title: Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies

acronym: EVEIL

summary:
In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms.

However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age.

The investigators have developed a questionnaire with the aim of quantifying the child's vision so that the decision is most justified. The items of this questionnaire were established based on the literature and were submitted to a panel of experts in ophthalmo-pediatrics. The objective of this study is to determine the internal validity and as far as possible (since there is no equivalent tool) the external validity of the questionnaire developed.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Is Adipose Tissue a Reservoir for SARS-Cov2 Spread?

summary: Resident cells of human adipose tissue express ACE2 and DPP4, receptors for SARS-Cov2. The hypothesis is that the virus may enter and spread in fat depots.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: The BD Odon DeviceTM for Assisted Vaginal Birth: a Feasibility Study to Investigate Safety and Efficacy

acronym: ASSIST

summary: Besancon ASSIST study will investigate if the BD Odon DeviceTM is safe, effective and acceptable to women and maternity staff for assisted vaginal birth.

study_start_date_type: Actual

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Device


title: Targeting Interleukin 1 Receptor Accessory Protein (IL1RAP) Expressing Acute Myeloid Leukemic (AML) Cells by Chimeric Antigen Receptor (CAR) Engineered T-cells

acronym: CAR-LAM

summary:
AML is one of the most aggressive forms of leukemia, where bone marrow transplantation remains the gold standard treatment, with its known associated toxicities and related mortality. Despite progress in the treatment of leukemic malignancies, especially the emergence of targeted- and immuno-therapies arising from biological genomic knowledge, there remains a need to provide additional strategies for refractory/relapsing (R/R) patients

Aim of this study is to collect biological samples of AML patients in order to validate our Chimeric Antigen Receptor T-cells immunotherapy approach

primary_purpose: Screening

collaborators:
Centre Hospitalier Universitaire Dijon
Etablissement Français du Sang

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

intervention_type: Other


title: Study of the Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy

acronym: BOM-ZEN

summary:
The bone marrow aspiration and biopsy (BMAB) is an essential and indispensable examination for the diagnosis and the follow-up of the hematological diseases but which remains painful and dread by the patients. Until then it was performed manually using a trocar. It is now practiced most often using a tool (like a small drill), device that pierces through the external iliac bone to extract a bone cylinder that will be analyzed

If the gesture is faster than with the manual method, it remains overall painful and the noise generated by the drill that passes through the periosteum of the iliac bone is impressive for the patient.

Prevention measures to limit pain and anxiety are put in place during the examination: local anesthesia, with or without a lidocaine patch, as well as inhalation of a mixture of nitrous oxide and oxygen (MEOPA®). These, recommended by the "Standards, Options, Recommendation" (SOR) often remain insufficient and are not devoid of undesirable effects.

Despite these precautions, several studies show that the action remains painful and anxiety-provoking.

An exploratory survey carried out in the hematology department of the François Baclesse Center in 2013 confirms these results and specifies that the pain remains present for another 30 minutes after the examination.

The investigators believe that associating a psycho-corporeal technique, as is sophrology, with the usual care, could contribute to the decrease of the threshold of pain and anxiety during the BMAB and avoid the use of a premedication.

The effectiveness of sophrology as a complementary technique in the field of pain prevention in invasive procedures is recognized by observations and clinical results. This complementary therapy, among others, has its place in the hospital.

To date, to investigator's knowledge, there is no published, randomized study evaluating the effectiveness of sophrology on pain in invasive procedures.

The investigators propose a study whose main objective is to evaluate the effectiveness of a session of sophrology on the pain felt during the realization of the BMAB, in patients with hematological malignancy. This session will be provided by a sophrologist nurse This study should include 90 patients undergoing a BMAB over a 24-month period.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: University Hospital, Caen

status_simplified: Completed


title: Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer

acronym: BOVARY Pilot

summary: BOVARY-Pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. The purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. The method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. The concordance of somatic mutations (SNV) found in tissue and in cell-free DNA (cfDNA) extracted from blood will then be compared

primary_purpose: Diagnostic

lead_sponsor: Institut de Cancérologie de Lorraine

intervention_type: Diagnostic Test

lead_sponsor_type: industriel


title: Validation of an Early Detection Questionnaire of Burnout in Healthcare Workers at Clermont-Ferrand University Hospital

summary: Burnout is a public health issue. Healthcare workers are particularly at risk of burnout with occupational stress identified as the major risk factor. The "Health Work Environment" service is composed of physicians, nurses and psychologist with the aim of providing efficient and adapted care for healthcare workers at CHU of Clermont-Ferrand. In addition, they must ensure a role of primary, secondary and tertiary prevention. With regard to burnout, the majority of the work carried out concerns tertiary prevention, that is to say the care of a person in a situation of burnout. It would be necessary to carry out secondary prevention in order that people at risk of burnout can be detected earlier. However, there is currently no individual questionnaire to detect early burnout

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Clermont-Ferrand


type: Registry Identifier

title: Study of Ventricular Repolarization in Patients With Premature Ovarian Insufficiency and Influence of Estrogen-progestin Replacement Therapy

acronym: QT-IOP

summary: Ventricular repolarization, measured by corrected QT interval (QTc), is influenced by sex hormones. A QTc above 460msec predisposes to the risk of "torsades-de-pointes"(TdP). The investigators have recently shown that estradiol determines an increase in QTc elongation and progesterone shortens it. In addition, high gonadotropin levels (FSH or LH) are associated with QTc prolongation. Hypergonadotropic hypogonadisms (low progesterone and high gonadotropins) are therefore hormonal situations that promote QTc prolongation. Premature ovarian insufficiency (POI) is one of them. Its management is based on the prescription of hormone replacement therapy (HRT). Epidemiological studies have shown that these patients would be at increased risk of cardiovascular mortality. Our team is interested in the effect of this pathological hormonal situation and its HRT on ventricular repolarization in order to define whether this is a population at risk for long QTc.

status: Recruiting

primary_purpose: Basic Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug

status_simplified: Ongoing


acronym: SPLEMENGO

intervention_type: Biological

summary: The purpose of the study is to evaluate the immunological response and tolerance of 3 vaccine strategies against meningococcus B, a potentially fatal invasive infection.

ReferenceType: background

ReferenceCitation: Borrow R. Advances with vaccination against Neisseria meningitidis. Trop Med Int Health. 2012 Dec;17(12):1478-91. doi: 10.1111/j.1365-3156.2012.03085.x. Epub 2012 Sep 4.

ReferenceCitation: Frosi G, Biolchi A, Lo Sapio M, Rigat F, Gilchrist S, Lucidarme J, Findlow J, Borrow R, Pizza M, Giuliani MM, Medini D. Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine. 2013 Oct 9;31(43):4968-74. doi: 10.1016/j.vaccine.2013.08.006. Epub 2013 Aug 14.

ReferenceCitation: Murphy E, Andrew L, Lee KL, Dilts DA, Nunez L, Fink PS, Ambrose K, Borrow R, Findlow J, Taha MK, Deghmane AE, Kriz P, Musilek M, Kalmusova J, Caugant DA, Alvestad T, Mayer LW, Sacchi CT, Wang X, Martin D, von Gottberg A, du Plessis M, Klugman KP, Anderson AS, Jansen KU, Zlotnick GW, Hoiseth SK. Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis. 2009 Aug 1;200(3):379-89. doi: 10.1086/600141.

ReferenceCitation: Balmer P, Falconer M, McDonald P, Andrews N, Fuller E, Riley C, Kaczmarski E, Borrow R. Immune response to meningococcal serogroup C conjugate vaccine in asplenic individuals. Infect Immun. 2004 Jan;72(1):332-7. doi: 10.1128/IAI.72.1.332-337.2004.

ReferenceCitation: 5. Hcsp. Avis du hcsp relatif à l'utilisation du vaccin bexsero® (novartis vaccines and diagnostics). 2013. (link:http://www.hcsp.fr/explore.cgi/telecharger?nomfichier=hcspa20131025_vaccmeningocoquebbexsero®.pdf.

ReferenceCitation: McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Houlden J, Voysey M, Toneatto D, Kitte C, Dull PM, Pollard AJ. Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J. 2014 Jul;33(7):760-6. doi: 10.1097/INF.0000000000000327.

ReferenceCitation: Wasserstrom H, Bussel J, Lim LC, Cunningham-Rundles C. Memory B cells and pneumococcal antibody after splenectomy. J Immunol. 2008 Sep 1;181(5):3684-9. doi: 10.4049/jimmunol.181.5.3684.

ReferenceCitation: Mori M, Morris SC, Orekhova T, Marinaro M, Giannini E, Finkelman FD. IL-4 promotes the migration of circulating B cells to the spleen and increases splenic B cell survival. J Immunol. 2000 Jun 1;164(11):5704-12. doi: 10.4049/jimmunol.164.11.5704.

ReferenceCitation: Sullivan JL, Ochs HD, Schiffman G, Hammerschlag MR, Miser J, Vichinsky E, Wedgwood RJ. Immune response after splenectomy. Lancet. 1978 Jan 28;1(8057):178-81. doi: 10.1016/s0140-6736(78)90612-8.

ReferenceCitation: Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969 Jun 1;129(6):1307-26. doi: 10.1084/jem.129.6.1307.

sponsor_collaborators: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

sponsor_collaborators: Innovative clinical research in vaccinologie (I-REIVAC)

title: Multicenter, Randomized, Phase III, Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia

type: EudraCT Number

source: euctr

ipd_sharing: Undecided

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: SPLEMENGO

titre: Essai multicentrique, randomisé de phase 2, évaluant l'immunogénicité et la tolérance de trois stratégies vaccinales contre le Méningocoque B chez des patients présentant une asplénie.

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: Launay

prenom_porteur: Odile


title: A Prospective, Monocentric, Uncontrolled Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume

acronym: BeautyVolume

summary:
Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection.

In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled.

Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.

primary_purpose: Treatment

lead_sponsor: Laboratoires Vivacy


title: Study of the Sars-Cov2 Neuroinvasiveness - COVID19

acronym: CORONEVRAXE

summary: Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia, ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can be safely removed from the patient. In this study, COVID-19 patients will be evaluated first, for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.

status: Terminated

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


title: Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography: Comparison of the Injection of Contrast in the Upper and Lower Caval Territories (FOP-TP)

acronym: FOP-TP

summary: The investigators hypothesis is that an injection into the inferior vena cava associated with a provocation maneuver should allow to increase the incidence of FOP found by transesophageal echocardiography in a population of patients undergoing lung transplantation.

lead_sponsor: Hopital Foch


type: Other Identifier

title: Randomized Study Comparing the Low Impact Laparoscopy Concept to Conventional Laparoscopy in Terms of Ambulatory Care

acronym: RANDOLIL

summary:
Outpatient surgical management has been developing in recent years and High Authority of Health recommendations in French for this type of management is a postoperative pain score of less than 3 on the VAS.

The feasibility and safety of laparoscopy is well established, particularly in the field of gynecology, but this technique often causes postoperative pain. Techniques are being developed to reduce postoperative pain in laparoscopic surgery. Low pressure insufflation (7 to 10 mmHg) compared to standard pressure insufflation (12 to 15 mmHg) significantly reduces postoperative pain. Microcoelioscopy (use of 3 mm trocars instead of 5 to 12 mm trocars in standard laparoscopy), by reducing the size of incisions, also significantly reduces postoperative pain.

The Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation and microcoelioscopy which would have the advantage of reducing postoperative pain. This technique would therefore, by reducing postoperative pain, to improve outpatient management, particularly in cases of hysterectomies for which the outpatient management rate could be increased.

The hypothesis is that using the Low Impact Laparoscopy concept would increase outpatient management rate compared to conventional laparoscopy in gynecological surgeries for hysterectomy.

The study aims to compare the Low Impact Laparoscopy concept with conventional laparoscopy in terms of ambulatory care rates in patients undergoing surgery for hysterectomy.

lead_sponsor: Hospices Civils de Lyon


title: Tolerance and Efficacy Study of Second-line Surgery After Percutaneous Needle Aponeurotomy for Dupuytren's Disease. URAM 3

summary: As part of a graduated medical-surgical strategy, and in our practice, surgery for Dupuytren's disease appears as a second-line treatment indicated in a situation of failure after treatment with percutaneous needle aponeurotomy.The results of second-line surgery in terms of safety and efficacy have not been specifically evaluated in patients who underwent failed percutaneous needle aponeurotomy. This evaluation nevertheless appears necessary for the validation of a medical-surgical strategy during Dupuytren's disease.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
Dr ROULOT


title: Management of Anal Fistula of Crohn Disease

acronym: FISTUCROHN

summary: The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

time_perspective: Other

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes


title: Morbimortality of Covid-19 in Patients With Chronic Inflammatory Rheumatism Treated With Immunosuppressants

acronym: CORhum

summary: A retrospective monocentric study with large active files of patients monitored for rheumatoid arthritis, spondyloarthritis and systemic lupus erythematosus with as main endpoint the morbimortality of Covid-19 in these patients (number of patients hospitalized in conventional units and/or in intensive care and/or deceased). The results will be compared with those of the general population based on the epidemiological data of Covid-19.

time_perspective: Retrospective

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

evidence: oa repository (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_normalized: medRxiv

version: submittedVersion

repositories:
PubMed Central
medRxiv

repositories_concat: PubMed Central;medRxiv

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Monti S, Balduzzi S, Delvino P, Bellis E, Quadrelli VS, Montecucco C. Clinical course of COVID-19 in a series of patients with chronic arthritis treated with immunosuppressive targeted therapies. Ann Rheum Dis. 2020 May;79(5):667-668. doi: 10.1136/annrheumdis-2020-217424. Epub 2020 Apr 2. No abstract available.

ReferenceCitation: Gianfrancesco MA, Hyrich KL, Gossec L, Strangfeld A, Carmona L, Mateus EF, Sufka P, Grainger R, Wallace Z, Bhana S, Sirotich E, Liew J, Hausmann JS, Costello W, Robinson P, Machado PM, Yazdany J; COVID-19 Global Rheumatology Alliance Steering Committee. Rheumatic disease and COVID-19: initial data from the COVID-19 Global Rheumatology Alliance provider registries. Lancet Rheumatol. 2020 May;2(5):e250-e253. doi: 10.1016/S2665-9913(20)30095-3. Epub 2020 Apr 16. No abstract available.

ReferenceCitation: Haberman R, Axelrad J, Chen A, Castillo R, Yan D, Izmirly P, Neimann A, Adhikari S, Hudesman D, Scher JU. Covid-19 in Immune-Mediated Inflammatory Diseases - Case Series from New York. N Engl J Med. 2020 Jul 2;383(1):85-88. doi: 10.1056/NEJMc2009567. Epub 2020 Apr 29. No abstract available.

ReferenceCitation: Michaud K, Wipfler K, Shaw Y, Simon TA, Cornish A, England BR, Ogdie A, Katz P. Experiences of Patients With Rheumatic Diseases in the United States During Early Days of the COVID-19 Pandemic. ACR Open Rheumatol. 2020 Jun;2(6):335-343. doi: 10.1002/acr2.11148. Epub 2020 May 9.

ReferenceCitation: Favalli EG, Ingegnoli F, De Lucia O, Cincinelli G, Cimaz R, Caporali R. COVID-19 infection and rheumatoid arthritis: Faraway, so close! Autoimmun Rev. 2020 May;19(5):102523. doi: 10.1016/j.autrev.2020.102523. Epub 2020 Mar 20.

lead_sponsor: University Hospital, Lille


title: " Brain Changes After Repetitive Head Impacts in Soccer and the Effects of a Protective Device: Biomechanical, Cognitive, Electrophysiological and Multimodal Neuroimaging Study "

acronym: Soccer-BRAIN

summary: Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired

lead_sponsor: University Hospital, Bordeaux


title: Study of Autophagy and the Effects of GALIG Gene Products in HIV-1 Infected Patients Who Are Under Antiretroviral Therapy Since Primary-infection, Chronic Phase, or Never Treated.

acronym: ATGALIG-HIV

summary:
Little is known about autophagy during HIV infection. Recently, two different teams reported important dysfunctions of autophagy in HIV-infected patients despite sustained suppressive antiretroviral therapy. As altered autophagy is strongly linked to cellular senescence and chronic inflammation, two hallmarks of HIV-infected patients despite long-term suppressive antiretroviral therapy, it is important to improve our knowledge in the area.

Our main objective is to determine whether all or part of mononuclear cell subpopulations (CD4+ and CD8+ T lymphocytes, and monocytes) exhibit a defect in autophagy function in a cohort of HIV-infected patients who are virologically-controlled (plasma HIV RNA <50 copies / ml) either spontaneously (i.e. HIV controllers or post-treatment controllers) or after they started antiretroviral therapy at different time points (i.e. at the acute or chronic phases), as compared with a control group (i.e. uninfected healthy blood donors).

time_perspective: Cross-Sectional

ReferenceCitation: Deeks SG, Lewin SR, Havlir DV. The end of AIDS: HIV infection as a chronic disease. Lancet. 2013 Nov 2;382(9903):1525-33. doi: 10.1016/S0140-6736(13)61809-7. Epub 2013 Oct 23.

ReferenceCitation: Ipp H, Zemlin A. The paradox of the immune response in HIV infection: when inflammation becomes harmful. Clin Chim Acta. 2013 Feb 1;416:96-9. doi: 10.1016/j.cca.2012.11.025. Epub 2012 Dec 7.

ReferenceCitation: Serrano A, El Haddad S, Moal F, Prazuck T, Legac E, Robin C, Brule F, Charpentier S, Normand T, Legrand A, Hocqueloux L, Mollet L. Dysregulation of apoptosis and autophagy gene expression in peripheral blood mononuclear cells of efficiently treated HIV-infected patients. AIDS. 2018 Jul 31;32(12):1579-1587. doi: 10.1097/QAD.0000000000001851.

ReferenceType: result

ReferenceCitation: Gomez-Mora E, Robert-Hebmann V, Garcia E, Massanella M, Clotet B, Cabrera C, Blanco J, Biard-Piechaczyk M. Brief Report: Impaired CD4 T-Cell Response to Autophagy in Treated HIV-1-Infected Individuals. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):201-205. doi: 10.1097/QAI.0000000000001201.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP)

acronym: ESPT-PP

summary: The purpose of this study is to estimate the prevalence of post-traumatic stress disorder (PTSD) at one month in women who have given birth at the University Hospital of Angers over a period of 1 year.

lead_sponsor: University Hospital, Angers


title: Study of the Psychological Profile of Type 2 Diabetic Patients With Foot Wounds, Compared to Diabetic Patients Without Foot Wounds

acronym: Bortner Pied

summary:
Several studies have highlighted the value of analyzing a patient's psychological profile with the Bortner scale questionnaire (defined as type A or B personality). This analysis helps to better understand and anticipate patients' behaviour, stress and compliance with their disease and its progression. The Type A personality profile combines hyperactivity, competitiveness and exaggerated ambition, while the B profile is characterized by lower sensitivity to stress and reduced competitiveness.

It has been shown that the type B psychological profile in patients with type 2 diabetes is an independent risk factor for inflammation and that, in type 1 diabetes, the type A psychological profile is associated with a decrease in the expression of the pro-inflammatory cFos gene.

Thus, the psychological profile appears to have an impact not only on the patient's behaviour but also on his or her biology.

It has never been determined whether the type A or B psychological profile assessed by Bortner's self-administered questionnaire can influence the development of foot wounds in patients with type 2 diabetes who often have a medically unfavourable prognosis and socio-economic difficulties. We would therefore like to study the psychological profile of these individuals in order to make comparisons with the data obtained in a previous study that included patients with type 2 diabetes who did not have a foot wound.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy

acronym: DEMOGRAFT

summary: Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

ReferenceType: derived

ReferenceCitation: Perone JM, Goetz C, Zevering Y, Derumigny A, Bloch F, Vermion JC, Lhuillier L. Graft Thickness at 6 Months Postoperatively Predicts Long-Term Visual Acuity Outcomes of Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Dystrophy and Moderate Phakic Bullous Keratopathy: A Cohort Study. Cornea. 2022 Nov 1;41(11):1362-1371. doi: 10.1097/ICO.0000000000002872. Epub 2021 Oct 22.

oa_host_type: repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

unpaywall_oa_status: green

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Evaluation of an Opioid Decrease Strategy in Chronic Pain Patients at the Pain Assessment and Treatment Center in Montpellier: Prospective Study Over 6 Months.

acronym: EODSCPP

summary:
Increase in the consumption of analgesics observed in many countries with a mediatic crisis resulting in an increasingly frequent wish of patients to wean themselves from opiates. A recent update (B. Rolland 2017) suggests that upon initiation of an opioid analgesic treatment, the patient should be informed of the risk of opioid dependence and misuse. There is no clearly validated decay scheme in the event of dependence in patients with Chronic Non-Cancer Pain.

Hypotheses:

Possibility of a rapid decrease in opioid analgesic treatments at DCNC sensitized to the risk of DOP and MOP. (Protocol implemented: Multidisciplinary assessment, workshops and information sheet on chronic pain, treatments and risk of DOP, pharmacological and nonpharmacological adaptation)
Highlight the need for additional information from patients and prescribers on the risk of DOP and MOP in DCNC.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Deformation of the Diaphragm Zone of Apposition During the Loading of the Respiratory System in the Healthy Volunteer. Evaluation of a New Index Measured by Speckle Tracking

acronym: ZADSPECTRA

summary:
The assessment of the work of the respiratory muscles is a fundamental clinical data in intensive care, especially to guide the management of patients requiring ventilatory support. This data is difficult to access in current practice. The reference technique to estimate the work of breathing (transdiaphragmatic pressure) is not feasible in clinical routine and evaluates only the respiratory work of the diaphragm, not that of the accessory muscles. The ultrasound technique of speckle tracking allows a fine and multidimensional analysis of the deformation of the respiratory muscles during the respiratory cycle.

The investigators hypothesize that the analysis of the multidimensional deformation of the diaphragm at the level of the apposition zone can produce a robust and reproducible index, which is correlated with the work of breathing. The performance of this index will be compared to that of the thickening fraction of the diaphragm. On the other hand, the investigators will evaluate the feasibility of measuring the thickening of the accessory respiratory muscles (scalene and intercostal).

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon


title: Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial

acronym: CORTIFRENCH

summary:
Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer.

A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.

ReferenceCitation: Magnin J, Fournel I, Doussot A, Regimbeau JM, Zerbib P, Piessen G, Beyer-Berjot L, Deguelte S, Lakkis Z, Schwarz L, Orry D, Ayav A, Muscari F, Mauvais F, Passot G, Trelles N, Venara A, Benoist S, Messager M, Fuks D, Borraccino B, Tresallet C, Valverde A, Souche FR, Herrero A, Gaujoux S, Lefevre J, Bourredjem A, Cransac A, Ortega-Deballon P. Benefit of a flash dose of corticosteroids in digestive surgical oncology: a multicenter, randomized, double blind, placebo-controlled trial (CORTIFRENCH). BMC Cancer. 2022 Aug 23;22(1):913. doi: 10.1186/s12885-022-09998-z.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

appel_a_projets: PHRCK

region: Bourgogne-Franche-Comté

nom_etablissement: CHU DIJON BOURGOGNE

type_etablissement: CH

acronyme: CORTIFRENCH

titre: CORTIFRENCH01 : Bénéfice d'un flash de corticoïdes dans la chirurgie des cancers digestifs : essai randomisé, en double aveugle, contre placebo

discipline_principale: cancer

nom_porteur: ORTEGA-DEBALLON

prenom_porteur: Pablo


title: APHP Plateform for Assessement of Hepatic Grafts Initialy Discarded by Normothermic Perfusion

acronym: PENOFOR

summary: This study aimed to evaluate fatty liver grafts, considered as unsuitable for upfront liver transplantation, by using normothermic perfusion. Grafts have to be allocated to one of 3 liver transplantation centres of Paris. After evidence of viability while on perfusion, these grafts will be transplanted to recipients with an estimated waiting time > 6 months.


title: Study of Gait and Posture in Subacute Acquired Neuropathies and in Hereditary Neuropathies

acronym: PONE

summary: If the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. Clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level of impairment, but this has never been clearly demonstrated.


title: Phase II Multicenter Randomized Trial Evaluating the Association of PIPAC and Systemic Chemotherapy Versus Systemic Chemotherapy Alone as 1st-line Treatment of Malignant Peritoneal Mesothelioma

acronym: MESOTIP

summary:
MESOTIP is a randomized trial evaluating the association of PIPAC and systemic chemotherapy versus systemic chemotherapy alone as 1st-line treatment of Malignant Peritoneal Mesothelioma In this study, patients in the experimental arm will be treated by 4 PIPAC (Cisplatine+Doxorubicine) alternating with 6 cycles of standard intravenous chemotherapy (Cisplatine+Pemetrexed).

MESOTIP aim to show an improvement of the overall survival in the experimental arm.

ReferenceCitation: Kim J, Bhagwandin S, Labow DM. Malignant peritoneal mesothelioma: a review. Ann Transl Med. 2017 Jun;5(11):236. doi: 10.21037/atm.2017.03.96.

ReferenceCitation: Boffetta P. Epidemiology of peritoneal mesothelioma: a review. Ann Oncol. 2007 Jun;18(6):985-90. doi: 10.1093/annonc/mdl345. Epub 2006 Oct 9.

ReferenceCitation: Bossard N, Velten M, Remontet L, Belot A, Maarouf N, Bouvier AM, Guizard AV, Tretarre B, Launoy G, Colonna M, Danzon A, Molinie F, Troussard X, Bourdon-Raverdy N, Carli PM, Jaffre A, Bessaguet C, Sauleau E, Schvartz C, Arveux P, Maynadie M, Grosclaude P, Esteve J, Faivre J. Survival of cancer patients in France: a population-based study from The Association of the French Cancer Registries (FRANCIM). Eur J Cancer. 2007 Jan;43(1):149-60. doi: 10.1016/j.ejca.2006.07.021. Epub 2006 Nov 3.

ReferenceCitation: Alexander HR Jr, Li CY, Kennedy TJ. Current Management and Future Opportunities for Peritoneal Metastases: Peritoneal Mesothelioma. Ann Surg Oncol. 2018 Aug;25(8):2159-2164. doi: 10.1245/s10434-018-6337-5. Epub 2018 Feb 8.

ReferenceCitation: Yan TD, Deraco M, Baratti D, Kusamura S, Elias D, Glehen O, Gilly FN, Levine EA, Shen P, Mohamed F, Moran BJ, Morris DL, Chua TC, Piso P, Sugarbaker PH. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol. 2009 Dec 20;27(36):6237-42. doi: 10.1200/JCO.2009.23.9640. Epub 2009 Nov 16.

ReferenceCitation: Baratti D, Kusamura S, Cabras AD, Bertulli R, Hutanu I, Deraco M. Diffuse malignant peritoneal mesothelioma: long-term survival with complete cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC). Eur J Cancer. 2013 Oct;49(15):3140-8. doi: 10.1016/j.ejca.2013.05.027. Epub 2013 Jul 4.

ReferenceCitation: Helm JH, Miura JT, Glenn JA, Marcus RK, Larrieux G, Jayakrishnan TT, Donahue AE, Gamblin TC, Turaga KK, Johnston FM. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: a systematic review and meta-analysis. Ann Surg Oncol. 2015 May;22(5):1686-93. doi: 10.1245/s10434-014-3978-x. Epub 2014 Aug 15.

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

location_facility: Institut réginal du Cancer de Montpellier

region: Occitanie

nom_etablissement: ICM MONTPELLIER

type_etablissement: CLCC

acronyme: MESOTIP

titre: MESOTIP : Etude de phase II multicentrique randomisée évaluant l'utilisation de la PIPAC en alternance avec la chimiothérapie systémique versus chimiothérapie systémique seule dans la 1ère ligne de traitement du Mésothéliome Péritonéal Malin

nom_porteur: SGARBURA

prenom_porteur: Olivia


acronym: CAPEMCHAR

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

summary:
Our hypothesis is that the doxorubicin eluting-beads currently used in hepato-oncology might be applicable to high-grade prostate cancer before radical prostatectomy.

The primary objective of this Phase IIa pilot study is to evaluate the safety of performing prostate embolization with doxorubicin eluting-beads according to different loading doses. Four dose levels will be tested: doxorubicin-free beads to test the effect of embolization alone, 2.5 mg of doxorubicin (1/20 of the dose administered for liver cancers), 5 mg and 10 mg of doxorubicin.

The secondary objectives of the study are to evaluate the tolerance (functionnal questionaries at D0, D14 M1 and M3; collection of complications at D1, D5, D14, M1, M3; MRI at D14), evaluate the systemic diffusion of doxorubicin (doxorubinemia at D1), evaluate an early anti-tumor effect of the treatment (via a prostate-specific antigen test at D14 M1, M3 and magnetic resonance imaging at D14), describe the distribution of beads observed on the surgical specimen and evaluate the dose effect at 1 month and 3 months after surgery (via a prostate-specific antigen test at D14, M1, M3 and magnetic resonance imaging at D14).

title: Evaluation of the Safety, Tolerability, Distribution and Dose Effect of Neoadjuvant Transarterial Chemoembolization With Doxorubicin in Prostate Cancer Patients at a High Risk of Recurrence Before Radical Prostatectomy: A Phase IIa Study


title: The Effect of Exposure to Aversive Non-verbal Vocalizations on Pain Tolerance

acronym: CRYPAIN

summary:
Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in various contexts that are likely to perform biological functions.

and important social issues. Yet despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal vocalizations remain little studied and poorly understood including in humans.

In this context, the investigators wish to examine how the perception of vocalizations non-verbal aversive behaviours influence pain tolerance in healthy adults.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Laboratoire ENES-CNPS (Université Lyon/Saint Etienne)

location_facility: Centre Hospitalier Universitaire SAINT-ETIENNE


title: Contributions and Limitations of the Stress Test on the Prediction of Cardiovascular Events in a High-risk Firefighter Population

acronym: FIRE-PREV

summary: If the risk of myocardial infarction in activity is widely demonstrated to date for firefighters, and the realization of a stress test in those at high cardiovascular risk included in the practice habits, no study has evaluated the contributions and limits of the realization of a stress test in this specific population of firefighters at high cardiovascular risk for the prediction of cardiovascular events.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Clinical and Economic Evaluation of Outpatient Bariatric Surgery

acronym: Bariatric Ambu

summary: This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient). Then, the study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences.

primary_purpose: Health Services Research

ReferenceCitation: Cobourn C, Mumford D, Chapman MA, Wells L. Laparoscopic gastric banding is safe in outpatient surgical centers. Obes Surg. 2010 Apr;20(4):415-22. doi: 10.1007/s11695-009-0065-7.

ReferenceCitation: McCarty TM, Arnold DT, Lamont JP, Fisher TL, Kuhn JA. Optimizing outcomes in bariatric surgery: outpatient laparoscopic gastric bypass. Ann Surg. 2005 Oct;242(4):494-8; discussion 498-501. doi: 10.1097/01.sla.0000183354.66073.4c.

ReferenceCitation: Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.

publisher_dissemination: Oxford University Press

ReferenceCitation: Ignat M, Ansiaux J, Osailan S, D'Urso A, Morainvillers-Sigwalt L, Vix M, Mutter D. A Cost Analysis of Healthcare Episodes Including Day-Case Bariatric Surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy) Versus Inpatient Surgery. Obes Surg. 2022 Aug;32(8):2504-2511. doi: 10.1007/s11695-022-06144-3. Epub 2022 Jun 10.

lead_sponsor: IHU Strasbourg

location_facility: University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery


title: Prediction for Coma Recovery in ICU With Comaweb: a Validation Study

acronym: COMASCORE

summary: The general objective of the comaScore project is to provide an external validation of the accuracy of the comaScore, a score derived from magnetic resonance imaging (MRI), to predict 1 year outcome of patients unresponsive to simple orders after traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhages (aSAH) and cardiac arrest (CA) in the day 7 - day 45 period post brain injury.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronyme: ComaScore

titre: Prédiction de la récupération neurologique des patients dans le coma en unité de soins intensifs: une étude de validation

discipline_principale: anesthésiologie / réanimation

nom_porteur: Puybasset

prenom_porteur: Louis


title: Foci of Tumor Heterogeneity in IDH1-mutated Diffuse Low-Grade Gliomas Reveal STAT3 Activation and Downregulation of the Phosphoethanolamine Enzyme ETNPPL Acting as a Negative Regulator of Glioma Growth

acronym: FDLGG

summary:
Background:

Diffuse low-grade gliomas (DLGG) are slow-growing primary-cancer of the brain and spinal cord. They represent up to 15% of the developing tumors in those organs with fatal outcome for the patients because of their evolution. The reasons for this transformation towards more malignant tumors still remain ill defined. Previously, the research team in neuro oncology at Montpellier University Hospital found foci of tumor heterogeneity within 20 to 30 % of the patients developing a DLGG and published their results. The investigators assumed that those foci represent the early beginning of the transformation from a diffuse low-grade glioma to a glioblastoma, tumor with highly malignant cells and a life expectancy of two years in average for the patient.

Methods:

The investigators selected adult patients with no prior surgery nor neuro oncology treatment when enrolled. They presented a specific mutation for an enzyme of the metabolism named IDH1, standing for Isocitrate Dehydrogenase 1, found in 70% of DLGG. Patients were also selected because they presented foci of tumor heterogeneity. After obtaining their consent, the investigators studied by immunohistochemistry the pathways deregulated between the DLGG and the foci. The investigators also extracted RNAs, molecules expressing the life and metabolism of tumor cells, and compared them to know what genes were differentially expressed between the DLGG and the foci. All RNAs were tested for quality control prior to be processed further. The investigators then studied 8 patients with compliance with ethics, authorizations and institutional guidelines. Genes of interest were studied in vitro to assess their functions. The investigators found a barely described enzyme of the catabolism of the phosphoethanolamines and discovered a new anti-proliferative tumor-role for it.

•Discussion: The investigators first showed that foci have a higher percentage of p-STAT3+ cells which indicates STAT3 pathway activation in these cells. Phosphorylated STAT3 translocates to the cell nucleus to regulate many genes involved in proliferation, apoptosis and angiogenesis. As such, phosphorylation of STAT proteins, notably STAT3, is involved in the pathogenesis of many cancers, including GBM, by promoting cell cycle progression, stimulating angiogenesis, and impairing tumor immune surveillance.

The investigators found that ETNPPL RNA and protein are reduced in foci cells and absent in glioblastomas. This is consistent with glioma database analyses showing that ETNPLL expression is inversely correlated to STAT3 and MKI67 whose expression are higher in foci and glioblastomas. In addition, Kaplan-Meier analysis shows that patients with low expression of ETNPPL have lower overall survival These observations suggested that this enzyme may oppose glioma cells proliferation. The investigators demonstrated this hypothesis by overexpressing ETNPPL in 3 glioblastoma cell cultures. Two were sensitive to ETNPPL overexpression which reduced their growth while no effect was detected in Gli4 cells. These glioblastoma-derived cultures have different types of mutations.


title: Cross-cultural Adaptation and Validation of the French Version of the EXIT (EXperiences of Induction Tool) Self-questionnaire Assessing Women's Feelings About the Onset of Childbirth

acronym: EXIT

summary: The objective of the study is to cross-culturally adapt and validate the French version of the EXIT scale: an assessment tool on induction of labor.

lead_sponsor: University Hospital, Clermont-Ferrand


title: New Tools for Predicting Capillary Leak Shock During Dengue Fever

acronym: PrediDengue

summary: Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.

ReferenceCitation: Djossou F, Vesin G, Elenga N, Demar M, Epelboin L, Walter G, Abboud P, Le-Guen T, Rousset D, Moreau B, Mahamat A, Malvy D, Nacher M. A predictive score for hypotension in patients with confirmed dengue fever in Cayenne Hospital, French Guiana. Trans R Soc Trop Med Hyg. 2016 Dec 1;110(12):705-713. doi: 10.1093/trstmh/trx004.

lead_sponsor: Centre Hospitalier de Cayenne

sponsor_collaborators:
Centre Hospitalier de Cayenne
European Regional Development Fund


title: Comparison Between the Assessment of Anxious and Depressive Symptomology by the Patient and the Evaluation of the Patient's Symptoms by Caregivers: a Pilot Study Carried Out in a French Palliative Care Unit.

acronym: EDAPAL

summary:
In palliative care, anxiety and depression in advanced cancer are under evaluated, under diagnosed and therefore under treated. 5 to 30% of patients present anxious and depressive disorders.

Physical symptoms are easy to assess. But in palliative care it is important to take care of moral suffering.

However, evaluation and management of patient's anxiety and depressive symptoms are difficult for physicians and caregivers.

The investigators would like to specifically compare the patient's evaluation of anxious and depressive symptomatology in palliative care with the evaluation by the physician, the nurse and the caregiver.

Then the investigators will try to collect the caregivers's difficulties in the management of anxious and depressive symptoms.

lead_sponsor: Hospices Civils de Lyon


title: Identification and Characterization of microRNAs Involved in Esophageal, Gastric and Duodenal Fibrotic Manifestations of Systemic Scleroderma

acronym: Dig-ScS

summary:
No studies have investigated the expression of miRNAs in Dig-ScS tissues. In the absence of specific treatment for this frequent impairment in this connectivity, the team proposes to study miRNA profiles in the esophagus and duodenum to identify new therapeutic targets. The team is studying the involvement of pro-fibrotic "key" miRNAs called "FibromiRs", including 3 miRNAs from the DNM3os locus (miR-199a-3p, miR-199a-5p and miR-214 - characterized by the host laboratory) associated with monitoring the response to TGF-β in fibroblasts and their potential interaction with pharmacological treatments such as nintedanib and/or PPARγ agonists. The approach is part of a pilot study that can lead to a larger project after validation of the hypotheses.

It also seems interesting to make a precise anatomopathological description with a gradation of the digestive fibrotic damage in view of the paucity of medical literature in this field

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Epidemiology of Suspected Epileptic Seizures

acronym: EPI-lepsie

summary: The occurrence of isolated or recurring epileptic seizures accounts for an important use of the healthcare system. Typically, epileptic patient will consult ten times a year a physician (specialist or familial doctor) and will justify 24 diagnostic procedures or additional examinations. Moreover, epileptic seizures are associated with frequent use of emergency departments. From the first emergency call received by the Emergency medical assistance service (SAMU), the actual management of the patient having epileptic seizure includes the eventual transfer to the paramedical team then within an emergency unit. However in some cases, emergency allocation may be avoided as 70% of patients recover their baseline condition upon admission. The main objective of this study is to describe the management of the adult population suffering from suspected seizure by the emergency structures. For 3 consecutive days, all patients with suspected epileptic seizures (diagnosed by the SAMU, paramedics and emergency unit) will be enrolled in the study. Data of medical care management and information from patients or witnesses will be collected on a questionnaire by the physicians of the SAMU, paramedics and emergency unit. Then, the anonymized questionnaires will be sent to RESUVAL (Emergency Network of the Rhone Valley) to ensure data entry and statistical analysis. By identifying the factors leading the SAMU to transfer a patient with suspected epileptic seizure to an emergency unit, this study will provide a more appropriate procedure to prevent unnecessary emergency admissions. It will also gain more insights into the patient outcomes, such as complementary medication, brain examination or referral to a neurologist.

ipd_sharing_description: The questionnaires contain personal data: age and sex of the patient, place of care, treatment and home address.

collaborators: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône

sponsor_collaborators: Centre Hospitalier Saint Joseph Saint Luc de Lyon


title: Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial

acronym: IDEAL

summary:
Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.

Total proctocolectomy with IPAA is the gold standard for surgical management of ulcerative colitis (UC). This demanding procedure is often performed in 2 or 3 stages, namely subtotal colectomy, completion proctectomy with IPAA and defunctioning ileostomy closure. Subtotal colectomy with double stoma is first performed to allow nutritional support, reduce inflammation and stop immunosuppressive agents. Completion proctectomy with IPAA is then performed on a healthier patient. Hence, the need for a systematic defunctioning ileostomy is questioned. No study addressed specifically the question of completion proctectomy, whereas it concerns 36% to 42% of patients undergoing IPAA. Globally, the overall 6-month morbidity rate is 55% in case of stoma creation vs. 30% otherwise in IPAA.

Moreover, defunctioning ileostomy has several drawbacks including an additional surgical procedure (stoma closure), a worse quality of life before closure, and the risk of dehydration that may require readmission. Following stoma closure, the risk of anastomotic leakage is around 4%. Overall, during the stoma period, 8% of patients will require reoperation. Finally, the risk of incisional hernia is 15-20% at the ex-ileostomy site.

Therefore, the aim of this trial is to assess the need for a systematic defunctioning ileostomy after completion proctectomy with IPAA.

ReferenceCitation: Beyer-Berjot L, Baumstarck K, Loubiere S, Vicaut E, Berdah SV, Benoist S, Lefevre JH; GETAID Chirurgie group. Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271). BMC Surg. 2019 Dec 12;19(1):192. doi: 10.1186/s12893-019-0657-7.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

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

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Transient Thermal Behavior and Diabetic Foot

acronym: PICOTE

summary: In our study, the investigators propose to analyze the transient thermal responses taken at the level of the sole of the foot, following the application of a cold stimulus. By combining a spatio-temporal analysis of these temperature fields and a thermal modeling of the heat transfer in the thickness of the foot, the investigators want to highlight differences between healthy feet vs. pathological feet. Therefore, the investigators will determine the transient thermal responses at the level of the sole of the foot and correlate them with the podological grade.

sponsor_collaborators:
University Hospital, Montpellier
Université Montpellier


title: Drug Hypersensitivity Reactions To Cephalosporins

acronym: CephALL

summary:
Background :

Although the hypersensitivity reactions to cephalosporins have been recently a more focused subject, studies on the cephalosporin as an allergen are significantly less frequent that those regarding penicillins. Most of the available data regards cephalosporin sensitization in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one of the most prescribed classes of antibiotics. The diagnosis of cephalosporin hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation tests (DPT). This succession of tests, performed in specialized services, allows to eliminate responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.

Objective: To analyse the characteristics of patients studied in our Unit for suspicion of cephalosporin hypersensitivity.

Methods: This retrospective study will comprise all the patients who attended the allergy service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).


title: Efficacy of the Memory Motivation (MEMO) Web Application for Cognitive and Behavioral Training in Patients With Neurocognitive Disorders

acronym: MeMo

summary:
Memory, attentional, and behavioural symptoms are the clinical hallmarks of Neurocognitive disorders (NCD) such as Alzheimer's disease and related disorders. The World Health Organisation (WHO) guidelines for risk reduction of cognitive decline and dementia indicate that Cognitive training may be offered to older adults with normal cognition and with mild cognitive impairment to reduce the risk of cognitive decline and/or dementia. The use of Information and Communication Technologies (ICT) in the health domain is progressively expanding. The Alzheimer Innovation Association have developed MeMo (Memory Motivation) a free web application that can be used at home by patients.

The objective of the present study was to assess the effectiveness of employing the MeMo platform on cognitive performance in patients suffering from NCD.

ReferenceCitation: Robert P, Manera V, Derreumaux A, Ferrandez Y Montesino M, Leone E, Fabre R, Bourgeois J. Efficacy of a Web App for Cognitive Training (MeMo) Regarding Cognitive and Behavioral Performance in People With Neurocognitive Disorders: Randomized Controlled Trial. J Med Internet Res. 2020 Mar 11;22(3):e17167. doi: 10.2196/17167.

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

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

publisher_dissemination: JMIR Publications

lead_sponsor: Innovation Alzheimer

collaborators: Centre Hospitalier Universitaire de Nice


title: Long Term Follow-up for Hypospadias. Hypospadias KOK

acronym: KOK

summary:
Hypospadias is a frequent malformation. The definition of hypospadias is a ventral tissues hypoplasia, with an abnormal position of the urethral meatus, a chordee of the penis and an open foreskin. It can be associate with other genital malformation; in that case it can be classified in the wider field of the disorder of sex development (DSD). There is a lot of surgical technics for those malformations.

In the pediatric surgical department, in Lyon, three technics are the most used because of their reliability and their good outcomes in short and mid term.

This is essential for investigator to have a long term evaluation, with a physical exam and paraclinical exams, after the puberty, to assess the outcomes after the changes especially at the puberty.

location_facility: Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant


title: Study of the Contribution of Automatic Image Fusion of a Cone-beam CT Volume With Ultrasound During Percutaneous Ablation Treatment of Hepatic Tumors

acronym: IAT

summary: The automatic fusion of the ultrasound with a cone-beam CT volume will guide the positioning of the electrodes, despite the visibility of the tumor in ultrasound, in patients treated with irreversible electroporation in the interventional radiology room at Avicenna Hospital for hepatocellular carcinoma (HCC). The objective is to evaluate the primary success rate of the automatic cone-beam CT fusion procedure and ultrasound, regardless of the tumor's visibility status in ultrasound.

ReferenceCitation: Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.

ReferenceCitation: Yu H, Burke CT. Comparison of percutaneous ablation technologies in the treatment of malignant liver tumors. Semin Intervent Radiol. 2014 Jun;31(2):129-37. doi: 10.1055/s-0034-1373788.

ReferenceCitation: Monfardini L, Orsi F, Caserta R, Sallemi C, Della Vigna P, Bonomo G, Varano G, Solbiati L, Mauri G. Ultrasound and cone beam CT fusion for liver ablation: technical note. Int J Hyperthermia. 2018;35(1):500-504. doi: 10.1080/02656736.2018.1509237. Epub 2018 Sep 11.

ReferenceCitation: Lee LH, Hwang JI, Cheng YC, Wu CY, Lee SW, Yang SS, Yeh HZ, Chang CS, Lee TY. Comparable Outcomes of Ultrasound versus Computed Tomography in the Guidance of Radiofrequency Ablation for Hepatocellular Carcinoma. PLoS One. 2017 Jan 9;12(1):e0169655. doi: 10.1371/journal.pone.0169655. eCollection 2017.

ReferenceCitation: Cornelis FH, Korenbaum C, Ben Ammar M, Tavolaro S, Nouri-Neuville M, Lotz JP. Multimodal image-guided electrochemotherapy of unresectable liver metastasis from renal cell cancer. Diagn Interv Imaging. 2019 May;100(5):309-311. doi: 10.1016/j.diii.2019.01.001. Epub 2019 Jan 26. No abstract available.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
General Electric

intervention_type: Radiation


title: Evaluation of the Impact of a Pharmaceutical Interview on the Adherence to Hormonotherapy in Women With Breast Cancer

acronym: HORMONOVILLE

summary:
Breast cancer is the first cancer in women and 60% of new cases occurring in women 50 to 74 years old. With about 50,000 new cases, it is the second cancer the most serious cancers. In the therapeutic strategy, hormone therapy takes pride of place by allowing a significant reduction in the recurrence rate.

For the hormonotherapy be effective, patient compliance should be optimal during treatment. Different factors or barriers may lead to a lack of adherence, such as the occurrence of adverse effects, treatment fatigue, a difficult relationship with the health care team, beliefs about success or the need for treatment.

In order to facilitate the compliance of hormonoherapy treatment by patients, it is important to include different health professionals such as pharmacists.

status: Active, not recruiting

lead_sponsor: Centre Georges Francois Leclerc


title: Incidence of Use of High-Flow Nasal Cannula Oxygen Therapy in Intensive Care Units : Prospective, Multi-center, Epidemiological, Uncontrolled Study

acronym: OHE-REA

summary:
Patients with one or more organ failure (heart, lung) require hospitalization in intensive care where these failures can be managed. Nearly 30% of patients in intensive care units are hospitalized for acute respiratory distress (lung failure). This failure occurs in about 20% of postoperative patient, but it can also occur in the context of a pathology specific to the lung or after weaning of mechanical ventilation.

It is therefore interesting to develop several techniques to provide oxygen to these patients with the aim in particular to avoid the use of intubation (insertion of a tube into the trachea to achieve artificial ventilation). For the past ten years, High-Flow Nasal Canula (HFNC) has developed. This technique reduces the need for intubation but the studies are contradictory, however they agree on its ease of use and the few risks associated with it. The principle of this technique is to deliver a humidified and heated gas mixture at a high rate through large nasal cannula. The advantage of this device is its non-invasive and the possibility of administering a large amount of oxygen. There is a certain craze for this oxygenation technique despite few scientific studies in the literature. However, it requires the expertise of the medical and paramedical team so as not to delay intubation.

The investigators propose to carry out an observational study (without any modification of the usual practices) with epidemiological aim in order to make an inventory of the modes of use of the HFNC, in particular on its frequency of use and on its duration of use per patient hospitalized in intensive care. The investigators will recruit all HFNC patients in intensive care units (20 centers) (30 patients / center): 15 after weaning of mechanical ventilation and 15 others for other reasons. Patients will be followed every day and up to 48 hours after removal of the HFNC.

lead_sponsor: Nantes University Hospital


title: Patient Blood Management in Cardiac Surgery by Erythropoietin, Ferric Carboxymaltose and Metabolic Adjustment (ScvO2): A Randomized Controlled Study

acronym: BLOOCOST

summary: Preoperative anemia, bleeding and transfusions have been recognized as a "Deadly triad" in cardiac surgery associated with an increased morbidity,mortality, and costs related. Thus strategies to reduce unnecessary RBC transfusions and to optimize preoperative anemia must be developed .The study evaluate an individual blood conservation strategy based on patient blood management bundles in cardiac surgery patients: optimisation perioperative hemoglobin level by erythropoietin and ferric carboxymaltose (Ferinject) associated with the use of ScV02 to guide perioperative erythrocyte transfusion.

ReferenceCitation: Ranucci M, Baryshnikova E, Castelvecchio S, Pelissero G; Surgical and Clinical Outcome Research (SCORE) Group. Major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013 Aug;96(2):478-85. doi: 10.1016/j.athoracsur.2013.03.015. Epub 2013 May 11.

ReferenceCitation: Plicht B, Lind A, Erbel R. [Infective endocarditis : New ESC guidelines 2015]. Internist (Berl). 2016 Jul;57(7):675-90. doi: 10.1007/s00108-016-0086-y. German.

ReferenceCitation: Alghamdi AA, Davis A, Brister S, Corey P, Logan A. Development and validation of Transfusion Risk Understanding Scoring Tool (TRUST) to stratify cardiac surgery patients according to their blood transfusion needs. Transfusion. 2006 Jul;46(7):1120-9. doi: 10.1111/j.1537-2995.2006.00860.x.

ReferenceCitation: Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.

location_facility: DEpartement d'anesthésie et réanimation D - Arnaud de Villeneuve


title: Effects of Short-term Therapeutic Fasting on Nausea and Vomiting Due to Chemotherapy

acronym: CHEMO-FAST

summary: This study aims to estimate the effect of the practice of a short-term partial fasting compared to a usual alimentation on nausea and vomiting within 5 days after the start of a chemotherapy session on 2 successive chemotherapy courses (4 sessions of chemotherapy) in patients starting treatment with highly emetogenic chemotherapy (ABVD or AVD protocol).

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

acronym: CARDIALA

summary: The heart has the ability to respond to different patho-physiological conditions by adapting its energy metabolism. In diabetic subjects, the myocardium uses only fatty acids as a substrate. This is the cause of diabetic cardiomyopathy (DCM). The activation of the transcription factor PPARβ/δ allows a good use of fatty acids. The staff have demonstrated that alpha lipoic acid (AαL), a molecule with antioxidant properties present in food supplements and in certain foods (broccoli, cabbage, offal...), induces the expression of PPARβ/δ in skeletal muscle and thus increases the activity of this transcription factor.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

intervention_type: Dietary Supplement


title: Interest of Virtual Reality to Prevent Cancer Patient Anxiety Before Chemotherapy or an Invasive Act

acronym: REV

summary:
The aim of the REV clinical trial is to evaluate the impact of a virtual reality exposure to decrease patient anxiety before chemotherapy or an invasive act. If positive, the access to virtual reality exposure is aimed to be used as standard of care at Lyon's hospital to improve cancer patient well-being in a drug-free manner.

The majority of cancer patients lives with high level of anxiety as soon as diagnosed. This level anxiety is particularly high before invasive acts but also before chemotherapy by side effects anticipation.

Hypnosis is a highly interesting drug-free approach to decrease patient's anxiety. It however requires on site specialists to be available whenever needed.

Virtual reality provides a distractive environment enabled to shift patient focus. It can support a switch of patient mindset by providing positive emotions.

Since 5 years, this disruptive technology is being more and more used as medical support thanks to a new generation of headsets enabling improved performance at cheaper prices.

Many publications have now demonstrated the positive impact of virtual reality to take in charge patients' pain or pre-operational anxiety.

primary_purpose: Supportive Care

location_facility: Service d'oncologie médicale, Institut de Cancérologie des Hospices Civils de Lyon, Hôpital Lyon sud

intervention_type: Behavioral


title: Evaluation of the Efficacy of Sleepinnov© (Spiri+) Continuous Positive Airway Pressure Device

acronym: Spiri+

summary: Continuous Positive Airway Pressure (CPAP) is the reference treatment of patients suffering from Obstructive Sleep Apnea Syndrome (OSAS).This device functions as a pneumatic stent that stabilizes the upper airway, prevents periodic collapses during sleep.The correction of abnormal respiratory events during sleep allows improvement of symptoms related to OSAS and restores quality of life.The purpose of this study is to validate the efficacy of a new CPAP brand developed by Sleepinnov©.

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

ReferenceCitation: Levy P, Kohler M, McNicholas WT, Barbe F, McEvoy RD, Somers VK, Lavie L, Pepin JL. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers. 2015 Jun 25;1:15015. doi: 10.1038/nrdp.2015.15.

lead_sponsor: Sleepinnov Technology

sponsor_collaborators:
Sleepinnov Technology
University Hospital, Grenoble
ICUREsearch


title: Evolution of the Endonasal Microbiota After Endoscopic and Local Treatment or Local Treatment Alone in Patients With Chronic Rhinosinusitis

acronym: METEL-RC

summary:
Chronic rhinosinusitis (CRS) is defined according to the French society of otorhinolaryngology as chronic non-mechanical damage to the nasal structures, excluding infectious damage to the sinus structures. The duration of the chronic impairment must be at least 12 consecutive weeks. It causes many symptoms such as rhinorrhea, nasal blockage and anosmia. It is a poorly understood pathology that affects a large part of the population. Its prevalence has increased significantly over the past 30 years. It affects about 11% of the population in Europe. It has become one of ten high-cost medical conditions for employers. Initially, it was accepted that CRS was due to chronic nasal infection. It is very debilitating for patients leading to a major consultation with practitioners (general practitioners and ENT specialists). Many treatments are used such as nose washes, nasal or oral corticosteroids, antibiotic therapy or even surgical management is possible. Thèses treatments allow an improvement in the symptomatology but no treatment allows a stable result over time, making long-term treatments essential.

Today, it is recognized that CRS has a multifactorial etiology including inflammatory processes, hyperresponsiveness of the nasal mucosa and abnormalities in immune phenomena. The endonasal microbiota plays a role in these processes. Germs like Staphylococcus aureus and Pseudomonas aeruginosa were identified as pathogens in CRS in the first studies with bacterial cultures. Thanks to the 16S ribosomal RNA sequencing technique, recent studies have demonstrated a modification in the diversity and abundance of the microbiota in patients with CRS compared to healthy subjects, notably with a modification of the germs of the firmicutes group. .

Few studies have studied the modification of the microbiota with the treatment of CRS today. However, local treatments based on nosewashing with physiological saline associated with local corticosteroids and endoscopic treatments lead to an improvement in the symptomatology for patients suffering from CRS. This study will describe the modification of endonasal microbiota in différent conditions, such medical and surgical treatments, that usually improve patients symptomatology.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Phase II, Open-label, Randomized, Non-comparative Study Evaluating the Impact of Short Message Service (SMS) on Compliance With Surveillance of Patients With Germ-cell Tumors. (TEXTIS Study)

acronym: TEXTIS

summary: This study will evaluate the impact of Short Message Service (SMS) on compliance with surveillance of patients with germ-cell tumors. Patients will be randomized in a 2:1 ratio to get 2 groups : (1) patients will receive reminder SMS before appointment detailing the date of consultation and exams to be performed before; (2) standard of care without SMS.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Study of the Link Between the Slope of the Photomotor Reflex and the Depth of Anesthesia. Prospective, Monocentric, Observational Compendium

acronym: ILLUMINANS

summary:
Pupillary diameter monitoring is currently used routinely for assessment of the nociception / antinociception balance during surgery.

Pupillary diameter decreases reflexively in response to light flash, called photomotor reflex. The photomotor reflex is described by the latency between the light flash and the beginning of the decay expressed in milliseconds, the slope or decay rate expressed in millimeters per second, and the percentage of variation, corresponding to the ratio between the basal pupil diameter and the minimum diameter reached during the light stimulation.

The AlgiScan™ videopupillometer used includes a device for producing a flash light, designed for this purpose.

It has recently been shown that the slope (or rate) of pupillary diameter decrease during a light flash varies during anesthesia, independently of any nociceptive stimulus.


title: Changes in Brain Tissue Pulsatility With Musical Stimuli

acronym: M-PULSE

summary: Music Perception is well known to elicit emotions and neuronal activations. Changes in the cerebrovascular physiology have also been found in emotional tasks but only few studies have investigated markers of cerebrovascular physiology in a music task and no study has used the Ultrasound method of Tissue Pulsatility Imaging (TPI) in a music task. The use of TPI to measure reactivity of Brain Tissue Pulsatility Imaging (BTP) could further elucidate the cerebral basis of music perception.

lead_sponsor: University Hospital, Tours


title: Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled Pilot Study

acronym: MOBŒDEM

summary:
We hypothesize that the use of MOBIDERM® after total knee prosthesis allows a greater and faster resorption of periarticular edema:

improvement of knee flexion;
faster functional gain;
faster decrease in postoperative pain by decreasing tissue tension.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation of Non-invasive Measurement of Electrophysiological "HV" Interval Using a High-density and High-fidelity Signal Averaging ECG Device

acronym: BIOSEMI-HV

summary: His-Ventricle (HV) measurement is only obtained invasively using transvenous catheters. This kind of procedure is routinely performed but some risks of complication exist. HV interval prolongation is correlated with increased risk of occurrence of complete atrioventricular block which could lead to syncope or cardiac sudden death. A new non invasive, high density and high fidelity system (BioSemi, BioSemi B.V., Amsterdam, Netherlands) can theorically collect such electrophysiological signal using a signal averaging acquisition method. We want to assess the possibility of non invasive HV interval measurement using this new device.

lead_sponsor: University Hospital, Bordeaux


title: A Prospective Post Marketing Surveillance Study Study for the Evaluation of the Safety and Efficacy of the Predictix Antidepressant (PAD) Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder

summary:
The study is designed as an open label, one arm study. Up to 30 eligible patients will be enrolled, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.

Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the subjects and/ or by the clinician.

lead_sponsor: Taliaz Ltd.


title: Evaluation of a Patient Blood Management Program in Total Hip or Total Knee Arthroplasty

summary:
Total hip and knee arthroplasty are among the most common surgical procedures for which blood transfusion is prescribed. Patient blood management program has been proposed to decrease the need for transfusion. This program involve three pillars: preoperative improvement of erythropoiesis, intraoperative reduction of bleeding and postoperative management of anemia.

Among the different steps of this program, reduction of bleeding and optimization of anemia are gaining popularity, but preoperative improvement of erythropoiesis is underused. The preoperative step of the blood management program is not systematically used because it requires a complex organization, is considered expensive, and finally because the others available techniques to reduce blood transfusion are easier to implement.

The aim of this study was to assess, within a patient blood management program, the effectiveness of erythropoietin on reducing allogenic blood transfusion and anemia in patients requiring elective total hip or knee arthroplasty. "

lead_sponsor: University Hospital, Montpellier


title: Ontological Addiction Scale: Study Protocol for Scale Validation

acronym: OAS

summary:
Background:

Bypassing a reductionist view of existing diagnostic categories, ontological addiction theory (OAT) is a new psychological model of human functioning and mental illness. Ontological addiction is a maladaptive condition that stems from an erroneous belief in an inherently existing Self or "I", which is deemed to be the root of all suffering. Five experts from four different countries have created the Ontological Addiction Scale (OAS) to measure the condition and its impact on people's lives. The purpose of this study is to test this scale, evaluating levels of ontological addiction in individuals suffering from emotional or mood disorder, and assess its psychometric properties.

Methods:

This trial will be conducted in compliance with the COSMIN Guidelines. The investigators will collect data from 400 individuals, aged 18 to 70, suffering from emotional or mood disorder, referred to the Therapeutic Center for Mood and Emotional Disorders for an 8-week-mindfulness-based-intervention. Patients will complete the OAS at three time points: one month before the beginning of the therapy, within one week prior to the beginning of therapy, and one year after the end of the therapy. This scale will be completed in conjunction with other practice assessments relating to the psychotherapeutic program. The psychometric properties of the OAS will be assessed.

Discussion:

The Investigators aim to validate a scale assessing a psychological dimension as the root of all mental disorders. The present study may contribute to overcoming limitations of categorical understanding of mental disorders, thus moving toward a more encompassing dimensional comprehension. The scale is responsive to current thinking in modern psychiatry, and it is envisaged that its validation will deeply impact research and care perspectives


title: Exploration of the the Relationship Between Inflammation and Integrity of the Blood-brain Barrier in Suicidal Behaviour

acronym: IBIS

summary: Recent studies have revealed an association between history of suicide attempt and inflammatory markers in both the cerebrospinal fluid and the plasma. Post mortem studies have shown an increase in microglial activation in the brain tissue of suicide victims. However the relationship between peripheral and central inflammation in suicide is probably mediated by complex biological processes that are yet elucidated. An increase of blood S100B levels (biomarker of neurovascular damage; PMID 14530574) has been reported in adolescents with suicidal ideation vs. controls and independently of psychiatric disorder. The investigators hypothesize that peripheral inflammation may alter BBB which normally acts as a filter to ensure proper neuronal functioning in suicidal vs. non suicidal patients.


title: Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways

acronym: H-CORT

summary:
The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e., administration by systemic way.

The investigators therefore propose to identify biomarkers that clearly distinguish between an authorized local administration of hydrocortisone and a prohibited systemic administration, by studying the impact of 5-day administration of hydrocortisone per 2 different routes.

ReferenceCitation: Arlettaz A, Portier H, Lecoq AM, Rieth N, De Ceaurriz J, Collomp K. Effects of short-term prednisolone intake during submaximal exercise. Med Sci Sports Exerc. 2007 Sep;39(9):1672-8. doi: 10.1249/mss.0b013e3180dc992c.

ReferenceCitation: Buisson C, Mongongu C, Frelat C, Jean-Baptiste M, de Ceaurriz J. Isotope ratio mass spectrometry analysis of the oxidation products of the main and minor metabolites of hydrocortisone and cortisone for antidoping controls. Steroids. 2009 Mar;74(3):393-7. doi: 10.1016/j.steroids.2008.11.001. Epub 2008 Nov 13.

ReferenceCitation: Collomp K, Arlettaz A, Buisson C, Lecoq AM, Mongongu C. Glucocorticoid administration in athletes: Performance, metabolism and detection. Steroids. 2016 Nov;115:193-202. doi: 10.1016/j.steroids.2016.09.008. Epub 2016 Sep 16.

ReferenceCitation: Collomp K, Arlettaz A, Portier H, Lecoq AM, Le Panse B, Rieth N, De Ceaurriz J. Short-term glucocorticoid intake combined with intense training on performance and hormonal responses. Br J Sports Med. 2008 Dec;42(12):983-8. doi: 10.1136/bjsm.2007.043083. Epub 2007 Nov 29.

lead_sponsor: Centre Hospitalier Régional d'Orléans

sponsor_collaborators:
Centre Hospitalier Régional d'Orléans
French Anti-Doping Agency (AFLD)
University Hospital, Tours


title: Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine.Descriptive Monocentric Study for Identification and Validation of Biomarkers Predictive of Clinical Evolution

acronym: MUCOthèque

summary: The objective of this study is to evaluate the relevance of Porphyromonas as a biomarker predicting the risk of P. aeruginosa primocolonization in children form 0 to 18 years old with cystic fibrosis.


title: Importance of Ionized Magnesium Measurement for Monitoring of Continuous Venovenous Haemodialysis With Citrate Anticoagulation

acronym: MagiCC

summary: It has been reported in several studies that ionized hypomagnesemia is associated with higher morbidity and mortality rates. During continuous renal replacement therapy with regional citrate anticoagulation (CRRT-RCA), the loss of magnesium has been reported to not be covered by magnesium concentration in ordinary dialysis fluid. This may lead to ionized hypomagnesemia. However the incidence of ionized hypomagnesemia in patients requiring CRRT-RCA remains unclear and need to be estimated to determine if ionized magnesium monitoring could be of interest. This study aim to assess the incidence of ionized hypomagnesemia induced by CRRT-RCA.

sponsor_collaborators:
University Hospital, Montpellier
Novamedica Laboratories


title: Training of Persons With Complete Spinal Cord Injury for Pedaling on a Tricycle, Induced by Electrical Stimulation of the Paralysed Muscles: a Case Series

summary: The main objective of this study is to validate the effectivity of a simple home-based training for cycling with functional electrical stimulation (FES). The training is designed to progressively increase strength and endurance of the paralysed muscles of a person with complete spinal cord injury. After a limited period of only several months, performance will be assessed during FES-assisted cycling on a recumbent tricycle over flat ground. The outcomes of this study should provide evidence for the effectivity of FES-cycling as potential rehabilitation method.

ReferenceCitation: Fattal C, Schmoll M, Le Guillou R, Raoult B, Frey A, Carlier R, Azevedo-Coste C. Benefits of 1-Yr Home Training With Functional Electrical Stimulation Cycling in Paraplegia During COVID-19 Crisis. Am J Phys Med Rehabil. 2021 Dec 1;100(12):1148-1151. doi: 10.1097/PHM.0000000000001898.

repositories_concat: PubMed Central

lead_sponsor: Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie

collaborators: Institut National de Recherche en Informatique et en Automatique

location_facility: Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie


title: A Pilot Study to Assess the Concordance of Genomic Alterations Between Urine and Tissue to Develop Precision Medicine-Based Immunotherapy Approaches in High-Risk NMIBC Patients

acronym: ALU

summary:
The analysis of cell-free tumor DNA (cfDNA) in plasma has emerged as a clinically relevant predictive and prognostic biomarker in several metastatic solid malignancies, and even now represents standard-of-care for prescription of some targeted therapies in non-small cell lung cancer (blood-based T790M companion diagnostic test). cfDNA can be detected not only in plasma but also in urine, even in patients with non-invasive disease. Recent studies found that the detection of genomic alterations in plasma of urothelial bladder carcinoma patients was relatively uninformative in the localized setting. However, urine cfDNA has been shown to provide a promising resource for robust whole-genome tumor profiling in clinically localized Muscle invasive Bladder cancer (MIBC) and Non-Muscle Invasive Bladder Cancer (NMIBC). Genomic alterations using a targeted next-generation sequencing (NGS) panel have been recently documented in a series of treatment-naïve high-risk NMIBC.

The investigator's aim is to determine whether liquid biopsies can be used as a new diagnostic assay to guide immunotherapeutic approaches in patients with high-risk NMIBC. The ultimate goal is to develop a "testing decision tree" to segment patients for informing on therapeutic decision and customizing treatment.

lead_sponsor: Hopital Foch

sponsor_collaborators:
Hopital Foch
AstraZeneca


title: Bayesian Network to Predict Transfer in Intensive Care Units or Death in Newly Covid-19 Hospitalized Patient

summary:
The project is a part of the "Protocol for a multicentre study of nosocomial SARS-CoV2 transmission: The NOSO-COR Project" registered in ClinicalTrials (NCT04290780).

In the current pandemic context, medical resources have often been exceeded. Developing, using artificial intelligence techniques, an algorithm capable of detecting patients at risk of acute respiratory distress following Sars-Cov2 infection could help physicians to optimize the treatment of patients and health decision-makers to optimize resources. Thus, the goal of this project is to create a prediction model using artificial intelligence to predict an unfavorable evolution of Covid-19 at the hospital admission of patients

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital E Herriot - Hospices Civils de LYON


title: Improvement of Neuromuscular Function, Fatigue and Quality of Life by Optimizing Muscle Building and Nutrition in Colorectal Cancer: a Pilot Study

acronym: ColCanter

summary: This study is based on the assumption that muscle strength and muscle mass will be better preserved in an "intervention" group with specific management combining retraining and nutritional monitoring compared to the "no intervention" group and that this will be positive consequences for fatigue and quality of life. In addition, this project is also based on the assumption that these gains will be at least partially preserved 3 months after the end of specific care.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
Dr Laurent GERGELE


title: Establishment of a Monocentric and Prospective Clinico-biological Database in Patients With Pancreatic Adenocarcinoma

acronym: BCBPancréas

summary:
Pancreatic adenocarcinoma (PA) is a solid cancer with a very poor prognosis with overall survival, all stages combined, not exceeding 5% at 5 years. The incidence and number of deaths caused by this type of tumor have been steadily increasing for two decades. In the absence of therapeutic advances, PA will be one of the leading causes of cancer deaths in 2030.

In recent years, researchers and clinicians have now attempted to characterize and understand PA as a whole, through the various stages of its carcinogenesis and the analysis of its microenvironment. Indeed, the stroma of PA can represent up to 80% of the tumor mass and mainly composed of activated fibroblasts (CAF), endothelial and immune cells and extracellular matrix (collagen and fibronectin). However, the characterization of cell subtypes of this stroma is under study, as the pro or anti-tumor role of each cell subtype is not yet well understood.

New technologies such as the CyTOF that has just been acquired by the ICM and the IRCM will make it possible to study these problems and to examine the cellular subpopulations that make up the tumor. On the other hand, active research is conducted to disrupt the dialogue between the tumor cells and those of the microenvironment.

The search for innovative treatments in pancreatic adenocarcinoma requires the use of models of relevant preclinical studies. The most widely used models are based on cell lines of human origin used in vitro or in vivo after xenograft in immunodeficient mice. In particular, studies with pancreatic adenocarcinomas (PDX) derived tumors of patients reported that the response rate of PDX to certain drugs (gemcitabine, erlotinib ...) used clinically was similar to the response rates of patients enrolled in clinical studies. of these agents as monotherapy. A number of studies have evaluated the efficacy of targeted anti-tumor, anti-angiogenic or anti-stroma therapies from these PDTX models. Personalized medicine strategies can be envisioned as well as the study of new biomarkers, drugs or molecular mechanisms involved in therapeutic resistance. For several years, the investigators have been developing AP PTDX in the INSERM 1194 unit.

The investigators propose to continue the development of this collection of pancreatic adenocarcinoma PDTX prospectively and to carry out their histological, molecular and mutational characterization.

ReferenceCitation: Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155. Erratum In: Cancer Res. 2014 Jul 15;74(14):4006.

ReferenceCitation: Garrido-Laguna I, Hidalgo M. Pancreatic cancer: from state-of-the-art treatments to promising novel therapies. Nat Rev Clin Oncol. 2015 Jun;12(6):319-34. doi: 10.1038/nrclinonc.2015.53. Epub 2015 Mar 31.

ReferenceCitation: Chiorean EG, Coveler AL. Pancreatic cancer: optimizing treatment options, new, and emerging targeted therapies. Drug Des Devel Ther. 2015 Jul 7;9:3529-45. doi: 10.2147/DDDT.S60328. eCollection 2015.

ReferenceCitation: Rubio-Viqueira B, Jimeno A, Cusatis G, Zhang X, Iacobuzio-Donahue C, Karikari C, Shi C, Danenberg K, Danenberg PV, Kuramochi H, Tanaka K, Singh S, Salimi-Moosavi H, Bouraoud N, Amador ML, Altiok S, Kulesza P, Yeo C, Messersmith W, Eshleman J, Hruban RH, Maitra A, Hidalgo M. An in vivo platform for translational drug development in pancreatic cancer. Clin Cancer Res. 2006 Aug 1;12(15):4652-61. doi: 10.1158/1078-0432.CCR-06-0113.

ReferenceCitation: Leconet W, Larbouret C, Chardes T, Thomas G, Neiveyans M, Busson M, Jarlier M, Radosevic-Robin N, Pugniere M, Bernex F, Penault-Llorca F, Pasquet JM, Pelegrin A, Robert B. Preclinical validation of AXL receptor as a target for antibody-based pancreatic cancer immunotherapy. Oncogene. 2014 Nov 20;33(47):5405-14. doi: 10.1038/onc.2013.487. Epub 2013 Nov 18.

ReferenceCitation: Ogier C, Colombo PE, Bousquet C, Canterel-Thouennon L, Sicard P, Garambois V, Thomas G, Gaborit N, Jarlier M, Pirot N, Pugniere M, Vie N, Gongora C, Martineau P, Robert B, Pelegrin A, Chardes T, Larbouret C. Targeting the NRG1/HER3 pathway in tumor cells and cancer-associated fibroblasts with an anti-neuregulin 1 antibody inhibits tumor growth in pre-clinical models of pancreatic cancer. Cancer Lett. 2018 Sep 28;432:227-236. doi: 10.1016/j.canlet.2018.06.023. Epub 2018 Jun 20.

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

location_facility: Institut Régional du Cancer de Montpellier


title: Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks

summary: Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The investigators described the different techniques of type 2 endovascular repair, and their efficacy at short and long term..

ipd_sharing_description:
All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes.

Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Cardiovascular and thoracic surgery unit, CHU Dijon


title: Staphylococcus Lugdunensis Prosthetic Joint Infection: a Retrospective Cohort Study

summary: Staphylococcus lugdunensis is a coagulase-negative staphylococcus belonging to the human commensal cutaneous flora, and has been little studied in the field of prosthetic joint infections. However, it shares many virulence traits with Staphylococcus aureus, including many adhesins and its ability to form biofilm, and the few series of cases reports a significant failure rate.


title: Evaluation of the Efficacy of a Homeopathic Protocol to Reduce the Onset or Aggravation of Joint Pain or Stiffness Following the Taking of Anti-aromatases (AI) in Patients With Non-metastatic Breast Cancer

summary: Interventional, randomised, prospective, monocentric study

lead_sponsor: Institut Jean-Godinot


title: Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study ScanRach Study

acronym: SCANRACH

summary: Investigators team propose to evaluate the impact of the use of intraoperative scanning coupled with Stryker navigation, compared to the conventional fluoroscopy technique, on the accuracy of pedicle screws, in instrumented spinal surgery, by a randomised prospective study, in terms of pedicular screw accuracy. We will also evaluate the radiation exposure of the neurosurgical team and the patient in these two techniques.


title: Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D. 3D-HAM Study.

summary: The automated TALAS measurement tool, working with the Cone Beam 3D scanner under load, provides a reproducible measurement of the Foot Ankle Offset (FAO). It is possible to determine an average value and the standard deviation of FAO in the relevant population. And to differentiate significantly the populations with a neutral alignment, varus or valgus.

sponsor_collaborators:
Ramsay Générale de Santé
Dr François Lintz