title: Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy

acronym: PRECONISE

summary:
A prospective prevalence study recorded that up to 50% of adult patients with newly diagnosed epilepsy had at least one cognitive impairment before initiation of antiepileptic drug (AED). Multiple factors exist and interact in the same patient. Cognitive impairments may affect psychiatric (loss of self-esteem, anxiety, depression) and social status (e.g., vocational aptitude, educational). These factors in turn influence cognitive abilities in a triangular and bidirectional relationship. In addition, the type of epilepsy, development in childhood or cerebral ageing, antiepileptic treatments (AED, surgery) and etiology also have an impact on cognitive performances. The burden of these factors differs from patient to another and must be determined individually. Longitudinal follow-up seems to be crucial because it will allow us to highlight the change in the cognitive profile of newly diagnosed patients over time.

The main objective is to compare the prevalence of cognitive impairment in patients with newly diagnosed epilepsy prior to the initiation of AED with healthy subjects matched on age, sex, manual laterality and socio-educational level. But also to compare the longitudinal evolution of the cognitive profile of patients with healthy controls (0 to 10 years) to determine, among the age of onset seizures, their etiology, the syndrome, the sex, the socio-educational level and the cognitive reserve, which one are related to the severity of cognitive disorders.

time_perspective: Other

location_facility: Department of neurology - Hospital of Nancy


title: Interest of PFS Modelling in the Quantitative Analysis of Brain PET Scans in Patients With Alzheimer's Disease Acquired on a Numerical System

acronym: PET-SF

summary: PET/CT scans with 18F-FDG can be carried out for the detection of neurodegenerative diseases with hypometabolisms characteristic of the pathologies sought. The diagnosis is given by the clinician after a visual analysis of the data. To complete the diagnosis, a semi-quantitative analysis of the images is recommended (European recommendations) in addition to the visual analysis.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

location_facility: Nuclear medicine department CHRU de NANCY Brabois

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Good Prognosis Factors After Decompressive Craniectomy : a Ten-year Retrospective Study

summary:
Decompressive craniectomy is a treatment of refractory intracranial hypertension after various etiologies : malignant ischemic stroke, traumatic brain injury, intraparenchymal hemorrhage, aneurysmal subarachnoid hemorrhage, cerebral venous thrombosis.

Initially considered as a lifesaving therapy, benefits in terms of survival were shown compared to medical treatment alone.

However, despite a better survival, morbidity and poor neurological outcome are frequent among survivors.

The objective of the study is to identify initial good neurological outcome factors after decompressive craniectomy in a large series of patients, in order to argue surgical and intensive care decisions, considering expected benefit and quality of life.

intervention_type: Procedure


title: Postural Control Quality in Chiari I Malformation: Evaluation in a Pediatric Population

summary:
BACKGROUND: Chiari I malformation is a rare disease characterized by cerebellar amygdalae descent under the level of the foramen magnum. It causes troubles in cerebrospinal fluid circulation and direct compression on brainstem, producing characteristic headaches, neurological impairment and syringomyelia. Surgery is the only treatment, indicated when symptomatology exists. However, sometimes patients complaint about atypical symptoms that are difficult to interpret.

We would like to study one of these atypical symptoms, gait imbalance, in a pediatric population thanks to a computerized dynamic posturography (Equitest®).

METHOD: infants from 6 to 18 years of age presenting a radiologically confirmed Chiari I malformation will be included in the study. We will compare posturographic results of patients which will be operated on with the results of the patients which will not; furthermore, we will compare preoperative and postoperative results in operated patients.

RESULTS: 19 patients have been enrolled in the study, and data have been collected for 12 of them. Seven patients belong to operated population.

CONCLUSIONS: even if enrolment of the patients is satisfactory, disposable data are not enough to perform statistical analysis and to put forward any conclusion.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Stella I, Remen T, Petel A, Joud A, Klein O, Perrin P. Postural control in Chiari I malformation: protocol for a paediatric prospective, observational cohort - potential role of posturography for surgical indication. BMJ Open. 2022 May 12;12(5):e056647. doi: 10.1136/bmjopen-2021-056647.

intervention_type: Diagnostic Test

status_simplified: Ongoing


title: Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy

summary: The first period of COVID 19 Lockdown Measures (From 18 March to 11 may 2020) change the French people way of life and their medicine knowledges. A study which evaluates the Nancy's Pediatric emergencies population utilization during this time could detect pathological changes. The medical impact of Home Confinement will show an increase (trauma, maltreatment) or decrease (virus disease) of several pathology. The study aims to help clinicians to the children care if another time of Home Confinement happened. The main objective is to evaluate the behavioural changes and the reason consultation in Nancy's Pediatric Emergencies from 18 March to 30 June 2020 comparate to the same time in 2019. We will continue the search after the end of Home Confinement until 30 June 2020 to evaluate what happened just after.

ipd_sharing: Undecided


title: Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography

summary:
Pulmonary embolism is a common cardiovascular disease and thoracic CT angiography is currently considered the gold standard for its non-invasive diagnosis. However, the diagnostic performance of CT angiography can be hampered by an insufficient enhancement of pulmonary arteries. Contrast Enhancement Boost (CE Boost) is a post-processing technique using an iodine density map to artificially improve pulmonary artery enhancement.

This retrospective study compares standard CT-angiography images with CE Boost images to assess the potential improvement of diagnostic performance for the detection of pulmonary embolism.


title: Cross Sectional Relation of Digital Vascular Function Measured by EndoPAT® in elderlY Patients to Arterial Stiffness

acronym: ENDY

summary:
Due to the aging of populations worldwide, we observe an increase of age-related diseases and loss of autonomy with consequent personal, social, medical and economic implications. The aging population is a target for geriatric medicine, necessitating the development of specific diagnostic and therapeutic approaches in order to estimate cardio vascular risk in these individuals.

It is thought that arterial stiffening and endothelial dysfunction are among the earliest vascular properties altered with the onset of cardiovascular disease. Moreover aging is characterized by progressive fragmentation and break down of the elastic components of the aortic media, which are partially replaced by highly cross-linked collagen leading to stiffening, dilation, and elongation of the aorta . A major underlying mechanism of these modifications is endothelial dysfunction due to high oxidative stress and low-grade inflammation. Reactive hyperemia index (RHI), a key outcome of peripheral arterial tonometry (PAT) has recently become a reliable tool to measure microvascular endothelial function. Some studies have recently demonstrated the interest to measure in elderly patients arterial stiffness parameters in order to prevent loss of autonomy. This cross sectional study aimed at demonstrating the link between arterial stiffness evaluated by pulse wave velocity and endothelial dysfunction evaluated by RHI to implement the tools of cardio vascular risk evaluation in a population of elderly patients referred in a geriatric day hospital.


title: Optimization of the Acquisition Sequence to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam

acronym: AIMANT

summary: The purpose of this study is to evaluate the optimization of MRI acquisition sequences.

study_type: Interventional

primary_purpose: Other

intervention_type: Other


title: Positive Diagnosis of Heart Failure With Preserved LVEF by Exercise Pulmonary Ultrasound.

acronym: E-LUS

summary:
The E-LUS study is a prospective, non randomised, monocenter case-control study.

The main objective is to evaluate the association of exercise lung ultrasound data acquired during a stress test on a bicycle ergometer with the diagnosis of heart failure with preserved ejection fraction (HFpEF).


title: Evaluation of the Clinical and Functional Results Obtained After a Total Elbow Arthroplasty, All Indications Combined

summary: Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is

status: Active, not recruiting


title: First-time Fathers' Experiences of Childbirth in Lorraine.

acronym: PRIMIPERE

summary:
The primary aim of this study is to evaluate first time father's experience during childbirth in three different maternity hospitals in Lorraine.

Secondary aims of this study is to identify domains that need improvement in order to enhance fathers's experience during childbirth.

ReferenceType: result

ReferenceCitation: Premberg Å, Carlsson G, Hellström AL, Berg M. First-time fathers' experiences of childbirth--a phenomenological study. Midwifery. 2011 Dec;27(6):848-53. doi: 10.1016/j.midw.2010.09.002. Epub 2010 Oct 16.

ReferenceCitation: Premberg Å, Taft C, Hellström AL, Berg M. Father for the first time--development and validation of a questionnaire to assess fathers' experiences of first childbirth (FTFQ). BMC Pregnancy Childbirth. 2012 May 17;12:35. doi: 10.1186/1471-2393-12-35.

ReferenceCitation: Capponi I, Carquillat P, Premberg Å, Vendittelli F, Guittier MJ. [Translation and validation in French of the First-Time Father Questionnaire]. Gynecol Obstet Fertil. 2016 Sep;44(9):480-6. doi: 10.1016/j.gyobfe.2016.07.011. Epub 2016 Aug 24. French.


title: Intérêt de la réinterprétation Des CNV de Signification Inconnue Mis en évidence Par ACPA

acronym: ReAC

summary: We aim to assess the usefulness of systematic reinterpretation of CNV of unknown significance. To investigate this question we will study all CNV of unknown significance detected between 2010 and 2017.

ReferenceType: background

ReferenceCitation: Palmer E, Speirs H, Taylor PJ, Mullan G, Turner G, Einfeld S, Tonge B, Mowat D. Changing interpretation of chromosomal microarray over time in a community cohort with intellectual disability. Am J Med Genet A. 2014 Feb;164A(2):377-85. doi: 10.1002/ajmg.a.36279. Epub 2013 Dec 5.

intervention_type: Genetic


title: SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods

acronym: SporTRIA

summary: Intra-articular and peri-articular glucocorticoid (GC) injections are common in sports medicine. However, from 1st January 2022, all injectable GC routes (including intra-articular administration (IA)) will be prohibited in-competition by World Anti-Doping Agency (WADA). Due to these rules, an IA GC treatment out-of-competition could result in an adverse analytical finding (AAF) in-competition if the washout period is not clearly defined. The aim of this study is to determine the urinary excretion profile of triamcinolone acetonide following IA to help in the definition of the washout periods.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Screening

ReferenceCitation: Allado E, Poussel M, Gambier N, Saunier V, Starck M, Buisson C, Cinquetti G, Albuisson E, Chenuel B. SporTRIA study-a multicentre trial protocol for excretion kinetics of triamcinolone acetonide following sport-related intra-articular injections in knees: definitions of the washout periods. BMJ Open. 2021 Jun 9;11(6):e047548. doi: 10.1136/bmjopen-2020-047548.

ipd_sharing: Yes

ipd_sharing_description:
The data from all patients will be centrally stored in Nancy. Data management will be carried out by CHRU de Nancy (Direction de la Recherche et de l'Innovation). The conditions for data transfer of all or part of the study database are decided by the study sponsor and are the subject of a written contract. This study and the data collected fall within the scope of Reference Methodology MR001.

The data may be transmitted to the companies in the group to which the promoter belongs and to its contractual partners in a form which should not permit the direct or indirect identification of persons lending themselves to research

location_facility: Centre Hospitalier Régional Universitaire de Nancy.

intervention_type: Drug


title: Prognostic Value of Low Irradiation Cardiac Stress Perfusion Scans

acronym: PROSPERCARS

summary:
Stress myocardial perfusion scintigraphy is a reference examination for the detection and monitoring of coronary patients, and this examination has already been the subject of multiple validation studies, including for the stratification of the prognosis of these patients, information that can usefully guide therapeutic choices.

Today, this reduction in the activity of injected radiopharmaceuticals is taking place in a growing number of nuclear medicine departments.

The implications are unknown in terms of the risk of death of the different parameters studied


title: Giant Cell Arteritis and Differential Diagnoses Associated With Positive Temporal Artery Biopsy: a Monocentric Retrospective Study

summary: Temporal artery biopsy is a useful tool helping to the diagnosis of giant cell arteritis. However, other diagnoses might be associated with abnormal temporal artery biopsy. The purpose of this study is to describe the frequency of giant cell arteritis differential diagnoses with positive temporal artery biopsy.

status: Unknown status

status_simplified: Unknown


title: EvaLuation de l'Apport de l'Irm Virtuelle Sur la qualité de la Prise en Charge Des Enfants en Irm

acronym: LIVE

summary:
The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. General anesthesia or sedation, may be considered to obtain diagnostic quality examinations. Our hypothesis is that a scenario as close as possible to reality to prepare children before the MR exam could reduce their anxiety, improve the quality of the exams and reduce its duration.

The purpose of this study is to evaluate the effect of virtual reality on MRI exam preparation to reduce the anxiety of children (aged from 6 to 12 years) who are referred to their first MRI exam, as compared to the current practice.

design_allocation: Randomized


title: Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?

summary:
The malaise of the infant represents a polymorphic pathology in its clinical presentation.

Due to the young age of the patients concerned and the parental anxiety generated, hospital management is necessary, for clinical and paraclinical evaluation and monitoring.

The practice of complementary examinations is guided by personal and family history, and the precise description of the discomfort as well as clinical examination of the child and assessment of his vital parameters.

However, in view of the particular terrain represented by infants under one year of age, a number of tests are carried out systematically, and therefore empirically, because they are not guided by the clinic.

These various tests can be invasive, anxiety-provoking for parents and generate a significant additional cost during hospital management.

An evaluation of the indication and interest of these tests is necessary in order to propose a homogeneous clinical and paraclinical management of the discomfort of the infant, in particular of discomforts of type BRUE (Brief Resolved Unexplained Events), as described in the 2016 American Academy of Pediatrics (AAP) recommendations.


title: Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion: a Prospective Comparative Pilot Study

acronym: AGATA

summary:
Clinical diagnosis of adnexal torsion is difficult because the symptomatology is dominated by abrupt onset pelvic pain, an aspecific sign which does not allow a diagnosis of certainty to be made.

To confirm the diagnosis, the reference examination is pelvic ultrasound with Doppler flow analysis. However, its intake is low, its sensitivity varies from 46 to 73% depending on the studies. Other imaging techniques have been considered, such as MRI, with a sensitivity far superior to ultrasound, but its difficult accessibility, in particular in the context of an emergency, makes it unusable in clinical practice.

The use of ultrasound with the injection of an ultrasound contrast agent, strict intravascular, seems to be an interesting technique to assess the perfusion parameters of the ovary and improve the diagnostic sensitivity of the adnexal torsion. Its interest has already been demonstrated in the diagnosis of testicular torsion in animals but to date, no study has evaluated its contribution in adnexal torsion.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

location_facility: Centre Hospitalier Régional Universitaire de Nancy


title: Study of the Acceptability of a New Distance-learning Tool for Functional Insulin Therapy "MyFIT" by Patients With Type 1 Diabetes (T1D) and by Healthcare Professionals

acronym: MyFIT

summary:
The investigators developed an on-line learning tool "MyFIT" enabling to patients with T1D to acquire the knowledge and skills for practicing functional insulin therapy from their home.

The aim of the present study is to evaluate the acceptability of this new learning modality via the tool "MyFIT" by the patients and by the health professionnals.


title: CT Abnormalities Evocative of Lung Infection Are Associated With Lower 18F-FDG Uptake in Confirmed COVID-19 Patients

summary: CT signs that are evocative of lung COVID-19 infections have been extensively described, whereas 18F-FDG-PET signs have not. Our current study aimed to identify specific COVID-19 18F-FDG-PET signs in patients that were (i) suspected to have a lung infection based on 18F-FDG-PET/CT recorded during the COVID-19 outbreak and (ii) whose COVID-19 diagnosis was definitely established or excluded by appropriate viral testing.


title: Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas

acronym: RADDOPAG

summary: The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis.


title: Study of the Preventable Passage of Patients Over 75 Years of Age to the Emergency Room of the CHRU of Nancy

summary:
The adult emergency service of the Nancy CHRU welcomes an average of 135 visits per day. Approximately 18% are patients over 75 years old, among them 45% go home at the end of their care. The mobile geriatric liaison team intervenes with these patients at the request of the emergency doctors before they return home in order to identify their fragility and implement appropriate measures.

We wish to know the characteristics of these avoidable passages in order to propose preventive measures upstream of these passages. To do this, we need to know the characteristics of those patients with an avoidable passage.


title: Evaluation of the Couple's Sexuality During a Pregnancy Resulting From Medically Assisted Procreation and Comparison With Sexuality During a Spontaneous Pregnancy

summary: We wish to evaluate sexuality during pregnancy between spontaneous pregnancies and resulting from assisted procreation The literature is poor on thie subject


title: Multicenter Retrospective Study Evaluating the Impact of Early Palliative Care on the Survival of Patients With Locally Advanced and / or Metastatic Cholangiocarcinoma (CCK)

summary: The prognosis for cholangiocarcinoma is bad. Potentially, early management by a palliative care team could increase overall survival. We will also assess whether early management by a palliative care team could impact progression-free survival, the place of death and the date of the last chemotherapy, in particular to avoid unnecessary chemotherapy cures in an imminent end of life


title: Birth Experience During COVID-19 Confinement (Confinement and Fostering Intrapartum Care)

acronym: CONFINE

summary: Different studies have demonstrated that the absence of companionship during labor and childbirth may be responsible for a negative birth experience, an increased risk of postnatal depression and/or post traumatic stress disorders. These situation may also have a negative impact on mother-child interaction, on marital and family relationship and on the rate of maternal suicide in postpartum. However, these previous results cannot be extrapolated in the current context where the absence of the companionship is imposed by the confinement framework. The objective of the CONFINE study is to assess, for the first time, the birth experience of women in the context of limited social support in the immediate post-partum period due to confinement, as well as the associated over-risk of mental disorders, compared to a post-partum without social restriction.

ReferenceCitation: Bertholdt C, Epstein J, Banasiak C, Ligier F, Dahlhoff S, Olieric MF, Mottet N, Beaumont M, Morel O. Birth experience during COVID-19 confinement (CONFINE): protocol for a multicentre prospective study. BMJ Open. 2020 Dec 10;10(12):e043057. doi: 10.1136/bmjopen-2020-043057.

ipd_sharing_description: All data generated during this study will be made available via CIC-EC, CHRU Nancy, Nancy- FRANCE in accordance with protocol promotor. Data obtained from this study will be deposited at CIC-EC Nancy where they will be maintained for a minimum of 15 years.


title: Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection altérée ou modérément altérée

acronym: AHF-CODE-R

summary:
The AHF-CODE reduced study is a prospective, non-randomized, monocenter study performed in patients with heart failure with reduced ejection fraction admitted for worsening heart failure.

The main objective of the AHF-CODE study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.


title: Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection préservée

acronym: AHF-CODE-P

summary:
The AHF-CODE preserved study is a prospective, non-randomized, monocenter study performed in patients with heart failure with preserved ejection fraction admitted for worsening heart failure.

The main objective of the AHF-CODE preserved study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.


title: MRI Screening of Placenta Adhesion Abnormalities

acronym: DIANE

summary:
Placenta Adhesion Abnormalities (PAA) are the consequence of an excessive invasion of the placenta within the myometrium. PAA are related to severe maternal pregnancy outcomes, especially in case of incidental discovery during delivery that increase the risk of intraoperative massive bleeding, hysterectomy and even maternal death. Ultrasound is the standard modality for diagnosing PAA, but Magnetic Resonance Imaging (MRI) has been increasingly performed in the case of inconclusive sonographic findings. However, standard morphological MRI sequences appear as insufficient to improve the sensitivity and specificity values for detecting PAA, while quantitative MRI may be more efficient.

The main objective of this study is to characterize the diagnostic performance of quantitative MRI parameters (mainly Apparent Diffusion Coefficient, T2 and T2*) reflecting placental perfusion and/or oxygenation at high field, without injection of gadolinium-based agent, for the detection of PAA in women with ongoing pregnancy between 30 and 38 weeks of gestation with risk factors for PPA.


title: Impact of Bariatric Surgery in Patients With Morbid Obesity. Prospective Study With Comparison Before and After

acronym: IVBIA

summary:
The main objective is to compare the prevalence of anal incontinence (AI) before and after bariatric surgery in obese patients.

Inclusion: Patients who are scheduled for a bariatric surgical procedure after a multidisciplinary evaluation for about 1 year (following french national recommendations).

Primary objective: After inclusion, all patients will fill in a specific self-questionnaire evaluating AI (PFDI-20 score) before surgery and at 6 months after surgery.

Investigators will evaluate the prevalence of anal incontinence before and at 6months after surgery using this PFDI- 20 score.

In those patients with preoperative anal incontinence (only in patients with 3 positive answers to question n°9,10, and 11 of PFDI-20 score self-questionnaire), a pelvic MRI will be performed before and at 6 months after surgery. Consequently, no further imaging exam will be performed in patients without preoperative anal incontinence (less than 3 positive answers to question n°9,10, and 11),

Secondary objectives:

to evaluate the AI severity variation before and at 6 months after bariatric surgery regarding the percentage of postoperative weight loss.
to compare the quality of life (PFIQ-7 score) related to AI day before and at 6 months after bariatric surgery.

location_facility: CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)


title: Pertinence of Pediatric Message Delivered to Parents During Antenatal Consultations

acronym: INFONEO

summary:
Antenatal consultations are experienced as traumatic for many couples. Moreover, when informations are given urgently ; comprehension and psychological impact aren't well evaluate.

This project aims to evaluate comprehension and psychological impact, for both members of the couple, when informations are provided urgently or during usual consultations.


title: Comparative Study of DaTSCAN ™ Cerebral SPECT Recorded by Conventional Anger Cameras and Semiconductor Camera (VERITON-CT ™)

acronym: VERIDAT

summary:
The semiconductor (cadmium-zinc-telluride, CZT) cameras significantly increase detection sensitivity in Single Photon Emission Computer Tomoscintigraphy (SPECT)(1) . The clinical routine applications of these cameras are today mainly limited to myocardial tomoscintigraphy with CZT dedicated cameras. Several studies whose one was done in Hospital of Nancy, made it possible to demonstrate a good diagnosis agreement between conventional cameras and semiconductor cameras in this indication, with better image quality obtained with semiconductor cameras (2). Today, so-called "wide field" semiconductor cameras are available in the clinic and allow for any type of SPECT examination. A comparative study between conventional and semiconductor cameras has been conducted for bone scintigraphy, and shows diagnostic superiority with this new type of camera (3).

In addition, the new VERITON-CT ™ (Spectrum Dynamics Medical) camera has 12 mobile CZT-based detectors positioned around the patient allowing tomographic acquisitions and focusing the acquisition on the organ studied. This camera has a sensitivity of detection higher than that of conventional cameras and thus reduces the activity injected into the patient and / or the recording time.

To date, no study has compared the two types of cameras in nuclear neurology and in particular, for the SPECT DaTSCAN ™ imaging of the pre-synaptic dopaminergic pathway.

DaTSCAN ™ exam is used in clinical routine:

for the diagnosis of Parkinson's disease or related diseases when in doubt with an essential tremor (4) or
if suspicion of Lewy body disease, if in doubt with Alzheimer's disease (5). If the interpretation of DaTSCAN ™ exam is first visual, the quantification may increase accuracy diagnosis (6). Also, the database creation specific to each type of camera is recommended(7).

The purpose of this study is to compare the diagnostically relevant informations and the quantitative analysis provided by the DaTSCAN™ SPECT, recorded on the conventional camera and recorded on the semiconductor camera VERITON-CT™


title: Effect of DIRECT Transfer to ANGIOsuite on Functional Outcome in Patient With Severe Acute Stroke Treated With Thrombectomy: the Randomized DIRECT ANGIO Trial

acronym: DIRECTANGIO

summary:
Rationale: Acute large-vessel strokes, requiring endovascular treatment, are currently being managed through radiology department before being transferred to the angiography room. However, patients with severe neurological deficit have demonstrated even greater benefits from recanalization as the symptom onset-to-reperfusion time is shortened to less than 1 hour. Recent pilot study have shown a benefit in reducing management delays with direct admission to the angiography room and subsequently in increasing functional independence at 3 months. Therefore, the aim is to demonstrate the superiority of the direct angio-suite transfer versus the standard management, in terms of 3-month functional independence, in patients strongly suspected of having a severe ischemic stroke related to acute large-vessel occlusion of the anterior circulation, and treated by mechanical thrombectomy ± intravenous thrombolysis.

Methods and Design: The DIRECT ANGIO trial is a (PROBE) randomized, multicenter, controlled, open-label, blinded endpoint clinical trial.

Study Outcomes: The primary outcome is the rate of patients with 3-month functional independence defined as modified Rankin Scale score ≤2 at 3 months.

primary_purpose: Treatment

ReferenceCitation: Ribo M, Boned S, Rubiera M, Tomasello A, Coscojuela P, Hernández D, Pagola J, Juega J, Rodriguez N, Muchada M, Rodriguez-Luna D, Molina CA. Direct transfer to angiosuite to reduce door-to-puncture time in thrombectomy for acute stroke. J Neurointerv Surg. 2018 Mar;10(3):221-224. doi: 10.1136/neurintsurg-2017-013038. Epub 2017 Apr 26.

ReferenceCitation: Jadhav AP, Kenmuir CL, Aghaebrahim A, Limaye K, Wechsler LR, Hammer MD, Starr MT, Molyneaux BJ, Rocha M, Guyette FX, Martin-Gill C, Ducruet AF, Gross BA, Jankowitz BT, Jovin TG. Interfacility Transfer Directly to the Neuroangiography Suite in Acute Ischemic Stroke Patients Undergoing Thrombectomy. Stroke. 2017 Jul;48(7):1884-1889. doi: 10.1161/STROKEAHA.117.016946. Epub 2017 May 23.

ReferenceCitation: Spieler JF, Lanoë JL, Amarenco P. Costs of stroke care according to handicap levels and stroke subtypes. Cerebrovasc Dis. 2004;17(2-3):134-42. Epub 2003 Dec 29.

ReferenceCitation: Spieler JF, de Pouvourville G. [Cost evaluation of post-stroke outpatient care: results of a mail survey of patients in the Dijon population-based stroke registry]. Presse Med. 2007 Mar;36(3 Pt 1):399-403. Epub 2007 Jan 25. French.

ReferenceCitation: Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castaño C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro Á, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647.

ReferenceCitation: Bracard S, Ducrocq X, Mas JL, Soudant M, Oppenheim C, Moulin T, Guillemin F; THRACE investigators. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial. Lancet Neurol. 2016 Oct;15(11):1138-47. doi: 10.1016/S1474-4422(16)30177-6. Epub 2016 Aug 23. Erratum in: Lancet Neurol. 2016 Nov;15(12):1203.

ReferenceCitation: Xie Y, Oppenheim C, Guillemin F, Gautheron V, Gory B, Raoult H, Soize S, Felblinger J, Hossu G, Bracard S; THRACE investigators. Pretreatment lesional volume impacts clinical outcome and thrombectomy efficacy. Ann Neurol. 2018 Jan;83(1):178-185. doi: 10.1002/ana.25133.

ReferenceCitation: Achit H, Soudant M, Hosseini K, Bannay A, Epstein J, Bracard S, Guillemin F; THRACE Investigators. Cost-Effectiveness of Thrombectomy in Patients With Acute Ischemic Stroke: The THRACE Randomized Controlled Trial. Stroke. 2017 Oct;48(10):2843-2847. doi: 10.1161/STROKEAHA.117.017856. Epub 2017 Sep 15.

ReferenceCitation: Cotté FE, Chaize G, Kachaner I, Gaudin AF, Vainchtock A, Durand-Zaleski I. Incidence and cost of stroke and hemorrhage in patients diagnosed with atrial fibrillation in France. J Stroke Cerebrovasc Dis. 2014 Feb;23(2):e73-83. doi: 10.1016/j.jstrokecerebrovasdis.2013.08.022. Epub 2013 Oct 8.

ReferenceCitation: Chevreul K, Durand-Zaleski I, Gouépo A, Fery-Lemonnier E, Hommel M, Woimant F. Cost of stroke in France. Eur J Neurol. 2013 Jul;20(7):1094-100. doi: 10.1111/ene.12143. Epub 2013 Apr 8.

ReferenceCitation: Riou-Comte N, Zhu F, Cherifi A, Richard S, Nace L, Audibert G, Achit H, Costalat V, Arquizan C, Beaufils O, Consoli A, Lapergue B, Loeb T, Rouchaud A, Macian F, Cailloce D, Biondi A, Moulin T, Desmettre T, Marnat G, Sibon I, Combes X, Lebedinsky AP, Vuillemet F, Kempf N, Pierot L, Moulin S, Lemmel P, Mazighi M, Blanc R, Sabben C, Schluck E, Bracard S, Anxionnat R, Guillemin F, Hossu G, Gory B; DIRECT ANGIO Investigators. Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol. BMJ Open. 2021 Mar 15;11(3):e040522. doi: 10.1136/bmjopen-2020-040522.

location_facility: Centre Hospitalier Régional Universitaire


title: Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts

acronym: ATLAS

summary: Aim of this study is to collect data from pace mapping performed in three groups of patients : patients presenting ventricular tachycardia and infarction history, patients presenting infarction history without presenting ventricular tachycardia, and in patients without structural heart disease.

ReferenceCitation: de Chillou C, Groben L, Magnin-Poull I, Andronache M, MagdiAbbas M, Zhang N, Abdelaal A, Ammar S, Sellal JM, Schwartz J, Brembilla-Perrot B, Aliot E, Marchlinski FE. Localizing the critical isthmus of postinfarct ventricular tachycardia: the value of pace-mapping during sinus rhythm. Heart Rhythm. 2014 Feb;11(2):175-81.


title: Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)

acronym: LVAD-ECMO

summary:
Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD.

LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies.

In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.


title: Characterization of Movements Occurring During Sleep in Very Premature Neonates: Relationship With Neurodevelopmental Outcome

acronym: DODOPREMA

summary: Sleep is a key factor for normal brain development of the newborn. However, it is poorly studied and little is known about its characterization, especially in premature infants. Body movements during sleep are easy to evaluate but studies on their relationship to normal sleep states are scarce and limited. This project aims to characterize body movements during sleep, assessed by electroencephalography, in very premature infants. Then, a correlation between body movements, sleep organization and neurodevelopmental outcome will be evaluated at 3 years of age.


title: Registre Tumeurs Endocrine - Eurocrine

acronym: eurocrine

summary: This registry aims to collect informations about patients with endocrine tumors (Thyroid, Parathyroid, Adrenal, Endocrine Pancreas, Endocrine Digestive Tube) who undergo endocrine surgical procedures. This registry is part of the Eurocrine Project.

ReferenceCitation: Greilsamer T, Nomine-Criqui C, Thy M, Ullmann T, Zarnegar R, Bresler L, Brunaud L. Robotic-assisted unilateral adrenalectomy: risk factors for perioperative complications in 303 consecutive patients. Surg Endosc. 2019 Mar;33(3):802-810. doi: 10.1007/s00464-018-6346-2. Epub 2018 Jul 11.


title: Assessment of Positron Emission Tomography to Early Detect Frailty in Onco-geriatry

acronym: FOGTEP

summary:
Oncogeriatric frailty assessment is a multifactorial approach to determine the most appropriate treatment for the health status of elderly cancer patients and this assessment is recommended for patients over 75 years of age.

Oncogeriatric frailty is based on the SIOG-2 (International Society of Geriatric Oncology-2) clinical scale (assessing comorbidities, autonomy, nutrition, cognitive and thymic domains) defining 3 levels of frailty: (1) harmonious aging, (2) vulnerability (reversible stage), (3) fragility (irreversible stage).

So,the management of very old or very frailty patients with poor tolerance or compliance to treatment, often requires to defer standard treatment and monitoring procedures. That is detrimental to these patients prognosis. By contrast with elderly or very old patients without frailty criteria, could benefit from more efficient procedures.

More generally, frailty is associated directly with a cerebral impact on a cognitive or thymic status or indirectly with the cognitive or thymic impacts related with other components (nutritional or autonomy or walking poor status, comorbidities) 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET), is routinely performed in follow-up cancer patients in most cases, including older patients, to detect neoplastic localizations on the whole body. It also accurately quantifies cerebral glycolytic metabolism when early brain recording is performed. Brain metabolism reflects the neuronal synaptic activity. It is generally decreased in particular brain areas due of neurodegenerative damage with a little or no symptom, of thymic involvement particular in depression or during accelerated cerebral aging of vascular origin. The impairment of the brain function of the elderly, as evidenced by 18F-FDG PET, is most often multifactorial, as frailty. Above all, brain changes are visualized with 18F-FDG PET much earlier than using neuropsychological tests, especially for cognitive impairment.

Our hypothesis is that with 18F-FDG PET, performed routinely in the initial assessment in elderly patients with cancer, it is also possible to obtain reliable and objective parameters of brain function and frailty. 18F-FDG PET is already used to identify cognitive and thymic impairment. This exam would help to assess the frailty and to adapt as best oncologic treatments some of which can also be neurotoxic. 18F-FDG PET is therefore related to brain function in frail patients

location_facility: CHRU NANCY Brabois, nuclear medicine department

intervention_type: Radiation


title: EEG Analysis During Light Propofol Sedation

acronym: MOTANA

summary: The hypothesis of this study is that propofol sedation does not affect the detectability of a movement intention in the EEG motor cortex signal. EEG signals will be recorded during the realization of intentional movements and movement intentions by the healthy volunteers, as well as during median nerve stimulation before and during propofol perfusion according to a target control infusion. (0 µg/mL; 0.5 µg/mL and 1 µg/mL).

primary_purpose: Basic Science

ReferenceCitation: Blokland YM, Farquhar JD, Mourisse J, Scheffer GJ, Lerou JG, Bruhn J. Towards a novel monitor of intraoperative awareness: selecting paradigm settings for a movement-based brain-computer interface. PLoS One. 2012;7(9):e44336. doi: 10.1371/journal.pone.0044336. Epub 2012 Sep 6.

ReferenceCitation: Blokland Y, Farquhar J, Lerou J, Mourisse J, Scheffer GJ, Geffen GJ, Spyrou L, Bruhn J. Decoding motor responses from the EEG during altered states of consciousness induced by propofol. J Neural Eng. 2016 Apr;13(2):026014. doi: 10.1088/1741-2560/13/2/026014. Epub 2016 Feb 9.

ReferenceCitation: Lindig-León C, Bougrain L. Comparison of sensorimotor rhythms in EEG signals during simple and combined motor imageries over the contra and ipsilateral hemispheres. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:3953-6. doi: 10.1109/EMBC.2015.7319259.

ReferenceCitation: Rimbert S, Schmartz D, Bougrain L, Meistelman C, Baumann C, Guerci P. MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation. Trials. 2019 Aug 28;20(1):534. doi: 10.1186/s13063-019-3596-9.

location_facility: Department of Anesthesiology and Critical Care Medicine - University Hospital of Nancy


title: Assessement of a Multi-organ Screening Procedure for the Detection of Pre-clinical Ischaemia in Antiphospholipid Syndrome The COBRA Study (CardiO-Brain Renal Involvement in Antiphospholipid Syndrome)

acronym: COBRA

summary:
Introduction

AntiPhospholipid antibody Syndrome (APS) is an acquired autoimmune disorder defined by the presence of persistent thrombosis or obstetric manifestations together with the presence of persistent antiphospholipid antibodies (aPL). Patients are young and at high risk of recurrence. The current challenge is the identification of patients at high risk of organ damage that directly impact morbidity and mortality.

Small vessels thrombosis can be asymptomatic but detectable by MRI. Apart from APS, it was shown that the detection of asymptomatic ischemic events identify patients at risk for symptomatic ischemic events. Demonstrating this in patients with APS would prevent thrombotic complications.

The investigators' hypothesis is that a significant proportion of patients with APS would have asymptomatic organ involvement.

Objectives

The primary objective is to determine the frequency of asymptomatic target organ (s) (heart, brain, kidney) in APS patients.

Secondary objectives are (i) to determine the frequency of each type of MRI abnormality, (ii) to identify the factors associated with asymptomatic target organ lesion, (iii) to describe the parameters of echocardiography associated with cerebral and cardiac MRI, and (iv) to assess the feasibility of a one-time cardiovascular and brain MRI.

Methods and analysis

This is a prospective interventional, cross-sectional, non-randomized, monocentric clinical study. The investigators expect to include 50 consecutive patients with APS followed in the department of Vascular Medicine at Nancy University Hospital.

Within 15 days post-inclusion, a one-time cardiac and cerebral MRI will be performed. For each patient, the number of target organs involvements will be calculated and the frequencies will be compared by Fisher or chi-2 tests.

intervention_type: Biological


title: Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.

acronym: PACTEP

summary:
Cerebral glycolytic metabolism can be quantified by quantitative analysis of 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET). This allows to identify neurological diseases at an early stage of functional abnormalities, before any anatomical lesions, and to differentiate them from the "normal" brain aging. Aging mainly leads to atrophy with a decrease in cerebral metabolism in the prefrontal cortex, with consequent deterioration of cognitive processes, in particular executive functions (5).

In a population of 92 "control" subjects, investigators have already quantified the importance of the aging in frontal cortex hypometabolism. These patients were referred for a 18F-FDG PET in the follow-up of lymphoma considered to be in complete remission (PET without cerebral step), without any chemoradiotherapy within 2 months and with normal neuropsychological tests (Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Battery FAB).

However, cerebral aging can be "accelerated" by vascular risk factors, including increased central blood pressure, as investigators have recently reported in a pilot study involving elderly patients. This central pressure, which is directly linked to the cerebral micro-vascularization, can be easily measured by applanation tonometry. In this pilot study, investigators showed that a central pulse pressure equal or greater than 50 mmHg was associated with a significant frontal hypometabolism in elderly patients. This confirmed, at a stage of pre-clinical remodeling, the worse prognostic significance for this criterion, as reported in large epidemiological studies (increased risk of stroke and cardiac vascular events).

However, it is not yet known whether the level of central blood pressure interfere with the brain metabolism of younger subjects, especially with regard to aging observed throughout life. If this hypothesis is confirmed, preventive therapeutic strategies for accelerated aging, could thus integrate the monitoring of central pressure and cerebral metabolism.

The objective of this study is to determine, in a population of control subjects and on a larger scale, the impact of central blood pressure on brain metabolic aging , by using 18F-FDG PET.

primary_purpose: Prevention


title: First Trimester Screening for Preeclampsia and Intrauterine Growth RestrIction Using Three Dimensional Doppler Angiography (SPIRIT): A Prospective Study in Nulliparous Pregnant Women

acronym: SPIRIT

summary:
Introduction: Preeclampsia (PE) and intrauterine growth restriction (IUGR) are two major pregnancy complications, related to a chronic utero-placental hypoperfusion. Nowadays, there isn't a screening or diagnostic test in clinic for utero-placental vascularization deficiency. Since 2004, 3D Power Doppler angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). A high intra and inter-observer reproducibility and its potential interest for placental function study were reported. The investigator's main hypothesis is that these 3DPD indices could provide predictive values for PE and/or IUGR occurrence much higher than those observed with the currents other markers.

Objectives: The main objective of this study is to determine differences in 3DPD indices at first trimester between pregnancies defined at their outcome as uncomplicated pregnancy, PE (mild and severe) and IUGR in nulliparous women.

Methods and analysis: This is a prospective study. The investigators expect to include 2200 women in 4 French centers: Centre Hospitalier Universitaire de Nancy, Paris-Port-Royal (Assistance Publique - Hôpitaux de Paris), Strasbourg and Belfort (Hôpital Nord Franche-Comté).

The nulliparous pregnant women will be recruited during their 1st trimester consultation for routine Down syndrome screening (11-13+6 gestation weeks). Especially for the study, the 3DPD and Uterine Artery Doppler (UAD) acquisition, which last less than 10 min, will be included in the current routine 11-13+6 gestation weeks ultrasound screening. Also, additional blood samples will be taken for biomarker analysis (PAPP-A and P1GF) and biological collection. Utero-placental vascularization indices (VI, FI, VFI) will be quantified using VOCAL® software. For each subgroup (uncomplicated pregnancy, PE and IUGR) mean values in 3DPD indices will be computed and compared using a pairwise t test with a Bonferroni correction p value adjustment.

ReferenceCitation: Bertholdt C, Hossu G, Banasiak C, Beaumont M, Morel O. First trimester screening for pre-eclampsia and intrauterine growth restriction using three-dimensional Doppler angiography (SPIRIT): protocol for a multicentre prospective study in nulliparous pregnant women. BMJ Open. 2020 Oct 19;10(10):e037751. doi: 10.1136/bmjopen-2020-037751.


title: Intravitreous CytokinE Level in pAtient With retiNal Detachment

acronym: ICELAND

summary:
Photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal disorders including age-related macular degeneration (AMD) and retinal detachment (RD). Thus, despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous RD leading to a primary reattachment rate over 95%, some patients show poor visual recovery because of photoreceptor apoptosis.

Physiologically, microglial cells (resident macrophages) are present only in the inner retina. The subretinal space, located between the retinal pigment epithelium (RPE) and the photoreceptor outer segments (POS), is devoid of all mononuclear phagocytes and form a zone of immune privilege. In AMD, several studies showed a strong association between subretinal mononuclear phagocytes infiltration and advanced forms of AMD. Experimental work in mice suggest that this infiltration plays an important role in the pathogenesis of this condition by producing inflammatory cytokines.

RD-induced photoreceptor apoptosis might result from similar mechanisms. The aim of this study is to determine the cytokine profile in vitreous samples from patients with RD and to compare it with those from control patients with macular hole.

ReferenceCitation: Conart JB, Blot G, Augustin S, Millet-Puel G, Roubeix C, Beguier F, Charles-Messance H, Touhami S, Sahel JA, Berrod JP, Leveillard T, Guillonneau X, Delarasse C, Sennlaub F. Insulin inhibits inflammation-induced cone death in retinal detachment. J Neuroinflammation. 2020 Nov 26;17(1):358. doi: 10.1186/s12974-020-02039-1.


type: Registry Identifier

title: Intraoperative Monitoring (Parathormone Values and Continuous Neuromonitoring) to Predict Postoperative Complications After Total Thyroidectomy

acronym: PARACAL

summary: The goal of this study is to evaluate the role of intraoperative continous and intermittent neuromonitoring and intraoperative parathormone (PTH) to predict postoperative nerve morbidity and hypocalcemia.


title: Visual Maturation in Prematurely Born Infants According to Factors Influencing Its Development. Premavision Follow-up at 18 Months Corrected Age, 4 and 7 Years of Age.

acronym: PrmvsionSuiv

summary:
This study aim at following a cohort of prematurely born infants at 18 months corrected age, 4 and 7 years of age. This cohort had an evaluation of visual maturation at term equivalent age (TEA) with factors associated with impaired visual maturation. (PREMAVISION-CLinicalTrials.gov ID: NCT02890251).

In this follow-up study, prematurely born infants vision will be compared to term born infants matched for postnatal age.

status: Terminated


title: Study of Gut Microbiota in Crohn's Disease Patients Suffering From Spondylarthritis

acronym: FLORACROHN

summary:
The FLORACROHN project aims to compare gut microbiota of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA).

3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA.

Fecal microbiota will be determined by 16SRNA gene sequencing.


title: VECU EMOTIONNEL CHEZ LES PATIENTES SOUFFRANT DE CRISES NON EPILEPTIQUES PSYCHOGENES : ETUDE EN IMAGERIE PAR RESONANCE MAGNETIQUE FONCTIONNELLE-ETUDE EMOCRISES

acronym: EMOCRISES

summary:
Currently, hypothetical models of understanding Psychogenic Non-epileptic Seizures (PNES) involve emotional dysregulation.

The hypothesis of a disorder of emotional experience is mainly based on behavioral data and disturbance of autonomic responses in response to images in emotional content (Mignot et al 2015, in submission; Bakvis et al 2013). Various imaging studies have identified brain structures belonging to the limbic system in particular that seem functionally impaired in this population. These functional connectivity abnormalities are correlated with dissociation scores in PNES patients (Van der Kruijs et al 2012 and 2014).

Investigators propose to specifically study the brain activity of PNES patients during tasks emotional content to identify the mechanisms involved in this emotional dysregulation. This work is essential to understanding the mechanisms and the development of new therapeutic strategies

intervention_type: Behavioral


title: Recurrence of Suicide Attempt in Adolescents Lost to Contact Early by Clinicians : The 10-years REPEATERS Cohort of French Adolescents

summary: Losing contact with adult suicide attempters in the year after the suicide attempt (SA) increases the risk of recurrence. The situation with adolescents is unknown. Investigators aimed to determine whether being lost to contact early (LCE) by clinicians is a risk factor of longterm SA recurrence among adolescents and the associated factors.

ReferenceCitation: Ligier F, Guillemin F, Angot C, Bourion S, Kabuth B. Recurrence of suicide attempt in adolescents lost to contact early by clinicians: The 10-year REPEATERS cohort of French adolescents. J Adolesc. 2015 Aug;43:111-8. doi: 10.1016/j.adolescence.2015.05.011. Epub 2015 Jun 12. Erratum in: J Adolesc. 2017 Jan;54:135-136.

ipd_sharing_description: open to partnership


title: Développement Méthodologique de l'Imagerie Par Résonance Magnétique (IRM)

acronym: METHODO

summary: The purpose of this study is to optimize clinical MR protocols and to validate MR acquisition parameters.


title: Development of the General Scale Observance for Chronic Diseases (EGOMAC)

acronym: EGOMAC

summary:
The main objective is to assess the measurement characteristics (validity, reproducibility) and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology and rheumatology hospital and liberal and hospital oncology and Infectious disease, by following the evolution of patient compliance at D0 and D15.

The second objective is to assess the sensitivity to change of scale EGOMAC following developments compliance 3 months.


title: Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse

acronym: STAMP

summary:
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia.

Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ECG, cardiac MRI) and a close follow-up.

External loop recording and exercise ECG have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation.

More recently, detection of myocardial fibrosis among patients with MVP and severe ventricular arrhythmia has been identified. Fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. However, no study has specifically characterized myocardial lesions among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions.

Identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.

ReferenceCitation: Basso C, Perazzolo Marra M, Rizzo S, De Lazzari M, Giorgi B, Cipriani A, Frigo AC, Rigato I, Migliore F, Pilichou K, Bertaglia E, Cacciavillani L, Bauce B, Corrado D, Thiene G, Iliceto S. Arrhythmic Mitral Valve Prolapse and Sudden Cardiac Death. Circulation. 2015 Aug 18;132(7):556-66. doi: 10.1161/CIRCULATIONAHA.115.016291. Epub 2015 Jul 9.

ReferenceCitation: Huttin O, Pierre S, Venner C, Voilliot D, Sellal JM, Aliot E, Sadoul N, Juillière Y, Selton-Suty C. Interactions between mitral valve and left ventricle analysed by 2D speckle tracking in patients with mitral valve prolapse: one more piece to the puzzle. Eur Heart J Cardiovasc Imaging. 2017 Mar 1;18(3):323-331. doi: 10.1093/ehjci/jew075.

location_facility: Nancy University Hospital, Department of Cardiology


title: Expression of Ku70/XRCC6 and Others NHEJ Components in Waldenström's Macroglobulinemia in Comparison With Others B-cell Lymphoproliferative Disorders and Normal B Cells.

acronym: WAL-KU

summary:
Waldenström's macroglobulinemia is a rare disease whose pathophysiology remains at present poorly understood, although a recurrent mutation (L265P MYD88) has recently been described. Unlike other lymphoproliferative disorders, there is a defect in isotype switching, mechanism involving AID and NHEJ complex. Using a two-dimensional electrophoresis technology, our group showed that MW had a specific proteomic profile, and one of the differentially expressed proteins is Ku70 (encoded by XRCC6 belonging to NHEJ complex) .

The investigators purpose to explore the mechanisms of underexpression of Ku70/XRCC6 (genetic or epigenetic modification) in comparison with other lymphoid malignancies and normal B cells.


title: Use of a New ElectroCardioGraph to Create an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease in Order to Let go of Artifacts.

summary: The aim is to create a database including recordings of ECG data recorded in an MRI acquisition

location_facility: Centre Hospitalier Universitaire de Nancy


title: Promoting Parental Skills and Enhancing Attachment in Early Childhood

acronym: CAPEDP

summary: Child psychological/behavioural disorders such as withdrawal may persist when the psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a program of home visits in France

ReferenceCitation: Dugravier R. [Understanding consequences of hospitalization within attachment theory]. Arch Pediatr. 2010 Jun;17(6):723-4. doi: 10.1016/S0929-693X(10)70078-6. French.

ReferenceCitation: Guedeney A, Guedeney N, Tereno S, Dugravier R, Greacen T, Welniarz B, Saias T, Tubach F; CAPEDP Study Group. Infant rhythms versus parental time: promoting parent-infant synchrony. J Physiol Paris. 2011 Dec;105(4-6):195-200. doi: 10.1016/j.jphysparis.2011.07.005. Epub 2011 Jul 12. Review.

ReferenceCitation: Saïas T, Lerner E, Greacen T, Simon-Vernier E, Emer A, Pintaux E, Guédeney A, Dugravier R, Tereno S, Falissard B, Tubach F; CAPEDP Study Group, Revah-Levy A. Evaluating fidelity in home-visiting programs a qualitative analysis of 1058 home visit case notes from 105 families. PLoS One. 2012;7(5):e36915. doi: 10.1371/journal.pone.0036915. Epub 2012 May 18.

ReferenceCitation: Greacen T, Welniarz B, Purper-Ouakil D, Wendland J, Dugravier R, Saïas T, Tereno S, Tubach F, Haddad A, Guedeney A; CAPEDP STUDY GROUP. BEST PRACTICE IN INDIVIDUAL SUPERVISION OF PSYCHOLOGISTS WORKING IN THE FRENCH CAPEDP PREVENTIVE PERINATAL HOME-VISITING PROGRAM: RESULTS OF A DELPHI CONSENSUS PROCESS. Infant Ment Health J. 2017 Mar;38(2):267-275. doi: 10.1002/imhj.21630. Epub 2017 Feb 25.

ReferenceCitation: Dugravier R, Tubach F, Saias T, Guedeney N, Pasquet B, Purper-Ouakil D, Tereno S, Welniarz B, Matos J; CAPEDP Study Group, Guedeney A, Greacen T. Impact of a manualized multifocal perinatal home-visiting program using psychologists on postnatal depression: the CAPEDP randomized controlled trial. PLoS One. 2013 Aug 19;8(8):e72216. doi: 10.1371/journal.pone.0072216. eCollection 2013.

ReferenceCitation: Tubach F, Greacen T, Saïas T, Dugravier R, Guedeney N, Ravaud P, Tereno S, Tremblay R, Falissard B, Guedeney A; CAPEDP Study Group. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France. BMC Public Health. 2012 Aug 13;12:648. doi: 10.1186/1471-2458-12-648.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Development of a Tool for the Self-assessment of Flare in Patients With Osteoarthritis of Lower Limbs

acronym: FLARE-OA

summary:
The need for a tool to measure flare in lower limb osteoarthritis (OA of the hip and knee) is justified by the opportunities for development of clinical trials targeting hip and knee OA long-term treatment (slow acting drug, disease modifying drug) and short-term treatment of symptoms. Such treatments are currently under development and will likely bring important changes in the treatment of patients. The development of a Flare-OA tool would be essential to capture the occurrence of flare, and to implement and adapt treatment strategies.

This project was elaborated with the aims to:

define the construct through development of a conceptual framework
use the conceptual framework to inform the development of a patient-reported outcome measure, Flare-OA tool, for people with OA
evaluate the psychometric properties of the new measure using the OMERACT (Outcome Measures in Rheumatology) filter 2.0 and Rasch measurement methods.

ReferenceCitation: Guillemin F, Ricatte C, Barcenilla-Wong A, Schoumacker A, Cross M, Alleyrat C, Buttel T, Cembalo M, Manseur H, Urban H, Fautrel B, Conaghan PG, Hawker G, Rutherford C, March L, Spitz E, Hunter DJ. Developing a Preliminary Definition and Domains of Flare in Knee and Hip Osteoarthritis (OA): Consensus Building of the Flare-in-OA OMERACT Group. J Rheumatol. 2019 Sep;46(9):1188-1191. doi: 10.3899/jrheum.181085. Epub 2019 May 15.

ReferenceCitation: Traore Y, Epstein J, Spitz E, March L, Maillefert JF, Rutherford C, Ricatte C, Alleyrat C, Cross M, King LK, Callahan LF, Fautrel B, Buttel T, Hawker G, Hunter DJ, Guillemin F. Development and validation of the Flare-OA questionnaire for measuring flare in knee and hip osteoarthritis. Osteoarthritis Cartilage. 2022 May;30(5):689-696. doi: 10.1016/j.joca.2021.12.011. Epub 2022 Jan 20.

location_country: Australia Canada France

location_facility: Institute of Bone and Joint Research - University of Sydney


title: Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study Comparing Outcome of Patients Aged From 50 to 70 Years With or Without Donor

acronym: ONIalloMDS

summary: The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.

lead_sponsor: Saint-Louis Hospital, Paris, France


title: Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects

acronym: FUSION

summary: This study evaluates the stiffness and interface pressures of a new compression system URGOBD001 on healthy subjects, compares with a short stretch bandage and a multi component bandage.

lead_sponsor: Laboratoires URGO

lead_sponsor_type: industriel


title: Comparison of the Benefit Experienced by Patients With Ankylosing Spondylitis, Under Biotherapy, During Management by an Adapted Physical Activity Compared to a Standard Treatment by Kinesitherapy.

acronym: SPIKE

summary:
The current management of Spondylarthritis Ankylosant (SA), according to the recommendations of the HAS (High Authority of Health), must be a multidisciplinary global approach coordinated by the rheumatologist combining a pharmacological aspect (NSAID, analgesics, biotherapy ...) and not pharmacological (physical treatments, educational approaches, social measures ...). The therapeutic aim of this management is to achieve a low level of activity of the disease and a decrease of the repercussion of this one in the daily life of the patient.

The standard physical treatment currently provided is physiotherapy. This can be prescribed throughout the disease by the rheumatologist, adapted to the stage of AS and the clinical condition of the patient. The medical teams note in their daily practice that there may be a lack of attendance of patients at prescribed physiotherapy sessions. This has been confirmed in research on certain chronic rheumatic diseases, including AS, for which patients became less adherent to physical treatments and thus lost the expected benefits, particularly in terms of the functional impact of AS in the patient's daily life. (BASFI). Various studies have also shown that combining several physical activities (including aerobic and muscle building) or / and performing them in groups at a regular frequency (three times a week) could significantly improve several AS parameters, including BASFI.

From these different findings, we hypothesized that a multidisciplinary treatment combining a "cardio training" with muscle strengthening, supervised by qualified sports coaches, for a year, could reduce the impact of SA in the daily life of patients balanced by a biotherapy, compared to standard physiotherapy. This original care is part of the Adapted Physical Activity (APA), whose application decree came into force on March 1, 2017 and allows doctors to prescribe a physical therapy tailored to the needs of the patient. At present, the APA remains at the expense of the patients in ALD and in some cases, it can be supported, partially or totally, by the complementary health. APA could therefore be an alternative and / or complementary to physiotherapy as a physical therapy in the management of AS, in addition to pharmacological treatments.

primary_purpose: Supportive Care

lead_sponsor: Hospital St. Joseph, Marseille, France


title: Monocentric Study Evaluating the Efficiency and Safety of Anti-reflux Mucosectomy ARMS for the Gastro-Esophageal Reflux Disease

acronym: RESECT-RGO

summary:
Currently patients with gastroesophageal reflux disease (GERD) are treated with proton pump inhibitors (PPIs). This long-term PPI treatment would likely increase the risk of pulmonary and digestive infections and would not prevent evolution to adenocarcinoma of Barrett's Esophagus. Surgical fundoplication is generally recommended when symptoms are poorly controlled with PPIs and considered as standard treatment despite celioscopy risk. A variety of endoscopic techniques for the treatment of GERD has been proposed to obtain non-surgical control. These endoscopic techniques aim to bring the tissues closer to the Œsogastric (JOG) junction. But a low response rate has been demonstrated with these techniques.

H. Inoue (inventor of the anti-reflux mucosectomy 20 years ago) and his team postulated that the reflux symptoms would be reduced by creating a relative restriction of gastric cardia. The healing of the mucosectomy zone led to restriction of gastric cardia. This observation suggested that ARMS could represent an effective anti-reflux procedure with the advantage that no prostheses would be left in situ.

Few studies have evaluated this new endoscopic technique. The purpose of this study is to evaluate the feasibility and safety of gastric mucosectomy for patients with GERD resistant to medical treatment or requiring long-term maintenance medical treatment.

status: Suspended

ReferenceCitation: Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Långström G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626.

ReferenceCitation: Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529. Review.

ReferenceCitation: Kellokumpu I, Voutilainen M, Haglund C, Färkkilä M, Roberts PJ, Kautiainen H. Quality of life following laparoscopic Nissen fundoplication: assessing short-term and long-term outcomes. World J Gastroenterol. 2013 Jun 28;19(24):3810-8. doi: 10.3748/wjg.v19.i24.3810.

ReferenceCitation: Marret H, Pierre F, Chapron C, Perrotin F, Body G, Lansac J. [Complications of laparoscopy caused by trocars. Preliminary study from the national registry of the French Society of Gynecologic Endoscopy]. J Gynecol Obstet Biol Reprod (Paris). 1997;26(4):405-12. French.

ReferenceCitation: Rickenbacher N, Kötter T, Kochen MM, Scherer M, Blozik E. Fundoplication versus medical management of gastroesophageal reflux disease: systematic review and meta-analysis. Surg Endosc. 2014 Jan;28(1):143-55. doi: 10.1007/s00464-013-3140-z. Epub 2013 Sep 10. Review. Erratum in: Surg Endosc. 2014 Jun;28(6):2002.

ReferenceCitation: Mahmood Z, Byrne PJ, McMahon BP, Murphy EM, Arfin Q, Ravi N, Weir DG, Reynolds JV. Comparison of transesophageal endoscopic plication (TEP) with laparoscopic Nissen fundoplication (LNF) in the treatment of uncomplicated reflux disease. Am J Gastroenterol. 2006 Mar;101(3):431-6.

ReferenceCitation: Triadafilopoulos G. Stretta: a valuable endoscopic treatment modality for gastroesophageal reflux disease. World J Gastroenterol. 2014 Jun 28;20(24):7730-8. doi: 10.3748/wjg.v20.i24.7730. Review.

ReferenceCitation: Feretis C, Benakis P, Dimopoulos C, Dailianas A, Filalithis P, Stamou KM, Manouras A, Apostolidis N. Endoscopic implantation of Plexiglas (PMMA) microspheres for the treatment of GERD. Gastrointest Endosc. 2001 Apr;53(4):423-6.

ReferenceCitation: Cicala M, Gabbrielli A, Emerenziani S, Guarino MP, Ribolsi M, Caviglia R, Costamagna G. Effect of endoscopic augmentation of the lower oesophageal sphincter (Gatekeeper reflux repair system) on intraoesophageal dynamic characteristics of acid reflux. Gut. 2005 Feb;54(2):183-6.

ReferenceCitation: Wong RF, Davis TV, Peterson KA. Complications involving the mediastinum after injection of Enteryx for GERD. Gastrointest Endosc. 2005 May;61(6):753-6.

ReferenceCitation: Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G, Pleskow D, Zaman M, Lembo A. A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study. Gastrointest Endosc. 2003 Nov;58(5):770-6.

ReferenceCitation: Cadière GB, Buset M, Muls V, Rajan A, Rösch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Devière J. Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg. 2008 Aug;32(8):1676-88. doi: 10.1007/s00268-008-9594-9.

ReferenceCitation: Satodate H, Inoue H, Yoshida T, Usui S, Iwashita M, Fukami N, Shiokawa A, Kudo SE. Circumferential EMR of carcinoma arising in Barrett's esophagus: case report. Gastrointest Endosc. 2003 Aug;58(2):288-92.

ReferenceCitation: Inoue H, Ito H, Ikeda H, Sato C, Sato H, Phalanusitthepha C, Hayee B, Eleftheriadis N, Kudo SE. Anti-reflux mucosectomy for gastroesophageal reflux disease in the absence of hiatus hernia: a pilot study. Ann Gastroenterol. 2014;27(4):346-351.

ReferenceCitation: Velanovich V, Vallance SR, Gusz JR, Tapia FV, Harkabus MA. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg. 1996 Sep;183(3):217-24.

ReferenceCitation: Laquière A, Trottier-Tellier F, Urena-Campos R, Lienne P, Lecomte L, Katsogiannou M, Penaranda G, Boustière C. Evaluation of Antireflux Mucosectomy for Severe Gastroesophageal Reflux Disease: Medium-Term Results of a Pilot Study. Gastroenterol Res Pract. 2022 Feb 21;2022:1606944. doi: 10.1155/2022/1606944. eCollection 2022.


title: A Prospective Study Comparing the Evolution of Visual Acuity Measured by Electronic Tablet or Computer and the Visual Acuity Measured by ETDRS in Patients Monitored and Treated for Exudative AMD

summary:
This pathology, DMLA, whose evolution is chronic, requires regular follow-up and care (IVTs) over a long period (several months or even years).

Increasing the number of patients to be followed and treated poses increasing problems for ophthalmologists to ensure regular follow-up of patients, followed by a need for satisfactory functional results.

Moreover, this regular follow-up imposes enormous constraints on patients and their families (some children or patients are still working).

Studies are beginning to emerge on the reliability of patient follow-up in telemedicine. The use of a measure of visual acuity by patients, Electronic Tablet (TE) or computer (O), and at home, seems a logical step to help us improve the quality of patient follow-up while spacing controls.

The aim of our study is thus to demonstrate that the measurement of the VA performed by TE or O is reliable. Indeed, during the follow-up of the patients, in the case where the patient's AV decreases, and whatever the reason


title: Study GO-PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care

summary: This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation


title: Evaluation of the Prevalence of Asthma in a Cohort of Children Born After In Vitro Fertilization (Aged 11-15) Compared With Spontaneously Conceived Children of the Same Age Range

acronym: EMCeFIV

summary:
Assisted Reproduction Technologies (ART) are increasingly being used worldwide as a result of fertility decline likely caused by changes in both environment and social behaviour. Considering this large usage, it is important to evaluate the potential risk on the health of children conceived using ART.

According to the literature, children born after ART are more likely to be at higher risk of health problems than spontaneously conceived ones. Interestingly, recent studies suggested an increase of asthma prevalence in children conceived using In Vitro Fertilization (IVF).

The purpose of this study is to evaluate the prevalence of asthma in school adolescents from a cohort of children born after In Vitro Fertilization (IVF), aged 11-15 years as compared to a control group composed of the same age range spontaneously conceived individuals.

The expected outcome of this study will provide new information regarding these children to ART professionals of and to their own families, by focusing on an age range (between 11 and 15 years) for which very little information is available to date.

ReferenceCitation: Anzola AB, Pauly V, Geoffroy-Siraudin C, Gervoise-Boyer MJ, Montjean D, Boyer P. The first 50 live births after autologous oocyte vitrification in France. J Assist Reprod Genet. 2015 Dec;32(12):1781-7. doi: 10.1007/s10815-015-0603-2. Epub 2015 Oct 30.

ReferenceCitation: Meddeb L, Boyer M, Pauly V, Tourame P, Rossin B, Pfister B, Boyer P. [Procedure used to follow-up a cohort of IVF children. Interests and limits of tools performed to longitudinal follow up for a monocentric cohort]. Rev Epidemiol Sante Publique. 2011 Apr;59(2):97-105. doi: 10.1016/j.respe.2010.11.004. Epub 2011 Mar 22. French.


title: Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.

acronym: ELOUAN

summary: Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).


title: Extending the Prerogatives of Colorectal Cancer Screening French Organizations to the Follow-up After Colonoscopy of Patients Aged 50 or More: Pilot Study in the Rhône Administrative Department

acronym: Tempo-colo

summary: France is one of the European countries where the incidence of colorectal cancer is the highest among cancers for both sexes. Fecal occult blood screening has been implemented since 2008. However, this screening excludes high risk people who have a 10 to 30 % risk of developing a CRC during their lifetime. Colonoscopy follow up of these persons is not organized, and it is up to the attending physician to recall the date of the surveillance colonoscopy. This results in a poor compliance with the recommendations by these people. A postal reminder of the surveillance colonoscopies sent by The French screening organizations to the patients should increase adherence to follow-up recommendations. The colorectal cancer screening organizations will collects from the hepatogastroenterologists (HGE) informations on colonoscopies of people more than 50 years old who live in the Rhone. These informations will allow to send a reminder 3 months before the date recommended by the HGE. Participation rate and timeliness will be assessed, as well as the severity of the lesions found. A medico-economic analysis will also be carried out.

lead_sponsor: Association pour le Dépistage Organisé des Cancers dans le Rhône


title: L-Arginine Treatment for Severe Vascular Fetal Intrauterine Growth Restriction: a Randomized Double Bind Controlled Trial

summary: Although there is a strong rationale to supplement gravid patients suffering intrauterine growth restriction (IUGR) or preeclampsia with Arginine or other nitric oxide donors, evidence in the literature has been inconclusive. The current study was designed to determine whether oral treatment with L-Arginine, a nitric oxide (NO) donor, would enhance birth weight and/or decrease neonatal morbidity in pregnancies with severe vascular intrauterine growth restriction (IUGR).

ReferenceCitation: Winer N, Branger B, Azria E, Tsatsaris V, Philippe HJ, Rozé JC, Descamps P, Boog G, Cynober L, Darmaun D. L-Arginine treatment for severe vascular fetal intrauterine growth restriction: a randomized double-bind controlled trial. Clin Nutr. 2009 Jun;28(3):243-8. doi: 10.1016/j.clnu.2009.03.007. Epub 2009 Apr 8.

lead_sponsor: Nantes University Hospital


title: Assessment of Pain During Intramuscular Injection Delay in Adult Psychiatry

acronym: evadoulim

summary: Since psychiatry is still too often confronted with a dichotomy between psyche and soma, the assessment of pain and anxiety at RMI is still rarely done (Willer et al., 1982). The objective of this exploratory study is to evaluate the influence of pharmacological factors (type of injected molecules, injection frequency, injection site, treatment duration, treatment dose, time since last injection) and individual about the pain perceived when injecting antipsychotic therapy (diagnosis, sex, age, weight, duration of illness, level of anxiety, psychiatric and somatic comorbidity, insight). In the future, this study will develop a suitable procedure to limit pain and anxiety during RMI. Taking these dimensions into account will probably allow a better compliance of patients for this type of care, and thus a decrease in the number of relapses in the long term.

lead_sponsor: Centre hospitalier de Ville-Evrard, France


title: Evaluation of Desensitization Therapy and Re-treatment of Eye Movement Information [EMDR] in Patients With Post-traumatic Stress Disorder [PTSD]: Neuronal Correlates and Cognitive Impact on the Attention and Memory of Emotional Stimuli.

acronym: ICE-EMDR

summary:
This research aims to confirm that the therapeutic effect of EMDR is associated with changes in the interaction between cognitive function and emotional stimuli in PTSD patients compared to a controlled therapy in a randomized, single-blind study.On the other hand, this study aims to observe neuronal and cognitive correlates related to EMDR therapy compared to a control therapy.

This investigation would improve the understanding of the mechanisms of action of the EMDR, still unknown to date.


title: Psychological Outcome of COVID-19 Lockdown on Psychiatric Hospital Staff and Close Relatives (ICOS)

acronym: ICOS

summary: The purpose of the investigators is to study the psychological impact of the COVID-19 lockdown on the members of the Ville Evrard Hospital staff and their close relatives, and to identify potential lockdown conditions that could increase anxiety, anger and depressive symptoms in this population.


title: Evaluation of a Cognitive Remediation Program for Mood Disorders

acronym: ECO-DBP

summary: Psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder


title: Efficacy of tDCS in the Treatment of Resistant Auditory Hallucinations in Schizophrenia: A Double Blind, Randomized Controlled Study

acronym: TDCSHALLU

summary:
the regions which are assumed to underlie the pathophysiology of schizophrenia, namely hypoactivity at the prefrontal level and pathological hyperactivity of the associative regions of the language located in the left temporoparietal region.

to assess the effuicacy of tDCS on auditory hallucinations we perfor an randomized double blind versus placebo trial. In each arms patients will receive two tDCS sessions a day during two weeks

location_facility: unité de recherche clinique de l'E.P.S de Ville Evrard


title: Validation of a Cognitive Remediation Program for Bipolar Disorders

acronym: ECO-BIP

summary: This study evaluates the effect of a new cognitive remediation program designed for patients suffering from a bipolar disorder, on cognitive functions, psychosocial functioning and neural processes. In this double-blind (patient, outcomes assessor) controlled randomized trial the investigators compare patients receiving the ECo program for bipolar disorders, to patients benefiting from the broadly used cognitive remediation program CRT and to patients receiving supportive psychotherapy. Patients are treated for 3 months and monitored for 9 months.

ReferenceCitation: Altshuler LL, Ventura J, van Gorp WG, Green MF, Theberge DC, Mintz J. Neurocognitive function in clinically stable men with bipolar I disorder or schizophrenia and normal control subjects. Biol Psychiatry. 2004 Oct 15;56(8):560-9.

ReferenceCitation: Deckersbach T, Nierenberg AA, Kessler R, Lund HG, Ametrano RM, Sachs G, Rauch SL, Dougherty D. RESEARCH: Cognitive rehabilitation for bipolar disorder: An open trial for employed patients with residual depressive symptoms. CNS Neurosci Ther. 2010 Oct;16(5):298-307. doi: 10.1111/j.1755-5949.2009.00110.x.

ReferenceCitation: Martínez-Arán A, Torrent C, Solé B, Bonnín CM, Rosa AR, Sánchez-Moreno J, Vieta E. Functional remediation for bipolar disorder. Clin Pract Epidemiol Ment Health. 2011;7:112-6. doi: 10.2174/1745017901107010112. Epub 2011 Jun 6.

location_facility: Unité de Recherche Clinique, EPS Ville Evrard


title: Factors Associated With Complications of Cervical Necrotizing Fasciitis

summary:
Cervical necrotizing fasciitis (CNF) is a rare but severe complication of pharyngeal or dental infections. The infection can rapidly descend into the mediastinum and lead to a life-threatening prognosis. Treatment consists of a multidisciplinary approach in intensive care with radiologist and with early and repeated surgical debridement. Anti-inflammatory drugs have been incriminated by authors in the development of necrotizing fasciitis. Recently, a single-center study demonstrated that pharyngeal source of CNF and oral glucocorticoid intake before admission was associated with the occurrence of mediastinitis.

The aim of the study is to assess the incidence and factors associated with CNF complications, in particular mediastinitis. Secondary outcome is to describe patient characteristics, medical and surgical management.

Methods: A retrospective, observational, non-interventional multicentre study is conducted in nine intensive care units in France from January 2005 to December 2016.

lead_sponsor: Hospices Civils de Lyon

location_facility: Intensive Care unit, Edouard Herriot Hospital


title: Study of the Kinetics of Microparticles Under Chemotherapy in Patients With Gastric or Pancreatic Cancer

acronym: DOMICA

summary:
Microparticles have recently emerged as a thrombotic risk marker with a potential role in determining which patients are at greatest risk for developing thrombosis. Available data show an increase in the level of microparticles in cancer patients who are undergoing chemotherapy for solid tumors with a possible link to their thrombogenic state.

Our study focuses on the kinetics of microparticles under chemotherapy in patients with pancreatic or gastric cancer by serial measurements of microparticles procoagulant activity.

Detailed Description:

The impact of chemotherapy on microparticles expression will be assessed by measuring their procoagulant activity on blood samples taken during the course of chemotherapy. The thrombotic risk will be evaluated by the score of Khorana in parallel. Microparticles expression in patients with thrombosis will be compared to that in other patients.

lead_sponsor: Poitiers University Hospital


title: Comparison of the Prosthesis Ugytex by the Trans-obturator Approach and Anterior Colporrhaphy for the Surgical Treatment of Anterior Vaginal Wall Prolapse

summary:
Hypothesis / aims of study A RCT has shown that results of prolapse repair via vaginal approach could be improved when a polypropylene mesh is used as tissue support (1). However, non protected heavy-weight meshes were associated with a high rate of local complications such as vaginal erosions and dyspareunia (2). The aim of this multicentre study is to evaluate anatomical and functional results of an innovative low-weight polypropylene mesh protected by an absorbable hydrophilic film in the prolapse repair by vaginal route, in comparison by the standard anterior colporrhaphy.

Study design, materials and methods This study involves 15 centres in French Private or Public Hospital. Patients will be randomly allocated to be operated by a standard anterior colporrhaphy or by an anterior repair reinforced by a specially designed mesh: UgytexTM (Sofradim, France). Ugytex is a low-weight (38g/m²) and highly porous (average porosity: 89%, pores over 1.5mm) polypropylene monofilament mesh offering tissue ingrowth and connective differentiation for a stable and long-term support. The mesh is coated with a hydrophilic film composed of atelocollagen, polyethylene glycol and glycerol. The absorbable coating protects delicate pelvic viscera from the risk of acute inflammation during the healing's inflammatory peak. Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up (3), as well as a validated questionnaire on sexual problems. The difference on one-year cure rate should be 15% (80% for the anterior colporrhaphy and 95% for the mesh repair). Then the estimated number of patient is 97 in each arm.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Optimized Phase III Trial of Immuno-stimulation With Maraviroc, a CCR5 (Chemokine Receptor 5) Antagonist, Combined With Anti Retroviral Therapy in Advanced, Late Diagnosed HIV-1 Infected Patients With an AIDS-defining Event and/or CD4 (Cluster of Differentiation 4) Counts Below 200 Cells/mm³. ANRS 146 OPTIMAL

acronym: OPTIMAL

summary:
The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients counts may accelerate the kinetics of immune restoration and decrease the risk of disease progression and death.

It is a randomized, versus placebo, double-blind trial, conducted in France, Spain and Italy.

ReferenceCitation: Lévy Y, Lelièvre JD, Assoumou L, Aznar E, Pulido F, Tambussi G, Crespo M, Meybeck A, Molina JM, Delaugerre C, Izopet J, Peytavin G, Cardon F, Diallo A, Lancar R, Béniguel L, Costagliola D. Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial. Ann Intern Med. 2020 Mar 3;172(5):297-305. doi: 10.7326/M19-2133. Epub 2020 Feb 11.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer

acronym: TRECAM

summary: In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.

ReferenceCitation: Barranger E, Uzan S, Pitre S, Duval MA, Charon Y. [Development of a hand-held gamma camera (POCI) in the sentinel node biopsy for breast cancer]. Pathol Biol (Paris). 2008 Jul;56(5):254-6. doi: 10.1016/j.patbio.2007.09.009. Epub 2008 Feb 21. French.

ReferenceCitation: Medina-Franco H, Abarca-Pérez L, García-Alvarez MN, Ulloa-Gómez JL, Romero-Trejo C, Sepúlveda-Méndez J. Radioguided occult lesion localization (ROLL) versus wire-guided lumpectomy for non-palpable breast lesions: a randomized prospective evaluation. J Surg Oncol. 2008 Feb 1;97(2):108-11. doi: 10.1002/jso.20880.

ReferenceCitation: Lavoué V, Nos C, Clough KB, Baghaie F, Zerbib E, Poulet B, Lefrère Belda MA, Ducellier A, Lecuru F. Simplified technique of radioguided occult lesion localization (ROLL) plus sentinel lymph node biopsy (SNOLL) in breast carcinoma. Ann Surg Oncol. 2008 Sep;15(9):2556-61. doi: 10.1245/s10434-008-9994-y. Epub 2008 Jun 24.

ReferenceCitation: Monti S, Galimberti V, Trifiro G, De Cicco C, Peradze N, Brenelli F, Fernandez-Rodriguez J, Rotmensz N, Latronico A, Berrettini A, Mauri M, Machado L, Luini A, Paganelli G. Occult breast lesion localization plus sentinel node biopsy (SNOLL): experience with 959 patients at the European Institute of Oncology. Ann Surg Oncol. 2007 Oct;14(10):2928-31. Epub 2007 Aug 1.

ReferenceCitation: Kerrou K, Pitre S, Coutant C, Rouzier R, Ancel PY, Lebeaux C, Huchet V, Montravers F, Pascal O, Duval MA, Lefebvre F, Menard L, Uzan S, Charon Y, Barranger E. The usefulness of a preoperative compact imager, a hand-held gamma-camera for breast cancer sentinel node biopsy: final results of a prospective double-blind, clinical study. J Nucl Med. 2011 Sep;52(9):1346-53. doi: 10.2967/jnumed.111.090464. Epub 2011 Aug 17.

ReferenceCitation: Bricou A, Duval MA, Charon Y, Barranger E. Mobile gamma cameras in breast cancer care - a review. Eur J Surg Oncol. 2013 May;39(5):409-16. doi: 10.1016/j.ejso.2013.02.008. Epub 2013 Mar 7. Review.

ReferenceCitation: The Tumor Resection Camera (TReCam), a multipixel imaging probe for radio-guided surgery.E. Netter, L. Pinot, L. Ménard, M.-A. Duval, B. Janvier, F. Lefebvre, R. Siebert, Y. Charon. Nuclear Science Symposium Conference Record (NSS/MIC), 2009 IEEE, 2573-2576


acronym: ADRIE

summary: The ADRIE study is an observational study on the clinical relevance of platelet reactivity in aspirin and clopidogrel treated cardiovascular patients.

ReferenceCitation: Reny JL, Berdagué P, Poncet A, Barazer I, Nolli S, Fabbro-Peray P, Schved JF, Bounameaux H, Mach F, de Moerloose P, Fontana P; Antiplatelet Drug Resistances and Ischemic Events (ADRIE) Study Group. Antiplatelet drug response status does not predict recurrent ischemic events in stable cardiovascular patients: results of the Antiplatelet Drug Resistances and Ischemic Events study. Circulation. 2012 Jun 26;125(25):3201-10. doi: 10.1161/CIRCULATIONAHA.111.085464. Epub 2012 May 21.

ReferenceCitation: Fontana P, James R, Barazer I, Berdagué P, Schved JF, Rebsamen M, Vuilleumier N, Reny JL. Relationship between paraoxonase-1 activity, its Q192R genetic variant and clopidogrel responsiveness in the ADRIE study. J Thromb Haemost. 2011 Aug;9(8):1664-6. doi: 10.1111/j.1538-7836.2011.04409.x.

lead_sponsor: Pierre Fontana

location_facility: University Hospital Geneva; Beziers and Monpellier University Hospitals, France


title: Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients - Estimabl

acronym: Estimabl

summary:
In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff.

Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.

ReferenceCitation: Schlumberger M, Leboulleux S, Catargi B, Deandreis D, Zerdoud S, Bardet S, Rusu D, Godbert Y, Buffet C, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Toubert ME, Kelly A, Benhamou E, Borget I. Outcome after ablation in patients with low-risk thyroid cancer (ESTIMABL1): 5-year follow-up results of a randomised, phase 3, equivalence trial. Lancet Diabetes Endocrinol. 2018 Aug;6(8):618-626. doi: 10.1016/S2213-8587(18)30113-X. Epub 2018 May 26.

ReferenceCitation: Schlumberger M, Catargi B, Borget I, Deandreis D, Zerdoud S, Bridji B, Bardet S, Leenhardt L, Bastie D, Schvartz C, Vera P, Morel O, Benisvy D, Bournaud C, Bonichon F, Dejax C, Toubert ME, Leboulleux S, Ricard M, Benhamou E; Tumeurs de la Thyroïde Refractaires Network for the Essai Stimulation Ablation Equivalence Trial. Strategies of radioiodine ablation in patients with low-risk thyroid cancer. N Engl J Med. 2012 May 3;366(18):1663-73. doi: 10.1056/NEJMoa1108586.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris