title: Decision-making Regarding the Possibility of Medical Termination of Pregnancy on Two Multidisciplinary Prenatal Diagnosis Centers of Maternities Level 3 in Lyon in 2019

acronym: DEFIMEG

summary:
The aim of this study is to improve professional practices by better understanding parents who face the choice of medical termination of pregnancy.

The hypothesis of the study is that the decision to continue the pregnancy with a serious fetal pathology is more based on the belief and the representations of parents than on the diagnosis or prognosis criteria of the fetus.

A better understanding of the parents' motivations on their decision making by knowing what they expect from the caregivers would allow the division of representations, a better prenatal advice and a better perinatal support.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'obstétrique et de néonatologie, psychiatrie périnatale - Hôpital de la Croix-Rousse


title: Constitution of a Biological Collection to Study the Pathophysiology in Noonan Syndrome and to Identify Predictive Factors of Disease Progression

acronym: Noonan

summary: The present study will establish a collection of biological samples from Noonan patients to be used for research purposes only, with due respect for confidentiality.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


title: Non Transplantable Recurrence After Percutaneous Thermal Ablation of ≤3cm HCC: Predictors and Implications for Treatment Allocation

summary: Percutaneous thermal ablation (PTA), resection and liver transplantation (LT) are the standard curative options for hepatocellular carcinoma (HCC). LT yields the best long-term outcomes but is limited by graft shortage. Thus, patients with ≤3cm HCC are mainly treated by PTA although recurrence is frequent and may occur outside transplant criteria. However, data on non transplantable recurrence (NTR) following PTA are lacking. Therefore, the investigators investigated the incidence and predictors of NTR among transplantable patients with ≤3cm HCC(s) treated by PTA, in order to stratify them according to their NTR risk and to improve treatment allocation.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure

status_simplified: Completed


title: Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology

acronym: REAVIR

summary: As a part of the current rheumatological practice skills, epidural injections through the sacrococcygeal hiatus take part in the strategy for managing radicular diseases. This technical act is easily performed in an outpatient context since it is a brief procedure, performed under clinical and ultrasound control, with good tolerance. Nevertheless, epidural injections by the way of the sacrococcygeal hiatus can be responsible of anxiety for the patient and meet the definition of pain induced by treatment. Among the non-pharmacological methods that can be offered to the patient in this context, hypnosis and distraction allow psycho-corporal support acting on certain factors influencing the painful experience of the gesture: duration of the gesture, calm and pleasant environment, etc... That is the context in which the use of virtual reality is of interest. Its use in supporting procedures generating induced pain has already been evaluated in several studies, in particular in the fields of surgery and anaesthesiology. The use of a virtual reality device also seems suitable in the context of epidural injections, but this theoretical and plausible interest remains to be demonstrated. To our knowledge, the literature on the use of a virtual reality headset to support invasive procedures in rheumatology remains poorly developed. The objective of this study is therefore to assess the interest of using a virtual reality headset in the support of pain relief and the management of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier le Mans

intervention_type: Device


type: Registry Identifier

title: Prospective and Monocentric Pilot Study of the Evaluation of the Music Delivered by the Music-Care Device on the Level of Anxiety Felt During External Radiotherapy Sessions

acronym: MUSIC-RT

summary: This is a prospective study with a historical comparator. Each of the prospective study endpoints will be compared to data collected retrospectively in patients treated with radiation therapy prior to the implementation of the MUSIC-CARE device.

status: Active, not recruiting

lead_sponsor: Center Eugene Marquis

location_facility: Centre de Lutte contre le Cancer Eugène Marquis

lead_sponsor_type: industriel


title: Tumor Recurrence After Abdominal-perineal Amputation in Squamous Cell Carcinoma of the Anus

acronym: RTA

summary: Squamous cell carcinoma of the anal canal is a rare cancer with an increasing incidence. It represents 2.5% of digestive cancers and occurs more frequently in immunocompromised persons, in particular HIV positive. It is a cancer that develops essentially locally, with only 5% of metastases at diagnosis. The reference treatment for forms deemed localized after clinico-bio-radiological pre-therapeutic evaluation is radiochemotherapy allowing a 5-year survival rate of about 80%. However, up to 30% of patients fail radiochemotherapy. Failure is defined as persistent disease (non response or progression in 10 to 15% of patients) or relapse (local or metastatic in 10 to 15% of patients). Salvage surgery by abdominoperineal amputation is indicated in this case after elimination of the metastatic character with an overall survival rate at 5 years varying from 23 to 69%. This complex and cumbersome surgery is burdened with significant postoperative morbidity with alteration of the quality of life. Investigators would like to perform a retrospective and prospective study in the Paris Saint-Joseph hospital group to evaluate the interest of abdominoperineal amputation in case of failure of radiochemotherapy in patients with squamous cell carcinoma of the anal canal.

ReferenceType: background

ReferenceCitation: Abramowitz L, Mathieu N, Roudot-Thoraval F, Lemarchand N, Bauer P, Hennequin C, Mitry E, Romelaer C, Aparicio T, Sobhani I. Epidermoid anal cancer prognosis comparison among HIV+ and HIV- patients. Aliment Pharmacol Ther. 2009 Aug 15;30(4):414-21. doi: 10.1111/j.1365-2036.2009.04026.x. Epub 2009 Apr 17.

ReferenceCitation: Glynne-Jones R, Nilsson PJ, Aschele C, Goh V, Peiffert D, Cervantes A, Arnold D; ESMO; ESSO; ESTRO. Anal cancer: ESMO-ESSO-ESTRO clinical practice guidelines for diagnosis, treatment and follow-up. Radiother Oncol. 2014 Jun;111(3):330-9. doi: 10.1016/j.radonc.2014.04.013. Epub 2014 Jun 16.

ReferenceCitation: Hagemans JAW, Blinde SE, Nuyttens JJ, Morshuis WG, Mureau MAM, Rothbarth J, Verhoef C, Burger JWA. Salvage Abdominoperineal Resection for Squamous Cell Anal Cancer: A 30-Year Single-Institution Experience. Ann Surg Oncol. 2018 Jul;25(7):1970-1979. doi: 10.1245/s10434-018-6483-9. Epub 2018 Apr 24.

ReferenceCitation: James RD, Glynne-Jones R, Meadows HM, Cunningham D, Myint AS, Saunders MP, Maughan T, McDonald A, Essapen S, Leslie M, Falk S, Wilson C, Gollins S, Begum R, Ledermann J, Kadalayil L, Sebag-Montefiore D. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2 × 2 factorial trial. Lancet Oncol. 2013 May;14(6):516-24. doi: 10.1016/S1470-2045(13)70086-X. Epub 2013 Apr 9.

ReferenceCitation: Jemal A, Simard EP, Dorell C, Noone AM, Markowitz LE, Kohler B, Eheman C, Saraiya M, Bandi P, Saslow D, Cronin KA, Watson M, Schiffman M, Henley SJ, Schymura MJ, Anderson RN, Yankey D, Edwards BK. Annual Report to the Nation on the Status of Cancer, 1975-2009, featuring the burden and trends in human papillomavirus(HPV)-associated cancers and HPV vaccination coverage levels. J Natl Cancer Inst. 2013 Feb 6;105(3):175-201. doi: 10.1093/jnci/djs491. Epub 2013 Jan 7.

ReferenceCitation: Lee JY, Cutts RJ, White I, Augustin Y, Garcia-Murillas I, Fenwick K, Matthews N, Turner NC, Harrington K, Gilbert DC, Bhide S. Next Generation Sequencing Assay for Detection of Circulating HPV DNA (cHPV-DNA) in Patients Undergoing Radical (Chemo)Radiotherapy in Anal Squamous Cell Carcinoma (ASCC). Front Oncol. 2020 Apr 17;10:505. doi: 10.3389/fonc.2020.00505. eCollection 2020.

ReferenceCitation: Lefèvre JH, Corte H, Tiret E, Boccara D, Chaouat M, Touboul E, Svrcek M, Lefrancois M, Shields C, Parc Y. Abdominoperineal resection for squamous cell anal carcinoma: survival and risk factors for recurrence. Ann Surg Oncol. 2012 Dec;19(13):4186-92. doi: 10.1245/s10434-012-2485-1. Epub 2012 Jul 24.

ReferenceCitation: Longo WE, Vernava AM 3rd, Wade TP, Coplin MA, Virgo KS, Johnson FE. Recurrent squamous cell carcinoma of the anal canal. Predictors of initial treatment failure and results of salvage therapy. Ann Surg. 1994 Jul;220(1):40-9.

ReferenceCitation: van der Wal BC, Cleffken BI, Gulec B, Kaufman HS, Choti MA. Results of salvage abdominoperineal resection for recurrent anal carcinoma following combined chemoradiation therapy. J Gastrointest Surg. 2001 Jul-Aug;5(4):383-7.

ReferenceCitation: Rouquie D, Lasser P, Castaing M, Boige V, Goéré D, Pignon JP, Ducreux M, Elias D, Pocard M. [Complete (R0) resection is the only valid prognostic factor in abdominoperineal resection for recurrent cancer of the anal canal (a consecutive series of 95 patients)]. J Chir (Paris). 2008 Jul-Aug;145(4):335-40. French.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


type: Other Identifier

title: Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families

summary:
Severe and sometimes irreversible sequelae are observed in people who have developed a severe form of COVID-19 (pulmonary, cardiovascular, renal, neurological sequelae among others). More than 10% of individuals who contracted the disease, even in a mild form, still have at least one of the initial symptoms at six months, also known as prolonged symptoms or long COVID syndrome. The most frequently observed symptoms are asthenia, neurological disorders (headache, anosmia, ageusia, etc.), cardio-thoracic disorders, pain, digestive or skin disorders. Very recently, the first results of a British prospective cohort study (PHOSPCovid) indicate that more than half of the COVID-19 survivors who were hospitalised experienced a very severe to moderate deterioration in their mental and/or physical health five months after hospitalisation. Women are particularly affected. Another American study shows that 85% of non-hospitalised COVID-19 patients developed at least 4 neurological symptoms impacting their quality of life. The most common are: "brain fog" (81%), headaches (68%), numbness or tingling (60%), taste impairment (59%) and loss of smell (55%).

These disabling symptoms may persist for weeks or months, deteriorating the quality of life of patients and making it difficult for some to return to a normal life. On the basis of current knowledge concerning the long-term sequelae of SARS-CoV-2 infection, it seems necessary to offer these subjects a specific care pathway and to adapt their living and working conditions beyond their medical care.

The present study is aimed at measuring the impact of long COVID on the health and quality of life of the defence community (military personnel and their families).

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Centre d'Epidémiologie et de Santé Publique des Armées

intervention_type: Other


title: TANYCYTES' ROLE IN ALZHEIMER'S DISEASE AND FRONTOTEMPORAL DEMENTIA: ARE THEY THE KEY TO WELL AGING?

acronym: BIOWATCH

summary:
Metabolic and hormonal deregulations are both a risk factor and a hallmark of Alzheimer's disease (AD) and frontotemporal dementia (FTD), occurring early in the course of the disease. In FTD in particular, hyperorality and dietary changes are associated with metabolic and hormonal changes such as altered levels of the anorexigenic hormone leptin.

The hypothalamus is a brain region that controls metabolism and hormonal systems. Hypothalamic function depends on its ability to sense peripheral signals. The hypothalamus sits on a circumventricular organ called the median eminence (ME) that puts it in contact with systemic blood circulation. In the ME, fenestrated capillaries allow the diffusion of bloodborne factors. However, despite the lack of blood-brain barrier at brain microvessels, diffusion is controlled by specialized ependymoglial cells, the tanycytes, which exert a barrier function between the ME and the third ventricle and controls the access of blood-borne molecules into the hypothalamus. Previous work from our laboratory and the ERC consortium has highlighted the role of tanycytes not only in the regulation of the release of neurohormones from neuroendocrine nerve terminals into the pituitary portal blood circulation, but also in the transport of circulating leptin into the hypothalamus. Hence hypothalamic dysfunction in AD and FTD can result either from dysregulation of neuroendocrine secretions, direct neuronal loss or from defective transport (and hence resistance) to hormones like leptin.

This study is to demonstrate that leptin transport though tanycytes is early altered in FTD and AD and correlates

lead_sponsor: University Hospital, Lille

location_facility: Memory Resources and Research Center Lille


type: EudraCT Number

title: Serotonin Role on Brain Circuits Involved in Food Avoidance in Anorexia Nervosa : Study of Gaze Control and Multimodal Brain Imaging

acronym: SEVIALANO

summary: Serotoninergic activity in brain structures involved in food control and avoidance, such as the basal ganglia, is poorly understood in Anorexia Nervosa.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Clinical Relevance of Nicardipine Induced Hypoxemia in the Intensive Care Unit. A Multicenter Prospective Observational Study Comparing Nicardipine and Urapidil

acronym: ECRHIN-ICU

summary:
In the context of postoperative hypertension in the intensive care units, or after rescusitation of hypertensive patients, intravenous antihypertensive drugs are often used. Among thoses druges, Nicardipine is an effective drug, but with side effects such as inhibition of pulmonary vasoconstriction. Only preclinical studies have investigated the pathophysiology of this mechanism, and no clinical study have proven its clinical relevance.

The aim of this study is to establish the incidence of Nicardipine induced hypoxemia and to compare it to another antihypertensive agent, Urapidil.

lead_sponsor: University Hospital, Caen

intervention_type: Drug


title: Developmental Coordination Disorder: Role of Perceptual Deficits and Body Representation

acronym: DYSENS

summary:
Developmental Coordination Disorder (DCD) corresponds to a clumsiness, a slowness and an inaccuracy of motor performance. This neurodevelopmental disorder affects 6% of school-aged children, and disturbs daily life activities and academic performances. The etiology of DCD is still unknown. An understanding of this disorder is necessary to improve interventions and therefore quality of life of these people.

A deficit of the so-called internal models is the most commonly described hypothesis of DCD. Indeed, children with DCD exhibit difficulties in predictive control. Internal models, useful for motor control, are closely related to the sensory system, as they are elaborated on and constantly fed by sensory feedback. Deficits in sensory performance are described in DCD, mostly in the visual system, which could in turn partly explain poor motor performance. However, visuo-perceptual deficits cannot explain the entire motor difficulties because some activities in daily life, as buttoning a shirt, are often performed without visual control. Although the integrity of proprioceptive and tactile systems is necessary for the building of internal models, and therefore for a stable motor control, these sensory systems have been very little investigated in DCD.

Moreover, using a tool is often disturbed in children with DCD. In neurotypical subjects, tool use induces a plasticity of body representation, as reflected by modifications of movement kinematics after tool use. Proprioceptive abilities are necessary for this update of the body schema. Thus, potential deficits of the proprioceptive system in children with DCD could impair the plastic modification of the body schema, and hence of motor performance, when using a tool. The aim of this study is to identify the main cause of the DCD, both by evaluating the tactile and proprioceptive abilities and by assessing the body schema updating abilities in children with DCD.

While some daily life activities improve with age, some motor difficulties persist in adults with DCD. To our knowledge, perceptual abilities have never been investigated in adults with DCD and it is thus unknown whether perceptual deficits are still present in adulthood. This information could allow us to understand if motor difficulties in adult DCD are caused by enduring perceptual deficits and/or impaired plasticity of body schema. The second aim of this study is to evaluate abilities of perception and of body schema plasticity in adults with DCD.

location_facility: Equipe IMPACT du CRNL INSERM U1028, CNRS UMR 5292

intervention_type: Behavioral


title: Impact of the Implementation of a Referral Veno-venous Extracorporeal Membrane Oxygenation Centre on Mortality

acronym: ECMO UNIT

summary:
Current evidence suggest that regrouping patient supported by veno-venous ECMO in high-volume centre could improve outcome. A dedicated ECMO unit was implemented in Dijon.

The objective of the present study was to evaluate the implementation of this unit. The hypothesis was that patient taken care within this structured care system would have lower mortality.

This research comprises a retrospective observational study conducted in Dijon university hospital

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery : Comparative Study Using Propensity-score

summary: This study aims to compare the hemodynamic impact of two anaesthetic strategies : Regional anesthesia versus General anesthesia in proximal humeral fracture surgery.


title: Abnormal Thyroid Profile in Children With Attention Deficit With Hyperactivity Disorder (ADHD)

acronym: THYRADHD

summary:
Rationale: The observational data of University Children's Hospitals of Nice, suggest that about a quarter of children and adolescents with ADHD may present with an abnormal thyroid profile.

Main objective: To confirm that a subsample of children and adolescents with ADHD present with an abnormal thyroid profile using the gold standard for free fraction of hormones : chromatography with mass spectrometry.

Secondary objective: To examine to what extent this categorization holds using classic immuno-analytic assays. To characterize clinically and from a neuropsychological point of view this subsample and compare it to the other participants.

Study duration and design: 30 months (24 months for inclusion and 6 months for data analyses) open-label, (category 2 : interventional research with minimal risks or constraints), multicentre, without treatment or placebo administration.

Expected outcomes: Ancillary studies will investigate genetic physiopathological mechanisms (polymorphisms of deiodase or transmembrane carriers of thyroid hormones) and link this profile to other biological markers proposed in the literature (low ferritinemia, higher oxidative stress, atopic comorbid disease). The clinical trajectory of this subgroup and the persistence of this abnormal thyroid profile in adulthood will be a relevant issue in the future.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

intervention_type: Diagnostic Test


title: Evaluation of Implant Therapies Performed Under General Anesthesia in Patients With Specific Dental Needs

summary:
Implant placement is the solution of choice for replacing missing teeth in a fixed way. However, dental practitioners and surgeons are reluctant to place implants in the population of patients with special needs. They argue different arguments which involve various risk factors. A systematic review shows that it is clear that there is a gap in knowledge about implant placement in patients with special needs in order to argue the choices of prosthetic rehabilitation or abstention based on a scientific evidence-based approach. There is a need of studies with a large number of patients and implants.

The Unit of Special Care Dentistry at the University Hospital of Clermont-Ferrand started to place implants in 2007. This study should present the evaluation of the survival, success and failure rate of implants placed under general anesthesia and of the prosthesis rehabilitation that followed.

lead_sponsor: University Hospital, Clermont-Ferrand


title: ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging

acronym: Adodream

summary: To date, no MRI study has been published describing the prevalence of endometriosis in adolescent girls, not even in those with significant dysmenorrhea and therefore more particularly at risk. Likewise, there are no precise data on the type of superficial or early-onset deep endometriosis that appears in adolescence. The collection of these data would allow an earlier diagnosis, because it is better documented, of endometriosis. The lesions would then be treated earlier, avoiding their development and the problems of infertility related to this pathology. The aim of this sudy is to assess the prevalence of endometriosis and its phenotypic representation in the study population consulting for dysmenorrhea with suspected endometriosis.

lead_sponsor: Ramsay Générale de Santé


title: Tractography and Diffusion Tensor Imaging of the Human Spinal Cord in Healthy Subjects : Anatomical Atlas

acronym: TRACTOCORD

summary:
Today, Spinal cord pathologies, whether are tumoral, vascular, traumatic, malformative, inflammatory, or degenerative still constitute a major medico-surgical challenge due to the particular anatomy of the spinal cord. Indeed, the spinal fibers (whether they have a sensory or motor function) are all condensed in an extremely small volume. To date, there is no reliable technique to know the precise position of the spinal tracts specifically involved in the sensory and motor functions of the upper and lower limbs.

The purpose of this study is to evaluate the feasibility for differentiating spinal tracts by tractography from a cerebral Diffusion tensor imaging (DTI) Magnetic Resonance Imaging (MRI) sequence (associated with an anatomical sequence) by performing a stitching process with spinal cord DTI MRI sequence, in healthy subjects. The criterion of differentiation of the tracts will be assessed by highlighting already known cerebral tracts (cortico-spinal fibers, spinothalamic, posterior cord) and which will be monitored at the spinal level.


title: Effectiveness of Intraoral Scanners as a Motivation Method for Oral Hygiene Instruction

summary:
Periodontal diseases are highly prevalent inflammatory diseases. These diseases are mostly due to the development and the maturation of bacterial plaque which lead to local inflammation. Individuals can develop severe attachment loss which could lead to dental loss. To prevent them, individual plaque removal procedures self-performed by the patient by tooth brushing or interdental brushes or made by professional care (scaling), are known to improve periodontal health, and thus to prevent periodontal diseases. Moreover, oral hygiene is a major factor to increase increasing the outcomes when treatments are needed. However, patients' compliance in oral health program is one of the major limits to periodontal therapeutics.

In this study, the investigators evaluate the effectiveness of 3D intra-oral camera compared with conventional oral hygiene instructions, to improve oral health motivation.

primary_purpose: Prevention

lead_sponsor: CHU de Reims


title: Clinical and Biological Responses to Repeated Administration of Low-dose Interleukin-2 in Patients With Type 1 Diabetes and a Residual Insulin Secretion

summary:
Type 1 diabetes (T1D) is caused by the destruction of insulin-producing cells by effector T cells (Teffs), due to a deficiency of regulatory T cells (Tregs).

Ciclosporin effectively blocks the Teffs and controls diabetes, but cannot be considered as a long-term treatment. Low-dose interleukin-2 (ld IL-2) activates and expands Tregs in humans.

Hence, Ld IL-2 in patients in whom the autoimmune process was blocked early by a short treatment (2 months) of cyclosporine should restore immune homeostasis and maintain some insulin production over the long term.

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia: Myth or Reality? Retrospective Study of Premature Infants Inferior to 29 Weeks of Gestation

acronym: FunDyP

summary: The aim of this study is to determine if fungal colonization is associated to severe bronchopulmonary dysplasia in premature infants less than 29 weeks of gestation, and to determine if an association exists between fungal colonization and complications of prematurity and death.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Evaluation of the Criteria and Modalities of Screening for Retinopathy of Prematurity in Two French Tertiary NICU : is a Simplification Possible ?

summary: The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two French tertiary NICU and to identify co-morbidities associated with the development of severe ROP.


title: Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV

acronym: FRAMIVIH

summary:
Analysis of gut microbiota becomes more and more accessible in recent years. Experimental data in both animal and human studies have demonstrated that imbalance of the gut microbiota which is called symbiosis may participate in an accelerated procedure of ageing as well as the expression of frailty phenotype. People living with HIV (PLHIV) present markers of phenotypic frailty on average 10 years before uninfected people.

In this population structural and functional modifications of GALT (Gut Associated Lymphoid Tissue) are observed early after HIV infection and persist despite virological suppression on ART (AntiRetroviral Treatment). These GALT modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis.

The objective of study is to explore gut microbiota of PLWH over 5 years, as well as to study associations of its longitudinal evolution with frailty markers and burden of comorbidities.

lead_sponsor: Hôpital Européen Marseille


title: Montreal Toulouse 86 Test Modified to be Used With Eye Tracking: Test Automation and Eye Course in Healthy Volunteers and Intensive Care Patients

acronym: MEXICO

summary: Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.

lead_sponsor: University Hospital, Tours


title: Diagnostic Value of sFlt-1/PlGF Ratio for the Etiology of Intra Uterine Growth Restriction

acronym: ANGIOPAG

summary: The main aim of this project is to determine the Placental Growth Factor and Vascular Endothelial Growth Factor ratio's performance (sFlt-1/PlGF) for the etiological diagnosis of vascular Intrauterine growth restriction (IUGR) compared to a non-vascular IUGR.


title: Evaluation of the Dental Movements Caused by Oral Appliance in Syndrome Sleep Apnea Syndrome(DPOAM)

acronym: DPOAM

summary:
The DO OAM study is a mono-center, interventional, prospective study carried out in CH VALENCE.

It will estimate the prevalence of dental movements in patients treated by oral Appliance for Sleep Apnea syndrome.

The investigators will used fingerprinting technique by taking multiple photographs of the teeth that allow for the three-dimensional reconstruction of the teeth

this study will provide a better understanding of dental movement caused by oral appliance

lead_sponsor: Centre Hospitalier de Valence


acronym: APERITIF

title: Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction

source: euctr

summary: APERITIF is a prospective randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing the "FRENCHIE" registry, a French multicenter prospective observational study granted by "ANR-RHU Grand Emprunt", in which all consecutive patients admitted within 48 hours after symptom onset in a cardiac Intensive Care Unit (ICU) for an acute myocardial infarction (AMI) are included (NCT04050956). Among them, eligible Patients for "APERITIF" will be randomized into two groups: Dual Anti-Platelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, prescribed as soon as possible after admission and completion of the initial percutaneous coronary intervention/angiography procedure.


title: Impact of Severe to Profound Deafness on Cognitive Functions in Middle-aged Adults

acronym: SURDICOG

summary: A mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. No studies analysed cognition in patients younger than 65 years. The aim of our study was to compare cognitive function between patients with severe and profound hearing loss and patients with normal hearing in patients aged 45 to 64 years.

ipd_sharing_description: All data will be collected and analysed into the GH Pitié-Salpêtrière (AP-HP)

location_facility: Centre de Recherche en Audiologie (CReA) - Groupe Hospitalier Pitié-Salpêtrière


title: Coagulopathy in Acute Aortic Syndrome

acronym: SAACAOG

summary:
The existence of AAS coagulopathy has been reported, related to blood contact with the walls of the non-endothelialized false lumens. It is likely that endothelial dysfunction generated by vascular lesions may largely contribute to the development of coagulopathy, such as described in trauma-induced coagulopathy. This endotheliopathy of the AAS has never been evaluated. The coagulopathy of AAS and more specifically the endotheliopathy are poorly described and therefore have no standardized treatment.

The main objective of this study is to describe the coagulopathy

ipd_sharing_description: we will maybe try later to make a multicentric descriptive analysis with other french hospitals

lead_sponsor: European Georges Pompidou Hospital


title: Electrical Impedance Tomography: Effect of Extubation on Functional Residual Capacity

acronym: PULMOVISTA

summary:
The extubation phase is a risky period of anesthesia management. During this step, serious complications can arise: hypoxemia, laryngospasm, pharyngeal obstruction, pneumonia… In spite of these complications, extubation and its impact on respiratory function, particularly on the Functional Residual Capacity (FRC), remains poorly studied because of the difficulty to make bedside measurements.

The PulmoVista 500 is a clinical routine which provide effective non-invasive bedside measurements. It would be interesting to evaluate the impact of extubation on respiratory function, and more specifically FRC changes during and after extubation.

This study will allow a better physiopathological knowledge and a quality improvement patient extubation management.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Hôpital d'Instruction des Armées de Sainte Anne


title: Prenatal Screening of Intestinal Malrotation With a Higher Risk of Volvulus: Value of the Ultrasound Study of the Relative Position of the Superior Mesenteric Vessels and Fetal Abdominal MRI.

acronym: MALROT

summary:
Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.

The aim of the study is to study the neonatal outcome of fetus confirm to have an abnormal positionning of mesenteric vessels

lead_sponsor: University Hospital, Montpellier


title: Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions

acronym: IRM SAOS

summary: The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.

primary_purpose: Other


title: Impact of the FilmArray® Test on the Management of Ventilator Associated Pneumonia in COVID-19 ARDS

acronym: COVIDARRAY

summary:
Ventilator Associated Pneumonia (VAPs) are a very common side effect in intensive care units. They are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%.

VAPs complicate about 40-50% of COVID-19 acute respiratory distress syndrome (ARDS) and the mortality would be twice higher.

Thus, in this context of the COVID-19 pandemic, this represents a considerable rate of patients.

Unfortunately, the risk factors for VAPs are poorly understood and the bacterial ecology varies around the world. Also, facing a high prevalence of multi-resistant bacteria in this population, the choice of probabilistic antibiotic therapy is complex and represents a considerable impact for care.

New microbiological rapid diagnostic techniques have appeared in recent years, among them the FilmArray® seems to present interesting diagnostic performances with the ability to detects resistance to antibiotics.

This technique has been studied in acute community pneumonia but has not been validated in VAP and even less during the COVID-19 period.

Investigators decide to conduct this study to investigate if the early identification of the pathogens and their mechanism of resistance using FilmArray® would improve the relevance of the antibiotic treatment.

The aim of this project is to evaluate the contribution of a rapid diagnostic technique to the management of Ventilator Associated Pneumonia during COVID-19 acute respiratory distress syndrome before an interventional study.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Evaluation of Gastric Echography for Early Diagnosis of Nutritional Intolerance.

acronym: NUTRIGUS 2

summary:
In intensive care, gastrointestinal dysfunction may occur in response to systemic insult. Acute gastrointestinal dysfunction (AGID) has been clinically defined by consensus and several grades of severity have been defined. Biomarkers of digestive distress have also been described in intensive care and can be measured directly in the plasma (lipopolysaccharide, intestinal fatty acid binding protein, citrulline, glucagon-like peptide-1).

Enteral nutrition is a frequent therapy in intensive care patients, and its administration is recommended. In general, nurtition is resumed early via a nasogastric tube in patients placed on mechanical ventilation. The resumption of nutrition can be seen as a "challenge" to the gastrointestinal tract, and may thus unmask underlying gastrointestinal dysfunction. Intolerance of enteral nutrition is a symptom of gastrointestinal dysfunction and is associated with poor clinical outcomes. Indeed, it is both a marker of severity by reflecting organ dysfunction and responsible for a reduction in caloric intake that can influence prognosis.

There is no consensus on the definition of intolerance to enteral nutrition. In practice, it is most often recognized because of regurgitation or vomiting, requiring reduction or discontinuation. In a recent review, the authors emphasize the need for digestive monitoring for early diagnosis of nutritional intolerance.

Gastric echography is a minimally invasive and reliable means of monitoring the gastric contents. In particular, the surface of the antrum has been validated as a way to diagnose a full stomach in intensive care. The measurement of echographic variations in gastric residue with the resumption of enteral nutrition could thus allow the early diagnosis of gastrointestinal dysfunction and food intolerance by preceding vomiting.

Our objective is to show the interest of echographic monitoring of the stomach during the resumption of enteral feeding for the diagnosis of nutritional intolerance. As nutritional intolerance is a symptom of gastrointestinal dysfunction, we will also study this phenomenon by measuring the associations between echographic data, clinical data and biomarkers of gastrointestinal dysfunction.


title: Impact of a Modified Schedule Including a Day Without Clinical Activity Before Night Shift on Non-technical Skills of French Residents in Intensive Care Unit, a Prospective Randomized Multi Center Study: REPOPREGARD Protocol Study

acronym: REPOPREGARD

summary:
In this proposal, investigators seek to address conclusively two knowledge gaps: 1) the lack of data on the impact of a schedule including a day off clinic before night shift on performances of residents in anesthesia or critical care medicine and 2) the lack of data on the relationship between resident sleep deprivation and their non technical skills impairment. Investigators designed a prospective, randomized, blinded in cross over evaluation of medical pratices. Investigators will compare resident's performance during a high fidelity simulation session, on crisis managment in intensive care unit, after a night shift in intensive care unit, of residents who work on an intervention schedule with no clinical activity before night shift, with resident's performance of residents who had a traditionnal schedule including an usual clinical day before night shift. Investigators also assess cognitive performances, sleepiness and self esteem before and after night shift. Investigators specific aims will be:

To test the hypothesis that residents working on an intervention schedule will have non technical skills, assessed by Ottawa GRS global score, significantly less impaired after a night shift, than those on traditionnal schedule

To test the hypothesis that residents working on an interveniton schedule will have cognitive performances, sleepiness and self esteem less impaired after night shift than those on a traditionnal schedule


title: Clonal Hematopoiesis of Indeterminate Potential and Accelerated Atherosclerosis in Patients With Systemic Lupus Erythematosus

acronym: HEMATOPLUS

summary: Accelerated atherosclerosis in patients with systemic lupus erythematosus (SLE) is not fully explained by Framingham risk factors. The detection in asymptomatic patients of somatic mutations in genes involved in hematopoietic malignancy- defining clonal hematopoiesis of indeterminate potential (CHIP) - predisposes to cardiovascular events (CVE) in general population. We aimed to determine whether CHIP is associated with CVE in SLE.

ReferenceType: derived

ReferenceCitation: David C, Duployez N, Eloy P, Belhadi D, Chezel J, Guern VL, Laouénan C, Fenwarth L, Rouzaud D, Mathian A, de Almeida Chaves S, Duhaut P, Fain O, Galicier L, Ghillani-Dalbin P, Kahn JE, Morel N, Perard L, Pha M, Sarrot-Reynauld F, Aumaitre O, Chasset F, Limal N, Desmurs-Clavel H, Ackermann F, Amoura Z, Papo T, Preudhomme C, Costedoat-Chalumeau N, Sacre K. Clonal haematopoiesis of indeterminate potential and cardiovascular events in systemic lupus erythematosus (HEMATOPLUS study). Rheumatology (Oxford). 2022 Nov 2;61(11):4355-4363. doi: 10.1093/rheumatology/keac108.


title: Personalization of 99mTc-Sestamibi Activities in SPECT/CT Myocardial Perfusion Imaging With the Cardiofocal SmartZoom® Collimator

acronym: OSPECT

summary: This work suggests a methodology to adapt the injected radionuclide activity to the level of attenuation of each patient. The investigators propose a dose reduction adapted to the patient's weight, with no significant degradation of the image quality, in order to improve patients and staff radioprotection, standardize the image quality for easier clinical interpretation, and lead to radiopharmaceutical saving in the context of myocardial perfusion Imaging.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study

acronym: PARAVA

summary: The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.

lead_sponsor: Centre Henri Becquerel


title: Instrumented POsterolateral Arthrodesis for Adolescent Idiopathic Scoliosis: Observational Study

acronym: APOSIA

summary:
The study population concerns adolescent patients with idiopathic scoliosis which requires surgical management and who have a longer waiting period of 6 months.

The aim of this study is to research the predictive factors of an improvement in the quality of life of adolescents who have had surgery.

lead_sponsor: Elsan


title: Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.

acronym: EnDol

summary: The present study aimed to assess the diagnostic performance of ultrasound-guided endobronchial intra-nodal miniforceps biopsy (EBUS-MFB) in the diagnosis of "de novo" mediastinal lymphoma.

lead_sponsor: University Hospital, Caen


title: Effect of Progesterone Levels on 15th Day After Embryo Transfer in Early Miscarriage < 7 WG or Evolving Pregancy Rates

summary: Progesterone level has been studied at days before embryo transfert. But, progesterone blood level has not been studied 15 days after embryo transfert. The aim of this study is to study progesterone level impact at 15 days after embryo transfert on evolving pregnanies or early miscarriages.


title: Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment: Clinical and Radiological Outcome

acronym: KOA-RI

summary: This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)

status: Enrolling by invitation

status_simplified: Unknown


title: Acceptance and Efficacy of a Smartphone-based App Using a Conversational Agent to Monitor Health Status and/or Deliver Behavioral Intervention to Reduce Psycho-social Stress

acronym: KANOPEE

summary:
KANOPEE is a free smartphone application providing screening, follow-up tools and autonomous digital interventions to lower psycho-social stress and its repercussions on sleep and behaviors in the general population.

Additionally, KANOPEE permits an adaptation of the intervention to the subject (i.e., an adapted waiting period, frequency, and content), enabling to perform innovative trial conditions.

The objective of this long-term study is to evaluate the efficacy of KANOPEE on users among the French general population exposed to psycho-social stress.

lead_sponsor: University of Bordeaux


title: Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions

summary:
The major aim is to evaluate accuracy of 2 Continuous Glucose Monitoring Systems (CGMS) : Dexcom G6® and FreeStyle Libre® in standardized hypoxemia conditions (artificial normobaric hypoxia).

Our purpose is to demonstrate the good performance and calibration of these CGM sensors in hypoxemia conditions.

lead_sponsor: Poitiers University Hospital


title: Constitution of a Prospective Twin Pregnancy Cohort in Order to Study the Risk Factors for Obstetric Complications COGEM

acronym: COGEM

summary:
The investigators know that multiple factors are involved in the risk of obstetric complications. The twin pregnancy model appears to be an interesting model for a bio-statistical analysis of data collected in the context of a complete pregnancy, in particular because it can reveal differences for a common exposure.

The aim of the study is to constitute a prospective cohort of twin pregnancies. The collection of data on the health of mothers, pregnancies, childbirth, and the health of twins at birth should make it possible to reveal results with sufficient statistical power for a prospective study.


title: Assessment of Visual and Refractive Results, and Rotational Stability of the TECNIS® Eyhance Toric II 1-piece Posterior Chamber Lens in Patients With Astigmatism Undergoing Cataract Surgery: a Prospective Cohort Study - STATE

acronym: STATE

summary:
Cataract surgery is one of the most common procedures performed worldwide. Astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. Access to astigmatism correction during cataract surgery allows for improved visual outcomes for patients. Toric intraocular lenses (IOLs) are the procedure of choice to correct corneal astigmatism of one diopter or more in cases undergoing cataract surgery. Rotational stability is a key factor for successful outcomes with toric IOLs. Postoperative toric IOL misalignment is the major factor responsible for suboptimal visual outcomes after toric IOL implantation.

The TECNIS® Eyhance Toric II 1-piece posterior chamber lens is a new toric IOL which is FDA approved and CE marked. Marketed by Johnson & Johnson Vision, it is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder.

No study assessing the early rotational stability of the TECNIS® Eyhance Toric II IOL has been published yet.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Systemic Treatment of Moderate-to-severe Psoriasis in Adults: Update of the French Guidelines Using Delphi Consensus Statement

summary: French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults have been developed by the psoriasis research group of the French Society of Dermatology using literature available until July 2017 (Amatore et al, 2019). Because several systemic treatments have been marketed since then, new guidelines are mandatory. The aim of this study coordinated by the Centre of Evidence of the French Society of Dermatology is to update the available French guidelines using a Delphi method.

ReferenceType: result

ReferenceCitation: Amatore F, Villani AP, Tauber M, Viguier M, Guillot B; Psoriasis Research Group of the French Society of Dermatology (Groupe de Recherche sur le Psoriasis de la Société Française de Dermatologie). French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):464-483. doi: 10.1111/jdv.15340. Epub 2019 Feb 22.


title: Perception of Music and Facial and Vocal Emotions in a Population With and Without Depression

acronym: MusInDep

summary:
Depressed subjects display a cognitive bias of information processing and emotional self-regulation, which reinforces negative experiences more than positive ones, known as the negativity bias. The link between depressive disorder and negativity bias has been much studied in terms of genetic, neurobiology, structural and functional neuroanatomy and cognitive sciences. It has been admitted that depressed subjects show impairment of facial expressions and prosody recognition, and of implicit memory.

Induction of depressive or elated mood with musical excerpts listening in healthy subjects influences facial emotions perception, respectively by reducing or enhancing recognition skills. However, no study to date already explored the interest of music-induced positive mood for alleviating negativity bias in depressed elderly population.

Main objective : to assess the impact of exposure to positive valence musical excerpts, on evaluation of facial emotions intensity, in a population of elderly patients hospitalized for depression, compared to neutral valence music listening.

Secondary objectives : to assess the impact of exposure to positive valence musical excerpts, on facial and vocal emotions recognition, and on implicit memory of faces, compared to neutral valence music listening.

The same methodology is also applied in a sample of control participants over 65 years to study the mood induction effect by music in elderlies.

lead_sponsor: Hôpital le Vinatier


title: A Phase 1 First-In-Human Study of the Anti-CD73 IPH5301 Alone or in Combination With Chemotherapy and Trastuzumab in Patients With Advanced Solid Tumors

acronym: CHANCES

summary:
CHANCES-IPC 2021-008 is First In Human, Phase I, multicenter, European study evaluating an anti-CD73, IPH5301 in advanced and/or metastatic cancer.

The trial will be conducted in two parts, Part I- Dose escalation: This part aims to identify the maximum tolerated dose (MTD) of IPH5301 agent in monotherapy and recommended phase 2 dose (RP2D) for future trials, followed by a safety expansion study part cohort.

Part II- Expansion cohort: A total of 12 HER2+ cancer patients, respectively 6 breast cancer patients and 6 gastric cancer patients, is planned to be enrolled into the next expansion cohort to select a recommended dose of IPH5301 to be administered in combination with chemotherapy and trastuzumab for evaluation in future trials with selected advanced solid tumors.

lead_sponsor: Institut Paoli-Calmettes


title: Evaluation of the Effectiveness of Self-hypnosis on Anxiety and Burnout of Nursing Staff

acronym: ESHABC

summary: Its a prospective, non-interventional, single-center study, involving the human person evaluating the impact of self-hypnosis training on anxiety level and burn out in nursing and medical staff


title: Study of Pulmonary Infections (Pneumonia) in Kidney Transplant Recipients Admitted to Hospital

summary: The investigators aimed to identify prognosis factors associated with in-hospital complications and assess the epidemiology, management, and outcomes of community-acquired pneumonia in a kidney transplant recipients' cohort. The investigators intend to identify each stay by a national database. Then they will be consulted by 2 clinicians to assert CAP clinical definition. After that radiographic evidence will be reviewed to validate CAP diagnoses. Then clinical data are collected in each center.

lead_sponsor: CHU de Reims


title: A Retrospective Study Using Mass Spectrometry to Characterize Post-translational Modifications to Circulating Histones in Pregnant Women Developing Pre-eclampsia

acronym: GHISPE

summary:
This is a descriptive pilot study on a ready-constituted biobank (outside the Jardé Law). It is an ancillary study to the "GrossPath" cohort (RCB ID number: 2014-A01120-47).

Pregnancy generates an increased risk of thrombosis, and placenta-mediated diseases constitute a risk factor for cardiovascular pathologies responsible for significant maternal-fetal morbidity and mortality. Understanding and exploring the cellular and molecular mechanisms of dysfunctions of the vascular-placental interface could provide arguments to understand the systemic vascular risk, characterize it and finally detect it on the basis of new markers, thus opening the way for targeted preventive management to reinforce the general principles of precision medicine.

Netosis is a process of activation of neutrophils, which then generate filaments containing DNA, enzymes and extracellular histones. Netosis occurs in pregnancy and is increased in vascular-placental complications. It can be studied by measuring circulating histones, particularly the citrullinated histone H3. Levels of this modified histone H3, as well as those of two other modifications, have recently been shown to increase during pregnancy. These levels have also been shown to be even greater in pregnancy complications.

The aim of this study is to complete this mapping in order to obtain a precise signature for all post-translational histone modifications in normal pregnancies and pregnancies complicated by pre-eclampsia from the "GrossPath" cohort in order to propose new circulating biomarkers for placental vascular pathologies.

The post-translational histone modification profiles (mapping) of pregnant women with normal pregnancies will be compared with those developing pre-eclampsia.

ipd_sharing_description:
All data collection and management will be carried out by the BESPIM (Biostatistique, Epidémiologie clinique, Santé Publique & Innovation en Méthodologie).

The conditions of transfer of all or part of the research database are decided by the principal investigator and the research sponsor and are the subject of a written contract.


title: Fall Risk Assessment in a Population of Charcot-Marie-Tooth Disease Type 1A (CMT 1A) by Timed Up and Go Test

acronym: DeteCTCMT

summary:
The main objective of this study is to explore the relationship between the onset of fall and the time taken to complete the Timed Up and Go test (TUG) in this CMT1A patient population.

The investigators hypothesize that patients with balance disorders and therefore a risk of major fall will require a longer time to perform the Timed Up and Go test. In addition, it seems important to confirm that the severity of the disease has a negative impact on the frequency of balance disorders.

ReferenceCitation: Reilly MM, Shy ME, Muntoni F, Pareyson D. 168th ENMC International Workshop: outcome measures and clinical trials in Charcot-Marie-Tooth disease (CMT). Neuromuscul Disord. 2010 Dec;20(12):839-46. doi: 10.1016/j.nmd.2010.08.001. Epub 2010 Sep 17.

ReferenceCitation: Ramdharry GM, Thornhill A, Mein G, Reilly MM, Marsden JF. Exploring the experience of fatigue in people with Charcot-Marie-Tooth disease. Neuromuscul Disord. 2012 Dec;22 Suppl 3:S208-13. doi: 10.1016/j.nmd.2012.10.016.

ReferenceCitation: Ribiere C, Bernardin M, Sacconi S, Delmont E, Fournier-Mehouas M, Rauscent H, Benchortane M, Staccini P, Lantéri-Minet M, Desnuelle C. Pain assessment in Charcot-Marie-Tooth (CMT) disease. Ann Phys Rehabil Med. 2012 Apr;55(3):160-73. doi: 10.1016/j.rehab.2012.02.005. Epub 2012 Mar 6. English, French.

ReferenceCitation: Reynaud V, Muti D, Pereira B, Greil A, Caillaud D, Richard R, Coudeyre E, Costes F. A TUG Value Longer Than 11 s Predicts Fall Risk at 6-Month in Individuals with COPD. J Clin Med. 2019 Oct 22;8(10). pii: E1752. doi: 10.3390/jcm8101752.

ReferenceCitation: Anens E, Emtner M, Hellström K. Exploratory study of physical activity in persons with Charcot-Marie-Tooth disease. Arch Phys Med Rehabil. 2015 Feb;96(2):260-8. doi: 10.1016/j.apmr.2014.09.013. Epub 2014 Oct 5.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Retrospectice Evaluation of the Feasibility and Usefulness of a Percutaneous Vertebroplasty Performed on Patients Treated With Posterior Fixation Suffering Non-union After a Traumatic Non-neurologic Vertebral Fracture

summary:
Traumatic thoracolumbar vertebral fractures are frequently treated with posterior fixation (PF) and vertebral augmentation, but sometimes vertebral augmentation is not performed, being judged too risky under fluoroscopic guidance alone. An adjuvant CT/fluoroscopy guided percutaneous vertebroplasty (PVP) could be an option.

The aim was to evaluate feasibility, safety and effectiveness of PVP in patients with vertebral non-union (VNU) following PF performed without concomitant vertebral augmentation.

All patients treated in our institution with PVP between July 2015-July 2020 were retrospectively reviewed. Patients treated with CT/fluoroscopy guided PVP under local anesthesia for symptomatic VNU following PF were selected. Three criteria were established to assess cement distribution, considering vertebral filling of: 1)fracture cleft, 2)anterior two-thirds of the vertebral body, 3)from superior to inferior endplates. Numeric pain rating scale (NPRS) assessing grade of discomfort (0=no pain; 10=worst pain) and complications were evaluated before and one month after PVP.

ipd_sharing_description: no data sharing plan has been established

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery

summary: This study is a Pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named CATSYS.

lead_sponsor: Ilasis Laser

location_facility: Institut Opthalmologique Sourdille Atlantique


title: Identification of the Determinants of the Perceived Workload of Intensive Care and Pediatric Continuous Monitoring Nurses

acronym: CHARMIREA

summary: The purpose of this study is to identify the determinants of the perceived workload of intensive care and pediatric continuous monitoring nurses (factors liked to the care service, staff, patients treated)

time_perspective: Cross-Sectional

ReferenceCitation: Lebet RM, Hasbani NR, Sisko MT, Agus MSD, Nadkarni VM, Wypij D, Curley MAQ. Nurses' Perceptions of Workload Burden in Pediatric Critical Care. Am J Crit Care. 2021 Jan 1;30(1):27-35. doi: 10.4037/ajcc2021725.

ReferenceCitation: Helmreich RL. On error management: lessons from aviation. BMJ. 2000 Mar 18;320(7237):781-5.

ReferenceCitation: Llenore E, Ogle KR. Nurse-patient communication in the intensive care unit: a review of the literature. Aust Crit Care. 1999 Dec;12(4):142-5. Review.

ReferenceCitation: Gurses AP, Carayon P, Wall M. Impact of performance obstacles on intensive care nurses' workload, perceived quality and safety of care, and quality of working life. Health Serv Res. 2009 Apr;44(2 Pt 1):422-43. doi: 10.1111/j.1475-6773.2008.00934.x. Epub 2008 Dec 16.

ReferenceCitation: Nasirizad Moghadam K, Chehrzad MM, Reza Masouleh S, Maleki M, Mardani A, Atharyan S, Harding C. Nursing physical workload and mental workload in intensive care units: Are they related? Nurs Open. 2021 Jul;8(4):1625-1633. doi: 10.1002/nop2.785. Epub 2021 Feb 17.

ReferenceCitation: Young G, Zavelina L, Hooper V. Assessment of workload using NASA Task Load Index in perianesthesia nursing. J Perianesth Nurs. 2008 Apr;23(2):102-10. doi: 10.1016/j.jopan.2008.01.008.

ReferenceCitation: Tubbs-Cooley HL, Mara CA, Carle AC, Gurses AP. The NASA Task Load Index as a measure of overall workload among neonatal, paediatric and adult intensive care nurses. Intensive Crit Care Nurs. 2018 Jun;46:64-69. doi: 10.1016/j.iccn.2018.01.004. Epub 2018 Feb 12.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


acronym: ARTEGENE

intervention_type: Genetic

title: A Phase 1/2 Open Label Non Randomized Study, Multicentric, Single Arm Evaluating the Safety and Efficacy of Gene Therapy of the Severe Combined Immunodeficiency (SCID) Caused by Mutations in the Human DCLRE1C Gene (Artemis) by Transplantation of a Single Dose of Autologous CD34+ Cells Transduced ex Vivo With the G2ARTE Lentiviral Vector Expressing the DCLRE1C cDNA

location_facility: Department of Pediatric Immunology, Hematology and Rheumatology UIHR, Necker-Enfants Malades Hospital

summary: The purpose of this study is to evaluate the Safety and Efficacy of Gene Therapy of the severe combined immunodeficiency (SCID) caused by mutations in the human DCLRE1C gene (Artemis) by transplantation of a single dose of autologous CD34+ cells transduced ex vivo with the G2ARTE lentiviral vector expressing the DCLRE1C cDNA.


title: 5 Years Hemodynamic and Clinical Follow-up of the SAPIEN 3 Transcatheter Heart Valve According to the Implantation Strategy: Insight From the Randomized DIRECTAVI Trial

acronym: DIRECTAVILONG

summary: A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Whether the initial implantation strategy may impact the long-term trans catheter heart valve (THV) performances and patient outcomes remains unknown to date. The Investigators therefore aimed to evaluate the 5-years impact of the implantation strategy on THV hemodynamic performances and clinical outcomes in patients included in the DIRECTAVI trial.


title: Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence

acronym: OSE

summary: To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Effectiveness Randomized Controlled Trial on Eating Disorders Group Treatment: a Cognitive Dissonance, a Mindfulness and a Person-centered Based Program

summary: This trial aims at comparing three group treatments designed for eating disorders: a Cognitive-dissonance, a Mindfulness and a Person-centered based programs. Women with eating disorders will be recruited and randomized to one of the three programs. Participants will complete a pretest, a posttest, a 3-months follow-up and a 1-year follow-up. This trial aims to compare the programs to analyze the specific dimensions upon which each program acts. The investigators therefore made hypotheses according to the programs' theory: participants in the Cognitive-dissonance based program should experience a greater decrease in eating disorders symptoms, thin-ideal internalization and body dissatisfaction and a greater improvement in quality of life than other participants. Participants in the Mindfulness-based program should show a greater improvement in negative affect and in equanimity than other participants. Participants in the Person-Centered based program should report a greater increase in congruence than other participants.

lead_sponsor: University Grenoble Alps


title: Phenotype Severity of RSV-infections in Twins During the First Year of Life

acronym: TwinSeVeRS

summary: Respiratory syncytial virus (RSV) infection is the most common cause of severe lower respiratory tract infection (LRTI) in the pediatric population worldwide. Age at the time of infection, prematurity, multiparity, exposure to smoke and the level of passive immunity transmitted at birth are the main risk factors for lower respiratory infection associated with RSV. Other factors, including the innate immune response, respiratory microbiota, and intra-host viral heterogeneity, may also affect outcomes but are not fully considered in RSV infection. Exploring the impact of these factors is difficult due to the heterogeneity of the population which makes statistical adjustment difficult. Thus, twin models are useful in understanding the impact of the host on the environment, as twins often share similar exposure to infection and many risk factors, but not all are ie different prenatal and postnatal conditions, differential transfer of maternal antibodies and the genetic makeup of heterozygotes.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon


title: Mercuri Analysis Contribution on Handicap Evaluation in ArthrogypOsis, a Congenital Neuromuscular Disease

acronym: MACHAON

summary: The aim is to evaluate the correlation of quantified fibro-adipous infiltration of muscles, using the MRI-based Mercuri score, with deficiencies, activity limitations and social participation in patients with arthrogryposis multiplex congenita.

ReferenceCitation: Liu CY, Yao J, Kovacs WC, Shrader JA, Joe G, Ouwerkerk R, Mankodi AK, Gahl WA, Summers RM, Carrillo N. Skeletal Muscle Magnetic Resonance Biomarkers in GNE Myopathy. Neurology. 2021 Feb 2;96(5):e798-e808. doi: 10.1212/WNL.0000000000011231. Epub 2020 Nov 20.

ReferenceCitation: Hall JG. Arthrogryposis multiplex congenita: etiology, genetics, classification, diagnostic approach, and general aspects. J Pediatr Orthop B. 1997 Jul;6(3):159-66.

ReferenceCitation: Mercuri E, Pichiecchio A, Counsell S, Allsop J, Cini C, Jungbluth H, Uggetti C, Bydder G. A short protocol for muscle MRI in children with muscular dystrophies. Eur J Paediatr Neurol. 2002;6(6):305-7. doi: 10.1016/s1090-3798(02)90617-3.

ReferenceCitation: Figueroa-Bonaparte S, Segovia S, Llauger J, Belmonte I, Pedrosa I, Alejaldre A, Mayos M, Suarez-Cuartin G, Gallardo E, Illa I, Diaz-Manera J; Spanish Pompe Study Group. Muscle MRI Findings in Childhood/Adult Onset Pompe Disease Correlate with Muscle Function. PLoS One. 2016 Oct 6;11(10):e0163493. doi: 10.1371/journal.pone.0163493. eCollection 2016.

ReferenceCitation: Dai S, Dieterich K, Jaeger M, Wuyam B, Jouk PS, Perennou D. Disability in adults with arthrogryposis is severe, partly invisible, and varies by genotype. Neurology. 2018 May 1;90(18):e1596-e1604. doi: 10.1212/WNL.0000000000005418. Epub 2018 Apr 6.

lead_sponsor: University Hospital, Grenoble


title: Development of a Bayesian Estimator for Calculating Plasma Iohexol Clearance Using Limited Sample Strategy for the Evaluation of Kidney Donation Candidates.

acronym: CLIO

summary:
In kidney transplantation, donor selection is based in part on the assessment of the functional capacity of the kidneys. For this purpose, it is recommended to measure the glomerular filtration rate (GFR) by a reference technique. To estimate GFR, several approaches are possible depending on the type of measurement (urinary or plasma) and the marker (exogenous or endogenous) used. Among these methods, the measurement of inulin clearance has long been considered the reference method. The occurrence of anaphylactic reactions led to its withdrawal from the market. Iohexol, an iodinated contrast agent, has characteristics similar to inulin. It is eliminated by glomerular filtration and its biological determination is simple.

Nevertheless, the techniques currently used to calculate plasma clearance of Iohexol have been imperfectly validated and are not always easy to implement in practice. the investigators propose to develop a Bayesian estimator for estimating Iohexol clearance applied to a population of healthy subjects, representative of potential kidney donors.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Efficacy and Safety of Prostate Biopsies by Transperineal Versus Transrectal Route: Randomized Study

acronym: PERFECT

summary: Comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments

acronym: HOPICOV

summary: The purpose of the study is to describe medical care strategies implemented by healthcare establishments for patients affected by COVID-19

lead_sponsor: Centre Hospitalier Emile Roux


title: Role of the Gastric Tube in the Preoperative Management of Hypertrophic Pyloric Stenosis

acronym: SONPYL

summary: Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Postoperative Analgesic Benefit of iPACK Block in the Anterior Cruciate Ligament Reconstruction Surgery, the LIGA-PACK Study

acronym: Liga-PACK

summary: This randomised clinical trial evaluates the analgesia provided by an iPack block associated with an adductor canal block in patients who undergo anterior cruciate ligament reconstruction surgery, compared to an adductor canal block alone. The objective is to prove the superiority of this locoregional anesthesia in terms of analgesia and functional rehabilitation.

lead_sponsor: University Hospital, Toulouse


title: Combined Flow-pressure Study of Cerebrospinal Circulation Using CSF Perfusion Tests and Phase-contrast MRI - Reversible Dementia Substudy

acronym: REVERT

summary:
Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms.

The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.


title: Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated: a Prospective, Randomized Study

acronym: TELEGLIO

summary: This study is to evaluate the efficacy of a mobile app for monitoring the quality of life of patients but also on detection delay of side effects and/or complications linked to the therapeutic management. This allow to adapt their care more quickly, through a prospective randomized study. The impact of this connected monitoring of patients' anxiety will also be evaluated in this study as well as the time taken by the medical team to manage alerts generated by this application.

lead_sponsor: Ramsay Générale de Santé


title: Advanced Lipoproptein Profiling and Cardiovascular Risk Stratification in Familial Hypercholesterolemia

acronym: CARDIOMET

summary:
Familial hypercholesterolaemia (FH) is a genetic disorder characterised by elevated plasma LDLC levels.

The causal role of low-density lipoprotein cholesterol (LDLC) in the progression of cardiovascular disease (CVD) is indisputable: genetic, epidemiological and interventional trials have unanimously shown that a reduction in LDL-C is associated with a reduced risk of CVD.

Some drawbacks related to the limitations of the analytical methods are slowly surfacing due to the lower LDLC target achieved with the combination of several new treatments. This is mainly due to the fact that LDLC is not a comprehensive marker to stratify cardiovascular risk in subjects with increased levels of other atherogenic lipoproteins.

Direct measurement of the concentration of apolipoproteins involved in cholesterol and triglycerides transportation, may provide more information than the simple measure of the cholesterol contained in these particles. There is an interest in measuring the various players involved in the lipoprotein processing chain. These apolipoproteins are increasingly being considered as possible biomarkers of cardiovascular disease risk.

Indeed, there is increasing evidence that advanced lipoprotein testing methods, such as multiplexed measurements of apolipoprotein panels (ApoA-I, A-II, A-IV, B-100, C-I, C-II, C-III, E), provide more detailed information on the dyslipidaemic profiles of patients compared to conventional lipid testing, finally allowing a better understanding and stratification of subclinical atherosclerosis in these patients.

The main objective of this study is to compare the apolipoprotein profile of patients with FH by comparing those with associated hypertriglyceridemia (hyperTG) to those with isolated hypercholesterolaemia.

Adult subjects with a molecular diagnosis of Familial Hypercholesterolemia, treated by a statin, on primary prevention, asymptomatic for cardiovascular symptoms, will be recruited and stratified according to the presence/absence of hyperTG in a case-control prospective observational study design.


title: Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments (FRESSPED): a French Multicenter Prospective Observational Study

acronym: FRESSPED

summary: With 25.2 million children affected and 3.4 million deaths in 2017, paediatric sepsis is the leading cause of under-five mortality worldwide and has recently been described as "significant global health threat" by the World Health Organization. In addition to early antibiotics, fluid bolus therapy (FBT) is one of the cornerstones of management, due to the theoretical improvement of cardiac output, oxygen delivery and organ perfusion. In the absence of a consensual and operational definition to date, the latest international guidelines of the Surviving Sepsis Campaign 2020 (SSC-2020), refers to children (≥ 37 weeks gestation at birth to 18 years old) with severe infection leading to cardiovascular (i.e., "septic shock") or non-cardiovascular organ dysfunction (i.e., "other sepsis-associated organ dysfunction" or former "severe sepsis"). The SSC-2020 specifies the modalities for paediatric sepsis management, particularly concerning FBT, with, for example, the preferential use of balanced crystalloids, and a target volume of 40-60ml/kg at one hour of recognition using boluses of 10-20ml/kg in children who have access to a paediatric intensive care unit (PICU) in their health system. Further, it is now well established that compliance with international guidelines is associated with improved outcomes in paediatric sepsis. Despite the importance of awareness and implementation of the SSC-2020, there are, to our knowledge, no studies evaluating its application in children. We prospectively conducted the Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments (FRESSPED) study in 25 hospitals over five weeks between November 2021 and March 2022, whose principal objective was to assess doctors adherence to the SSC-2020 guidelines when performing FBT in infants and children with suspected sepsis in French paediatric emergency departments.


title: Monocentric Randomized Study Evaluating the Impact of an Early Multidisciplinary Program in Elderly Subjects Starting a Chemotherapy for Digestive Cancer: Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)

acronym: EPODIG-G

summary: This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Study of the Contribution of Virtual Reality Distraction in Peripheral Intravenous Catheter Insertion to Children From 6 to 11 Years in a Pediatric Day Hospital

summary:
Main objective :

Evaluate the effect of using a virtual reality mask during the peripheral intravenous catheter insertion in a pediatric day hospital on the pain and anxiety in children from 6 to 11 years old.

Hypothesis :

Using virtual reality mask during the peripheral intravenous catheter insertion would reduce the 6 to 11 child's pain, the children and parents' anxiety, would improve satisfaction of children, parents and nurse about the care and would reduce time and cost of the procedure.


title: Randomized Phase II Trial Evaluating the Efficacy of a Sequential Treatment Gemcitabine Plus Nab-paclitaxel (Gembrax) Followed by Folfirinox Versus Folfirinox Alone in Patients Treated in First Metastatic Line Pancreatic Cancer

summary: The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer

ReferenceCitation: Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol. 2016 Sep - Oct;55(9-10):1158-1160. doi: 10.1080/0284186X.2016.1197419. Epub 2016 Aug 23.

ReferenceCitation: Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13.

ReferenceCitation: Sultana A, Smith CT, Cunningham D, Starling N, Neoptolemos JP, Ghaneh P. Meta-analyses of chemotherapy for locally advanced and metastatic pancreatic cancer. J Clin Oncol. 2007 Jun 20;25(18):2607-15.

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

ReferenceCitation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

ipd_sharing: Yes

ipd_sharing_description: All IPD that underlie results in a publication and all sutdy documents can be share.

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

location_facility: Institut régional du Cancer de Montpellier

intervention_type: Combination Product


title: Imaging for the Evaluation of Transthyretin Cardiac Amyloidosis Prevalence of Patients Over 65 Hospitalized in Cardiology Wards (the IMPACT Study)

acronym: IMPACT

summary: Heart failure with preserved ejection and hypertrophic cardiomyopathy are common diseases and often associated with transthyretin cardiac amyloidosis (TTR-CM), especially in elderly people. Nevertheless, research of TTR-CM is recommended in patients with ventricular hypertrophy without other cause such as valvular disease or hypertension. Therefore, the exact prevalence of TTR-CM remains unknown. We aim to determine the prevalence of TTR-CM in patients with ventricular hypertrophy and aged ≥ 60 years old, hospitalized in our cardiology department (CHU de Poitiers) by performing bone scintigraphy and research of AL amyloidosis.

lead_sponsor: Poitiers University Hospital


title: Pharmacological Evaluation of Antifungal Drugs in Respiratory Samples of Patiens With Chronic Pulmonary Aspergillosis

acronym: EPAR-APC

summary: At present, pulmonary diffusion and target antifungal concentrations for APC in patients with sarcoidosis or chronic obstructive pulmonary disease (COPD) are unknown.


acronym: HLH-JAK

title: Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB a Phase II Prospective Trial

ReferenceCitation: Ménasché G, Feldmann J, Fischer A, de Saint Basile G. Primary hemophagocytic syndromes point to a direct link between lymphocyte cytotoxicity and homeostasis. Immunol Rev. 2005 Feb;203:165-79. Review.

ReferenceCitation: Pachlopnik Schmid J, Ho CH, Chrétien F, Lefebvre JM, Pivert G, Kosco-Vilbois M, Ferlin W, Geissmann F, Fischer A, de Saint Basile G. Neutralization of IFNgamma defeats haemophagocytosis in LCMV-infected perforin- and Rab27a-deficient mice. EMBO Mol Med. 2009 May;1(2):112-24. doi: 10.1002/emmm.200900009.

ReferenceCitation: Billiau AD, Roskams T, Van Damme-Lombaerts R, Matthys P, Wouters C. Macrophage activation syndrome: characteristic findings on liver biopsy illustrating the key role of activated, IFN-gamma-producing lymphocytes and IL-6- and TNF-alpha-producing macrophages. Blood. 2005 Feb 15;105(4):1648-51. Epub 2004 Oct 5.

ReferenceCitation: Vainchenker W, Constantinescu SN. JAK/STAT signaling in hematological malignancies. Oncogene. 2013 May 23;32(21):2601-13. doi: 10.1038/onc.2012.347. Epub 2012 Aug 6. Review.

ReferenceCitation: Maschalidi S, Sepulveda FE, Garrigue A, Fischer A, de Saint Basile G. Therapeutic effect of JAK1/2 blockade on the manifestations of hemophagocytic lymphohistiocytosis in mice. Blood. 2016 Jul 7;128(1):60-71. doi: 10.1182/blood-2016-02-700013. Epub 2016 May 24.

summary: This project aims to test the effectiveness of ITACITINIB in sporadic Hemophagocytosis Lymphohistiocytosis (HLHs)


title: A Randomised Controlled Trial Comparing Pre-oxygenation Strategies With High-flow Humidified Nasal Oxygenation Versus Apnoeic Facemask Oxygenation During Rapid Sequence Induction in Children Aged Less Then 11 Years

acronym: OPTINECK

summary:
This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children.

170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris).

Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation.

HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.


title: Nterest of Drug Reconciliation to Ensure the Continuity of the Treatment at Discharge

acronym: ICOCON

summary:
From a regulatory point of view, medication reconciliation is a necessary process to ensure safe medication management for patients. According to national studies and the international scientific literature, the information received by patients and health professionals at discharge from hospital is insufficient.

Medication reconciliation at discharge reduces medication errors and rehospitalisation, but few studies have been conducted on the impact of a coordinated and reliable care pathway on medication continuity.

The iCoCon study will enable a new healthcare organisation to be set up in order to improve the quality of the patient pathway and the patient's medication management.

This new organisation is part of the policy of continuous improvement of the quality and safety of care

lead_sponsor: Centre Hospitalier le Mans


title: Validation of a Predictive Rule for the Diagnosis of Viral Meningitis in Adult Emergency Departments

acronym: Adult-BMS

summary:
Meningitis is the development of an inflammatory reaction in the meningeal space, most often of infectious origin. Many pathogens can cause meningitis, the severity of which varies greatly. Patients presenting with a febrile meningeal syndrome are most often managed in the emergency room, where the challenge for physicians is to quickly differentiate bacterial and viral meningitis.

Viral meningitis is the most common, with enterovirus meningitis having a classically excellent prognosis. Bacterial meningitis is less frequent but more serious.The current public health objective is to save antibiotics.

Investigator hypothesizes that the BMS score can be used to exclude bacterial meningitis in the emergency department in an adult European population of patients with suspected bacterial meningitis.


title: Comparison of Defocus Incorporated Multiple Segments® (DIMS®) Lenses Alone Versus Monofocal Lenses + Atropine 0.05% Eyedrops on the Evolution of Ocular Axial Length at 2 Years in Myopia Control in Children: Single-centre Prospective Randomised Controlled 1:1 Open-label Non-inferiority Study

acronym: ATROSMART

summary:
Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation.

Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses.

The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Comparison of Gripstrength Assessment Between the Gripwise® and JAMAR® Dynamometers in Elderly Inpatients

acronym: HANDGAGES

summary:
It is recommended to screen ageing patients for sarcopenia, due to the increased risk of morbimortality if detected positive. According to the consensus of the European Working Group on Sarcopenia in Older People, the diagnosis of sarcopenia is based, among other things, on grip strength measurement.

Our study will compare the performance of the new GRIPWISE digital device with the mechanical dynamometer JAMAR, the gold standard currently used to assess the grip strength. We propose to evaluate it in an elderly hospitalized population where the prevalence of sarcopenia is likely to be high due to the high prevalence of various chronic illness, notably oncological and cardiological ones.

This cross-sectional study will include 348 patients.

lead_sponsor: University Hospital, Caen


title: Prognosis of Right Ventricular Dysfunction Assessed by Speckle Tracking in Postoperative Thoracic Surgery: a Pilot Study

acronym: SPECKLETHO

summary:
In postoperative thoracic surgery (lobe resection, pneumonectomy or wedge resection), cardiovascular complications are the most frequent (10 to 15%) with a significant morbi-mortality rate. Right ventricular (RV) dysfunction is a complication that can be multifactorial in post thoracic surgery. The RV longitudinal shortening fraction (RV-LSF) is a new 2D-STE parameters able to more accurately detect patients with RV dysfunction compared to conventional echocardiographic parameters.

This project is a single-center, prospective, interventional study of patients hospitalized at the Amiens University Hospital for scheduled thoracic surgery. TTE is performed preoperatively, at day 2 and day 15 following the thoracic surgery. Echocardiographic parameters will be measured by an echocardiographic expert in offline with a dedicated software. MACE criteria will be collected at day 2, day 15 and day-30 following the thoracic surgery.


title: The Injury and Its Consequences in the Sports Lower Limb Amputee

acronym: PREV'AMP SPORT

summary:
This study was motivated by the lack of data in the literature on the injury of the major lower limb amputee playing sports and its socio-professional impact.

It aims to study sports-related injuries in lower limb amputees. Its objective is to determine the prevalence, but also to describe the injuries (type, location, duration, type of management) and their repercussions in terms of after-effects, and repercussions on sports, professional and personal practice. It also aims to begin a correlation between injury and sports load, type of sport (discipline, practice modality), technical aids used

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery

acronym: Cryogenou

summary: Interventional, comparative, randomized, controlled study versus standard treatment, in 3 parallel groups, monocentric, aiming to demonstrate the superiority of preoperative cryoneurolysis versus no procedure, in patients operated on for knee arthroplasty and receiving standard analgesia.


title: Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.

acronym: MacSize

summary: Endotracheal intubation is a frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital) but optimal Macintosh blade size remains unknown to date.

lead_sponsor: University Hospital, Clermont-Ferrand


title: "Evaluation of a Locoregional Anesthesia Protocol by Pudendal Block in Reconstructive Surgery Clitoral " Pudendal Block in Clitoral Surgery (Pain REparation CLItoris)

acronym: DORECLI

summary:
Reconstructive surgery of the clitoris is part of the care offered during a process of care of women victims of MSF. It consists in reconstituting a clitoral neogland after removal of the vulvar excisional scar and recovery of the remaining clitoris. Studies that have monitoring the implementation of this surgery show that it improves the well-being of the patients, brings benefits anatomically, sexual health, personal development, and in the long term decreases chronic pain.

Currently the standard method used in the usual care of the patient is: general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco The pudendal block that the investigators want to evaluate in this research, is a technique that has made proven in several types of surgery, associated with very few complications and easily reproducible.

lead_sponsor: Raincy Montfermeil Hospital Group


title: Choice And Real Experience of Therapeutic deEscalation in Women Over 65 Year With Breast Cancer (CARTE)

acronym: CARTE

summary:
Standard treatment for women with early breast cancer (HR+, HER2-, T1N0) consists of the removal of the tumor from the breast by surgery with or without chemotherapy, followed by a whole-breast radiation therapy (usually one radiation treatment a day, five days a week, for 3 to 6 weeks)

In some cases, for elderly patients older than 65 years with other associated pathologies, therapeutic de-escalation might be proposed in order to reduce the radiation doses received. Two options can be considered:

Intraoperative radiotherapy: radiation is delivered in a single dose directly to the tumor bed during the surgery.
Radiotherapy omission

These three treatment options (whole-breast radiation therapy, Intraoperative radiotherapy or -Radiotherapy omission) have advantages and disadvantages. Intraoperative radiotherapy allows a targeted treatment and avoids several weeks of daily radiation. Radiotherapy omission prevents acute or late toxicities of the radiotherapy, as well as the constraints of daily travel over a period of 3 to 6 weeks.

The aim of this trial is to offer patients aged 65 and over with early breast cancer, after surgery, these three treatment options and to study the choice and experience of treatment by patients. This study will assess the reasons that prompted patients to choose one of the three treatment options, the impact of medical and personal characteristics on this choice and the experience of therapeutic de-escalation as well as its effects, in particular on the course of care.

This assessment will be carried out with self-administered questionnaires before and after the choice of treatment.

In addition, to standardize the information given to patients in order to support them in their treatment choice and promote patient involvement in treatment decision-making, an encounter decision aid will be available for the patients. This encounter will detail the advantages and disadvantages of the three treatment options and will help in discussions with the physicians to determine the best choice of treatment.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

intervention_type: Radiation


title: Effects of Large Tidal Volumes Despite Minimal Inspiratory Support in Spontaneously Ventilated Intubated Resuscitation Patients. Pathophysiological Exploratory Study.

acronym: InLarge

summary:
Some ICU ventilated patients might present with large tidal volume despite very low or inexistant presser support. Patient-Self Inflicted Lung Injury (P-SILI) might appear related with large alveolar stretch an distension. Two clinical presentations are observed: patients with or without respiratory distress signs such as supra-clavicular depression and thoracic-abdominal asynchronies.

The aim of this study is to compare the pulmonary physio(-patho)logical parameters of these two types of patients (eupneic or with respiratory distress signs), and presenting important TV in spite of a minimal adjustment of the ventilatory support, except for Acute Respiratory Distress Syndrome (ARDS).


title: How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolve According to Propulsion: Control With Each mm of Advancement"

acronym: OAMMM

summary:
The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence

Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).

Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.

The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.

lead_sponsor: Centre Hospitalier de Valence


title: Dose Dense Re-challenge of High Dose Methotrexate (HD-MTX) With Glucarpidase (CPG2) for Relapsed Primary Central Nervous System Lymphoma (PCNSL): A Phase I Trial

acronym: METHOGLU

summary:
High dose intravenous Methotrexate (HD-MTX) is the key drug in the treatment of primary central nervous system lymphoma (PCNSL). HD-MTX is usually delivered with time interval ranging from 10 to 21 days. Reduction of injection time interval is limited by MTX renal excretion and systemic toxicity.

Glucarpidase (CPG2) is a recombinant bacterial rescue enzyme that cleaves circulating MTX into inactive metabolites, reducing plasma MTX concentrations within few minutes.

The research hypothesis is that CPG2 used after HD-MTX injection allows to reduce time interval between MTX injections, increase dose intensity of the chemotherapy, reduce systemic toxicity and duration of hospitalization.

ipd_sharing_description:
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris