title: Discovery of New Biomarkers in Pancreatic Cancer Using Novel Nondestructive OMICS Methodology

acronym: PANEXPEL

summary:
The investigators recently engineered a novel biomarker discovery approach that is non-destructive and fully compatible with OMICS profiling as well as routine clinical procedures (5). The latter approach - termed EXPEL - mines the interstitial tissue fluid that is the richest source of soluble, undiluted and uncontaminated biomarkers. The method notably gives access to proteins, metabolites, RNA, DNA and exosomes, thus enabling holistic biomarker discovery. Owing to its non-destructive nature, EXPEL provides for the first time both clinicians and researchers with the opportunity to analyze identical material.

The investigators hypothesize that the conservation liquid used to collect cells and biopsy after endoscopic ultrasound for pancreatic biopsy could contain the tissue secretome and permit a comprehensive OMICS analysis of PDAC (all stages confounded) by using a "modified EXPEL" procedure. These are ideal conditions for EXPEL approach that will additionally to finding novel biomarkers also shed light on complex network of cancer cell-stroma interactions.

ReferenceCitation: Souche R, Tosato G, Rivière B, Valats JC, Debourdeau A, Flori N, Pourquier D, Fabre JM, Assenat E, Colinge J, Turtoi A. Detection of soluble biomarkers of pancreatic cancer in endoscopic ultrasound-guided fine-needle aspiration samples. Endoscopy. 2021 Aug 26. doi: 10.1055/a-1550-2503. [Epub ahead of print]

name: Department of Digestive Surgery and Transplantation, Hôpital Saint Eloi, Centre Hospitalier Universitaire, Université de Montpellier, Montpellier, France

name: Tumor Microenvironment and Resistance-to-Treatment Laboratory, Institut de Recherche en Cancérologie de Montpellier, INSERM U1194, Montpellier, France

name: Institut régional du Cancer Montpellier (ICM), Parc Euromédecine, Montpellier, France

family: Souche

full_name: Régis Souche

given: Régis

name: Cancer Bioinformatics and Systems Biology, Institut de Recherche en Cancérologie de Montpellier, Montpellier, France

name: Centre Hospitalier Universitaire Lapeyronie, Montpellier, France

family: Tosato

full_name: Guillaume Tosato

family: Colinge

full_name: Jacques Colinge

given: Jacques

family: Turtoi

full_name: Andrei Turtoi

given: Andrei

name: Department of Pathology, Hôpital Saint Eloi, Centre Hospitalier Universitaire, Université de Montpellier, Montpellier, France

family: Rivière

full_name: Benjamin Rivière

given: Benjamin

name: Department of Hepatogastroenterology, Hôpital Saint Eloi, Centre Hospitalier Universitaire, Université de Montpellier, Montpellier, France

family: Valats

full_name: Jean-Christophe Valats

given: Jean-Christophe

family: Debourdeau

full_name: Antoine Debourdeau

given: Antoine

name: Clinical Nutrition, Gastroenterology and Endoscopy, Univ Montpellier, Institut régional du Cancer Montpellier (ICM), Montpellier, France

family: Flori

full_name: Nicolas Flori

given: Nicolas

name: Department of Pathology, Institut Régional du Cancer Montpellier (ICM), Montpellier, France

family: Pourquier

full_name: Didier Pourquier

given: Didier

family: Fabre

full_name: Jean-Michel Fabre

given: Jean-Michel

name: Department of Medical Oncology, Hôpital Saint Eloi, Centre Hospitalier Universitaire, Université de Montpellier, Montpellier, France

family: Assenat

full_name: Eric Assenat

journal_name: Endoscopy

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme


type: Other Identifier

title: In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion

acronym: ABGPVVP

summary:
The aim of this study is to analyze the palpation and perforation motion performed by the practitioner during the insertion of a catheter while measuring the loads applied on the skin and the veins.

These experimental measures will be used for the design of a more realistic peripheral venous catheter insertion simulator in order to better prepare healthcare students for their first in vivo venous puncture.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Laboratory of Biomechanics and Impact Mechanics - Centre Hospitalier Lyon Sud

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Efficacy and Safety of Levocetirizine Alone or in Combination With Tranexamic Acid in the Treatment of Spontaneous Chronic Urticaria. Multicentric Controlled Randomized Study in Cross-over, Double-blind

acronym: TACUS

summary:
Spontaneous chronic urticaria (UCS) is a disease that affects 1% of the general population with a potentially severe impact on quality of life. Most patients respond favorably to long-term antihistamine treatment, but sometimes it is necessary to give a high dose (4 times the formal dose, Berlin consensus 2016). These high doses are often accompanied by side effects requiring cessation of treatment. The therapeutic alternative is then omalizumab, an expensive biotherapy. UCS is secondary to non-specific mast cell activation. It has been shown to be associated with activation of fibrinolysis that correlates with the severity of symptoms. Patients with UCS resistant to levocetirizine were shown to have higher D-dimer levels than patients who responded to antihistamines. Tranexamic acid is a molecule with antifibrinolytic propertiesSeveral cases of severe chronic urticaria responding favorably to treatment with tranexamic acid have been reported. In our department, Investigators also noticed the improvement of some of their patients on tranexamic acid. The combination of these two treatments appears to be synergistic: action on histamine receptors and control of fibrinolysis.

The investigators propose to evaluate the association of tranexamic acid and levocetirizine for the treatment of chronic spontaneous urticaria.

status: Recruiting

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Grenoble

intervention_type: Drug

status_simplified: Ongoing


title: Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique

acronym: TADDA

summary: Comparison of ablation technique of drains

primary_purpose: Supportive Care

ipd_sharing: No

lead_sponsor: University Hospital, Rouen


title: " Ilomedin for Treatment of Septic Shock With Persistent Microperfusion Defects ", a Double-blind, Randomized Controlled Trial:The I-MICRO Trial

acronym: I-MICRO

summary: Septic shock remains a major cause of death in critically ill patients. Alterations in microcirculation have long been proposed as a key pathophysiological factor of organ dysfunction and death in septic shock patients. Persistence of mottling, prolonged skin recoloration time and cyanosis of the extremities are the easily and frequently observed manifestations of these microcirculatory disorders. Ilomedin is a prostaglandin analog with a potent vasodilatory effect together with anti-thrombotic properties (inhibition of platelet aggregation) preferentially at the microcirculatory level. An increase in cardiac output with increased arterial oxygen delivery has been observed in clinical and preclinical studies with no episodes of hypotension. Improvement in mesenteric perfusion has moreover been observed in experimental sepsis using Ilomedin. Our group has furthermore reported that administration of Ilomedin in patients with refractory septic shock (peripheral hypoperfusion) resulted in a rapid and sustained improvement in peripheral perfusion. Altogether, Ilomedin may prevent or improve recovery of organ dysfunction in septic shock patients through recruitment of the microcirculation and, thereby, ultimately improve outcome.

ReferenceType: background

ReferenceCitation: De Backer D, Donadello K. Assessment of microperfusion in sepsis. Minerva Anestesiol. 2015 May;81(5):533-40. Epub 2014 Jun 19. Review.

ReferenceCitation: Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G. Mottling score predicts survival in septic shock. Intensive Care Med. 2011 May;37(5):801-7. doi: 10.1007/s00134-011-2163-y. Epub 2011 Mar 4.

ReferenceCitation: Müller B, Schmidtke M. Microvascular effects of iloprost in the hamster cheek pouch. Adv Prostaglandin Thromboxane Leukot Res. 1987;17A:455-8.

ReferenceCitation: Johannes T, Ince C, Klingel K, Unertl KE, Mik EG. Iloprost preserves renal oxygenation and restores kidney function in endotoxemia-related acute renal failure in the rat. Crit Care Med. 2009 Apr;37(4):1423-32. doi: 10.1097/CCM.0b013e31819b5f4e.

ReferenceCitation: Hoeper MM, Gall H, Seyfarth HJ, Halank M, Ghofrani HA, Winkler J, Golpon H, Olsson KM, Nickel N, Opitz C, Ewert R. Long-term outcome with intravenous iloprost in pulmonary arterial hypertension. Eur Respir J. 2009 Jul;34(1):132-7. doi: 10.1183/09031936.00130408. Epub 2009 Feb 27.

ReferenceCitation: Lara B, Enberg L, Ortega M, Leon P, Kripper C, Aguilera P, Kattan E, Castro R, Bakker J, Hernandez G. Capillary refill time during fluid resuscitation in patients with sepsis-related hyperlactatemia at the emergency department is related to mortality. PLoS One. 2017 Nov 27;12(11):e0188548. doi: 10.1371/journal.pone.0188548. eCollection 2017.

ReferenceCitation: Dépret F, Sitbon A, Soussi S, De Tymowski C, Blet A, Fratani A, Legrand M. Intravenous iloprost to recruit the microcirculation in septic shock patients? Intensive Care Med. 2018 Jan;44(1):121-122. doi: 10.1007/s00134-017-4935-5. Epub 2017 Sep 18.

ReferenceType: derived

ReferenceCitation: Legrand M, Oufella HA, De Backer D, Duranteau J, Leone M, Levy B, Rossignol P, Vicaut E, Dépret F; I-MICRO trial investigators. The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial-study protocol for a randomized controlled trial. Trials. 2020 Jul 1;21(1):601. doi: 10.1186/s13063-020-04549-y.

family: Legrand

full_name: Matthieu Legrand

given: Matthieu

sequence: first

family: Oufella

full_name: Hafid Ait Oufella

given: Hafid Ait

sequence: additional

family: De Backer

full_name: Daniel De Backer

given: Daniel

family: Duranteau

full_name: Jacques Duranteau

family: Leone

full_name: Marc Leone

given: Marc

family: Levy

full_name: Bruno Levy

given: Bruno

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Dépret

full_name: François Dépret

given: François

family: Depret

full_name: François Depret

family: Constantin

full_name: Jean-Michel Constantin

family: Ait Oufella

given: Hafid

family: Dureanteau

full_name: Jacques Dureanteau

family: Gaugain

full_name: Samuel Gaugain

given: Samuel

family: Audart

full_name: Jules Audart

given: Jules

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Megarbane

full_name: Bruno Megarbane

family: Pottecher

full_name: Julien Pottecher

given: Julien

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

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

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

repository_institution: California Digital Library - eScholarship

title: The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial—study protocol for a randomized controlled trial

location_facility: Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital


title: L'Etude préopératoire de la Microcirculation Pour la prédiction Des Complications après Une Chirurgie Cardiaque Sous Circulation Extracorporelle.

acronym: MONS

summary:
Cardiac surgery is responsible for many complications. Microcirculation is involved in many of them. The objective of this study is to prospectively investigate the prognostic value of preoperative microcirculatory assessment in patients scheduled for cardiac surgery with CPB for the occurrence of postoperative complications.

Microvascular dysfunction is suspected of being involved in postoperative psycho-cognitive decline. The influence of microcirculation on the evolution of psycho-cognitive assessment is also analyzed in this study.

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceCitation: Abrard S, Fouquet O, Riou J, Rineau E, Abraham P, Sargentini C, Bigou Y, Baufreton C, Lasocki S, Henni S. Preoperative endothelial dysfunction in cutaneous microcirculation is associated with postoperative organ injury after cardiac surgery using extracorporeal circulation: a prospective cohort study. Ann Intensive Care. 2021 Jan 7;11(1):4. doi: 10.1186/s13613-020-00789-y.

family: Abrard

full_name: Stanislas Abrard

given: Stanislas

family: Fouquet

full_name: Olivier Fouquet

given: Olivier

family: Riou

full_name: Jérémie Riou

given: Jérémie

family: Rineau

full_name: Emmanuel Rineau

given: Emmanuel

family: Abraham

full_name: Pierre Abraham

given: Pierre

family: Sargentini

full_name: Cyril Sargentini

given: Cyril

family: Bigou

full_name: Yannick Bigou

given: Yannick

family: Baufreton

full_name: Christophe Baufreton

given: Christophe

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Henni

full_name: Samir Henni

given: Samir

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Intensive Care

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Angers

status_simplified: Completed


title: Retrospective Study of Carotid Surgery in Dijon

acronym: RESCADI

summary:
The results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons.

The indications have evolved with the development of symptomatic stenosis surgery, and results analysis has allowed us to improve our practices.

It would be of great use to have the statistics obtained in previous years to continue improving our practices.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Chronic Cough and Small Fiber Neuropathy

acronym: CHROCOS

summary: Diabetic patients with and without chronic cough will be included in this study. After giving their informed consent, the patients will perform a spirometry, chest X-ray at the inclusion visit. Cough will be assessed using the cough visual analog scale (VAS) and the Leicester Cough Questionnaire (LCQ). Within 60 days, the patient will perform neurophysiological tests. The neurophysiological assessment will be concluded with a skin biopsy to evaluate small fiber neuropathy. The aim of the study is to compare the proportion of small fiber neuropathy between diabetic patients with chronic cough and those without chronic cough.

ReferenceCitation: Chung KF. Chronic 'cough hypersensitivity syndrome': a more precise label for chronic cough. Pulm Pharmacol Ther. 2011 Jun;24(3):267-71. doi: 10.1016/j.pupt.2011.01.012. Epub 2011 Feb 1.

ReferenceCitation: De Santi F, Zoppini G, Locatelli F, Finocchio E, Cappa V, Dauriz M, Verlato G. Type 2 diabetes is associated with an increased prevalence of respiratory symptoms as compared to the general population. BMC Pulm Med. 2017 Jul 17;17(1):101. doi: 10.1186/s12890-017-0443-1.

ReferenceCitation: Pavy-Le Traon A, Fontaine S, Tap G, Guidolin B, Senard JM, Hanaire H. Cardiovascular autonomic neuropathy and other complications in type 1 diabetes. Clin Auton Res. 2010 Jun;20(3):153-60. doi: 10.1007/s10286-010-0062-x. Epub 2010 Mar 31.

ReferenceCitation: Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013 Nov;15(11):948-53. doi: 10.1089/dia.2013.0129. Epub 2013 Jul 27.

name: Strelitz Diabetes Center for Endocrine and Metabolic Disorders and the Neuroendocrine Unit, Department of Medicine, Eastern Virginia Medical School.

family: Casellini

full_name: Carolina M. Casellini

given: Carolina M.

family: Parson

full_name: Henri K. Parson

given: Henri K.

family: Richardson

full_name: Margaret S. Richardson

given: Margaret S.

family: Nevoret

full_name: Marie L. Nevoret

given: Marie L.

family: Vinik

full_name: Aaron I. Vinik

given: Aaron I.

journal_name: Diabetes Technology & Therapeutics

oa_host_type: repository

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

repository_institution: PubMed Central - Europe PMC

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

title: Sudoscan, a Noninvasive Tool for Detecting Diabetic Small Fiber Neuropathy and Autonomic Dysfunction

lead_sponsor: University Hospital, Toulouse

intervention_type: Other


type: Registry Identifier

title: Experimentation of a Protocol of Psychiatric Advance Directives: Randomized Controlled Multi-site Trial

acronym: DAiP

summary:
Severe mental illness is accompanied by cognitive fluctuations that can alter decision-making skills and lead to coerced care. Taking into account, on the one hand, the health, social and economic impact of forced hospitalization, on the other hand the importance of self-determination, the reinforcement of the power to act in the evolution of these disorders, new strategies to better reflect the views of people have been developed.

Among these, the drafting of Advanced Directives in Psychiatric (ADP), allows people with mental disorders to write while their decision-making skills are restored care instructions in case of decompensation.

It is a tool of "advanced therapeutic education" and early prevention of relapses.

It is hypothesized that the implementation of drafting accompanied by advance directives to people with severe psychiatric disorders decreases in the short term the number of forced hospitalization care pathway of these people, compared to the subjects having not benefited from this device.

This research will take the form of a randomized controlled trial on 3 sites. The "quantitative" evaluation component of results and processes will be completed with a qualitative anthropological and socio-political evaluation component documenting the trajectories of individuals and the implementation of the program, as well as a "participatory research" component aimed at a dialogue between users, researchers and professionals.

The patient who is a beneficiary of the "Advanced Directives in Psychiatric" program will be encouraged to complete the " Advanced Directives in Psychiatric" document and will receive support in drafting them. The non-beneficiary patient of the program will follow up with his psychiatrist unchanged.

The experimental design of the quantitative component is based on an experimental, randomized, prospective, controlled, parallel study, comparing two groups of subjects with severe psychiatric disorders.

This research will assess the effectiveness, efficiency and impact of the " Advanced Directives in Psychiatric" program compared to conventional psychiatric care alone.

Ultimately, the objective of describing the effects of the program on health organizations and on the representations and practices of professionals, caregivers and users is at the service of a better understanding of the conditions of possibility of the generalization of this experimentation.

ReferenceCitation: Tinland A, Leclerc L, Loubière S, Mougeot F, Greacen T, Pontier M, Franck N, Lançon C, Boucekine M, Auquier P. Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial - DAiP study. BMC Psychiatry. 2019 Dec 27;19(1):422. doi: 10.1186/s12888-019-2416-9.

family: Tinland

full_name: Aurélie Tinland

given: Aurélie

family: Leclerc

full_name: Léa Leclerc

given: Léa

family: Loubière

full_name: Sandrine Loubière

given: Sandrine

family: Mougeot

full_name: Frederic Mougeot

given: Frederic

family: Greacen

full_name: Tim Greacen

given: Tim

family: Pontier

full_name: Magali Pontier

given: Magali

family: Franck

full_name: Nicolas Franck

given: Nicolas

family: Lançon

full_name: Christophe Lançon

family: Boucekine

full_name: Mohamed Boucekine

given: Mohamed

family: Auquier

full_name: Pascal Auquier

given: Pascal

bso_classification: Social sciences

journal_name: BMC Psychiatry

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

title: Psychiatric advance directives for people living with schizophrenia, bipolar I disorders, or schizoaffective disorders: Study protocol for a randomized controlled trial – DAiP study

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Behavioral


title: Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study

acronym: NBHS

summary:
Hair toxicological analysis is nowadays a complementary technique to blood and urinary analyses because it allows a better detection of xenobiotics in time.

The detection of xenobiotics is expressed in hours in blood and in days in urines; it is several months in the hair. So, hair makes it possible to establish a retrospective timetable of consumption and exposure to xenobiotics.

In newborns, hair has different morphological characteristics than adults' hair. It is thinner, more porous and the development phases are not the same.

Nevertheless, it is recognized that the absorption mechanisms of xenobiotics in newborns' hair are similar to those of adults. On the other hand, some difficulties of interpretation and discernment are observed between in utero exposure and environmental exposure after birth.

It is interesting to have data to estimate the absorption of psychoactive substances in newborns' hair following an utero exposure.

The main objective of this project is to study the mechanisms of incorporation of psychoactive substances administered to the mothers during pregnancy in newborns' hair.

study_start_date_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction


title: Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

summary:
Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines.

The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.

location_facility: Hôpital Pasteur 2 - Service d'Ophtalmologie


title: R-WITT Study : Revaluation of Wells' Clinical Prediction Score in Inpatients With Thromboprophylaxis Treatment

acronym: R-WITT

summary: This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an inpatient population; and the weight of the presence of thromboprophylaxis treatment on the score, and (2) evaluating the correlation of a risk stratification established between a physician specialised in thrombosis and any other doctor.

time_perspective: Prospective

ReferenceCitation: Trihan JE, Adam M, Jidal S, Aichoun I, Coudray S, Laurent J, Chaussavoine L, Chausserie S, Guillaumat J, Lanéelle D, Perez-Martin A. Performance of the Wells score in predicting deep vein thrombosis in medical and surgical hospitalized patients with or without thromboprophylaxis: The R-WITT study. Vasc Med. 2021 Jun;26(3):288-296. doi: 10.1177/1358863X21994672. Epub 2021 Mar 22.

name: Vascular Medicine Department, University Hospital Poitiers, Poitiers, France

family: Trihan

full_name: Jean-Eudes Trihan

given: Jean-Eudes

name: Vascular Medicine Department, University Hospital Nîmes, Nîmes, Languedoc-Roussillon, France

family: Adam

full_name: Michael Adam

given: Michael

family: Jidal

full_name: Sara Jidal

given: Sara

family: Aichoun

full_name: Isabelle Aichoun

given: Isabelle

family: Coudray

full_name: Sarah Coudray

given: Sarah

family: Laurent

full_name: Jeremy Laurent

given: Jeremy

name: Vascular Medicine Department, University Hospital Caen, Caen, Basse-Normandie, France

family: Chaussavoine

full_name: Laurent Chaussavoine

given: Laurent

family: Chausserie

full_name: Sebastien Chausserie

given: Sebastien

family: Guillaumat

full_name: Jerome Guillaumat

given: Jerome

family: Lanéelle

full_name: Damien Lanéelle

given: Damien

family: Perez-Martin

full_name: Antonia Perez-Martin

given: Antonia

journal_name: Vascular Medicine

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Diagnostic Test


title: Multiple Drug Hypersensitivity Syndrome in a Large Database

acronym: MDH

summary:
Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the basis of positive allergy tests are lacking.

Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a large database.

Methods: All the patients who consulted and were tested in our Allergy Unit between September 1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD). The frequency of MDH will be calculated, MDH patients will be described, the most frequent associations of DHRs will be identified and analysed.

lead_sponsor: University Hospital, Montpellier


title: Secondary Intention Wound Healing Versus Axillary Perforator Flaps for Axillary Reconstruction, After Surgical Wide Excision for Hidradenitis Suppurativa : a Randomized Multicentered Controlled Trial

acronym: HS-PAX

summary:
Hidradenitis Suppurativa (HS) is a recurrent inflammatory disease (< 2 episode /6 months) with 1%-4% prevalence in Europe. Suppurating lesions are painful and involve one or more regions (axilla, genitofemoral, perineum, gluteal areas and inframammary, creases).

For recalcitrant stage II and III, wide surgical skin excision is the only recommended and validated treatment in case inefficacity of medical conventional systemic therapies or limited-local surgery.

Perforator Flaps (PF) surgery, are a new and innovative surgical technique, that, unlike secondary wound healing, allows a single stage reconstruction at the same time as skin excision without its disadvantages.: prolonged healing time, with multiple painful dressings (costs) retractile scar with reduction of the range of motion, dyschromia, unstable and fragile scar.

The hypothesis of study is a 30% reduction of time to healing by using perforators flaps technique (PF) versus wound healing (SIWH), for axillary reconstruction after surgical wide excision in axillary hidradenitis suppurativa stage II or III in adults with inadequate response to conventional systemic therapy.

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service PREMIER ( Plastique, Reconstruction, Esthétique, Microchirugie et Régénération tissulaire)CHU TENON- APHP


title: BIOLOGICAL EXPLORATION OF THE VASCULAR FRACTION FROM THE ADIPOSE TISSUE OF PATIENTS WITH SCLERODERMIA IN THE CONTEXT OF THE DEVELOPMENT OF AN INNOVATIVE CELLULAR THERAPY FOR THE TREATMENT OF FUNCTIONAL HANDICAP OF THE HAND

acronym: sclerabio

summary:
The overall objective is to propose a comprehensive analysis of the biological properties of the stromal vascular fraction evaluated in the SCLERADEC 2 clinical trial (n = 15 available) and preserved in the biological collection, compared to healthy donors (n = 10). This characterization will focus on the exploration of the phenotypic and functional characteristics of the main cellular subpopulations present in the stromal vascular fraction of scleroderma patients likely to be associated with a better regenerative vascular or anti-fibrotic activity of the cell therapy product.

The main objective will be to validate whether the supposed mechanism of action of this innovative therapy, in relation to the representativity of the endothelial progenitors, carrying the vascular regeneration activity, is preserved in the sclerodermic context.

A total of 30 subjects (20 systemic Scleroderma patients and 10 healthy donors) will be included.

location_facility: Direction de la Recherche Clinique et Innovation

intervention_type: Biological


title: Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients

acronym: SIVOC

summary:
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. Propofol is recommended for this purpose, injected administered in slow IV bolus injections according to the technique known as manual titration. But despite this precaution, temporarily excessive sedation can happen, and a side effect can appear (arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise constant and stable concentration of medication, boluses volumes of injection being calculated and delivered automatically by an electric syringe equipped with a software obedient to existing pharmacokinetic models. In the operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2 to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in emergency departments (ED), the brain propofol concentrations which are necessary for sedation and awakening of the patient are not known and must be determined experimentally.

In this single-center, prospective, interventional study, safety and feasibility of TCI will be studied in one ED with the primary objective of determining the brain propofol concentrations necessary to reach the an optimal sedation in for patients with indications of sustaining very painful orthopedic emergency emergent procedures


title: Diagnosis and Definition of Local Involvement of Musculoskeletal Tumors: Assessment of Ultra-high Field MRI Exploration Contribution

summary:
Sarcomas are aggressive malignant tumors issued from mesenchymatous cells. Their curative treatment is mainly surgical, especially in soft tissue sarcomas, which are mostly localized in limbs. Surgical margins remain a major prognosis factor and are directly linked to recurrence risk. Curative surgery applies resection margins removing healthy tissue surrounding the tumor and is meticulously planned thanks to tight cooperation between expert surgeons and radiologist, based on pre-operative Magnetic resonance imaging(MRI). Resection planning optimizes chances to perform a safe carcinological resection procedure sparing these structures. Resection planning is based upon conservation (or sacrifice) of anatomic compartments limited by fascia and routine MRI might also be outdated in some cases to predict whether the fascia is involved in the tumor or not. Such uncertainties complexify the surgical procedure, lead to unnecessary healthy tissue sacrifices and increase functional impairments, which can be significant. A new MRI offering higher spatial resolution could allow tumoral satellites, previously undetected on conventional MRI, which might explain some of the observed recurrences. Ultra-high field MRI, considered as harmless and without pharmaceutical agent injection, could bring benefits to tumoral extension comprehension and should be considered as a breakthrough in medical oncology field. This is particularly true in soft tissue sarcoma pathology field, where the only curative treatment to date remains surgery.

It will be propose in this project to determine the contribution of ultra-high field MRI in Soft tissue sarcomas management and to evaluate for the first time the potential superiority of 7 Tesla imaging over routine MRI through usual data comparison in 20 patients between 1,5Tesla and 7 Tesla MRI.

intervention_type: Device


title: Five-year Mortality Rate in People With Diabetic Foot Ulcer

acronym: DIAFOOT

summary:
As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU).

This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM


title: Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.

acronym: TOPP PLAGIO

summary:
Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull.

The main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.

the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months.

Methodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months.

Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice.

The perspectives are:

the decrease in the prevalence of CPP after early osteopathic treatment.
Defining a decision algorithm for early osteopathic treatment.
Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.

primary_purpose: Prevention


title: Diagnostic Accuracy of the Central Venous Pressure (CVP) Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients

acronym: VPVC

summary:
Volume expansion (VE) is often administered in intensive care (ICU)-patient to improve arterial oxygen delivery. Such effect is secondary to an increase in stroke volume and cardiac output. However, cardiac output increase in response to VE (fluid responsiveness) only occurs when the heart is preload-dependant. Increasing evidence of the deleterious effects of inappropriate fluid administration encourages the development of variables predicting fluid responsiveness, but few have been validated in spontaneously breathing patients.

Central venous pressure (CVP) variation in spontaneously patients during standardized or unstandardized inspiratory maneuver may represent an easy tool to predict fluid responsiveness. The hypothesise is that inspiratory maneuver may increase CVP variation in fluid responsiveness patient whereas no or few variation may reflect fluid unresponsiveness.

lead_sponsor: University Hospital, Lille


title: Efficacy of Cryoablation of Abdominal Wall Endometriosis: a Phase II Trial

acronym: CRYOENDOMET

summary: The aim of this study is to evaluate for the first time prospectively the efficacy on the symptoms and the tolerance of percutaneous cryoablation performed under radiological guidance of endometriosis of the abdominal wall in alternative to surgery after validation in multidisciplinary meeting.


title: Manual Versus Assisted Fluid Management in Patients Undergoing Major Abdominal and Orthopedic Surgery: A Randomized Controlled Trial

acronym: AFM

summary: This study will compare a group of patients managed with a manual GDFT protocol (using the EV1000 monitoring device; Edwards Lifesciences, Irvine, USA) to a group of patients managed using a decision support system for GDFT guidance (implemented on the same EV1000 monitoring) in patients undergoing major abdominal and orthopedic surgery.

status: Withdrawn

lead_sponsor: Erasme University Hospital


title: Regulation of CCL18 by Corticosteroids in Severe Asthma

summary: The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.


title: Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated With Rituximab

acronym: EXPRIME

summary:
Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases.

The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.


title: Retrospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circuferential Body Lift

summary: The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


title: The Calming Effect of Vanilla Odor on Preterm Infant Without Mother's Breast Milk Feeding

acronym: VANILLE

summary:
Pain is a frequent occurrence during the early life of premature newborns. Studies on the short term effects of pain, and potential for long-term ones, have shown that pain affects various physiological and behaviorial parameters. Sucrose during a painful procedure reduce behaviorial and cardiac manifestations in preterm infant, but a recent study casts doubt on its efficacy. Analgesic treatments are available, but a large number of experimental studies in animals ended up with questioning the safety of their use in neonates, particularly in premature ones. Soothing and analgesic methods have been developed such nonnutritive suckling, sucrose, skin to skin contact, and breastfeeding. Therefore, it is important to explore other methods of analgesia. Recently, the role of olfaction as a soothing tool in full term newborns was examined in several studies. The olfactory system is more mature at birth than the others senses. The neonates reacted with significant facial and respiratory changes to low concentration of olfactory stimuli during the various behaviorial states. The analysis of olfacto-facial configurations revealed that behaviorial markers of disgust discriminated between some odors judged as pleasant and unpleasant by adults rather.

Objective The study was designed to assess the analgesic effect of vanilla odor on preterm neonates. The primary outcome was the Premature Infant Pain Profile (PIPP) score. The secondary outcomes were: the French scale Faceless Acute Neonatal pain Scale (FANS), salivary cortisol.

Study design This is a prospective, randomized, controlled, double-blind and monocentric trial. It is conducted in a level III maternity unit at the North Hospital in Marseille. The infant will feed without their own mother's breast milk, clinically stable, born between 30 and 36 weeks and 6 days gestational age, and of less than 10 days postnatal age. In both groups, the painful stimulus is a venipuncture for blood collection. In the experimental group, called "vanilla odor" group, the venipuncture will be performed on the neonate in the presence of a diffuser spreading the vanilla odor and ingestion of water. In the control group, the venipuncture will be performed with an odorless diffuser and ingestion of sucrose. Both group have non nutritive sucking. The diffuser will place under a Hood with an air-flow of 7 l/min. It will manually switch on 3 minutes before the venipuncture and switch off 3 minutes later. The type and quantity of vanillin to be used were determined during a pre-testing phase. Assessment Scale shows significant improvement in the neonates, with good interobserver agreement.

Attempt results A current randomized study compare effects of breast milk and vanilla odors, on premature neonate's pain during and after venipuncture. Our previous study has shown that maternal breast milk odor in preterm neonates reduces PIPP scores during a venipuncture and markedly reduces crying after this procedure. Therefore, from a clinical perspective, the odor of mother's own breast milk has an analgesic effect on the premature neonate. Olfactory stimulation using maternal breast milk odor could have other clinical implications in neonatal medicine in addition to pain prevention, as does olfactory stimulation with a pleasant vanilla-based odor. It could be integrated into developmental care of premature neonates.


title: Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy

summary:
Several studies have reported a deficit and/or a defect in regulatory T cells in allergic subjects, which can be correlated with the allergic responses, especially for respiratory allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2 would control allergic responses.

This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch allergen exposure.

status: Suspended


title: Impact of Juvenile Obesity on Emotional Memory and Functional Connectivity Between the Amygdala and the Hippocampus

acronym: OBETEEN

summary: Recent studies indicate that obese teenagers exhibit memory disturbances. Adolescence represents a crucial period in the development of the hippocampus and the amygdala, necessary for the implementation of memory and emotional functions for the rest of life. Disturbances of the interaction between amygdala and hippocampus during adolescence have been associated with the development of neuropsychiatric disorders. However, the impact of juvenile obesity on functional amygdala-hippocampus connectivity has not been evaluated yet. The main objective of this study is to compare the emotional memory performance and the level of functional connectivity between the hippocampus and the amygdala during the realization of an emotional associative memory task, in obese and control adolescents.

primary_purpose: Basic Science

ReferenceType: result

ReferenceCitation: Vértes PE, Bullmore ET. Annual research review: Growth connectomics--the organization and reorganization of brain networks during normal and abnormal development. J Child Psychol Psychiatry. 2015 Mar;56(3):299-320. doi: 10.1111/jcpp.12365. Epub 2014 Dec 1. Review.

apc_source: openAPC

name: Behavioural and Clinical Neuroscience Institute Department of Psychiatry University of Cambridge Cambridge UK

name: Cambridgeshire and Peterborough NHS Foundation Trust Cambridge UK

family: Vértes

full_name: Petra E. Vértes

given: Petra E.

name: ImmunoPsychiatry, Alternative Discovery and Development GlaxoSmithKline Cambridge UK

family: Bullmore

full_name: Edward T. Bullmore

given: Edward T.

journal_name: Journal of Child Psychology and Psychiatry

oa_colors: green hybrid

evidence: open (via crossref license)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Annual Research Review: Growth connectomics – the organization and reorganization of brain networks during normal and abnormal development

lead_sponsor: University Hospital, Bordeaux


title: Characterization of Cortical Injury in Early MS Patients: a 7T MRI Study

summary:
The main aim of the present study is to assess the prevalence, the topography and the clinical counterpart of cortical lesions in patient included early after the first clinical episode of multiple sclerosis. A second aim is to assess the direct contribution of cortical lesions - independent of WM injury - on the diffuse grey matter damage.

Thirty MS patients will be included in the six months after the first clinical episode of multiple sclerosis for a monocentric transversal MRI study at 7T to assess cortical MS injury. Clinical (EDSS) and neuropsychological assessments will be performed in the population the same day of a multi-parametric MRI. MRI protocol is designed to increase the detection rate of CL using multiple contrasts at high isotropic resolution (600µm3) on a whole brain exploration. Thus, MRI acquisition will include MP2RAGE, T2*, FLAIR and DIR as previously published but also recent MRI technique like FLAWS, focusing on the grey matter by attenuating the white matter and CSF signal. Finally, QSM sequences will be performed. QSM measures tissue magnetic susceptibility mostly influenced by iron, myelin and calcium content in the brain. Due to physical properties of the technique (bipolarity), we suppose that high resolution QSM will be more sensitive that previous used sequences to depict cortical lesions. Using this multi-contrast approach with relevant MRI sequence and with a high resolution whole brain exploration might improve the detection of CL in early MS.

Furthermore, MRI protocol allow us to estimate neuronal loss (T1 relaxation time), myelin and iron content (QSM and T2* relaxation time) within and outside cortical lesions in GM.

The present study is an opportunity to assess cortical pathology in MS from the onset of the disease, allowing to a better understanding of its origins and its impact and disease severity. This study is a preliminary requirement to longitudinal studies to precisely depict the kinetic of cortical lesion accumulation and the links with disease aggravation.

location_facility: Assistance Publique Hopitaux de Marseille


title: Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening

summary: Dosage of progastrin in asymptomatic person participating in colon cancer screening

ipd_sharing_description: Monocentric study; No IPD sharing

lead_sponsor: ECS-Progastrin SA

location_facility: Centre Hospitalier Princesse Grace, Monaco

lead_sponsor_type: industriel


title: Optimizing the Management of Patients With Oral Therapy: a Randomized Trial Evaluating the Impact of Management on the Occurrence of Side Effects

acronym: IPAC

summary:
Oral anticancer treatments account a quarter of cancer treatments. These oral treatments are allowed at home, avoid hospitalization and limit the use of central venous routes. Oral treatments cause many side effects and patients are reluctant to report them because they are afraid that their treatment will be changed. But when these side effects are poorly managed, they can reduce adherence to treatment.

The main hypothesis of this randomized study is that the combination of an initial consultation with a trio (nurse, doctor, pharmacist) and a weekly telephone nurse follow-up during the administration of oral anticancer treatments decreases the rate and duration of side effects.

The main objective is to evaluate the impact at 3 months of a optimized management by an initial consultation with a trio nurse, doctor, pharmacist and a weekly nurse telephone follow-up versus a standard management on the level of digestive, skin and mucosal side effects of grade 3 in patients with oral chemotherapy.

This randomized study is realized in patients with kidney or breast cancer.

lead_sponsor: Centre Georges Francois Leclerc


title: Evolution of Dyspnea After Bariatric Surgery in Patient With Obesity

acronym: OBES-DYSP

summary: Obesity, defined as a Body Mass Index greater than or equal to 30 kg/m2, represents a significant public health issue. Dyspnea is a very common and crippling symptom in obesity. About 80% of people with obesity experience dyspnea in daily living. Bariatric surgery has been demonstrated to be an excellent treatment for obesity by inducing significant weight loss. Nevertheless, changes in dyspnea in daily living after bariatric surgery and the links between variations in dyspnea and lung function tests after bariatric surgery have not been previously investigated.

ReferenceCitation: Boissière L, Perotin-Collard JM, Bertin E, Gaubil I, Diaz Cives A, Barbe C, Dury S, Nardi J, Lebargy F, Deslée G, Launois C. Improvement of dyspnea after bariatric surgery is associated with increased Expiratory Reserve Volume: A prospective follow-up study of 45 patients. PLoS One. 2017 Sep 20;12(9):e0185058. doi: 10.1371/journal.pone.0185058. eCollection 2017.

lead_sponsor: CHU de Reims


title: Clinical Aspect of Erosive Pustular Dermatosis of the Leg

acronym: Clin-EPDL

summary:
Erosive pustular dermatosis of the leg is a fairlyrecent clinical entity that was described the first time in 1987.

Diagnosis of erosive pustular dermatosis of the leg is made on clinical grounds. It presents as non-follicular pustules of variable size and numbers that rapidly give way to erosions and crusts on one or both legs, and which are found in particular on the anterior aspect of the middle third of the leg (. The lesions are of chronic progression, despite topical therapy. Erosive pustular dermatosis of the leg is seen in elderly patients, mainly female, and may be associated with chronic venous insufficiency or cutaneous atrophy. In the absence of specific criteria and because of the existence of misleading clinical forms, diagnosis is based upon exclusion.

ReferenceCitation: Nicol P, Perceau G, Barbe C, Bernard P; members of GAD. Erosive pustular dermatosis of the leg: A prospective, multicentre, observational study of 36 cases. Ann Dermatol Venereol. 2017 Oct;144(10):582-588. doi: 10.1016/j.annder.2017.02.007. Epub 2017 May 19.


title: Influence of the Radiological Stage on the Efficiency of Intra-articular Injection of Hyaluronic Acid in Basal Thumb Arthritis

acronym: INSTINCT

summary:
The rhizarthrose is the most frequent affection of the hand at the age fifty and beyond. For the moderate forms of the disease, the majority of the studies recommend the recourse to the viscosupplement because of its efficiency in the long term.

On the other hand, no study was focused on the impact of the anatomical severity on the clinical result of the treatment by intra-articular injection of hyaluronic acid.

The present research has for objective to study the influence of the radiological severity on the result of the viscosupplement, in the conditions of daily practice, in patients affected by rhizarthrose.

It is an open observational multicentrical prospective study realized by 10 investigators rheumatologists and liberal orthopedic surgeons. The recruitment is competitive and the study will be ended when 55 patients will have been included by taking into account a risk of trial exits or of lost of sight of 10 %.The main criterion is the influence of the radiological stage on the answer to the treatment.

Duration of inclusion 6 months. Duration of follow-up 3 months. Total duration of the study 9 months.

lead_sponsor: Labrha


title: De-escalation of Antifungal Treatment in Immunocompromised Critically Ill Patients With Suspected Invasive Candida Infection: Incidence, Associated Factors, and Safety

acronym: D-ATFIM

summary:
A small proportion of intensive care unit patients receiving antifungals have a proven invasive fungal infection. However, antifungal treatment has side effects such as toxicity, emergence of resistance, and high cost. Moreover, empirical antifungal treatment is still a matter for debate in these patients. Our study aimed to determine the incidence, associated factors, and safety of de-escalation of antifungals in immunocompromised critically ill patients.

This prospective observational study is conducted in 14 ICU, during a 6 months period. All immunocompromised patients hospitalized for >5d and treated with antifungals for suspected or proven invasive candida infection will be included De-escalation is defined as a reduction in antifungal spectrum or stopping initial drugs within the 5 days following their initiation. The three antifungals considered in this study are from the narrowest to the widest spectrum: fluconazole, caspofungin and liposomal amphotericin B.


title: Strengthening Equilibrium and Educational Support in Preventing Falls in the Thermal Center

acronym: RESPECT

summary: Preventing falls among people 65 years of age or older is a priority to promote healthy aging and reduce the number of hospitalizations, institutionalizations and years lived with disability. A preliminary study carried out at the Balaruc-les-Bains Thermal Center showed that one-third of people aged 65 are at significant risk of falling. Thermal establishments could therefore play a role in initiating measures to prevent falls among people aged 65 and over screened at risk.The main objective is to evaluate the impact on the incidence of falls at 12 months (M12) to add to the usual care (control group) a program combining, during the treatment, adapted physical activities (APA) and a Therapeutic patient education (FTE) followed by an educational follow-up for 12 months (intervention group) for people aged 65 and over who were at risk of falling on arrival at the Thermal


title: Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

acronym: TargetOH

summary: The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease


title: A Comparative Pharmacokinetic Study in Healthy Volunteers to Evaluate the Ability of TURMIPURE GOLD Formulation to Enhance the Bioavailability of Curcuminoids

acronym: TURBIO

summary:
The rhizome of Curcuma longa (turmeric) is commonly used as a spice and for its medicinal properties traditionally in Asian countries. Turmeric extract usually contains 95% curcuminoids with a specific ratio (approximately 75-80% curcumin, 15-20% demethoxycurcumin (DMC), and 0-10% bisdemethoxycurcumin (BDMC)).

Curcuminoids have higher solubility in organic solvents than in water. As a consequence, curcuminoids have low aqueous solubility and poor gastrointestinal absorption. They also exhibit rapid metabolism and systemic elimination and are therefore known to have limited bioavailability, which limits the use of turmeric extract in general health care and as an adjunct in managing various diseases. In order to improve the bioavailability of curcumin, several approaches have been undertaken. The use of adjuvant like piperine that interferes with glucuronidation; liposomal curcumin, nanoparticles, phospholipid complex; and structural analogues of curcumin.

Recently, Naturex has developed a dried emulsion formulation using a turmeric extract mixed together with a quillaja extract, sunflower oil and arabic gum. This formulation is highly dispersible in water and should therefore improve the bioavailability of curcuminoids. The aim of this study is to assess the bioavailability of curcuminoids and their metabolites after oral intake of 4 turmeric extract-based formulations in comparison to a standard unformulated turmeric extract.

ReferenceCitation: Fança-Berthon P, Tenon M, Bouter-Banon SL, Manfré A, Maudet C, Dion A, Chevallier H, Laval J, van Breemen RB. Pharmacokinetics of a Single Dose of Turmeric Curcuminoids Depends on Formulation: Results of a Human Crossover Study. J Nutr. 2021 Jul 1;151(7):1802-1816. doi: 10.1093/jn/nxab087.

family: Fança-Berthon

full_name: Pascale Fança-Berthon

given: Pascale

family: Tenon

full_name: Mathieu Tenon

given: Mathieu

family: Bouter-Banon

full_name: Sabrina Le Bouter-Banon

given: Sabrina Le

family: Manfré

full_name: Alexis Manfré

given: Alexis

family: Maudet

full_name: Corinne Maudet

given: Corinne

family: Dion

full_name: Angelina Dion

given: Angelina

family: Chevallier

full_name: Hélène Chevallier

given: Hélène

family: Laval

full_name: Julie Laval

given: Julie

name: Linus Pauling Institute, Oregon State University, Corvallis, OR, USA

family: van Breemen

full_name: Richard B van Breemen

given: Richard B

journal_name: The Journal of Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Naturex SA

intervention_type: Dietary Supplement


title: Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity

acronym: Paracetamol

summary:
Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT).

Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity.

Methods:This retrospective study, using the survival analysis and the multivariate analysis, will comprise all patients who attended the allergy service of the University Hospital of Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who underwent Paracetamol DPT and who gave their consent to be included in the study. The patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).


title: Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center

summary: Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)

lead_sponsor: Hospices Civils de Lyon


type: EudraCT Number

title: Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Disease : Multicentric Randomized Phase III Trial

acronym: CATR-PAT

summary:
"Antisynthetase syndrome (ASS) is one of the most severe inflammatory myopathy (IM), due to pulmonary involvement (interstitial lung disease, ILD). Until now, the most commonly used immunosuppresive therapy in Europe is Cyclophosphamide followed by different immunosuppressive drugs as maintenance therapy, including Azathioprine (and so called " European Strategy "). In the USA however, the first-line immunosuppressive treatment is Tacrolimus (so called " American Strategy "). None of these two different strategies has ever been studied prospectively, and there is no clear comparison of short and long-term treatment efficacy and tolerance. Thus, there are yet no evidences helping the clinicians in the therapeutic management of patients with ASS-related ILD.

The aim of this study is therefore to compare both strategies as first line treatments or in relapsing patients : CATR.PAT study is a 52 weeks, randomized, comparative, controlled, open-labeled, phase III, therapeutic clinical trial, comparing two treatment strategies."


title: Attentats - Continuité Des Soins

summary: On November 13th 2015, a terrorist attack killed 129 victims in Paris. An emergency crisis unit (CUMP) has been activated in Paris in the days following the attack and a subunit was in charge to answer to the phone calls of victims and their relatives. The same emergency crisis unit have been activated for the terrorist attack in London, 2017 june 3, terrorist attack in Barcelone 2017 august 17-18, terrorist attack in Strasbourg 2018 December 11 The purpose of this observational study is to document the evolution of psychiatric symptoms among subjects who called the CUMP and to collect information about the type of medical or non-medical care they were seeking for.


lead_sponsor: University Hospital, Limoges

acronym: DFG HEP

source: euctr

title: Description of the Evolution of Plasma and Urinary Concentrations of Iohexol in a Cirrhotic Patient Population: "Pilot Study on 9 Patients"

summary:
Background: It is important to accurately assess the glomerular filtration rate (GFR) of patients with liver diseases, particularly cirrhosis, to deliver care and adjust the drugs' posology.

Purpose: The frequency of chronic renal failure is underestimated in patients with advanced liver disease and the difficulty to assess kidney failure justifies the investigator's study, which aims to describe, by means of a population pharmacokinetic model, the evolution of plasma and urinary concentrations of iohexol, an effective non-ionic, water-soluble contrast agent which is used in radiographic procedures, in cirrhotic patients.


title: Production et Perception émotionnelle Chez Les Patients paralysés Faciaux: Marqueurs Respiratoires, Phonatoires et expressivité Faciale.

acronym: ResPPF

summary:
Respiratory function, phonation and facial expressivity are related to emotional reaction through neurophysiological process. Specific emotional respiratory, vocal and facial patterns had been described in literature. Respiratory cycles variation is modulated by stimulus arousal. Furthermore, inspiratory-to-expiratory time ratio in abdominal area is modulated by emotional valence. Inextricably linked to respiration, vocal production depends on emotional arousal and valence too.

According to embodied cognition, the effector pattern of an emotion initiates the corresponding subjective activation. Facial recognition is influenced by automatic mimicry and facial feedback. Most facial feedback studies included patients with diplegia but few studies dealt with emotional perception in Bell's palsy.

The aim of the present study is to understand production and perception of emotion in Bell's palsy with respiratory, vocal and facial markers. What impact lack of mimicry have on physiological emotional reaction in Bell's palsy? To this end, prospective monocentric study will be conducted with 60 patients with Bell's Palsy from grade II to grade VI of House & Brackmann's scale. During production and perception of vocal and facial expression, respiratory rate and thoraco-abdominal movements will be analyzed. The investigators hypothesize that severity of facial deficit is negatively correlated with variation of respiratory cycles, lower segmental and suprasegmental changes during vocal expression, and lower facial perception (congruency and arousal).

primary_purpose: Screening

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation


title: Necrotizing External Otitis : Study in a Regional Bone and Joint Infection

summary: The malignant external otitis is a rare disease which arises more frequently at the elderly and the diabetics patients. To our knowledge, there are few data and it is not wellc known byclinicians. Nevertheless it exposes to neurological complications potentially serious and crippling.


title: Study of the Effects of Farnesoid X Receptor (FXR) Ligands on the Reactivation of Latent Provirus in Circulating CD4 + T Cells Isolated From Patients With Undetectable HIV Viremia Under cART

acronym: FXReservoir

summary:
The Farnesoid X receptor (FXR) is a nuclear receptor that controls the transcription of many genes involved in lipid and glucose metabolism. A recent study opens the hypothesis that Farnesoid X receptor also participates in deoxyribonucleic acid repair mechanisms and possibly in the fight against cell invasion by foreign genomes. This hypothesis implied that modulation of Farnesoid X receptor by ligands could modify Human Immunodeficiency Virus replication. The results of in vitro studies with Human Immunodeficiency Virus-infected cell lines indicate that indeed the modulation of Farnesoid X receptor activity by its ligands induces stimulation of virus production rapidly followed by cell death; the overall effect is therefore antiviral. Farnesoid X receptor ligands have also shown an effect on the reactivation of proviruses in cellular models of viral latency studies. This last data raises the hope of being able to intervene on the reservoir of Human Immunodeficiency Virus.

It is therefore crucial to confirm on quiescent CD4 + T lymphocytes of patients whose viral load is controlled by antiretroviral treatment combining several antiretrovirals the results obtained with the in vitro models.

Providing proof of concept that Farnesoid X receptor agonists can reactivate latent proviruses will open new therapeutic perspectives for attacking the Human Immunodeficiency Virus reservoir with a view to achieving a functional cure for Acquired Immune Deficiency Syndrome. The objective of the study is to confirm ex vivo the data obtained in vitro with cellular models and laboratory viral strains. It is therefore necessary to show that Farnesoid X receptor agonists can reactivate latent viruses or proviruses present in quiescent CD4 + T circulating lymphocytes prepared from venous blood of HIV-positive patients under cART. Human Immunodeficiency Virus-positive patients will be any patients, irrespective of the viral genotype, who initiated antiretroviral therapy, regardless of the combination of antiretrovirals, away from primary infection, when they already had a complete western blot, indicating an evolution of the infection without treatment and constitution of an already evolved reservoir. Patients will have had an undetectable viral load since initiation of treatment with a follow-up of at least one year and will have at least 500 CD4 + T lymphocytes / mm3.

location_facility: Service des maladies infectieuses et tropicales - Hôpital de la Croix Rousse - GHN


title: Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours

acronym: AVAAS

summary:
Stroke is a common disease. It is increasingly managed in non-specialized centers.

The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.

There is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.

The Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.

Manual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study

acronym: GOALDAN

summary:
The primary purpose of GOALDAN study is to demonstrate the superiority of a targeted perioperative analgesic strategy by the ANI over the usual practice on the incidence of immediate postoperative pain.

The investigators hypothesized that a prophylactic administration of morphine in patients with risk of postoperative pain determined by the ANI at the end of the intervention would reduce the incidence of immediate postoperative pain and that the targeted analgesia to ANI and minimal alveolar concentration (MAC) of desflurane could improve the perioperative hemodynamic, and the postoperative becoming.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study

summary:
The aim of this study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset.

This is a monocentric, randomized, parallel group, prospective and open-label study.

status: Active, not recruiting

ReferenceCitation: Garnier L, Tonetti J, Bodin A, Vouaillat H, Merloz P, Assaker R, Court C; French Society for Spine Surgery. Kyphoplasty versus vertebroplasty in osteoporotic thoracolumbar spine fractures. Short-term retrospective review of a multicentre cohort of 127 consecutive patients. Orthop Traumatol Surg Res. 2012 Oct;98(6 Suppl):S112-9. doi: 10.1016/j.otsr.2012.03.018. Epub 2012 Aug 28.

lead_sponsor: University Hospital, Grenoble


title: MTBVAC in Newborns: Epidemiological Study In Tuberculosis-Endemic Regions of Sub-Saharan Africa

acronym: MTBVAC-EPI

summary: A cross-sectional childhood M. tuberculosis infection survey of age-specific rates (defined by positivity to the test QuantiFERON-TB Gold Plus) will be conducted in Senegal to collect information on the local TB endemic to inform site selection, sample size, and recruitment strategies for a future efficacy trial of vaccine candidate MTBVAC in young children.

ReferenceCitation: Arbues A, Aguilo JI, Gonzalo-Asensio J, Marinova D, Uranga S, Puentes E, Fernandez C, Parra A, Cardona PJ, Vilaplana C, Ausina V, Williams A, Clark S, Malaga W, Guilhot C, Gicquel B, Martin C. Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials. Vaccine. 2013 Oct 1;31(42):4867-73. doi: 10.1016/j.vaccine.2013.07.051. Epub 2013 Aug 17.

ReferenceCitation: Marinova D, Gonzalo-Asensio J, Aguilo N, Martin C. MTBVAC from discovery to clinical trials in tuberculosis-endemic countries. Expert Rev Vaccines. 2017 Jun;16(6):565-576. doi: 10.1080/14760584.2017.1324303. Epub 2017 May 12. Review.

ReferenceCitation: Cuevas LE, Browning R, Bossuyt P, Casenghi M, Cotton MF, Cruz AT, Dodd LE, Drobniewski F, Gale M, Graham SM, Grzemska M, Heinrich N, Hesseling AC, Huebner R, Jean-Philippe P, Kabra SK, Kampmann B, Lewinsohn D, Li M, Lienhardt C, Mandalakas AM, Marais BJ, Menzies HJ, Montepiedra G, Mwansambo C, Oberhelman R, Palumbo P, Russek-Cohen E, Shapiro DE, Smith B, Soto-Castellares G, Starke JR, Swaminathan S, Wingfield C, Worrell C. Evaluation of tuberculosis diagnostics in children: 2. Methodological issues for conducting and reporting research evaluations of tuberculosis diagnostics for intrathoracic tuberculosis in children. Consensus from an expert panel. J Infect Dis. 2012 May 15;205 Suppl 2:S209-15. doi: 10.1093/infdis/jir879. Epub 2012 Apr 3.

ReferenceCitation: Nemes E, Rozot V, Geldenhuys H, Bilek N, Mabwe S, Abrahams D, Makhethe L, Erasmus M, Keyser A, Toefy A, Cloete Y, Ratangee F, Blauenfeldt T, Ruhwald M, Walzl G, Smith B, Loxton AG, Hanekom WA, Andrews JR, Lempicki MD, Ellis R, Ginsberg AM, Hatherill M, Scriba TJ; C-040-404 Study Team and the Adolescent Cohort Study Team. Optimization and Interpretation of Serial QuantiFERON Testing to Measure Acquisition of Mycobacterium tuberculosis Infection. Am J Respir Crit Care Med. 2017 Sep 1;196(5):638-648. doi: 10.1164/rccm.201704-0817OC.

name: South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and

name: Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa

family: Nemes

full_name: Elisa Nemes

given: Elisa

family: Rozot

full_name: Virginie Rozot

given: Virginie

family: Geldenhuys

full_name: Hennie Geldenhuys

given: Hennie

family: Bilek

full_name: Nicole Bilek

given: Nicole

family: Mabwe

full_name: Simbarashe Mabwe

given: Simbarashe

family: Abrahams

full_name: Deborah Abrahams

given: Deborah

family: Makhethe

full_name: Lebohang Makhethe

given: Lebohang

family: Erasmus

full_name: Mzwandile Erasmus

given: Mzwandile

family: Keyser

full_name: Alana Keyser

given: Alana

family: Toefy

full_name: Asma Toefy

given: Asma

family: Cloete

full_name: Yolundi Cloete

given: Yolundi

family: Ratangee

full_name: Frances Ratangee

given: Frances

name: Statens Serum Institut, Copenhagen, Denmark

family: Blauenfeldt

full_name: Thomas Blauenfeldt

given: Thomas

family: Ruhwald

full_name: Morten Ruhwald

given: Morten

name: South Africa Department of Science and Technology–National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa

family: Walzl

full_name: Gerhard Walzl

given: Gerhard

family: Smith

full_name: Bronwyn Smith

given: Bronwyn

family: Loxton

full_name: Andre G. Loxton

given: Andre G.

family: Hanekom

full_name: Willem A. Hanekom

given: Willem A.

name: Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, California; and

family: Andrews

full_name: Jason R. Andrews

given: Jason R.

family: Lempicki

full_name: Maria D. Lempicki

given: Maria D.

family: Ellis

full_name: Ruth Ellis

given: Ruth

family: Ginsberg

full_name: Ann M. Ginsberg

given: Ann M.

family: Hatherill

journal_name: American Journal of Respiratory and Critical Care Medicine

ipd_sharing_description: A plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers will be defined in the next semester by partners of the project.


title: Study of a Simplified Geriatric Evaluation Performed by Oncologists Prior to Cancer Treatment by Radiotherapy or Chemotherapy in Subjects Aged 70 Years or Older With Inoperable Squamous Cell Cancer of the Head and Neck

acronym: ELAN-ONCOVAL

summary: Use by Oncologists of Validated Geriatric Assessment Tools: G8 Screening Test and Certain Tests for Thorough Geriatric Evaluation

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring Vs End-tidal Partial Pressure Carbon Dioxide (PetCO2) Measurement in the Diagnosis of Hyperventilation Syndrome (HVS) (TCvsPETCO2 )

summary:
Hyper Ventilation Syndrome is a frequent disease affecting adults whose diagnosis is often belated or even unrecognized due to the lack of "gold standard" criteria. Its diagnosis currently relies on the Nijmegen score associated with a PetCO2 assesment using a hyperventilation provocation test. Correlation between Nijmegen Questionnaire scores and PetCO2 appears highly variable. PtcCO2 monitoring is a noninvasive alternative method providing a continuous estimation of arterial CO2 pressure (PaCO2) which could represent an advantageous alternative to PetCO2 measurements. Several reports have demonstrated that PtcCO2 monitoring reflects more faithfully PaCO2 than PetCO2, no study have evaluated its value in this indication.

The primary aim of the study is to compare the diagnostic value of PtcPCO2 monitoring with PetCO2, the method currently used.

Included patient will be invited to fill in the Nijmegen questionnaire and an ambient air gas measurement will be performed. PtcCO2 (mmHg) will be simultaneously measured during hyperventilation test. Nijmegen score signs reproduced by the test will be analysed. HVS diagnosis will be assessed by usual criteria (PetCO2 <30 mmHg at the end of hyperventilation test or under the PetCO2 value at rest, Nijmegen score> 23).

PtcCO2 data will be blinded interpreted later. We will compare if PetCO2 and PtcCO2 leads to the same diagnosis or not.

lead_sponsor: University Hospital, Rouen

location_facility: Physiology department of Rouen University Hospital,


title: Développement de Tests Fonctionnels in Vitro à Partir de Cellules Primaires de Patients Atteints de Maladies Monogéniques

acronym: OPERANDO

summary:
The objective of this project is to build a collection of biological samples consisting of fibroblasts and primary keratinocytes from patients with orphan monogenic diseases and to use these cells in the customization of functional tests. The miniaturized tests we are setting up make it possible to distinguish patient cells from control cells. They can be used to test molecules or for the development of diagnostic tests.

As part of the research protocol, the investigating physicians will be able to perform a skin biopsy on their patient included in the study. APTEEUS will isolate fibroblasts and keratinocytes and ensure their preservation. As part of the project, it is planned to preserve the biological samples collected and to preserve the collection after the end of the study. Skin fibroblasts and keratinocytes that are isolated from the biopsy are cells that can be preserved and amplified. They are a material of choice for the functional study of many monogenic diseases.

This study will allow the adaptation of tools dedicated to the functional study of monogenic diseases in order to help in the research and development of new treatments for these diseases, but also to highlight and explain the inter-individual variability of symptoms and responses to treatments, and finally, to help in the development of diagnostic methods.

Patients with orphan monogenic diseases whose genetic defect has been confirmed and for whom the study of the disease can be performed on fibroblasts, keratinocytes or cells derived from them, may be included in the study. Subjects, after information and consent, will undergo a skin biopsy. The sample will be sent directly to the promoter company APTEEUS, which will carry out all in vitro developments. The fibroblasts and keratinocytes will be preserved and will constitute a collection of cells "orphan monogenic diseases". The samples can be reused for new research in the same field.

status: Enrolling by invitation

lead_sponsor: Apteeus


title: Impact on Postoperative Pain of Three Single-use Adult Supraglottic Airway Devices in Short General Anesthetic Under Controlled Ventilation

acronym: DISPOSITIF LAR

summary: The investigators hypothesize that incidence of pharyngolaryngeal postoperative pain caused by the I-gel and LMA-Suprême devices will be ≤ 5%

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Daily Urinary Urea Excretion to Guide Renal Replacement Therapy Weaning in Intensive Care Units

acronym: D-STOP

summary:
Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in Intensive Care Units.

The objective is to show that remove the dialysis catheter, once daily urinary urea excretion is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis catheters, and thus without dialysis, the first 28 days after insertion.

Daily urinary urea excretion = urea (mmol/L) x diuresis (L/d) / weight (kg).

time_perspective: Other

ReferenceCitation: Aniort J, Ait Hssain A, Pereira B, Coupez E, Pioche PA, Leroy C, Heng AE, Souweine B, Lautrette A. Daily urinary urea excretion to guide intermittent hemodialysis weaning in critically ill patients. Crit Care. 2016 Feb 19;20:43. doi: 10.1186/s13054-016-1225-5.

lead_sponsor: Dr Alexandre Gros


title: How Nicardipine and Labetalol Affect Cerebral Hemodynamics in Severe Preeclamptic Patients: A Pilot Observational Study

acronym: PREMODYM

summary: Realization of transcranial doppler and optic nerve sheath in severe preeclamptic patients to evaluate the impact of nicardipine and labetalol on cerebral hemodynamics.

lead_sponsor: Hopital Antoine Beclere


title: Performance of Non-targeted and/or Non-invasive Respiratory Samples for the Rapid Diagnosis of Pneumocystis Pneumonia Using the BDMAX TM Molecular Biology Platform (Becton Dickinson)

acronym: DANIPOP

summary:
Incidence and morbi-mortality of Pneumocystis pneumonia (PCP) are increasing. Early and fast diagnosis and treatment improve PCP prognosis. Biological diagnosis is based on the detection of Pneumocystis jirovecii, mainly by PCR, in broncho-alveolar lavage (BAL) obtained from bronchial fibroscopy. However this invasive exam is not always possible in emergency in suspected patient and others non invasive (sputa) and/or non-targeted (bronchial aspiration) are sent to the laboratory (25% of cases, data from the Grenoble University Hospital). Diagnosis performances of these non invasive/non-targeted samples are not clearly established.

In this study, the investigators aimed to establish the diagnosis value of non-invasive and/or non-targeted respiratory samples (oral fluids, sputa and bronchial aspiration) for the PCP diagnosis, compared to the gold-standard (Pneumocystis PCR on BAL, beta-D-glucans testing on serum and radio-clinical records).


title: Detection of Myocardial Dysfunction in Non-severe Subarachnoid Hemorrhage (WFNS 1-2) Using Speckle-tracking Echocardiography (STRAIN)

acronym: SAH-STRAIN

summary: Subarachnoid hemorrhage (SAH) can cause transient myocardial dysfunction. Recently, it have been reported that myocardial dysfunctions that occur in SAH are associated with poor outcomes. It therefore appears essential to detect theses dysfunctions with the higher sensitivity as possible. Strain measurement using speckle-tracking echocardiography may detect myocardial dysfunction with great sensitivity. The main objective of this study is to assess the prevalence of myocardial dysfunction in "non-severe" SAH (defined by a WFNS grade 1 or 2), using speckle-tracking echocardiography. This study also aims to analyse Strain measurement with classical echocardiography and serum markers (troponin, BNP) of cardiac dysfunction.

lead_sponsor: University Hospital, Bordeaux


title: A Phase-I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Oral Doses of GRT0151Y in Healthy Male and Female Subjects

summary: The aim of this clinical study in healthy participants is to investigate the safety and tolerability of GRT0151Y after multiple oral intake of different increasing doses and to evaluate the pharmacological effects (action of the compound) by means of pupillometry (measuring the pupil size of the eye) and Cold Presser Test (measuring the pain when immersing the hand in 2 degree Celsius cold water). An additional aim of the study is to investigate the pharmacokinetics of GRT0151Y (how it is taken up into the body and how it is excreted from the body)."

lead_sponsor: Grünenthal GmbH


title: Evaluation of the Restorative Efficacy of the Cosmetic Product "Onco-Repair" vs. Placebo on Grade 2 Hand Foot Syndrome Induced by Targeted Therapies or Conventional Chemotherapy. Randomized, Multicentre, Double Blind, Controlled Study Versus Placebo.

acronym: OCRP

summary: The aim of the study is to assess the restorative efficacy of the cosmetic product "Onco-Repair" vs placebo of the most affected palmer face in subject with grade 2 HFS induced by targeted therapies or conventional chemotherapy.

ReferenceCitation: Lipworth AD, Robert C, Zhu AX. Hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia): focus on sorafenib and sunitinib. Oncology. 2009;77(5):257-71. doi: 10.1159/000258880. Epub 2009 Nov 16. Review.

ReferenceCitation: Zhang RX, Wu XJ, Lu SX, Pan ZZ, Wan DS, Chen G. The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: a phase II randomized prospective study. J Cancer Res Clin Oncol. 2011 Jun;137(6):953-7. doi: 10.1007/s00432-010-0958-9. Epub 2010 Nov 27.

lead_sponsor: Quanta Medical


title: Transformed Waldenström Macroglobulinaemia: Clinical Presentation and Outcome. A Multi-institutional Retrospective Study of 77 Cases From the French Innovative Leukemia Organization (FILO)

acronym: tWM

summary: Histological transformation to diffuse large B-cell lymphoma is a rare complication which may occur in Waldenstrom macroglobulinemia. In this multicenter study, we retrospectively analyzed the clinico-biological features, therapy, outcomes and prognostic factors in 77 Waldenstrom macroglobulinemia patients with biopsy-proven transformation to diffuse large B-cell lymphoma.

ReferenceCitation: Durot E, Tomowiak C, Michallet AS, Dupuis J, Hivert B, Leprêtre S, Toussaint E, Godet S, Merabet F, Van Den Neste E, Ivanoff S, Roussel X, Zini JM, Regny C, Lemal R, Sutton L, Perrot A, Le Dû K, Kanagaratnam L, Morel P, Leblond V, Delmer A. Transformed Waldenström macroglobulinaemia: clinical presentation and outcome. A multi-institutional retrospective study of 77 cases from the French Innovative Leukemia Organization (FILO). Br J Haematol. 2017 Nov;179(3):439-448. doi: 10.1111/bjh.14881. Epub 2017 Aug 2.

lead_sponsor: CHU de Reims


title: Study of the Expression of MMPs (Metalloproteinase Matricial) in OME (Otitis Media With Effusion) in Children Under Twelve Years Old With Atrophy of the Eardrum

acronym: MMP and OME

summary:
Metalloproteinases (MMPs) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. Activity of MMP has been shown in some otitis media with effusion (OME) fluids. These enzymes could be directly linked to the prosnostic of OME as it may damage the eardrum and leads to tympanic atrophy.

The main goal of the study is to find out the correlation between activity of MMPs and tympanic atrophy. The investigator will also study if there is any clinical predictive factors in relation to the level of MMPs.

lead_sponsor: University Hospital, Montpellier


title: Observatory of Patients With Metastatic ProstAte Adenocarcinoma That is Resistant to Castration and Multi-LinE Strategies

acronym: OPALE

summary: Evaluation the overall survival of patients with metastatic prostate adenocarcinoma resistant to castration


title: Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine

summary:
Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection [PJI]) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as PSAT could be a convenient way to limit catheter-related complications and facilitate ambulatory care.

However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.

The aim of this study is is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.

lead_sponsor: Hospices Civils de Lyon


title: Multicentric Observational Study of the Touch® Trapezo-metacarpal Prosthesis

summary: Prospective observational study of implanted patients with a new orthopaedic implant: the Touch trapezo-metacarpal prosthesis

lead_sponsor: Groupe Concepteur Touch


title: Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care

acronym: Colon-Ambu

summary:
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.

The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors.

While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.

Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.

primary_purpose: Health Services Research

ReferenceCitation: Gignoux B, Pasquer A, Vulliez A, Lanz T. Outpatient colectomy within an enhanced recovery program. J Visc Surg. 2015 Feb;152(1):11-5. doi: 10.1016/j.jviscsurg.2014.12.004. Epub 2015 Feb 7.

ReferenceCitation: Chasserant P, Gosgnach M. Improvement of peri-operative patient management to enable outpatient colectomy. J Visc Surg. 2016 Nov;153(5):333-337. doi: 10.1016/j.jviscsurg.2016.07.006. Epub 2016 Sep 23.

ReferenceCitation: Slim K; Groupe GRACE (Groupe francophone de réhabilitation améliorée après chirurgie), Amalberti R. Ambulatory colectomy: no innovation without evaluation. J Visc Surg. 2015 Feb;152(1):1-3. doi: 10.1016/j.jviscsurg.2015.01.001. Epub 2015 Jan 31.

ReferenceCitation: Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. Review.

ReferenceCitation: Walter CJ, Collin J, Dumville JC, Drew PJ, Monson JR. Enhanced recovery in colorectal resections: a systematic review and meta-analysis. Colorectal Dis. 2009 May;11(4):344-53. doi: 10.1111/j.1463-1318.2009.01789.x. Epub 2009 Feb 4. Review. Erratum in: Colorectal Dis. 2010 Jul;12(7):728.

ReferenceCitation: Gouvas N, Tan E, Windsor A, Xynos E, Tekkis PP. Fast-track vs standard care in colorectal surgery: a meta-analysis update. Int J Colorectal Dis. 2009 Oct;24(10):1119-31. doi: 10.1007/s00384-009-0703-5. Epub 2009 May 5.

ReferenceCitation: Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.

ReferenceCitation: Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.

ReferenceCitation: Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2. Review.

ReferenceCitation: Slim K, Delaunay L, Joris J, Léonard D, Raspado O, Chambrier C, Ostermann S; Le Groupe francophone de réhabilitation améliorée après chirurgie (GRACE). How to implement an enhanced recovery program? Proposals from the Francophone Group for enhanced recovery after surgery (GRACE). J Visc Surg. 2016 Dec;153(6S):S45-S49. doi: 10.1016/j.jviscsurg.2016.05.008. Epub 2016 Jun 14. Review.

family: Slim

full_name: K. Slim

given: K.

family: Delaunay

full_name: L. Delaunay

given: L.

family: Joris

full_name: J. Joris

given: J.

family: Léonard

full_name: D. Léonard

given: D.

family: Raspado

full_name: O. Raspado

given: O.

family: Chambrier

full_name: C. Chambrier

given: C.

family: Ostermann

full_name: S. Ostermann

given: S.

journal_name: Journal of Visceral Surgery

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gustafsson UO, Oppelstrup H, Thorell A, Nygren J, Ljungqvist O. Adherence to the ERAS protocol is Associated with 5-Year Survival After Colorectal Cancer Surgery: A Retrospective Cohort Study. World J Surg. 2016 Jul;40(7):1741-7. doi: 10.1007/s00268-016-3460-y.

ReferenceCitation: Lawrence JK, Keller DS, Samia H, Ermlich B, Brady KM, Nobel T, Stein SL, Delaney CP. Discharge within 24 to 72 hours of colorectal surgery is associated with low readmission rates when using Enhanced Recovery Pathways. J Am Coll Surg. 2013 Mar;216(3):390-4. doi: 10.1016/j.jamcollsurg.2012.12.014. Epub 2013 Jan 23.

ReferenceCitation: Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4.

ReferenceCitation: Levy BF, Scott MJ, Fawcett WJ, Rockall TA. 23-hour-stay laparoscopic colectomy. Dis Colon Rectum. 2009 Jul;52(7):1239-43. doi: 10.1007/DCR.0b013e3181a0b32d.

ReferenceCitation: Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.

ReferenceCitation: Rogers JP, Dobradin A, Kar PM, Alam SE. Overnight hospital stay after colon surgery for adenocarcinoma. JSLS. 2012 Apr-Jun;16(2):333-6.

ReferenceCitation: Dobradin A, Ganji M, Alam SE, Kar PM. Laparoscopic colon resections with discharge less than 24 hours. JSLS. 2013 Apr-Jun;17(2):198-203. doi: 10.4293/108680813X13654754535791.

ReferenceCitation: Martín-Ferrero MÁ, Faour-Martín O, Simon-Perez C, Pérez-Herrero M, de Pedro-Moro JA. Ambulatory surgery in orthopedics: experience of over 10,000 patients. J Orthop Sci. 2014 Mar;19(2):332-338. doi: 10.1007/s00776-013-0501-3. Epub 2014 Jan 7.

ReferenceCitation: Verrier JF, Paget C, Perlier F, Demesmay F. How to introduce a program of Enhanced Recovery after Surgery? The experience of the CAPIO group. J Visc Surg. 2016 Dec;153(6S):S33-S39. doi: 10.1016/j.jviscsurg.2016.10.001. Epub 2016 Nov 16. Review.

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lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil


title: USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE

acronym: CUFF-TROCADERO

summary:
The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy.

This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group

lead_sponsor: Clinique du Trocadéro