title: Impact of Fecal transPlantAtion on MiCrobotia and hosT in Crohn's Disease

acronym: IMPACT-Crohn

summary: Crohn's disease is a chronic and relapsing inflammatory bowel disease. Many data show that the intestinal flora is involved in the disease and it has been show that patients with Crohn's disease exhibit an abnormal fecal flora that might play a role in inflammation. The purpose of this study is to determine the effect of the fecal flora transplantation on Crohn's disease.

ReferenceCitation: Sokol H, Landman C, Seksik P, Berard L, Montil M, Nion-Larmurier I, Bourrier A, Le Gall G, Lalande V, De Rougemont A, Kirchgesner J, Daguenel A, Cachanado M, Rousseau A, Drouet É, Rosenzwajg M, Hagege H, Dray X, Klatzman D, Marteau P; Saint-Antoine IBD Network, Beaugerie L, Simon T. Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. Microbiome. 2020 Feb 3;8(1):12. doi: 10.1186/s40168-020-0792-5.

family: Sokol

full_name: Harry Sokol

given: Harry

family: Landman

full_name: Cecilia Landman

given: Cecilia

family: Seksik

full_name: Philippe Seksik

given: Philippe

family: Berard

full_name: Laurence Berard

given: Laurence

family: Montil

full_name: Mélissa Montil

given: Mélissa

family: Nion-Larmurier

full_name: Isabelle Nion-Larmurier

given: Isabelle

family: Bourrier

full_name: Anne Bourrier

given: Anne

family: Le Gall

full_name: Guillaume Le Gall

given: Guillaume

family: Lalande

full_name: Valérie Lalande

given: Valérie

family: De Rougemont

full_name: Alexis De Rougemont

given: Alexis

family: Kirchgesner

full_name: Julien Kirchgesner

given: Julien

family: Daguenel

full_name: Anne Daguenel

family: Cachanado

full_name: Marine Cachanado

given: Marine

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

family: Drouet

full_name: Élodie Drouet

given: Élodie

family: Rosenzwajg

full_name: Michelle Rosenzwajg

given: Michelle

family: Hagege

full_name: Hervé Hagege

given: Hervé

family: Dray

full_name: Xavier Dray

given: Xavier

family: Klatzman

full_name: David Klatzman

given: David

family: Marteau

full_name: Philippe Marteau

family: Beaugerie

full_name: Laurent Beaugerie

given: Laurent

family: Simon

full_name: Tabassome Simon

given: Tabassome

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

title: Fecal microbiota transplantation to maintain remission in Crohn’s disease: a pilot randomized controlled study

location_facility: Gastroenterology department, Saint Antoine Hospital


type: Other Identifier

title: Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury

summary: This prospective study focuses on the interest of the echocardiography for cirrhotic patients, who present acute kidney injury corresponding to the criteria of hepatorenal syndrome. This echocardiography will be done before the volemic expansion and the final diagnostic of hepatorenal syndrome or prerenal azotemia. The primary endpoint is to describe the hemodynamic characteristics of this population at the time of acute kidney injury and their association with diagnostic of hepatorenal syndrome or prerenal azotemia. Patients with elevated filling pressure, predicting poor outcome of volemic expansion will be excluded of the study after the echocardiography and will not undergo volemic expansion but appropriate management.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix-Rousse

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


summary: Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM

status: Unknown status

design_allocation: Randomized

lead_sponsor: Lionel Bouvet

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: Efficacy of Facilited Tucking and Non-nutritive Sucking of Sterile Water to Relieve Preterm Infants From Pain During Heel-stick Procedures.

acronym: BABYDOUL

summary: Preterm infants undergo very frequent painful procedures during neonatal care particularly during the first few days. The support for the pain of the preterm is a priority for nurses and neonatologists. Previous studies showed that non-nutritive sucking combined with sucrose ensures effective pain-relief for preterm (28-32 weeks GA). Unfortunately, the use of sucrose is limited to 4 administrations per day which is insufficient compared to the average of daily painful procedures. So, validation of an effective non-pharmacological intervention to relieve or avoid pain is essential. Facilitated tucking alone has been validated for preterm less than 37 GA during heel stick procedure with the PIPP score but no study looks for the benefit for pain relief of the association of non-nutritive sucking and facilitated tucking during heel stick procedure.

primary_purpose: Prevention

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other


title: Phase II Randomised Study Comparing the Tolerance of PICC Line (Peripherally Inserted Central Catheter) and Implanted Port for Adjuvant Chemotherapy in HER2-negative Early Breast Cancer

acronym: EPIC

summary:
Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (>6 months) a port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients.

The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.

study_completion_date_type: Anticipated

primary_purpose: Supportive Care

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Lefebvre L, Noyon E, Georgescu D, Proust V, Alexandru C, Leheurteur M, Thery JC, Savary L, Rigal O, Di Fiore F, Veyret C, Clatot F. Port catheter versus peripherally inserted central catheter for postoperative chemotherapy in early breast cancer: a retrospective analysis of 448 patients. Support Care Cancer. 2016 Mar;24(3):1397-403. doi: 10.1007/s00520-015-2901-8. Epub 2015 Sep 5.

family: Lefebvre

full_name: L. Lefebvre

given: L.

sequence: first

family: Noyon

full_name: E. Noyon

given: E.

sequence: additional

family: Georgescu

full_name: D. Georgescu

given: D.

family: Proust

full_name: V. Proust

given: V.

family: Alexandru

full_name: C. Alexandru

given: C.

family: Leheurteur

full_name: M. Leheurteur

given: M.

family: Thery

full_name: J. C. Thery

given: J. C.

family: Savary

full_name: L. Savary

family: Rigal

full_name: O. Rigal

given: O.

family: Di Fiore

full_name: F. Di Fiore

given: F.

family: Veyret

full_name: C. Veyret

family: Clatot

full_name: F. Clatot

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Supportive Care in Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Henri Becquerel


title: A Randomized, Open Label, Multicenter, Comparative Phase II Trial of Ipilimumab After Isolated Limb Perfusion (ILP), in Patients With In-transit Metastases Melanoma Stage IIIB and IIIC

acronym: ILP+/-IPI

summary: Isolated limb perfusion (ILP) results in good response rates for locally advanced melanoma (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the progression free survival for the patients having an adjuvant treatment by Ipilimumab in this patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at least a doubling of this period would be a clinically highly significant result.

primary_purpose: Treatment

ReferenceCitation: Tulokas SKA, Kohtamäki LM, Mäkelä SP, Juteau S, Albäck A, Vikatmaa PJ, Mattila KE, Skyttä TK, Koivunen JP, Tyynelä-Korhonen K, Hernberg MM. Isolated limb perfusion with melphalan as treatment for regionally advanced melanoma of the limbs: results of 60 patients treated in Finland during 2007-2018. Melanoma Res. 2021 Oct 1;31(5):456-463. doi: 10.1097/CMR.0000000000000755.

family: Tulokas

full_name: Sanni K. A. Tulokas

given: Sanni K. A.

family: Kohtamäki

full_name: Laura M. Kohtamäki

given: Laura M.

family: Mäkelä

full_name: Siru P. Mäkelä

given: Siru P.

family: Juteau

full_name: Susanna Juteau

given: Susanna

family: Albäck

full_name: Anders Albäck

given: Anders

family: Vikatmaa

full_name: Pirkka J. Vikatmaa

given: Pirkka J.

family: Mattila

full_name: Kalle E. Mattila

given: Kalle E.

family: Skyttä

full_name: Tanja K. Skyttä

given: Tanja K.

family: Koivunen

full_name: Jussi P. Koivunen

given: Jussi P.

family: Tyynelä-Korhonen

full_name: Kristiina Tyynelä-Korhonen

given: Kristiina

family: Hernberg

full_name: Micaela M. Hernberg

given: Micaela M.

journal_name: Melanoma Research

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris

intervention_type: Drug


title: Effects of Decrease in Cholesterol Levels Induced by a Statin on Sperm Quality

summary:
Recently, concerns about the effect of atorvastatin intake on men fertility have been raised. However, this statin has never been investigated regarding its influence on male fertility, notably sperm quality.

The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of cholesterol blood levels, induced by taking atorvastatin, on sperm quality of normocholesterolaemic and healthy men without confounding factors.

design_allocation: Non-Randomized

ReferenceCitation: Pons-Rejraji H, Brugnon F, Sion B, Maqdasy S, Gouby G, Pereira B, Marceau G, Gremeau AS, Drevet J, Grizard G, Janny L, Tauveron I. Evaluation of atorvastatin efficacy and toxicity on spermatozoa, accessory glands and gonadal hormones of healthy men: a pilot prospective clinical trial. Reprod Biol Endocrinol. 2014 Jul 12;12:65. doi: 10.1186/1477-7827-12-65.

family: Pons-Rejraji

full_name: Hanae Pons-Rejraji

given: Hanae

family: Brugnon

full_name: Florence Brugnon

given: Florence

family: Sion

full_name: Benoit Sion

given: Benoit

family: Maqdasy

full_name: Salwan Maqdasy

given: Salwan

family: Gouby

full_name: Gerald Gouby

given: Gerald

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Marceau

full_name: Geoffroy Marceau

given: Geoffroy

family: Gremeau

full_name: Anne-Sophie Gremeau

given: Anne-Sophie

family: Drevet

full_name: Joel Drevet

given: Joel

family: Grizard

full_name: Genevieve Grizard

given: Genevieve

family: Janny

full_name: Laurent Janny

given: Laurent

family: Tauveron

full_name: Igor Tauveron

given: Igor

currency_apc_doaj: GBP

journal_name: Reproductive Biology and Endocrinology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

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

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: University Hospital, Clermont-Ferrand


title: Health Benefits of a 6-month Brisk Walking Program in Sedentary Postmenopausal Women : a Randomized Controlled Trial

acronym: ACTIMARCH

summary:
Community-dwelling women aged 55 or over are recruited at public meetings aimed at promoting physical activity in postmenopausal women. Women are eligible and enrolled in the study if they have no significant disease affecting lower limb function and if they have a sedentary lifestyle. All study participants provide written informed consent to participate to the study.

Women are then randomized either to the control group (women have to maintain their lifestyle) or to the exercise group : 40 minutes of brisk walking 3d/wk for 6 months (two supervised sessions and one session performed one their own per week with a detailed program). The intensity of the program is adapted to the heart rate work and gradually increases over the 6-month program. The objective of the study is to determine the health benefits of brisk on walking ability, diet, muscle strength, balance, blood pressure, bone density, body weight, lean and fat mass, depression symptoms, behavioral, emotional responses, sleep quality, and biological indicators of health.

lead_sponsor: University Hospital, Montpellier


title: Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer : a Qualitative Analysis

acronym: DECIDEO

summary: The aim of this study is to assess the impact of a decision aid leaflet on the participation of women invited to participate in the French national breast cancer screening program.

ReferenceType: background

ReferenceCitation: Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.

ReferenceCitation: Olsson S, Andersson I, Karlberg I, Bjurstam N, Frodis E, Håkansson S. Implementation of service screening with mammography in Sweden: from pilot study to nationwide programme. J Med Screen. 2000;7(1):14-8.

ReferenceCitation: Walter LC, Lewis CL. Maximizing informed cancer screening decisions. Arch Intern Med. 2007 Oct 22;167(19):2027-8.

ReferenceCitation: Raffle AE. Informed participation in screening is essential. BMJ. 1997 Jun 14;314(7096):1762-3.

ReferenceCitation: Barratt A, Trevena L, Davey HM, McCaffery K. Use of decision aids to support informed choices about screening. BMJ. 2004 Aug 28;329(7464):507-10. Review.

ReferenceCitation: Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. Epub 2006 Aug 14.

ReferenceCitation: Mathieu E, Barratt A, Davey HM, McGeechan K, Howard K, Houssami N. Informed choice in mammography screening: a randomized trial of a decision aid for 70-year-old women. Arch Intern Med. 2007 Oct 22;167(19):2039-46.

ReferenceCitation: Edwards A, Unigwe S, Elwyn G, Hood K. Effects of communicating individual risks in screening programmes: Cochrane systematic review. BMJ. 2003 Sep 27;327(7417):703-9. Review.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Single-dose and Steady-state Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects

summary: The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.

lead_sponsor: Bial - Portela C S.A.


type: EudraCT Number

title: A Two-part Phase I Study Composed of a Randomized, Double-blind, 4-parallel Group Study to Evaluate the Effect of Multiple Oral Doses of GFT505 on the QT/QTc Interval Compared to Placebo With Moxifloxacin (400 mg in Single Oral Dose) as a Positive Control, in Healthy Male and Female Volunteers, Preceded by a Double-blind, Placebo-controlled, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Volunteers in Order to Define the Supra-therapeutic GFT505 Dose in a Multiple Dosing Regimen.

summary:
In accordance with International Conference on Harmonisation (ICH) E14 guidelines, this Phase I thorough QT (TQT) study will assess the arrhythmogenic potential of GFT505, by evaluating its effect on QT/QTc prolongation in healthy male and female subjects. According to the guidelines, such studies should typically be performed at the expected therapeutic dose and a supra-therapeutic dose that is 3-4-fold higher than the therapeutic dose.

GFT505 has previously been tested at 240 mg/d in 14-day multiple administration to healthy overweight subjects (study GFT505-111-7), and both safety and tolerability were very good. However, this dose corresponds to only 2-fold the expected therapeutic dose of 120 mg/d. Therefore, the current TQT study will be preceded by a multiple ascending dose study in which the safety and tolerability of 2 dose levels of GFT505 (300 and 360 mg) corresponding to 2.5 and 3 times the expected therapeutic dose will be evaluated. The highest dose level for which safety and tolerability are considered satisfactory will be the supra-therapeutic dose used in the TQT study.

lead_sponsor: Genfit


title: ULtrasound Imaging in Focal Cortical dYSplasia: a New Approach to Delineating the Dysplastic Cortex During Neurosurgery

acronym: ULYS

summary: High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery (ULYS)

status: Terminated

ReferenceType: result

ReferenceCitation: Mellerio C, Labeyrie MA, Chassoux F, Roca P, Alami O, Plat M, Naggara O, Devaux B, Meder JF, Oppenheim C. 3T MRI improves the detection of transmantle sign in type 2 focal cortical dysplasia. Epilepsia. 2014 Jan;55(1):117-22. doi: 10.1111/epi.12464. Epub 2013 Nov 15.

name: Department of Neuroimaging; Sainte-Anne Hospital Center; Paris Descartes Sorbonne Paris Cité University; Paris France

family: Mellerio

full_name: Charles Mellerio

given: Charles

family: Labeyrie

full_name: Marc-Antoine Labeyrie

given: Marc-Antoine

name: Department of Neurosurgery; Sainte-Anne Hospital Center; Paris Descartes Sorbonne Paris Cité University; Paris France

family: Chassoux

full_name: Francine Chassoux

given: Francine

family: Roca

full_name: Pauline Roca

given: Pauline

name: Department of Imaging; Le Mans Hospital Center; France

family: Alami

full_name: Odile Alami

given: Odile

family: Plat

full_name: Monique Plat

given: Monique

family: Naggara

full_name: Olivier Naggara

given: Olivier

family: Devaux

full_name: Bertrand Devaux

given: Bertrand

family: Meder

full_name: Jean-François Meder

given: Jean-François

family: Oppenheim

full_name: Catherine Oppenheim

given: Catherine

journal_name: Epilepsia

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Mellerio C, Labeyrie MA, Chassoux F, Daumas-Duport C, Landre E, Turak B, Roux FX, Meder JF, Devaux B, Oppenheim C. Optimizing MR imaging detection of type 2 focal cortical dysplasia: best criteria for clinical practice. AJNR Am J Neuroradiol. 2012 Nov;33(10):1932-8. doi: 10.3174/ajnr.A3081. Epub 2012 May 3.

full_name: C. Mellerio

given: C.

full_name: M.-A. Labeyrie

full_name: F. Chassoux

given: F.

family: Daumas-Duport

full_name: C. Daumas-Duport

family: Landre

full_name: E. Landre

given: E.

family: Turak

full_name: B. Turak

given: B.

family: Roux

full_name: F.-X. Roux

full_name: J.-F. Meder

full_name: B. Devaux

full_name: C. Oppenheim

publisher: American Society of Neuroradiology (ASNR)

title: Optimizing MR Imaging Detection of Type 2 Focal Cortical Dysplasia: Best Criteria for Clinical Practice


title: Phase II Study Evaluating the Influence of LV5FU2 Bevacizumab Plus Anakinra Association on Vascularization of Liver Metastases of Metastatic Colorectal Cancer: Proof of Concept Study

acronym: IRAFU

summary:
The metastatic colon cancer is a major public health problem despite advances in chemotherapy; few new drugs are in development for the treatment of this pathology.

Many studies have shown that human colon cancer is a tumor that is recognized by the immune system and the presence of lymphocytic infiltrates in the tumor bed is associated with a better prognosis. Conversely, the effect of chemotherapy on the immune response is little studied.

Recently the importance of myeloid suppressor cells (MDSC) in the development of colon cancer and the effect of 5- fluorouracil on this cell population has been highlighted. An accumulation of these cells in the blood and lymphoid organs during tumor progression is observed. Moreover, it has been established that the death of MDSC induced by 5-fluorouracil induces activation of caspase -1 and IL-1beta by these MDSC.

These events promote the polarization of CD4 T cells in intratumoral Th17 lymphocytes. The IL- 17 produced by these cells exerts a pro-angiogenic effect in inducing proliferation of endothelial cells expressing and thus limits the effect of 5- fluorouracil endoglin.

In humans, it has also been observed that chemotherapy using 5- fluorouracil and in particular LV5FU2 association +/- bevacizumab induces rapid death of blood MDSC as well as activation of caspase 1 in these cells. Thus, production of IL - 1 is detected in the serum of patients after 24 hours of the administration of 5-fluorouracil.

Chronic inflammation and the production of interleukin- 1 can alter the effectiveness of anti -tumor immune responses and facilitate angiogenesis. Many preclinical data suggest a role of anti -tumor inhibition of IL- 1beta, but the effect of a combination of chemotherapy and an inhibitor of IL - 1beta has not yet been tested in human.

Anakinra is a drug used in humans for many years to treat signs and symptoms of rheumatoid arthritis. In combination with methotrexate, in patients whose response to methotrexate alone is not satisfactory it had shown interesting results. The dose used clinically is 100 mg per day which is the dose that is proposed to be tested in this study.

In this context it should be remembered that methotrexate is a chemotherapeutic agent from the class of antimetabolites such as 5- fluorouracil.

RCP of this drug indicate that in studies originator toxicity was similar between the control arm and anakinra arm with an increase in serious infections (1.8 % vs 0.7 %) and an increased incidence of neutropenia (2.5 % neutropenia > grade = 1). The main toxicity observed is a painful inflammatory reaction at the injection site in 70 % of patients The investigators believe that this project could permit to validate in man preclinical observations showing an anti-tumor potential for combination anakinra and 5 fluorouracil.

lead_sponsor: Centre Georges Francois Leclerc


summary: The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications

lead_sponsor: Pierre Fabre Medicament


title: Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain

acronym: EGID

summary:
Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects.

In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.

lead_sponsor: University Hospital, Limoges


title: Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment

acronym: STEREO-SEIN

summary:
The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Indeed, there are two different oligometastatic states: "de novo", i.e. occurring at first metastatic presentation without any previous systemic therapy; and "secondary", defined as residual disease after systemic treatment.

The investigators wish to prospectively study the role of metastases SBRT with curative intent in de novo oligometastatic disease.

This clinical trial would be the first randomized study studying SBRT at onset of the metastatic disease. If this trial shows a PFS improvement, it will definitively change the standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).

status: Recruiting

intervention_type: Radiation

status_simplified: Ongoing


title: Safety and Efficacity of Corneal Collagen Crosslinking in Infectious Keratitis (Bacterial and Fungal ): Randomized,Controlled, Prospective Study.

acronym: CXL

summary: The corneal collagen cross linking is currently used in the treatment of keratoconus but this procedure has also a sterilizing non-specific effect on bacteria and fungus. So the corneal cross linking in association with the antibiotic treatment could result in a reduction of the duration of epithelial complete healing of the cornea.

ReferenceCitation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6:CD013001. doi: 10.1002/14651858.CD013001.pub2.

name: Ophthalmology and Ocuplastics Surgery; Cheyenne VA Hospital; Cheyenne Wyoming USA

family: Davis

full_name: Shadi A Davis

given: Shadi A

name: Department of Ophthalmology; Howard University; Washington, DC USA

family: Bovelle

full_name: Renee Bovelle

given: Renee

name: Department of Epidemiology; Johns Hopkins Bloomberg School of Public Health; Baltimore Maryland USA

family: Han

full_name: Genie Han

given: Genie

name: General Clinical Research Center; Howard University; Washington DC USA

family: Kwagyan

full_name: John Kwagyan

given: John

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

lead_sponsor: Nantes University Hospital


title: Development of General Practitioners Screening Tool of Frail Older Old Community-dwellers: a Cohort Population-based Study

acronym: ReperAge

summary:
The comprehensive geriatric assessment (CGA) is a multidimensional, interdisciplinary diagnostic process to determine the medical, psychological, and functional capabilities of an elderly person, in order to develop a coordinated and integrated plan for treatment. It represents the first stage of the most appropriate care for elderly people who are frail or who cannot perform at least three daily tasks unaided.

It has been shown that the integration of CGA in the decision-making and care management at hospital improves inpatient's health and functional status, and reduces mortality rate and healthcare expenditures. The effects of CGA in daily practice of general practitioners remain unknown.

Implementation of a systematic CGA for every older old community-dwellers performed by a general practitioner remains yet difficult because of number of issues. First, although the number of older old community-dwellers keeps increasing, the number of health care professional with geriatric skills does not. Second, CGA is a complex and time-consuming process. Third, CGA requires a multidisciplinary geriatric team that cannot support alone the care of all frail older old community-dwellers due to their limited number. An implication of non-geriatricians in CGA is therefore required.

Recently, it was confirmed that CGA cannot be applied to all older adults, and that the best compromise could be the use of a two-step approach. The first step is the identification by non-geriatricians of elderly inpatients at high risk of adverse outcomes using a screening tool, and the second step is a CGA by geriatricians with a diagnosis purpose.

None of existing tools used for screening is adapted to the population of elderly people who visit general practitioners.Thus, healthcare professionals working in ED need a simple, standardized and brief geriatric assessment (BGA) to identify as soon as possible frail older old community-dwellers requiring specialized geriatric care.

The investigators hypothesized that a BGA older old community-dwellers carried out by a general practitioner could predict the adverse health events (i.e. hospitalization, institutionalisation, medical consultations and death) occurring during a 6-months follow-up period before the evaluation.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Gerontopôle des Pays de la Loire


title: Prognosis Factors of Cardiac Complications After Liver Transplantation

acronym: PROCOM

summary: This is a prospective, multicenter, non-interventional, observational study of a cohort with a biological plasma and urine samples collection for the study of prognosis factors of cardiac complications after liver transplantation

ipd_sharing: No


title: Alcohol Consumption and Stress at Patients Alcohol-dependants

acronym: CASPA

summary: This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design.

location_facility: Hopital Louis Mourier, Service de psychiatrie


title: Dairy Product, Calcium & Vitamin D Supplementation and Cognitive-motor Function

summary:
Gait and posture disorders are very common in subjects aged 65 and over, and result mainly from neuromuscular and cognitive disorders.

Many studies have shown that 1) vitamin D deficiency is very common in women aged 65 and over, 2) individuals with hypovitaminosis D have lower muscle, gait and executive performances and are more prone to fail than individuals with no hypovitaminosis D, 3) the intake of vitamin D combined or not with calcium may improve muscle strength and cognitive performance.

The investigators hypothesized that the daily intake of 2 yogurts containing 200 IU of vitamin D and 400 mg of calcium 1) can improve spatiotemporal gait parameters, posture and executive performance, 2) and that this improvement depends of the initial level of vitamin D deficiency.

lead_sponsor: University Hospital, Angers

location_facility: Centre Hospitalier Universitaire d'Angers

intervention_type: Dietary Supplement


title: Role of Endothelin-1 in Mediating Flow-mediated Dilatation of Conduit Arteries During Sustained Hyperemic Stimulation

acronym: Endothelin

summary: Endothelial dysfunction of conduit arteries contributes to the increased morbidity and cardiovascular mortality in patients with essential hypertension and appears increasingly as an independent therapeutic target. We have shown previously that besides a decrease in the availability of NO and other endothelium-derived vasodilators factors, the epoxyeicosatrienoic acids, an increase in the vasoconstrictor endothelin-1 (ET-1) may play a role in the pathophysiology of this endothelial dysfunction. Indeed, the local concentrations of endothelin-1 during the endothelium-dependent dilation of the radial artery in response to a sustained increase in blood flow decreased significantly in healthy volunteers controls but not in hypertensive patients. This lack of adaptation of the endothelinergic system could be due to a decreased clearance of endothelin-1 by endothelial ETB receptors, potentiating the vasoconstrictor action of endothelin-1 mediated by ETA receptor activation at the muscular level. However, to validate this hypothesis , it is needed to demonstrate the physiological role of ETA receptor and ETB in sustained flow-mediated dilatation of conduit arteries.

lead_sponsor: University Hospital, Rouen


acronym: LOKOMAT

summary: Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. The objective of this study is to assess the effects of gait training in Lokomat on biomecanic gait parameters in stroke patients.

time_perspective: Retrospective

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?

acronym: VesiRop

summary:
Since the recommendations of the French Society of Digestive Surgery 2010, cholecystectomy can be performed as outpatient surgery. This approach is difficult in many centers because of post operative pain and nausea/vomiting.

The use of postoperative morphine may be responsible for the state of nausea. The use of ropivacaine allows a reduction of the morphine consumption and thus may allow the patient to have their surgery as an outpatient.

Currently, ropivacaine is used randomly during the investigators surgeries. Initially, it was used for the infiltration holes trocar. In recent years, ropivacaine is used for the reduction of intra-abdominal postoperative pain. Its use is made of parietal surgery ( hernia ) in cholecystectomy and colonic surgery. This mode of administration is allowed to view the many publications made on this subject. Its use in the investigators daily surgery, however, has not been evaluated in ambulatory surgery.

ReferenceCitation: Abet E, Orion F, Denimal F, Brau-Weber AG, de Kerviler B, Jean MH, Boulanger G, Dimet J, Comy M. Interest of Using Ropivacaine for Outpatient Laparoscopic Cholecystectomy: Prospective Randomized Trial. World J Surg. 2017 Mar;41(3):687-692. doi: 10.1007/s00268-016-3797-2.

family: Abet

full_name: Emeric Abet

given: Emeric

family: Orion

full_name: François Orion

given: François

family: Denimal

full_name: Fabrice Denimal

given: Fabrice

family: Brau-Weber

full_name: Anne-Géraldine Brau-Weber

given: Anne-Géraldine

family: de Kerviler

full_name: Benoît de Kerviler

given: Benoît

family: Jean

full_name: Marc-Henri Jean

given: Marc-Henri

family: Boulanger

full_name: Guillaume Boulanger

given: Guillaume

family: Dimet

full_name: Jérôme Dimet

given: Jérôme

family: Comy

full_name: Michel Comy

given: Michel

journal_name: World Journal of Surgery

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Quantitative and Qualitative MRI Study of Steatosis in Patients With Metabolic Steatopathy

acronym: IRM Stéatose

summary:
This is a single centre prospective open-label, non-randomised pilot study whose aim is to identify MRI parameters to better evaluate inflammation and liver fibrosis and thus, in the near future, to avoid the need for liver biopsy.

To achieve this:

The MRI study will be completed by adding two sequences: Measurement of T1 and multiecho T2*. The other data will be extracted from usual sequences.
Part of the histological samples will be used for the weighted levels of fat and iron, and for the lipidomic study.
Usual blood samples will be completed by samples for the serum library

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Screening for Kyphosis in the Mean Term in Patients Treated With Kyphoplasty Alone in the Management of Stable Traumatic Compression Fractures of the Thoracolumbar Spine

acronym: KIPHO

summary:
The aim of this retrospective study is to show that kyphoplasty is a reliable technique in the treatment of certain traumatic vertebral fractures.

Patients will be selected from medical records archived at the Neuroradiology Department of Dijon CHU.

An information sheet and questionnaire will be sent to patients together with a letter to ask them to have a radiographic examination.

The radiographic images will be interpreted by two independent experts to evaluate the angle pf vertebral kyphosis.


title: Is Impaired Activation and Migration of Circulating Leukocytes Associated With Overdue Birth in Obese Women?

acronym: LOST

summary:
This is a single-centre observational, prospective study carried out at the maternity unit of Dijon CHU. It will include pregnant women with a pre-conception BMI ≥ 30 kg/m² and will evaluate in these patients, the activation and migration capacities of circulating leukocytes and their association with the onset of spontaneous labour.

Patients who meet the inclusion criteria will be informed about the study during their consultation at the 7th or 8th month, and their gynecologist will invite them to take part. If the answer is positive, the patients will be seen again at a specific consultation for the study between the 37th and 38the Weeks of amenorrhea at the maternity unit of Dijon CHU. During this consultation, the gynecologist will conduct a medical examination, while the Plurithematic clinical investigation center nurse will take a blood sample (3 x 6ml tubes and 1 x 7ml tube).

If labour has not started by 41 Weeks of amenorrhea, the patients will be seen at another consultation (consultation programmed in the usual follow-up of pregnancy) and a second blood sample (1 x 6ml tube and 1 x 7ml) will be taken.

The patients will be followed until childbirth and will be split into two groups according to whether or not they gave birth after the onset of spontaneous labour.

primary_purpose: Other


title: ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery.

summary:
Malnutrition priori a major abdominal surgery is frequent and increases morbidity and mortality. The management of malnutrition has an impact in reducing postoperative complications. However malnutrition is rarely detected and Guidelines infrequently followed.

Recovery time and nutritional evaluation in elderly patients are major criteria in their postoperative management. Identifying malnutrition or malnutrition risk is fundamental to its treatment. It is therefore unsurprising that many validated tools for nutrition risk screening and nutrition assessment exist for the clinician to use in assisting with the accurate identification, referral and treatment of patients who are malnourished or at risk of malnutrition.

And nutritional management must be adapted and based on this evaluation and evolution of the general status (Guidelines Grade A).

A geriatric evaluation based on a screening of preoperative malnutrition should allow a better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN) guidelines.

primary_purpose: Screening

ReferenceCitation: Dupuis M, Kuczewski E, Villeneuve L, Bin-Dorel S, Haine M, Falandry C, Gilbert T, Passot G, Glehen O, Bonnefoy M. Age Nutrition Chirugie (ANC) study: impact of a geriatric intervention on the screening and management of undernutrition in elderly patients operated on for colon cancer, a stepped wedge controlled trial. BMC Geriatr. 2017 Jan 7;17(1):10. doi: 10.1186/s12877-016-0402-3.

family: Dupuis

full_name: Marine Dupuis

given: Marine

family: Kuczewski

full_name: Elisabetta Kuczewski

given: Elisabetta

family: Villeneuve

full_name: Laurent Villeneuve

given: Laurent

family: Bin-Dorel

full_name: Sylvie Bin-Dorel

given: Sylvie

family: Haine

full_name: Max Haine

given: Max

family: Falandry

full_name: Claire Falandry

given: Claire

family: Gilbert

full_name: Thomas Gilbert

given: Thomas

family: Passot

full_name: Guillaume Passot

family: Glehen

full_name: Olivier Glehen

given: Olivier

family: Bonnefoy

full_name: Marc Bonnefoy

given: Marc

journal_name: BMC Geriatrics

license: cc-by-sa

license_normalized: cc-by-sa

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

title: Age Nutrition Chirurgie (ANC) study: impact of a geriatric intervention on the screening and management of undernutrition in elderly patients operated on for colon cancer, a stepped wedge controlled trial

lead_sponsor: Hospices Civils de Lyon


title: Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia

acronym: QUICK

summary:
The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration.

Design: split-mouth design AND parallel-arm design

ReferenceCitation: Smaïl-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper™) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.

name: Hôpital Bretonneau, Service d'Odontologie Assistance Publique‐Hôpitaux de Paris Paris France

name: Faculté de Chirurgie Dentaire, Unité de Recherches Biomatériaux Innovants et Interface EA4462 Université Paris Descartes ‐ Sorbonne Paris Cité Montrouge France

family: Smaïl‐Faugeron

full_name: Violaine Smaïl‐Faugeron

given: Violaine

name: Department of Pediatric Dentistry UFR d’Odontologie de Nice Sophia Antipolis, Université Côte d’Azur, CHUN Nice France

family: Muller‐Bolla

full_name: Michèle Muller‐Bolla

given: Michèle

name: Université Européenne de Bretagne Université de Rennes 1 and Centre Hospitalier Universitaire de Rennes Rennes France

family: Sixou

full_name: Jean‐Louis Sixou

given: Jean‐Louis

family: Courson

full_name: Frédéric Courson

given: Frédéric

journal_name: International Journal of Paediatric Dentistry

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - hprints.org

version: submittedVersion

title: Evaluation of intraosseous computerized injection system (QuickSleeper™) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single‐blind, combined split‐mouth and parallel‐arm randomized controlled trial

ReferenceCitation: Smaïl-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial. BMJ Open. 2015 Jul 10;5(7):e007724. doi: 10.1136/bmjopen-2015-007724.

family: Smaïl-Faugeron

full_name: Violaine Smaïl-Faugeron

family: Muller-Bolla

full_name: Michèle Muller-Bolla

full_name: Jean-Louis Sixou

given: Jean-Louis

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

publisher: BMJ

publisher_dissemination: British Medical Journal


title: Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery

summary:
The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data.

The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.


title: Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

summary: It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine) potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic cholecystectomy performed in an ambulatory setting.

lead_sponsor: Hopital Foch


title: Self-perception of Dyspnea Threshold During the 6-minute Walk Test (DT6): A New Tool for Individualized Exercise Training With Chronic Obstructive Pulmonary Disease Patients (COPD)

summary:
In view of the multiple limitations and restrictions relative to CPET (technical, time, physical…), determination of individualized training threshold from this evaluation is today not possible for a lot of patients.

The aim of this study was to propose a new clinical tool from 6MWT for individualized exercise training: the dyspnea threshold (DT6).

lead_sponsor: 5 Santé


title: Post EVAR Endoleak Detection : Model-based Iterative Reconstruction (MBIR) vs Adaptive Statistical Iterative Reconstruction (ASIR) CTA; a Prospective Study

summary: The purpose of the study is to compare the accuracy of the diagnosis of endoleak in patient with EVAR comparing Adaptive statistical iterative reconstruction (ASIR) CTA and Model-based iterative reconstruction (MBIR- VEO TM).

lead_sponsor: University Hospital, Clermont-Ferrand


title: Bedside Assessment of PEEP-induced Lung Recruitment by Using Digital Chest-X-ray in ARDS Patients. A Multicenter Prospective Study.

acronym: RECRUTEX

summary: Lung recruitability is essential for optimal Positive end-expiratory pressure (PEEP) selection in ARDS patients. It is defined as the potential for the non aerated or poorly aerated lung mass to become aerated due to the increase in airway pressure. PEEP contributes to lung recruitment mostly by maintaining some amount of the end-inspiratory recruitment at the end of expiration. PEEP also stabilizes patency of the small airways and minimizes the repeated opening and closing of them during the breathing cycle, which is implicated in a further lung inflammation. The gold-standard method for assessing lung recruitability is lung CT scan. For economic and feasibility this technique cannot be used in routine. Therefore, techniques that can be used at the bedside to measure lung recruitability are very well known. The measurement of recruited lung volume (Vrec) by using pressure-volume curve generated by the ventilator is another reference method to approach lung recruitment. It can be done at the bedside. Chest-X-Ray (CXR) is an interesting option as done in routine in this setting. Furthermore, it allows quantifying aeration thanks numerical image processing and a regional approach. In a preliminary one-center study we found a significant negative correlation between the amount of Vrec and the reduction in lung density measured by digital CXR between 5 and 15 cm H2O PEEP. In present study we would like to extend this previous result on a larger number of patients in a multicenter investigation.

location_facility: Service de Réanimation Médicale, Hôpital Croix-Rousse, Hospices Civils de Lyon


title: Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD

summary: Peripheral muscle mass and strength are relevant indicators of COPD survival. Current guidelines recommend to assess muscle strength only in muscle wasted patients. However, a recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp. Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle wasting. We aimed at determining the prevalence of patients entering in pulmonary rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of muscle wasting clinical signs.


title: Sellick Maneuver Evaluation in Rapid Sequence Induction of General Anesthesia Non Inferiority Trial

acronym: IRIS

summary:
Lung aspiration can occur when a rapid sequence induction of anesthesia is performed (emergency and/or presence of at least one risk factor for regurgitation of stomach contents).

The aim of this study is to assess the Sellick maneuver, which is recommended for patient at high risk of aspiration of gastric content during induction of general anesthesia, despite the lack of solid evidence of its efficacy and possible adverse effects The primary outcome of this non inferiority study is the incidence of lung aspiration whether this maneuver is effectively applied or sham.

ReferenceCitation: Birenbaum A, Hajage D, Roche S, Ntouba A, Eurin M, Cuvillon P, Rohn A, Compere V, Benhamou D, Biais M, Menut R, Benachi S, Lenfant F, Riou B; IRIS Investigators Group. Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial. JAMA Surg. 2019 Jan 1;154(1):9-17. doi: 10.1001/jamasurg.2018.3577. Erratum in: JAMA Surg. 2019 Jan 1;154(1):96.

name: Department of Anesthesiology and Critical Care, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France

family: Birenbaum

full_name: Aurélie Birenbaum

given: Aurélie

name: Sorbonne Université, Department of Biostatistics Public Health and Medical Information, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France

family: Hajage

full_name: David Hajage

given: David

family: Roche

full_name: Sabine Roche

given: Sabine

name: Université Jules Verne, Department of Anesthesiology and Critical Care, CHI Amiens-Picardie, Amiens, France

family: Ntouba

full_name: Alexandre Ntouba

given: Alexandre

name: Department of Anesthesiology and Critical Care, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, Clichy, France

family: Eurin

full_name: Mathilde Eurin

given: Mathilde

name: Université de Montpellier, Department of Anesthesiology and Critical Care, Hôpital Carémeau, Nîmes, France

family: Cuvillon

full_name: Philippe Cuvillon

given: Philippe

name: Department of Anesthesiology and Critical Care, Centre Hospitalier Universitaire Regional de Lille, Lille, France

family: Rohn

full_name: Aurélien Rohn

given: Aurélien

name: Université de Haute-Normandie, Department of Anesthesiology and Critical Care, Hôpital, Rouen, France

family: Compere

full_name: Vincent Compere

given: Vincent

name: Université Paris-Sud, Department of Anesthesiology and Critical Care, Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Le Kremlin-Bicêtre, France

family: Benhamou

full_name: Dan Benhamou

given: Dan

name: Université Victor Segalen, Department of Anesthesiology and Critical Care, Hôpital Pellegrin, Bordeaux, France

family: Biais

full_name: Matthieu Biais

given: Matthieu

name: Université Toulouse 3-Paul Sabatier, Department of Anesthesiology and Intensive Care, University Hospital of Toulouse, Toulouse, France

family: Menut

full_name: Remi Menut

given: Remi

name: Department of Anesthesiology and Critical Care, Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris, Bobigny, France

family: Benachi

full_name: Sabiha Benachi

given: Sabiha

name: Department of Anesthesiology, Centre Hospitalier Simone Veil, Cannes, France

family: Lenfant

full_name: François Lenfant

given: François

name: Sorbonne Université, UMR Inserm, Institut hospitalo-universitaire ICAN, Department of Emergency Medicine and Surgery, Hôpital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Paris, France

family: Riou

full_name: Bruno Riou

given: Bruno

journal_name: JAMA Surgery

oa_colors: green other

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study in Leucocytes From Patients With Type 1 and Type 2 Diabetes Genetic Markers of Inflammation and Oxidative Stress (TÉLOMÈRES/ CANDIDATE GENES) According to the Type A or Type B Behavior Profile

acronym: Diatolepsy

summary:
This study will include 100 patients with Type 1 and Type 2 diabetes, split into 2 groups of 50 patients according to their behaviour type, and their adaptation to different factors of stress encountered in their lives:

the first group will consist of patients with a characteristic Type A behaviour profile, that is to say patients with a "proactive, impatient" behaviour pattern
the second group will consist of patients with a characteristic Type B behaviour profile that is to say patients with a "calm, slow" behaviour pattern The objective is to know if the different behaviour patterns are associated with distinct biological markers likely to influence the evolution of the diabetes.

Participation in this study will be approximately 1h30, patients will participate ONCE ONLY:

they will answer simple questions about their disease and then complete 3 questionnaires each with 14 items.
they will meet a clinical psychologist for an interview lasting approximately 45 minutes recorded on an audio recorder. The consultation will be used to seek links between the psyche and the disease.
they will provide one blood sample of 12 ml (equivalent to a soup spoon) drawn in the morning.


title: Transversus Abdominis Plane Block During Kidney Transplant Surgery: Prospective Controlled Randomized Double-blind Trial Comparing Ropivacaine 0.2% With Placebo.

summary:
The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo.

This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above.

This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant surgery.


summary: The aims of this cross over prospective study are to demonstrate that smoking two cigarettes do not change the gastric contents and volume in fasting volunteers.

ReferenceCitation: Lazaar S, Boselli E, Chassard D, Allaouchiche B, Bouvet L. Effect of acute cigarette smoking on gastric contents in regular smoker volunteers. A prospective randomized cross-over study. Br J Anaesth. 2015 Oct;115(4):590-4. doi: 10.1093/bja/aev264. Epub 2015 Aug 30.

family: Lazaar

full_name: S. Lazaar

given: S.

family: Boselli

full_name: E. Boselli

given: E.

family: Chassard

full_name: D. Chassard

given: D.

family: Allaouchiche

full_name: B. Allaouchiche

given: B.

family: Bouvet

full_name: L. Bouvet

given: L.

journal_name: British Journal of Anaesthesia

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Lionel Bouvet

intervention_type: Behavioral


title: Randomized, Comparative Study of 19G Flex Versus 22G Standard Needles for Pancreatic Solid Tumors Diagnosis.

acronym: EASYFLEX

summary: The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.

ReferenceCitation: Jenssen C, Dietrich CF. Endoscopic ultrasound-guided fine-needle aspiration biopsy and trucut biopsy in gastroenterology - An overview. Best Pract Res Clin Gastroenterol. 2009;23(5):743-59. doi: 10.1016/j.bpg.2009.05.006. Review.

ReferenceCitation: Takemoto T, Aibe T, Fuji T, Okita K. Endoscopic ultrasonography. Clin Gastroenterol. 1986 Apr;15(2):305-19.

ReferenceCitation: Erickson RA. EUS-guided FNA. Gastrointest Endosc. 2004 Aug;60(2):267-79. Review.

ReferenceCitation: Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.

ReferenceCitation: Song TJ, Kim JH, Lee SS, Eum JB, Moon SH, Park DY, Seo DW, Lee SK, Jang SJ, Yun SC, Kim MH. The prospective randomized, controlled trial of endoscopic ultrasound-guided fine-needle aspiration using 22G and 19G aspiration needles for solid pancreatic or peripancreatic masses. Am J Gastroenterol. 2010 Aug;105(8):1739-45. doi: 10.1038/ajg.2010.108. Epub 2010 Mar 9.

ReferenceCitation: Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy, Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029.

ReferenceCitation: Adler DG, Jacobson BC, Davila RE, Hirota WK, Leighton JA, Qureshi WA, Rajan E, Zuckerman MJ, Fanelli RD, Baron TH, Faigel DO; ASGE. ASGE guideline: complications of EUS. Gastrointest Endosc. 2005 Jan;61(1):8-12. Erratum in: Gastrointest Endosc. 2005 Mar;61(3):502.

ReferenceCitation: Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. Epub 2007 Dec 4.

ReferenceCitation: Carrara S, Arcidiacono PG, Mezzi G, Petrone MC, Boemo C, Testoni PA. Pancreatic endoscopic ultrasound-guided fine needle aspiration: complication rate and clinical course in a single centre. Dig Liver Dis. 2010 Jul;42(7):520-3. doi: 10.1016/j.dld.2009.10.002. Epub 2009 Dec 1.

ReferenceCitation: Boustière C, Veitch A, Vanbiervliet G, Bulois P, Deprez P, Laquiere A, Laugier R, Lesur G, Mosler P, Nalet B, Napoleon B, Rembacken B, Ajzenberg N, Collet JP, Baron T, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2011 May;43(5):445-61. doi: 10.1055/s-0030-1256317. Epub 2011 May 4.

ReferenceCitation: Fayers PM, Machin D. Sample size: how many patients are necessary? Br J Cancer. 1995 Jul;72(1):1-9. Review.

ReferenceCitation: Laquière A, Lefort C, Maire F, Aubert A, Gincul R, Prat F, Grandval P, Croizet O, Boulant J, Vanbiervliet G, Pénaranda G, Lecomte L, Napoléon B, Boustière C. 19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study. Endoscopy. 2019 May;51(5):436-443. doi: 10.1055/a-0757-7714. Epub 2018 Nov 19.

name: Hepatogastroenterology Department, Hôpital Saint Joseph, Marseille, France

family: Laquière

full_name: Arthur Laquière

given: Arthur

name: Hepatogastroenterology Department, Hôpital Privé Jean Mermoz, Lyon, France

family: Lefort

full_name: Christine Lefort

given: Christine

name: Hepatogastroenterology Department, Hôpital Beaujon (CHU) AP-HP, Clichy, France

family: Maire

full_name: Frédérique Maire

given: Frédérique

name: Hepatogastroenterology Department, Clinique Du Parc St Lazare, Beauvais, France

family: Aubert

full_name: Alain Aubert

given: Alain

name: Hepatogastroenterology Department, Hôpital Edouard Herriot (CHU) HCL, Lyon, France

family: Gincul

full_name: Rodica Gincul

given: Rodica

name: Hepatogastroenterology Department, Hôpital Cochin(CHU) AP-HP, Paris, France

family: Prat

full_name: Frédéric Prat

given: Frédéric

name: Hepatogastroenterology Department, Hôpital La Timone (CHU) AP-H, Marseille, France

family: Grandval

full_name: Philippe Grandval

name: Hepatogastroenterology Department, Clinique Pasteur, Toulouse, France

family: Croizet

full_name: Olivier Croizet

given: Olivier

name: Hepatogastroenterology Department, Clinique du Palais, Grasse, France

family: Boulant

full_name: James Boulant

given: James

name: Hepatogastroenterology Department, Hôpital L’Archet (CHU), Nice, France

family: Vanbiervliet

full_name: Geoffroy Vanbiervliet

given: Geoffroy

name: AlphaBio Laboratory, Biostatistics Department, Hôpital Européen, Marseille, France

family: Pénaranda

full_name: Guillaume Pénaranda

given: Guillaume

family: Lecomte

full_name: Laurence Lecomte

given: Laurence

family: Napoléon

full_name: Bertrand Napoléon

given: Bertrand

family: Boustière

full_name: Christian Boustière

given: Christian

journal_name: Endoscopy

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

lead_sponsor: French Society of Digestive Endoscopy


title: Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

summary: Respiratory failure is the main death cause in neuromuscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril (Psnip) and the maximal inspiratory pressure (PImax). Unfortunately, volitional maneuvers depend of patient effort. The aim of this research is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular diseases patients. The methodology consists to add to PImax and Psnip measures 5 phrenic nerves magnetical stimulation maneuvers (Pstim).Stimulations will be realize at 3 inspiratory pression levels (0, -1 cm H2O and -5 cm H2O).


title: Magnetoencephalographic Study of Glial Tumors Electromagnetic Signature

acronym: CONDUCTOME

summary: The purpose of this study is to determine the correlation between functional MEG analysis of the tumor and its periphery and the tumor stage and treatment response.

lead_sponsor: University Hospital, Grenoble


title: Investigation of Endocrin-metabolic Modifications Related to Diabetes Improvement After Sleeve Gastrectomy in Severly Obese

acronym: SLEEVEDIAB

summary: Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. According to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2 diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide 1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly. The important caloric restriction in the early postoperative period indeed improves hepatic insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of this surgical procedure cannot be excluded.The aim of our study is to explore the early and late metabolic effects of sleeve gastrectomy in severely obese patients with non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin secretion and incretin effect. We will include 14 obese patients with type 2 diabetes, considered eligible to bariatric surgery according to HAS criteria, and whose diabetes treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a 1-week caloric restriction period or no caloric restriction, immediately before surgery. Test meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month and 12 month after surgery.

lead_sponsor: University Hospital, Montpellier


title: Model-based Iterative Reconstruction (MB-IR VEOTM) in Ultra Low-dose Abdominal CT Versus Adaptative Statistical Iterative Reconstruction (ASIR): A Prospective Study for Acute Renal Colic

acronym: VEOLITH

summary: The purpose of this study is to determine if Model-based iterative reconstruction (MB-IR VEOTM) in ultra low-dose abdominal CT as the same accuracy for the diagnosis of acute renal colic versus standard CT with adaptative statistical iterative reconstruction (ASIR).


title: Identification by Microarrays of the Risks of Metastatic Relapse, Toxicity and Resistance to Adjuvant Chemotherapy in Completely Resected Non-small Cell Lung Cancer

acronym: SITRR

summary: Description of new transcriptional profiles associated with risk of relapse and identification of specific sites of relapse in non-small cell lung cancer, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer (NSCLC).


title: Descriptive Study of Biological Stress and Perceived Stress in Call Regulation Operators and Doctors When Processing a Call at the Center 15

acronym: RegulStress

summary: The purpose of this study is to describe biological stress (cortisolemia) and perceived stress in Emergency Call Center Operators and Doctors while processing a center 15 call.

ReferenceCitation: Weibel L, Gabrion I, Aussedat M, Kreutz G. Work-related stress in an emergency medical dispatch center. Ann Emerg Med. 2003 Apr;41(4):500-6.

ReferenceCitation: Nakajima Y, Takahashi T, Shetty V, Yamaguchi M. Patterns of salivary cortisol levels can manifest work stress in emergency care providers. J Physiol Sci. 2012 May;62(3):191-7. doi: 10.1007/s12576-012-0197-8. Epub 2012 Feb 19.

ReferenceCitation: Kirschbaum C, Hellhammer DH. Salivary cortisol in psychobiological research: an overview. Neuropsychobiology. 1989;22(3):150-69. Review.

ReferenceCitation: Hellhammer DH, Wüst S, Kudielka BM. Salivary cortisol as a biomarker in stress research. Psychoneuroendocrinology. 2009 Feb;34(2):163-171. doi: 10.1016/j.psyneuen.2008.10.026. Epub 2008 Dec 18. Review.

ReferenceCitation: Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. Review.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility: Centre Hospitalier Régional Metz Thionville


title: A Randomized, Controlled, Double-blind, Cross-over Clinical Trial, Evaluating the Effect of MealShape™ on the Postprandial Glycemia After Eating Standard Food, in Healthy Volunteers.

summary: The purpose of the study is to evaluate the effect of MealShape, a Ceylon cinnamon extract (Cinnamomum zeylanicum) on blood glucose and insulin response after consumption of a standard meal composed of white bread, in healthy male and female volunteers.

ReferenceCitation: Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. Review.

ReferenceCitation: Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, Dietz W. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012 Jun;42(6):563-70. doi: 10.1016/j.amepre.2011.10.026.

ReferenceCitation: Rafehi H, Ververis K, Karagiannis TC. Controversies surrounding the clinical potential of cinnamon for the management of diabetes. Diabetes Obes Metab. 2012 Jun;14(6):493-9. doi: 10.1111/j.1463-1326.2011.01538.x. Epub 2011 Dec 27. Review.

ReferenceCitation: Davis PA, Yokoyama W. Cinnamon intake lowers fasting blood glucose: meta-analysis. J Med Food. 2011 Sep;14(9):884-9. doi: 10.1089/jmf.2010.0180. Epub 2011 Apr 11. Review.

ReferenceCitation: Baker WL, Gutierrez-Williams G, White CM, Kluger J, Coleman CI. Effect of cinnamon on glucose control and lipid parameters. Diabetes Care. 2008 Jan;31(1):41-3. Epub 2007 Oct 1.

ReferenceCitation: Magistrelli A, Chezem JC. Effect of ground cinnamon on postprandial blood glucose concentration in normal-weight and obese adults. J Acad Nutr Diet. 2012 Nov;112(11):1806-9. doi: 10.1016/j.jand.2012.07.037.

ReferenceCitation: Beejmohun V, Peytavy-Izard M, Mignon C, Muscente-Paque D, Deplanque X, Ripoll C, Chapal N. Acute effect of Ceylon cinnamon extract on postprandial glycemia: alpha-amylase inhibition, starch tolerance test in rats, and randomized crossover clinical trial in healthy volunteers. BMC Complement Altern Med. 2014 Sep 23;14:351. doi: 10.1186/1472-6882-14-351.

family: Beejmohun

full_name: Vickram Beejmohun

given: Vickram

family: Peytavy-Izard

full_name: Marie Peytavy-Izard

given: Marie

family: Mignon

full_name: Cyril Mignon

given: Cyril

family: Muscente-Paque

full_name: Delphine Muscente-Paque

given: Delphine

family: Deplanque

full_name: Xavier Deplanque

given: Xavier

family: Ripoll

full_name: Christophe Ripoll

given: Christophe

family: Chapal

full_name: Nicolas Chapal

given: Nicolas

journal_name: BMC Complementary and Alternative Medicine

lead_sponsor: Dialpha


title: Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization

acronym: CareSSE

summary:
In the early 2000s , professional and patient organizations are mobilizing to highlight the psychosocial impact of cancer disease , not only during but also after the acute phase.

In 2003, the government launched the Cancer Plan I reinforced in December 2011 by the Cancer Plan II whose objectives include : " Develop a personalized care taking into account the pain and psychological and social support " and " increase opportunities for patients to benefit from supportive care "and" promote the professional integration .

This study aims to show that beyond the immediate benefits of the social aesthetic cares in hospital (direct soothing, improving the quality of the skin injured by chemotherapy , feeling of escape ... ), these treatments can also affect quality of life for patients during and after hospitalization. They also may have an impact on the maintenance of social and / or professional satisfactory throughout the planned chemotherapy aplastic period .


title: Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

acronym: CTC-Pancreas

summary:
Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).

Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).

The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.


title: Devenir au Long Cours de la Cellule bêta Chez Les Adultes Porteurs d'Anomalies génétiques à l'Origine du Diabète Néonatal

acronym: GLUCONEO

summary: The main objective of this study is to evaluate Beta cells in patients with a neonotal diabetes linked to a genetic abnormality Metabolic caracteristics will described using a transversal cohort study.

ReferenceCitation: Le Bourgeois F, Beltrand J, Baz B, Julla JB, Riveline JP, Simon A, Flechtner I, Ait Djoudi M, Fauret-Amsellem AL, Vial Y, Scharfmann R, Sommet J, Boudou P, Cavé H, Polak M, Gautier JF, Busiah K; TNDM Long-Term Follow-Up Study Group. Long-term Metabolic and Socioeducational Outcomes of Transient Neonatal Diabetes: A Longitudinal and Cross-sectional Study. Diabetes Care. 2020 Jun;43(6):1191-1199. doi: 10.2337/dc19-0324. Epub 2020 Apr 9.

family: Le Bourgeois

full_name: Fleur Le Bourgeois

given: Fleur

family: Beltrand

full_name: Jacques Beltrand

given: Jacques

family: Baz

full_name: Baz Baz

given: Baz

family: Julla

full_name: Jean-Baptiste Julla

given: Jean-Baptiste

family: Riveline

full_name: Jean-Pierre Riveline

given: Jean-Pierre

family: Simon

full_name: Albane Simon

given: Albane

family: Flechtner

full_name: Isabelle Flechtner

given: Isabelle

family: Ait Djoudi

full_name: Malek Ait Djoudi

given: Malek

family: Fauret-Amsellem

full_name: Anne-Laure Fauret-Amsellem

given: Anne-Laure

family: Vial

full_name: Yoann Vial

given: Yoann

family: Scharfmann

full_name: Raphael Scharfmann

given: Raphael

family: Sommet

full_name: Julie Sommet

given: Julie

family: Boudou

full_name: Philippe Boudou

given: Philippe

family: Cavé

full_name: Hélène Cavé

given: Hélène

family: Polak

full_name: Michel Polak

given: Michel

family: Gautier

full_name: Jean-François Gautier

given: Jean-François

family: Busiah

full_name: Kanetee Busiah

given: Kanetee

name: the TNDM Long-Term Follow-Up Study Group

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association


title: Vestibular and Multisensory Influence on Bodily and Spatial Representations. Behavioral and Electrophysiological Investigations in Vestibular-defective Patients and Healthy Volunteers

summary:
The present project aims at describing how vestibular signals contribute to the multisensory mechanisms of bodily self-consciousness.

There is a large body of data regarding the sensory and neural mechanisms of self-consciousness, but most studies have so far demonstrated the contribution of visual, tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have neglected the contribution of the vestibular system, a major sensory system for spatial and bodily representations. The vestibular system is sensitive to head motions in space and head inclinations with respect to gravity and it should therefore contribute significantly to several bodily experiences. This contribution should be put under neuroscientific scrutiny. We believe that the current neuroscientific models of bodily self-consciousness will be incomplete until they incorporate the contribution of vestibular signals.

The present project specifically aims at testing the hypothesis according to which vestibular signals significantly influence bodily self-consciousness, in particular first-person and third-person perspective taking and the internal body models (i.e. the body schema and body image). The present project also aims at describing how cortical vestibular processing is modified during experimental changes of perspective taking and viewpoint. In addition, the present project will describe whether vestibular disorders change performances in third-person perspective taking tasks and modify internal body models. This should help understanding bodily symptoms in vestibular-defective patients. To this end, we will combine approaches from psychophysics and electrophysiology (electromyography, electroencephalography) in healthy volunteers and behavioral approached in patients with vestibular disorders.

These studies should further the understanding of how the brain processes vestibular signals, which is to date poorly understood. In addition, the outcome of the present project should help understanding the multiple and complex symptoms reported by patients with vestibular diseases, and should therefore improve their treatment.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects

summary: To explore a neurophysiological marker (electroencephalography) of cognitive effect of vortioxetine

lead_sponsor: H. Lundbeck A/S


title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers

summary: The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.

lead_sponsor: Bial - Portela C S.A.


title: Evaluation of the Impact of an Electronic Pharmaceutical Record Used for Medication Reconciliation by a Pharmacist Associated to the Anesthesiologist Consultation

acronym: DP-CONCIL

summary:
The objective is to evaluate the impact of an electronic pharmaceutical record used for medication reconciliation by a pharmacist associated to the anesthesiologist consultation

Experimental intervention:

medication reconciliation by a pharmacist using an electronic pharmaceutical record before the anesthesiologist consultation for planned surgery patients. The clinical pharmacist communicates the recommendations regarding the drug therapy to the anesthesiologist orally and using a specific formulary.

Control intervention:

Conventional anesthesiologist consultation for planned surgery patients.

primary_purpose: Health Services Research

location_facility: Pharmacy Department - University Hospital of Grenoble


title: Predictive Values of Plasma Soluble RAGE Levels and RAGE Polymorphisms for the Onset of Acute Respiratory Distress Syndrome in Critically Ill Patients

acronym: PrediRAGE

summary:
Current clinical prediction scores for acute respiratory distress syndrome (ARDS) have limited positive predictive value. No studies have evaluated predictive kinetics of plasma biomarkers and receptor for advanced glycation end products (RAGE) polymorphisms in a broad population of critically ill patients or as an adjunct to clinical prediction scores.

The main objective of the investigators study is to evaluate the predictive values of plasma soluble RAGE levels for the onset of ARDS in a high risk population of patients admitted to the intensive care unit (ICU).

One of the investigators goals is to improve early identification of patients at risk for ARDS in order to better implement preventive stategies prior to ARDS development.

The primary outcome is the occurrence of ARDS during the first week after admission to the ICU.

ReferenceCitation: Blondonnet R, Joubert E, Godet T, Berthelin P, Pranal T, Roszyk L, Chabanne R, Eisenmann N, Lautrette A, Belville C, Cayot S, Gillart T, Souweine B, Bouvier D, Blanchon L, Sapin V, Pereira B, Constantin JM, Jabaudon M. Driving pressure and acute respiratory distress syndrome in critically ill patients. Respirology. 2019 Feb;24(2):137-145. doi: 10.1111/resp.13394. Epub 2018 Sep 5.

name: Department of Perioperative Medicine; CHU Clermont-Ferrand; Clermont-Ferrand France

name: GReD, CNRS UMR 6293, INSERM U1103, Université Clermont Auvergne; Clermont-Ferrand France

family: Blondonnet

full_name: Raiko Blondonnet

given: Raiko

family: Joubert

full_name: Elodie Joubert

given: Elodie

family: Godet

full_name: Thomas Godet

given: Thomas

family: Berthelin

full_name: Pauline Berthelin

given: Pauline

family: Pranal

full_name: Thibaut Pranal

given: Thibaut

name: Department of Medical Biochemistry and Molecular Biology; CHU Clermont-Ferrand; Clermont-Ferrand France

family: Roszyk

full_name: Laurence Roszyk

given: Laurence

family: Chabanne

full_name: Russell Chabanne

given: Russell

name: Intensive Care Unit; Jean Perrin Comprehensive Cancer Center; Clermont-Ferrand France

family: Eisenmann

full_name: Nathanael Eisenmann

given: Nathanael

name: Medical Intensive Care Unit; CHU Clermont-Ferrand; Clermont-Ferrand France

family: Lautrette

full_name: Alexandre Lautrette

given: Alexandre

family: Belville

full_name: Corinne Belville

given: Corinne

family: Cayot

full_name: Sophie Cayot

given: Sophie

family: Gillart

full_name: Thierry Gillart

given: Thierry

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Bouvier

full_name: Damien Bouvier

given: Damien

family: Blanchon

full_name: Loic Blanchon

given: Loic

family: Sapin

full_name: Vincent Sapin

given: Vincent

name: Department of Clinical Research and Innovation (DRCI); CHU Clermont-Ferrand; Clermont-Ferrand France

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

journal_name: Respirology

evidence: open (via free article)

ReferenceCitation: Pranal T, Pereira B, Berthelin P, Roszyk L, Godet T, Chabanne R, Eisenmann N, Lautrette A, Belville C, Blondonnet R, Cayot S, Gillart T, Skrzypczak Y, Souweine B, Bouvier D, Blanchon L, Sapin V, Constantin JM, Jabaudon M. Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study. Dis Markers. 2018 May 10;2018:7849675. doi: 10.1155/2018/7849675. eCollection 2018.

name: Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France

name: Department of Clinical Research and Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France

name: Université Clermont Auvergne, CNRS UMR 6293, and INSERM U1103, GReD, Clermont-Ferrand, France

name: Department of Medical Biochemistry and Molecular Biology, CHU Clermont-Ferrand, Clermont-Ferrand, France

name: Intensive Care Unit, Jean Perrin Comprehensive Cancer Center, Clermont-Ferrand, France

name: Medical Intensive Care Unit, UMR CNRS 6023, CHU Clermont-Ferrand, Clermont-Ferrand, France

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


title: Effect of Energy Density on Liking and on Caloric Adjustment Conditioning After Sweet Beverage Exposure in Children Aged 8-11 y

summary: The main objective is to study, in 8-11 year old children, the influence of energy density conditioning on liking for new flavored beverages and on caloric adjustment after the beverage consumption. The stability of the energy conditioning was evaluated after a period without exposure and after an extinction period during which the energy density of the beverages was changed.

primary_purpose: Basic Science

ReferenceCitation: Remy E, Divert C, Rousselot J, Brondel L, Issanchou S, Nicklaus S. Impact of energy density on liking for sweet beverages and caloric-adjustment conditioning in children. Am J Clin Nutr. 2014 Oct;100(4):1052-8. doi: 10.3945/ajcn.114.087452. Epub 2014 Aug 13.

family: Remy

full_name: Eloïse Remy

given: Eloïse

family: Divert

full_name: Camille Divert

given: Camille

family: Rousselot

full_name: Juliette Rousselot

given: Juliette

family: Brondel

full_name: Laurent Brondel

given: Laurent

family: Issanchou

full_name: Sylvie Issanchou

given: Sylvie

family: Nicklaus

full_name: Sophie Nicklaus

journal_name: The American Journal of Clinical Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

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


title: Effects of Fludrocortisone on Norepinephrine-mean Arterial Pressure Dose-response, Gastric Mucosal Perfusion and Arterial Stiffness in Septic Shock

acronym: FLUDRO

summary: Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone alone on norepinephrine-mean arterial pressure dose-response relationship, gastric mucosal perfusion and arterial stiffness in patients with septic shock.

status: Withdrawn

lead_sponsor: Rennes University Hospital

location_facility: Service de Réanimation Chirurgicale - Hôpital de Pontchaillou


title: Single Embryo Transfer: Comparison of Slow Freezing and Vitrification at Blastocyst Stage

summary:
Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.

However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .

Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.


title: Validation of the Measure of ETCO2, Compared to PTCO2 and PaCO2 in the Home-ventilated Neuromuscular Patient

acronym: Capnovivo

summary: The purpose of this study is to compare the measure of the CO2 obtained on the end-tidal expiratory gas (ETCO2) with the value of CO2 obtained by transcutaneous measure (PTCO2), in home-ventilated neuromuscular patients.

ReferenceCitation: Orlikowski D, Prigent H, Ambrosi X, Vaugier I, Pottier S, Annane D, Lofaso F, Ogna A. Comparison of ventilator-integrated end-tidal CO2 and transcutaneous CO2 monitoring in home-ventilated neuromuscular patients. Respir Med. 2016 Aug;117:7-13. doi: 10.1016/j.rmed.2016.05.022. Epub 2016 May 24.

family: Orlikowski

full_name: David Orlikowski

given: David

family: Prigent

full_name: Helene Prigent

given: Helene

family: Ambrosi

full_name: Xavier Ambrosi

given: Xavier

family: Vaugier

full_name: Isabelle Vaugier

given: Isabelle

family: Pottier

full_name: Sandra Pottier

given: Sandra

family: Annane

full_name: Djillali Annane

given: Djillali

family: Lofaso

full_name: Frederic Lofaso

given: Frederic

family: Ogna

full_name: Adam Ogna

given: Adam

journal_name: Respiratory Medicine

title: Comparison of ventilator-integrated end-tidal CO 2 and transcutaneous CO 2 monitoring in home-ventilated neuromuscular patients

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Study of Adaptation of the Right Ventricle to Systemic Afterload

acronym: STARS

summary: the first purpose of the study is to determine the adaptative mechanisms of right ventricle (RV) to systemic afterload, and the mechanisms of RV failure, in patients with congenital heart disease and subaortic RV, using cardiac magnetic resonance imaging (CMR).The mechanisms are evaluated by measures of RV remodelling and RV wall stress using CMR. Second objectives are to evaluate these mechanisms using echography, arterial properties study and neurohormonal levels


title: Impact of Dysmetabolic Iron Overload Syndrome on Polarization Capacity of Macrophages

acronym: MEPHISTO

summary: Dysmetabolic iron overload syndrome (DIOS), is a frequent hepatic iron overload associated with metabolic syndrome. We hypothesize that this mild iron overload can induce a increased macrophagic polarization towards inflammatory types, thereby contributing to cardiovascular risk. Our main objective is to highlight the influence of iron overload on polarization capacity of monocytes into alternative macrophages (called M2). We therefore compare phenotypic markers of monocytes/macrophages between subjects with DIOS, metabolic syndrome without iron overload and lean subjects.

time_perspective: Cross-Sectional


title: Clinical Audit of Cardio Pulmonary Resuscitation Management in Adults Patient Units of Care by in Situ Simulation

acronym: SIMACRIS

summary:
Clinical audit of in-hospital cardiac arrest management by in situ simulation

Objectives: correct latent safety threats, knowledge gap, and crisis resource management (CRM)

Design: clinical audit, observational sudy. Primary outcome: In Hospital resuscitation scale. Exploratory outcomes: non technical skills, validated stress inventory, and questionnaire on perceptions of the simulation and organisational changes needed.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene

summary: The purpose of this study is to evaluate the safety and tolerability profile of ascending doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.

ipd_sharing: Undecided

lead_sponsor: GenSight Biologics

intervention_type: Genetic


title: Volume or Concentration for the Transverse Abdominal Plane Block in Children Aged 1-5 Years: Analgesic Effects and Safety

acronym: TAP Bloc

summary: The transversus abdominis plane (TAP) block provide a local anesthesia drug diffusion between the transverse abdominis muscle and the internal oblique muscle. TAP block reaches the anterior rami of spinal nerves from T7 to L1 involved in the innervation of homolateral abdominal wall. The transversus abdominis plane block has shown promise for perioperative analgesia, but data on the optimal dose regimen are limited.Following previous research of optimal dose of local anesthesic solution, the investigators aim to evaluate if a "volume effect" would lead to a better diffusion of the local anesthesic solution to the overall nervous roots. The local anesthesia drug choosen is levobupivacaine with a unique posology of 0,4 mg/kg (either 0,2 ml/kg of 0,2% levobupivacaine for "small volume" group or 0,4 ml/kg of 0,1% levobupivacaine for "high volume" group).With the same dose of levobupivacaine, this study aims to assess the impact of volume effect on analgesia efficiency as well as the security as after ultrasound TAP block on one to five years' old children who undergo a peritoneal-vaginal duct surgery.

ReferenceCitation: Sola C, Menacé C, Bringuier S, Saour AC, Raux O, Mathieu O, Capdevila X, Dadure C. Transversus Abdominal Plane Block in Children: Efficacy and Safety: A Randomized Clinical Study and Pharmacokinetic Profile. Anesth Analg. 2019 Jun;128(6):1234-1241. doi: 10.1213/ANE.0000000000003736.

family: Sola

full_name: Chrystelle Sola

given: Chrystelle

family: Menacé

full_name: Cecilia Menacé

given: Cecilia

family: Bringuier

full_name: Sophie Bringuier

given: Sophie

family: Saour

full_name: Anne-Charlotte Saour

given: Anne-Charlotte

family: Raux

full_name: Olivier Raux

given: Olivier

family: Mathieu

full_name: Olivier Mathieu

family: Capdevila

full_name: Xavier Capdevila

family: Dadure

full_name: Christophe Dadure

given: Christophe

journal_name: Anesthesia & Analgesia


title: "Evaluation by Transcranial Magnetic Stimulation of the Benefit of Fluoxetine on Motor Recovery After Stroke"

acronym: EFLUSTIM

summary:
The objective of this study is to better characterize the mechanisms of action of fluoxetine in motor recovery and more specifically to identify the neurophysiological substrate underlying fluoxetine-induced motor recovery in stroke.

In this study, the investigators propose to use transcranial magnetic stimulation (TMS) to assess the effect of a chronic treatment of fluoxetine on corticospinal excitability and integrity.

lead_sponsor: Centre Hospitalier St Anne


title: Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.

acronym: MYELOME-PA

summary: The aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. During the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic changes will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.

lead_sponsor: Nantes University Hospital


title: Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: a Prospective Study in Patients Scheduled for Oncologic High-risk Surgery

acronym: ThermoD-PAC

summary:
Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. We currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. We chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Germany). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique.

In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.

ReferenceCitation: Suria S, Wyniecki A, Eghiaian A, Monnet X, Weil G. Measurement of cardiac index by transpulmonary thermodilution using an implanted central venous access port: a prospective study in patients scheduled for oncologic high-risk surgery. PLoS One. 2014 Aug 19;9(8):e104369. doi: 10.1371/journal.pone.0104369. eCollection 2014.

family: Suria

full_name: Stéphanie Suria

given: Stéphanie

family: Wyniecki

full_name: Anne Wyniecki

given: Anne

family: Eghiaian

full_name: Alexandre Eghiaian

given: Alexandre

family: Monnet

full_name: Xavier Monnet

family: Weil

full_name: Grégoire Weil

given: Grégoire

currency_apc_doaj: USD

journal_name: PLoS ONE

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Measurement of Cardiac Index by Transpulmonary Thermodilution Using an Implanted Central Venous Access Port: A Prospective Study in Patients Scheduled for Oncologic High-Risk Surgery

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris