these functions participates in the follow-up of the patient and makes it possible to better apprehend the evolution of these disorders in MS.

The investigators will use the concept of double-task to measure and evaluate these functional and cognitive disorders.

The dual task (DT) , is defined by the simultaneous completion of two tasks, one called "primary" and the other called "secondary", for which the performance changes are measured. The dual task paradigms are based on the assumption that two concurrently performed tasks interfere if they use identical functional and / or brain subsystems. In the case of a paradigm involving walking and another task, the interference is based on the assumption of the joint play of attention. The primary task is then the "attentional" task and the secondary task is represented by walking. Observed inferences are changes in the performance of one or both tasks that are measured by comparing single and dual task performance.

The assessment of DT's capabilities would improve the early detection of motor disorders in MS patients. Early identification of postural instability would make it easier to target care and improve patient follow-up. Conducting work on the concept of DT would improve our knowledge of this paradigm in MS.

Finally, a better understanding of double-stained mechanisms in MS could offer training programs


title: Impact of Anthropometrics Data and of Physical Activity Level in Closed kineTic Chain Upper Extremity Stability Test (CKCUEST) - EPOLTEST Study

acronym: EPOLTEST

summary: The purpose of this study is to evaluate impact of anthropometric criteria to CKCUEST score.

lead_sponsor: University Hospital, Brest


title: Basal Tumours in Bladder Cancer, Response to chemoTherapy

acronym: BoBCaT

summary: Determine the sensitivity/resistance to chemotherapy of the various subgroups of muscle-invasive bladder cancers, including the basal subgroup (about 25% of these tumours) according to 4 different classifications based on molecular or immunohistochemical classifiers.

lead_sponsor: University Hospital, Rouen

intervention_type: Combination Product


title: Randomized Open-label Trial Evaluating Light Therapy on Sleep Quality in Dialysis Patients

acronym: LUMIDIAL

summary:
Sleep disorders are common in dialysis patients. At present, the management of insomnia in patients with chronic renal failure is not significantly different from that of the general population, which focuses on the management of co-factors, sleep hygiene, and cognitive-behavioral therapy.

Light therapy is a paramedical practice that involves exposing a patient to a light intensity greater than 5000 Lux (usually 10,000 Lux) for 30 minutes in the morning between 7:00 and 8:30. Its impact is partly mediated by an improvement in the nycthemeral cycle of melatonin.

Light therapy may improve sleep disorders and anxious-depressive elements as suggested in the literature. This technique has not yet been evaluated in dialysis patients, whereas easy to set up.

lead_sponsor: Centre Hospitalier Annecy Genevois


title: A Prospective, Monocentric, Intra-individual, Randomized Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® HydroMax on Skin Moisturization and Elasticity

acronym: HYDRELA

summary: STYLAGE® HydroMax is a CE-marketed hyaluronic acid gel intended to improve skin moisturization and elasticity through injection into the dermis of the face, neck, neckline area and back of the hand. In this study, 47 female healthy subjects between the ages of 35 and 65, who have signs of cutaneous dryness and lack of elasticity on the cheek and on the neckline area, who have given her informed consent and met all the eligibility criteria, will be enrolled. One month apart subjects will randomly receive 3 injections of product in one cheek and in one side of the neckline area. Subjects will come to a total of 8 visits over a period of 9 months. Variation of moisturization, elasticity and roughness of treated areas in comparison with non-treated areas will be measured using specific devices by independent evaluators. Global aesthetic improvement, subject satisfaction, pain at injection and safety will also be assessed.

lead_sponsor: Laboratoires Vivacy


title: Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient

acronym: OSCIVARI

summary:
Prospective, single-arm, open label, multicentre, phase II pilot study to evaluate the immediate and short term (one month) impact of a new long acting double bronchodilator on innovative parameters in stable and moderate to severe COPD patients.

Variability and complexity of resting tidal breathing
Oscillatory resistance and reactance of airways Tidal volume variability and complexity is decreased in airway obstruction and is expected to improve with a bronchodilator treatment, together with lung mechanics.

The relationship with changes in dyspnea and conventional pulmonary function tests is the second aim of study.

After baseline assessment of these parameters, clinical and lung function evaluation will be performed 2 hours post-drug (peak drug effects). Patients will continue treatment with PT003 for 4 weeks. On Day 30, the same clinical and lung function assessments will be performed pre (trough) and 2h-post dose in order to obtain after-treatment measurements.

intervention_type: Drug


title: Validation of a Walk-Time Limit Test (WTLT) Derived From the 6-Minute Walk Test (6-MWT) in Patients With Chronic Cardiovascular or Respiratory Diseases

acronym: TTLM

summary:
Many exercise tests are commonly used to evaluate the changes of exercise tolerance following rehabilitation programs in patients with chronic respiratory diseases.

Among the tests (6-MWT, incremental test, ...), the literature seems to indicate that endurance time is the most responsive parameter for detecting and quantifying changes in exercise capacity following a rehabilitation program. Although its clinical interest is undeniable, the endurance shuttle walking test is rarely used because it requires the prior performance of two incremental shuttle walking tests to determine the walking speed imposed on the patient.

In this protocol, we propose to test a Walk-Time Limit Test (WTLT) derived from the 6-minute walk test (6-MWT) and based on the average walking speed achieved in this test commonly used in the follow-up of patients with chronic diseases.

TTLM validation would improve the functional assessment of patients with chronic diseases while limiting the number of exercise tests.


title: A Monocentric, Prospective Clinical Study to Evaluation of Cerebral Oxygen Saturation by Near InfraRed Spectroscopy (NIRS) in Children With Craniosynostosis

acronym: CraNIRS

summary:
Craniosynostosis is a rare disorder characterized by a premature fusion of one or more sutures of the skull. Craniosynostosis is usually diagnosed in the first years of life. Several complications may be identified if untreated, notably, developmental delay, and vision problems.

In some patients with craniosynostosis a decrease in cerebral blood perfusion can be identified. It might be related to the constriction of the brain caused by premature sutural fusion or the localized constriction of venous sinuses.

In this study the investigator use the NIRS which is defined as a non-invasive technique to monitor hemodynamic parameters and hemoglobin oxygen saturation of the brain during the surgical correction of the craniosynostosis. By applying this method the investigator will be able to analyse the changes in cerebral hemoglobin oxygen saturation related to the modification of the skull.

Determining changes in brain oxygen saturation by using NIRS before, during and after surgery will help both to better understanding the impact of surgical decompression on improving cerebral oxygenation and to better adapt anaesthesia strategies during surgery.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon service neurochirurgie pédiatrique


title: Obturator Nerve Block in Total Hip Arthrosplasty. a Randomized Controlled Double Blind Study

acronym: NOCH

summary:
Interest of obturator nerve block for analgesia in total hip arthroplasty remains controversial. This regional anesthesia procedure could provide post-operative pain relief as obturator nerve is responsible for innervation of the internal part of the hip joint capsule.

This randomized double-blind study aims to assess obturator nerve block for post-operative analgesia in total hip arthroplasty.

Before the surgery, an ultrasound guided obturator nerve block will be performed with either 20cc of saline or ropivacaine 0.2% (a long-acting local anesthetics). After regional anesthesia, a general anesthesia will be performed for intraoperative period.

This study aims to assess post-operative pain management during the first 24 hours. Ability to walk the day of the surgery will also be collected.

ReferenceCitation: Marty P, Chassery C, Rontes O, Vuillaume C, Basset B, Merouani M, Marquis C, Delussy A, Delbos MC, Ferre F, Bataille B, Joshi G, Delbos A. Obturator nerve block does not provide analgesic benefits in total hip arthroplasty under multimodal analgesic regimen: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):657-662. doi: 10.1136/rapm-2021-102531. Epub 2021 May 5.

family: Marty

full_name: Philippe Marty

given: Philippe

family: Chassery

full_name: Clement Chassery

given: Clement

family: Rontes

full_name: Olivier Rontes

given: Olivier

family: Vuillaume

full_name: Corine Vuillaume

given: Corine

family: Basset

full_name: Bertrand Basset

given: Bertrand

family: Merouani

full_name: Mehdi Merouani

given: Mehdi

family: Marquis

full_name: Constance Marquis

given: Constance

family: Delussy

full_name: Anne Delussy

given: Anne

family: Delbos

full_name: Marie-Claude Delbos

given: Marie-Claude

family: Ferre

full_name: Fabrice Ferre

given: Fabrice

family: Bataille

full_name: Benoit Bataille

given: Benoit

family: Joshi

full_name: Girish Joshi

given: Girish

full_name: Alain Delbos

given: Alain

journal_name: Regional Anesthesia & Pain Medicine

lead_sponsor: Clinique Medipole Garonne


title: Efficacy of 1g Versus 2g Intra-auricular Tranexamic Acid in Postoperative Bleeding After Total Knee Arthroplasty

summary: Tranexamic acid an antifibrinolytic that develops its anti-haemorrhagic action by inhibiting fibrinolytic activities of plasmin and many studies confirms its effectiveness in decreasing blood loss. The aim of this study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid in adult patients undergoing unilateral total knee replacement.

ReferenceCitation: Souza Neto EP, Usandizaga G. [Comparison of two doses of intra-articular tranexamic acid on postoperative bleeding in total knee arthroplasty: a randomized clinical trial]. Braz J Anesthesiol. 2020 Jul - Aug;70(4):318-324. doi: 10.1016/j.bjan.2020.03.015. Epub 2020 Jul 8. Portuguese.

apc_source: doaj

family: Souza Neto

full_name: Edmundo Pereira de Souza Neto

given: Edmundo Pereira de

family: Usandizaga

full_name: Gorka Usandizaga

given: Gorka

currency_apc_doaj: EUR

journal_name: Brazilian Journal of Anesthesiology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Comparação entre duas doses de ácido tranexâmico intra‐articular no sangramento pós‐operatório de artroplastia total do joelho: estudo clínico randomizado

ipd_sharing_description: The aim of our study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid.

lead_sponsor: Centre Hospitalier de Montauban


title: Added Value of Early Collected Ultrasound as Compared to Clinical Evaluation to Predict Definite Clinical Outcome and Therapeutic Response in Rheumatoid Arthritis Patients Treated by JAK Inhibitors

acronym: JAKPOT

summary:
Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function.

Sustained remission or low disease activity is the target to achieve in RA management. Ultrasound (US) is an imaging technique potentially helpful at several steps of the disease. A semi-quantitative (0-3) score of synovitis combining B-mode and Power Doppler abnormalities has been developed (GLOESS), and its responsiveness has been demonstrated. Patients Reported Outcomes (PROs) are important parameters in patient perceived health and are increasingly used in clinical practice. Prediction of therapeutic response to biological and targeted synthetic DMARDs remains a challenge for clinician, due to the potential adverse events and the cost of these drugs. To date, only few clinical and biological tools usable in clinical practice have a prognostic value. US or PRO could have added value for this purpose.

Objectives :

To determine the predictive added value of the variation of an US score to the variation of the DAS28-CRP (C-Reactive Protein) at 1 month on clinical outcome (low disease activity i.e. DAS28-CRP≤3.2) at 6 months, or on therapeutic response at 3 months (EULAR good or moderate response (DAS)), in RA patients starting a treatment with JAK (Janus Kinase) inhibitors (JAKi).
To determine the predictive added value of the variation several PROs to the variation of the DAS28-CRP at 1 month on clinical outcome (low disease activity i.e. DAS28-CRP≤3.2) at 6 months, or on therapeutic response at 3 months (EULAR good or moderate response (DAS)), in RA patients starting a treatment with JAKi.

lead_sponsor: University Hospital, Montpellier

location_facility: Rheumatology Department, Lapeyronie Hospital


title: Risk Factors and Prognosis of Acute Kidney Injury in Peri Operative Cardiac Surgery Adult Patients Supported by VA-ECMO

acronym: AKI-ECMO

summary: Post-cardiotomy cardiogenic shock (PCCS) occurs in 2-6% of patients undergoing cardiac surgery, and 1% of cardiac surgery patients will require mechanical circulatory support using Veno-Arterial ExtraCorporeal Membrane Oxygenation (VA-ECMO). Acute Kidney Injury is a frequent complication in this population and negatively impacts the survival. We aimed to determine whether the timing of ECMO implantation influence the renal prognosis of these patients.

ReferenceCitation: Lepère V, Duceau B, Lebreton G, Bombled C, Dujardin O, Boccara L, Charfeddine A, Amour J, Hajage D, Bouglé A. Risk Factors for Developing Severe Acute Kidney Injury in Adult Patients With Refractory Postcardiotomy Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation. Crit Care Med. 2020 Aug;48(8):e715-e721. doi: 10.1097/CCM.0000000000004433.

family: Lepère

full_name: Victoria Lepère

given: Victoria

family: Duceau

full_name: Baptiste Duceau

given: Baptiste

family: Lebreton

full_name: Guillaume Lebreton

given: Guillaume

family: Bombled

full_name: Camille Bombled

given: Camille

family: Dujardin

full_name: Olivier Dujardin

family: Boccara

full_name: Lucile Boccara

given: Lucile

family: Charfeddine

full_name: Ahmed Charfeddine

given: Ahmed

family: Amour

full_name: Julien Amour

given: Julien

family: Hajage

full_name: David Hajage

given: David

family: Bouglé

full_name: Adrien Bouglé

given: Adrien

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

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

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere