title: Intracoronary Injection of Epo During Reperfusion in Patients Hospitalized for First Acute Myocardial Infarct STEMI

summary:
Primary endpoint: Is intracoronary injection of a single dose of darbepoetin alpha, during reperfusion in patients hospitalized for ST segment elevation myocardial infarction (STEMI), able to reduce infarct size ?

In in vivo studies, many experiments evidenced infarct size reduction, due to anti-apoptotic compounds, when given during reperfusion, after cardiac ischemia. In humans, post-conditioning offers such a protection, as the investigators have previously showed (Staat P et al. Post-conditioning the human heart. Circulation. 2005 112(14):2143-8).

Infarct size reduction could lead to a reduced rate of complications (heart failure, rhythmic complications) and finally, morbidity and even mortality. This protection depends on anti-apoptotic properties (Zhao ZQ et al. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiology Heart Circ Physiology 2003 Aug; 285(2):H579-88). Many drugs have been proposed to be able to mimic this phenomenon. Among them, many are efficient but toxic in vivo or difficult to manage (insulin, morphin). One of the most promising agent could then be erythropoietin (EPO) (Opie LH et al. Postconditioning for protection of the infarcting heart. Lancet. 2006; 367(9509):456-8). In order to target ischemia-reperfusion injuries, EPO impact is better and better demonstrated (e.g.: Mudalagiri NR. Erythropoietin protects the human myocardium against hypoxia and reoxygenation injury via phosphatidylinositol-3 kinase and ERK1-2 activation. Br J Pharmacol. 2007 Oct 22). The purpose of the study is to test this hypothesis in humans, on the onset of the reperfusion, after myocardial ischemia (acute myocardial infarct). EPO could contribute to protect myocardium against ischemia-reperfusion injury. This impact could rely on anti-apoptotic properties.

ReferenceCitation: Roubille F, Micheau A, Combes S, Thibaut S, Souteyrand G, Cayla G, Bonello L, Lesavre N, Sportouch-Dukhan C, Klein F, Berboucha S, Cade S, Cung TT, Raczka F, Macia JC, Gervasoni R, Cransac F, Leclercq F, Barrere-Lemaire S, Paganelli F, Mottref P, Vernhet Kovacsik H, Ovize M, Piot C. Intracoronary administration of darbepoetin-alpha at onset of reperfusion in acute myocardial infarction: results of the randomized Intra-Co-EpoMI trial. Arch Cardiovasc Dis. 2013 Mar;106(3):135-45. doi: 10.1016/j.acvd.2012.12.001. Epub 2013 Feb 1.

lead_sponsor: University Hospital, Montpellier


title: Characterization of Sitting Postures in Healthy Subjects

acronym: CaPAS

summary: The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: University Hospital, Grenoble

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI

acronym: HISTO-RAD

summary:
Inclusion criteria:

Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR
Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)

Study Design:

Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.
Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.
Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).
Histoscanning™ and MRI results will be compared to biopsy results.

A total of 30 patients will be included

primary_purpose: Diagnostic

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other


acronym: PropofolTE

intervention_type: Drug

lead_sponsor: Fresenius Kabi

summary: The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI).

sponsor_collaborators:
Fresenius Kabi
Quintiles, Inc.

location_facility: CHU de Bordeaux, Groupe Hospitalier Pellegrin

title: Therapeutic Equivalence Study of Propofol Using Target-Controlled Infusion of Propofol 2% (20 mg/mL) MCT Fresenius Compared With Diprivan® 20 mg/mL (AstraZeneca) in Patients Undergoing Elective Surgery

primary_purpose: Treatment

type: EudraCT Number

source: euctr

design_allocation: Randomized

lead_sponsor_type: industriel


title: Up Regulation of Alpha-1 Receptors Upon Septic Shock ?

acronym: CATACHOC

summary: The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).

status: Terminated

enrollment_type: Anticipated

lead_sponsor: Direction Centrale du Service de Santé des Armées

status_simplified: Unknown


title: Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

acronym: Lymphoscreen

summary: The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).

design_allocation: Non-Randomized

lead_sponsor: Nantes University Hospital


title: Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

acronym: PHARO

summary:
Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these reflux and to identify patients with abnormal LPR.

To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.

lead_sponsor: University Hospital, Bordeaux


title: Chemoembolisation of Non Resectable, Non Metastatic Hepatocellular Carcinomas Combining DC Bead Microspheres Loaded With Idarubicin (Zavedos®): Phase I Trial

summary: The purpose of this study is to determine the maximal tolerated dose of idarubicin for chemoembolization of non resectable non metastatic hepatocellular carcinoma.

ReferenceType: derived

ReferenceCitation: Anota A, Boulin M, Dabakuyo-Yonli S, Hillon P, Cercueil JP, Minello A, Jouve JL, Paoletti X, Bedenne L, Guiu B, Bonnetain F. An explorative study to assess the association between health-related quality of life and the recommended phase II dose in a phase I trial: idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma. BMJ Open. 2016 Jun 24;6(6):e010696. doi: 10.1136/bmjopen-2015-010696.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ReferenceCitation: Boulin M, Hillon P, Cercueil JP, Bonnetain F, Dabakuyo S, Minello A, Jouve JL, Lepage C, Bardou M, Wendremaire M, Guerard P, Denys A, Grandvuillemin A, Chauffert B, Bedenne L, Guiu B. Idarubicin-loaded beads for chemoembolisation of hepatocellular carcinoma: results of the IDASPHERE phase I trial. Aliment Pharmacol Ther. 2014 Jun;39(11):1301-13. doi: 10.1111/apt.12746. Epub 2014 Apr 16.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Centre Hospitalier Universitaire de DIJON


title: Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients

acronym: ANRS 2H

summary:
To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for serious influenza forms during pandemic period in French HIV infected patients.

Definitions:

Influenza like illness is defined as fever> 37°8C and cough or pharyngalgia. (Centers for Disease Control definition).
Serious forms of influenza-like illness is defined by hospitalization within 14 days onset of symptoms or death attributed to influenza like illness.

Design:

Survey sampling for estimating H1N1v influenza-like illness incidence.
Out of approximately 50 000 patients under follow-up in one of the 40 ANRS centres, a sub-group will be selected by random sampling. Sampling will be stratified by centre and sampling fraction per site will vary in order to select 60 to 80 patients for this study per site. A total of 2500 to 3000 patients will be selected to allow for estimating the incidence of H1N1v influenza-like illness with an adequate precision.

Selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection.

Nested case-control study for the determination of risk factors for serious forms:

Cases: Serious forms (see definition above) identified by any clinical site or hospitalisation unit.
Controls: Patients of the randomly selected sample (see survey sampling above), presenting with influenza-like illness without any criterion for severity.

Exhaustivity check:

The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.

primary_purpose: Other

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

intervention_type: Biological


title: Prospective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan Study

acronym: APO-TEP

summary:
In Parkinson's disease, treatment mainly aims to improve motor functions. However, other dysfunctions are often observed in Parkinson's patients, and may have important consequences on the quality of life of patients.

Cognitive and neuropsychological troubles may be observed, as memory impairment or anxiety for example. As this kind of troubles is worrying for the patient himself (herself) and his/her family, treatment needs to take into account those troubles in addition to motor difficulties. In our centre, we have already used continuous Apomorphine infusions among Parkinson's patients and it seems to have good results. The present study aims to objectively assess the efficacy of continuous Apomorphine infusions on cognitive and neuropsychological functions in Parkinson's disease using clinical and positron emission tomography (PET)-scan measures.

study_start_date_type: Actual

ReferenceType: result

ReferenceCitation: Auffret M, Le Jeune F, Maurus A, Drapier S, Houvenaghel JF, Robert GH, Sauleau P, Verin M. Apomorphine pump in advanced Parkinson's disease: Effects on motor and nonmotor symptoms with brain metabolism correlations. J Neurol Sci. 2017 Jan 15;372:279-287. doi: 10.1016/j.jns.2016.11.080. Epub 2016 Dec 2.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: Rennes University Hospital


title: A Phase II Study Evaluating the Feasibility of a Dose Increase by a Boost of Curietherapy in PDR Associated With the Extern Radiotherapy in Intermediate Risk in the Prostate Cancer

acronym: CURIEBOOST

summary: The objective of the trial is to evaluating the feasibility of dose increase by a boost of curietherapy in PDR (at least 40 Gy on D95) associated to extern radiotherapy (34 Gy) in intermediate risk in prostate cancer.

lead_sponsor: Centre Francois Baclesse

intervention_type: Radiation


title: Accelerated Aging, HIV Infection, Antiretroviral Therapies

acronym: EP 45

summary: The main goal is to confirm, among HIV1-infected patients, data from in vitro studies showing that antiretroviral therapies induce an accelerated aging through the same mechanisms than genetic laminopathies or than "physiological " aging, that is through the synthesis and persistence of farnesylated prelamin A. The secondary goal is to measure the impact of HIV infection and of antiretroviral therapies on markers of cell ageing (proteasome, mitochondria, telomere). The perspective is to fix antiretroviral therapy side effects using the same drug combination that will be used in few weeks in Marseille to treat children suffering from progeria

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Perrin S, Cremer J, Faucher O, Reynes J, Dellamonica P, Micallef J, Solas C, Lacarelle B, Stretti C, Kaspi E, Robaglia-Schlupp A, Nicolino-Brunet C, Tamalet C, Levy N, Poizot-Martin I, Cau P, Roll P. HIV protease inhibitors do not cause the accumulation of prelamin A in PBMCs from patients receiving first line therapy: the ANRS EP45 "aging" study. PLoS One. 2012;7(12):e53035. doi: 10.1371/journal.pone.0053035. Epub 2012 Dec 28. Erratum In: PLoS One. 2013;8(8). doi:10.1371/annotation/f02cdfd3-b271-46fd-a78f-5a030f0b416d. Tamalet, Corine Nicolino-Brunet Catherine [corrected to Nicolino-Brunet, Corinne]; [ corrected to Tamalet, Catherine].

license: cc-by

license_normalized: cc-by

version: acceptedVersion

publisher_dissemination: Public Library of Science

ReferenceCitation: Perrin S, Cremer J, Roll P, Faucher O, Menard A, Reynes J, Dellamonica P, Naqvi A, Micallef J, Jouve E, Tamalet C, Solas C, Pissier C, Arnoux I, Nicolino-Brunet C, Espinosa L, Levy N, Kaspi E, Robaglia-Schlupp A, Poizot-Martin I, Cau P. HIV-1 infection and first line ART induced differential responses in mitochondria from blood lymphocytes and monocytes: the ANRS EP45 "Aging" study. PLoS One. 2012;7(7):e41129. doi: 10.1371/journal.pone.0041129. Epub 2012 Jul 19.

sponsor_collaborators: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: ANRS center from Marseille, Timone and Montpellier and Nice


title: Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People

acronym: VERNIS

summary: This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.

primary_purpose: Prevention

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Randomized Directed Immuno Nutrition by L-arginine for Critically Ill Patients

acronym: Immunolarg

summary: The main objective of this proof-of-concept study is to demonstrate that the only administration of L-arginine, based on a suspected deficit monitored by nasal nitric oxide measurement, can improve immune functions in critically ill patients at high risk of nosocomial infection.

ReferenceCitation: Marik PE, Zaloga GP. Immunonutrition in critically ill patients: a systematic review and analysis of the literature. Intensive Care Med. 2008 Nov;34(11):1980-90. doi: 10.1007/s00134-008-1213-6. Epub 2008 Jul 15.

ReferenceCitation: Tadie JM, Cynober L, Peigne V, Caumont-Prim A, Neveux N, Gey A, Guerot E, Diehl JL, Fagon JY, Tartour E, Delclaux C. Arginine administration to critically ill patients with a low nitric oxide fraction in the airways: a pilot study. Intensive Care Med. 2013 Sep;39(9):1663-5. doi: 10.1007/s00134-013-2984-y. Epub 2013 Jun 19. No abstract available.

publisher_dissemination: Springer

location_facility: Medical Intensive Care Unit, Pompidou Hospital


title: Evaluation of the Effect of the Oxytocin Administered in Nasal Pulverizing on the Social Skills, the Stress, the Anxiety and the Eating Habits at Grown-up Patients Presenting a Syndrome of Prader-Willi: Pilot Study

summary:
The role of oxytocin (OT) is already known in the regulation of satiety but some clinical studies demonstrated that OT participates also in the regulation of social behavior by its implication on a better comprehension of emotion which plays a role on theory of mind and empathy. By the way, these 2 behaviors are deviants for patients with Prader-Willi Syndrome (PWS). Actually, no study was led on the effect of OT on PWS patients but Swaab and al in 1995 showed a significant reduction in number and in volume of neurons expressing OT in the paraventricular nucleus of PWS patients. Recent data were obtained studying OT in patients with autism which showed a link between the deregulation of OT and the autistic pathology. Clinical and imaging studies obtained with PWS and autistic populations make us believe that some mechanisms are common between these two pathologies.

The objectives of this project are:

to look for an influence on the understanding of the social codes of the PWS patients,
to look for an influence on the behavior of stress and anxiety and on the regulation of eating habits when patients receive a nasal pulverizing of OT.

ReferenceCitation: Tauber M, Mantoulan C, Copet P, Jauregui J, Demeer G, Diene G, Roge B, Laurier V, Ehlinger V, Arnaud C, Molinas C, Thuilleaux D. Oxytocin may be useful to increase trust in others and decrease disruptive behaviours in patients with Prader-Willi syndrome: a randomised placebo-controlled trial in 24 patients. Orphanet J Rare Dis. 2011 Jun 24;6:47. doi: 10.1186/1750-1172-6-47.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse


title: Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study

acronym: EP 44

summary: HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication. This project aims to characterize the residual replication of HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.

intervention_type: Procedure


title: Randomized, Double-Blind, Placebo-Controlled Trial Assessing Norfloxacin in the Prevention of Complications in Patients With Cirrhosis and Severe Liver Failure

acronym: NORFLOCIR

summary: Patients with advanced cirrhosis have abnormal translocation of Gram-negative bacteria across the intestinal barrier and subsequent systemic inflammatory response. We hypothesized that this translocation may worsen the underlying liver disease. Thus, the aim of this trial was to assess the effects of the oral administration of norfloxacin (an antibiotic that suppresses intestinal Gram-negative bacteria) on the development of complications of cirrhosis.

ReferenceCitation: Moreau R, Elkrief L, Bureau C, Perarnau JM, Thevenot T, Saliba F, Louvet A, Nahon P, Lannes A, Anty R, Hillaire S, Pasquet B, Ozenne V, Rudler M, Ollivier-Hourmand I, Robic MA, d'Alteroche L, Di Martino V, Ripault MP, Pauwels A, Grange JD, Carbonell N, Bronowicki JP, Payance A, Rautou PE, Valla D, Gault N, Lebrec D; NORFLOCIR Trial Investigators. Effects of Long-term Norfloxacin Therapy in Patients With Advanced Cirrhosis. Gastroenterology. 2018 Dec;155(6):1816-1827.e9. doi: 10.1053/j.gastro.2018.08.026. Epub 2018 Aug 23.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid


title: In UTERO Treatment of Cytomegalovirus Congenital Infection With Valacyclovir: Prospective Multicenter Randomized Trial Versus Placebo

acronym: CYMEVAL

summary: The infection with cytomegalovirus (CMV) is the first cause of congenital neurological handicap of infectious origin. It is probable that the neonatal viral load is correlated with becoming of infected new-born babies. Among the active antiviral treatments against CMV, valacyclovir is the only whose fetal and maternal tolerance was evaluated during the pregnancy. Its harmlessness and its aptitude to decrease the CMV viral load justify to evaluate it in a study against placebo. Decrease the fetal viral load could make possible to decrease symptomatology neonatal in a group of infected fetuses.


type: Other Identifier

title: A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase

summary: To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

lead_sponsor: Bioprojet


title: In Vivo Discrimination of Hip Fracture With Quantitative Computed Tomography

acronym: FEMFRACT

summary:
Numerous geometric and bone mineral density (BMD) parameters can be derived from quantitative computed tomography (QCT) images of the proximal femur analyzed using dedicated software. The primary objective is to evaluate the contribution of QCT-image analysis to the prediction of the osteoporotic hip fracture risk, as compared to the reference standard, namely, dual energy X-ray absorptiometry (DXA).

Study hypothesis: For predicting osteoporotic hip fracture, findings from QCT images of the proximal femur analyzed using dedicated software are superior over DXA measurements of proximal femoral BMD.


title: Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)

acronym: GAME

summary: Pelvic girdle and low back pain are common in pregnancy, and cause severe impairment in 10% of women. Our hypothesis is that offering acupuncture in addition to standard care would reduce pain and impairment throughout pregnancy. 300 pregnant women from 5 maternity units will be randomized over a 3 year period to receive standard care or standard care plus acupuncture. Main outcome will be the number of days during pregnancy with maximum pain ≤ 4/10. Secondary outcomes will compare groups for an impairment score and for direct and indirect costs.

ReferenceCitation: Nicolian S, Butel T, Gambotti L, Durand M, Filipovic-Pierucci A, Mallet A, Kone M, Durand-Zaleski I, Dommergues M. Cost-effectiveness of acupuncture versus standard care for pelvic and low back pain in pregnancy: A randomized controlled trial. PLoS One. 2019 Apr 22;14(4):e0214195. doi: 10.1371/journal.pone.0214195. eCollection 2019.

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

repository_institution: RePEc: Research Papers in Economics - RePEc

repository_normalized: RePEc

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

repository_normalized: HAL

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

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

repositories:
HAL
PubMed Central
RePEc

repositories_concat: HAL;PubMed Central;RePEc

repositories_pmh: HAL RePEc europepmc.org

location_facility: Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière


title: Satisfaction Understanding of Patients and Relatives in Emergency Room

summary:
Evaluation of global understanding and with items of patients admitted to the emergency.

Prospective observational study randomized in cluster during 6 weeks in 14 centers

primary_purpose: Health Services Research


title: A Telemedicine System for the Follow-up of Patients With SAS

summary: Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.

location_facility: Assistance Publique - Hôpitaux de Paris, Béclère Hospital


summary:
In obstetric, the investigators can't predict accurately with current means (BISHOP score, traditional cervix ultrasonography and fibronectin) the childbirth time and delay.

If ultrasonography can determine the length, the cervix opening, it can't define its flexibility. Indeed, the conventional cervix ultrasonography can't inform us about the consistency of the uterine cervix.

The elastography (elasticity imagery) is an innovating technology. It is a new technology currently used as part of breast cancer estimate. This diagnosis mean use the ultrasonography to measure the tissues answer under pressure.

Its contribution in obstetric must be estimated to improve patients minimum fare.

The main target of the investigators study is to estimate the interest of the measure of cervix elasticity degree by elastography in prediction of premature birth within a population of pregnant women

ReferenceCitation: Sabiani L, Haumonte JB, Loundou A, Caro AS, Brunet J, Cocallemen JF, D'ercole C, Bretelle F. Cervical HI-RTE elastography and pregnancy outcome: a prospective study. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:80-4. doi: 10.1016/j.ejogrb.2015.01.016. Epub 2015 Jan 23.

oa_host_type: repository

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

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

repositories_concat: HAL

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

unpaywall_oa_status: green

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Evaluation of CNAP During Induction and Maintenance of General Anesthesia

acronym: CnapEval

summary:
The purpose of this study is to compare

the non invasive measurement of arterial pressure (CNAP monitor)
with the invasive measurement of arterial pressure (radial artery catheter) during induction and maintenance of general anesthesia

lead_sponsor: Hopital Foch


title: Mannitol Versus Hypertonic Saline to Treat Intracranial Hypertension After Severe Traumatic Brain Injury : a Comparative Study on the Effects on PtiO2 and Microdialysis Values

summary: The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.

study_completion_date_type: Anticipated

ReferenceType: background

ReferenceCitation: Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7. doi: 10.1097/01.CCM.0000063268.91710.DF.

ReferenceCitation: Sakowitz OW, Stover JF, Sarrafzadeh AS, Unterberg AW, Kiening KL. Effects of mannitol bolus administration on intracranial pressure, cerebral extracellular metabolites, and tissue oxygenation in severely head-injured patients. J Trauma. 2007 Feb;62(2):292-8. doi: 10.1097/01.ta.0000203560.03937.2d.

ReferenceCitation: Soustiel JF, Vlodavsky E, Zaaroor M. Relative effects of mannitol and hypertonic saline on calpain activity, apoptosis and polymorphonuclear infiltration in traumatic focal brain injury. Brain Res. 2006 Jul 26;1101(1):136-44. doi: 10.1016/j.brainres.2006.05.045. Epub 2006 Jun 19.

sponsor_collaborators: Direction Centrale du Service de Santé des Armées


title: Respiratory Muscle Endurance Training in Obese Patients

summary: Obese patients are known to have increased work of breathing inducing dyspnea, exercise intolerance and impaired quality of life. Respiratory muscle training is known to increase respiratory muscle capacity, reduce dyspnoea and improve exercise performance in healthy subjects and respiratory patients. The investigators hypothesized that Respiratory muscle training would reduce dyspnoea, increase exercise tolerance and quality of life in obese patients.

primary_purpose: Supportive Care

lead_sponsor: Fondation Edith Seltzer


type: Registry Identifier

title: Caractérisation et détection Des Mouvements Durant Les Crises d'épilepsie à Des Fins d'Alarme, Pour un Usage en Institution et en Famille.

summary:
CAPAMETRIM 2 aims to characterize epileptic motor patterns by a quantitative three-dimensional analysis of movements.

This is done to obtain a 3-D motor signature of seizures, for a given patient, and allows their detection with an ambulatory monitoring system.

The benefit for patients is to improve the diagnosis of their diseases by better characterizing their seizures.

location_facility: Grenoble University Hospital Epilepsy Monitoring Unit


title: Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment

acronym: Minivis

summary: The main objective of the investigators' study is to assess the efficacy of a course of treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental anchorage (reference) during dentofacial orthopedic treatment.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
DENTOS


title: Prospective Study on Swallowing/Breathing Interactions in Severe Guillain Barre Syndrome.

acronym: DGVSB

summary: To estimate, in a longitudinal and not invasive way, in patients with SGB at respiratory risk, the function of respiratory muscles and that of the upper airways muscles by investigating the force of the tongue, the gulp, and the breath during the sleep to be able to detect bulbar impairment and establish correlations enter the various parameters to estimate better the interactions between the dysfunction of the respiratory muscles and that upper airways muscles and so determine the risk acute respiratory failure.


title: Consideration of the Merits of Continuous Paravertebral Block in the Management of Renal and/or Adrenal Surgery by Laparotomy in Adults

acronym: BPV

summary:
The paravertebral block is an alternative in the analgesia epidural the major interest of which lives in the catheterisation of the paravertébral space allowing to assure/insure an one-sided continuous analgesia.

The main objective of the study is to bring to light the superiority of the continuous paravertébral block, as a supplement to analgesia, in the care of the renal and\or adrenal surgery by laparotomy at the adult in terms of consumption of morphine, with regard to the classic analgesia classic.

The main assessment criterion is the consumption of morphine within first 24 postoperative hours at the patients benefiting from a paravertébral continuous block besides the classic systematic analgesia.

lead_sponsor: University Hospital, Brest


title: Characterization and Analysis of Long-term Evolution of Renal and Extra-renal Damages in the Course of Nephronophthisis

acronym: NEPHAER

summary: to describe evolution of Nephronophthisis

intervention_type: Genetic


title: Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib

acronym: ProMETheX

summary: The purpose of this study is to evaluate the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib.

lead_sponsor: Centre Jean Perrin


title: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal

summary:
Complete response is a rare event in metastatic anal cancer in the case of unresectable recurrence after radiochemotherapy.

In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel, Cisplatin and 5-Fluorouracil.

In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection, that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was identified within the tumor samples.

The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with DCF and contributed to the elimination of the tumour cells and to the increase of complete responses. The aim to this study is to analyze immune response against HPV in this patients in complete response.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Medical Oncology - University Hospital of Besançon


title: The Prevalence of Chronic Kidney Disease at Adolescence in Patients With Congenital Cardiac Disease, Having Undergone Corrective Surgery During Childhood

acronym: PRECARDIO

summary: The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known, but there is evidence of CKD in young adults. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could by chart review and regression analysis.

ReferenceCitation: Dimopoulos K, Diller GP, Koltsida E, Pijuan-Domenech A, Papadopoulou SA, Babu-Narayan SV, Salukhe TV, Piepoli MF, Poole-Wilson PA, Best N, Francis DP, Gatzoulis MA. Prevalence, predictors, and prognostic value of renal dysfunction in adults with congenital heart disease. Circulation. 2008 May 6;117(18):2320-8. doi: 10.1161/CIRCULATIONAHA.107.734921. Epub 2008 Apr 28.

ReferenceCitation: Hogg RJ, Furth S, Lemley KV, Portman R, Schwartz GJ, Coresh J, Balk E, Lau J, Levin A, Kausz AT, Eknoyan G, Levey AS; National Kidney Foundation's Kidney Disease Outcomes Quality Initiative. National Kidney Foundation's Kidney Disease Outcomes Quality Initiative clinical practice guidelines for chronic kidney disease in children and adolescents: evaluation, classification, and stratification. Pediatrics. 2003 Jun;111(6 Pt 1):1416-21. doi: 10.1542/peds.111.6.1416.

ReferenceCitation: Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.

ReferenceCitation: Pedersen KR, Hjortdal VE, Christensen S, Pedersen J, Hjortholm K, Larsen SH, Povlsen JV. Clinical outcome in children with acute renal failure treated with peritoneal dialysis after surgery for congenital heart disease. Kidney Int Suppl. 2008 Apr;(108):S81-6. doi: 10.1038/sj.ki.5002607.

ReferenceCitation: Askenazi DJ, Feig DI, Graham NM, Hui-Stickle S, Goldstein SL. 3-5 year longitudinal follow-up of pediatric patients after acute renal failure. Kidney Int. 2006 Jan;69(1):184-9. doi: 10.1038/sj.ki.5000032.


title: Study of Eating in the Absence of Hunger and of Caloric Compensation in French Children, and of Their Relationships With Parental Feeding Practices

summary:
Objectives: The aims were to measure caloric compensation (CC) and eating in the absence of hunger (EAH) in 2 to 7 year-old French children in their regular eating context and to link these measurements with individual characteristics (adiposity, age, gender) and parental feeding practices.

Design: Three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Parental eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.

time_perspective: Cross-Sectional

ReferenceCitation: Remy E, Issanchou S, Chabanet C, Boggio V, Nicklaus S. Impact of adiposity, age, sex and maternal feeding practices on eating in the absence of hunger and caloric compensation in preschool children. Int J Obes (Lond). 2015 Jun;39(6):925-30. doi: 10.1038/ijo.2015.30. Epub 2015 Mar 17.

publisher_dissemination: Springer-Nature

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation

location_facility: Centre des sciences du goût et de l'alimentation


title: Improving the Assessment of Pulmonary Vein Disconnection With the Achieve Catheter During Atrial Fibrillation Cryoablation

summary: According to data from high volume Centres, documentation of entry block with the Achieve catheter may be possible in only about to 50% of pulmonary veins. The investigators aim to assess strategies using the Achieve catheter that can improve this performance.

ReferenceCitation: Boveda S, Providencia R, Albenque JP, Combes N, Combes S, Hireche H, Casteigt B, Bouzeman A, Jourda F, Narayanan K, Marijon E. Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases? Europace. 2014 Jun;16(6):826-33. doi: 10.1093/europace/eut366. Epub 2013 Dec 18.

publisher_dissemination: Oxford University Press

lead_sponsor: Clinique Pasteur


title: Erectile Rating During the Treatment of Rectal Cancers Localized. Exploratory Study

acronym: METEORR

summary: Erectile dysfunction will be explored by recording R / P and self-administered questionnaire IIEF-5.

lead_sponsor: Institut Bergonié


title: Associating Liver Partition and Portal Vein Ligation (ALPPS) for Potentially Resectable Liver Metastasis From Colorectal Cancer: Prospective Evaluation of the Early Two-stage Hepatectomy by the Simon's Methods

summary: The aim of this study is evaluate the feasibility of early two-stage hepatectomy in patients with liver metastasis from colorectal cancer.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Feasibility of the Use of Ultrasound-guided Paravertebral Catheterisation for the Analgesic Management of Thoracotomy

acronym: BPV échoguidé

summary:
Thoracotomy, is a surgical procedure performed routinely in connection with pulmonary surgery. Pain induced by thoracotomy is considered as the most severe post-operative pain. Control of the pain is essential in the perioperative management.

Nowadays, there are several strategies to support this pain, including regional anesthesia techniques in the context of multimodal analgesia. Epidural analgesia reduces pain scores and respiratory complications significantly. ParaVertebral Block (PVB) is a technique as effective as epidural analgesia in the treatment of pain after thoracotomy and could present a more limited number of complications. However, there is no consensus on the best technique for realisation of PVB.

Para-vertebral catheterisation can be performed by posterior approach in seeking a strength loss after bone contact of transverse vertebral process using the technique of Eason and Wyatt, but it is a blind technique. The ultrasonographic control, developed in the context of all puncture invasive actions, is an effective contribution to the realisation of a BPV, but still insufficiently validated. First used to measure the distance skin - posterior costo-transverse ligament and skin - parietal pleura before procedure, the ultrasonography has recently led to the publication of echo-guided techniques combining recognition of structures defining the space para- vertebral, viewing the progression of the needle and the spread of the local anesthetic. The handling of the ultrasonographic probe associated with the puncture requires additional learning.

The objective of this project is to study the feasibility of para-vertebral catheter insertion under ultrasonographic control. The appearance like "pigtail" of the catheter, the most recently proposed, seems the more attractive in terms of safety. The aim of this pilot prospective study is accurately quantify all qualitative parameters related to the technique in order to achieve a future validation with a medico-economic component.

Ultrasound-guided technique will correspond to a technique with a puncture of the lateral to medial space described by Shibata, after spotting of the first rib proposed by Bouzinac.

This study will be proposed to patients undergoing thoracotomy for total or partial pulmonary resection in Thoracic Surgery service of Centre Jean Perrin, the number of patients required is 60 patients over a period of inclusion of 12 months.

location_facility: Centre de lautte contre le cancer - Centre Jean Perrin


title: Prenatal Screening for Imprinting Anomalies Implicated in Beckwith Wiedemann and Silver Russell Syndromes

acronym: DASIRUWIBE

summary:
Losses of imprinting are involved in various syndromes. Those occurring in the 11p15 region lead to Beckwith-Wiedemann and Silver-Russell Syndromes. These losses of imprinting follow a mosaic pattern, rendering their detection difficult, especially given the scarcity of available DNA in amniotic fluid. Thus, in spite of growing demand, prenatal diagnosis (PND) for imprinting abnormalities of the 11p15 region is not available.

The recent development of a quantitative PCR method that permits the methylation index (MI) of imprinted regions to be calculated renders PND technically possible. Nevertheless, because of the mosaic nature of these anomalies, it is essential to verify that the methylation pattern of the 11p15 region obtained from the amniotic fluid matches that obtained from the blood.

status: Unknown status


title: Evaluation of Accuvein for Blood Sampling and for Intravenous Catheter Placement in Adult Patients

summary: The objective of this study is to evaluate the effectiveness of Accuvein to facilitate venous blood sampling and placement of peripheral intravenous catheters in adults. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks, and decreases the patient's perception of the pain.

ReferenceCitation: Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.


title: Effect of Music Therapy on Chronic Pain in Hospitalized Patients in a Pain Center

summary: The aim of study is to assess the effects of this new music therapy technique on pain treatment, anxiety and depression and on medicinal consumption.

ReferenceCitation: Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.

ReferenceCitation: Cepeda MS, Carr DB, Lau J, Alvarez H. Music for pain relief. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD004843. doi: 10.1002/14651858.CD004843.pub2.

ReferenceCitation: Guetin S, Portet F, Picot MC, Pommie C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.

lead_sponsor: Association de Musicothérapie Applications et Recherches Cliniques

collaborators: Centre d'Evaluation et du Traitement de la Douleur CHU Saint-Eloi

collaborators: Unité de Recherche Clinique et Epidémiologie (DIM) CHU Arnaud de Villeneuve

collaborators: Centre Mémoire de Ressource et de Recherche équipe INSERM U888 CHU Montpellier

location_facility: CHRU Saint Eloi, Centre d'Evaluation et du Traitement de la Douleur


title: Virologic and Immunologic Evaluation of the Deep Viral Reservoirs in HIV-1 Infected Patients With Long Term Viral Suppression

acronym: MUCOVIR

summary: Prospective study in HIV-1 infected patients with a plasma viral load below the limit of detection and stable for at least 5 years.

ReferenceCitation: Descours B, Lambert-Niclot S, Mory B, Samri A, Charlotte F, Peytavin G, Tubiana R, Papagno L, Bacchus C, Lecardonnel F, Katlama C, Autran B, Marcelin AG, Valantin MA, Carcelain G; DECAMUNE and ORVACS Study Groups. Direct quantification of cell-associated HIV DNA in isolated rectal and blood memory CD4 T cells revealed their similar and low infection levels in long-term treated HIV-infected patients. J Acquir Immune Defic Syndr. 2013 Mar 1;62(3):255-9. doi: 10.1097/QAI.0b013e318282537f.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Objectif Recherche Vaccins SIDA


title: Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients

summary:
The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients.

This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life.

Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.

ReferenceCitation: Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.

oa_colors: green hybrid

publisher_dissemination: American Diabetes Association

lead_sponsor: University Hospital, Grenoble

location_facility: Service de Diabétologie du Pr Halimi, CHU


title: Respiratory Mechanical Effects of Sevoflurane Administered With the Anesthetic Conserving Device in Pressure Support Ventilation

summary: Sevoflurane inhalational anesthetic has got pulmonary effects such as bronchodilatation. These effects could be of interest in intensive care patients ventilated in pressure support ventilation mode. The purpose of this study is to evaluate mechanical respiratory effects of sevoflurane administered through a new specific heat and moister exchanger called the Anesthetic Conserving Device (AnaConDa®) in pressure support ventilation in intensive care patients. In fact, dead space and resistance generated by the device could cancel and even deteriorate the potential positive effects of sevoflurane on ventilation.

ReferenceCitation: Constantin JM, Futier E, Perbet S, Roszyk L, Lautrette A, Gillart T, Guerin R, Jabaudon M, Souweine B, Bazin JE, Sapin V. Plasma neutrophil gelatinase-associated lipocalin is an early marker of acute kidney injury in adult critically ill patients: a prospective study. J Crit Care. 2010 Mar;25(1):176.e1-6. doi: 10.1016/j.jcrc.2009.05.010. Epub 2009 Sep 24.

lead_sponsor: University Hospital, Clermont-Ferrand


title: PROSPECTIVE EVALUATION OF OUTPATIENT APPENDECTOMY FOR NON COMPLICATED ACUTE APPENDICITIS: Intention-to-treat Study

acronym: APPENDAMBU

summary: The aim of our monocentric prospective in intention-to-treat study is to evaluate the feasibility of outpatient appendectomy for non complicated acute appendicitis.

ReferenceCitation: Sabbagh C, Brehant O, Dupont H, Browet F, Pequignot A, Regimbeau JM. The feasibility of short-stay laparoscopic appendectomy for acute appendicitis: a prospective cohort study. Surg Endosc. 2012 Sep;26(9):2630-8. doi: 10.1007/s00464-012-2244-1. Epub 2012 Mar 23.

ReferenceCitation: Sabbagh C, Masseline L, Grelpois G, Ntouba A, Dembinski J, Regimbeau JM. Management of Uncomplicated Acute Appendicitis as Day Case Surgery: Can Outcomes of a Prospective Study Be Reproduced in Real Life? J Am Coll Surg. 2019 Sep;229(3):277-285. doi: 10.1016/j.jamcollsurg.2019.04.031. Epub 2019 May 13.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

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

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


type: Other Grant/Funding Number

title: Biological Rhythms and Vestibular System

summary: The purpose of this study is to study the relationship between the vestibular system and chronobiology

lead_sponsor: University Hospital, Caen

intervention_type: Behavioral


title: Neuropsychological Impact of Hospitalization on Intubated, Ventilated and Sedated ICU Patients

acronym: NeuroPsy Réa

summary:
This is a prospective, single-center, pilot, cohort study. The first phase of this study is observational and the usual care of patients is maintained during the ICU stay, except for an interview with a psychologist preceding patient discharge. A phone interview at 2 months and a visit with a psychologist at four months after ICU discharge are specific to the study.

The main objective of this study is to make a first estimate of the percentage of patients (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence / absence of cognitive impairment will be determined by the D2 test.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

summary:
Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).

The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)

status: Active, not recruiting

ReferenceCitation: Leboulleux S, Bournaud C, Chougnet CN, Zerdoud S, Al Ghuzlan A, Catargi B, Do Cao C, Kelly A, Barge ML, Lacroix L, Dygai I, Vera P, Rusu D, Schneegans O, Benisvy D, Klein M, Roux J, Eberle MC, Bastie D, Nascimento C, Giraudet AL, Le Moullec N, Bardet S, Drui D, Roudaut N, Godbert Y, Morel O, Drutel A, Lamartina L, Schvartz C, Velayoudom FL, Schlumberger MJ, Leenhardt L, Borget I. Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer. N Engl J Med. 2022 Mar 10;386(10):923-932. doi: 10.1056/NEJMoa2111953.

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

status_simplified: Ongoing


title: Effectiveness of Relational Touch in the Management of Chronic Pain in Institutionalized Elderly

acronym: EFFITOUREL

summary: The aim is to investigate the feasibility and efficacy of a relational touch / relational intervention on persistent pain in a long term geriatric hospital care ward population. The main issue is the pain reduction. The hypothesis is that this type of intervention is very useful on pain reduction in old people even with physical or mental disability.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hopital René Muret - Head of department Long Term hospital ward


title: Evaluation of the Bone Mineralization by Quantitative Computed Tomodensitometry in Patients With Cystic Fibrosis : Validation Study

acronym: TOMODENS

summary: The purpose of this study is to conduct a comparative study for the study of bone mineralization evaluated with Quantitative computed tomodensitometry (QCT) compared to the reference technique, Dual-emission X-ray absorptiometry (DXA).

lead_sponsor: Hôpital Necker-Enfants Malades

sponsor_collaborators:
Hôpital Necker-Enfants Malades
Vaincre la Mucoviscidose


title: Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?

acronym: DEBRIEF-SIM

summary:
Simulation-based training is essential in learning or maintaining skills in high risk industry such as aviation and railway and in the medical field like anaesthesia. Debriefing following simulation is fundamental in order to reduce the emotional impact of the session and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing method is still to be found, individual debriefing is considered as the gold standard but time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and randomized study that will compare the individual (defined by learning couple resident and nurse) approach to a grouped (several couples) debriefing. The primary end point is to define the noninferiority of this approach compared to the individual one on the educational impact.

The learners will be debriefed according to their randomization after the first session, but will all undergo individual debriefing following the second session.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility: Faculté de Franche-Comte des études de medecine et pharmaceutiques


title: Identification of Early Markers of Response and Resistance to Trastuzumab in Patients With Localized Human Epidermal Growth Factor Receptor-2(HER-2)-Positive Breast Cancer Candidates for Breast Conserving Surgery

acronym: HERBIN

summary: The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis).

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris


title: Consultation at 8 Days to Reduce Hospitalisations in Heart Failure Patient.

acronym: CHIC

summary: Evaluate the benefit of systematic appointment with a cardiologist a week after hospitalisation for acute heart failure. Randomised, endpoint: number of day alive out of hospital during 6 months

ipd_sharing: Undecided


title: Physical and Psychological Evaluation of Patients Reaching End Stage Renal Disease : Effects on the Choice of Renal Replacement Therapy

summary: Highlighting the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Subgenual Cingulate Stimulation in Resistant Depression

summary:
Despite the availability of several treatments, a number of patients with major depression are refractory to therapeutical approaches and therefore suffer from chronic handicap. For these severe patients, neurosurgical therapies can be envisaged. They aim at interrupting bundles that link the orbitofrontal cortex with striatum and can therefore benefit for the patients.

This study intends to repeat Dr. Lozano's study, published in 2005 in the journal Neuron. In this study, they performed a preliminary evaluation of chronic deep brain stimulation (DBS) of the subgenual cingulate region (Brodmann area 25) to treat refractory depression as an alternative to subcaudate tractotomy. This last technique was employed in Grenoble in the 60s with satisfying results before neurosurgery for psychiatric disorders was abandoned. Since 1992, psychosurgical therapies that respect ethical recommendations have regained interest to treat highly impaired patients. Before the investigators can propose deep brain stimulation of subgenual cingulate brain region as a new therapeutic approach for the investigators patients in Grenoble, the investigators decided to reproduce their clinical evaluation on a group of 6 patients, repeating their methodology faithfully. Therefore nothing was changed to the model used by Drs. Lozano and Mayberg and the investigators took advantage of the investigators own expertise regarding deep brain stimulation and subcaudate tractotomy.

Protocol is strictly identical to the one of Mayberg and Lozano in order to confirm their preliminary results. Cartography of physiological consequences of this procedure will be assessed by measuring cerebral blood flow by PET scan (positron emission tomography). Patients will be monitored and thoroughly assessed during including psychiatric, neurological, neurosurgical, neuropsychological and PET scan exams to measure treatment efficacy and potential adverse reactions. Patients will be followed for two more years to assess medium-term complications. This study will be a first step toward further research including potentially a multicentric clinical trial.


title: Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients

acronym: PRESDIE

summary: Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.

lead_sponsor: Nantes University Hospital


title: Hodgkin's Lymphoma: Prognostic Value of the Kinetic of Decrease of 5 Cytokines Concentration During Treatment

acronym: CYTOKINES-LH

summary:
More than 90% of patients with Hodgkin lymphoma (HL) can recover thanks to conventional polychemotherapy regimens - ABVD or BEACOPP - with or without radiotherapy. Nevertheless, some patients relapse and others are resistant to any treatment. These patients represent 2-5% of stage I / II and 5-10% of disseminated stages. The usual prognostic index based on clinical and biological data (supradiaphragmatic HL: EORTC and advanced HL International Prognostic Score) cannot always detect patients at risk.

New prognostic factors are required to screen out these high risk patients. Among available biological factors, we will retain the cytokines secreted by tumor cells and cells from the environment.

Indeed, the prognostic value of plasma cytokines levels and their soluble receptors has recently been described by at least two teams. Olivier CASASNOVAS set up a prognostic index based on quantities of IL-1 RA, IL-6, sCD30 and TNFR1 at diagnosis,and the V. Diehl team published the prognostic value of the decrease of TARC (CC Thymus and Activation-related chemokine).

In daily practice, the early assessment of response by PET CT-scan is now an undeniable prognostic factor. Early identification of no-response or relapse is, in fact, based on clinical and imaging (PET-CT scan).

We propose to evaluate the decrease of cytokines concentration with a prognostic value (TARC, IL-6, IL1-RA, sCD30, TNFR1) as markers of response during treatment and during early follow-up. The dosage of these cytokines will be paired with radiological assessments.

A correlation between the decrease of cytokines plasma levels overtime and event-free survival will be searched afterwards.

lead_sponsor: Centre Henri Becquerel


title: Efficiency and Tolerance of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula in the Critically Ill Patient : a Prospective Randomized Trial

summary:
An early and efficient enteral nutritional support could improve the clinical outcomes of brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an increased gastric residual volume frequently occurs in these patients.

Previous experimental studies have suggested that a small-peptide enteral feeding formula could promote the gastric emptying compared to a whole-protein formula. An improved gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily caloric intake and enhance nutritional support of brain injured critically ill patients.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Surgical Critical Care Unit, CHRU Jean Minjoz

intervention_type: Dietary Supplement


title: Multipolar Radiofrequency Ablation for the Treatment of Hepatocellular Carcinoma Using Classical Intranodular Technique Versus Extra Nodular Technique So-called "No Touch" Technique: A Prospective Randomized Trial

acronym: ARMCENVIN

summary: The primary purpose of the trial is to demonstrate that at least a 40% drop of recurrence rate can be achieve in hepatocellular carcinoma patients treated with no touch multipolar radiofrequency ablation technique compared to those treated with usual intranodular multipolar technique.

ReferenceCitation: Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.

ReferenceCitation: Kotoh K, Enjoji M, Arimura E, Morizono S, Kohjima M, Sakai H, Nakamuta M. Scattered and rapid intrahepatic recurrences after radio frequency ablation for hepatocellular carcinoma. World J Gastroenterol. 2005 Nov 21;11(43):6828-32. doi: 10.3748/wjg.v11.i43.6828.

ReferenceCitation: Seror O, N'Kontchou G, Tin-Tin-Htar M, Barrucand C, Ganne N, Coderc E, Trinchet JC, Sellier N, Beaugrand M. Radiofrequency ablation with internally cooled versus perfused electrodes for the treatment of small hepatocellular carcinoma in patients with cirrhosis. J Vasc Interv Radiol. 2008 May;19(5):718-24. doi: 10.1016/j.jvir.2008.01.007. Epub 2008 Mar 17.

ReferenceCitation: Harrison LE, Koneru B, Baramipour P, Fisher A, Barone A, Wilson D, Dela Torre A, Cho KC, Contractor D, Korogodsky M. Locoregional recurrences are frequent after radiofrequency ablation for hepatocellular carcinoma. J Am Coll Surg. 2003 Nov;197(5):759-64. doi: 10.1016/S1072-7515(03)00750-6.

ReferenceCitation: Mazzaferro V, Battiston C, Perrone S, Pulvirenti A, Regalia E, Romito R, Sarli D, Schiavo M, Garbagnati F, Marchiano A, Spreafico C, Camerini T, Mariani L, Miceli R, Andreola S. Radiofrequency ablation of small hepatocellular carcinoma in cirrhotic patients awaiting liver transplantation: a prospective study. Ann Surg. 2004 Nov;240(5):900-9. doi: 10.1097/01.sla.0000143301.56154.95.

ReferenceCitation: Kotoh K, Morizono S, Kohjima M, Enjoji M, Sakai H, Nakamuta M. Evaluation of liver parenchymal pressure and portal endothelium damage during radio frequency ablation in an in vivo porcine model. Liver Int. 2005 Dec;25(6):1217-23. doi: 10.1111/j.1478-3231.2005.01167.x.

ReferenceCitation: Kotoh K, Nakamuta M, Morizono S, Kohjima M, Arimura E, Fukushima M, Enjoji M, Sakai H, Nawata H. A multi-step, incremental expansion method for radio frequency ablation: optimization of the procedure to prevent increases in intra-tumor pressure and to reduce the ablation time. Liver Int. 2005 Jun;25(3):542-7. doi: 10.1111/j.1478-3231.2005.01051.x.

ReferenceCitation: Nakamuta M, Kohjima M, Morizono S, Yoshimoto T, Miyagi Y, Sakai H, Enjoji M, Kotoh K. Comparison of tissue pressure and ablation time between the LeVeen and cool-tip needle methods. Comp Hepatol. 2006 Dec 21;5:10. doi: 10.1186/1476-5926-5-10.

ReferenceCitation: Okusaka T, Okada S, Ueno H, Ikeda M, Shimada K, Yamamoto J, Kosuge T, Yamasaki S, Fukushima N, Sakamoto M. Satellite lesions in patients with small hepatocellular carcinoma with reference to clinicopathologic features. Cancer. 2002 Nov 1;95(9):1931-7. doi: 10.1002/cncr.10892.

ReferenceCitation: Pawlik TM, Delman KA, Vauthey JN, Nagorney DM, Ng IO, Ikai I, Yamaoka Y, Belghiti J, Lauwers GY, Poon RT, Abdalla EK. Tumor size predicts vascular invasion and histologic grade: Implications for selection of surgical treatment for hepatocellular carcinoma. Liver Transpl. 2005 Sep;11(9):1086-92. doi: 10.1002/lt.20472.

ReferenceCitation: Shi M, Guo RP, Lin XJ, Zhang YQ, Chen MS, Zhang CQ, Lau WY, Li JQ. Partial hepatectomy with wide versus narrow resection margin for solitary hepatocellular carcinoma: a prospective randomized trial. Ann Surg. 2007 Jan;245(1):36-43. doi: 10.1097/01.sla.0000231758.07868.71.

ReferenceCitation: Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.

ReferenceCitation: Wong IH, Yeo W, Leung T, Lau WY, Johnson PJ. Circulating tumor cell mRNAs in peripheral blood from hepatocellular carcinoma patients under radiotherapy, surgical resection or chemotherapy: a quantitative evaluation. Cancer Lett. 2001 Jun 26;167(2):183-91. doi: 10.1016/s0304-3835(01)00455-4.


title: Evaluation of Low-energy Laser Therapy for Prevention and Reduction of Severity of Oral Mucositis in Children "Mucositis Laser 1"

summary: Oral mucositis represents a major complication of cytotoxic chemotherapy among cancer in children. Low-power laser therapy (LPLT) has been used to reduce the incidence of oral mucositis in patients who are receiving high-dose chemotherapy. The aim of this study is to compare two preventives energies delivered of LPLT to oral mucosa in decreasing the severity of mucositis in children.

collaborators: Centre Régional de Cancérologie et Thérapie Cellulaire Pédiatrique, CHU de Clermont-Ferrand

collaborators: Faculté de chirurgie dentaire, Clermont-Ferrand

collaborators: Centre de Pharmacologie Clinique, INSERM CIC 501

collaborators: Laboratoire des Matériaux Inorganiques, ESA CNRS 6002 et ENSCCF, Université Blaise-Pascal, Aubière


title: Sevoflurane Versus Propofol for Intubation in Neonatal Intensive Care

summary:
Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with high morbidity.

The aim of the study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study

summary: This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.

ReferenceCitation: Lilot M, Meuret P, Bouvet L, Caruso L, Dabouz R, Deleat-Besson R, Rousselet B, Thouverez B, Zadam A, Allaouchiche B, Boselli E. Hypobaric spinal anesthesia with ropivacaine plus sufentanil for traumatic femoral neck surgery in the elderly: a dose-response study. Anesth Analg. 2013 Jul;117(1):259-64. doi: 10.1213/ANE.0b013e31828f29f8. Epub 2013 Apr 16.

lead_sponsor: Hospices Civils de Lyon


title: A Feasibility Study for Daily Use of a Brain Computer Interface for Communication in an ICU

summary: The main objective of this study is to evaluate the usability of a system to assist verbal communication based on BCI system using the P300 wave in patients with tetraplegia who can no longer communicate because of severe engine damage (tetraplegia) and respiratory damage requiring invasive mechanical ventilation (intubation or tracheostomy) preventing verbal communication.

lead_sponsor: University of Versailles

location_facility: Service de reanimation, Hopital Raymond Poincare


title: Double-Blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Cyclosporine on Different Markers of Cardiac Ischemia Led by the Aortic Cross-clamp During Coronary Artery Bypass Surgery With Cardiopulmonary Bypass.

acronym: Ciclo et CEC

summary: Observe the effect of preliminary cyclosporine administration on different markers of cardiac ischaemia led by the aortic cross-clamp during coronary artery bypass surgery with Cardiopulmonary bypass.

ReferenceCitation: Crompton M. The mitochondrial permeability transition pore and its role in cell death. Biochem J. 1999 Jul 15;341 ( Pt 2)(Pt 2):233-49.

ReferenceCitation: Halestrap AP, Clarke SJ, Javadov SA. Mitochondrial permeability transition pore opening during myocardial reperfusion--a target for cardioprotection. Cardiovasc Res. 2004 Feb 15;61(3):372-85. doi: 10.1016/S0008-6363(03)00533-9.

ReferenceCitation: Hausenloy DJ, Duchen MR, Yellon DM. Inhibiting mitochondrial permeability transition pore opening at reperfusion protects against ischaemia-reperfusion injury. Cardiovasc Res. 2003 Dec 1;60(3):617-25. doi: 10.1016/j.cardiores.2003.09.025.

ReferenceCitation: Shanmuganathan S, Hausenloy DJ, Duchen MR, Yellon DM. Mitochondrial permeability transition pore as a target for cardioprotection in the human heart. Am J Physiol Heart Circ Physiol. 2005 Jul;289(1):H237-42. doi: 10.1152/ajpheart.01192.2004.

ReferenceCitation: Piot C, Croisille P, Staat P, Thibault H, Rioufol G, Mewton N, Elbelghiti R, Cung TT, Bonnefoy E, Angoulvant D, Macia C, Raczka F, Sportouch C, Gahide G, Finet G, Andre-Fouet X, Revel D, Kirkorian G, Monassier JP, Derumeaux G, Ovize M. Effect of cyclosporine on reperfusion injury in acute myocardial infarction. N Engl J Med. 2008 Jul 31;359(5):473-81. doi: 10.1056/NEJMoa071142.

location_facility: Department of cardiac surgery - University Hospital of Grenoble


title: A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator

acronym: PERLE

summary: To evaluate the clinical impact of an online video simulator during the learning period of laparoscopic radical prostatectomy.

status: Suspended


title: Genetic Study of Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy

acronym: DVDA

summary: The purpose of this trial is to study the genetic and phenotypic aspects of Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C), and determine the impact of genetic testing in clinical practice.


title: High Dose of Erythropoietin Analogue After Cardiac Arrest: a Multicentre, Randomised, Controlled Trial (Epo-ACR-02 Trial)

summary: The investigators hypothesised that the neuroprotective effects of erythropoietin and its analogues could lead to an improve outcome after cardiac arrest. To test this hypotheses, the investigators designed a randomized, multicentre, simple blind trial in which all participating patients will be receive usual treatments and 50% of them will also receive a high dose of epoetin alpha (an analogue of erythropoietin) in an "add on" fashion. The main end point will be the proportion of patients in each arm who will reach at day 60 the best level of recovery, using a 5 level score.

ReferenceCitation: Madelaine T, Cour M, Roy P, Vivien B, Charpentier J, Dumas F, Deye N, Bonnefoy E, Gueugniaud PY, Coste J, Cariou A, Argaud L. Prediction of Brain Death After Out-of-Hospital Cardiac Arrest: Development and Validation of the Brain Death After Cardiac Arrest Score. Chest. 2021 Jul;160(1):139-147. doi: 10.1016/j.chest.2021.01.056. Epub 2021 Jun 8.

ReferenceCitation: Boissady E, Kohlhauer M, Lidouren F, Hocini H, Lefebvre C, Chateau-Jouber S, Mongardon N, Deye N, Cariou A, Micheau P, Ghaleh B, Tissier R. Ultrafast Hypothermia Selectively Mitigates the Early Humoral Response After Cardiac Arrest. J Am Heart Assoc. 2020 Dec;9(23):e017413. doi: 10.1161/JAHA.120.017413. Epub 2020 Nov 17.

ReferenceCitation: Cariou A, Deye N, Vivien B, Richard O, Pichon N, Bourg A, Huet L, Buleon C, Frey J, Asfar P, Legriel S, Narcisse S, Mathonnet A, Cravoisy A, Dequin PF, Wiel E, Razazi K, Daubin C, Kimmoun A, Lamhaut L, Marx JS, de la Garanderie DP, Ecollan P, Combes A, Spaulding C, Barat F, Ben Boutieb M, Coste J, Chiche JD, Pene F, Mira JP, Treluyer JM, Hermine O, Carli P; Epo-ACR-02 Study Group. Early High-Dose Erythropoietin Therapy After Out-of-Hospital Cardiac Arrest: A Multicenter, Randomized Controlled Trial. J Am Coll Cardiol. 2016 Jul 5;68(1):40-9. doi: 10.1016/j.jacc.2016.04.040.

location_facility: Medical intensive care unit of Cochin-St Vincent de Paul university Hospital


title: Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function

summary: The goal of this study is to evaluate the effect of N-acetyl-cysteine (NAC) administration in organ donors on the kidney graft function of recipients.

ReferenceCitation: Orban JC, Quintard H, Cassuto E, Jambou P, Samat-Long C, Ichai C. Effect of N-acetylcysteine pretreatment of deceased organ donors on renal allograft function: a randomized controlled trial. Transplantation. 2015 Apr;99(4):746-53. doi: 10.1097/TP.0000000000000395.

evidence: open (via page says license)

license: unspecified-oa

license_normalized: unspecified-oa

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes


title: Phase 2 Study of Oral AB1010 in Non Pre-treated, Inoperable Patients With Locally Advanced/Metastatic Gastro-intestinal Stromal Tumour (GIST)

summary: The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.

ReferenceCitation: Le Cesne A, Blay JY, Bui BN, Bouche O, Adenis A, Domont J, Cioffi A, Ray-Coquard I, Lassau N, Bonvalot S, Moussy A, Kinet JP, Hermine O. Phase II study of oral masitinib mesilate in imatinib-naive patients with locally advanced or metastatic gastro-intestinal stromal tumour (GIST). Eur J Cancer. 2010 May;46(8):1344-51. doi: 10.1016/j.ejca.2010.02.014. Epub 2010 Mar 6.

lead_sponsor: AB Science


title: Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.

summary: The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommendation for subsequent phase II trials in patients with metastatic cancer.

ReferenceCitation: Bahleda R, Hollebecque A, Varga A, Gazzah A, Massard C, Deutsch E, Amellal N, Farace F, Ould-Kaci M, Roux F, Marzin K, Soria JC. Phase I study of afatinib combined with nintedanib in patients with advanced solid tumours. Br J Cancer. 2015 Nov 17;113(10):1413-20. doi: 10.1038/bjc.2015.374. Epub 2015 Oct 29.

lead_sponsor: Boehringer Ingelheim

location_facility: 1239.14.3301A Boehringer Ingelheim Investigational Site


title: Major Depression and Messenger RNAs

summary: Major Depressive Episode (MDE) affects nearly 15% of the general population. In a preliminary study, the investigators identified 12 genes whose expression was either altered between patient and control samples and/or between first patient samples and samples from the same patients obtained 8 weeks later. However, this study did not assess evolution of these alterations beyond an 8-week window and only 2 time points were considered. The investigators aim to compare gene expression difference for 21 candidate genes, of which 12 were already investigated, in 2 groups of subjects. MDE and control samples will be analyzed across a large time window to draw a better picture of the complex progression during MDE.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique-Hôpitaux de Marseille


title: Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort

acronym: NUMEVOX

summary: The NUMEVOX cohort is intended to follow-up the macro and microvascular dysfunction in relation to adipose tissue repartition in patients with metabolic syndrome associated to liver steatosis, sleep apnea. Duration of the follow-up is 3 years for each patient entering the cohort.

lead_sponsor: University Hospital, Angers

location_facility: Pôle Maladies Métaboliques et Médecine Interne


title: Effect of Preventive Sodium Lactate Infusion on Intracranial Hypertension in Severe Trauma Tic Brain Injury

summary: The goal of this study is to evaluate the effect of preventive intravenous infusion of half molar sodium lactate on the onset of hypertensive intracranial episodes in severe head trauma. The investigators hypothesize that preventive intravenous administration of sodium lactate will decrease the number of treatments required to decrease intracranial pressure during 48 hours.

ReferenceCitation: Ichai C, Armando G, Orban JC, Berthier F, Rami L, Samat-Long C, Grimaud D, Leverve X. Sodium lactate versus mannitol in the treatment of intracranial hypertensive episodes in severe traumatic brain-injured patients. Intensive Care Med. 2009 Mar;35(3):471-9. doi: 10.1007/s00134-008-1283-5. Epub 2008 Sep 20.

collaborators:
Université de Nice Sophia Antipolis
Medical University of Grenoble

sponsor_collaborators: Institut d'Anesthesiologie des Alpes Maritimes

location_facility: Institut d'Anesthesiologie des Alpes maritimes


title: Comparison of 20-core vs 12-core Prostate Biopsy Diagnostic Performance in the Detection of Prostate Cancer

summary: The optimal number of prostate cores extracted during a prostate biopsy performed because of a suspected prostate cancer is still debated. The present consensus is to sample 12 cores. However, recent data published in the literature brought arguments in favour of a higher number, probably 20. This would have the advantages of decreasing the false negatives and the re-biopsy rate.

ReferenceCitation: Irani J, Blanchet P, Salomon L, Coloby P, Hubert J, Malavaud B, Mottet N. Is an extended 20-core prostate biopsy protocol more efficient than the standard 12-core? A randomized multicenter trial. J Urol. 2013 Jul;190(1):77-83. doi: 10.1016/j.juro.2012.12.109. Epub 2013 Jan 9.

lead_sponsor: Poitiers University Hospital

location_facility: service d'Urologie - CHU de Poitiers - 2 rue de la Milétrie


title: Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).

summary: The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.

lead_sponsor: Bioxtract SA

sponsor_collaborators:
Bioxtract SA
Nukleus


title: A Phase 1, Multi-center, Randomized, Double-Blind, Placebo-controlled, Dose-escalation Safety Assessment Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients

summary: Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).

lead_sponsor: Idera Pharmaceuticals, Inc.


summary:
Rett syndrome is a neurodevelopmental disorder characterized by cognitive impairment, communication dysfunction, stereotypic movement disorder, and growth failure. Rett syndrome is caused by mutations in the Methyl CpG-Binding Protein-2 (MECP2) gene and has no treatment.

A mouse experimental model of Rett syndrome created by genetic invalidation of the MECP2 gene is available. It had been then observed that adult MECP2-deficient mice show respiratory alterations and found that endogenous noradrenaline helps to maintain a normal respiratory rhythm. Desipramine, a selective inhibitor of norepinephrine reuptake, seems to be efficient to reduce the respiratory alteration occuring in MECP2-deficient mice (Insem patent 2005, Villard and Roux 2006).

The aim of the study is to evaluate these obtained results in MECP2-deficient mice on patients with Rett syndrome.

ReferenceCitation: Mancini J, Dubus JC, Jouve E, Roux JC, Franco P, Lagrue E, Castelnau P, Cances C, Chaix Y, Rougeot-Jung C, Cornu C, Desportes V, Vallee L, Bahi-Buisson N, Truillet R, Attolini L, Villard L, Blin O, Micallef J. Effect of desipramine on patients with breathing disorders in RETT syndrome. Ann Clin Transl Neurol. 2017 Dec 27;5(2):118-127. doi: 10.1002/acn3.468. eCollection 2018 Feb.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

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

location_facility: Assistance Publique - Hopitaux de Marseille

title: Pilot Study of the Effects of the Desipramine on the Neurovegetative Parameters of the Child With Rett Syndrome


title: Impact of Neuropathic Post-zosterian Pain on the Cognition (NPZ and Cognition)

summary: Pain is defined as a sensorial and emotional phenomenon and lead consequences on the cognition. These consequences could be increased with usual treatment. So the aim of this study is to explore these cognitive consequences.

ReferenceCitation: Pickering G, Pereira B, Clere F, Sorel M, de Montgazon G, Navez M, Picard P, Roux D, Morel V, Salimani R, Adda M, Legout V, Dubray C. Cognitive function in older patients with postherpetic neuralgia. Pain Pract. 2014 Jan;14(1):E1-7. doi: 10.1111/papr.12079. Epub 2013 May 23.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.

acronym: BIP-ED

summary: This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Specifically, this project aims to assess neurophysiological (fMRI - activation and functional connectivity) and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar disorders and the therapeutic response to the psychoeducation. The results of this thesis project would also contribute to the validation of a pathophysiological model of the bipolar disorder.

ReferenceCitation: Favre P, Polosan M, Pichat C, Bougerol T, Baciu M. Cerebral Correlates of Abnormal Emotion Conflict Processing in Euthymic Bipolar Patients: A Functional MRI Study. PLoS One. 2015 Aug 5;10(8):e0134961. doi: 10.1371/journal.pone.0134961. eCollection 2015.

repository_institution: Max Planck Society - MPG.PuRe

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution:
Max Planck Society - MPG.PuRe
PubMed Central - Europe PMC

lead_sponsor: University Hospital, Grenoble


title: Randomised Multicenter Trial of Early EUS Followed by Endoscopic Sphincterotomy in Case of Bile Duct Stone vs Conservative Treatment in Severe Biliary Pancreatitis

summary: The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Is Access to Liver Transplantation Similar in Alcoholic or Not Patients? A Prospective Cohort Study

acronym: TRANSALC

summary: The purpose of this study is to determine whether there are reasons other than medical reasons that could limit access to liver transplantation in alcoholic patients.

ReferenceCitation: Perut V, Conti F, Scatton O, Soubrane O, Calmus Y, Vidal-Trecan G. Might physicians be restricting access to liver transplantation for patients with alcoholic liver disease? J Hepatol. 2009 Oct;51(4):707-14. doi: 10.1016/j.jhep.2009.04.018. Epub 2009 May 28.

ReferenceCitation: Cohen C, Benjamin M. Alcoholics and liver transplantation. The Ethics and Social Impact Committee of the Transplant and Health Policy Center. JAMA. 1991 Mar 13;265(10):1299-301. doi: 10.1001/jama.265.10.1299.

ReferenceCitation: Lucey MR, Beresford TP. Alcoholic liver disease: to transplant or not to transplant? Alcohol Alcohol. 1992 Mar;27(2):103-8.

ReferenceCitation: Ubel PA. Transplantation in alcoholics: separating prognosis and responsibility from social biases. Liver Transpl Surg. 1997 May;3(3):343-6.

ReferenceCitation: Vidal-Trecan G, Kone V, Pilette C, Nousbaum JB, Doll J, Buffet C, Eugene C, Podevin P, Boutet O, Puyeo J, Conti F, Calmus Y. Subjective parameters markedly limit the referral of transplantation candidates to liver transplant centres. Liver Int. 2016 Apr;36(4):555-62. doi: 10.1111/liv.13030. Epub 2015 Dec 21.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Saint Antoine Hospital (Pr Yvon Camus)


title: Efficacy and Pharmacokinetic/Pharmacodynamic Parameters of Cefoxitin in Women With Acute Pyelonephritis Without Severity Symptoms Due to Extended-spectrum β-lactamase Producing Escherichia Coli.

acronym: FOXICOLI

summary: Escherichia coli is the primary cause of urinary tract infections and Gram-negative bacteremia worldwide. Since the early years of the 21st century, E.coli has acquired a new mechanism of resistance to antibiotics: extended spectrum β-lactamase (ESBL), type CTX-M. These ESBL inactivate most β-lactams, the preferred class of antibiotics for the treatment of severe E.coli infections. Moreover, the strains that produce these ESBL are often resistant to other classes of antibiotics. Their rapid spread constitutes a major public health concern because of a serious risk of therapeutic impasse. Treatment options in cases of infection with ESBL-producing E.coli are often limited to carbapenems, a class of more recently developed β-lactams. Carbapenems have a very wide spectrum of activity but their effectiveness is threatened by the emergence of strains producing carbapenemases. The development of therapeutic alternatives to treat ESBL-producing E.coli infections is therefore essential. Cephamycins, including cefoxitin, are β-lactams marketed in the seventies but their use was practically abandoned when wide spectrum antibiotics became available. They are distinguished by the presence of an α-methoxy group in position 7 which interferes with the action of the extended-spectrum β-lactamase and renders it ineffective against cephamycins. Cefoxitin is therefore active in vitro against ESBL-producing E.coli and offers the advantage of a narrower antibacterial spectrum, thus reducing the selection pressure and the emergence of resistance. However, the in vivo activity of cefoxitin for the treatment of ESBL-producing E.coli infections has never been measured. Furthermore, available pharmacokinetic and pharmacodynamic (PK/PD) data for cefoxitin are dated and incomplete, which raises many questions concerning the optimal dosage regimen. We have shown in a mouse model of ESBL-producing E. coli CTX-M pyelonephritis that cefoxitin efficacy is comparable to that of carbapenems without selecting resistant mutants. Cefoxitin could thus constitute an alternative to carbapenems for the treatment of pyelonephritis caused by ESBL-producing E.coli.


title: Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.

acronym: ECAD-HF

summary:
After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome.

This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.

location_facility: Service de Cardiologie - Hopital Lariboisière


title: Efficacy of Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin. A Multi-center Randomized Controlled Study

acronym: TERAS

summary: Ascites is a common complication of cirrhosis. Sodium restriction and diuretics are the first step treatment. Refractory ascites (not responding to first step treatment) is treated with repeated large volume paracentesis followed by intra venous albumin expansion. In pilot studies vasoconstrictor agents such as terlipressin have shown beneficial effect on ascites production. Therefore the investigators will study the effect of combined therapy with albumin and terlipressin on recidivation ascites.

ReferenceCitation: Runyon BA. Management of adult patients with ascites caused by cirrhosis. Hepatology. 1998 Jan;27(1):264-72. doi: 10.1002/hep.510270139.

ReferenceCitation: Gines P, Quintero E, Arroyo V, Teres J, Bruguera M, Rimola A, Caballeria J, Rodes J, Rozman C. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987 Jan-Feb;7(1):122-8. doi: 10.1002/hep.1840070124.

ReferenceCitation: Moore KP, Wong F, Gines P, Bernardi M, Ochs A, Salerno F, Angeli P, Porayko M, Moreau R, Garcia-Tsao G, Jimenez W, Planas R, Arroyo V. The management of ascites in cirrhosis: report on the consensus conference of the International Ascites Club. Hepatology. 2003 Jul;38(1):258-66. doi: 10.1053/jhep.2003.50315.

ReferenceCitation: Gines A, Fernandez-Esparrach G, Monescillo A, Vila C, Domenech E, Abecasis R, Angeli P, Ruiz-Del-Arbol L, Planas R, Sola R, Gines P, Terg R, Inglada L, Vaque P, Salerno F, Vargas V, Clemente G, Quer JC, Jimenez W, Arroyo V, Rodes J. Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. Gastroenterology. 1996 Oct;111(4):1002-10. doi: 10.1016/s0016-5085(96)70068-9.

ReferenceCitation: Ruiz-del-Arbol L, Monescillo A, Jimenez W, Garcia-Plaza A, Arroyo V, Rodes J. Paracentesis-induced circulatory dysfunction: mechanism and effect on hepatic hemodynamics in cirrhosis. Gastroenterology. 1997 Aug;113(2):579-86. doi: 10.1053/gast.1997.v113.pm9247479.

ReferenceCitation: Gines P, Tito L, Arroyo V, Planas R, Panes J, Viver J, Torres M, Humbert P, Rimola A, Llach J, et al. Randomized comparative study of therapeutic paracentesis with and without intravenous albumin in cirrhosis. Gastroenterology. 1988 Jun;94(6):1493-502. doi: 10.1016/0016-5085(88)90691-9.

ReferenceCitation: Moreau R, Lebrec D. The use of vasoconstrictors in patients with cirrhosis: type 1 HRS and beyond. Hepatology. 2006 Mar;43(3):385-94. doi: 10.1002/hep.21094.

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