summary: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting the central and peripheral motor neurons, characterized by the rapidity of its evolution (median survival of 3 years). The pathophysiology of the disease is still poorly understood. Neuronal death results from several cellular mechanisms entangled, including mitochondrial dysfunction. The absence of diagnostic marker causes a significant delay in diagnosis, on average a year. On the other hand, the wish biomarker is important for therapeutic trials. Recently, MRI sodium (23Na) demonstrated its importance to detect noninvasively sodium accumulations associated with neuronal suffering. This neuronal pain can be caused by mitochondrial dysfunction causing the accumulation in the sodium and calcium cell causing neuronal death. These studies were conducted in multiple sclerosis, Alzheimer's disease, Huntington's disease, stroke and brain tumors. They demonstrated that sodium MRI could be an effective and sensitive biomarker for detecting and quantifying neuronal degeneration. The goal of this study is to assess neuronal damage noninvasively by MRI sodium in amyotrophic lateral sclerosis.

lead_sponsor: Assistance Publique Hopitaux De Marseille


type: Other Identifier

summary:
Drepanocytose disease is the first genetic disease in the world. It results in the synthesis of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to structural changes of red blood cells (RBC) which then take the shape of a sickle, become more fragile, more rigid and less deformable. The fragility of GR sickle causes their mass destruction, leading to chronic anemia (i.e. low levels of GR in the blood) associated with low tissue oxygenation. More rigid and less deformable, sickle GR tend to hang in the microvessels, leading to vaso-occlusive crises (CVO) particularly painful, can cause the failure of certain organs (spleen, kidneys, brain, lung, heart, liver , bone ...) and to life-threatening patients. Preliminary studies conducted on patients with drepanocytose disease (HbSS) have demonstrated changes of muscle tissue indicating a possible failure in the supply and use of oxygen. To date, the translation of this metabolic remodeling in the muscle work is not known.

This project's main objective is to evaluate muscle function in drepanocytose attempted patients. We hypothesized that muscle remodeling associated with sickle cell disease have a functional impact on strength and muscle metabolism. The main objective is to characterize the maximal voluntary plantar flexor muscles. The criteria for these targets will be based on the comparison between healthy subjects, carriers of the sickle cell trait (HbAS) and sickle cell patients (HbSS) oxygen saturation.

The strictly non-invasive approach proposed in this project will study the functional parameters of the muscle of sickle cell disease and the possible link with the clinical manifestations of the disease, including vaso-occlusive crisis, in which tissue oxygenation and pH plays a major role.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: No

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


summary: Viral infections are only recently been investigated in patients on mechanical ventilation (MV) in ICU. It is especially the progress in the direct detection of these pathogens that allowed intensivists to try to assess objectively the impact of viruses in their patients. This is of course of viral infections "Community" (influenza virus, rhinovirus ...), but some viruses also occur under mechanical ventilation in immunocompetent adults. This is called viral infection "nosocomial" whose Herpesviridae are the most frequent and best studied. This replication Herpesviridae in ICU patients is usually a reactivation as primary infection. This reactivation is explained by the fact that after a few days of mechanical ventilation appears immunoparalysis, which can make the bed of bacterial or viral infection.Several studies have compared the pp65 antigenemia for quantitative PCR in immmunodéprimés patients. For example, in transplant patients (solid organs), the sensitivity of antigenemia was 91%, Quantitative PCR of 95.6% while the specificity was 57% and 81.6% respectively. No work, however, has to date compared these techniques in the intensive care patient. In a subject shortly epidemiological study, the sensitivity of the quantitative PCR performed on the LBA is 80%, when compared to antigenemia. Moreover this same study shows that half of the positive PCR on the BAL are not accompanied by a positive antigenemia, suggesting that PCR may be more sensitive than antigenemia. This exam has never been validated to date in intensive care. Finally, no work has so far evaluated the diagnostic performance of quantitative PCR performed on BAL

study_type: Observational

time_perspective: Prospective

intervention_type: Biological


title: Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid

acronym: MICROPB

summary:
Autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis, linear IgA dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. Autoimmune bullous dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in Europe. The incidence of the individual entities is slight significantly different within Europe, but strongly also in comparison to other countries such as Kuwait, Singapore, USA and South America. The most common of these disorders is the bullous pemphigoid.

A considerable progress has been made in the last years to elucidate the pathogenic role of autoantibodies in these diseases. To this end, various in vitro and animal experiments have been used to understand some basic pathophysiological mechanisms in these diseases. Further studies are currently being carried out to explain a precise elucidation of the disease process and to be able to treat the patients targeted later.

At present, however, no data are available to explain why certain individuals develop the autoimmune disease and others do not. Epidemiological studies showed some triggers to the development of autoimmune dysregulation, e.g. drugs.

Furthermore, it has been shown that genetic factors play a role in the pathogenesis of the disease. A clear association with certain HLA regions have been shown in patients with pemphigus, e.g. about 95% of pemphigus patients from the group of Ashkenazi Jews have the HLA-DRB1*0402 haplotype. Recently, the first non-HLA gene associated with pemphigus was described. For other conditions such as bullous pemphigoid, pemphigoid gestationis or linear IgA dermatosis the association with HLA antigens is less pronounced. Another indication of the importance of the genetic background in these diseases can be elucidated from the observation of autoantibodies at a low concentration in healthy relatives of pemphigus patients.

lead_sponsor: CHU de Reims


title: Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas

summary: Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation

study_start_date_type: Actual

status: Active, not recruiting

primary_purpose: Treatment

lead_sponsor: Institut Curie

intervention_type: Procedure

status_simplified: Ongoing


title: Regeneration of Bronchial Epithelium During Chronic Obstructive Pulmonary Disease

acronym: EPITHREGENCOPD

summary: Airway epithelium integrity is essential to maintain its role of mechanical and functional barrier. Recurrent epithelial injuries require a complex mechanism of repair to restore its integrity. In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial repair may participate in airway remodelling. The objective was to determine if airway epithelial wound repair of airway epithelium is abnormal in COPD.

status: Completed

study_completion_date_type: Actual

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Perotin JM, Adam D, Vella-Boucaud J, Delepine G, Sandu S, Jonvel AC, Prevost A, Berthiot G, Pison C, Lebargy F, Birembaut P, Coraux C, Deslee G. Delay of airway epithelial wound repair in COPD is associated with airflow obstruction severity. Respir Res. 2014 Nov 27;15(1):151. doi: 10.1186/s12931-014-0151-9.

status_simplified: Completed


title: Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in an EHPAD

acronym: OPTIFEL

summary:
In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at least one meal per day is provided by a catering service - meals at home, old people's home). All of the recipes were developed thanks to the first two parts of the OPTIFEL project so as to take into account the needs of elderly people and recommendations in each country. The interest is to increase the sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional content of the foods, to meet the nutritional needs of this specific population with enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different cultures. This ongoing research is being conducted on 2-4 different variants of each type of product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit smoothies.

For each product family, two products will be selected for each country: the preferred product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins and minerals) and the standard product without enrichment.

Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary aids, 2 carrot purees, 2 desserts and 1 smoothie

design_allocation: Randomized

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Dietary Supplement


title: Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT)

acronym: CAMAT

summary: The first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. The second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. The third objective aims to show if therapeutic alliance is associated with insight in patients and with clinical and demographic data.

lead_sponsor: University Hospital, Caen

intervention_type: Behavioral


title: Elucidation of Sensory Characteristics and Food Preferences in the Elderly

acronym: AUPALESENS

summary: Malnutrition is a frequent problem in persons older than 65 years: the prevalence of malnutrition can reach 25 to 29% in persons living at home who require help, figures vary between 19 and 38% for those living in institutions, and finally, the prevalence of malnutrition in hospitalized elderly patients can reach 30 to 90%. A few studies have attempted to explain modifications in attitudes, behaviour, the frequency of meals or nutritional status in the elderly by a fall in chemosensory sensitivity The aim of this project is to test the hypothesis that perhaps it is not as much the capacity to perceive a smell or a taste that affects eating behaviour in the elderly as their ability to distinguish between smells or tastes on the one hand (perceptual processing), and their ability to correctly interpret a chemosensory signal on the other (cognitive processing).


title: Role of the Spouse/Partner of Persons Treated With Chemotherapy for Colon Cancer - Preliminary Validation of the Caregiver Objective Burden-Quality of Life (COBQoL) Questionnaire

acronym: APPACH

summary: Altered quality of life in patients with stage III or IV colon cancer is well known. At their sides, their spouse/partner must also cope with the suffering caused by the disease and the upheavals that it engenders, with the treatments, in the organization of their everyday life. The physical, emotional, social and financial impact of cancer in general and its treatment on care-givers has already been studied. However, there are no data concerning the "objective burden", that is to say the nature and the magnitude of the care weighing on the spouse of persons with colon cancer. Objective is to develop and validate a questionnaire that can be completed by the spouse/partner of patients with stage III or IV colon cancer so as to evaluate the burden of the disease in everyday life. It will allow medico-social professionals to identify spouses/partners in difficulty and the needs of patients so as to offer the best support.


title: Efficacy of Heat-shock Protein (HSP) Inhibitors in Myeloproliferative Syndromes (MPS): Fundamental Observational in Vitro Study Using Samples From a Collection

acronym: HSP-SMP

summary:
Heat-shock proteins (HSP) have been very highly conserved throughout the evolution of species and are characterized by their chaperone function, thanks to their ability to prevent aggregation and to promote the renaturation/break down of damaged proteins. Among other targets, they also chaperone JAK2, a key step that is deregulated in signalling in myeloproliferative syndromes (MPS) because of the JAK2V617F mutation. These HSP also have a potent cytoprotective action through their multiples inhibiting effects on apoptotic processes.

Little is known about levels of HSP expression, in particular for HSP70 and HSP27, in MPS cells.

However, in vitro studies of different cell models have shown the interest of HSP90 inhibitors in slowing cell proliferation in MPS. These results have been confirmed in animal models with results in terms of blood counts and overall survival. In addition, it seems that the V617F mutated form of JAK2 is more sensitive than the wild-type to HSP90 inhibitors. Finally, inhibitors of HSP90 remain efficacious with regard to the inhibition of cell growth, even in cases of resistance to JAK2 inhibitors. Nonetheless, HSP90 inhibitors are known to stimulate the expression of other HSP, notably HSP27 and HSP70, which are, through their properties, tumorigenic and could lead to an escape phenomenon. Thus the combined use of several HSP inhibitors could be beneficial, and eventually present synergistic effects on the inhibition of tumour processes.

time_perspective: Retrospective


title: Analysis of Transposon Control Pathways in Germinal Cancers of the Testicle

acronym: SEMINOMES

summary: By analogy with the mouse, the activity of control pathways for transposable elements (TE) in foetal primordial germinal cells could prove to be a determinant for fertility in adulthood in humans. Moreover, defects in the control of transposable elements (TE) could also contribute to the aetiology of germinal testicular cancer, by inducing chromosomal instability and tumorigenesis. In this context, the aim is to analyse a specific type of adult germinal testicular cancers, seminomas. Directly related to our research interest, the histological, transcriptomic and epigenetic features of theses adult tumours are reminiscent of germinal cells normally present in foetuses. The investigator postulates that these similarities could also extend to the biology of transposable elements (TE), and in particular to the initiation of the control of these elements. The management of seminomas requires surgery, orchiectomy, which consists of the total excision of the affected testicles. Using high-resolution high-throughput sequencing techniques, we propose to analyse the control pathways of transposable elements (TE) in tumour samples harvested from surgical pieces in comparison with adjacent healthy tissue. The results obtained in these tumour samples will be compared with those in normal foetal gonad samples.

intervention_type: Genetic


acronym: KTSS

intervention_type: Device

lead_sponsor: Centre Hospitalier Departemental Vendee

summary:
The main objective of this study is to show that postoperative Total Knee Replacement (TKR), an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor quadriceps femoral perineural catheter that (KTF) infused with even low doses of local anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking of the knee feasible at the bedside.

Patients will be randomized in two arms:

catheter in position under sartorial (experimental group)
femoral catheter (control group)

title: Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement: A Controlled, Randomized Study (KTSS)

primary_purpose: Other

source: euctr


title: Marqueurs de vulnérabilité Aux Jeux Pathologiques

acronym: GambleMMORe

summary: Addictions without substances are an emergent problem giving rise to a recent and increasing request of care. Among these new addictions, pathological gambling and pathological online video gaming which are up. The purpose of this study is to identify vulnerability factors (personality traits, decision making strategies...), which are common or specific to each type of game (on line poker, casino, MMORPG, and no-gamers).

ReferenceType: result

ReferenceCitation: Giustiniani J, Gabriel D, Nicolier M, Monnin J, Haffen E. Neural Correlates of Successful and Unsuccessful Strategical Mechanisms Involved in Uncertain Decision-Making. PLoS One. 2015 Jun 18;10(6):e0130871. doi: 10.1371/journal.pone.0130871. eCollection 2015.

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Pilot Project - Prospective Longitudinal Cohort of Patients Over 70 Years With Malignant Solid Tumors: Modification of Quality of Life Based on Objective Geriatric Tests

acronym: MEGERIA

summary:
The analysis of this study will achieve an improvement in the management of patients over 70 years with adaptation of chemotherapy regimens after analysis of the subject and its psychosocial environment.

The analysis of socio-economic impacts will implement actions to optimize the care of the elderly while emphasizing the value of management / cost of care.

primary_purpose: Supportive Care

ipd_sharing: Undecided

lead_sponsor: Centre Antoine Lacassagne

lead_sponsor_type: industriel


title: Impedance Cardiography by PhysioFlow® for Non-invasive Cardiac Output Monitoring: a Comparison With Trans-thoracic Echocardiography in Pediatric Intensive Care Patients.

acronym: PF-ECHO

summary: PhysioFlow® (PF®) is a new cardiac output (CO) monitoring method by impedance cardiography (IC), never studied in pediatric intensive care unit (PICU). The aim of the study was to compare CO and cardiac index (CI) measurements (IC) by trans-thoracic Doppler echocardiography (TTE) (COTTE and CITTE) and PF® (COIC and CIIC) in PICU.

lead_sponsor: University Hospital, Lille


title: Evaluation of the Potential Association Between 5α-reductase Inhibitors Prescription and Occurrence of High Grade Prostate Cancers

acronym: CANARI

summary: This is a multicenter, cohort study based on medico-administrative data from pathology laboratory registries and drug reimbursement files (CNAM-TS).

lead_sponsor: Rennes University Hospital


title: Diagnosis Accuracy of Noninvasive Screening by PCR Digital for Down Syndrom

summary:
The main objective of this study is to estimate the intrinsic diagnostic qualities of the digital dPCR in the screening of T21 from a multicentrique sample of patients with pregnancies at high risk of T21 (risk > 1/250).

The profit expected from this technique is to propose to the encircled women a screening more successful than that of the screening combined(organized) of the 1st quarter, simple of realization and in a moderate cost. We thus propose here an original alternative(alternate) method to the exclusive, expensive and binding techniques of top-debit(-flow). The recent technical improvements and his(her,its) advantages medical - economic allow to envisage a reliable, strong and long-lasting use of the dPCR in clinical routine in the DPNI of T21 in most of the laboratories. This pilot project could serve for the later development of a study of clinical validation multicentrique of large scale(big turntable ladder).

ReferenceCitation: Cans C, Amblard F, Devillard F, Pison H, Jalbert P, Jouk PS. Population screening for aneuploidy using maternal age and ultrasound. Prenat Diagn. 1998 Jul;18(7):683-92.

ReferenceCitation: Coutton C, Abada F, Karaouzene T, Sanlaville D, Satre V, Lunardi J, Jouk PS, Arnoult C, Thierry-Mieg N, Ray PF. Fine characterisation of a recombination hotspot at the DPY19L2 locus and resolution of the paradoxical excess of duplications over deletions in the general population. PLoS Genet. 2013 Mar;9(3):e1003363. doi: 10.1371/journal.pgen.1003363. Epub 2013 Mar 21.

ReferenceCitation: Nadeau G, Coutton C, Amblard F, Michalowicz G, Frasca S, Fertin A, Devillard F, Satre V, Usson Y, Jouk PS. Interphase fluorescent in situ hybridization detection of the 7q11.23 chromosomal inversion in a clinical laboratory: automated versus manual scoring. Clin Chem Lab Med. 2013 Apr;51(4):e41-4. doi: 10.1515/cclm-2012-0416. No abstract available.

ReferenceCitation: Coutton C, Bidart M, Rendu J, Devillard F, Vieville G, Amblard F, Lopez G, Jouk PS, Satre V. 190-kb duplication in 1p36.11 including PIGV and ARID1A genes in a girl with intellectual disability and hexadactyly. Clin Genet. 2013 Dec;84(6):596-9. doi: 10.1111/cge.12113. Epub 2013 Mar 25. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Ben Khelifa M, Coutton C, Zouari R, Karaouzene T, Rendu J, Bidart M, Yassine S, Pierre V, Delaroche J, Hennebicq S, Grunwald D, Escalier D, Pernet-Gallay K, Jouk PS, Thierry-Mieg N, Toure A, Arnoult C, Ray PF. Mutations in DNAH1, which encodes an inner arm heavy chain dynein, lead to male infertility from multiple morphological abnormalities of the sperm flagella. Am J Hum Genet. 2014 Jan 2;94(1):95-104. doi: 10.1016/j.ajhg.2013.11.017. Epub 2013 Dec 19.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repository_normalized: HAL

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Grenoble


title: Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock

acronym: MUEVELO

summary:
Cycloergometer is a validated method for different care. This kind of device allow passive and active care for patient. The interest of cycloergometer for patient hospitalized in Intensive Care Unit for Sepsis has never been demonstrated.

The main objective of this study is to determine the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients with septic shock

The secondary objectives of this study are to assess the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy on:

the duration between hemodynamic stability* and the removal of sedation
the duration between the removal of sedation and ICU discharge
the mechanical ventilation duration (invasive and noninvasive)

status: Terminated

lead_sponsor: University Hospital, Rouen

appel_a_projets: PHRIP

region: Normandie

nom_etablissement: CHU ROUEN

type_etablissement: CH

acronyme: MUEVELO

titre: Mobilisation précoce en réanimation : intérêt de la cyclo-ergométrie chez les patients au décours du choc septique

discipline_principale: anesthésiologie / réanimation

nom_porteur: BEDUNEAU

prenom_porteur: Gaëtan


title: Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer

acronym: COCA-MACS

summary:
The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient.

The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.

primary_purpose: Diagnostic


title: A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.

acronym: CXLMyopie

summary:
43 Subjects (43 eyes) qualified for participation will undergo the required screening procedures to determine study eligibility. The surgical protocol involves applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA (ultraviolet A) light with the KXL II system according to the programmed treatment pattern.

All use of the KXL II system will be in accordance with the general instructions in the operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24 months after treatment.

Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS), will be obtained at baseline and at appropriate times after the treatment.

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Glaukos Corporation


title: EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study

acronym: enteroMRI-TSI

summary:
Early diagnosis of tumors of the small intestine is a challenge for clinicians and for radiologists. The detection of tumors of the small intestine is a field in which the video capsule endoscopy has the lowest performance.

The entero-CT with enteroclysis is the imaging technique used primarily to explore patients with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the patient and it is a complicated examination in terms of logistics with necessity of specific equipment to insert the nasojejunal tube.

MRI has been proposed as an alternative imaging technique and satisfactory results have been reported with the MRI enteroclysis. However, this technique has several disadvantages related to nasojejunal tube insertion and the necessity of equipment compatible with the high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the small intestine by ingestion of large quantities of a liquid, has a major and undisputed role in the exploration of Crohn's disease of the small bowel. However, its capacity for distension of the small intestine for optimal tumor detection is questioned and its role in tumor detection is largely unknown.

intervention_type: Radiation


type: Registry Identifier

title: Characterization of Tissular T Follicular Helper Cells in IgG4-RD

summary:
IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells predominance, and fibrosis in involved tissues. Despite a preferential involvement of exocrine organs, virtually all tissues can be affected by the disease. Corticosteroids are usually effective in this indication, but with poor tolerance and a high risk of relapse after decrease or withdrawal of this treatment. In this context, identification of new therapeutic targets is a major concern for these patients. Physiopathology of IgG4-RD remains actually unknown. In previous studies, it has been shown that T follicular Helper (Tfh) cells are expanded in the blood of these patients. Tfh cells have an important role in the formation of germinal centers (GCs), and ectopic GCs have been found in tissues of patients with IgG4-RD. Tfh cells have a major role in proliferation and differentiation of B cell compartment. In this context, this population could have an important contribution in the pathophysiology of IgG4-RD and could represent a therapeutic target in this disease.

TIFOLH4 study intend to analyze tissue Tfh cells in patients with IgG4-RD at diagnosis. This study is an exploratory prospective multicentric study. Thirty patients with a suspected diagnosis of IgG4-RD, because of 1 or more suggestive organ involved, will be included in the study. A 50 mL blood sample and a biopsy, obtained in the same time of the diagnostic biopsy sample, will be obtained in this study. The results obtained in patients with a confirmed diagnosis of IgG4-RD (" IgG4-RD group ") will be compared to results of patients with another diagnosis (" control group "). Main objective of the study is to show by confocal microscopy an expansion of the number of Tfh cells (CD3+CD4+PD1+ cells) in tissue of IgG4-RD patients compared to controls. Secondary objectives include : tissue analysis of Tfh subsets (Tfh1, Tfh2 and Tfh17) ; tissue analysis of B regulatory cells, T regulatory cells, and T helper cells (Th1, Th2, Th17); correlation between tissue and circulating biomarkers; tissue proteomic analysis; and functional analysis of circulating Tfh cells after sorting of these cells and co-culture tests with autologous naive B cells. All these results will be compared between the " IgG4-RD group " and the " control group ". This study should clarify the role of these Tfh populations in IgG4-RD, identify diagnostic tissue and blood biomarkers, and identify therapeutic targets in these patients.

appel_a_projets: PHRCI

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

type_etablissement: CHUR

titre: Caractérisation des lymphocytes T follicular helper tissulaires : cible thérapeutique potentielle de la maladie associée aux IgG4

discipline_principale: autre

nom_porteur: EBBO

prenom_porteur: Mikael


title: Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.

acronym: NOBOBO

summary:
Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have long-term neurocognitive influences. Repetitive procedural pain can also lead to changes in the pain sensitivity threshold therefore. The most common painful procedures are lancing for blood glucose testing. In adults, infants and term newborns, forearm blood glucose testing has been demonstrated to be less painful than conventional sites (heel, fingers). But data is lacking in preterm neonates.

The primary purpose of this study is to demonstrate a significant reduction in pain response during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born up to 32 weeks gestation.

This study is an interventional multicenter (3 centers), randomized, double bind trial with a cross over assignment. 60 premature neonates born between 23 to 32 weeks.

Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose pricks will be included. The different sites will be randomly successively tested.

acronyme: NOBOBO

titre: Impact du site de prélèvement capillaire sur la douleur du nouveau-né grand prématuré

discipline_principale: néonatalogie

nom_porteur: LIGI

prenom_porteur: Isabelle


acronym: ECUN

summary:
Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.

The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.

Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.

The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.


title: Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study

acronym: MBCT

summary:
Mindfulness is both a natural resource of individuals present in all individuals in varying degrees characteristic ability of attention to the experience that unfolds moment by moment without judgment and a practice based on meditation, mindfulness exercises, which aims to enhance two central skills of mindfulness that are the presence and acceptanc. In the context of recurrent depression, the practice of mindfulness meditation in the frame of MBCT is recognized as effective in psychological suffering and relapse. The mechanisms implied in MBCT efficacy are emotional but especially cognitive. Among the cognitive mechanisms, reduction of rumination is a major factor in the action of MBCT, especially for patients with less than three depressive relapses.

This exploratory research focuses on the impact of mindfulness functioning (mindfulness resource level at baseline) on the benefits of MBCT for patients with recurrent depressive disorder.

The objective is to assess whether the level of mindfulness resource of patients with recurrent depression is a factor contributing to the positive effect of a MBCT applied in add-on to conventional care.

This objective will be measured by comparing the clinical improvement of patients secondary to MBCT according to the initial categorization of the mindfulness resource.

Clinical improvement will be more important for patients characterized by a lower initial level of mindfulness resource.


acronym: AMIKACINE

intervention_type: Drug

summary:
The loss of skin barrier function after burn causes increased susceptibility to infections, which are the leading cause of morbidity and mortality in burn patients. Topical antibiotics are one part of the therapeutic arsenal available to treat these infections. Pseudomonas aeruginosa and Staphylococcus aureus are the two major colonizing agents found in this population of patients.

The use of dressings impregnated with amikacin is a common practice. Actually, there are no available data on local and systemic effects with this antibiotic. The study of tissue and plasma pharmacokinetics of amikacin is therefore very important to secure and optimize this singular use of amikacin and improve the care of burn patients.

The objective of the study is to describe the plasma and tissue pharmacokinetics of amikacin after dermal administration and impregnated dressing to estimate the pharmacokinetic parameters and their variability in a burned population.

Secondary objectives are to assess on the one hand the relationship between the effectiveness of treatment and the concentration of antibiotic at the site of tissue infection, and on the other hand to assess the relationship between plasma concentration and the toxicity found of this treatment. We would like also to note the efficacy of the antibiotic treatment in terms of: need for repeat surgery (new skin graft), healing time and hospital length of stay.

Blood samples and skin biopsies will be made for each patient to day 3 and day 7 after the start of treatment.

The knowledge about the tissue concentrations obtained and a possible systemic absorption will then provide additional safety data and optimize the conditions of use of these dressings (dosage, frequency of administration) for effective treatment and safe.

title: Amikacin Pharmacokinetic Profile in Plasma and Tissue After an Administration Using Impregnated Dressings in Burned Patient Population

type: EudraCT Number


title: Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD

acronym: LAB-Card

summary: The aim of this interventional, randomized, double-blind, monocentric, cross-over study is to quantify the possible deleterious effect on the cardiac autonomic nervous system control of two long-acting anticholinergic bronchodilatators (tiotropium and glycopyrronium) and one beta-2 agonist long-acting bronchodilatator (indacaterol ) in patients with mild COPD.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire


title: Randomized Controlled Trial of the Effectiveness of Perineal Pain and Security of the Suture Led by the Result of Hemostasis Versus Manual Compression Routine Suture Perineal Tears of First Degree During Childbirth, ImSOLENCE Study

acronym: ImSOLENCE

summary:
During childbirth, the recommendations have evolved to a restriction of episiotomy. This reduction results in an increase of superficial vaginal and perineal tears. These lesions are usually routinely sutured which often causes the onset of discomfort and pain in the immediate postpartum period. Gordon showed, in 1998, improved comfort and pain when the skin was not sutured perineal tears during the second degree. Others have compared different techniques in the same indications (separated points running suture, biological adhesive) without demonstrated impact. These studies were not interested in isolated perineal tears or first degree or the application of a simple manual compression with or without a suture according to the result of hemostasis.

Our objective is to evaluate the possibility of not suture the perineum of the first degree. The use of suture only result of bleeding not yielding to manual compression.

Our approach is guided by the principles of "primum non nocere" and discerning about the dogmatic systematization.


title: Study of the Effectiveness of the Film-forming Solution Evonail® Versus Placebo in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.

acronym: EVONAIL

summary:
Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.

Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage.

The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.

lead_sponsor: Institut de Cancérologie de Lorraine

sponsor_collaborators:
Institut de Cancérologie de Lorraine
Clinact


summary: The perirenal fat may alter renal function by secreting fibrotic inflammatory agents when accumulates during obesity. Nephrectomy for renal tumor is a model that would provide tissue samples to test this hypothesis. Renal tumor could itself be responsible for inflammation and fibrosis in its environment. This study aims to measure the influence of the tumor on his kidney Environment and fat and define molecular markers not influenced by renal tumor. The main objective is to compare the inflammation of the perirenal fat taken in two locations in the same patient, in contact and 4 cm from the outer edge of the tumor, each patient as his own control. The secondary objective is to compare the degree of interstitial fibrosis of the renal cortex in the same sampling methods.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Interest of Measuring Lung Elasticity ELASTOgraphy in the Fetus in the Case of PreMAture Childbirth Threat

acronym: ELASTOMAP

summary: The objective of the study was to evaluated the feasibility and reproducibility of the measurement of lung elasticity report / fetal liver according to gestational age in a group of patients with a normal course of pregnancy and in a group of Patients at risk of preterm delivery.

ReferenceType: derived

ReferenceCitation: Mottet N, Aubry S, Vidal C, Boiteux G, Metz JP, Riethmuller D, Pazart L, Ramanah R. Feasibility of 2-D ultrasound shear wave elastography of fetal lungs in case of threatened preterm labour: a study protocol. BMJ Open. 2017 Dec 26;7(12):e018130. doi: 10.1136/bmjopen-2017-018130.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: British Medical Journal


acronym: HIF

summary:
Burn injury with full-thickness skin damage that encompass large body surface areas can induce local and systemic perturbations that are costly in terms of human suffering as well as in strains on the health care system. Characterization of new major molecular biomarkers involved in this process creates significant diagnostic and therapeutic challenges.

Hypoxia-inducible factor-1 α (HIF-1 α) is a ubiquitously expressed heterodimeric transcription factor comprising an α and a β subunit. It was shown that under normoxic conditions, the HIF-1α subunit is ubiquitinated and degraded, whereas under hypoxic conditions, HIF-1α accumulates, dimerizes with HIF-1β, and activates the transcription of a spectrum of target genes encoding multiple angiogenic growth factors and cytokines of potential importance in wound healing. Seven isoforms of HIF-1α issued from alternative splicing have been identified.

The importance of HIF-1α in wound healing in animal models has been suggested by several studies. Indeed, diminished HIF-1 levels and activity have been documented in conditions of impaired wound healing. The literature review shows a marked reduction of HIF-1α levels in mice in case of burn wound skin that in the case of excisional cutaneous wound. Other studies have shown that the expression of HIF-1α was correlated with the extent and depth of the burns.

This study aims to improve the knowledge on the pathophysiological factors involved in the field of wound healing. The assumptions are based on results of studies done on mice, and this work aims to document these findings in humans.

Objective

The main objective of the study is to compare the variations of expression of HIF-1α measured in blood and skin tissue samples in three groups:

Subjects with major burn wounds involving more than 20% of the total body surface area;
Subjects with burn wounds smaller than 5% of total body surface area;
Subjects with a skin wound after a surgical procedure requiring a skin resection.

Secondary objectives are to compare the expression levels of HIF-1α locally at the burn site to those observed in blood, to evaluate the expression of growth factors produced by HIF-1α target genes (VEGF and EPO) or playing a central role in the healing process (TGF-β1), and to assess the correlation between the expression of HIF-1α and the kinetics of wound healing of the subject rated by evaluation of time of donor sites complete epithelialization.

Material and Methods

We propose to create three groups:

15 patients with extensive third degree burns involving more than 20% of the total body surface area;
15 patients with less extensive third degree burns, involving less than 5% of body surface area;
15 patients with post-surgical wounds with skin resection. Skin and tissue specimens will be collected three times: day 0, 7 and 14 from burned patients (with more than 20% of the total body surface area and less than 5% of body surface area). Samples of skin tissue will be collected within the skin resection from patients with post-surgical wounds at day 0, blood samples will be collected at day 0 and 14.


acronym: ReTransQol

summary:
The project team developped and validated a French patient-based health-related quality of life instrument in kidney transplant: the QoL Retrans.

The aim of the study is to determine the minimum significant change of the valdiated tool: ReTransQol


title: Chemoembolization of Non-resectable Non-metastatic Hepatocellular Carcinoma Using Embolization Microspheres (DC Bead™) Loaded With Idarubicin (Zavedos®): Phase 1 Study

acronym: IDASPHERE

summary:
Chemoembolization is a recognized treatment strategy for hepatocellular carcinoma (HCC)

classical chemoembolization consists in injecting an emulsion of an anticancer agent in Lipiodol® via the hepatic artery
doxorubicin, an anthracycline, is the most frequently used drug in lipiodol chemoembolization (LCE)
however, less than half of HCC respond favourably to classical lipiodol chemoembolization (LCE) with doxorubicin/Lipiodol®

In this trial, we propose to introduce in clinical practice a strategy based on idarubicin to achieve a more effective antitumor effect for the following reasons, recently pointed out by our team:

idarubicin is an anthracycline that penetrates tumour cells more quickly and is more cytotoxic than doxorubicin on hepatocellular carcinoma cell lines
idarubicin is injected in a solution of embolization microspheres of a diameter of (300-500µm), which all the progressive and controlled release of the anticancer drug, whereas the doxorubicin/Lipiodol® emulsion is unstable


title: Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest

acronym: SACRE

summary: The aim of this study is to evaluate the prognostic value of the suppression ratio monitored by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient admitted to our intensive care unit after a cardiac arrest are included. The results of the suppression ratio will be collected in the 6 first hours of admission. We will evaluate the link between suppression ratio and cerebral performance category score collected at three months.


title: Dopaminergic Denervation and COMT Polymorphism in de Novo Patients With Parkinson's Disease

acronym: DATACOMT

summary:
Parkinson's disease onset is clinically defined as the appearance of motor symptoms including akinesia, tremor and hypertonia. Several studies have shown that motor symptoms occur when at least 50 % of dopaminergic neurons are lost. However, there are evidence suggesting that the level of dopaminergic denervation is not homogenous at the time of diagnosis.

Some patients have a higher level of dopaminergic loss at disease onset indicating the existence of compensation mechanisms. The aim of this study is to decipher how the metabolism of dopamine is involved in this compensation with a focus on the polymorphism of the COMT gene. This gene is expressed according to two variant: (i) COMT H that encodes a form of the enzyme with a high level of activity and (ii) COMT L that encode a form of the enzyme with a low level of activity. Thus, there are 3 possible genotypes in the population: (i) COMT HH associated with an increased degradation of dopamine, (ii) COMT LL associated with a decreased degradation of dopamine and (iii) COMT HH (intermediary between COMT HH and COMT LL).

The hypothesis is that this polymorphism of the COMT gene may participate to compensation mechanisms in early PD. Patients with COMT HH genotype may have an earlier motor symptoms onset than patients with COMT LL genotype.

To test this hypothesis, we will recruit 51 patients with de novo PD will be recruited (17 patients for each genotype). Given the distribution of COMT polymorphism in the population, a maximum sample of 76 patients will be screened to recruit 17 patients for each genotype.

Clinical evaluation will include MDS-UPDRS, Non Motor Symptoms Scale, segmental symptoms scale, Montreal Cognitive assessment, MMSE, Frontal assessment battery and Parkinson's disease behavioral assessment scale (ECMP). All the patients will have a monophotonic emission tomography with I-123-Ioflupane in order to assess the level of dopaminergic denervation and an MRI scan with resting state study. Cerebrospinal fluid sampling will be optional and will allow direct measurements of dopamine metabolites.

The main outcome measure will be the level of dopaminergic denervation on I-123-Ioflupane scans according to COMT genotype, age, gender and severity of motor symptoms on the MDS-UPDRS part 3.

If this hypothesis is confirmed, this will allow to test the efficacy of COMT inhibitors in order to delay dopaminergic drugs initiation for PD patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: DATaCOMT

titre: Dénervation dopaminergique et polymorphisme de la COMT chez les patients parkinsoniens de novo

discipline_principale: neurologie

nom_porteur: GRABLI

prenom_porteur: David


acronym: TEMP CORE BLOC

summary: Core temperature monitoring is mandatory during major surgery. The accurate techniques currently used are invasive, such as artery catheter and oesophagal probe. A new non-invasive cutaneous device, 3M SpotOn, using Zero Heath-Flux method, continuously measure core temperature. This prospective study compare the accuracy of Zero-Heath-Flux to oesophagal temperature (30 patients) and to artery catheter (20 patients) in adult patients during surgery.

ReferenceCitation: Boisson M, Alaux A, Kerforne T, Mimoz O, Debaene B, Dahyot-Fizelier C, Frasca D. Intra-operative cutaneous temperature monitoring with zero-heat-flux technique (3M SpotOn) in comparison with oesophageal and arterial temperature: A prospective observational study. Eur J Anaesthesiol. 2018 Nov;35(11):825-830. doi: 10.1097/EJA.0000000000000822.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Poitiers University Hospital


title: Divided Drug Delivery : a Way to Prevent Repeated Volutary Drug Intoxications.

summary: This study will evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated.

ReferenceCitation: Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, de Girolamo G, Graaf R, Demyttenaere K, Gasquet I, Haro JM, Katz SJ, Kessler RC, Kovess V, Lepine JP, Ormel J, Polidori G, Russo LJ, Vilagut G, Almansa J, Arbabzadeh-Bouchez S, Autonell J, Bernal M, Buist-Bouwman MA, Codony M, Domingo-Salvany A, Ferrer M, Joo SS, Martinez-Alonso M, Matschinger H, Mazzi F, Morgan Z, Morosini P, Palacin C, Romera B, Taub N, Vollebergh WA; ESEMeD/MHEDEA 2000 Investigators, European Study of the Epidemiology of Mental Disorders (ESEMeD) Project. Psychotropic drug utilization in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl. 2004;(420):55-64. doi: 10.1111/j.1600-0047.2004.00331.x.

ReferenceCitation: Aouba, A., Péquignot, F., Camelin, L., Laurent, F., Jougla, E. La mortalité par suicide en France en 2006. Etudes et résultats. 2009 ; (702) : 1-8.

ReferenceCitation: Beck, F., Guignard, R., Du Roscoät, E., Saïas, T. Tentatives de suicide et pensées suicidaires en France en 2010. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 488-492.

ReferenceCitation: Camidge DR, Wood RJ, Bateman DN. The epidemiology of self-poisoning in the UK. Br J Clin Pharmacol. 2003 Dec;56(6):613-9. doi: 10.1046/j.1365-2125.2003.01910.x.

ReferenceCitation: Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge: 24-month outcomes of a randomised controlled trial for hospital-treated self-poisoning. Br J Psychiatry. 2007 Dec;191:548-53. doi: 10.1192/bjp.bp.107.038406.

ReferenceCitation: Chan-Chee, C., & Jezewski-Serra, D. Hospitalisations pour tentatives de suicide entre 2004 et 2007 en France métropolitaine. Analyse du PMSI-MCO. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 492-496.

ReferenceCitation: Coben JH, Davis SM, Furbee PM, Sikora RD, Tillotson RD, Bossarte RM. Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. Am J Prev Med. 2010 May;38(5):517-24. doi: 10.1016/j.amepre.2010.01.022. Erratum In: Am J Prev Med. 2010 Dec;39(6):613.

ReferenceCitation: Dumesnil, S., Grandfils, N., Le Fur, P., Mizrahi, A. Mizrahi, A. Santé, Soins et protection Sociale en France en 1996. CREDES (en ligne). Novembre 1997, (consulté le 3/4/12).

ReferenceCitation: Fedyszyn IE, Harris MG, Robinson J, Edwards J, Paxton SJ. Characteristics of suicide attempts in young people undergoing treatment for first episode psychosis. Aust N Z J Psychiatry. 2011 Oct;45(10):838-45. doi: 10.3109/00048674.2011.595687. Epub 2011 Aug 23.

ReferenceCitation: Florentine JB, Crane C. Suicide prevention by limiting access to methods: a review of theory and practice. Soc Sci Med. 2010 May;70(10):1626-32. doi: 10.1016/j.socscimed.2010.01.029. Epub 2010 Feb 12. Erratum In: Soc Sci Med. 2010 Dec;71(11):2046.

ReferenceCitation: Fournet, N., Caillère, N., Fouillet, A., Caserio-Schönemann, C., Josseran, L. Le système français de surveillance sanitaire des urgences et des décès (Sur-SaUD®). Saint-Maurice : Institut de veille sanitaire : 2011. 12p.

ReferenceCitation: Gasquet I, Negre-Pages L, Fourrier A, Nachbaur G, El-Hasnaoui A, Kovess V, Lepine JP. [Psychotropic drug use and mental psychiatric disorders in France; results of the general population ESEMeD/MHEDEA 2000 epidemiological study]. Encephale. 2005 Mar-Apr;31(2):195-206. doi: 10.1016/s0013-7006(05)82386-3. French.

ReferenceCitation: Hovda KE, Bjornaas MA, Skog K, Opdahl A, Drottning P, Ekeberg O, Jacobsen D. Acute poisonings treated in hospitals in Oslo: a one-year prospective study (I): pattern of poisoning. Clin Toxicol (Phila). 2008 Jan;46(1):35-41. doi: 10.1080/15563650601185969.

ReferenceCitation: Kapur N, Cooper J, Hiroeh U, May C, Appleby L, House A. Emergency department management and outcome for self-poisoning: a cohort study. Gen Hosp Psychiatry. 2004 Jan-Feb;26(1):36-41. doi: 10.1016/j.genhosppsych.2003.06.002.

ReferenceCitation: Lamprecht HC, Pakrasi S, Gash A, Swann AG. Deliberate self-harm in older people revisited. Int J Geriatr Psychiatry. 2005 Nov;20(11):1090-6. doi: 10.1002/gps.1404.

ReferenceCitation: Large MM, Nielssen OB. Suicide in Australia: meta-analysis of rates and methods of suicide between 1988 and 2007. Med J Aust. 2010 Apr 19;192(8):432-7. doi: 10.5694/j.1326-5377.2010.tb03580.x.

ReferenceCitation: Le Pont F, Letrilliart L, Massari V, Dorleans Y, Thomas G, Flahault A. Suicide and attempted suicide in France: results of a general practice sentinel network, 1999-2001. Br J Gen Pract. 2004 Apr;54(501):282-4.

ReferenceCitation: Manchikanti L, Whitfield E, Pallone F. Evolution of the National All Schedules Prescription Electronic Reporting Act (NASPER): a public law for balancing treatment of pain and drug abuse and diversion. Pain Physician. 2005 Oct;8(4):335-47.

ReferenceCitation: Mann JJ, Apter A, Bertolote J, Beautrais A, Currier D, Haas A, Hegerl U, Lonnqvist J, Malone K, Marusic A, Mehlum L, Patton G, Phillips M, Rutz W, Rihmer Z, Schmidtke A, Shaffer D, Silverman M, Takahashi Y, Varnik A, Wasserman D, Yip P, Hendin H. Suicide prevention strategies: a systematic review. JAMA. 2005 Oct 26;294(16):2064-74. doi: 10.1001/jama.294.16.2064.

ReferenceCitation: Mateos Rodríguez, A.A, Huerta Arroyo, A., Benito Vellisca, M.A. The epidemiology of suicide attempts using drugs. Emergencias. 2007 ; 19 : 251-254.

ReferenceCitation: Mauri MC, Cerveri G, Volonteri LS, Fiorentini A, Colasanti A, Manfre S, Borghini R, Pannacciulli E. Parasuicide and drug self-poisoning: analysis of the epidemiological and clinical variables of the patients admitted to the Poisoning Treatment Centre (CAV), Niguarda General Hospital, Milan. Clin Pract Epidemiol Ment Health. 2005 Apr 28;1(1):5. doi: 10.1186/1745-0179-1-5.

ReferenceCitation: Michel, G., Aquaviva, E., Aubron, V., Purper-ouakil, D. Suicides : mieux comprendre, pour prévenir avec plus d'efficacité. In : Beck F, Guilbert P, Gautier A (dir). Baromètre santé 2005. Saint-Denis : Inpes. 2007 ; 487-506.

ReferenceCitation: Mouquet, M.C., & Bellamy, V. Suicides et tentatives de suicide en France. Etudes et Résutlats. 2006 ; 488 :1-8.

ReferenceCitation: Nordentoft M. Prevention of suicide and attempted suicide in Denmark. Epidemiological studies of suicide and intervention studies in selected risk groups. Dan Med Bull. 2007 Nov;54(4):306-69.

ReferenceCitation: Owens D, Horrocks J, House A. Fatal and non-fatal repetition of self-harm. Systematic review. Br J Psychiatry. 2002 Sep;181:193-9. doi: 10.1192/bjp.181.3.193.

ReferenceCitation: Prescott K, Stratton R, Freyer A, Hall I, Le Jeune I. Detailed analyses of self-poisoning episodes presenting to a large regional teaching hospital in the UK. Br J Clin Pharmacol. 2009 Aug;68(2):260-8. doi: 10.1111/j.1365-2125.2009.03458.x.

ReferenceCitation: Rodríguez, A.A.M., Arroyo, A.H., and Vellisca, M.A.B. (2007). The epidemiology of suicide attempts using drugs. Emergencias. 2007 ; 19 : 251-254.

ReferenceCitation: Saviuc, P., Bedry, R., Flesch, F. Epidémiologie des intoxications médicamenteuses volontaires. Médecine Thérapeutique. 1999; 5(1): 45-8.

ReferenceCitation: Staikowsky F, Theil F, Candella S. [Trends in the pharmaceutical profile of intentional drug overdoses seen in the emergency room]. Presse Med. 2005 Jul 2;34(12):842-6. doi: 10.1016/s0755-4982(05)84060-6. French.

ReferenceCitation: Simoni-Wastila L, Tompkins C. Balancing diversion control and medical necessity: the case of prescription drugs with abuse potential. Subst Use Misuse. 2001 Jul-Aug;36(9-10):1275-96. doi: 10.1081/ja-100106227.

ReferenceCitation: Theil, F. Evolution qualitative des médicaments incriminés dans les intoxications médicamenteuses sur une période de 10 ans. Créteil (Paris XII). 64 pages. 2007. (Thèse de médecine).

ReferenceCitation: Tournier M, Grolleau A, Cougnard A, Molimard M, Verdoux H. Factors associated with choice of psychotropic drugs used for intentional drug overdose. Eur Arch Psychiatry Clin Neurosci. 2009 Mar;259(2):86-91. doi: 10.1007/s00406-008-0839-2. Epub 2008 Sep 19.

ReferenceCitation: Vaiva G, Vaiva G, Ducrocq F, Meyer P, Mathieu D, Philippe A, Libersa C, Goudemand M. Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study. BMJ. 2006 May 27;332(7552):1241-5. doi: 10.1136/bmj.332.7552.1241.

ReferenceCitation: Vlad IA, Fatovich DM, Fenner SG, Daly FF, Soderstrom JH, Burrows SA. Patient perceptions of the potential lethality associated with deliberate self-poisoning. Emerg Med Australas. 2011 Oct;23(5):580-6. doi: 10.1111/j.1742-6723.2011.01434.x. Epub 2011 Jun 15.


title: Impact of a Training-action About Projects Leading for the Improvement of Care Quality in Managing Practice of Health Executive

acronym: ImpactFA

summary: The present study focuses on the quality of care and how the health executives can bring it to a central place in their management. A training-action has been set-up at the Health Executive training institute (University Hospital Grenoble) to improve care quality. Reports prepared by students (tutored projects) related to operational diagnosis and action plans about care quality improvement are given to health executives. The objective is to evaluate how the health executive will use the tutored project to improve care quality and set-up actions.The hypothesis is that the health executive will use the tutored project to improve project management.


title: Institut Paoli Calmettes Thyroid Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with thyroid cancer

status: Recruiting

lead_sponsor: Institut Paoli-Calmettes


title: Institut Paoli Calmettes Breast Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with breast cancer

ReferenceCitation: Houvenaeghel G, de Nonneville A, Cohen M, Chopin N, Coutant C, Reyal F, Mazouni C, Gimbergues P, Azuar AS, Chauvet MP, Classe JM, Darai E, Martinez A, Rouzier R, de Lara CT, Lambaudie E, Barrou J, Goncalves A. Lack of prognostic impact of sentinel node micro-metastases in endocrine receptor-positive early breast cancer: results from a large multicenter cohort☆. ESMO Open. 2021 Jun;6(3):100151. doi: 10.1016/j.esmoop.2021.100151. Epub 2021 May 10.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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


title: Institut Paoli Calmettes Prostate Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with prostate cancer


title: Institut Paoli-Calmettes Pancreatic Neoplasms Database

summary: Database of Institut Paoli Calmettes diagnosed with Pancreatic neoplasms


summary: Database of Institut Paoli-Calmettes patients diagnosed with ovarian cancer


title: Institut Paoli Calmettes Multiple Myeloma Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with multiple myeloma


summary: Database of Institut Paoli-Calmettes patients diagnosed with lymphoma


title: Institut Paoli Calmettes Chronic Lymphatic Leukemia Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia


title: Institut Paoli Calmettes Acute Leukemia Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with Acute Leukemia


title: Institut Paoli Calmettes Colorectal Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer


summary: Database of Institut Paoli-Calmettes patients diagnosed with cervical cancer


title: Institut Paoli Calmettes Cardia Cancer Database

summary: Database of Institut Paoli-Calmettes patients diagnosed with cardia cancer


title: TUDY OF THE EXPRESSION OF CIRCULATING AND INTRA-TUMORAL

acronym: CHEMOPROST

summary: Multicentric, observational, prospective, non-interventional study with occasional biological sample collection (serum bank, urine bank and tumor bank)

lead_sponsor: Institut Bergonié


title: Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia

acronym: MASEA

summary: The addition of morphine to a local anesthetic when performing an epidural analgesia during labor analgesia has improved the efficiency and the action duration of analgesia. One limitation of this technique is the time of installation of the analgesic effect (about 30 minutes) when using the only epidural. Therefore, the technique of sequential combined spinal epidural was introduced. This is to shorten the installation time by direct injection into the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the effect of the local anesthetic.

lead_sponsor: CHU de Reims


title: Interest of Serum Periostin Dosage in Patients With Bone Fibrous Dysplasia

acronym: PERIOSTINE

summary: Fibrous dysplasia is a rare bone disease which can cause pain and fractures. It has been shown that periostin is over expressed in fibrous component in patients bones ; but periostin has never been measured out in serum of patients, although it is easy to assess. This study aims to show whether serum periostin is elevated in serum of patients with fibrous dysplasia, and if it is more elevated in patients with severe forms of the disease.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de rhumatologie Pavillon F - Hôpital Edouard Herriot


title: Binge Eating Disorder and Obesity : Reward System Abnormalities in Response to Food Stimuli and Research Operability by Deep Brain Stimulation Criteria: Functional MRI Study

acronym: BED

summary: Obesity, defined as BMI> 30kg / m2, is a major public health problem, with devastating medical and psychological consequences. 30% of obese suffer from BED type of eating disorders. The optimal treatment of obesity remains bariatric surgery, failed in 20% of cases. Many arguments are in favor of the involvement of the reward circuitry, with the central role of NAc in the pathophysiology of BED and obesity. The recent application and effectiveness of DBS (Deep Brain Stimulation) in refractory psychiatric disorders suggest that DBS may be of interest in treating obesity and BED with potential target for the NAc. This project propose to study fMRI activation of the reward system in response to food stimuli to better direct the DBS targets. This is a pilot study to define indication criteria based on fMRI to obese BED patients are potential candidates for treatment with DBS.

ReferenceCitation: Charroud C, Poulen G, Sanrey E, Menjot de Champfleur N, Deverdun J, Coubes P, Le Bars E. Task- and Rest-based Functional Brain Connectivity in Food-related Reward Processes among Healthy Adolescents. Neuroscience. 2021 Mar 1;457:196-205. doi: 10.1016/j.neuroscience.2021.01.016. Epub 2021 Jan 21.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

evidence: open (author manuscript)

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

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

repositories_concat: HAL

ReferenceCitation: Charroud C, Menjot de Champfleur N, Sanrey E, Pfeuffer J, Deverdun J, Le Bars E, Coubes P. Differential effects of hunger on cerebral blood flow in healthy adolescents. Behav Brain Res. 2020 Apr 6;383:112505. doi: 10.1016/j.bbr.2020.112505. Epub 2020 Jan 23.

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

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

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

lead_sponsor: University Hospital, Montpellier


acronym: MENINGITE

summary: The primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims

acronym: EMIRATH

summary:
The objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management.

This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.


acronym: WHIPPLE

summary:
In 2012, a previous work showed that T. whipplei is a common bacterium detected in various situations. A large part of the population is therefore exposed to a T. whipplei but there is that some people probably with immunological and genetic factors predisposing which develop a disease. The association teams with experience in HLA-typing will allow us to better identify patients with a risk of chronic complication.

The main aim of this study is to evaluate if the HLA-DRB13 and/or HLA-DQB106 typing in patients are risk factors of chronic infection with T. whipplei (defined by classic Whipple disease and/ or, endocarditis and/or encephalitis).


title: Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood

acronym: CEREDIH

summary:
Background: Most children with primary immune deficiency (PID) now reach adulthood. However, few studies have evaluated their health status and health related quality of life (HRQoL).

Objective: To investigate long-term morbidity, the French Reference Center for PIDs initiated a prospective multicenter cohort: the F-CILC (French Childhood Immune deficiency Long-term Cohort). The data collected will be used to assess the physical health condition of patients who reached adulthood and the impact on their quality of life.

Methods: Patients are asked to complete health status questionnaires. A severity score (grade1 ["mild"] to grade 4 ["life-threatening"]) is assigned to each health condition. The HRQoL of patients is compared to age- and sex-matched French normal values using the SF36 HRQoL questionnaire.

Capsule summary. This will be the first study of adult survivors of childhood PID describing how the burden of health conditions affect their quality of life.

ReferenceCitation: Barlogis V, Mahlaoui N, Auquier P, Fouyssac F, Pellier I, Vercasson C, Allouche M, De Azevedo CB, Moshous D, Neven B, Pasquet M, Jeziorski E, Aladjidi N, Thomas C, Gandemer V, Mazingue F, Picard C, Blanche S, Michel G, Fischer A. Burden of Poor Health Conditions and Quality of Life in 656 Children with Primary Immunodeficiency. J Pediatr. 2018 Mar;194:211-217.e5. doi: 10.1016/j.jpeds.2017.10.029. Epub 2017 Dec 6.


acronym: SCHIFT

summary:
Quality of life (QoL) measurements have become an important way to evaluate the treatments and care provided to patients with schizophrenia. Understanding determinants of QoL in schizophrenia is of importance for developing effective interventions that would improve patient functional and subjective well-being. A challenge in the interpretation of QoL measures, especially in longitudinal studies, is that QoL is self-reported by the patient and might be influenced by psychological phenomena such as adaptation to illness. An important mediator of this adaptation process is a "response shift" (RS), which involves changing internal standards, values and the conceptualization of QoL. RS can be divided into three phases 1) reconceptualization (i.e., a redefinition of QoL), 2) reprioritization (i.e., a change in the importance attributed to component domains constituting QoL) and 3) recalibration (i.e., a change in a patient's internal standards of measurements). Patients may change their frame of reference, rendering scores from different measurement occasions incomparable. An RS is a potential explanation when the QoL of an individual who has experienced a serious health event or chronic condition is similar to the QoL of a healthy individual. With an RS, the concept of QoL changes over time and cannot be compared longitudinally because of changes in internal standards, values, and/or concepts. True change may be over- or underestimated when a RS is present, leading to biased estimates of the magnitude of change.The objective is to examine whether a response shift, a change in the internal standards of a patient, occurs in patients suffering from schizophrenia and in their caregivers.

This is a monocentric and propective design study, with inclusion of patients and caregivers on a 12-month period, and a follow up on a 12-month period.

100 patients with schizophrenia and 100 caregivers

Test approach (Response shift (RS) (pre-test - then-test), unadjusted effect (post-test - pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other statistical approaches such as confirmatory factorial analysis, multilevel models and CART method.


acronym: REPERM-OCT

summary: The treatment of neovascular age-related macular degeneration (ARMD) is a major issue of public health. The therapeutic arsenal has widely grown throughout the years with the emergence of intra-vitreous anti-angiogenic treatments, under different surveillance protocols. The "PRN" surveillance (pro re nata: an on-demand treatment with monthly follow-up) allows a faster re-injection in case of neovascular relapse in order to maintain the best visual acuity. This therapeutic protocol is guided by the sub-retinal neovascular signs of activity. The monitoring is done during common practice via OCT B scans showing indirect signs of neovascular activity (exudation signs). OCT retinal imaging has been recently enriched with new programs allowing the visualization of sub-retinal neovessels without the use dyes (OCT angiography). The OCT angiography is automatically done by a program using standard OCT sections. During the monitoring of a patient using the OCT A, the signs of renewed neovascular activity are represented by an "arterialization" or the development of an arteriole network of the neovessel with the reappearance of a hyper reflective flow after a neovascular regressive phase. Indeed, the visualization of neovessels during the monitoring by Angio-OCT may lead to therapeutical modifications (anticipation of the injections). Knowing that the injection time-table of ARMD patients treated with anti-angiogenics is determined by sub-retinal neovascular signs of activity. This activity is evaluated during routine clinical practice by very specific signs, observable on OCT B scans. The hypothesis of this study is that the search of activity sins on the Angio-OCT, a new technic of image analysis performed on the OCT, may modify this injection time-table, with an impact of the patient's visual acuity.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rotchschild


acronym: Botox shoulder

summary:
Botulinum toxin is used in musculoskeletal therapy routinely for 15 years. This is one of the most potent neurotoxins. It comes in 7 serotypes (A to G).Therapeutic application of botulinum toxin are mainly based on its ability to block the neuromuscular transmission by preventing the release of acetylcholine, creating paralysis muscle relative and reversible.

It has been used in the treatment of cervical dystonia, migraine headaches, and an antinociceptive effect. The analgesic effect occurred even prior to the release muscular. Several randomized studies have been published about it. The investigators assume that intramuscular injection of botulinum toxin is effective in the treatment of tendinopathy rotator cuff.

lead_sponsor: Versailles Hospital


title: Multiple Fields Radiotherapy Versus Intravenous Rituximab in the Treatment of Indolent Cutaneous Lymphomas B-cell With Multiple or Recurrent Lesions

acronym: RADIO-LYMPH

summary:
Cutaneous lymphomas are the most frequent extranodal lymphomas after digestive lymphomas. A quarter are B-cell lymphomas. 80% of cutaneous B cell lymphomas are indolent cutaneous B cell lymphomas. These indolent cutaneous B cell lymphomas are characterized by good prognosis (survival rate at 5 years: 90%), but also by the frequency of cutaneous recurrences. The radiotherapy is currently the most widely used treatment, with complete response rate close to 100% for a lesion treated. However, it has limits when there are outset multiple lesions inaccessible to a single radiotherapy field (concerning one case in three), or during recurrences. In these situations, conventional chemotherapy is not recommended and multi-field radiotherapy is often used empirically, but its effectiveness has never been studied prospectively.

Recently, retrospective studies with small numbers patients (totaling sixty patients) reported complete response rates of 80 to 100% with rituximab (anti-cluster of differentiation antigen 20 (CD20) antibodies) used as monotherapy in non-standardized treatment by intravenous with a recurrence rate of less than one case in three. These data suggest that rituximab by intravenous with a standardized initial cycle followed by a maintenance therapy could improve the prognosis of indolent cutaneous B cell lymphomas with multiple lesions or of recurrent lesions.


title: Comparison of Endoscopy and Diffusion-weighted Enterography-MRI for the Diagnosis of Crohn's Disease Recurrence Following Ileocolic Resection: a Pilot Study

acronym: MRI-CROHN

summary:
Nearly three-quarters of patients with Crohn's disease have small bowel involvement and 80% of them will have complications that will require a surgical procedure, usually an ileocolonic resection with ileocolonic anastomosis. The rate of recurrence at the anastomosis site and in the ileum after surgery, whether symptomatic or not, is high, at least 60% in one year and 80% within three years. The gold standard for monitoring being ileocolonoscopy, endoscopic surveillance is recommended in these patients, once between 6 to 12 months after surgery and then every 2 years.

The MRI enterography is a validated technique for the assessment of small bowel Crohn's disease. The enterography MRI is a validated technique for the assessment of small bowel Crohn's disease. The MRI enteroclysis was evaluated in two studies compared to endoscopy, with excellent performance in terms of recurrence detection sensitivity and suggested as an alternative to it to avoid an invasive procedure repeated in these patients. The MRI enterography (without enteroclysis) does not provide as good distension of the bowel loops as MRI enteroclysis because it relies on the principle of oral ingestion prior to the examination of large amounts of liquid. However, it is much better tolerated by the patient, does not involve radiation that exists with enteroclysis, is much simpler to use and requires no special equipment to magnetic fields.


title: Prospective Constitution of Database Gathering Data of Patients Suffering From Glaucoma Followed at University Hospital of Grenoble

summary: Few publications provide information on the natural history of glaucoma, outside of clinical trials do not always reflect what is observed in common situation for various reasons (specific selection criteria and sometimes restrictive, stronger motivations patients and physicians to comply with follow-up visits and prescribed treatments, etc.). Therefore, much information on the natural history of glaucoma are unknown to date (degradation rate of visual field and visual function over time, risk of blindness in the years following diagnosis, effects of various treatments to reduce intraocular pressure and preserving visual field deterioration, etc.). Obtaining such important data to improve the management of glaucoma patients (choice of treatment methods, identification of predictors of rapid change that can make choosing more aggressive treatment and more regular monitoring, etc.) requires the establishment of cohort of patients followed and treated with the methods usually used in current practice, and besides therapeutic trial.


title: Physical Activity in Patients With Cancer: Epidemiological Study of Patients' Beliefs and Promotional Messages Efficiency

acronym: RESCA

summary:
Study 1:

The investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in AP.

lead_sponsor: Centre Antoine Lacassagne


title: Information Consultation by a Manipulator Radiotherapy: Impact on Information to Patients Treated With Radiotherapy for Cancer

acronym: INFORTH

summary:
The medical teams are increasingly sought by patients to get the most possible information, probably expressed in a different form and thereby supplementing the information already received. Coulter et al. reached similar conclusions in their study of the writings of patient information documents. They point out, moreover, the best adaptation of the patients better informed compared to those with less or no information.

This need for information varies over time. It is present before treatment begins, continues during treatment and persists after treatment. Given the specific features of radiotherapy, the manipulators are important interlocutors to participate in the accompanying caregiver time.

In conclusion, the quality of information delivered to the patient has been poorly evaluated, let alone with validated tools in this area.

The impact of information on the tolerance of the treatment also needs to be confirmed, knowing that an informed patient seems less anxious and better prepared for future treatment.


title: PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.

acronym: CYBERBOOST

summary:
The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin.

CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments.

The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation.

The results, in terms of local control, will be evaluated on clinical monitoring.


title: Phase I Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer

acronym: PROSTIRNA

summary:
This is a single site, open-label, non-randomized, dose escalation phase I study designed to evaluate the safety, the tolerability and the Recommended Phase II Dose (RP2D) of SXL01, a synthetic small interfering ribonucleic acid (RNA) targeting the androgen receptor messenger RNA (mRNA), in patients with metastatic castration-resistant prostate cancer.

A standard method "3+3" will be used for dose escalation. A maximum of 30 patients will complete the dose-escalation phase of the study; 12 additional patients will be included at the RP2D in the expansion phase.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Institut Claudius Regaud


title: Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy

acronym: BioConnect

summary:
Patients should receive a chemotherapy regimen with an overall risk of febrile neutropenia ≥ 20%. The use of the web-application their will be proposed .

They will be informed of the risk of neutropenia, fever and bleeding which may occur beyond the fifth day of each chemotherapy cycle (to eliminate fevers related to treatment).

The temperature measurement is performed at home by an infrared forehead thermometer provided as part of the study, in a systematic manner once daily at the same time of day and in case of unexplained fatigue or chills.

Before any fever reported to the physician via the web-application (alert), a questionnaire will be completed by the patient to the search for gravity criteria to assess his condition at home. The patient will be hospitalized immediately if it shows signs of severity in order to document the infection and provide intravenous antibiotics adapted to the clinical condition; in the absence of these signs, the patient will make a count to the nearest lab and will receive oral antibiotics if indicated. The subsequent strategy will be defined by the web-application algorithm to optimize the care of patients.

The ability to use a web-application could allow early detection of complications of post-chemotherapy haematological toxicity and offer a taking over guided by a decision-making algorithm managed by the physician.

The aim is to favour the taking over at home.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm

acronym: DEP-AIC

summary:
During the last decade, the embolization has become the treatment of choice for ruptured intracranial aneurysms, to improve the neurological outcome of patients. At the same time, for his safety, she also became the technique allowing prophylactic treatment of unruptured intracranial aneurysms discovered incidentally during imaging exams.

Regarding patients with ruptured intracranial aneurysms, patients who survive often have a reduced quality of life while one in two has a good neurological outcome after embolization. Depression, anxiety and fatigue, whose the psycho-social impact is important, are often cited. This description has often been done without considering the realized type of treatment (surgery or embolization) and mostly of neurological and functional status of the patient remotely (disability or not in daily activities).

Regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and embolization is programmed. They would present an cognitive impairment in one case in five at 1 month of treatment.

If depression, fatigue and difficult return to working life are logically found in patients with severe sequelae (disability in daily activities) of their ruptured intracranial aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms.

A precise status of these populations is necessary, especially as the discovery and treatment of their intracranial aneurysms is often early (between 40 and 60 years) and that their good neurological status should allow "a priori" to return easily at the active life.


title: Assessment of the Efficacy and Tolerance of Sub-cutaneous Re-injection of Autologous

acronym: REGENDER

summary:
Diabetic foot ulcer (DFU) is a major complication and the leading cause of hospitalization among people with diabetes mellitus. It occurs in 15% of all patients with diabetes and precedes 84% of all lower leg amputations. Despite many therapeutic advances over the past decades, including dressings (hydrocolloids, alginate, skin substitutes) and growth factors, healing rates of DFU remain low.

Mechanisms of faulty wound healing in diabetic patients are complex, related to both intrinsic and extrinsic factors. The main reasons for impaired healing appears to be: 1/exhaustion of local cell populations that promote wound healing; 2/excessive production of matrix metalloproteases (MMPs) coupled with reduced expression of the tissue inhibitors of MMPs; 3/impaired neovascularisation coupled with reduced numbers of endothelial progenitor cells and impairment of their functioning. These imbalances may result in excessive degradation of extracellular matrix components, as well as an inappropriate local inflammatory response .

Adipose-derived stroma vascular fraction provides a rich and easily accessible source of autologous cells for regenerative medicine applications. Il contains multipotent stem cells and progenitors called adipose-derived regenerative cells (ADRCs) able to stimulate wound healing. There are attracted to the wound site where they supplement the wound bed with similar cell types, secrete numerous growth factors and cytokines, increase macrophage recruitment, enhance granulation tissue, and improve vascularisation . The reparative capabilities coupled with good safety of ADRCs have been illustrated in a study for treating severe and irreversible radiation-induced lesions, and in a study for treating sclerodactyly in patients with diffuse scleroderma. Numerous case reports showing healing of refractory wounds following treatment with autologous ADRCs have also been reported.

Based on these previous reports, the present study aims to assess the efficacy and tolerance of injection of ADRCs for the local treatment of neuropathic or neuro-ischemic DFU.

status: Not yet recruiting

appel_a_projets: PHRCN

acronyme: REGENDER

titre: Evaluation de l'efficacité et de la tolérance de la réinjection sous-cutanée de cellules régénénatives autologues dérivées du tissu adipeux dans le traitement local des ulcères de pied chez les patients atteints de neuropathie diabétique: étude ouverte multicentrique de phase II

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: DARMON

prenom_porteur: Patrice


acronym: SCLERADECIII

summary:
Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis. As a result, patients suffer from everyday disability, with consequences on their occupational activities and social contact, sometimes severely altering their quality of life. To date, no anti-fibrosis treatment has proven effective; existing vasodilation treatments are unfortunately not very effective, and are associated with adverse effects or restrictions. It is consequently of utmost importance that an effective treatment for sclerodermic hands be developed. The injection of adipose autologous tissue is a common practice in plastic surgery, and has been known for over a century. Adipose tissue, originally used to increase volume, is also characterized by trophic properties associated to stromal vascular fraction (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc. The injection of SVF into the fingers would also make it possible to control the production of the extracellular matrix and to improve the balance between fibrosis and fibrolysis, resulting in an improvement of cutaneous sclerosis

The main purpose is to evaluate the efficacy of SVF injections in the fingers of patients suffering from SSc on the Cochin hand functional scale evaluated at 12 months, in comparison to the control group.


title: Incidence of High Levels of Transpulmonary Pressure During the Use of Airway Pressure Release Ventilation.

summary:
Mechanical ventilation can induce pulmonary lesions called ventilator induced lung injury (VILI). High levels of Transpulmonary pressure is one of the most important mechanism of VILI during the use of mechanical ventilation. The use of bilevel pressure ventilator modes like APRV could generate high levels of transpulmonary pressure.

The aim of this study is to evaluate the variations of transpulmonary pressure during the use of APRV by clinicians

location_facility: Assistance Publique Hôpitaux de Marseille hôpital de la Timone


title: Efficacy of the Implementation of a Food and Nutritional Support Strategy Adapted to Dependent Elderly Subjects: Controlled Trial.

acronym: RENES+

summary:
Malnutrition particularly affects people who delegate the preparation of their meals with 46% of persons living at home and using a meals-on-wheels service, or those in old people's homes (Etablissement d'Hebergement pour Personnes Agees Dependantes - EHPAD) at risk of malnutrition, compared with 16% in persons who have help, but not for their meals, and 8% in independent persons (Aupalesens Survey). This proportion, which is particularly high, is essentially due to the absence or insufficient level of individual monitoring of the nutritional status of these "dependent" populations despite the different recommendations. EHPAD (old people's homes) are invited to respect meal rhythms, to adapt the nutritional and gustatory qualities of the food, to propose a pleasant environment (Survey CLCV 2012: data collection in 2012); in parallel, few professionals are really trained in the needs of the elderly. In meals-on-wheels services, apart from the distribution of meals, no nutritional follow-up is proposed (Guide 2012).

Symmetrically, the constant search to control costs in western healthcare systems has led managers to systematically reduce care costs, in particular those that are not directly related to medico-pharmaceutical or care personnel expenditure in the strictest sense. In the collective catering services, there is, for example, a systematic effort to reduce daily "costs/materials", without measuring the global cost related to the efficacy of care.

The present work is part of the RENESSENS project: these studies will be conducted in two elderly populations, one living at home and receiving meals on wheels daily and a regular visit of a dietician, who will propose individual nutritional follow-up and the second living in an old people's home (EHPAD) that will benefit from the improved management of its catering service (good culinary practices, including specific training for personnel and meals adapted to the needs of residents). The principal aim of these two studies will be common and will be to evaluate the efficacy of this specific type of management of meals and nutrition compared with a reference meals-on-wheels service and a reference EHPAD.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study

acronym: PREGAB

summary: Spinal surgery is associated with intense pain and associated to a history of preoperative chronic pain. Pregabalin is licensed to treat chronic neuropathic pain, particularly when high dose of opioid are required. Preoperative pain is associated with high postoperative pain scores and opioid requirement promoting persistent hyperalgesic state. The investigators will evaluate the postoperative opioid consumption and pain scores in patients scheduled for lumbar surgery and taking pregabalin since more than 15 days and compare with preoperative pregabalin-free patient that will receive pregabalin only during surgery.

lead_sponsor: Christophe Aveline, MD

sponsor_collaborators:
Christophe Aveline, MD
Rennes University Hospital


title: Identification of the Molecular Bases of Syndromic Congenital Neutropenia With Development Anomalies

acronym: neutropenias

summary:
Syndromic congenital neutropenia (SCN) includes a heterogeneous group of diseases characterized by congenital neutropenia associated with the involvement of other organs. Most patients have syndromic congenital neutropenia, which does not correspond, either clinically or genetically, to any other previously described form. A large number of genes still have to be identified in these syndromic forms.

The aim of this study is to identify the molecular bases of congenital neutropenias that have not yet been classified, by taking advantage of high-throughput exome sequencing.


title: Prospective Study to Evaluate Ultrasound Verification of the Correct Position of Gastric Tubes in Intensive Care

acronym: SNG echo

summary: There are several ways to verify the correct positioning of a gastric tube. Radiography is considered the reference method. The use of ultrasonography could diminish the number of radiographies necessary. The hypothesis of this research is that gastric ultrasonography performed during insertion of the tube is a reliable examination to check the correct positioning of gastric tubes in intensive care.