title: Chronobiological Characterization of Smith Magenis Syndrome in Paediatric Age

acronym: SMS

summary:
Smith Magenis Syndrome (SMS) is a complex disorder characterized by severe neurological, psychological and behavioral disorders including sleep-wake rhythm disorders. It is a rare disease with a prevalence of 1/25 000.

The sleep disorders observed could be the consequence of a general dysregulation of the circadian system, since these patients show an inversion of the melatonin secretion profile. In SMS, the peak of melatonin is observed at 12 o'clock, whereas it is nocturnal in healthy subjects (3-4 o'clock in the morning). Daylight plays a important role in circadian regulation by inducing an inhibition of melatonin secretion via the suprachiasmatic nuclei of the hypothalamus. This mechanism could be affected in SMS children, explaining the lag of melatonin profile.

These sleep-wake disturbances cycle could play a significant role in learning deficits and in the frequency and severity of behavioral abnormalities observed in SMS.

In this project, investigators propose to study the mechanisms involved in the sleep-wake cycle disorders observed in Smith Magenis children, in particular by evaluating the quality of the pupillary reflex using a pupillometer. The pupillary reflex is a simple and non-invasive method to test light sensitivity and the photobiological mechanisms involved.

In this way, investigators want to evaluate the diurnal profile of the pupillary reflex in children with Smith Magenis syndrome in relation to the diurnal melatonin profile.

Investigators will complete this study by determining the chronobiological profile of Smith Magenis patients by measuring different variables:

Diurnal cortisol and amylase profile
24h body temperature and heart rate profile
Urinary cortisol and 6-sulfatoxymelatonin (major metabolite of melatonin) profiles
Daytime sleepiness profile measured subjectively by questionnaire and objectively via a waking EEG recording.
Actimetry at home
Polysomnography
A neurocognitive and behavioural assessment

location_facility: Service Épilepsie-Sommeil-Explorations Fonctionnelles Neurologiques Pédiatriques Hôpital Femme-Mère-Enfant HCL

location_facility: GénoPsy, Reference Center for Diagnosis and Management of Genetic Psychiatric Disorders, Centre Hospitalier le Vinatier and EDR-Psy Q19 Team (Centre National de la Recherche Scientifique & Lyon 1 Claude Bernard University)


title: Pilot Study to Validate ex Vivo Expression of Specific Biomarkers of Human Resolutive Macrophages

acronym: RESOMACRO

summary: Human resolutive macrophages are essential immune cells in the resolution of inflammation. This particular type of macrophages remains poorly known and currently there are no biomarkers to identify them in vivo. Within UMR1098-RIGHT, specific biomarkers (secreted molecules and membrane receptors) of human resolutive macrophages (healthy volunteers) have been identified in vitro, but their existence in vivo remains an outstanding issue. An exploratory study (lack of data from the literature) will validate the ex vivo expression of these markers in samples of patients whose inflammation is not, or little, supported by the available therapies (NSAIDs, biotherapies, corticosteroids).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Dentist'S Office
CHRU Besançon

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo Conrolled Pilot Study.

acronym: NUTRIBIOTE

summary: The effects of daily supplementation of the NUTRIOSE® on the fecal microbiota. The hypothesis of the study is that the NUTRIOSE® is able to modulate the intestinal microbiota in a positive way, compare to a placebo, in healthy volunteers.

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Roquette Freres

sponsor_collaborators:
Roquette Freres
BioFortis

location_facility: Clinical Investigation Unit of Biofortis Paris

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


title: A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies

acronym: PLANET

summary: The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Centre Leon Berard

location_facility:
HOPITAL Pierre WERTHEIMER - HCL
Centre Léon Bérard

intervention_type: Biological


type: Other Identifier

title: Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Patients With Lung and Head and Neck Cancers, Treated With an Immunotherapy-based Therapy

acronym: MADMAS

summary:
Immunotherapy is widely administrated as anticancer treatment in metastatic setting. Despite a proved efficacy in several cancer types and clinical situations, it exists a wide variability of responses in terms of efficacy and toxicity. The rate of responders depends mostly on the type of pathology, with 40% of responders among melanoma patients, 20-30% among lung and head and neck cancer patients and only 1% of responders among pancreatic cancer patients. Thus, the main challenge today is to be able to select patients for whom the treatment is likely to be effective. Several studies suggested that tumors with a high mutational burden and expressing PD-L1 are better responders to immunotherapy.

However, a proportion of PD-L1 negative cancers responds to immunotherapy, suggesting that other parameters have to be considered together with PD-L1 expression. Of that, the immunotherapy clearance seems to have an impact on overall survival, but larger studies, including different molecules and cancer types, are needed to better understand the correlation between the clearance and the response to immunotherapy.

Tumor cells released from the primary tumor in the blood circulation (CTCs, for circulating tumor cells) are considered as "liquid biopsies", as they contain the entire genetic and phenotypic information representative of the tumor, including PD-L1 expression. Thus, the variation of PD-L1 expression under treatment can be easily followed-up on blood samples collected during the time.

The objective of MADMAS is to study the correlation between the immunotherapy clearance, measured at the different times during treatment, and the variation of the number of CTCs expressing PD-L1 after two cures of treatment.

MADMAS will enroll patients with lung or head and neck cancers, treated with an immunotherapy-based therapy. Blood samples will be collected at the baseline and before the first two cures of treatment. The immunotherapy clearance will be measured with an innovative approach of Mass Spectrometry, and PD-L1 expression will be measured on CTCs, purified with a highly sensitive microfluidics technology.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Croix Rousse Hospital
Lyon Sud Hospital

intervention_type: Other


type: Registry Identifier

title: Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation

acronym: TEERMISO

summary: The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.

status: Enrolling by invitation

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Cardiologique du Nord

collaborators: Università degli Studi 'G. d'Annunzio' Chieti e Pescara

location_facility:
Francesco Nappi
Centre Cardiologique Du Nord

intervention_type: Device

status_simplified: Unknown


title: Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4

summary:
Multi-cohort exploratory prospective study. Participation in the ALCINA 4 study does not change the standard management of the patient, including the treatments administered. A sampling schedule will be set up for each cohort.

Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples taken per patient for up to 12 or 18 months. If a specific tumor sample is required, it will be collected only once during the study.

lead_sponsor: Institut Curie


title: Prospective Multicenter Randomized Controlled 1:1 Study Evaluating the Efficacy of a 3D Digital Operating Microscope Compared to Conventional Microscopes Microscopes on the Comfort and Subjective Visual Sensations of the Patients Related to the Microscope Light During Initial Cataract Surgery Under Topical Anesthesia Topical Anesthesia

acronym: COOL

summary:
Digital 3D microscopes require less light and may be more comfortable for patients requiring cataract surgery under topical anesthesia compared to conventional microscopes.

To date, no studies have evaluated the comfort and subjective visual sensations related to the light of the 3D digital microscope in cataract surgery patients.

The purpose of this study is to evaluate the effectiveness of the Ngenuity 3D digital operating system (Alcon, Fort Worth, TX) compared to conventional microscopes on the comfort and subjective visual sensations related to of patients undergoing initial cataract surgery under topical anesthesia (pure or combined with intravenous sedation).

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hôpital Fondation A. de Rothschuld
Clinique Honoré Cave

status_simplified: Completed


title: Validation of the Relationship Between Oxygenation Parameters and the Oxygen Reserve Index (ORI™), in Mechanically Ventilated ICU Patients: An Exploratory Pathophysiology Study

summary: The ORI™ or Oxygen Reserve Index (Masimo, Irvine, CA, USA) is a non-invasive monitoring system for measuring oxygen reserve. It is a digital sensor (almost identical to the SpO2 sensor) which allows an analysis of the absorption of arterial, venous and capillary components. The measured index, unitless, ranges from 0.00 to 1.00 for moderate hyperoxia levels: from 100 to 200 mmHg. It can alert the clinician to a drop in oxygen stores via the drop in SvO2 before a drop in SpO2 is observed. We propose to carry out a study to elucidate correlation between ORI™ and PaO2.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Clermont-Ferrand University Hospital
CHU


title: Erythropoietin to Improve Critical Care Patient Outcomes: Feasibility Study of a Multicenter, Randomized, Placebo-controlled Trial of Subcutaneous Erythropoietin Injection for Intensive Care Patients

acronym: EPO-ICU-FS

summary:
Recently, the french societies for critical care (SFAR and SRLF) produced guidelines for anemia treatment in critically ill patients that recommend the use of erythropoietin (EPO) in these patients, but the european society (ESICM) recommended against the use of EPO in this patients, despite recent meta analysis showing a lower mortality in patients treated with EPO.

Nevertheless, RCT on EPO in the ICU are quite all, new data are thus needed. Before conducting a large study on EPO in anemic patients in the ICU, we propose to cinduct a feasability RCT to evaluate the feasability of such a study.

status: Active, not recruiting

ipd_sharing_description: Yes

lead_sponsor: University Hospital, Angers

location_facility:
UH Tours
Cholet Hospital

intervention_type: Drug


title: Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy Associated With Adipose Tissue Grafting Compared to Aponeurectomy Alone, on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY).

acronym: REMEDY

summary:
Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence.

Various medical and surgical treatments are available.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Selles RW, Zhou C, Kan HJ, Wouters RM, van Nieuwenhoven CA, Hovius SER. Percutaneous Aponeurotomy and Lipofilling versus Limited Fasciectomy for Dupuytren's Contracture: 5-Year Results from a Randomized Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):1523-1531. doi: 10.1097/PRS.0000000000004982.

ReferenceCitation: Henry M. Dupuytren's disease: current state of the art. Hand (N Y). 2014 Mar;9(1):1-8. doi: 10.1007/s11552-013-9563-0.

ReferenceCitation: Engstrand C, Krevers B, Nylander G, Kvist J. Hand function and quality of life before and after fasciectomy for Dupuytren contracture. J Hand Surg Am. 2014 Jul;39(7):1333-1343.e2. doi: 10.1016/j.jhsa.2014.04.029.

ReferenceCitation: Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7.

ReferenceCitation: Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.

ReferenceCitation: Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f.

ReferenceCitation: Verhoekx JSN, Mudera V, Walbeehm ET, Hovius SER. Adipose-derived stem cells inhibit the contractile myofibroblast in Dupuytren's disease. Plast Reconstr Surg. 2013 Nov;132(5):1139-1148. doi: 10.1097/PRS.0b013e3182a3bf2b.

ReferenceCitation: Foucher G, Medina J, Navarro R. Percutaneous needle aponeurotomy: complications and results. J Hand Surg Br. 2003 Oct;28(5):427-31. doi: 10.1016/s0266-7681(03)00013-5.

ReferenceCitation: Kan HJ, Verrijp FW, Hovius SER, van Nieuwenhoven CA; Dupuytren Delphi Group; Selles RW. Recurrence of Dupuytren's contracture: A consensus-based definition. PLoS One. 2017 May 15;12(5):e0164849. doi: 10.1371/journal.pone.0164849. eCollection 2017. Erratum In: PLoS One. 2019 Apr 25;14(4):e0216313.

ReferenceCitation: Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.

ReferenceCitation: Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17.

lead_sponsor: Elsan

location_facility:
Institut Aquitain de la Main
Clinique du Diaconat


title: Retrospective Study on Prolonged Sedation Effects With Inhaled Agents in Pediatric Intensive Care Unit

acronym: RESPIRE

summary:
The objective of the study is to evaluate the effects of halogenated gases on sedation and analgesia, to describe the tolerance and to determine the risk factors for failure, in pediatric intensive care patients during prolonged sedation.

This study will be based on the medical records of patients hospitalized between 2015 and 2020.

ReferenceType: result

ReferenceCitation: Halogenated volatile anaesthetics for prolonged sedation in pediatric intensive care unit: first experience in two French pediatric intensive care units. https://doi.org/10.1007/s44253-023-00009-y.Léo Berger, Yohan Soreze, Jérome Rambaud, Julie Starck, Yael Levy, Pierre Tissières, Jordi Miatello, Luc Morin & Pierre-Louis Léger

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Bicêtre
Hôpital Armand Trousseau


title: Prediction of Chronic Kidney Disease Following Pre-eclampsia: Diagnosis and Early Care

acronym: PRECEDE

summary:
Pre-eclampsia (PE) is a pregnancy-associated syndrome of variable severity, classically defined by the combination of hypertension and proteinuria in a previously non-hypertensive or proteinuric patient. These symptoms normally resolve within 2-3 months after delivery regardless of the severity of the pre-eclampsia.

Regardless of its definition, preeclampsia is associated with an increased risk of obstetric events and, for the mother, an increased risk of developing chronic kidney disease (CKD), hypertension, diabetes and cardiovascular disease in the broad sense.

The relationship between preeclampsia and Chronic Kidney Disease is, however, complex and not fully understood.

Investigator proposes an interventional study to identify the diagnosis of Chronic Kidney Disease in patients who have developed an episode of Preeclampsia.

lead_sponsor: Centre Hospitalier le Mans

location_facility:
Chu Angers
Centre Hospitalier Du Mans


title: Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

acronym: RFSI-OPI

summary: Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident.

primary_purpose: Screening

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Equipe Résidente de Recherche Subaquatique Opérationnelle

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


acronym: COVIMMUNAGE

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary: Age is the main risk factor associated with the severity of COVID-19. From the beginning of the vaccination campaign, elderly subjects are part of the priority population. However, immunosenescence appears to play a role in the natural post-COVID-19 immunity of convalescent elderly subjects and also in the post-vaccination response. However, vaccination recommendations for both naïve (2 doses of vaccine) and convalescent subjects (1 dose of vaccine) do not differ according to age. To date, there is little data to suggest that the response to the vaccine in naïve or convalescent subjects may vary according to age in terms of qualitative and quantitative response and duration.

location_facility:
HCL - Hôpital Croix Rousse
CHU de Saint-Etienne

title: Factors Influencing the COVID-19 Vaccine Immune Response (Reactogenicity and Immunogenicity) According to Age and Presence or Not of a Past History of COVID-19

type: EudraCT Number

source: euctr

collaborators:
Sanofi Pasteur, a Sanofi Company
Bioster, a.s.


title: Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.

acronym: VLAP

summary: During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.

location_facility:
CH d'Issoire
CHU clermont-ferrand


title: IDEntification of New Predisposition Genes in Differentiated THYroid Cancer

acronym: IDENTHY-K

summary: The purpose of this research is to find new predisposition genes for differentiated thyroid cancer (DTC).

lead_sponsor: Nantes University Hospital

location_facility:
Vendée Hospital
Nantes University Hospital

intervention_type: Genetic


title: Wheelchair Positioning and Neuromuscular Diseases Database (Retrospective and Prospective)

acronym: BDD-POSIT-MNM

summary: This database will describe sitting postural control in wheelchair, as well as PW pain, and pressure ulcers associated with sitting, in patients with neuromuscular disease (NMD).

time_perspective: Prospective

collaborators: Association Française contre les Myopathies (AFM), Paris

location_facility: Groupement Hospitalier Intercommunal du Vexin / Site d'Aincourt - Pôle Soins de Suite et de Réadaptation spécialisés


title: Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)

summary: This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation.

time_perspective: Other

lead_sponsor: Zimmer Biomet

location_facility:
Clinique Saint-Jean (Group ORTHOSUD)
Lyon Ortho Clinic


title: Evaluation of Anti-cancer Drugs Sensitivity on Fresh Samples From Healthy Patients and Patients With Myeloproliferative or Lymphoproliferative Disorders

acronym: ESAAC

summary:
Hematological malignancies gather several various pathologies included myeloproliferative disorders (as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML)) and lymphoproliferative disorders (as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)) .

Over the last decade, the treatments have evolved significantly but the overall survival remains limited, especially for the AML and MM patients. There's an ongoing imperative to continue in-vitro and in-vivo studies to better evaluate the anti-cancer drugs sensitivity and therefore improving the response to treatments and open new fields of application. The healthy control group will be contributing to produce some pertinent and significant data for the results of the index cases group.

The investigators aim to analyze 10 differents drugs, common use in chemotherapy or immunotherapy and evaluate by 2 ways the sensitivity: first, Flow cytometry (cells apoptosis by Annexine V and propidium iodide) on fresh samples and in a second time, monitoring of the blasts in the mouse's blood after injection.

study_start_date_type: Anticipated

status: Not yet recruiting

location_facility: Centre Hospitalier Lyon Sud -Service de médecine du vieillissement

location_facility: Centre Hospitalier Lyon Sud -Service d'Hématologie


title: Pharmacokinetics of Calcineurin & mTOR Inhibitors in HIV-1 Infected Kidney Transplant Recipients After Switch to BIC/FTC/TAF: a Pilot Study - KINETIK (KIdNEy Transplant bIKtarvy) IMEA 064

acronym: KINETIK

summary:
Chronic kidney disease (CKD) is a critical comorbidity for patients living with HIV (PLWH), with an estimated prevalence between 2.4 and 17%, leading to end-stage renal disease 3 to 6 fold more than non-HIV population. However kidney transplantation for PLWH has become the first-line therapy for end-stage renal disease, with an enhanced survival benefit compared to remaining on dialysis.

Management of antiretroviral therapy (ART) in HIV-infected kidney transplant recipients (HIV-KTR) has historically been problematic because of the potential nephrotoxicity of some antiretroviral drugs and the interactions between calcineurin inhibitors, mTOR inhibitors, and ritonavir or cobicistat-boosted containing-ART. The use of tenofovir disoproxil fumarate (TDF), a widely recommended nucleotide analogue for the treatment of both HIV and HIV/hepatitis B virus (HBV) co-infection, is restricted in vulnerable kidney population as HIV-KTR due to its major potential toxicity consistent with tubular dysfunction and rarely with a progressive sustained decline in renal function. The optimal long-term ART regimen is not known in HIV-KTR, though it makes intuitive sense to avoid regimens containing TDF, given its potential nephrotoxicity. Nevertheless the potent virological efficacy of TDF both on HIV and HBV and its highest in-vitro barrier to resistance among the Nucleoside Reverse Transcriptase Inhibitors makes tenofovir use highly recommended or even essential in HIV/HBV co-infections.

Tenofovir alafenamide (TAF) and bictegravir (BIC) are 2 novel antiretroviral drug available in HIV treatment in combination with emtricitabine (F) (B/F/TAF):

* TAF is a novel prodrug of tenofovir that may offer improved renal safety over TDF. TAF is more stable in plasma and is metabolized intracellularly by cathepsin A, an enzyme that is highly expressed in lymphoid tissues. Therefore, TAF can achieve higher intracellular levels of the active moiety tenofovir diphosphate, with lower levels of circulating tenofovir when compared with TDF. This more targeted treatment could potentially result in fewer renal and bone complications despite the same clinical efficacy as TDF. TAF was approved for use in PLWH with mild-moderate CKD (eGFR: 30-69 mL/min).

The availability of TAF seems a potential addition to the antiretroviral armamentarium in HIV-KTR. * BIC is a novel second-generation integrase strand transfer inhibitor (INSTI) has a high in-vitro barrier to resistance and in-vitro activity against most INSTI-resistant variants and has low potential for clinically meaningful drug-drug interactions. BIC has been recently approved by the FDA, in coformulated B/F/TAF for the treatment of HIV-1 infection in antiretroviral naïve subjects and in those with suppressed viremia.

No data are available yet with TAF use in HIV-infected kidney transplant recipients as well as with BIC, especially about potential drug-to-drug interactions with immunosuppressive drugs such as calcineurin & mTOR inhibitors.

At last simplification to a single tablet regimen (STR) may offer a once-daily option for HIV-KTR who have multiple comorbidities, often requires complex regimens with a high pill burden.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

collaborators: Sebastien GALLIEN/Henri Mondor University Hospital- Infectiology Department

collaborators: THOMAS STEHL/ HENRI MONDOR HOSPITAL-Department of Nephrology

location_facility:
Hopital Hotel Dieu
Hopital Henri Mondor


title: Observational Study Evaluating the Number of Symptomatic Cystitis-like Episodes and Urinary Comfort of Women Consuming Cranberry, Cinnamon and Probiotic Strain Extracts

summary:
Cranberries are traditionally used for urinary comfort and prevention of urinary disorders of bacterial origin and despite an EFSA opinion invalidating the clinical efficacy of cranberries, its mechanism of action has been several times proposed by the scientific community: it would act by inhibiting the synthesis of P-fimbriae leading to a complete disappearance of these adhesins, and to bacterial-type deformation by lengthening of the cell body. Cinnamon and microbiotic strains could enhance this synergy.

This study aims to evaluate the effectiveness of a food supplement based on cranberry, cinnamon and microbiotic strains (Feminabiane CBU) on the symptoms of cystitis, urinary discomfort and the number of cystitis reported by women.

lead_sponsor: CEN Biotech

sponsor_collaborators:
CEN Biotech
PiLeJe


title: Assessment of Depression in the Elderly : a Bias Related to the Stigmatisation of Patients Presenting in Wheelchairs

acronym: WHEELDEP

summary:
This study aims to test for a " wheelchair effect ", as a potential impact of stigma, during the evaluation of clinical global impression of depression.Elderly patients will be asked to sit in a wheelchair, or in a regular chair during recording a 5 minute video of spontaneous speech collected the iCGI semi-structured interview.

The videos are showed to 10 different psychiatrists whom each proceed to 10 iCGI rating assessments.The psychiatrists are blinded evaluators. They are not aware of the real objective of the study.

ReferenceCitation: Krendl AC, Kensinger EA, Ambady N. How does the brain regulate negative bias to stigma? Soc Cogn Affect Neurosci. 2012 Aug;7(6):715-26. doi: 10.1093/scan/nsr046. Epub 2011 Sep 5.

ReferenceCitation: Henderson C, Noblett J, Parke H, Clement S, Caffrey A, Gale-Grant O, Schulze B, Druss B, Thornicroft G. Mental health-related stigma in health care and mental health-care settings. Lancet Psychiatry. 2014 Nov;1(6):467-82. doi: 10.1016/S2215-0366(14)00023-6. Epub 2014 Nov 5.

ReferenceCitation: MacDonald ML, Butler AK. Reversal of helplessness: producing walking behavior in nursing home wheelchair residents using behavior modification procedures. J Gerontol. 1974 Jan;29(1):97-101. doi: 10.1093/geronj/29.1.97. No abstract available.

ReferenceCitation: Delmas H, Batail JM, Falissard B, Robert G, Range M, Brousse S, Soulabaille J, Drapier D, Naudet F. A randomised cross-over study assessing the "blue pyjama syndrome" in major depressive episode. Sci Rep. 2017 Jun 1;7(1):2629. doi: 10.1038/s41598-017-02411-x.

ReferenceCitation: Kadouri A, Corruble E, Falissard B. The improved Clinical Global Impression Scale (iCGI): development and validation in depression. BMC Psychiatry. 2007 Feb 6;7:7. doi: 10.1186/1471-244X-7-7.

ReferenceCitation: Laux G; VIVALDI Study Group. The antidepressant agomelatine in daily practice: results of the non-interventional study VIVALDI. Pharmacopsychiatry. 2012 Nov;45(7):284-91. doi: 10.1055/s-0032-1309003. Epub 2012 May 16.

ReferenceCitation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

ipd_sharing: Yes

ipd_sharing_description: Data about study protocol and clinical information will be available on request from other researchers.

lead_sponsor: Hospital Center Guillaume Régnier

location_facility:
EPSM Saint Avé
Centre Hospitalier Guillaume Regnier


title: Anti-Covid-19 Vaccine Protection in Immunocompromised Children (1 to 15 Years Old) With Acute Leukemia and Their Siblings (≥12 Years Old). Phase I-II Trial Evaluating Post-vaccine Safety and Humoral and Cellular Immunogenicity.

acronym: PACIFIC

summary:
Mortality in case of SARS-CoV-2 infection (Covid-19) during acute leukemia (AL) treatment is around 30%, i.e. more than 10 times the one of general population. Severe forms are reported in children receiving chemotherapy for AL. However, the main risk, largely underestimated, is related to delay in chemotherapy administration in case of infection, leading to an increased risk of relapse. Therefore, it is justified to propose an anti-Covid-19 vaccination to these patients. Vaccination of siblings also seems necessary given the uncertainty regarding vaccine response in children with AL and given that household is the main source of contamination. The messenger ribonucleic acid (mRNA) vaccine COMIRNATY® (BNT162b2) is already approved by health authorities for individuals older than 12. In immunocompromised children with AL, safety and efficacy data are unknown. The benefit/risk balance encourages to use the vaccine without health authority approval in children aged 1 to 15 with AL. Regarding household, parents are vaccinated for several months as standard of care, but vaccination will be proposed to siblings aged 12 to 15 years old in this protocol.

The primary objective of this study is to evaluate safety and immunogenicity of COMIRNATY® (BNT162b2) vaccine (two injections 21-28 days apart) in children with acute leukemia (1 to 15 years old) and their siblings (≥12-15 years old).

A secondary objective of the study is to compare the quality of humoral and cellular vaccine responses in children with AL and healthy children.

status: Unknown status

location_facility:
Hôpital Armand Trousseau
Hôpital Robert Debré


title: Integrated Management of Chronic Respiratory Diseases - eMEUSE-SANTE

acronym: eMEUSE-SANTE

summary:
Chronic respiratory diseases such as obstructive sleep apnea syndrome (OSA) and chronic obstructive pulmonary disease (COPD) constitute a major public health problem, due to their high prevalence, but especially because of their cardiovascular and metabolic morbidity and mortality and the associated costs for the health system. The organization of long-term management of these diseases is now part of the e-health process, digital health with the use of massive "big data" generated by care and follow-up. Therapeutic patient education and the integration of connected objects will allow personalized therapeutic education support with interventions by local medical staff adapted to the needs of the patients.

This will also allow to objectify the effect of treatments such as continuous positive airway pressure (CPAP) for OSA or non-invasive ventilation (NIV) and/or oxygen therapy for COPD, not only on the prevention of respiratory decompensation but also on cardiovascular and metabolic risk factors which are major elements of the prognosis. This project will therefore make it possible to demonstrate the feasibility and to deploy a multi-actor care pathway in the territory.

The investigators propose a prospective clinical study, conducted at the Verdun Hospital, with the main objective of studying the evolution of the quality of life of patients with a chronic respiratory pathology, during an integrated management at home for 6 months.

The secondary objectives:

To study the evolution of the following parameters, before treatment (at inclusion) and after 6 months of integrated management:

Treatment compliance (CPAP or NIV/oxygen therapy)
Physical activity
Weight
Mean arterial pressure
Oxygen saturation, heart rate and respiratory rate for COPD patients
Severity of COPD for the patients concerned
Daytime sleepiness
Fatigue
Patient acceptability of the use of connected objects
To analyze the trajectories of the measures collected throughout the integrated management to identify specific profiles.
To analyze the daily data of the different connected objects and treatments with regard to the patients' profiles (according to age, gender, comorbidities, OSA or COPD group).

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Grenoble

collaborators: EFCR Department and Sleep Laboratory, Grenoble Alpes University Hospital

collaborators: ADOR - Territorial Support Network, Device and Tools for Primary Care Teams

collaborators: PULSY - Regional Support Group for the Development of e-health

location_facility:
Verdun Hospital
Grenoble Alpes University Hospital


title: Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort

acronym: Retine-Foch

summary:
Retinal surgeries are now performed in some hospitals with sub-Tenon anesthesia to replace conventional peribulbar anesthesia. The advantages of performing the surgery with Tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no waiting period for the effectiveness of the peribulbar anesthesia (15-20min to have the effect of anesthesia of the eye). In addition, there are more numerous and dangerous complications of peribulbar anesthesia than sub-Tenonian anesthesia, however it allows the eye to remain stationary and to perform precise surgery safely, as long as the patient does not move his head.

Performing a sub-Tenonian anesthesia also makes it possible to carry out surgeries more quickly, this method having an immediate effect and being performed by the surgeon, without the intervention of an anesthesiologist.

The edema effect under the post / conjunctiva swells the area around the eye and allows partial oculomotor limitation. Finally, for the patient, recovery is faster: no sedation or venous route.

To date, however, no study has proven that the surgeon can safely operate on the patient without increased complications compared to peribulbar anesthesia.

This study aims to show that simple sub-Tenonian anesthesia in a short outpatient circuit does not induce more pain or discomfort for the patient than a longer outpatient circuit with bed and anesthesiologist. No studies have been performed on purely local anesthesia without a venous route.

For this, patients operated on at the Foch hospital without an anesthesiologist under subtenon's anesthesia will be compared to patients operated on under peribulbar anesthesia with an anesthesiologist at the Pierre Cherest clinic.

lead_sponsor: Hopital Foch

location_facility:
Clinique Pierre Cherest
Foch Hospital


title: Retrograde Approach in Ambulatory Practice

acronym: RAAR

summary:
Obliterative arterial disease of the lower limbs affects 200 million people worldwide, including approximately 40 million in Europe. This disease is associated with a significant increase in morbidity and mortality.

The most common clinical symptomatology is difficulty walking (intermittent claudication). Less frequent but more severe, critical ischemia includes rest pain requiring analgesics, and trophic disorders (ulcers, gangrene), which may lead to amputation. The Rutherford classification groups the different clinical forms of this pathology. The classic risk factors of cardiovascular pathologies, such as age, smoking, hypertension, diabetes and hypercholesterolemia, are closely linked to Obliterative arterial disease of the lower limbs. Over the past 20 years, the interventional management of this condition has undergone a paradigm shift. The rise of endovascular surgery has broadened the range of therapeutic possibilities, while reducing the impact on patients. Advances in equipment and imaging quality have made it possible to treat increasingly complex lesions, allowing this type of technique to be offered to patients initially treated with conventional surgery (Trans-Atlantic Inter-Society Consensus (TASC) C and D). Unfortunately, for long recanalizations and calcified lesions, the crossing of the lesion and its re-entry into the true arterial lumen is a failure in 25% of cases. It is with this in mind that retrograde puncture and the associated SAFARI (Subintimal Arterial Flossing with Anterograde-retrograde Intervention) technique were developed. In case of failure to cross the lesion by anterograde, intraluminal or subintimal, a retrograde puncture downstream, echo or radio guided, is performed. The vessels most often punctured are the popliteal artery or the leg axes. Recanalization of the lesion is done by retrograde approach. The guidewire introduced distally is recovered in the introducer through which the first recanalization attempt was made. The procedure is then performed in the classical way using the anterograde approach. At the end of the procedure, hemostasis of the puncture site is obtained by prolonged inflation of a balloon or the placement of a covered stent. Initially reserved for critically ischemic patients (Rutherford 4-6), this technique tends to be extended to claudicant patients (Rutherford 2-3). Zhuang et al have recently demonstrated the efficacy and safety of this technique in a large cohort of patients.

In parallel with the evolution of revascularization techniques, the evolution of care pathways has given ambulatory care a prominent place. Since January 2020, in the vascular surgery department of GHPSJ, peripheral angioplasties are mostly performed on an outpatient basis. The patients treated are classified as Rutherford 2 to 5 in most cases. No adverse events related to this management have been reported. To date, no study evaluating the feasibility and safety of retrograde punctures in the outpatient setting has been performed.

time_perspective: Cross-Sectional

ReferenceCitation: Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.

ReferenceCitation: Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.

ReferenceCitation: Sampson UK, Fowkes FG, McDermott MM, Criqui MH, Aboyans V, Norman PE, Forouzanfar MH, Naghavi M, Song Y, Harrell FE Jr, Denenberg JO, Mensah GA, Ezzati M, Murray C. Global and regional burden of death and disability from peripheral artery disease: 21 world regions, 1990 to 2010. Glob Heart. 2014 Mar;9(1):145-158.e21. doi: 10.1016/j.gheart.2013.12.008.

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility: Centre Hospitalier Universitaire de Brest


title: Evaluation du Test " Sofia SARS Antigen FIA Assay " Dans le Cadre du dépistage de la COVID-19

acronym: ESADEC

summary: Evaluating the performance of the Sofia SARS Antigen FIA

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHRU de brest
Centre de dépistage - CHRU BREST


title: Modifications in Retinal Microvascularization With OCT- Angiography in Patients With First-line Colorectal Cancer, Treated With Targeted Anti-angiogenic Therapy.

acronym: VOCANGIO

summary: Retinal microvascularization can provide important informations to systemic vascular phenomena. The non-invasive quantitative description of the retinal vascularization is now possible by performing OCT-angiography and their image analysis software (vascular density and retinal perfusion). Systemic microvacular changes during the establishment of oncological treatment by targeted antiangiogenic therapy are little described in the literature. The objective of this pilot study is to describe the evolution of the retinal vascular density of patients with antiangiogenic drugs. In addition, the evolution of the retinal vascular density of patients on antiangiogenic drugs will study as a function of the response to the treatment and the toxicity of these treatments.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHU de Dijon
Centre Georges François Leclerc


title: Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome

acronym: PTSD-FMS

summary:
The aim of the study is to demonstrate a significant improvement in quality of life specific to patients with fibromyalgia syndrome in patients with fibromyalgia syndrome with comorbid posttraumatic stress disorder, treated with reconsolidation blockade.

Patients receive a treatment with propranolol associated with reconsolidation blockade of traumatic story once a week during 6 weeks, with evaluation at inclusion and at 3 months.

lead_sponsor: Centre Hospitalier Henri Laborit

location_facility:
Centre Hospitalier Henri Laborit
Centre Hospitalier Nord-Deux-Sèvres


title: Validation of Serum Neurofilament Light Chain as a Biomarker to Differentiate Cognitive Impairment From Neurodegenerative or Psychiatric Diseases

summary:
The validation of biomarkers allowing the discrimination of cognitive and behavioral disorders of psychiatric origin from those of neurodegenerative origin would facilitate diagnosis and improve patient management. Neurofilaments, which are markers of neuronal lysis, appear to be a promising biomarker. In a previous preliminary study, the investigators demonstrated significantly lower concentrations of neurofilaments in CSF of psychiatric patients compared to neurodegenerative diseases.

The main objective of this study is to validate the plasma assay of neurofilament light chain as a biomarker for the differential diagnosis of psychiatric or neurodegenerative cognitive impairment. Other biomarkers of interest (Tau, TDP-43, GFAP and UCH-L1) will also be analyzed.

A sub-part of this study will also focus on the retrospective analysis of the CSF/Plasma correlations of the different biomarkers mentioned above from tube bottom samples taken in routine care.

ipd_sharing_description: Clinical and biological IPD

lead_sponsor: Hôpital le Vinatier

location_facility: HCL Consultation mémoire Neurologique -Hôpital Neurologique

intervention_type: Diagnostic Test


title: Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients

summary:
RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.

PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and biopathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Impact of Antimicrobial Stewardship on Outcomes of Patients With Hospital-acquired Pneumonia Due to Gram-negative Bacilli - A Before-after ORACLE Study

acronym: ORACLE

summary:
Hospital-acquired pneumonia (HAP) is one of the most frequent complications and the main cause of antibiotics use in hospitalized patients, particularly in intensive care units (ICUs). The latest European and French recommendations for the management of HAP were published in 2017 and 2018. Gram-negative bacilli are frequently identified in this pneumonia.

The experts discussed the issue of tailored-empiric antimicrobial therapy. Because delayed antimicrobial therapy is associated with poor outcomes, their conclusion was to reduce the time to deliver proper antimicrobial therapy, but to limit over-use of broad-spectrum molecules. Since delays in microbiological identification hinder the ability of clinicians to streamline therapy, rapid diagnostic with multiplex PCR, which decreases the time to organism identification by 2 days compared to conventional methods, is appealing, especially for gram-negative bacilli. The FilmArray® Lower Respiratory Tract Infection Panel is a rapid multiplex PCR which tests for the most frequently pathogens (18 bacteria including plenty of gram-negative bacilli +5 genes of resistance, and 9 viruses) involved in HAP. The FilmArray® Lower Respiratory Tract Infection (LRTI) Panel has a sensitivity and a specificity of 95% and 99% respectively and can be implemented in a personalized antimicrobial guidance to treat HAP due to gram-negative bacilli. The investigators hypothesized that a rapid multiplex PCR for guidance of empiric antimicrobial therapy, especially for gram-negative bacilli, reduces the time-to-proper antimicrobial therapy and reduces the risk of death of patients suffering of HAP.

The investigators aim to assess the efficacy of an antimicrobial stewardship including the results of a rapid respiratory panel multiplex PCR for empiric antimicrobial guidance in patients with hospital-acquired pneumonia due to gram-negative bacilli.

The investigators will use a before-after design to test the efficiency of an antimicrobial stewardship including a highly innovative intervention.

location_facility:
CHU Rennes
CHU de Nantes


title: A Randomized Control Trial of Bilateral Lateral OFC rTMS in Obsessive Compulsive Disorder

summary: According to the literature the lateral part of the Orbito Frontal Cortex (lOFC) is a relevant bilateral target for repetitive Trans-cranial Magnetic Stimulation (rTMS) in Obsessive Compulsive Disorder (OCD). Both hemispheres are concerned in terms of target.

location_facility: Sorbonne University, Pitié-Salpêtrière Hospital


title: Impact of Dapagliflozin on Vascular Function in Chronic Kidney Disease Patients

acronym: DAPAVASC

summary: This study aims to determine whether dapaglfiflozin 12-week administration is associated with a beneficial impact on the vasculature of patients with chronic kidney disease.

lead_sponsor: University Hospital, Rouen

sponsor_collaborators:
University Hospital, Rouen
AstraZeneca

location_facility:
Department of Nephrology
Department of Pharmacology


title: Immunomonitoring of Breast Cancer Patients During Systemic Treatment

acronym: IMMUNE CAPTURE

summary: This study aims to constitute a most complete biological collection for patients treated for localized or metastatic breast cancer (in different cohorts depending on the type of systemic treatment received), in order to describe the basal immune response of patients treated for a breast cancer according to the stage of the disease, but above all to study how the different systemic treatments used in the management of breast cancer modulate this immune response.

location_facility:
Centre Georges Francois Leclerc
CHRU Jean Minjoz


title: MATRIX - "Modeling Macrophages Activation Pattern in X-linked Adrenoleukodystrophy, Metachromatic Leukodystrophy and Adult Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia"

acronym: MATRIX

summary:
This study is a national, non-randomized, open-label, multi-site with minimal risk study in adult with adrenomyeloneuropathy (AMN), childhood and adult subjects with cerebral ALD (cALD), juvenile/adult metachromatic leukodystrophy (MLD) and adults with leukoencephalopathy and axonal spheroids and pigmented glia (ALSP). 49 subjects will be enrolled with one blood sample collection during one of their medical follow-up visit.

This trial will evaluate the role of innate immunity to influence disease progression in X-ALD, MLD and ALSP, and if the mutations related to these leukodystrophies result in a specific immune response leading to the pathogenesis.

ReferenceCitation: Miron VE, Boyd A, Zhao JW, Yuen TJ, Ruckh JM, Shadrach JL, van Wijngaarden P, Wagers AJ, Williams A, Franklin RJM, Ffrench-Constant C. M2 microglia and macrophages drive oligodendrocyte differentiation during CNS remyelination. Nat Neurosci. 2013 Sep;16(9):1211-1218. doi: 10.1038/nn.3469. Epub 2013 Jul 21.

ReferenceCitation: Weinhofer I, Zierfuss B, Hametner S, Wagner M, Popitsch N, Machacek C, Bartolini B, Zlabinger G, Ohradanova-Repic A, Stockinger H, Kohler W, Hoftberger R, Regelsberger G, Forss-Petter S, Lassmann H, Berger J. Impaired plasticity of macrophages in X-linked adrenoleukodystrophy. Brain. 2018 Aug 1;141(8):2329-2342. doi: 10.1093/brain/awy127.

ReferenceCitation: Berger J, Forss-Petter S, Eichler FS. Pathophysiology of X-linked adrenoleukodystrophy. Biochimie. 2014 Mar;98(100):135-42. doi: 10.1016/j.biochi.2013.11.023. Epub 2013 Dec 4.

ReferenceCitation: Gieselmann V, Krageloh-Mann I. Metachromatic leukodystrophy--an update. Neuropediatrics. 2010 Feb;41(1):1-6. doi: 10.1055/s-0030-1253412. Epub 2010 Jun 22.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
AP-HP Hôpital Bicêtre
AP-HP Hôpital La Pitié Salpêtrière


title: Real World Effectiveness and Treatment Sequences in Patients With Extensive Stage SCLC Who Received Atezolizumab Combined With Chemotherapy as Part of the French Early Access Program (ATU).

acronym: CLINATEZO

summary: CLINATEZO cohort will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received atezolizumab combined with chemotherapy part of the French Early Access Program (ATU). Subsequent treatments (treatment delivered immediately after treatment with atezolizumab and chemotherapy) will be recorded. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

collaborators:
Roche Pharma AG
GFPC

location_facility:
Chalon-sur-Saône - CH
Paris - Institut Curie


title: Motor Asymmetry in Progressive Multiple Sclerosis Patients

acronym: MAP-MS

summary:
Project Rational

A better understanding of the causes of physical disability is an important unmet need in progressive Multiple Sclerosis patients. Progressive Multiple Sclerosis patients most often present a worsening pyramidal syndrome of lower and, to a lesser extent, upper limbs (Lublin et al., 2014) suggesting a strong corticospinal tract involvement. The systematic high resolution Magnetic Resonance Imaging exploration of lesions location and severity, as well as extra-lesional tissue, on pan-medullar and encephalic motor tracts offers the opportunity to better understand the pathological mechanism associated with motor impairment.

Scientific aims

This project will follow a twofold approach. First, the investigators will consider an "inter-patient" approach where independent and absolute Magnetic Resonance metrics for each limb will be related to disability. Second, the investigators will consider an "intra-patient" approach (i.e. comparing differences of Magnetic Resonance metric and of clinical score from the left and the right side in the same patient). For this purpose, progressive Multiple Sclerosis patients with asymmetric motor impairment will be studied. Confronting clinical and Magnetic Resonance Imaging metric value asymmetries indeed offers the unique opportunity to free oneself from many confounding factors such as genetics, age, duration of disease evolution, acquisition bias, etc. These two approaches will allow us to precisely study the impact of local factors such as Multiple Sclerosis lesions located on motor tracts on motor disability.

Methodology

The investigators propose an observational multicenter cross-sectional and prognostic study. This study will involve two French centers (Rennes, Marseille) and will include a total of 40 progressive Multiple Sclerosis patients with an asymmetrical motor deficit. Twenty sex and age matched controls will be needed to calibrate quantitative Magnetic Resonance imaging (magnetization transfer ratio). Encephalic and pan medullar structural and quantitative Magnetic Resonance images will be acquired at inclusion and clinical follow-up examinations will be performed at inclusion and 24 months. Detailed motor evaluation "per limb" will be performed, including the motor American Society Injury. Association sub-score and upper and lower limbs muscle strength measurements using a dynamometer.

lead_sponsor: Rennes University Hospital

location_facility:
Hôpital de la Timone, AP-HM
CHU de Rennes - Hôpital Pontchaillou


title: Impact of Emergency Physician-Performed Ultrasound for the Evaluation of Patients With Acute Abdominal Pain, Prospective Randomized Dual Centre Study

acronym: EchoPAIN

summary:
Non-traumatic abdominal pain is one of the most frequent complaints in Emergency Medicine. Point-of-Care Ultrasound (POCUS) has good performance in these situations. It is performed at the patient's bedside with immediate results. It has been demonstrated that a clinician-performed ultrasound was able to increase the diagnosis accuracy in patients with acute abdominal pain. However, the level of evidence of its diagnostic efficacy remains controversial in particular in Europe.

The principal investigators thus aimed to investigate the efficacy of early POCUS on diagnostic accuracy in the context of of non-traumatic abdominal pain by a randomized control study conducted in two emergency departments (ED). Secondary objectives will be comparison between the two groups for time spent in the ED before diagnosis and disposition (discharged home or hospitalization), prescription of complementary examinations and in particular, radiologic exams.

ReferenceType: derived

ReferenceCitation: Brau F, Martin S, Le Bastard Q, Ricaud P, Legrand A, Montassier E, Le Conte P. Impact of emergency physician-performed ultrasound for the evaluation of patients with acute abdominal pain, prospective randomized dual Centre study: study protocol for a diagnostic trial. Trials. 2022 Sep 24;23(1):804. doi: 10.1186/s13063-022-06755-2.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Centre Hospitalier Universitaire de Nantes


title: Validating Digital Mobility Assessment Using Wearable Technology - the Mobilide-D Clinical Validation Study

acronym: MOBILISE-D

summary: Background and study aims The ability to move is important for general well-being. Ageing and chronic health conditions can lead to a loss of mobility and a loss of independence. In order to treat mobility loss, tools are needed that can detect and accurately measure mobility. Existing measures of mobility (based on self-reporting and one-off tests) are highly limited. Wearable digital technology (a small device worn on the body) that can be used in the home and the community can provide a simple, accurate and low-cost measure of mobility. The researchers have validated a wearable mobility monitor which can accurately measure how well a person walks by measuring aspects of mobility such as speed and symmetry. The aim of this study is to investigate the ability of the mobility monitor to measure and predict outcomes in proximal femoral fracture (PFF) patients. The digital assessment of mobility developed in this study will be used in clinical trials and in clinical practice.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Newcastle-upon-Tyne Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Evaluation of the Effect of Peptides and n-3 Polyunsaturated Fatty Acids (n-3 PUFAs) From a Blue Fish Hydrolysate on Memory in Healthy Elderly People : a Randomised, Placebo-controlled, Double-blind Study.

acronym: BRAINBOOSTER

summary: This interventional, randomised, placebo-controlled and double-blind study aims to evaluate the effect of a dietary supplementation with a blue fish hydrolysate derived from marine by-products, containing peptides and n-3 polyunsaturated fatty acids, on cognitive performance in a healthy older population, between 60 and 73 years old, with lower memory performance.

lead_sponsor: Abyss Ingredients

collaborators: Laboratoire Nutrition et Neurobiologie intégrée

location_facility: Plateforme de Recherche Neuro-Psychopharmacologique USR CNRS 3413 SANPSY, CHU de Bordeaux

location_facility: Laboratoire Nutrition et Neurobiologie Intégrée


title: Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs

acronym: MEMBRAN

summary:
Masquelet's induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. The particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). The presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery).

In view of the excellent clinical results obtained with this procedure, the Masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery.

However, orthopedic surgeons sometimes observe failures in bone consolidation. To our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility:
Hôpital d'Instruction des Armées Percy
Hôpital d'Instruction des Armées Bégin


title: Response of Haemodialysis Patients to BNT162b2 mRNA Cov-19 Vaccine

acronym: ROMANOV

summary:
Vaccination against SARS-Cov2 is a necessity for haemodialysis patients because difficulties to maintain a self-isolation (leading to a higher contamination than general population) and an increase of mortality in case of contamination (more than 20% of mortality in this population). However, vaccine efficiency is known to be decreased in haemodialysis patients. This lead critical the rapid description of immunogenicity of anti SARS-Cov2 vaccine in haemodialysis patients.

The aim of this study is to describe the immunogenicity of the BTN162b2 SARS-Cov2 vaccine in haemodialysis patients.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Nephrology, Centre Hospitalier Lyon Sud

location_facility: Department of Nephrology, Hopital Edouard Herriot


title: Epidemiology of Anaerobic Bacteria in Cystic Fibrosis Patients Followed by the Perharidy Cystic Fibrosis Resource and Skills Centre, Roscoff: Descriptive and Non-interventional Study

acronym: ANA-MUCO

summary:
Recently, the respiratory microbiota characterisation of a Cystic Fibrosis (CF) patients' cohort has highlighted the potential role of anaerobes, and specially species belonging to the genus Porphyromonas, in the first P. aeruginosa colonization.

The aim of this project is to describe the bacterial anaerobic population in the respiratory microbiota of a CF cohort. At the end of this study, an inventory of the anaerobic microbiota in CF respiratory samples will be establish in relation to the patients' pulmonary function and P. aeruginosa colonization status in order to speculate about the pulmonary anaerobes roles, still unknown.

The innovative aspect of the ANA-MUCO study is the use of a specific sample kit designed for the study which allows preserving anaerobic bacteria in sputum according to the recommendations of the International Human Microbiome Standards (IHMS). Extended-culture and molecular approaches will be performed to identify and describe the anaerobic bacteria which could be involved in the pulmonary homeostasis in CF respiratory samples.

ReferenceCitation: Nixon GM, Armstrong DS, Carzino R, Carlin JB, Olinsky A, Robertson CF, Grimwood K. Clinical outcome after early Pseudomonas aeruginosa infection in cystic fibrosis. J Pediatr. 2001 May;138(5):699-704. doi: 10.1067/mpd.2001.112897.

ReferenceCitation: Cox MJ, Allgaier M, Taylor B, Baek MS, Huang YJ, Daly RA, Karaoz U, Andersen GL, Brown R, Fujimura KE, Wu B, Tran D, Koff J, Kleinhenz ME, Nielson D, Brodie EL, Lynch SV. Airway microbiota and pathogen abundance in age-stratified cystic fibrosis patients. PLoS One. 2010 Jun 23;5(6):e11044. doi: 10.1371/journal.pone.0011044.

ReferenceCitation: Renwick J, McNally P, John B, DeSantis T, Linnane B, Murphy P; SHIELD CF. The microbial community of the cystic fibrosis airway is disrupted in early life. PLoS One. 2014 Dec 19;9(12):e109798. doi: 10.1371/journal.pone.0109798. eCollection 2014.

ReferenceCitation: Klepac-Ceraj V, Lemon KP, Martin TR, Allgaier M, Kembel SW, Knapp AA, Lory S, Brodie EL, Lynch SV, Bohannan BJ, Green JL, Maurer BA, Kolter R. Relationship between cystic fibrosis respiratory tract bacterial communities and age, genotype, antibiotics and Pseudomonas aeruginosa. Environ Microbiol. 2010 May;12(5):1293-303. doi: 10.1111/j.1462-2920.2010.02173.x. Epub 2010 Feb 23.

ReferenceCitation: Sibley CD, Surette MG. The polymicrobial nature of airway infections in cystic fibrosis: Cangene Gold Medal Lecture. Can J Microbiol. 2011 Feb;57(2):69-77. doi: 10.1139/w10-105.

ReferenceCitation: Bernarde C, Keravec M, Mounier J, Gouriou S, Rault G, Ferec C, Barbier G, Hery-Arnaud G. Impact of the CFTR-potentiator ivacaftor on airway microbiota in cystic fibrosis patients carrying a G551D mutation. PLoS One. 2015 Apr 8;10(4):e0124124. doi: 10.1371/journal.pone.0124124. eCollection 2015.

ReferenceCitation: Guilloux CA, Lamoureux C, Hery-Arnaud G. [Anaerobic bacteria, the unknown members of the lung microbiota]. Med Sci (Paris). 2018 Mar;34(3):253-260. doi: 10.1051/medsci/20183403014. Epub 2018 Mar 16. French.

ReferenceCitation: Tunney MM, Field TR, Moriarty TF, Patrick S, Doering G, Muhlebach MS, Wolfgang MC, Boucher R, Gilpin DF, McDowell A, Elborn JS. Detection of anaerobic bacteria in high numbers in sputum from patients with cystic fibrosis. Am J Respir Crit Care Med. 2008 May 1;177(9):995-1001. doi: 10.1164/rccm.200708-1151OC. Epub 2008 Feb 8.

ReferenceCitation: Smyth AR, Bell SC, Bojcin S, Bryon M, Duff A, Flume P, Kashirskaya N, Munck A, Ratjen F, Schwarzenberg SJ, Sermet-Gaudelus I, Southern KW, Taccetti G, Ullrich G, Wolfe S; European Cystic Fibrosis Society. European Cystic Fibrosis Society Standards of Care: Best Practice guidelines. J Cyst Fibros. 2014 May;13 Suppl 1:S23-42. doi: 10.1016/j.jcf.2014.03.010.

ReferenceCitation: Hery-Arnaud G, Nowak E, Caillon J, David V, Dirou A, Revert K, Munck MR, Frachon I, Haloun A, Horeau-Langlard D, Le Bihan J, Danner-Boucher I, Ramel S, Pelletier MP, Rosec S, Gouriou S, Poulhazan E, Payan C, Ferec C, Rault G, Le Gal G, Le Berre R. Evaluation of quantitative PCR for early diagnosis of Pseudomonas aeruginosa infection in cystic fibrosis: a prospective cohort study. Clin Microbiol Infect. 2017 Mar;23(3):203-207. doi: 10.1016/j.cmi.2016.11.016. Epub 2016 Nov 27.

ReferenceCitation: Lamoureux C, Guilloux CA, Beauruelle C, Jolivet-Gougeon A, Hery-Arnaud G. Anaerobes in cystic fibrosis patients' airways. Crit Rev Microbiol. 2019 Feb;45(1):103-117. doi: 10.1080/1040841X.2018.1549019. Epub 2019 Jan 21.

ReferenceCitation: Société Française de Microbiologie. REMIC, Référentiel en Microbiologie Médicale, 2 volumes. SFM, 2015. 856 p. ISBN 9782878050325.

ReferenceCitation: CA-SFM EUCAST [En ligne]. Société Française de Microbiologie, 2013 [consulté le 11 janvier 2018]. Available on: http://www.sfmmicrobiologie.org/UserFiles/files/casfm/CASFM2013vjuin.pdf

ReferenceCitation: Héry-Arnaud et al., 2017, European patent EP17306297 Methods for predicting the risk of developping pulmonary colonization/infection by Pseudomonas aeruginosa.

ReferenceCitation: Keravec M, Mounier J, Guilloux CA, Fangous MS, Mondot S, Vallet S, Gouriou S, Le Berre R, Rault G, Ferec C, Barbier G, Lepage P, Hery-Arnaud G. Porphyromonas, a potential predictive biomarker of Pseudomonas aeruginosa pulmonary infection in cystic fibrosis. BMJ Open Respir Res. 2019 Mar 12;6(1):e000374. doi: 10.1136/bmjresp-2018-000374. eCollection 2019.

ipd_sharing_description: All collected data that underlie results in a publication.

sponsor_collaborators:
University Hospital, Brest
Vaincre la Mucoviscidose

location_facility:
Fondation Ildys
CHRU de Brest


title: Etude de l'INflammation systémique de Bas GRade Chez Les Patients Adultes Atteints de PHénylcétonurie

acronym: INGRAPH

summary:
Patient suffering from phenylketonuria have chronic hyperphenylalaninemia. Hyperphenylalaninemia is known to be toxic to central nervous system and cardiovascular system in particular through oxydative stress.

In this context, research of low grade systemic inflammation through cytokine assay appears legitimate.

The primary outcome of this study is to describe inflammation profile of patients with phenylketonuria.

ReferenceCitation: Solverson P, Murali SG, Brinkman AS, Nelson DW, Clayton MK, Yen CL, Ney DM. Glycomacropeptide, a low-phenylalanine protein isolated from cheese whey, supports growth and attenuates metabolic stress in the murine model of phenylketonuria. Am J Physiol Endocrinol Metab. 2012 Apr 1;302(7):E885-95. doi: 10.1152/ajpendo.00647.2011. Epub 2012 Jan 31.

ReferenceCitation: van Spronsen FJ, van Wegberg AM, Ahring K, Belanger-Quintana A, Blau N, Bosch AM, Burlina A, Campistol J, Feillet F, Gizewska M, Huijbregts SC, Kearney S, Leuzzi V, Maillot F, Muntau AC, Trefz FK, van Rijn M, Walter JH, MacDonald A. Key European guidelines for the diagnosis and management of patients with phenylketonuria. Lancet Diabetes Endocrinol. 2017 Sep;5(9):743-756. doi: 10.1016/S2213-8587(16)30320-5. Epub 2017 Jan 10.

ReferenceCitation: Boulet L, Besson G, Van Noolen L, Faure P; ECOPHEN Study Group; Maillot F, Corne C. Tryptophan metabolism in phenylketonuria: A French adult cohort study. J Inherit Metab Dis. 2020 Sep;43(5):944-951. doi: 10.1002/jimd.12250. Epub 2020 Jun 4.

ReferenceCitation: Stroup BM, Nair N, Murali SG, Broniowska K, Rohr F, Levy HL, Ney DM. Metabolomic Markers of Essential Fatty Acids, Carnitine, and Cholesterol Metabolism in Adults and Adolescents with Phenylketonuria. J Nutr. 2018 Feb 1;148(2):194-201. doi: 10.1093/jn/nxx039.

ReferenceCitation: Matalon R, Surendran S, McDonald JD, Okorodudu AO, Tyring SK, Michals-Matalon K, Harris P. Abnormal expression of genes associated with development and inflammation in the heart of mouse maternal phenylketonuria offspring. Int J Immunopathol Pharmacol. 2005 Jul-Sep;18(3):557-65. doi: 10.1177/039463200501800316.

lead_sponsor: University Hospital, Tours

location_facility: Clinical investigation center, University Hospital, Tours

location_facility: Internal Medicine Service, University Hospital, Tours


title: Evaluation and Support Care Process Within the Care Pathway of Heart Failure Patients

acronym: FIL-EAS

summary:
Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Moreover, extra cardiological follow-up such as in social, geriatric or vaccination fields remain low compared to real needs.

Current recommendations incite health professionals to better define care pathways and to rationalize resources. Guidelines toward creation of hospitalization alternatives or limitation of time spent in hospital are given. In the same time, lack of cardiologic care management within heart failure patient care pathway is associated to poor prognosis and medical desertification as well as resource concentration on important health centers exacerbate this phenomenon. Innovative projects are then needed to improve patient care pathways, to open up areas without specialized health professionals and to rationalize care management by encouraging communication and skill exchange between hospitals and private practices.

FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices. This second care pathway should help to optimize therapeutics in home living conditions.

primary_purpose: Health Services Research

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

appel_a_projets: PHRCI

region: Provence-Alpes-Côte d'Azur

nom_etablissement: CHI TOULON LA SEYNE SUR MER

type_etablissement: CH

acronyme: FIL-EAS-ic

titre: FILière d'Evaluation et d'Accompagnement dans le parcours de Soins du patient insuffisant cardiaque

discipline_principale: non , hors cancer , cardiologie

nom_porteur: TARTIERE

prenom_porteur: Jean-Michel


title: Efficacy of PyROphosPHate Supplementation to Fight ECtopIc Calcification in PseudoXanthoma Elasticum - PROPHECI-PPI Study

acronym: PROPHECI-PPI

summary: Pseudoxanthoma elasticum (PXE) is a rare inherited metabolic disorder (OMIM 264800, frequency 1/25000) characterized by progressive ectopic calcification of connective tissues. PXE mainly affects the skin (inesthetic papules and plaques in the skin folds), the retina (central blindness), the vasculature (peripheral arterial occlusive disease and stroke) and the renal system (renal lithiasis) in adulthood. Although rarely, early lethal forms have been reported. This chronic and highly disabling condition results from a loss of function of the gene encoding for the ABCC6 membrane transporter primarily expressed in the hepatocytes and renal tubular cells. Recently, it has been reported that PXE was characterized by a 50-60% decrease in the plasma level of inorganic pyrophosphate (PPi), a major physiological anti-calcifying factor. PXE is an incurable disease which therapeutic options are limited to symptomatic treatments to stem the devastating effect of the ectopic calcifications. Recently, encouraging proof of concept studies with animals PXE models and healthy volunteers have shown that, contrary to what was initially reported and thought, the oral administration of PPi salts are able to increase PPi plasma levels, opening up new therapeutic perspectives in PXE. Therefore, we propose to perform the first Phase II randomized controlled trial (RCT) to evaluate the safety and efficacy of a daily and oral administration of PPi salts against placebo in PXE patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Angers Hospital
Nice Hospital

appel_a_projets: PHRCN

nom_etablissement: CTRE HOSPITALIER UNIVERSITAIRE DE NICE

type_etablissement: CHUR

acronyme: PROPHECI

titre: Supplémentation en Pyrophosphate (PPi) pour traiter les calcifications ectopiques dans le Pseudo-Xanthome élastique (PXE)

discipline_principale: médecine vasculaire

nom_porteur: LEFTHERIOTIS

prenom_porteur: Georges


title: Clinical Study of Repetitive Transcranial Magnetic Stimulation (RTMS) Efficacy Coupled With Mirror Therapy for Neuropathic Pain Relief

acronym: STIRM

summary: Neuropathic pain is particularly difficult to treat with classic first-line drugs. Neuromodulation techniques using repetitive transcranial magnetic stimulation (rTMS) are useful alternative, but there is a need to improve their analgesic effect.Virtual reality mirror therapy has shown the capacity to alleviate pain and may be easily coupled with rTMS.The present project will investigate in individuals with neuropathic pain the effects of the rTMS coupled with virtual reality mirror therapy.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Saint-Etienne


title: Multicenter Prospective Study Evaluating the Interest of HE4 in the Diagnostic Approach of Endometrial Cancer in Patients With Postmenopausal Bleeding

acronym: METRODEC

summary: This study aims to explore the sensitivity of an innovative marker, HE4, in the diagnosis approach of endometrial cancer in case of postmenopausal bleedings.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Roche Diagnostics

location_facility:
Vendee Hospital Center
Saint-Nazaire Hospital


title: Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia

acronym: IFEH

summary:
The discovery of FGF23, the missing link in the long researched and finally found phosphate metabolism, marked a turning point in the understanding and physiopathology of specific hypophosphatemia. By inhibiting the renal reabsorption of phosphate and the production of calcitriol, FGF23 behaves like a hypophosphatemia hormone.

Hypersecretion of FGF23 can occur in the case of genetic abnormalities (X-linked hypophosphatemic vitamin-resistant rickets, recessive or dominant hypophosphatemic rickets, McCune-Albright syndrome ...) or acquired abnormalities (oncogenic osteomalacia). Oncogenic osteomalacia can be induced by hyperproduction of FGF23 by benign tumours of mesenchymal origin. But more recently, several cases of malignant tumours secreting FGF23 have also been described (prostate, colon, breast, ovarian and lung cancers, pulmonary carcinoma, etc.)

ReferenceCitation: Suvannasankha A, Tompkins DR, Edwards DF, Petyaykina KV, Crean CD, Fournier PG, Parker JM, Sandusky GE, Ichikawa S, Imel EA, Chirgwin JM. FGF23 is elevated in multiple myeloma and increases heparanase expression by tumor cells. Oncotarget. 2015 Aug 14;6(23):19647-60. doi: 10.18632/oncotarget.3794.

ReferenceCitation: Imel EA, Biggin A, Schindeler A, Munns CF. FGF23, Hypophosphatemia, and Emerging Treatments. JBMR Plus. 2019 May 13;3(8):e10190. doi: 10.1002/jbm4.10190. eCollection 2019 Aug.

ReferenceCitation: Endo I, Fukumoto S, Ozono K, Namba N, Inoue D, Okazaki R, Yamauchi M, Sugimoto T, Minagawa M, Michigami T, Nagai M, Matsumoto T. Nationwide survey of fibroblast growth factor 23 (FGF23)-related hypophosphatemic diseases in Japan: prevalence, biochemical data and treatment. Endocr J. 2015;62(9):811-6. doi: 10.1507/endocrj.EJ15-0275. Epub 2015 Jul 1.

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
DiaSorin ; Saluggia, Italia

location_facility:
Centre Jean Perrin
Chu Clermont Ferrand

intervention_type: Behavioral


title: Proteomic Characterization of Aggressive Oligodendrogliomas

acronym: PROGLIO

summary:
Oligodendrogliomas represent a distinct subgroup of adult gliomas characterized by specific molecular alterations (1p/19q codeletion, mutations of IDH, TERT promoter, CIC, FUBP1). These tumors account for 5 to 10% of adult gliomas and are of special relevance in the neuro-oncology field because of their frequent chemosensitivity (Louis et al. 2016). The genetics of oligodendrogliomas is relatively well characterized but the mechanisms of oncogenesis for these tumors are poorly understood.

Although oligodendrogliomas prognosis is usually better than that of other adult glioma subtypes, it remains heterogeneous and there is no effective treatment at recurrence after radiotherapy and chemotherapy. Our recent work conducted within the INCa-funded national POLA network has related this clinical heterogeneity to inter-tumoral heterogeneity. Based on a transcriptomic analysis of a large series of oligodendroglial gliomas we identified 3 subgroups, the most aggressive group being characterized by aggressive clinical and molecular pattern. Recent studies, however, have shown a relatively low level of concordance between mRNA and protein expression, emphasizing the need to use proteomic-based approaches to better understand tumor biology. Taking advantage of the POLA cohort, we propose to expand our previous analysis by integrating a proteomic analysis of oligodendrogliomas.

The aim of this project is to identify drivers of oligodendroglioma subgroups, among which potential druggable targets (i.e receptors, metabolism effectors). For this purpose, the proteomic profiles of 90 oligodendrogliomas will be generated and integrated with transcriptomic, genomic and methylation profiles in order to identify signaling pathways specifically associated with each subtype, especially with the most aggressive one. Associations will be explored between candidate signaling pathways expression and clinical outcomes (survival, progression-free survival, objective response). The relevance of the 2 most promising candidate signaling pathways will be assessed in vitro and in vivo using genetically relevant mouse and xenograft models.

Our project will identify targetable oncogenic pathways associated with poor prognosis that could lead to new therapeutic strategies.

location_facility:
Institut du Cerveau et de la Moelle
Groupement Hospitalier Est HCL


title: ERASE VITILIGO Early Repigmentation Approach for Stopping the Evolution of VITILIGO Prospective Multicentric Interventional Study With Blinded Evaluation

acronym: ERASE

summary:
Vitiligo affects 1 to 2% of worldwide population and has a demonstrated impact on the quality of life.

Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), in particular T cells, but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). Ultimately, the treatment should also prevent the recurrences of depigmentation. Indeed, when repigmentation is achieved, 40 to 50% of lesions reoccur within one year, suggesting that skin resident memory T cell clones remain in repigmented vitiligo skin and might explain these recurrences.

The investigators hypothesize that a very early intervention could prevent the accumulation of the skin resident memory T cells in vitiligo lesions. Moreover, they also think that such an early treatment would also optimize the repigmentation process, even in traditionally resistant areas, as some remaining pre-melanocytes and maybe even some melanocytes, could proliferate and recolonize the epidermis.

Objectives : to compare the resident memory T-cell infiltrate in perilesional vitiligo skin after 6 months of treatment with OMP and UVB, between three groups of patients suffering from non-segmental vitiligo Interventions The 3 groups will receive a combination of narrowband UVB (Nb-UVB) 3 times a week and oral mini pulses of systemic steroids (5 mg of d medrol 16mg twice a week) for 24 weeks.

Three visits will be done (inclusion, Week 12 and 24) A skin biopsy will be done on lesional and peri-lesional area at baseline. Another skin biopsy will be taken after 24 weeks but only in perilesional area. A blood sample for assessing the circulating memory T cells and for checking the tolerance will be performed at baseline, then at W12 and W24.

The combination of narrowband UVB and oral minipulse of steroids are considered as a standard care of active vitiligo patients. Clinical assessment (including blood pressure) and hemogram, liver enzymes, urea, creatinemia, glycemia, natremia and kaliema will be assessed at baseline, 3 and 6 months.

Main criteria of evaluation:

The target lesion will be chosen before any treatment. The minimal size will be 2cm². Considering that skin on the face usually responds very well whilst that of hands and feet respond poorly, to avoid potential bias due to the location of treatment, these locations won't be taken as target lesions. In any cases, no biopsy will be taken on the face or in the folds.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
CHU Bordeaux


title: Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients

acronym: FELSA-SEP

summary: The goal of this study is to assess the role of sociocognitive and interpersonal factors in the therapeutic adherence of multiple sclerosis patients. This study will provide a better understanding of the socio-psychological issues associated with different types of non-adherence to treatment, and identify the risk factors and vulnerability of each patient.

lead_sponsor: Lille Catholic University

location_facility:
Hôpital Saint-Vincent de Paul
Hôpital Saint-Philibert


title: Contribution of PET Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

acronym: TEP-ENDORUN

summary:
Endometriosis is an inflammatory condition that is often treated by surgery. MRI and ultrasound are used for the preoperative morphological assessment. Currently, only surgery allows the exhaustive and qualitative diagnosis of lesions.

The PET scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Centre Hospitalier Universitaire Réunion


title: Association Between Preoperative Fasting, Intraoperative Glycemic Control, and Hospital Lenght of Stay in Children Younger Than 24 Months of Age Undergoing Scheduled Conventional Inpatient Surgery

acronym: GLYNEMCaen

summary: In 2018, the main societies of anesthesia (European Society Anaesthesiology, European Society Pediatric Anesthesia, and Association des Anesthésistes Réanimateurs Pédiatriques d'Expression Française) changed the current recommendations for preoperative fasting time in children, reducing the time to last intake of clear liquids from two to one hour before anesthetic induction. Prolonged fasting may have a deleterious impact on blood glucose homeostasis. The consequences of intraoperative hypoglycemia in children can be serious in the short term, but also in the long term. The objective of multicenter prospective, observational cohort study is to investigate- in children younger than 24 months of age undergoing scheduled conventional inpatient surgery- a correlation between the duration of preoperative fasting, glycemic intraoperative homeostasis and the criteria of enhanced recovery after surgery, which are the hospital length of stay (main outcome), postoperative pain and postoperative nausea-vomiting (secondary outcomes). By identifying non-adherence to fasting rules as one of the causes of prolonged hospitalization, this study will highlight the need to develop effective strategies to promote adherence to fasting rules in pediatric surgery and minimize the potential deleterious impact on intraoperative glycemic control.

lead_sponsor: University Hospital, Caen

location_facility:
Hôpital Necker Enfants Malades
CHU Caen Normandie


title: Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)

acronym: CAMIL

summary: The purpose of this study is to compare the predictive value in terms of specificity of circulating tumor DNA (ctDNA) and positron emission computed tomography (PET-CT) after 2 cycles of chemotherapy (C2), on the probability of obtaining a metabolic complete response after 4 cycles of induction chemotherapy (C4) in patients with primary mediastinal large B cell lymphoma (PMBL) receiving standard R-CHOP14 or R-ACVBP.

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Hospitalier Lyon Sud
Centre Henri Becquerel


title: Perception of the Doctor/Patient Relationship, Disease and Treatment Among Physicians and Their Patients Treated With Systemic Therapy for Hepatocellular Carcinoma

summary:
atients with cancer face difficult choices that require balancing competing priorities such as survival, functional capacity and symptom relief. Most patients with advanced cancer (>80%) expect their sensitive discussions with physicians about prognosis and treatment choices, in order to be involved in the decision making process. Nevertheless, this kind of discussion is frequently lacking. Consequently, patients often have a biased view of their own prognosis such as an underestimation of disease severity, or unrealistic expectations for cure.

Patients with advanced hepatocellular carcinoma (HCC) may be treated with systemic therapies which may prolong survival, but are not curative. Patients with advanced HCC often report expectations for survival and treatment-related side-effects that differ from their treating physician. Accordingly, communication on prognostic and treatment choices is essential to obtain an accurate understanding of the disease that allows patients to make informed decisions. To the best of our knowledge, a thorough evaluation of the physician-patient communication quality has never been performed in advanced HCC patients.

The aim of our study, is to assess the perception of the expected prognosis, the treatment side-effects; by the patient and by his investigator during the first consultation before the initiation

ReferenceCitation: Loh KP, Mohile SG, Lund JL, Epstein R, Lei L, Culakova E, McHugh C, Wells M, Gilmore N, Mohamed MR, Kamen C, Aarne V, Conlin A, Bearden J 3rd, Onitilo A, Wittink M, Dale W, Hurria A, Duberstein P. Beliefs About Advanced Cancer Curability in Older Patients, Their Caregivers, and Oncologists. Oncologist. 2019 Jun;24(6):e292-e302. doi: 10.1634/theoncologist.2018-0890. Epub 2019 Apr 23.

ReferenceCitation: Yennurajalingam S, Rodrigues LF, Shamieh O, Tricou C, Filbet M, Naing K, Ramaswamy A, Perez-Cruz PE, Bautista MJS, Bunge S, Muckaden MA, Sewram V, Fakrooden S, Noguera-Tejedor A, Rao SS, Liu D, Park M, Williams JL, Lu Z, Cantu H, Hui D, Reddy SK, Bruera E. Perception of Curability Among Advanced Cancer Patients: An International Collaborative Study. Oncologist. 2018 Apr;23(4):501-506. doi: 10.1634/theoncologist.2017-0264. Epub 2017 Nov 20.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Avicenne
Assistance Publique - Hôpitaux de Paris


title: Effects of Training on a Rower Assisted by Electrostimulation of Lower Limbs in Paraplegic Patients (FES-ROW)

acronym: FES-ROW

summary: The main objective of this project is to measure the increase in aerobic physical and metabolic capacities with a 6-month training on a rower assisted by electrostimulation of lower limbs in a population of adults with traumatic paraplegia.

ReferenceCitation: Wheeler GD, Andrews B, Lederer R, Davoodi R, Natho K, Weiss C, Jeon J, Bhambhani Y, Steadward RD. Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. Arch Phys Med Rehabil. 2002 Aug;83(8):1093-9. doi: 10.1053/apmr.2002.33656.

ReferenceCitation: Popovic-Maneski L, Aleksic A, Metani A, Bergeron V, Cobeljic R, Popovic DB. Assessment of Spasticity by a Pendulum Test in SCI Patients Who Exercise FES Cycling or Receive Only Conventional Therapy. IEEE Trans Neural Syst Rehabil Eng. 2018 Jan;26(1):181-187. doi: 10.1109/TNSRE.2017.2771466.

ReferenceCitation: Deley G, Denuziller J, Babault N. Functional electrical stimulation: cardiorespiratory adaptations and applications for training in paraplegia. Sports Med. 2015 Jan;45(1):71-82. doi: 10.1007/s40279-014-0250-2.

lead_sponsor: UGECAM Rhône-Alpes

sponsor_collaborators:
UGECAM Rhône-Alpes
University of Franche-Comté
Hospices Civils de Lyon
University of Lyon

location_facility:
SSR Val Rosay UGECAM
HIA Desgenettes


title: A 3D Tablet Sensor Approach to the Measurement of an Upper and Lower Limb Volume in the Monitoring of a Lymphedema

summary: Up to now, the diagnosis of lymphedema remains hard and delayed. It suffers from many limitations such as lack of coordination and formation of the health-care network. The diversity of used tools is another obstacle because all provided solutions on the market are either costless with poor accuracy, or highly expensive but with excellent accuracy. Therefore, we decided to evaluate an affordable and open-source 3D iPad sensor sharing the same technology used in Kinect sensors.

lead_sponsor: University Hospital, Brest

location_facility:
CHU de Brest
CH Pont l'Abbé


title: Alterations of Innate and Adaptive Immune Cells During the Course of SARS CoV-2 Pneumonia

acronym: IMMUNO-COVID

summary:
The ongoing pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) has infected more than one hundred twenty million peoples worldwide one year after its onset with a case-fatality rate of almost 2%. The disease due to the coronavirus 2019 (i.e., COVID-19) is associated with a wide range of clinical symptoms. As the primary site of viral invasion is the upper respiratory airways, lung infection is the most common complication. Most infected patients are asymptomatic or experience mild or moderate form of the disease (80 %). A lower proportion (15%) develop severe pneumonia with variable level of hypoxia that may required hospitalization for oxygen therapy. In the most severe cases (5%), patients evolve towards critical illness with organ failure such as the acute respiratory distress syndrome (ARDS). At this stage, invasive mechanical ventilation is required in almost 70 % and the hospital mortality rises to 37 %.

Immune cells are key players during SARS CoV-2 infection and several alterations have been reported including lymphocytes (T, B and NK) and monocytes depletion, and cells exhaustion. Such alterations were much more pronounced in patients with the most severe form of the disease. Beside, a dysregulated proinflammatory response has also been pointed out as a potential mechanism of lung damage. Finally, COVID-19 is associated with an unexpectedly high incidence of thrombosis which probably results from the viral invasion of endothelial cells.

The investigators aim to explore prospectively the alterations of innate and adaptive immune cells during both the acute and the recovery phase of SARS CoV-2 pneumonia. Flow and Spectral cytometry will be used to perform deep subset profiling focusing on T, B, NK, NKT, gamma-gelta T, monocytes and dendritic cells. Each specific cell type will be further characterized using markers of activation/inhibition, maturation/differenciation and senescence as well as chemokines receptors.

T-cell memory specificity will be explore using specific SARS CoV-2 pentamer. Platelet activation and circulating microparticles will be explore using flow cytometry. Serum SARS CoV-2 antibodies (IgA, IgM, IgG), serum cytokines, and serum biomarkers of alveolar epithelial and endothelial cells will be analyze using ELISA and correlate with the severity of the disease.

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Medical Association

ReferenceCitation: Kuri-Cervantes L, Pampena MB, Meng W, Rosenfeld AM, Ittner CAG, Weisman AR, Agyekum RS, Mathew D, Baxter AE, Vella LA, Kuthuru O, Apostolidis SA, Bershaw L, Dougherty J, Greenplate AR, Pattekar A, Kim J, Han N, Gouma S, Weirick ME, Arevalo CP, Bolton MJ, Goodwin EC, Anderson EM, Hensley SE, Jones TK, Mangalmurti NS, Luning Prak ET, Wherry EJ, Meyer NJ, Betts MR. Comprehensive mapping of immune perturbations associated with severe COVID-19. Sci Immunol. 2020 Jul 15;5(49):eabd7114. doi: 10.1126/sciimmunol.abd7114.

ReferenceCitation: Giamarellos-Bourboulis EJ, Netea MG, Rovina N, Akinosoglou K, Antoniadou A, Antonakos N, Damoraki G, Gkavogianni T, Adami ME, Katsaounou P, Ntaganou M, Kyriakopoulou M, Dimopoulos G, Koutsodimitropoulos I, Velissaris D, Koufargyris P, Karageorgos A, Katrini K, Lekakis V, Lupse M, Kotsaki A, Renieris G, Theodoulou D, Panou V, Koukaki E, Koulouris N, Gogos C, Koutsoukou A. Complex Immune Dysregulation in COVID-19 Patients with Severe Respiratory Failure. Cell Host Microbe. 2020 Jun 10;27(6):992-1000.e3. doi: 10.1016/j.chom.2020.04.009. Epub 2020 Apr 21.

ReferenceCitation: Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248.

ReferenceCitation: Zheng M, Gao Y, Wang G, Song G, Liu S, Sun D, Xu Y, Tian Z. Functional exhaustion of antiviral lymphocytes in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):533-535. doi: 10.1038/s41423-020-0402-2. Epub 2020 Mar 19. No abstract available.

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lead_sponsor: Institut Hospitalo-Universitaire Méditerranée Infection

collaborators: Assistance Publique Hopitaux De Marseille

location_facility:
Hopital Europeen Marseille
Hopital Nord