title: Regulatory T-cell Induction by Low-dose Interleukin-2 in Women With Unexplained Repeated Spontaneous Early Miscarriages

summary: The purpose of this study is to demonstrate the ability of low dose IL-2 to stimulate peripheral blood Tregs of women with unexplained repeated early spontaneous miscarriages for development of a therapy to prevent fetal rejection by low dose IL-2.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Iltoo Pharma

location_facility: Mekinian Kayem Bornes


title: Deciphering Mechanisms Underlying Cancer Immunogenicity

acronym: DECIDE

summary:
This trial is a translational, open-label, multicentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.

The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial.

Patients with any of the following tumor types may be enrolled in the trial:

Head and neck cancer,
Ovarian cancer,
Cervical cancer,
Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),
Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)

Each tumor type will be considered as an independent cohort.

For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.

Study participation of each patient will be 5 years.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer

acronym: QUALITY-AGE

summary: The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre François Baclesse
Centre Henri Becquerel
CHU Amiens

status_simplified: Completed


type: Other Identifier

title: OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD

acronym: QUAOBARE

summary: The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre d'exploration ophtalmologique de l'odéon

lead_sponsor_type: academique


title: Psychological and Social Determinants of Physical Activity Practice From Diagnose to Survival Among French Cancer Patients

acronym: PERTINENCE

summary: The litterature has demonstrates that physical activity can play an important role in decreasing patient mortality rates and increasing its well-being at all time of cancer. Despite this evidence, there is a weak adhesion in patients. It is therefore appropriate to look and see which may explain the high prevalence of physical inactivity in patients with cancer. The main objective of this study will be to recognize psychological and social factors which could explain the commitment or not to a physical activity in cancer patients. Besides the physical limitations related to the cancer and its treatment, socio-economic and psycho-social factors can often play an extremely important role in engagement or maintenance of sporting activity.

ReferenceType: derived

ReferenceCitation: Van Hoye A, Omorou Y, Rotonda C, Gendarme S, Tarquinio C, Houtmann B, Peiffert D, Longo R, Martin-Krumm C. Psychological and social determinants of physical activity from diagnosis to remission among French cancer patients (PERTINENCE): protocol for a mixed-method study. BMC Public Health. 2019 Aug 6;19(1):1053. doi: 10.1186/s12889-019-7368-y.

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 OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
CHR Metz Thionville
Institut de Cancérologie de Lorraine


title: Role of the NLRP3 Inflammasome in Escherichia Coli and Staphylococcus Aureus Bacteria

summary: Our previous studies delineate a novel pathway of immune activation in animals that the investigators have named Anti-Virulence Immunity (AVI). Using a mice model of bacteremia, the investigators have demonstrated that Escherichia coli Cytotoxic Necrotizing Factor 1 (CNF1) activity is sensed by the immune system. This immune sensing results in a rapid bacterial clearing during bacteremia triggered by uropathogenic E. coli-expressing CNF1. The investigators already confirmed the involvement of one inflammasome using macrophages isolated from Knock-out mice. The investigators have recently determined the conservation in human monocytes of the interleukin -1beta maturation triggered by CNF1 and observed the heterogeneous capacity of monocytes to respond to the CNF1 treatment depending on the donors. Here, to determine the importance in natura of AVI the investigators will analyze the blood content of patients presenting E. coli and S. aureus bacteremia. The DNA of monocytes isolated from patients will be extracted and various genes implicated in the activity of various inflammasomes will be sequenced to identify mutations that could explain the susceptibility to bacteremia or a specific clinical presentation, i.e. requirement of a management in ICU because of organ failure.

study_start_date_type: Anticipated

status: Unknown status

ReferenceType: background

ReferenceCitation: Lee CC, Chen SY, Chang IJ, Chen SC, Wu SC. Comparison of clinical manifestations and outcome of community-acquired bloodstream infections among the oldest old, elderly, and adult patients. Medicine (Baltimore). 2007 May;86(3):138-44. doi: 10.1097/SHK.0b013e318067da56. Erratum In: Medicine (Baltimore). 2013 Jul;92(4):216.

ReferenceCitation: Weinstein MP, Towns ML, Quartey SM, Mirrett S, Reimer LG, Parmigiani G, Reller LB. The clinical significance of positive blood cultures in the 1990s: a prospective comprehensive evaluation of the microbiology, epidemiology, and outcome of bacteremia and fungemia in adults. Clin Infect Dis. 1997 Apr;24(4):584-602. doi: 10.1093/clind/24.4.584.

ReferenceCitation: Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004 Aug 1;39(3):309-17. doi: 10.1086/421946. Epub 2004 Jul 15. Erratum In: Clin Infect Dis. 2004 Oct 1;39(7):1093. Clin Infect Dis. 2005 Apr 1;40(7):1077.

ReferenceCitation: Valles J, Palomar M, Alvarez-Lerma F, Rello J, Blanco A, Garnacho-Montero J, Martin-Loeches I; GTEI/SEMICYUC Working Group on Bacteremia. Evolution over a 15-year period of clinical characteristics and outcomes of critically ill patients with community-acquired bacteremia. Crit Care Med. 2013 Jan;41(1):76-83. doi: 10.1097/CCM.0b013e3182676698.

ReferenceCitation: Herrmann JB, Muenstermann M, Strobel L, Schubert-Unkmeir A, Woodruff TM, Gray-Owen SD, Klos A, Johswich KO. Complement C5a Receptor 1 Exacerbates the Pathophysiology of N. meningitidis Sepsis and Is a Potential Target for Disease Treatment. mBio. 2018 Jan 23;9(1):e01755-17. doi: 10.1128/mBio.01755-17.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CH Pierre Nouveau
CHU de Lenval
CHG d'Antibes

intervention_type: Genetic

status_simplified: Unknown


acronym: DUPECZEMAIN

intervention_type: Drug

lead_sponsor: University Hospital, Toulouse

summary: Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.

ReferenceCitation: Halioua B. [Hand eczema : disability and impact]. Ann Dermatol Venereol. 2014 Jun;141 Suppl 1:S111-6. doi: 10.1016/S0151-9638(14)70148-6. French.

ReferenceCitation: Cortesi PA, Scalone L, Belisari A, Bonamonte D, Cannavo SP, Cristaudo A, De Pita O, Gallo R, Giannetti A, Gola M, Pigatto PD, Mantovani LG. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014 Mar;70(3):158-68. doi: 10.1111/cod.12130. Epub 2013 Sep 19.

ReferenceCitation: Fowler JF, Graff O, Hamedani AG. A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy. J Drugs Dermatol. 2014 Oct;13(10):1198-204.

ReferenceCitation: Blauvelt A, de Bruin-Weller M, Gooderham M, Cather JC, Weisman J, Pariser D, Simpson EL, Papp KA, Hong HC, Rubel D, Foley P, Prens E, Griffiths CEM, Etoh T, Pinto PH, Pujol RM, Szepietowski JC, Ettler K, Kemeny L, Zhu X, Akinlade B, Hultsch T, Mastey V, Gadkari A, Eckert L, Amin N, Graham NMH, Pirozzi G, Stahl N, Yancopoulos GD, Shumel B. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017 Jun 10;389(10086):2287-2303. doi: 10.1016/S0140-6736(17)31191-1. Epub 2017 May 4.

ReferenceCitation: Molin S, Merl J, Dietrich KA, Regauer M, Flaig M, Letule V, Saucke T, Herzinger T, Ruzicka T, Hauck SM. The hand eczema proteome: imbalance of epidermal barrier proteins. Br J Dermatol. 2015 Apr;172(4):994-1001. doi: 10.1111/bjd.13418. Epub 2015 Feb 26.

location_facility:
Hôpital Saint Eloi
Saint André Hospital
Larrey Hospital

title: DUPECZEMAIN : Double Blind Placebo-controlled Randomized Multicenter Study Assessing the Efficacy and Safety of Dupilumab in Moderate to Severe Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

primary_purpose: Treatment

type: EudraCT Number

source: euctr

design_allocation: Randomized


title: Multiple Sclerosis in the Elderly: Epidemiology, Clinical and MRI Characteristics

acronym: OLDMUS

summary:
Little is known about old MS patients. In a previous work, systematic search in Bordeaux, Strasbourg and Dijon university hospital regional MS center databases European Database for Multiple Sclerosis (EDMUS) retrieved 2% of 75 years old or older Multiple Sclerosis (MS) patients in the 3 databases. Data analysis showed that MS may switch off in the very old patients with mild progression and very few relapses. The project is to continue this preliminary work and extend it with a systematic study of MS in the elderly.

The scientific aims: To add new insights into long lasting MS natural history in the growing population of elderly patients with MS.

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux

collaborators: Observatoire Français de la sclérose en plaques (OFSEP)

location_facility: Hôpital neurologique - Pierre Wertheimer

location_facility: CHU de Bordeaux - Pellegrin - service de neurologie


title: SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)

acronym: SAVE

summary:
Bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. Previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria.

This is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-VEGF therapy with bevacizumab.

lead_sponsor: University Hospital, Tours

location_facility: Oncological Gastroenterology Service, University Hospital, Tours

location_facility: Medical Oncology Service, University Hospital, Tours


title: High-Flow Nasal Oxygenation Versus Standard Oxygenation in Gastrointestinal Endoscopy With Sedation. A Prospective Multicenter Randomized Study

acronym: ODEPHI

summary: This study is a randomized controlled trial comparing high-flow nasal oxygen therapy (HFNO) versus standard oxygen therapy (nasal prongs, nasopharyngeal catheter or standard face mask) during gastrointestinal (GI) endoscopy with sedation to reduce the incidence of hypoxia.

ReferenceType: result

ReferenceCitation: Qadeer MA, Lopez AR, Dumot JA, Vargo JJ. Hypoxemia during moderate sedation for gastrointestinal endoscopy: causes and associations. Digestion. 2011;84(1):37-45. doi: 10.1159/000321621. Epub 2011 Feb 8.

ReferenceCitation: Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.

ReferenceCitation: Cohen LB, Wecsler JS, Gaetano JN, Benson AA, Miller KM, Durkalski V, Aisenberg J. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006 May;101(5):967-74. doi: 10.1111/j.1572-0241.2006.00500.x.

ReferenceCitation: Griffin SM, Chung SC, Leung JW, Li AK. Effect of intranasal oxygen on hypoxia and tachycardia during endoscopic cholangiopancreatography. BMJ. 1990 Jan 13;300(6717):83-4. doi: 10.1136/bmj.300.6717.83. No abstract available.

ReferenceCitation: Woods A, Sanowski RA, Wadas DD, Manne RK, Friess SW. Eradication of diminutive polyps: a prospective evaluation of bipolar coagulation versus conventional biopsy removal. Gastrointest Endosc. 1989 Nov-Dec;35(6):536-40. doi: 10.1016/s0016-5107(89)72906-0.

ReferenceCitation: Nay MA, Fromont L, Eugene A, Marcueyz JL, Mfam WS, Baert O, Remerand F, Ravry C, Auvet A, Boulain T. High-flow nasal oxygenation or standard oxygenation for gastrointestinal endoscopy with sedation in patients at risk of hypoxaemia: a multicentre randomised controlled trial (ODEPHI trial). Br J Anaesth. 2021 Jul;127(1):133-142. doi: 10.1016/j.bja.2021.03.020. Epub 2021 Apr 28.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Eugene A, Fromont L, Auvet A, Baert O, Mfam WS, Remerand F, Boulain T, Nay MA. High-flow nasal oxygenation versus standard oxygenation for gastrointestinal endoscopy with sedation. The prospective multicentre randomised controlled ODEPHI study protocol. BMJ Open. 2020 Feb 18;10(2):e034701. doi: 10.1136/bmjopen-2019-034701.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: British Medical Journal

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Pole santé ORELIANCE
Hospital Center of DAX
Orleans Hospital Center

intervention_type: Device


title: Prospective Evaluation of the Efficacy and Safety of a Simplified Procedure for the Percutaneous Closure of the Patent Foramen Ovale

acronym: IDFFOP

summary:
Patent Foramen Ovale, is an embryonic remnant, formed by apposition of the septum primum and septum secondum composing the interatrial septum. This foramen ovale is permeable during intra-uterine life and allows inter-auricular communication. It tends to close at birth, due to increased pressure from the left atrium. However, it remains permeable in almost 25% of the general population. Several studies have shown that this cardiac "anomaly" associated with the atrial septum aneurysm (ASA), easily diagnosed by ultrasound, is more common in patients with cryptogenic stroke. The diagnosis of patent foramen ovale is performed by a cardiac ultrasound with a "bubble" test: a volume of micro-bubbles obtained by emulsion of saline (9 ml) and air (1 ml) is injected intravenously. The path of these microbubbles is observed by trans-thoracic ultrasound and can detect a shunt right / left. This test can be sensitized by Valsalva maneuver and / or cough. The shunt is quantified by the number of microbubbles flowing through the right / left shunt: positive diagnosis: more than 3 bubbles passing; minimal shunt <10 bubbles, moderate shunt between 10 and 30 bubbles, massive shunt if> 30 bubbles.

Patent Foramen Ovale Closure is an interventional cardiac catheterization procedure by venous femoral approach. Several clinical trials show that Patent Foramen Ovale closure prevents stroke recurrence in young people and that this procedure is more effective than antiplatelet therapy. Nevertheless, an increase in the incidence of peri-procedural atrial fibrillation has been observed. For some researchers, this would be explained by irritation of the atrial muscle due to the establishment of the device.

To date, only percutaneous closures made in clinical trials have been evaluated. In fact, there are no specific recommendations. The use in clinical practice of this percutaneous treatment therefore requires an evaluation of the indications but also the profile of the patients to optimize these procedures and reduce the complication rate.

The closure technique and the choice of the size of the prosthesis are not standardized. The closure is done under trans-esophageal echocardiography (invasive method) or trans-thoracic echocardiography (non-invasive method) depending on the choice of the practitioner. In CLOSE study, this rate is not specified. The procedure rate under general anesthesia is 54%. This category of patients can be assumed to use a trans-esophageal echocardiography.

The absence of specific recommendations concerning the technical modalities of this procedure lead us to study the closure of Patent Foramen Ovale standardized under trans-thoracic echocardiography and to evaluate its possible reliefs by avoiding the general anesthesia and the use of trans-esophageal echocardiography. The objective of the study is to bring elements of standardization of the technique. As part of a "real life" study, we will evaluate the success rate of procedure under local anesthesia and under trans-thoracic echocardiography control. This evaluation will be done by trans-thoracic echocardiography at 3 months, the re-endothelisation time of the medical device being between 1 and 3 months.

status: Active, not recruiting

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
Centre Chirurgical Marie Lannelongue
Centre Cardiologique du Nord
Groupe Hospitalier Paris Saint-Joseph


title: Evaluation of the Mobility of the Digital Flexor Tendons Operated by Dynamic MRI: a Pilot Study.

acronym: DynamicMRI

summary: To study flexor tendon excursion in the hand after surgery by dynamic MRI

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Clinique Keraudren
HIA
CHRU de Brest


title: Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria

summary:
Evaluation of the efficacy of stiripentol (Diacomit) as monotherapy for the treatment of primary hyperoxaluria.

Pilot clinical study, open, prospective and multicenter.

lead_sponsor: Biocodex

location_facility:
Hôpital Tenon
Hôpital Robert Debré
Hôpital Necker


title: Study of Exosomes in Monitoring Patients With Sarcoma (EXOSARC)

acronym: EXOSARC

summary:
Sarcomas are rare cancers with a high risk of metastatic progression and a major pejorative factor with respect to patient survival. The estimation of the metastatic risk of sarcomas is very complex given the histological heterogeneity of this entity. It is therefore essential that, at diagnosis, a reliable evaluation of this metastatic potential be made, in order to adapt the therapeutic strategy as well as possible.

It has recently been discovered that sarcomas secrete many exosomes that appear to play an important role in tumorogenesis, growth, tumor progression and the onset of metastases. They contain many proteins and nucleic acids (DNA, RNA, microRNA), reflecting the characteristics of the tumor. It has been shown that the amount of exosomes can be correlated with the grade of malignancy of the tumor. Present in the blood, exosomes offer the possibility of non-invasively analyzing the molecular information of the cancer cell. As a result, the study of serum exosomes derived from sarcomas has a high potential as a liquid biopsy to evaluate cancer pathogenesis, progression, and treatment efficacy.

The purpose of this study is to demonstrate in patients with sarcomas that exosomes can be used to monitor their disease and be used as a predictor of the risk of recurrence.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHU de Poitiers
CHU de Besançon
Centre Georges François Leclerc

intervention_type: Biological


title: Comparison of the Acute Hemodynamic Effect of Three Modes of Stimulation in Cardiac Resynchronization.

acronym: 3 STIM

summary:
Cardiac Resynchronization Therapy (CRT) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality.

Adjusting atrio-ventricular (AV) delay, vector optimization and choice of different modes of stimulation can influence the acute hemodynamical consequences of CRT but also its medium-term and long-term clinical and echocardiographic effects.

The aim of the present prospective study is to investigate whether the different stimulation modes lead to different acute hemodynamic response, by evaluating the highest systolic pressure using the Finapress ® method.

status: Terminated

ReferenceCitation: Ferchaud V, Garcia R, Bidegain N, Degand B, Milliez P, Pezel T, Moubarak G. Non-invasive hemodynamic determination of patient-specific optimal pacing mode in cardiac resynchronization therapy. J Interv Card Electrophysiol. 2021 Nov;62(2):347-356. doi: 10.1007/s10840-020-00908-6. Epub 2020 Oct 30.

oa_host_type: closed

lead_sponsor: CMC Ambroise Paré

location_facility:
Cmc Ambroise Pare
CHU Poitiers
Gehm Site D'Eaubonne


title: French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (A Psoriatic Arthritis CoHort)

acronym: APACHE

summary:
Psoriatic arthritis (PsA) is a chronic inflammatory rheumatic disease, belonging to the wide spectrum of spondyloarthritis, but with the particularity to be associated with personal psoriasis or familial psoriasis. PsA can be a very disabling disease through progressive and irreversible joint damage. Long-term functional prognosis of patients with PsA is correlated with the presence and severity of the radiographic joint lesions of the disease.

However, the proportion of patients who will develop those peripheral joint damages is not yet known and less over the factors which are associated/involved in such an aggressive pattern of the disease. Early identification of this subgroup of patients is particularly important for determining early "intensive" treatment, strict management with a Treat To Target approach, and identification of new treatments with a stronger structural effect.

The main objective of this prospective 10 years cohort is to describe the 5 years structural (radiographic) severity of recent PsA with recent peripheral arthritis.Some of the secondary objectives are to describe the 10 years structural severity within those patients, and to determine the predictive factors of those 5 and 10 years radiographic lesions (genetic, environmental, clinic, therapeutic factors).

APACHE will provide a unique longitudinal standardized database concerning patients with PsA with very recent peripheral arthritis. Research projects which will based on those collected data should allow to identify the mechanisms of aggressive joint damage, to highlight mew treatments targets, to better describe the burden of the disease, to test previous or develop new assessments tolls, to develop early diagnostic criteria

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Saint Joseph Hospital
Lapeyronie Hospital
Henri-Mondor Hospital


title: Effects of Obstructive Sleep Apnea on the Frequency of Vaso-occlusive Crises Events and Bio-physical Markers in Sickle Cell Disease

acronym: DREPAPNEE

summary: Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell population, studies focusing on the associations of the two diseases and their common pathophysiological mechanisms are scarce. OSA is one of the most common conditions responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients, could increase the risk for complications. Finally, OSA is accompanied by impaired vascular function and autonomic nervous system dysfunction in the general population. Indeed, the presence of OSA in SCD could increase the clinical severity of patients and the frequency of VOC.

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceCitation: Stauffer E, Poutrel S, Cannas G, Gauthier A, Fort R, Bertrand Y, Renoux C, Joly P, Boisson C, Hot A, Peter-Derex L, Pialoux V, PetitJean T, Connes P. Nocturnal Hypoxemia Rather Than Obstructive Sleep Apnea Is Associated With Decreased Red Blood Cell Deformability and Enhanced Hemolysis in Patients With Sickle Cell Disease. Front Physiol. 2021 Sep 24;12:743399. doi: 10.3389/fphys.2021.743399. eCollection 2021.

publisher_dissemination: Frontiers

lead_sponsor: Hospices Civils de Lyon

location_facility:
Centre Léon Berard
Hôpital Edouard Herriot
Hôpital de la Croix Rousse


title: 18FluoroDeoxyGlucose-Positron Emission Tomography (PET) in Patients With Melanoma or Non Small Cell Lung Cancer Treated With Immunotherapy

acronym: IMMUNOPET

summary: Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy.

location_facility:
CH de LANDERNEAU
CHRU de Brest
Centre Hospitalier de Morlaix


title: Comparison of the Efficacy of Hybrid Ablative Therapy for Patients With Persistent Atrial Fibrillation Versus Conventional Catheter Ablation

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a prevalence ranging from 5% over 60 years old to 17% after 85 years old. Besides hemodynamical compromises and occurrence of heart failure, stroke remains the most feared complication related to AF with a risk increased by 5-fold.

Catheter ablation with the aim of pulmonary veins isolation (PVI) has evolved as a standardized treatment option in paroxysmal AF (PAF), supported by the current guidelines. However, due to advanced electrical and structural remodeling, catheter ablation for persistent AF is rather disappointing with a limited success rate, at least after a single procedure. Due to these shortcomings, minimally invasive thoracoscopic surgical techniques have gained attention with good results in persistent AF patients. Comparison between thoracoscopic surgical ablation and catheter ablation have shown that surgical ablation was associated with higher success rates, less redo procedures but also with higher complication rates. The main issue with surgical ablation is the difficulty to check the ablation lines and pulmonary vein isolation, which are the cornerstones for achieving good long-term results.

Hybrid therapy, combining both epicardial surgical and endocardial catheter ablation is expected to be the most effective technique. It would avoid incomplete lesions or incomplete pulmonary vein isolation, and would provide complete lesion set. Hybrid therapy of AF has been compared with mini-invasive surgical ablation of AF, showing a significant higher rate of sinus rhythm achievement in the hybrid therapy group. However, no comparative clinical trials data are currently available in the setting of persistent AF comparing hybrid ablation and conventional catheter ablation.

sponsor_collaborators:
University Hospital, Toulouse
AtriCure, Inc.

location_facility:
CHU Toulouse, Hôpital Rangueil
Cardiology-rytmology service
Cardiology-rytmology

intervention_type: Procedure

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

titre: Comparaison des résultats médicaux et économiques de la l'ablation hybride médico-chirurgicale et de l'ablation conventionnelle percutanée par cathéter de la fibrillation atriale persistante

discipline_principale: cardiologie

nom_porteur: Maury

prenom_porteur: Jean-Philippe


title: FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU

acronym: FURTHER

summary: Ischemic acute tubular necrosis (ATN) is one of the main cause of acute kidney injury (AKI) in intensive care units (ICU). Sepsis and cardio-pulmonary bypass (CPB) are major providers. There is no validated tool to predict the evolution of AKI is ICU. Furosemide Stress Test (FST) may predict evolution of ATN-related AKI outside ICU in terms of progressive AKI, need for renal replacement therapy (RRT) or inpatient mortality with improved performance comparing to biomarkers. FST has not been validated in a prospective cohort in ICU in the settings of ischemic ATN. FURTHER aim to determine whether FST would be a useful tool to identify patients with slight to moderate AKI (KDIGO stage 1 and 2) who will evolve towards need for RRT following AKIKI (The Artificial Kidney Initiation in Kidney Injury ) delayed initiation criteria.

ipd_sharing: Undecided

location_facility:
CH Cote Basque
Hopital Saint Louis
Hopital Bichat


title: Changes in Cerebral Circulation and Oxygenation During Hemodynamic Resuscitation in Critically Ill Children Without Head Trauma

acronym: CIRCU-REAPED

summary:
The principal purpose of this study is to describe the changes in cerebral circulation (assessed by transcranial ultrasound) and oxygenation (assessed by Near InfraRed spectroscopy, NIRS) during resuscitation for hemodynamic failure (arterial hypotension or shock) in critically ill children treated with vasoactive or inotropic drugs.

The secondary objectives are :

i) to evaluate the association between an alteration of cerebral circulation and/or oxygenation and an alteration in macro-circulatory parameters (Mean Arterial Blood Pressure and cardiac output) or a bad outcome, ii) to study if cerebral autoregulation is impaired

ReferenceCitation: Vedrenne-Cloquet M, Chareyre J, Leger PL, Genuini M, Renolleau S, Oualha M. Low Dosing Norepinephrine Effects on Cerebral Oxygenation and Perfusion During Pediatric Shock. Front Pediatr. 2022 Jul 6;10:898444. doi: 10.3389/fped.2022.898444. eCollection 2022.

location_facility:
Hôpital Trousseau
Hôpital Robert Debré
Hôpital Necker


title: Stereotactic Radiotherapy for Cerebral Metastases With Recent Hemorrhagic Signal: Phase 2 Study in 2 Steps

acronym: STEREO-HBM

summary: This prospective 2-stage, non-randomized Phase 2 trial evaluates the safety and efficacy of FSRT for the management of hemorrhagic brain metastases

ReferenceCitation: Lesueur P, Kao W, Leconte A, Geffrelot J, Lequesne J, Lacroix J, Brachet PE, Hrab I, Royer P, Clarisse B, Stefan D. Stereotactic radiotherapy on brain metastases with recent hemorrhagic signal: STEREO-HBM, a two-step phase 2 trial. BMC Cancer. 2020 Feb 22;20(1):147. doi: 10.1186/s12885-020-6569-1.

lead_sponsor: Centre Francois Baclesse

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

location_facility:
Institut de Cancérologie de Lorraine
Centre de la Baie
Centre François Baclesse

intervention_type: Radiation

appel_a_projets: PHRCI

region: Normandie

nom_etablissement: CRLCC FRANCOIS BACLESSE - CAEN

type_etablissement: CLCC

acronyme: Stereo-HBM

titre: Radiothérapie stéréotaxique pour les métastases cérébrales avec signal hémorragique récent : étude de phase 2 en 2 étapes

discipline_principale: radiothérapie stéréotaxiqueradiothérapie hypofractionnéemétastases cérébralessignaux hémorragiquesqualité de vie

nom_porteur: GEFFRELOT

prenom_porteur: Julien


title: Dépistage Des métastases cérébrales Par IRM Chez Les Patients Avec un adénocarcinome Colorectal métastatique

summary: The aim of this study is to prospectively determine the incidence of brain metastases in metastatic colorectal cancer patients using systematic annual screening by MRI.

primary_purpose: Screening

lead_sponsor: Poitiers University Hospital

location_facility:
C.H.U. de Poitiers
C.H.U. de Tours
C.H.U. d'Amiens


title: Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study

acronym: PNEUM-AMBU

summary: The management of spontaneous large pneumothorax is not consensual. The current management involves the establishment of a Fuhrman catheter and an outpatient monitoring in pneumology consultation. Another alternative is widespread: simple exsufflation. However, no study has looked at the direct prospective comparison of these 2 treatments.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Rennes
CH Lorient
CH Saint-Malo


title: Pilot Feasibility Study for Cystic Fibrosis Sputum Validation for the Molecular Diagnosis of Respiratory Viral Infections

acronym: EXPIRE

summary: The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.

location_facility:
Hôpital Foch
CHU d'Angers
Centre de Perharidy


acronym: ANTICIPUSC

lead_sponsor: Institut Cancerologie de l'Ouest

summary:
Postoperative pulmonary complications are one of the most common complications after surgery.

Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications.

Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest.

The difficulty for the practitioner is to target patients at higher risk of developing a postoperative pulmonary complications in order to guiding them to a post-operative specialized care pathway.

The use of the ARISCAT score, validated on a large European prospective cohort, makes it possible to evaluate, preoperatively, the risk of occurrence of postoperative pulmonary complication in the patient.

The hypothesis of the present research is that early postoperative preventive treatment with noninvasive ventilation, in patients at risk of postoperative pulmonary complications according to the preoperative evaluation according to the ARISCAT score, could have an interest in reducing these complications with a superior efficiency over standard techniques.

ReferenceCitation: Abrard S, Rineau E, Seegers V, Lebrec N, Sargentini C, Jeanneteau A, Longeau E, Caron S, Callahan JC, Chudeau N, Beloncle F, Lasocki S, Dupoiron D. Postoperative prophylactic intermittent noninvasive ventilation versus usual postoperative care for patients at high risk of pulmonary complications: a multicentre randomised trial. Br J Anaesth. 2023 Jan;130(1):e160-e168. doi: 10.1016/j.bja.2021.11.033. Epub 2022 Jan 5.

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Direction Générale de l'Offre de Soins

location_facility:
Chu D'Angers
Ch Du Mans
Institut de Cancerologie de L'Ouest

title: Multicenter, Randomized, Open Study, Assessing Prophylactic Noninvasive Ventilation in Intensive Care Unit vs Postoperative Standard Care for Patients With High Risk of Postoperative Pulmonary Complication With Preoperative ARISCAT Score

primary_purpose: Supportive Care


title: Effects of Menthol on Dyspnoea Induced by Exercise in COPD Patients

acronym: MEDiC

summary: Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dyspnoea is a common symptom among patients with Chronic Obstructive pulmonary Disease (COPD). Dyspnea is the primary symptom limiting exercise and daily activities in these patients. It has been reported that breathing cold air could decrease dyspnoea induced by exercise and could improve exercise performance. The aim of this study is to carry out the effect of cooling sensation induced by menthol chewing-gum on dyspnoea and exercise performance among patients with COPD.

ipd_sharing_description: Data type : deidentified participtant data

lead_sponsor: Groupe Hospitalier du Havre

location_facility:
Resp'Air
Centre hospitalier des Pays de Morlaix
Groupe Hospitalier du Havre


title: Validation of a Genetic Signature to Predict the Development of Sarcomas

acronym: PREDISARC

summary:
The aim of the SARI study was to describe biomarkers of predisposition to the development of sarcomas in irradiated territory. This study included 120 patients with sarcoma in irradiated territory and 240 patients who had been treated with radiotherapy for more than 5 years and had not developed sarcoma.

Following the sequencing of the exomes of all these patients, the SARI study made it possible to highlight a genetic signature from 11 genes, predictive of the appearance of a sarcoma after a first radiotherapy. This signature is the subject of a patent (BFF 170286 / VF, filed on June 22, 2017). A final validation step with samples that have not been used to optimize this signature is now required. Moreover, it is now necessary to validate if this signature is specific to the predisposition to the development of radiation-induced sarcomas only or if this signature is also valid for the predisposition to the development of all sarcomas, even primary ones.

The objective of the PREDISARC study is to evaluate the specificity of this genetic signature (11 genes) with the appearance of sarcomas in irradiated territory compared to a population without sarcoma that has been treated with radiotherapy.

location_facility:
Institut Gustave Roussy
Centre Georges François Leclerc
Institu Bergonie


title: Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.

acronym: CITHARE

summary:
This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma.

In this phase II trial, patients will be assigned in one of the two treatment arms:

Arm A (standard arm): Chemoradiotherapy arm
Arm B (Experimental arm): Immunotherapy + Radiotherapy arm

Total duration of treatment will be 6 months (at maximum in the experimental arm).

Patients will be followed for a maximum of 2 years following the date of randomization.

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
AstraZeneca

location_facility: Institut Universitaire du Cancer Toulouse (IUCT-O)


title: Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes

acronym: MODIFY

summary: Myelodysplastic syndromes (MDS) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. Morphological analysis of peripheral blood (PB) and bone marrow (BM) remains the cornerstone of the diagnosis. Preliminary studies identified Flow Cytometry (FC) markers on red cells, platelets and circulating leukocytes that are expressed differently in MDS and in controls. However, these markers have been evaluated separately. The investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a PB FC-based diagnosis score that would discriminate between MDS and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHRU Lille
CHU Amiens-Picardie
CHU Rouen

intervention_type: Diagnostic Test


title: Pemetrexed in Maintenance in Patients With Impaired Renal Function: Randomized Phase 4 Multicenter Study Comparing 2 Dose Calculation Strategies (PKAPIR)

acronym: PKAPIR

summary:
Pemetrexed is used in the treatment of non-small cell lung cancer (NSCLC). Its elimination is mainly renal and its nephrotoxicity requires an interruption of treatment when the CrCLCG falls below 45 mL / min. Patients with NSCLC frequently have impaired renal function by other cytotoxic drugs.

The dose adjustment of pemetrexed is performed as a function of body surface area (SC) without any pharmacokinetic rational. The challenge is to treat patients with renal insufficiency (RR) with a safe dose, based on CRCL, providing equivalent biological exposure to patients with preserved renal function.

location_facility: Centre Universitaire Hospitalier de Dijon


title: Olfactory Training and Emotional State

acronym: ENOLFEA

summary:
During the past three decades, researchers have paid particular attention to the study of olfactory disorders in depression. Recent studies have shown that depression is characterized by a change in olfactory and emotional perception resulting in a decrease of the perception of positive stimuli (odors and facial expressions) and an increase in perception of negative stimuli (odors). Moreover, it has also been shown in healthy subjects that the presence of minor depressive symptoms leads to a decreasing of olfactory sensitivity. However, odor discrimination was not impaired in these subjects. This observation suggest the presence of a change in "targeted" olfactory perception in people with depressive symptoms without reporting major depression. In addition, studies in subjects with olfactory disorders (following respiratory tract infections or following Parkinson's disease) have shown an improvement in olfactory function after daily training with odors during 12 weeks.

From all these observations, the hypothesis is that an olfactory training could improve the overall olfactory functioning and the emotional perception of the subjects presenting minor depressive symptoms and of the depressed patients.

location_facility: University Psychiatric Clinic, University hospital,Tours

location_facility: University health service, University ,Tours


title: Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation

acronym: COROCAN

summary: To measure coronary calcium score in adults treated during childhood or adolescence for irradiation cancer in the heart and / or anthracycline area and compare them to determine whether irradiation of the heart area is associated with increased calcium score after adjustment for other cardiovascular risk factors (age, sex, smoking, dyslipidemia, obesity, diabetes, high blood pressure and renal failure).

primary_purpose: Prevention

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Gustave Roussy
Hôpital Trousseau
Hôpital Bichat


title: X-linked Hypophosphatemia and Carbohydrate and Lipid Metabolism: a Role for FGF21?

acronym: XLH 21

summary:
Fibroblast Growth Factor 23 and Fibroblast Growth Factor 21 are two endocrine Fibroblast Growth Factors, requiring Klotho as a co-factor to promote their systemic actions. Fibroblast Growth Factor 21 is involved in the regulation of glucid and lipid metabolism. Fibroblast Growth Factor 21 Knock Out mice display obesity and hyperglycemia.

In investigators experience, patients with X-linked hypophosphatemia often present with early-onset over-weight that could be partly explained by decreased physical activity because of bone pains and deformations after puberty; however, patients usually display progressive over-weight earlier in life, when there is no limitation of physical activity yet.

To the knowledge of investigators the association between Fibroblast Growth Factor 23, Fibroblast Growth Factor 21 and Klotho in patients with X-linked hypophosphatemia has never been evaluated. Thus, the main objective of this study is to evaluate the glucid and lipid metabolism in patients with X-linked hypophosphatemia, the main working hypothesis being that the genetic deregulation in the Fibroblast Growth Factor 23 axis in patients with X-linked hypophosphatemia induces modifications of Klotho levels (namely decreased levels) that in turn will deregulate the Fibroblast Growth Factor 21 axis (resistance to Fibroblast Growth Factor 21 because of decreased Klotho levels).

time_perspective: Cross-Sectional

location_facility: Centre de Référence des Maladies Rénales Rares - Centre de Référence des Maladies Rares du Calcium et du Phosphate - Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant

location_facility: Endocrinologie, Maladies Osseuses, Gynécologie, Génétique, Hôpital des Enfants, CHU de Toulouse

location_facility: Centre de Référence des Maladies Rares du Calcium et du Phosphore, Service d'Endocrinologie Pédiatrique - Hôpital du Kremlin Bicêtre


title: Healthcare Renunciation in Patient With Respiratory Chronic Disease and Treatment Compliance

acronym: OBSERVE

summary:
Health care renunciation is a factor that can alter patients' health status and increase the costs of its support.

To date, there is no national data on the renunciation of care. This study will initially characterize the different forms of health care renunciation in patients with chronic respiratory diseases, treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) , and analyze it impact on treatment compliance and health processes.

The follow-up of these patients during 5 years will define renunciation trajectories (transition from the state of "renouncing" to "non-renouncing" and vice versa) and their impact on treatment compliance.

The investigators hypothesize that a patient becoming renounced on a given treatment also decreases his treatment compliance (CPAP or NIV ).

The impact of the renunciation trajectory on the patient's follow-up in terms of hospitalizations and deaths will also be studied.

ReferenceCitation: Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.

ReferenceCitation: Deniz S, Sengul A, Aydemir Y, Celdir Emre J, Ozhan MH. Clinical factors and comorbidities affecting the cost of hospital-treated COPD. Int J Chron Obstruct Pulmon Dis. 2016 Dec 2;11:3023-3030. doi: 10.2147/COPD.S120637. eCollection 2016.

ReferenceCitation: Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Daabek N, Tamisier R, Foote A, Revil H, Joyeux-Jaure M, Pepin JL, Bailly S, Borel JC. Impact of Healthcare Non-Take-Up on Adherence to Long-Term Positive Airway Pressure Therapy. Front Public Health. 2021 Aug 17;9:713313. doi: 10.3389/fpubh.2021.713313. eCollection 2021.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
AGIR à Dom

location_facility:
Bruno LEPAULE
Centre Santé Sommeil
EFCR HP2 Laboratory


title: IBD-Disk Validation Study for Disability Assessment Functional of Patients With Inflammatory Diseases Intestinal Chronic

acronym: VALIDate

summary: Inflammatory Bowel Diseases (IBD) often affect psychological, family, social and professional dimensions of patients' life, leading to disability which is essential to quantify as part of Patient-Reported Outcomes (PROs) newly included in the therapeutic targets to reach in IBD patients. Up to now, the IBD-Disability Index (IBD-DI) was the only validated tool to assess functional status, but it is not appropriate for use in clinical practice. The IBD Disk was then developed, a shortened and self-administered tool, adapted from the IBD-DI, in order to give immediate representation of patient-reported disability. However, the IBD Disk has not been validated yet in clinical practice. The aims of the VALIDate study is to validate this tool in a large population of French IBD patients and to compare it to the already validated IBD-DI.

ReferenceCitation: Le Berre C, Bourreille A, Flamant M, Bouguen G, Siproudhis L, Dewitte M, Dib N, Cesbron-Metivier E, Goronflot T, Hanf M, Gourraud PA, Kerdreux E, Poinas A, Trang-Poisson C. Protocol of a multicentric prospective cohort study for the VALIDation of the IBD-disk instrument for assessing disability in inflammatory bowel diseases: the VALIDate study. BMC Gastroenterol. 2020 Apr 16;20(1):110. doi: 10.1186/s12876-020-01246-7.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
University Hospital, Angers
Rennes University Hospital

location_facility:
Rennes University Hospital
Angers University Hospital
Nantes University Hospital


type: Registry Identifier

title: Qi Gong as a Method of Craving Reduction in Severe Addict Patients

acronym: QICA

summary:
Craving arises in response to an affective tone that is associated with perceptual representations of a sensory object, rather than directly in response to the object.

The investigators presume that qi gong functions to decouple pleasant and unpleasant experience from habitual reactions by removing the affective bias that fuels such emotional reactivity. Qi gong training may specifically target the associated learning process with an emphasis on the critical link between affect and craving in an addictive loop.

location_facility:
Hôpital Saint ELOI
Groupe Hospitalier Pitié Salpêtrière
Hôpital L'ARCHET

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: QICA

titre: Le Qi gong, une méthode de réduction du craving dans le cadre d'une prise en charge addictologique complexe.

discipline_principale: médecine interne

nom_porteur: BAUMELOU

prenom_porteur: Alain


title: National, Multicentre, Pilot Study, to Evaluate Safety and Performance of the V-STRUT© Transpedicular Vertebral System Indicated for Vertebral Compression Fracture Treatment

summary: The purpose of this pilot study is to evaluate the safety and performance of the V-STRUT© Transpedicular Vertebral System for the treatment of vertebral compression fractures of the thoracic or lumbar spine.

ReferenceCitation: Cornelis FH, Tselikas L, Carteret T, Lapuyade B, De Baere T, Le Huec JC, Deschamps F. Percutaneous internal fixation with Y-STRUT(R) device to prevent both osteoporotic and pathological hip fractures: a prospective pilot study. J Orthop Surg Res. 2017 Feb 9;12(1):27. doi: 10.1186/s13018-017-0514-2.

ReferenceCitation: Cornelis FH, Deschamps F. Augmented osteoplasty for proximal femur consolidation in cancer patients: Biomechanical considerations and techniques. Diagn Interv Imaging. 2017 Sep;98(9):645-650. doi: 10.1016/j.diii.2017.06.014. Epub 2017 Jul 27.

ReferenceCitation: Cornelis FH, Tselikas L, Carteret T, Lapuyade B, De Baere T, Cabane V, Rodrigues L, Maas C, Deschamps F. A Novel Implant for the Prophylactic Treatment of Impending Pathological Fractures of the Proximal Femur: Results from a Prospective, First-in-Man Study. Cardiovasc Intervent Radiol. 2017 Jul;40(7):1070-1076. doi: 10.1007/s00270-017-1613-5. Epub 2017 Feb 23.

ReferenceCitation: Szpalski M,Le Huec JC, Jayankura M, Reynders P, Maas C(2017) Contralateral Prophylactic Reinforcement in Case of First Low-Energy Hip Fracture: First-in-Man Clinical Data of a New Percutaneous Internal Fixation Device. J Osteopor Phys Act 5:202. doi:10.4172/2329-9509.100020

ReferenceCitation: Upasani VV, Robertson C, Lee D, Tomlinson T, Mahar AT. Biomechanical comparison of kyphoplasty versus a titanium mesh implant with cement for stabilization of vertebral compression fractures. Spine (Phila Pa 1976). 2010 Sep 1;35(19):1783-8. doi: 10.1097/BRS.0b013e3181b7cc5d.

ReferenceCitation: Ghofrani H, Nunn T, Robertson C, Mahar A, Lee Y, Garfin S. An evaluation of fracture stabilization comparing kyphoplasty and titanium mesh repair techniques for vertebral compression fractures: is bone cement necessary? Spine (Phila Pa 1976). 2010 Jul 15;35(16):E768-73. doi: 10.1097/BRS.0b013e3181d260bf.

ReferenceCitation: Belkoff SM, Mathis JM, Jasper LE. Ex vivo biomechanical comparison of hydroxyapatite and polymethylmethacrylate cements for use with vertebroplasty. AJNR Am J Neuroradiol. 2002 Nov-Dec;23(10):1647-51.

ReferenceCitation: Rodrigues DC, Ordway NR, Ma CR, Fayyazi AH, Hasenwinkel JM. An ex vivo exothermal and mechanical evaluation of two-solution bone cements in vertebroplasty. Spine J. 2011 May;11(5):432-9. doi: 10.1016/j.spinee.2011.02.012. Epub 2011 Apr 11.

ReferenceCitation: Tutton SM, Pflugmacher R, Davidian M, Beall DP, Facchini FR, Garfin SR. KAST Study: The Kiva System As a Vertebral Augmentation Treatment-A Safety and Effectiveness Trial: A Randomized, Noninferiority Trial Comparing the Kiva System With Balloon Kyphoplasty in Treatment of Osteoporotic Vertebral Compression Fractures. Spine (Phila Pa 1976). 2015 Jun 15;40(12):865-75. doi: 10.1097/BRS.0000000000000906.

ReferenceCitation: Dohm M, Black CM, Dacre A, Tillman JB, Fueredi G; KAVIAR investigators. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2014 Dec;35(12):2227-36. doi: 10.3174/ajnr.A4127. Epub 2014 Oct 9.

ReferenceCitation: Olivarez LM, Dipp JM, Escamilla RF, Bajares G, Perez A, Stubbs HA, Block JE. Vertebral augmentation treatment of painful osteoporotic compression fractures with the Kiva VCF Treatment System. SAS J. 2011 Dec 1;5(4):114-9. doi: 10.1016/j.esas.2011.06.001. eCollection 2011.

ReferenceCitation: Wang CH, Ma JZ, Zhang CC, Nie L. Comparison of high-viscosity cement vertebroplasty and balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Pain Physician. 2015 Mar-Apr;18(2):E187-94.

ReferenceCitation: Li X, Yang H, Tang T, Qian Z, Chen L, Zhang Z. Comparison of kyphoplasty and vertebroplasty for treatment of painful osteoporotic vertebral compression fractures: twelve-month follow-up in a prospective nonrandomized comparative study. J Spinal Disord Tech. 2012 May;25(3):142-9. doi: 10.1097/BSD.0b013e318213c113.

ReferenceCitation: Deschamps F, de Baere T. Cementoplasty of bone metastases. Diagn Interv Imaging. 2012 Sep;93(9):685-689. doi: 10.1016/j.diii.2012.06.009. Epub 2012 Aug 11.

ReferenceCitation: Kobayashi N, Numaguchi Y, Fuwa S, Uemura A, Matsusako M, Okajima Y, Ishiyama M, Takahashi O. Prophylactic vertebroplasty: cement injection into non-fractured vertebral bodies during percutaneous vertebroplasty. Acad Radiol. 2009 Feb;16(2):136-43. doi: 10.1016/j.acra.2008.05.005.

ReferenceCitation: Otten LA, Bornemnn R, Jansen TR, Kabir K, Pennekamp PH, Wirtz DC, Stuwe B, Pflugmacher R. Comparison of balloon kyphoplasty with the new Kiva(R) VCF system for the treatment of vertebral compression fractures. Pain Physician. 2013 Sep-Oct;16(5):E505-12.

ReferenceCitation: Yang EZ, Xu JG, Huang GZ, Xiao WZ, Liu XK, Zeng BF, Lian XF. Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study. Spine (Phila Pa 1976). 2016 Apr;41(8):653-60. doi: 10.1097/BRS.0000000000001298.

ReferenceCitation: Korovessis P, Vardakastanis K, Repantis T, Vitsas V. Balloon kyphoplasty versus KIVA vertebral augmentation--comparison of 2 techniques for osteoporotic vertebral body fractures: a prospective randomized study. Spine (Phila Pa 1976). 2013 Feb 15;38(4):292-9. doi: 10.1097/BRS.0b013e31826b3aef. Erratum In: Spine (Phila Pa 1976). 2013 Nov 1;38(23):E1506.

ReferenceCitation: Shindle MK, Gardner MJ, Koob J, Bukata S, Cabin JA, Lane JM. Vertebral height restoration in osteoporotic compression fractures: kyphoplasty balloon tamp is superior to postural correction alone. Osteoporos Int. 2006 Dec;17(12):1815-9. doi: 10.1007/s00198-006-0195-x. Epub 2006 Sep 16.

ReferenceCitation: Liu JT, Li CS, Chang CS, Liao WJ. Long-term follow-up study of osteoporotic vertebral compression fracture treated using balloon kyphoplasty and vertebroplasty. J Neurosurg Spine. 2015 Jul;23(1):94-8. doi: 10.3171/2014.11.SPINE14579. Epub 2015 Apr 17.

ReferenceCitation: Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.

ReferenceCitation: Chen D, An ZQ, Song S, Tang JF, Qin H. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. 2014 Mar;21(3):473-7. doi: 10.1016/j.jocn.2013.05.017. Epub 2013 Aug 8.

ReferenceCitation: Comstock BA, Sitlani CM, Jarvik JG, Heagerty PJ, Turner JA, Kallmes DF. Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year. Radiology. 2013 Oct;269(1):224-31. doi: 10.1148/radiol.13120821. Epub 2013 May 21.

ReferenceCitation: Tan HY, Wang LM, Zhao L, Liu YL, Song RP. A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture. Pain Res Manag. 2015 Jan-Feb;20(1):e8-e11. doi: 10.1155/2015/181487. Epub 2014 Jun 19.

ReferenceCitation: Korovessis P, Repantis T, Miller LE, Block JE. Initial clinical experience with a novel vertebral augmentation system for treatment of symptomatic vertebral compression fractures: a case series of 26 consecutive patients. BMC Musculoskelet Disord. 2011 Sep 22;12:206. doi: 10.1186/1471-2474-12-206.

ReferenceCitation: Yi X, Lu H, Tian F, Wang Y, Li C, Liu H, Liu X, Li H. Recompression in new levels after percutaneous vertebroplasty and kyphoplasty compared with conservative treatment. Arch Orthop Trauma Surg. 2014 Jan;134(1):21-30. doi: 10.1007/s00402-013-1886-3. Epub 2013 Nov 28.

ReferenceCitation: Vogl TJ, Pflugmacher R, Hierholzer J, Stender G, Gounis M, Wakhloo A, Fiebig C, Hammerstingl R. Cement directed kyphoplasty reduces cement leakage as compared with vertebroplasty: results of a controlled, randomized trial. Spine (Phila Pa 1976). 2013 Sep 15;38(20):1730-6. doi: 10.1097/BRS.0b013e3182a14d15.

ipd_sharing_description:
The data analysis of the investigation will carry out a final report that will be sent to the CPP and ANSM.

According to the law N°2002-303 dated March 4, 2002, the patients involved in the study will be informed on demand on the global data analysis.

Regarding publication, if the data analysis provides important and interesting information on the device and its associated procedure for the treatment of vertebral compression fracture which aims to complete the state of the art, it may be decided to publish the corresponding data. In this case, the IPD that will be shared will consists of all IPD that underlie results in this publication.

lead_sponsor: Hyprevention

location_facility:
Institut Gustave Roussy
APHP - Hôpital Tenon
Polyclinique Bordeaux Nord Aquitaine


title: Creation of a Tool to Assess Quality of Life in Patient With Auto-inflammatory Diseases

acronym: MAI-PATIENT

summary: This qualitative interview-based study aim to build a tool to assess quality of life in patients (adults or children) suffering from 6 autoinflammatory diseases (FMF, TRAPS, CAPS, MKD, Still and PFAPA).

location_facility:
Dr Maryam PIRAM
CH André Mignot
TENON

acronyme: MAI-PATIENT

titre: Création d'un outil d'évaluation de la qualité de vie chez les patients atteints de maladies auto-inflammatoires.

discipline_principale: autre

nom_porteur: PIRAM

prenom_porteur: Maryam


title: Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine

acronym: GEN-EPA

summary: The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.

location_facility: Cabinet médical des Docteurs Le Vagueres et Godard,


title: Medico-economic Assessment of a "IsereADOM" Package of Services Versus Conventional Monitoring in the Care of a Population of Frail Elderly People With Loss of Autonomy.

acronym: PARC

summary:
The goal of this study is to evaluate the effectiveness of the IsereADOM service package compared to conventional follow-up on the risk of recurrence of falls at 6 months in frail elderly subjects.

There is a medico-economic goal too, is to conduct a cost-utility analysis of the IsereADOM service bundle compared to conventional 6-month follow-up from the community perspective in the cheat population at risk of re-offending.

primary_purpose: Health Services Research

ReferenceCitation: Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.

ReferenceCitation: Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.

ReferenceCitation: Gates S, Smith LA, Fisher JD, Lamb SE. Systematic review of accuracy of screening instruments for predicting fall risk among independently living older adults. J Rehabil Res Dev. 2008;45(8):1105-16.

ReferenceCitation: Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.

ReferenceCitation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944.

location_facility:
CHU Grenoble-Alpes
Centre Hospitalier de Voiron
Centre Hospitalier Pierre Oudot


title: Short-, Medium- and Long-term (up to 3 Years) Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.

acronym: BIORELICA

summary: The investigators will evaluate the benefit of a new bioresorbable screw for repair of anterior cruciate ligament over 3 years.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Centre Régina
CHU Nimes
Polyclinique Urbain V


title: Validation of the French Version of the Three Scales for Assessing the Fear of Type 1 Hypoglycemia (HFS-C, HFS-PYC and HFS-P) in Children, Adolescents and Their Parents by a Monocentric Transverse Psychometric Study

acronym: FHS

summary:
Type 1 diabetes usually appears brutally in children or young adults. While many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is the most common acute complications. It would be an important physiological and psychological barrier for the patient and his parents to manage this diabetes, the latter seeking to keep the blood glucose levels above the objectives in order to avoid the occurrence of a hypoglycemia, especially nocturnal.

If there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia (HFS, Hypoglycemia Fear Survey is available in three versions: L'HFS-Child (HFS-C) for children over 6 years old, HFS-Parents of Young children ( HFS-PYC) for parents of young children (under 8 years of age) and HFS-Parents (HFS-P)) for parents of children over 8 years of age, on the other hand, there are no French and no French studies have evaluated the prevalence and impact of the fear of hypoglycemia in French patients with type 1 diabetes.

It is therefore essential to use a reliable and valid tool to identify patients affected by the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an optimum quality of life. Having a tool in French and validated on the scientific level would allow to propose adapted therapeutic treatments (psychological follow-up, individual or collective sessions of therapeutic education, material assistance (sensor of blood glucose, pump with insulin stop...) In order to both improve metabolic balance while increasing the quality of life of patients by lowering secondary anxiety to hypoglycemia

lead_sponsor: University Hospital, Brest

location_facility:
Centre Hospitalier de Bretagne Sud
Hôpital Universitaire Robert-Debré
CHRU de Brest


title: Semantic and Syntactic Computerized Analysis of Free Speech

acronym: ASESID

summary: Subtle speech disorganization could be predictive of a transition to schizophrenia of ultra-high-risk patients. The aim of our longitudinal multicenter cohort study is to identify specific linguistic markers of the psychotic transition to validate a french predictive model of this transition using computerized speech analysis techniques

location_facility:
CH de SAINT ANNE
CHRU de Brest
Meunier Sophie


title: Pharmacologic Interaction Between Ifosfamide and Aprepitant in Treated Patients With Soft Tissue Sarcoma

acronym: IPIAP-STM

summary:
This trial is a multicentric study aiming to assess the evolution of the serum ifosfamide concentrations and its serum metabolites in patients treated for an Soft Tissue Sarcoma and co-exposed to Aprepitant.

The study will be conducted on a population of patients treated with Doxorubicin and Ifosfamide. The Aprepitant can be prescribed to patients from cycle 2, according to the current recommendations. Doxorubicin, Ifosfamide and Aprepitant will be administered in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

Patients will be followed during the two first cycles of treatment. For the pharmacokinetic study, blood samples will be collected at different time points during the 2 treatment cycles.

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole

location_facility: Institut Regional Du Cancer de Montpellier (Icm)


title: Effet de la tDCS Sur l'impulsivité Chez Les Personnes Souffrant d'un Trouble Borderline : TIMBER

acronym: TIMBER

summary: The study aims to evaluate the impact of transcranial direct current stimulation (tDCS) on impulsiveness of adults suffering from Borderline Personality Disorder. Short- and long-term effects are assessed by electroencephalography (EEG) records, experimental tasks and self-rated scales.

ReferenceCitation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

oa_host_type: repository

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

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

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: University of Nottingham - Nottingham ePrints

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Teti Mayer J, Nicolier M, Gabriel D, Masse C, Giustiniani J, Compagne C, Vandel P, Pazart L, Haffen E, Bennabi D. Efficacy of transcranial direct current stimulation in reducing impulsivity in borderline personality disorder (TIMBER): study protocol of a randomized controlled clinical trial. Trials. 2019 Jun 10;20(1):347. doi: 10.1186/s13063-019-3427-z.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Pôle Hospitalo-Universitaire de Psychiatrie du Grand Nancy

location_facility: Centre Hospitalier Spécialisé de Rouffach


title: Improving the Headache Management Care in the Emergency Unit by Using a Biological Marker: S100B Protein.

summary: The purpose of this study is to determine the negative predictive value of protein S100B that could exclude subarachnoid and intracranial haemorrhage for patient that present severe headache within the last 3 hours.

ReferenceCitation: Latinovic R, Gulliford M, Ridsdale L. Headache and migraine in primary care: consultation, prescription, and referral rates in a large population. J Neurol Neurosurg Psychiatry. 2006 Mar;77(3):385-7. doi: 10.1136/jnnp.2005.073221.

ReferenceCitation: Edlow JA, Panagos PD, Godwin SA, Thomas TL, Decker WW; American College of Emergency Physicians. Clinical policy: critical issues in the evaluation and management of adult patients presenting to the emergency department with acute headache. Ann Emerg Med. 2008 Oct;52(4):407-36. doi: 10.1016/j.annemergmed.2008.07.001.

ReferenceCitation: Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53. doi: 10.1097/01.shk.0000209534.61058.35.

ReferenceCitation: Gilbert JW, Johnson KM, Larkin GL, Moore CL. Atraumatic headache in US emergency departments: recent trends in CT/MRI utilisation and factors associated with severe intracranial pathology. Emerg Med J. 2012 Jul;29(7):576-81. doi: 10.1136/emermed-2011-200088. Epub 2011 Aug 19.

ReferenceCitation: Morgenstern LB, Huber JC, Luna-Gonzales H, Saldin KR, Grotta JC, Shaw SG, Knudson L, Frankowski RF. Headache in the emergency department. Headache. 2001 Jun;41(6):537-41. doi: 10.1046/j.1526-4610.2001.041006537.x.

ReferenceCitation: Edlow JA, Caplan LR. Avoiding pitfalls in the diagnosis of subarachnoid hemorrhage. N Engl J Med. 2000 Jan 6;342(1):29-36. doi: 10.1056/NEJM200001063420106. No abstract available.

ReferenceCitation: Muller P, Mitri F, Houlle A, Vidal PO, Gasperini G, Cazes N, Renard A. S100ss protein for non-traumatic subarachnoid hemorrhage diagnosis. Am J Emerg Med. 2022 Jul;57:39-41. doi: 10.1016/j.ajem.2022.04.030. Epub 2022 Apr 25.

ipd_sharing_description: There is no IPD sharing plan

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Hôpital d'Instruction des Armées Laveran

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne-sur-Mer

location_facility: Hôpital d'Instruction des Armées Sainte Anne


title: Longitudinal Study of Cognition in Primary Progressive Multiple Sclerosis: a Cohort Study

acronym: PRO-COG

summary:
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40 and 60%. Cognitive impairment affects quality of life and vocational status in MS patients.

Until recently, little information was available on the cognitive dysfunction and their evolution that occur in primary progressive multiple sclerosis (PPMS) as compared with relapsing-remitting MS (RRMS). In PPMS pathological studies have shown the importance of cortical demyelination and meningeal inflammation suggesting that the GM alteration could play a major role in the cognitive impairment in this phenotype. The cognitive evolution and the brain tissue alteration at the origin of these difficulties remain poorly understood in PPMS. The use of new techniques for morphological and functional MRI can study the contribution of diffuse White Matter (WM) alteration (probably through disconnexion of relevant network) and diffuse Grey matter (GM) alterations in the cerebral cortex and other structures (the hippocampi, the cerebellum, and the thalami) in cognitive impairment in PPMS patients and on their evolution.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Roche Pharma AG

location_facility:
CHU de Poitiers
CHU de Bordeaux
CHU de Limoges


title: Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM).

acronym: DECLAM

summary: Neutropenia after induction or consolidation therapy for acute myeloid leukemia (AML) patients is associated with a high morbi-mortality rates, especially due to infectious complications. These are managed according to international recommandations (ECIL and IDSA) with antibiotherapy and antifungal strategy. Although the patients suffer of digestive symptoms, intestinale complications are really less explored. Neutropenic enterocolitis (NE), cytomegalovirus (CMV) colitis, Clostridium difficile colitis, specific lesion, ischemic colitis are not well-known. No prospective study evaluate NE and these digestive complications which have high morbi-mortality rates.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

location_facility:
Henri Becquerel Center
CHU Amiens-Picardie
CHU de Caen

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

acronyme: DECLAM

titre: Incidence des complications digestives du patient neutropénique fébrile lors du traitement d'induction et de consolidation intensive des leucémies aiguës myéloïdes.

discipline_principale: leucémie aiguë myéloïde, neutropénie fébrile, entérocolite du neutropénique, complications digestives, tdm abdominale

nom_porteur: LEBON

prenom_porteur: Delphine


title: Assessment of Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling for ICU Patients With Mechanical Ventilation. The EVALDM Study

acronym: EVALDM

summary: Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.

lead_sponsor: Centre Hospitalier Metropole Savoie

location_facility:
CHU Grenoble Alpes
Ch Bourg En Bresse
Centre Hospitalier Metropole Savoie


title: Development and Validation of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations Aged 11 to 15 Years-old.

acronym: MVFL

summary:
The low-flow malformations include venous and lymphatic malformations. The malformation often affects the skin and can extend deep to the muscles and bone, as well as to deep organs. Children with low-flow vascular malformation and their family have difficulty living with their illness and have an impact on their life quality.

In this context, the aim of the study is to develope life quality test for the children between 11 to 15 years old.

lead_sponsor: University Hospital, Toulouse

location_facility: UHBordeaux UHNantes UHChambray

intervention_type: Behavioral


title: Reference Curve on Bone Mineral Density in Men

summary: In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are the three factors that explain the lower incidence of osteoporosis in men.

ReferenceCitation: Abrahamsen B, Hansen TB, Jensen LB, Hermann AP, Eiken P. Site of osteodensitometry in perimenopausal women: correlation and limits of agreement between anatomic regions. J Bone Miner Res. 1997 Sep;12(9):1471-9. doi: 10.1359/jbmr.1997.12.9.1471.

ReferenceCitation: Smotherman MS, Narins PM. Effect of temperature on electrical resonance in leopard frog saccular hair cells. J Neurophysiol. 1998 Jan;79(1):312-21. doi: 10.1152/jn.1998.79.1.312.

ReferenceCitation: Baumgartner RN. Body composition in elderly persons: a critical review of needs and methods. Prog Food Nutr Sci. 1993 Jul-Sep;17(3):223-60.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHU de Saint Etienne
Hopital Lariboisiere
CHU Amiens


title: TOXODIAG: New Diagnostic Approach for Congenital Toxoplasmosis

acronym: TOXODIAG

summary:
Caused by Toxoplasma gondii, toxoplasmosis is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental passage of the parasite, which occurs in 30% of cases of primary infection during pregnancy. Neonatal biological diagnosis of toxoplasmosis is essential in the case of (i) suggestive clinical signs in the newborn with no information on the serological status of the mother, (ii) seroconversion diagnosed during pregnancy, (iii) not or poorly followed pregnancy, and (iiii) for enhanced effectiveness of treatments administered as soon as possible to the newborn. Given the limitations of current diagnostic tests, the characterization of specific immunoglobulin (Ig)G neo-synthesized by the newborn would be of great help for an early diagnosis of CT.

The main objective of the TOXODIAG project is to validate and evaluate the ELISPOT (Enzyme-Linked Immunosorbent SPOT assay) method for detecting, in the newborn, B lymphocytes (LyB) sensitized in utero to produce T. gondii specific immunoglobulins (Ig) following a primary infection of the mother during the pregnancy. More precisely, the detection and quantification of LyB secreting IgG and IgM specific for T. gondii using the ELISPOT method will be applied i) to mononuclear cells of women in seroconversion following a toxoplasmic primo-infection during pregnancy and ii) to cord blood mononuclear cells of newborns suspected of CT, in comparison to positive and negative infection controls.

To reach this goal, TOXODIAG is a diagnostic, multicentric, prospective, non-randomized, comparative and controlled study. It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP (Louis MOURIER, Bichat-Claude Bernard and Cochin) which ensure mother/child follow-up and biological sampling, with great gynecology and obstetrics expertise. Sixty women will be selected and included into 3 groups according to toxoplasmic seroconversion during pregnancy (n=30), positive (n=15) or negative (n=15) toxoplasma serology. The necessary biological material will consist in additional blood tubes which will be taken at the same time as those performed for the usual pregnancy follow-up examinations and will correspond to maternal peripheral blood at inclusion, seroconversion and delivery as well as cord blood.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hopital Louis Mourier
Hopital Cochin
Hopital Bichat


title: Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure

summary:
The software embedded in recent continuous positive pressure devices enables the analysis of the level of leakage that occurs during treatment around the mask or from the mouth. However, there is no clear threshold defining when it would be appropriate to implement means for correcting these leaks. In addition, the calculation methods used to detect/measure leaks and the terminology used vary according to the manufacturers of continuous pressure devices, which also complicates the clinical interpretation of the leakage reports provided by the various devices.

In daily practice, when a patient complains of unintentional leakage, technicians adjust the mask, replace the nasal-mask by an oro-nasal mask or install a chinstrap. Nevertheless, those strategies are not always effective in reducing leakage or patient's complaints. A better understanding of the mechanisms beyond leak appearance for a given patient could lead to individualised leak-treatment solutions. Pressure level, mandibular behaviour, respiratory effort, sleep position or sleep stages may contribute to leak emergence.

A recent exploratory study has proposed a genuine analysis method of determining factors of unintentional-leaks using polysomnographic recordings in OSA patients treated with automatic Continuous Positive Airway Pressure (auto-CPAP). Based on the same methodology, the NOMICS company (Liège, Belgium) has developed a polygraphic device (Brizzy®) recording unintentional leakage during auto-CPAP treatment and providing an etiological analysis of unintentional-leaks via a software named APIOS.

Due to the innovative nature of the analysis, it appears necessary to validate it onto a population of OSA patients treated with auto-CPAP. Also, to our knowledge, there is no descriptive data of the distribution of the determinants of unintentional leaks in such a population. From this perspective, the investigators aim to retrospectively analyse some polygraphic recordings that have been performed with the Brizzy® on OSA patients treated with auto-CPAP.

The primary objective of this study is to identify and describe the determinants of unintentional leaks for a population of patients with OSA and treated with an auto-CPAP device

ReferenceCitation: Lebret M, Arnol N, Martinot JB, Lambert L, Tamisier R, Pepin JL, Borel JC. Determinants of Unintentional Leaks During CPAP Treatment in OSA. Chest. 2018 Apr;153(4):834-842. doi: 10.1016/j.chest.2017.08.017. Epub 2017 Aug 26.

ReferenceCitation: Lebret M, Jaffuel D, Suehs CM, Mallet JP, Lambert L, Rotty MC, Pepin JL, Matzner-Lober E, Molinari N, Borel JC. Feasibility of Type 3 Polygraphy for Evaluating Leak Determinants in CPAP-Treated OSA Patients: A Step Toward Personalized Leak Management. Chest. 2020 Nov;158(5):2165-2171. doi: 10.1016/j.chest.2020.05.593. Epub 2020 Jun 13.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repositories_concat: HAL

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospital of Grenoble
Hôpital Arnaud de Villeneuve
Polyclinic Saint-Privat


title: A Prospective RegistrY of Cardiac Echographic Loops

acronym: ARYEL

summary:
CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated treatment of AS, i.e. TAVI (Transcatheter Aortic Valve Implantation) or SAVR (Surgical Aortic Valve Replacement). This therapy consists in focusing ultrasound on aortic valve transthoracically and use high energy to soften calcification from the target valve. In order to do so, we develop a device able to deliver high energy ultrasounds to a targeted valve thanks to the synchronization of patient hearts live imaging and therapy in real time.

Live imaging will use an algorithm to realize 'valve tracking': an automatic detection of aortic valve position and shape as fast as image acquisition time. In order to develop and validate this 'valve tracking' algorithm, CARDIAWAVE requires cardiac echographic loops of patients with aortic valve calcification, with 30 seconds or 60 seconds recording.

The objective of the present study is to develop and validate the 'valve tracking' processing algorithm of CARDIAWAVE.

ARYEL is a prospective, multicenter, non-interventional study.

lead_sponsor: Cardiawave SA

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Charles Nicolle
CHU de Caen


title: Innovative Strategies for Perinatal Infectious Risk Reduction

acronym: InSPIRe

summary: The purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections.

ReferenceCitation: Joubrel C, Tazi A, Six A, Dmytruk N, Touak G, Bidet P, Raymond J, Trieu Cuot P, Fouet A, Kerneis S, Poyart C. Group B streptococcus neonatal invasive infections, France 2007-2012. Clin Microbiol Infect. 2015 Oct;21(10):910-6. doi: 10.1016/j.cmi.2015.05.039. Epub 2015 Jun 5.

ReferenceCitation: Dussaux C, Senat MV, Bouchghoul H, Benachi A, Mandelbrot L, Kayem G. Preterm premature rupture of membranes: is home care acceptable? J Matern Fetal Neonatal Med. 2018 Sep;31(17):2284-2292. doi: 10.1080/14767058.2017.1341482. Epub 2017 Jul 6.

ReferenceCitation: Kayem G, Batteux F, Girard N, Schmitz T, Willaime M, Maillard F, Jarreau PH, Goffinet F. Predictive value of vaginal IL-6 and TNFalpha bedside tests repeated until delivery for the prediction of maternal-fetal infection in cases of premature rupture of membranes. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:8-14. doi: 10.1016/j.ejogrb.2017.01.013. Epub 2017 Jan 12.

ReferenceCitation: Lorthe E, Ancel PY, Torchin H, Kaminski M, Langer B, Subtil D, Sentilhes L, Arnaud C, Carbonne B, Debillon T, Delorme P, D'Ercole C, Dreyfus M, Lebeaux C, Galimard JE, Vayssiere C, Winer N, L'Helias LF, Goffinet F, Kayem G. Impact of Latency Duration on the Prognosis of Preterm Infants after Preterm Premature Rupture of Membranes at 24 to 32 Weeks' Gestation: A National Population-Based Cohort Study. J Pediatr. 2017 Mar;182:47-52.e2. doi: 10.1016/j.jpeds.2016.11.074. Epub 2017 Jan 9.

ReferenceCitation: Delorme P, Goffinet F, Ancel PY, Foix-L'Helias L, Langer B, Lebeaux C, Marchand LM, Zeitlin J, Ego A, Arnaud C, Vayssiere C, Lorthe E, Durrmeyer X, Sentilhes L, Subtil D, Debillon T, Winer N, Kaminski M, D'Ercole C, Dreyfus M, Carbonne B, Kayem G. Cause of Preterm Birth as a Prognostic Factor for Mortality. Obstet Gynecol. 2016 Jan;127(1):40-48. doi: 10.1097/AOG.0000000000001179.

ReferenceCitation: Plainvert C, El Alaoui F, Tazi A, Joubrel C, Anselem O, Ballon M, Frigo A, Branger C, Mandelbrot L, Goffinet F, Poyart C. Intrapartum group B Streptococcus screening in the labor ward by Xpert(R) GBS real-time PCR. Eur J Clin Microbiol Infect Dis. 2018 Feb;37(2):265-270. doi: 10.1007/s10096-017-3125-2. Epub 2017 Oct 29.

ReferenceCitation: Six A, Firon A, Plainvert C, Caplain C, Bouaboud A, Touak G, Dmytruk N, Longo M, Letourneur F, Fouet A, Trieu-Cuot P, Poyart C. Molecular Characterization of Nonhemolytic and Nonpigmented Group B Streptococci Responsible for Human Invasive Infections. J Clin Microbiol. 2016 Jan;54(1):75-82. doi: 10.1128/JCM.02177-15. Epub 2015 Oct 21. Erratum In: J Clin Microbiol. 2016 Jul;54(7):1932.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Bforcure
BPIfrance
INSERM U1153
Institut Cochin
INSERM IAME UMR 1137

location_facility:
Hopital Louis Mourier
Hôpital Cochin
Hopital Bichat


title: SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly

acronym: SAMPHYR

summary:
Sarcopenia is associated with lower prognosis in solid tumors, but this has not been studied in bladder carcinoma requiring cystectomy.

According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking speed, grip strength and muscle mass. These three elements can easily be measured (specially muscle mass measurement by bioimpedencemetry or tomodensitometry).

This cohort study will collect clinical complementary elements to better understand the associated factors present with sarcopenia, in order to prepare an interventional preoperative physical reconditioning study.

The mobility measurement will be carried out by the QAPPA questionnaire (validated in French in the elderly) and the quantitative measurement of activity and rest hours during a week by a wrist actimeter.

Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP tool for potentially inappropriate medication.

Post-operative morbidity mortality at 30 days will be evaluated according to Clavien-Dindo classification. Investigators will also evaluate 6 months geriatric complications : falls, loss of autonomy and decreased mobility and physical activity, cognitive degradation, undernutrition, institutionalization

ReferenceCitation: Audisio RA, Bozzetti F, Gennari R, Jaklitsch MT, Koperna T, Longo WE, Wiggers T, Zbar AP. The surgical management of elderly cancer patients; recommendations of the SIOG surgical task force. Eur J Cancer. 2004 May;40(7):926-38. doi: 10.1016/j.ejca.2004.01.016.

ReferenceCitation: Huisman MG, van Leeuwen BL, Ugolini G, Montroni I, Spiliotis J, Stabilini C, de'Liguori Carino N, Farinella E, de Bock GH, Audisio RA. "Timed Up & Go": a screening tool for predicting 30-day morbidity in onco-geriatric surgical patients? A multicenter cohort study. PLoS One. 2014 Jan 24;9(1):e86863. doi: 10.1371/journal.pone.0086863. eCollection 2014. Erratum In: PLoS One. 2014;9(7):e103907. de'Liguori Carino, Nicola [corrected to Carino, Nicola de'Liguori]. PLoS One. 2016;11(1):e0147993.

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher_dissemination: Public Library of Science

ReferenceCitation: Shachar SS, Williams GR, Muss HB, Nishijima TF. Prognostic value of sarcopenia in adults with solid tumours: A meta-analysis and systematic review. Eur J Cancer. 2016 Apr;57:58-67. doi: 10.1016/j.ejca.2015.12.030. Epub 2016 Feb 13.

ReferenceCitation: Psutka SP, Carrasco A, Schmit GD, Moynagh MR, Boorjian SA, Frank I, Stewart SB, Thapa P, Tarrell RF, Cheville JC, Tollefson MK. Sarcopenia in patients with bladder cancer undergoing radical cystectomy: impact on cancer-specific and all-cause mortality. Cancer. 2014 Sep 15;120(18):2910-8. doi: 10.1002/cncr.28798. Epub 2014 May 19.

ReferenceCitation: Smith AB, Deal AM, Yu H, Boyd B, Matthews J, Wallen EM, Pruthi RS, Woods ME, Muss H, Nielsen ME. Sarcopenia as a predictor of complications and survival following radical cystectomy. J Urol. 2014 Jun;191(6):1714-20. doi: 10.1016/j.juro.2013.12.047. Epub 2014 Jan 11.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: University Hospital, Caen

location_facility:
Rouen UH
APHM
Caen University Hospital


title: A Phase II Trial Aiming to Evaluate the Clinical Interest of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6

acronym: ABORL

summary:
This trial is an open-label, single arm, Phase II study using an A'Hern single stage design.

The molecular prescreening step will allow to defined HPV tumor status as well as molecular status CDKN2A, CCND1 and CDK6. Following this centralized molecular screening, only patients with HPV negative status and with tumor harboring CDKN2A homozygous deletion and/or CCND1 amplification and/or CDK6 amplification could initiate abemaciclib at time of documented radiological progression. Patients will be treated with ABEMACICLIB, 400 mg/day with 2 doses of 200 mg 12 hour apart (QH12). A cycle is defined as an interval of 28 days. For each 28-day cycle, a total of 56 doses of study drug will be dispensed.

ReferenceCitation: Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. doi: 10.1056/NEJM199301213280306. No abstract available.

ReferenceCitation: Molin Y, Fayette J. Current chemotherapies for recurrent/metastatic head and neck cancer. Anticancer Drugs. 2011 Aug;22(7):621-5. doi: 10.1097/CAD.0b013e3283421f7c.

ReferenceCitation: Vermorken JB, Trigo J, Hitt R, Koralewski P, Diaz-Rubio E, Rolland F, Knecht R, Amellal N, Schueler A, Baselga J. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007 Jun 1;25(16):2171-7. doi: 10.1200/JCO.2006.06.7447.

ReferenceCitation: Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

ReferenceCitation: Fayette J, Montella A, Chabaud S, Bachelot T, Pommier P, Girodet D, Racadot S, Montbarbon X, Favier B, Zrounba P. Paclitaxel is effective in relapsed head and neck squamous cell carcinoma: a retrospective study of 66 patients at a single institution. Anticancer Drugs. 2010 Jun;21(5):553-8. doi: 10.1097/CAD.0b013e3283388e60.

ReferenceCitation: Ortega S, Malumbres M, Barbacid M. Cyclin D-dependent kinases, INK4 inhibitors and cancer. Biochim Biophys Acta. 2002 Mar 14;1602(1):73-87. doi: 10.1016/s0304-419x(02)00037-9.

ReferenceCitation: Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol. 2006 Apr 10;24(11):1770-83. doi: 10.1200/JCO.2005.03.7689.

ReferenceCitation: Sherr CJ, Roberts JM. CDK inhibitors: positive and negative regulators of G1-phase progression. Genes Dev. 1999 Jun 15;13(12):1501-12. doi: 10.1101/gad.13.12.1501. No abstract available.

ReferenceCitation: Michalides RJ, van Veelen NM, Kristel PM, Hart AA, Loftus BM, Hilgers FJ, Balm AJ. Overexpression of cyclin D1 indicates a poor prognosis in squamous cell carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 1997 May;123(5):497-502. doi: 10.1001/archotol.1997.01900050045005.

ReferenceCitation: Akervall JA, Michalides RJ, Mineta H, Balm A, Borg A, Dictor MR, Jin Y, Loftus B, Mertens F, Wennerberg JP. Amplification of cyclin D1 in squamous cell carcinoma of the head and neck and the prognostic value of chromosomal abnormalities and cyclin D1 overexpression. Cancer. 1997 Jan 15;79(2):380-9.

ReferenceCitation: Liggett WH Jr, Sewell DA, Rocco J, Ahrendt SA, Koch W, Sidransky D. p16 and p16 beta are potent growth suppressors of head and neck squamous carcinoma cells in vitro. Cancer Res. 1996 Sep 15;56(18):4119-23.

ReferenceCitation: Kothari V, Mulherkar R. Inhibition of cyclin D1 by shRNA is associated with enhanced sensitivity to conventional therapies for head and neck squamous cell carcinoma. Anticancer Res. 2012 Jan;32(1):121-8.

ReferenceCitation: Chung CH, Zhang Q, Kong CS, Harris J, Fertig EJ, Harari PM, Wang D, Redmond KP, Shenouda G, Trotti A, Raben D, Gillison ML, Jordan RC, Le QT. p16 protein expression and human papillomavirus status as prognostic biomarkers of nonoropharyngeal head and neck squamous cell carcinoma. J Clin Oncol. 2014 Dec 10;32(35):3930-8. doi: 10.1200/JCO.2013.54.5228. Epub 2014 Sep 29.

lead_sponsor: Centre Leon Berard

location_facility:
Hôpital Saint-André
Centre Léon Bérard
Centre Antoine Lassagne


title: Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)

acronym: VISIONUM

summary:
This project is working on orthoptic rehabilitation for low vision people. The aim of the project is to assess the interest and integration of this rehabilitation device used at home, in low-vision private practice and at the hospital. It leads to develop and evaluate an innovative device to integrate and adjust monitoring of patients according to their need and their progress, to create new interactions with the patient, enabling the orthoptist to stay in touch with his patient at home between rehabilitation sessions and to obtain a more fine and objective analysis of the exercises done by the patient.

Using an eye tracker and a digital tactile screen with data uploads allows the practitioner to observe the progress objectively. It also leads the patient to a better understanding of his/her visual behavior and of the effects of rehabilitation. Therefore, it will be easier to adopt better strategies.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts