title: Efficacy Of A Removable Intraductal Stent In Duct-To-Duct Biliary Reconstruction To Prevent Biliary Complications In Liver Transplantation: A Randomized Controlled Trial

acronym: BILIDRAINT

summary:
Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the patients is made when enlisted for liver transplantation (LT). Definitive inclusion and randomization is performed during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a T-tube is placed into the bile duct, and removed endoscopically four to six months postoperative. The surgical technique is available on a movie during randomization on the website. The primary endpoint is the occurrence of biliary complications, including biliary fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are the incidence of complications related to the stent placement and its extraction by endoscopy.

Discussion: Biliary complications following LT are significant causes of morbidity, retransplantation and eventually mortality. Although controversial, the use of a T-tube has been proven to be useless and even responsible for specific complications in many studies, including several randomized trials. However, several studies have identified a small bile duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be significantly associated to biliary stenosis. Our team published a preliminary study including 20 patients using a new technique of intraductal stenting. Only 4 complications were reported in the overall study population while no biliary complication occurred in the subgroup of patients who received a whole graft LT. Moreover, no technical failure and no procedure-related complications were noted before and during drain removal. Although intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a multicentric randomized controlled study is needed to validate it as a protective tool for biliary complications following LT.

ReferenceCitation: National Institutes of Health Consensus Development Conference Statement: liver transplantation--June 20-23, 1983. Hepatology. 1984 Jan-Feb;4(1 Suppl):107S-110S.

ReferenceCitation: Consensus conference: Indications for Liver Transplantation, January 19 and 20, 2005, Lyon-Palais Des Congrès: text of recommendations (long version). Liver Transpl. 2006 Jun;12(6):998-1011.

ReferenceCitation: Neuhaus P, Blumhardt G, Bechstein WO, Steffen R, Platz KP, Keck H. Technique and results of biliary reconstruction using side-to-side choledochocholedochostomy in 300 orthotopic liver transplants. Ann Surg. 1994 Apr;219(4):426-34.

ReferenceCitation: Akamatsu N, Sugawara Y, Hashimoto D. Biliary reconstruction, its complications and management of biliary complications after adult liver transplantation: a systematic review of the incidence, risk factors and outcome. Transpl Int. 2011 Apr;24(4):379-92. doi: 10.1111/j.1432-2277.2010.01202.x. Epub 2010 Dec 10. Review.

ReferenceCitation: Roberts MS, Angus DC, Bryce CL, Valenta Z, Weissfeld L. Survival after liver transplantation in the United States: a disease-specific analysis of the UNOS database. Liver Transpl. 2004 Jul;10(7):886-97.

ReferenceCitation: Jain A, Reyes J, Kashyap R, Dodson SF, Demetris AJ, Ruppert K, Abu-Elmagd K, Marsh W, Madariaga J, Mazariegos G, Geller D, Bonham CA, Gayowski T, Cacciarelli T, Fontes P, Starzl TE, Fung JJ. Long-term survival after liver transplantation in 4,000 consecutive patients at a single center. Ann Surg. 2000 Oct;232(4):490-500.

ReferenceCitation: Sharma S, Gurakar A, Jabbour N. Biliary strictures following liver transplantation: past, present and preventive strategies. Liver Transpl. 2008 Jun;14(6):759-69. doi: 10.1002/lt.21509.

ReferenceCitation: Duailibi DF, Ribeiro MA Jr. Biliary complications following deceased and living donor liver transplantation: a review. Transplant Proc. 2010 Mar;42(2):517-20. doi: 10.1016/j.transproceed.2010.01.017. Review.

ReferenceCitation: Park JB, Kwon CH, Choi GS, Chun JM, Jung GO, Kim SJ, Joh JW, Lee SK. Prolonged cold ischemic time is a risk factor for biliary strictures in duct-to-duct biliary reconstruction in living donor liver transplantation. Transplantation. 2008 Dec 15;86(11):1536-42. doi: 10.1097/TP.0b013e31818b2316.

ReferenceCitation: Marubashi S, Dono K, Nagano H, Kobayashi S, Takeda Y, Umeshita K, Monden M, Doki Y, Mori M. Biliary reconstruction in living donor liver transplantation: technical invention and risk factor analysis for anastomotic stricture. Transplantation. 2009 Nov 15;88(9):1123-30. doi: 10.1097/TP.0b013e3181ba184a.

ReferenceCitation: Hwang S, Lee SG, Sung KB, Park KM, Kim KH, Ahn CS, Lee YJ, Lee SK, Hwang GS, Moon DB, Ha TY, Kim DS, Jung JP, Song GW. Long-term incidence, risk factors, and management of biliary complications after adult living donor liver transplantation. Liver Transpl. 2006 May;12(5):831-8.

ReferenceCitation: Shaked A. Use of T tube in liver transplantation. Liver Transpl Surg. 1997 Sep;3(5 Suppl 1):S22-3. Review.

ReferenceCitation: Rolles K, Dawson K, Novell R, Hayter B, Davidson B, Burroughs A. Biliary anastomosis after liver transplantation does not benefit from T tube splintage. Transplantation. 1994 Feb;57(3):402-4.

ReferenceCitation: Ben-Ari Z, Neville L, Davidson B, Rolles K, Burroughs AK. Infection rates with and without T-tube splintage of common bile duct anastomosis in liver transplantation. Transpl Int. 1998;11(2):123-6.

ReferenceCitation: Vougas V, Rela M, Gane E, Muiesan P, Melendez HV, Williams R, Heaton ND. A prospective randomised trial of bile duct reconstruction at liver transplantation: T tube or no T tube? Transpl Int. 1996;9(4):392-5.

ReferenceCitation: Scatton O, Meunier B, Cherqui D, Boillot O, Sauvanet A, Boudjema K, Launois B, Fagniez PL, Belghiti J, Wolff P, Houssin D, Soubrane O. Randomized trial of choledochocholedochostomy with or without a T tube in orthotopic liver transplantation. Ann Surg. 2001 Mar;233(3):432-7.

ReferenceCitation: Weiss S, Schmidt SC, Ulrich F, Pascher A, Schumacher G, Stockmann M, Puhl G, Guckelberger O, Neumann UP, Pratschke J, Neuhaus P. Biliary reconstruction using a side-to-side choledochocholedochostomy with or without T-tube in deceased donor liver transplantation: a prospective randomized trial. Ann Surg. 2009 Nov;250(5):766-71. doi: 10.1097/SLA.0b013e3181bd920a.

ReferenceCitation: Zalinski S, Soubrane O, Scatton O. Reducing biliary morbidity in full graft deceased donor liver transplantation: is it really a matter of T-tube? Ann Surg. 2010 Sep;252(3):570-1; author reply 571-2. doi: 10.1097/SLA.0b013e3181f07a6b.

ReferenceCitation: López-Andújar R, Orón EM, Carregnato AF, Suárez FV, Herraiz AM, Rodríguez FS, Carbó JJ, Ibars EP, Sos JE, Suárez AR, Castillo MP, Pallardó JM, De Juan Burgueño M. T-tube or no T-tube in cadaveric orthotopic liver transplantation: the eternal dilemma: results of a prospective and randomized clinical trial. Ann Surg. 2013 Jul;258(1):21-9. doi: 10.1097/SLA.0b013e318286e0a0.

ReferenceCitation: Sherman S, Jamidar P, Shaked A, Kendall BJ, Goldstein LI, Busuttil RW. Biliary tract complications after orthotopic liver transplantation. Endoscopic approach to diagnosis and therapy. Transplantation. 1995 Sep 15;60(5):467-70.

ReferenceCitation: Ostroff JW. Post-transplant biliary problems. Gastrointest Endosc Clin N Am. 2001 Jan;11(1):163-83. Review.

ReferenceCitation: Vandenbroucke F, Plasse M, Dagenais M, Lapointe R, Lêtourneau R, Roy A. Treatment of post liver transplantation bile duct stricture with self-expandable metallic stent. HPB (Oxford). 2006;8(3):202-5. doi: 10.1080/13651820500501800.

ReferenceCitation: Chaput U, Scatton O, Bichard P, Ponchon T, Chryssostalis A, Gaudric M, Mangialavori L, Duchmann JC, Massault PP, Conti F, Calmus Y, Chaussade S, Soubrane O, Prat F. Temporary placement of partially covered self-expandable metal stents for anastomotic biliary strictures after liver transplantation: a prospective, multicenter study. Gastrointest Endosc. 2010 Dec;72(6):1167-74. doi: 10.1016/j.gie.2010.08.016.

ReferenceCitation: Farhat S, Bourrier A, Gaudric M, Dousset B, Scatton O, Chaussade S, Prat F. Endoscopic treatment of biliary fistulas after complex liver resection. Ann Surg. 2011 Jan;253(1):88-93. doi: 10.1097/SLA.0b013e3181f9b9f0.

ReferenceCitation: Tranchart H, Zalinski S, Sepulveda A, Chirica M, Prat F, Soubrane O, Scatton O. Removable intraductal stenting in duct-to-duct biliary reconstruction in liver transplantation. Transpl Int. 2012 Jan;25(1):19-24. doi: 10.1111/j.1432-2277.2011.01339.x. Epub 2011 Sep 29.

ReferenceCitation: Cotton PB, Garrow DA, Gallagher J, Romagnuolo J. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc. 2009 Jul;70(1):80-8. doi: 10.1016/j.gie.2008.10.039. Epub 2009 Mar 14.

ReferenceCitation: Gastaca M. Biliary complications after orthotopic liver transplantation: a review of incidence and risk factors. Transplant Proc. 2012 Jul-Aug;44(6):1545-9. doi: 10.1016/j.transproceed.2012.05.008. Review.

ReferenceCitation: CATTELL RB, BRAASCH JW. An eveluation of the long T-tube. Ann Surg. 1961 Aug;154:252-4.

ReferenceCitation: Goumard C, Cachanado M, Herrero A, Rousseau G, Dondero F, Compagnon P, Boleslawski E, Mabrut JY, Salamé E, Soubrane O, Simon T, Scatton O. Biliary reconstruction with or without an intraductal removable stent in liver transplantation: study protocol for a randomized controlled trial. Trials. 2015 Dec 30;16:598. doi: 10.1186/s13063-015-1139-6.

family: Goumard

full_name: Claire Goumard

given: Claire

family: Cachanado

full_name: Marine Cachanado

given: Marine

family: Herrero

full_name: Astrid Herrero

given: Astrid

family: Rousseau

full_name: Géraldine Rousseau

given: Géraldine

family: Dondero

full_name: Federica Dondero

given: Federica

family: Compagnon

full_name: Philippe Compagnon

given: Philippe

family: Boleslawski

full_name: Emmanuel Boleslawski

given: Emmanuel

family: Mabrut

full_name: Jean Yves Mabrut

given: Jean Yves

family: Salamé

full_name: Ephrem Salamé

given: Ephrem

family: Soubrane

full_name: Olivier Soubrane

given: Olivier

family: Simon

full_name: Tabassome Simon

given: Tabassome

family: Scatton

full_name: Olivier Scatton

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL


title: Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome

summary: This study will try to determine if the measure of the platelet reactivity of the patients receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary angioplasty allows to predict the hemorrhagic risk.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Laine M, Frere C, Cuisset T, Paganelli F, Morange PE, Dignat-George F, Berbis J, Camoin-Jau L, Bonello L. Potential mechanism of acute stent thrombosis with bivalirudin following percutaneous coronary intervention in acute coronary syndromes. Int J Cardiol. 2016 Oct 1;220:496-500. doi: 10.1016/j.ijcard.2016.06.247. Epub 2016 Jun 28.

family: Laine

full_name: Marc Laine

given: Marc

sequence: first

family: Frere

full_name: Corinne Frere

given: Corinne

sequence: additional

family: Cuisset

full_name: Thomas Cuisset

given: Thomas

family: Paganelli

full_name: Franck Paganelli

given: Franck

family: Morange

full_name: Pierre-Emmanuel Morange

given: Pierre-Emmanuel

family: Dignat-George

full_name: Francoise Dignat-George

given: Francoise

family: Berbis

full_name: Julie Berbis

given: Julie

family: Camoin-Jau

full_name: Laurence Camoin-Jau

given: Laurence

family: Bonello

full_name: Laurent Bonello

given: Laurent

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Cardiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: A Comparison Between the Aysis® Cs2 (General Electrics) Ventilator in EtControl® Mode and the Perseus® A 500 (Dräger) in VaporView® Mode on Maniability and Consumption of Desflurane

acronym: ConsoHalo

summary:
The Aysis® Cs2 ventilator offers an automated control of end-tidal inhalation anesthetic concentration, the EtControl® mode. A low Fresh Gas Flow (FGF) (0.5L/min) is kept during the maintenance of the anesthesia, decreasing the expensive consumption of halogenated agents.

The Perseus® A 500 offers a VaporView® mode that gives the evolution of inspired (Fi) and end-tidal (Fe) fractions of halogenated agents for 20 minutes based on the delivered fraction (Fd). FGF remains adjusted manually by the practitioner. This mode also makes it possible to maintain a low FGF (0.5 L/min), provided the halogen Fd is set to maintain a steady Fe curve.

The goal of this work was to compare the maniability of the intraoperative administered concentrations and the consumption of Desflurane between these 2 modalities of administration.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Saint Antoine University Hospital

status_simplified: Unknown


type: Other Identifier

title: Effectiveness of Maintaining a Prone Position After Use of an Epidural Blood Patch for the Treatment of Post-dural Puncture Headache

acronym: UpSideDown

summary: The main objective of this study is to assess the rate of recurrence of headache following a first blood patch where patients will be positioned in the prone position for an hour after each blood patch needed during this study.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis

acronym: PARABONE

summary: The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Henri Becquerel

intervention_type: Drug

lead_sponsor_type: industriel


title: Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter, in Rest and Maximal Voluntary Contraction

acronym: EVEREST

summary:
Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory dysfunction and follow up of treatment effectiveness is currently based only on clinical features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in order to study its viscoelastic properties.

In this study, the investigators study the correlation between changes of shear wave elastography modulus and surface electromyogram features of the masseters between rest and maximal voluntary contraction.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Device


title: Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions

summary: Different definitions of nocturnal hypoventilation are used in the recent literature. The investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature.

time_perspective: Retrospective

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Adoptive Transfer of CD8+ T Cells, Sorted With HLA-peptide Multimers and Specific for Melan-A and MELOE-1 Melanoma Antigens, to Metastatic Melanoma Patients. A Phase I/II, Non-randomized, Open Monocentric Study

acronym: MelSort

summary: This study evaluates the safety as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages IIIc and IV).

study_start_date_type: Actual

lead_sponsor: Nantes University Hospital

intervention_type: Biological


title: Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients

acronym: RRR

summary: COPD is characterized by exagerated decline FEV1 related to obstructive non reversible airflow. This could be the consequence of structural changes and inflammatory pattern of the bronchial wall. Lesions could lead to normal but also abnormal remodeling specially in COPD including a decrease in Club cells number and function.There is no treatment actually available targeted to a normal repair of the epithelium. The objective of this work is to identify potential targets for reprograming bronchial epithelial cells I order to achieve a good repair.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Montpellier


title: HYPOCHOL : A Genetically-based Strategy to Identify New Targets in Cholesterol Metabolism

acronym: HYPOCHOL

summary: The aim of this study is to identify new targets in cholesterol metabolism thanks to a genetically-based strategy.

status: Recruiting

primary_purpose: Other

intervention_type: Genetic

status_simplified: Ongoing


title: Efficacy of Parietal Continuous Infiltration of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery Through a Subcostal Incision

acronym: CATPAR

summary: Upper abdominal surgery is known to induce such pulmonary complications as pneumonia, atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to these complications and lasts for 7 days after upper abdominal surgery. The sniff-test is a recognized tool for measuring the diaphragmatic function.The purpose of this study is to evaluate the effectiveness of parietal analgesia with continuous infiltration of local anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal incision. Our main outcome is to measure the diaphragmatic function with the sniff test in 44 patients with parietal infiltration of ropivacaine and in 44 patients with placebo. Our secondary outcomes are the evaluation of the effect of continuous parietal analgesia with ropivacaine on IPmax and EPmax, oxygen saturation, post operative pulmonary complications and post operative recovery. This prospective study will determine if the pre peritoneal local infiltration of ropivacaine is useful to decrease post operative diaphragmatic dysfunction.

lead_sponsor: University Hospital, Rouen


title: Postprandial Glycaemic and Insulinaemic Responses After Consumption of Dairy Desserts Containing Fructo-oligosaccharides in Adults.

acronym: GLYCOFOS-cream

summary: The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.

lead_sponsor: Institut Pasteur de Lille


title: Postprandial Glycaemic and Insulinaemic Responses After Consumption of Minicakes Containing FOS in Adults

acronym: GLYCOFOS-cake


type: Registry Identifier

title: Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients

summary:
Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that leads irrevocably to death within 2 or 5 years of clinical onset.

Since there is no cure for ALS, the management of the disease is supportive and palliative. Riluzole is the only drug that has been shown to extend survival by about three months. The identification of biomarkers sensitive to the progression of the disease might enhance the diagnostic and provide new drug targets.

Dysfunction of the immune system is a pathological hallmark of ALS. Increased levels of interferon gamma (IFNgamma) were found in the serum and cerebrospinal fluid (CSF) of ALS patients. However, the cell origin as well as the pathogenic influence of this peripheral source of IFNg is unknown. Thus, IFNgamma might have a role in the pathogenic process of ALS and might be a potential biomarker of the disease.

design_allocation: Non-Randomized

location_facility: Assistance Publique Hôpitaux de Marseille


title: Fetal Aneuploidies Screening (21,18 and 13) by Cell Free Fetal DNA Analysis. Pilot Study in Low Risk Population and Pregnant Women After in Vitro Fertilisation (IFV)

acronym: DEPOSA

summary: The purpose of this study is to evaluate the performance of non invasive screening in a population of pregnant women with and without in vitro fertilisation (IVF) concomitantly to regular first trimester trisomy 21 (T21) screening using maternal age, nucal fold measurement and serum screening.

primary_purpose: Screening

ReferenceCitation: Dabi Y, Guterman S, Jani JC, Letourneau A, Demain A, Kleinfinger P, Lohmann L, Costa JM, Benachi A. Autoimmune disorders but not heparin are associated with cell-free fetal DNA test failure. J Transl Med. 2018 Dec 3;16(1):335. doi: 10.1186/s12967-018-1705-2.

family: Dabi

full_name: Yohann Dabi

given: Yohann

family: Guterman

full_name: Sarah Guterman

given: Sarah

family: Jani

full_name: Jacques C. Jani

given: Jacques C.

family: Letourneau

full_name: Alexandra Letourneau

given: Alexandra

family: Demain

full_name: Adèle Demain

given: Adèle

family: Kleinfinger

full_name: Pascale Kleinfinger

given: Pascale

family: Lohmann

full_name: Laurence Lohmann

family: Costa

full_name: Jean-Marc Costa

given: Jean-Marc

family: Benachi

full_name: Alexandra Benachi

currency_apc_doaj: GBP

journal_name: Journal of Translational Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Costa JM, Letourneau A, Favre R, Bidat L, Belaisch-Allart J, Jouannic JM, Quarello E, Senat MV, Broussin B, Tsatsaris V, Demain A, Kleinfinger P, Lohmann L, Agostini H, Bouyer J, Benachi A. Cell-free fetal DNA versus maternal serum screening for trisomy 21 in pregnant women with and without assisted reproduction technology: a prospective interventional study. Genet Med. 2018 Nov;20(11):1346-1353. doi: 10.1038/gim.2018.4. Epub 2018 Mar 1.

family: Favre

full_name: Romain Favre

given: Romain

family: Bidat

full_name: Laurent Bidat

family: Belaisch-Allart

full_name: Joelle Belaisch-Allart

given: Joelle

family: Jouannic


type: Other Grant/Funding Number

title: Antibiotic Treatment for 7 Days Versus 14 Days in Patients With Acute Male Urinary Tract Infection Due to Fluoroquinolones Susceptible Bacteria: a Multicentre, Non-inferiority, Double Blind, Randomized Placebo-controlled Trial

acronym: PROSTASHORT

summary: This study will investigate the treatment of urinary tract infection (UTI) in men. The investigators are looking to see if shorter duration of antibiotics (7 days) is not inferior to a longer duration of antibiotics (14 days). The investigators will also study whether longer treatment leads to an increase in antibiotic resistant bacteria in the gut microbiota or an increase in drug side effects.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


lead_sponsor: University Hospital, Grenoble

acronym: PHRC-Merkel

type: EudraCT Number

source: euctr

title: Traitement Des Carcinomes à Cellules de Merkel inopérables et/ou métastatiques Par Analogue de la Somatostatine - Etude Nationale Multicentrique Mono-bras de Phase II.

summary:
The purpose of this trial is to evaluate the efficacy of lanreotide on locally evolving and/or metastatic MCC in a national prospective multicentre phase II study (centres belonging to the skin cancer task force of the French Society of Dermatology namely "Groupe de Cancérologie Cutanée de la Société Française de Dermatologie"). This one-arm study, for which the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one step (A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001, 20:859-66) with main evaluation at 12 weeks on a population of 35 patients. The investigators make assumption that a 40% success rate at 3 months would be desirable, but if it was 20% or less the treatment would be unacceptable. It gives a trial size of 35 patients with a cut-off of 12 patients. Over 12 patients lanreotide will be considered as effective.

The lanreotide treatment (Somatuline LP 120 mg injected subcutaneously every 28 days) will be provided by IPSEN Pharma laboratory. An ancillary immunohistochemistry study on somatostatine receptors 2,3,5, dopamine receptors 1,2 and polyomavirus MCPyV will bring new data on this neuroendocrine tumour and potentially provide new therapeutic perspectives.

The results of this study may :

determine whether somatostatin analogues may help to treat locally advanced and/or metastatic MCC;
address whether there is a correlation between positive SPECT-CT (octreoscan) assessment and therapeutic response to lanreotide;
evaluate the place of TEP-CT and SPECT-CT for MCC evaluation/staging;
evaluate in future studies, with the ancillary data, other analogues or hybrid molecules;
consider, if positive results are obtained from this study, somatostatin analogues as adjuvant treatment after surgery of primary MCC.


title: Interest of Evaluating the Movement of the Center of Mass in a Dynamic Avoidance Task as the Endpoint of the Dynamic Equilibrium of Hemiplegic Patients

acronym: EQHEM

summary:
For several years, the postural disorders assessment in hemiplegic patients was conducted through force plate, using the center of plantar pressure displacement in a static position.

These are widely used in physical therapy both for assessment and rehabilitation of patients with balance disorders.

For hemiplegic patients, an asymmetric distribution support on each foot and an increased surface area of postural sways (more marked on the medio lateral axis) are observed.

These studies, based on the study of plantar pressure ,are not enough to providea full description of the spatio-temporal organization of postural components in hemiplegic patients.

Indeed, postural stabilometric evaluation is based on a simplification of the human skeleton by considering it as a simple inverted pendulum swinging on his ankles.

This simplified model can't be used in dynamic assessment because of the simultaneous contributions of several joints during movement. This restricts its clinical interest because patients are more exposed to imbalances and falls in dynamic situations. Thus, the hip angular movement results in a center plantar pressure displacementwhich is impossible to discriminate from the ankle axis movement using stabilometric signal only.

Thus, it seemed interesting to study another variable valid in dynamic conditions : the displacement of center of mass during a dynamic balancing task. This variable is obtained through 3D motion capture of the different segments of the human body. The dynamic test is a dynamic postural assessment following ball avoidance from three different directions. The center of mass displacement will be compared with a functional test known to be representative of dynamic balance of the individual capacities: The Timed Up and Go test (TUG).

All of this data aims to improve the hemiplegic postural assessment for physical therapy and to help develop new rehabilitative approaches.

lead_sponsor: Rennes University Hospital


acronym: MONACO

summary:
This study is multicentric, single-blind, and interventional with a randomization into two parallel arm, between a standard of care information and an additional information of the patient, with a 12 month follow up.

The aim of this study is to evaluate the effectiveness of a personalized information program versus information provided from standard of care in patients taking Xarelto for Stroke Prevention in Atrial Fibrillation.

primary_purpose: Supportive Care


title: Gait, cOgnitiOn & Decline (GOOD)

summary: The main objective of the GOOD initiative was to determine which spatio-temporal gait parameters and/or combination(s) of spatio-temporal gait parameters best differentiate between cognitively healthy individuals (CHI), patients with mild cognitive impairment (MCI) and those with mild and moderate dementia.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Angers


title: Exploratory Study, Prospective, of Volume, Composition and Bacteriology of the Recovered Blood of Multi-perforated Catheter Inserted in the Drapes Thickness of Incisional Sternal Area During Heart Surgery

acronym: Blood-in-drape

summary:
The recovered blood into the surgical site at the border of the fields, is very rich in red blood cells, due to the adjacency of the bone marrow and the sternum.

The blood recovered from the surgical site at the border of the fields, is richer in red blood cells than the bloodstream of the patient.

The recovered blood into the surgical site at the border of the fields, is not contaminated and bacteriological cultures are negative.

Consequences: The recovered blood in the surgical site at the edge of fields, can be recovered in the Saver® Cell for reprocessing and re-injected into the patient.

There isn't in our knowledge of published clinical data on the volume and composition of the recovered blood in the surgical site after cardiac surgery.

The analysis of the available literature does not allow to estimate the expected outcomes us. Therefore, this study will be exploratory in nature and will aim to estimate the volume and the content of red blood cells from blood recovered, and generate clinical data to be used in subsequent confirmatory tests.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Universitaire d'Amiens

intervention_type: Procedure


title: Controlled Randomized Trial Estimating the Efficiency of Blue Enriched White Light on Sequel Fatigue, in Victims of Severe Cranial Traumas

acronym: phototrauma

summary: After a brain injury (BI) , patients complain in particular about sequel fatigue. This symptom affects about 50 % of the patients; it is severe, with a repercussion on quality of life, reeducation and occupational reintegration, and persists often at a distance of the accident. The investigators' hypothesis is that patients who presented a severe BI could benefit from a treatment by withe blue enriched bright light in order to improve fatigue and quality of life.

ReferenceCitation: Quera Salva MA, Azabou E, Hartley S, Sauvagnac R, Leotard A, Vaugier I, Pradat Diehl P, Vallat-Azouvi C, Barbot F, Azouvi P. Blue-Enriched White Light Therapy Reduces Fatigue in Survivors of Severe Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2020 Mar/Apr;35(2):E78-E85. doi: 10.1097/HTR.0000000000000500.

family: Quera Salva

full_name: Maria-Antonia Quera Salva

given: Maria-Antonia

family: Azabou

full_name: Eric Azabou

given: Eric

family: Hartley

full_name: Sarah Hartley

family: Sauvagnac

full_name: Rebecca Sauvagnac

given: Rebecca

family: Leotard

full_name: Antoine Leotard

given: Antoine

family: Vaugier

full_name: Isabelle Vaugier

given: Isabelle

family: Pradat Diehl

full_name: Pascale Pradat Diehl

family: Vallat-Azouvi

full_name: Claire Vallat-Azouvi

given: Claire

family: Barbot

full_name: Frederic Barbot

given: Frederic

family: Azouvi

full_name: Philippe Azouvi

given: Philippe

journal_name: Journal of Head Trauma Rehabilitation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions for Overweight and Obese People (eMouve3)

summary: The aim of this study was to validate functions for estimating energy expenditure in controlled and free-living conditions. This method was based on accelerometry data acquired from smartphones worn in a trouser pocket. The developed functions have been compared to the estimations provided by three research devices named Fitmate, Armband and Actiheart.

ReferenceType: background

ReferenceCitation: Rousset S, Fardet A, Lacomme P, Normand S, Montaurier C, Boirie Y, Morio B. Comparison of total energy expenditure assessed by two devices in controlled and free-living conditions. Eur J Sport Sci. 2015;15(5):391-9. doi: 10.1080/17461391.2014.949309. Epub 2014 Aug 21.

ReferenceCitation: Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudière N, Manenq PH, Paris L, Ren L, Rousset S. A smartphone-driven methodology for estimating physical activities and energy expenditure in free living conditions. J Biomed Inform. 2014 Dec;52:271-8. doi: 10.1016/j.jbi.2014.07.009. Epub 2014 Jul 15.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine d'Auvergne

intervention_type: Behavioral


title: Randomized Study Comparing the ASV to Conventional Ventilation for Intubated Patients During Inter-hospital Transfers. Controlled Randomized Monocentric Prospective Study Comparing ASV Versus Conventional Ventilation Modes

summary: Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode, on intubated, ventilated and sedated patients, during their secondary transfer from an hospital to another, by a SMUR team.

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie


title: Phase III Study of IV Vinflunine in Combination With Methotrexate Versus Methotrexate Alone in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With Platinum-based Chemotherapy

summary:
For patients relapsing after platinum-based therapy, few data are available. The current use of cetuximab associated with radiotherapy in localized disease and associated with platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based on a clinical review, show encouraging antitumour activity and an acceptable safety profile. Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen after platinum failure.

The present study has been designed as a multicenter, randomised phase III study which will compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN patients having failed platinum-based therapy.

lead_sponsor: Pierre Fabre Medicament


title: Non-invasive Analgesic Stimulation of the Motor Cortex at Home

acronym: STIMATHOME

summary:
The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic pain, to estimate the importance and the duration of this effect, and to improve its efficiency by the use at home.

It is established that the repetition of the sessions of cortical stimulation over a week improves their analgesic efficacy. However, this effect does not exceed a few weeks and is much lower than that of the stimulation implanted surgically. Implanted stimulation operates periodically, several times a day, and this "repetition of doses ", akin to the regular taking of a medicine, may explain its longer efficacy for pain relief which, may extend over several years (André-Obadia and al 2014).

No study at this date has estimated the long-term effect of non-invasive stimulation when is also periodically repeated on a daily basis, over several weeks.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Neurological Hospital - University Pain Clinic (CETD)


title: Evaluation of Adverse Long-term Effects in Young Adult Survivors of Acute Leukemia-LEA-JA-IPC 2014-005

acronym: LEA-JA

summary: Taking into account the specificities of adolescent and young adult cancer patients led agencies (in particular the French National Cancer Institute INCa, through the last Cancer Plan), to initiate projects targeting this population. Acute leukemia is among the most common cancers in adolescents and young adults. Recent therapeutic advances now allow hope for a cure in about 50% of this population. The issue of post-cancer is therefore of particular importance for young adults with cancer. Our aim is to establish the health determinants in young adult leukemia survivors and to compare the frequency of these effects and their explanatory factors to the data collected in children or adolescent leukemia survivors program (LEA). 90 patients followed up at the Institut Paoli-Calmettes cancer center and Nice University Hospital have been identified and would be included in this study.Collected data will include information on the initial disease and its treatments, physical sequelae (fertility, thyroid function, heart function, visual function, secondary tumors, viral infections, lung function, bone metabolism, iron metabolism, metabolic syndrome, osteonecrosis, alopecia ... ), quality of life, social and occupational integration and relationship with care system.

lead_sponsor: Institut Paoli-Calmettes


title: Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome : a Randomised Controlled Trial of Continuous Positive Airway Pressure Effectiveness (CIH - Gait)

acronym: CIH-Gait

summary: The purpose of this randomised controlled study is to determine the impact of continuous positive airway pressure (CPAP) versus sub-therapeutic CPAP (placebo) on the control of gait upon severe sleep apnea patients, based on stride time variability.

ReferenceCitation: Allali G, Perrig S, Cleusix M, Herrmann FR, Adler D, Gex G, Armand S, Janssens JP, Pepin JL, Assal F. Gait abnormalities in obstructive sleep apnea and impact of continuous positive airway pressure. Respir Physiol Neurobiol. 2014 Sep 15;201:31-3. doi: 10.1016/j.resp.2014.06.012. Epub 2014 Jul 4.

ReferenceCitation: Celle S, Annweiler C, Camicioli R, Barthélémy JC, Roche F, Beauchet O. Sleep-related breathing disorders and gait variability: a cross-sectional preliminary study. BMC Pulm Med. 2014 Aug 23;14:140. doi: 10.1186/1471-2466-14-140.

ReferenceCitation: Baillieul S, Wuyam B, Pérennou D, Tamisier R, Bailly S, Benmerad M, Piscicelli C, Le Roux-Mallouf T, Vergès S, Pépin JL. A randomized sham-controlled trial on the effect of continuous positive airway pressure treatment on gait control in severe obstructive sleep apnea patients. Sci Rep. 2021 Apr 29;11(1):9329. doi: 10.1038/s41598-021-88642-5.

family: Baillieul

full_name: Sébastien Baillieul

given: Sébastien

family: Wuyam

full_name: Bernard Wuyam

given: Bernard

family: Pérennou

full_name: Dominic Pérennou

given: Dominic

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Bailly

full_name: Sébastien Bailly

family: Benmerad

full_name: Meriem Benmerad

given: Meriem

family: Piscicelli

full_name: Céline Piscicelli

given: Céline

family: Le Roux-Mallouf

full_name: Thibault Le Roux-Mallouf

given: Thibault

family: Vergès

full_name: Samuel Vergès

given: Samuel

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Scientific Reports

location_facility: Institut de rééducation, Hôpital Sud, CHU de GRENOBLE


title: Impact of a Loading Dose of Caspofungin on Pharmacokinetic and Pharmacodynamic Parameters Target Achievements for Severe Candida Infections in ICU Patients

acronym: CASPOLOAD

summary:
Echinocandins are the drug of choice in severe candida infections. Efficacy of echinocandins is related to concentration and area under the curve (AUC) of the drug.

Available pharmacokinetic studies found that concentration of echinocandins mainly caspofungin is sub-optimal in severe candida infections in intensive care unit (ICU) patients.

Higher dose of caspofungin has been proven to be safe in critically ill patients but its impact on the ability to reach PK/PD target is unknown.

The aim of this study is to evaluate the impact of a loading dose of caspofungin on PK/PD parameters within the first 24-hours.

ReferenceCitation: Shields RK, Nguyen MH, Press EG, Updike CL, Clancy CJ. Caspofungin MICs correlate with treatment outcomes among patients with Candida glabrata invasive candidiasis and prior echinocandin exposure. Antimicrob Agents Chemother. 2013 Aug;57(8):3528-35. doi: 10.1128/AAC.00136-13. Epub 2013 May 13.

ReferenceCitation: Safdar A, Rodriguez G, Rolston KV, O'Brien S, Khouri IF, Shpall EJ, Keating MJ, Kantarjian HM, Champlin RE, Raad II, Kontoyiannis DP. High-dose caspofungin combination antifungal therapy in patients with hematologic malignancies and hematopoietic stem cell transplantation. Bone Marrow Transplant. 2007 Feb;39(3):157-64.

ReferenceCitation: Betts RF, Nucci M, Talwar D, Gareca M, Queiroz-Telles F, Bedimo RJ, Herbrecht R, Ruiz-Palacios G, Young JA, Baddley JW, Strohmaier KM, Tucker KA, Taylor AF, Kartsonis NA; Caspofungin High-Dose Study Group. A Multicenter, double-blind trial of a high-dose caspofungin treatment regimen versus a standard caspofungin treatment regimen for adult patients with invasive candidiasis. Clin Infect Dis. 2009 Jun 15;48(12):1676-84. doi: 10.1086/598933.

ReferenceCitation: Louie A, Deziel M, Liu W, Drusano MF, Gumbo T, Drusano GL. Pharmacodynamics of caspofungin in a murine model of systemic candidiasis: importance of persistence of caspofungin in tissues to understanding drug activity. Antimicrob Agents Chemother. 2005 Dec;49(12):5058-68.

ReferenceCitation: Sinnollareddy M, Peake SL, Roberts MS, Lipman J, Roberts JA. Using pharmacokinetics and pharmacodynamics to optimise dosing of antifungal agents in critically ill patients: a systematic review. Int J Antimicrob Agents. 2012 Jan;39(1):1-10. doi: 10.1016/j.ijantimicag.2011.07.013. Epub 2011 Sep 16. Review.

ReferenceCitation: Nguyen TH, Hoppe-Tichy T, Geiss HK, Rastall AC, Swoboda S, Schmidt J, Weigand MA. Factors influencing caspofungin plasma concentrations in patients of a surgical intensive care unit. J Antimicrob Chemother. 2007 Jul;60(1):100-6. Epub 2007 May 24.

ReferenceCitation: Bailly S, Gautier-Veyret E, Lê MP, Bouadma L, Andremont O, Neuville M, Mourvillier B, Sonneville R, Magalhaes E, Lebut J, Radjou A, Smonig R, Wolff M, Massias L, Dupuis C, Timsit JF. Impact of Loading Dose of Caspofungin in Pharmacokinetic-Pharmacodynamic Target Attainment for Severe Candidiasis Infections in Patients in Intensive Care Units: the CASPOLOAD Study. Antimicrob Agents Chemother. 2020 Nov 17;64(12). pii: e01545-20. doi: 10.1128/AAC.01545-20. Print 2020 Nov 17.

name: Univ. Grenoble Alpes, INSERM, CHU Grenoble Alpes, Grenoble, France

name: Laboratory of Pharmacology-Pharmacogenetics-Toxicology, Biology and Pathology Department, CHU Grenoble Alpes, Grenoble, France

family: Gautier-Veyret

full_name: Elodie Gautier-Veyret

given: Elodie

name: AP-HP, Bichat Claude Bernard Hospital, Pharmacology-Toxicology Department, UMR 1137, IAME, INSERM/Paris Diderot University, Paris, France

name: INSERM UMR_S 1144, Université de Paris, Paris, France

family: Lê

full_name: Minh P. Lê

given: Minh P.

name: Department of Intensive Care Medicine and Infectious Diseases, AP-HP, Bichat-Claude Bernard University Hospital, Paris, France

family: Bouadma

full_name: Lila Bouadma

given: Lila

family: Andremont

full_name: Olivier Andremont

given: Olivier

family: Neuville

full_name: Mathilde Neuville

given: Mathilde

name: AP-HP, Medical and Infectious Diseases ICU (MI2), Bichat-Claude Bernard University Hospital, Paris, France

name: UMRS 1136, iPLESP, Institut Pierre-Louis d'Épidémiologie et de Santé Publique, Sorbonne Université, Paris, France

family: Mourvillier

full_name: Bruno Mourvillier

given: Bruno

name: UMR 1148, Laboratory for Vascular and Translational Science, INSERM/Paris Diderot University, Paris, France

family: Sonneville

full_name: Romain Sonneville

given: Romain

family: Magalhaes

full_name: Eric Magalhaes

family: Lebut

full_name: Jordane Lebut

given: Jordane

family: Radjou

full_name: Aguila Radjou

given: Aguila

family: Smonig

full_name: Roland Smonig

given: Roland

family: Wolff

full_name: Michel Wolff

given: Michel

family: Massias

full_name: Laurent Massias

given: Laurent

name: Medical ICU, Gabriel-Montpied University Hospital, Clermont-Ferrand, France

family: Dupuis

full_name: Claire Dupuis

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

journal_name: Antimicrobial Agents and Chemotherapy

oa_host_type: repository

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

ipd_sharing: Undecided

lead_sponsor: Outcome Rea

location_facility: Reanimation Medicale et Infectieuse-Hopital Bichat


title: Quantification of the Pressure Threshold Related to Tissue Injury in Bedriden Paraplegics

summary:
The aim of this study is to correlate the intensity and the duration of a mechanical strain, applied over the skin of a bedridden paraplegics, with the microvascularization parameters (oxygen saturation, blood flow and blood volume) and the early inflammatory mechanism. We want to detect the early stage of irreversible damage for each patient. To achieve this goal, we measure some specifics data over a group of 48 paraplegics admitted in the hospital for a pressure ulcer surgical treatment. The patients are randomly distributed in 4 groups. First the interface pressure between the patient body and the air mattress is recorded continuously for 3 hours (= the repositioning patient frequency): we have the pressure over each point of the patient body in contact with the mattress on this time lap. Then, we will measure the microvascularization parameters, using an O2C medical device over a trochanter on a specific anatomical area which will be thereafter biopsied. Finally, depending on the group in which they were randomly distributed, the patient will undergo a muscle biopsy on his or her trochanter at 0h, 1h, 2h or 3h after they lie down on the air mattress. This way, we will be able to determine the effect of the mechanical strain duration on the physiologic parameters. The following day, the patient is undergoing his or her surgery for removing the necrotic area of the bedsore. At the same time, we will recover some of the sample near the bedsore which would serve as a maximum inflammatory response. Then a second muscle biopsy will be performed on an innervated area to be able to determine a basal concentration of biomarkers.

The inclusion period for this study will be 3 years. All the patients are followed for 24 hours then they will be followed by medical staff in their bedsore resection setting.

The data gained for this study will hopefully help the scientific world to achieve a better understanding of the pressure ulcer aetiology. They will also be helpful to achieve a mobilization of the patient specific of his or her inherent characteristics with a high sensitivity level. This way we will have a more efficient bedsore prevention.


acronym: PHONORESPI

summary:
Communication is essential for patients quality of life because it impact on patients care quality. Neuromuscular diseases, caracterised by motor damages, hinder non-verbal communication of the patient. Therefore, speech must to be functional.

However, correlation between respiratory failure and voice quality is not very well known. The aim of the study is to search a link between respiratory failure and speech impairment in patients with neuromuscular diseases.


title: Randomized, Double-blind, Placebo-controlled, Parallel-group Design, Monocentric Study on Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidemia

acronym: LLAX

summary: The purpose of this study is to investigate whether astaxanthin supplementation can impact triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.

lead_sponsor: Ajinomoto Foods Europe SAS

intervention_type: Dietary Supplement


title: Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.

acronym: FamiréaXVII

summary: The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ

ReferenceCitation: Azoulay E, Forel JM, Vinatier I, Truillet R, Renault A, Valade S, Jaber S, Durand-Gasselin J, Schwebel C, Georges H, Merceron S, Cariou A, Moussa M, Hraiech S, Argaud L, Leone M, Curtis JR, Kentish-Barnes N, Jouve E, Papazian L. Questions to improve family-staff communication in the ICU: a randomized controlled trial. Intensive Care Med. 2018 Nov;44(11):1879-1887. doi: 10.1007/s00134-018-5423-2. Epub 2018 Oct 21.

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Forel

full_name: Jean-Marie Forel

given: Jean-Marie

family: Vinatier

full_name: Isabelle Vinatier

given: Isabelle

family: Truillet

full_name: Romain Truillet

family: Renault

full_name: Anne Renault

given: Anne

family: Valade

full_name: Sandrine Valade

given: Sandrine

family: Jaber

full_name: Samir Jaber

given: Samir

family: Durand-Gasselin

full_name: Jacques Durand-Gasselin

given: Jacques

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Georges

full_name: Hughes Georges

given: Hughes

family: Merceron

full_name: Sybille Merceron

given: Sybille

family: Cariou

full_name: Alain Cariou

given: Alain

family: Moussa

full_name: Myriam Moussa

given: Myriam

family: Hraiech

full_name: Sami Hraiech

given: Sami

family: Argaud

full_name: Laurent Argaud

family: Leone

full_name: Marc Leone

given: Marc

family: Curtis

full_name: J. Randall Curtis

given: J. Randall

family: Kentish-Barnes

full_name: Nancy Kentish-Barnes

given: Nancy

family: Jouve

full_name: Elisabeth Jouve

given: Elisabeth

family: Papazian

full_name: Laurent Papazian

journal_name: Intensive Care Medicine

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

repository_normalized: HAL

version: submittedVersion

title: Questions to improve family–staff communication in the ICU: a randomized controlled trial

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital Nord Assistance Publique Hôpitaux de Marseille


title: Tolerance of Early Exercise in Intensive Care Unit

summary: Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.

lead_sponsor: University Hospital, Clermont-Ferrand


title: E-coaching for Patients With Abdominal Obesity and Type 2 Diabetes : the A.N.O.D.E. Study

acronym: ANODE

summary: Abdominal obesity and its metabolic consequences, particularly type 2 diabetes, require personalized nutritional monitoring. Today, it is not always possible to provide patients with appropriate care to both, the diet plan, physical activity, stress and sleep management. Emerging data have shown the effectiveness of remote support (e- coaching), in order to increase the level of physical activity and reducing calorie intake which causes weight loss similar to that obtained during a face to face consultation. Compared to a food survey conducted by a dietician, the dietary survey MXS computer software showed similar results on the collection of nutritional data. Furthermore, users preferred this method of remote collection compared to direct interview. The investigators recently developed a tool for e-coaching combining this computerized dietary survey and education and support modules on diet and physical activity (MXS- health program) for the patients. The aim of the investigators' study is to compare efficacy of this new software vs usual care.

ReferenceType: result

ReferenceCitation: Hansel B, Giral P, Gambotti L, Lafourcade A, Peres G, Filipecki C, Kadouch D, Hartemann A, Oppert JM, Bruckert E, Marre M, Bruneel A, Duchene E, Roussel R. A Fully Automated Web-Based Program Improves Lifestyle Habits and HbA1c in Patients With Type 2 Diabetes and Abdominal Obesity: Randomized Trial of Patient E-Coaching Nutritional Support (The ANODE Study). J Med Internet Res. 2017 Nov 8;19(11):e360. doi: 10.2196/jmir.7947.

family: Hansel

full_name: Boris Hansel

given: Boris

family: Giral

full_name: Philippe Giral

given: Philippe

family: Gambotti

full_name: Laetitia Gambotti

given: Laetitia

family: Lafourcade

full_name: Alexandre Lafourcade

given: Alexandre

family: Peres

full_name: Gilbert Peres

given: Gilbert

family: Filipecki

full_name: Claude Filipecki

given: Claude

family: Kadouch

full_name: Diana Kadouch

given: Diana

family: Hartemann

full_name: Agnes Hartemann

given: Agnes

family: Oppert

full_name: Jean-Michel Oppert

given: Jean-Michel

family: Bruckert

full_name: Eric Bruckert

given: Eric

family: Marre

full_name: Michel Marre

given: Michel

family: Bruneel

full_name: Arnaud Bruneel

given: Arnaud

family: Duchene

full_name: Emilie Duchene

given: Emilie

family: Roussel

full_name: Ronan Roussel

given: Ronan

journal_name: Journal of Medical Internet Research

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications


title: Phenylbutyrate Effect on Lcn2 Urianry Expression in Proteinuric Patients

acronym: PIRATE

summary: The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2 urinary expression in proteinuric patients.


title: Comparative Study of Different Non-invasive Measurement Methods of Hepatic Fibrosis in Cystic Fibrosis

acronym: MUCO-FIBRO

summary:
Non-invasive methods of the quantification of fibrosis may help to assess the development of fibrosis at a specific moment of the evolution of the disease, in the order to decide the initiation of treatment with ursodeoxycholic acid which may slow the progression to hepatic cirrhosis:

FibroTest,
The ultrasound impulse elastography, Fibroscan (FS)
Ultrasound Elastography by ShearWave (SWE)
Magnetic resonance elastography (MRE). The purpose of this study is to assess the contribution of these methods in the diagnosis of hepatic fibrosis during the evolution of the cystic fibrosis.


acronym: SEMAINE

summary: The SEMAINE project will investigate intracranial EEG (icEEG) simultaneously recorded with either fMRI or MEG to 1) improve identification of the epileptogenic zone in patients suffering from drug-resistant partial epilepsy, and 2) define the functional organization of neural networks underlying human perception and cognition in order to prevent inadvertent deficits resulting from neurosurgical resection. In particular, high-frequency activity (HFA), as measured with icEEG, has been demonstrated in recent years as a relevant index for both epileptogenic tissue and healthy cortical processing, but its correlates in fMRI and MEG require further investigation. This will be a pioneering effort in several respects, as the first to directly measure high-frequency neural activity in tandem with fMRI, and among the first to do so with MEG. In addition to their attractiveness as noninvasive imaging techniques, fMRI and MEG have the potential to examine whole-brain networks that are not accessible to icEEG's necessarily limited spatial coverage. Furthermore, such a campaign of simultaneous recordings will take unprecedented advantage of icEEG as the bridge between the two noninvasive techniques, providing compelling evidence for the links between all three measurements with respect to underlying high-frequency neural activity in both health and disease. This project will therefore lead to improved selection of epilepsy surgery candidates and improved neurosurgical outcomes from the precise mapping of epileptogenic and healthy brain networks. The same techniques will be immediately applicable to functional mapping of other types of neurosurgery populations as well as diagnostic neuroimaging of neurological and psychiatric populations.

primary_purpose: Diagnostic


title: Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003

summary: PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.

status: Active, not recruiting

ReferenceCitation: Bertucci F, Gonçalves A, Guille A, Adelaïde J, Garnier S, Carbuccia N, Billon E, Finetti P, Sfumato P, Monneur A, Pécheux C, Khran M, Brunelle S, Mescam L, Thomassin-Piana J, Poizat F, Charafe-Jauffret E, Turrini O, Lambaudie E, Provansal M, Extra JM, Madroszyk A, Gilabert M, Sabatier R, Vicier C, Mamessier E, Chabannon C, Pakradouni J, Viens P, André F, Gravis G, Popovici C, Birnbaum D, Chaffanet M. Prospective high-throughput genome profiling of advanced cancers: results of the PERMED-01 clinical trial. Genome Med. 2021 May 18;13(1):87. doi: 10.1186/s13073-021-00897-9.

family: Bertucci

full_name: François Bertucci

given: François

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

family: Guille

full_name: Arnaud Guille

family: Adelaïde

full_name: José Adelaïde

given: José

family: Garnier

full_name: Séverine Garnier

given: Séverine

family: Carbuccia

full_name: Nadine Carbuccia

given: Nadine

family: Billon

full_name: Emilien Billon

given: Emilien

family: Finetti

full_name: Pascal Finetti

given: Pascal

family: Sfumato

full_name: Patrick Sfumato

given: Patrick

family: Monneur

full_name: Audrey Monneur

given: Audrey

family: Pécheux

full_name: Christophe Pécheux

given: Christophe

family: Khran

full_name: Martin Khran

given: Martin

family: Brunelle

full_name: Serge Brunelle

given: Serge

family: Mescam

full_name: Lenaïg Mescam

given: Lenaïg

family: Thomassin-Piana

full_name: Jeanne Thomassin-Piana

given: Jeanne

family: Poizat

full_name: Flora Poizat

given: Flora

family: Charafe-Jauffret

full_name: Emmanuelle Charafe-Jauffret

given: Emmanuelle

family: Turrini

full_name: Olivier Turrini

given: Olivier

family: Lambaudie

full_name: Eric Lambaudie

family: Provansal

full_name: Magali Provansal

given: Magali

family: Extra

full_name: Jean-Marc Extra

given: Jean-Marc

family: Madroszyk

full_name: Anne Madroszyk

given: Anne

family: Gilabert

full_name: Marine Gilabert

given: Marine

family: Sabatier


title: AVEC-TC : Post-traumatic Behavioral Disorders : Analysis and Valuation of the Expertise of Use of the Close Relations of People Victims of Traumatic Brain Injury

acronym: AVEC-TC

summary: Post-traumatic behavioral disorders : analysis and valuation of the expertise of use of the close friends of people victims of traumatic brain injury.

ReferenceCitation: Saoût V, Gambart G, Leguay D, Ferrapie AL, Launay C, Richard I. Aggressive behavior after traumatic brain injury. Ann Phys Rehabil Med. 2011 Jun;54(4):259-69. doi: 10.1016/j.rehab.2011.04.003. Epub 2011 May 5. English, French.

family: Saoût

full_name: V. Saoût

given: V.

family: Gambart

full_name: G. Gambart

given: G.

family: Leguay

full_name: D. Leguay

given: D.

family: Ferrapie

full_name: A.-L. Ferrapie

family: Launay

full_name: C. Launay

given: C.

family: Richard

full_name: I. Richard

given: I.

journal_name: Annals of Physical and Rehabilitation Medicine

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Agressive behavior after traumatic brain injury

ReferenceCitation: Bayen E, Pradat-Diehl P, Jourdan C, Ghout I, Bosserelle V, Azerad S, Weiss JJ, Joël ME, Aegerter P, Azouvi P; Steering Committee of the PariS-TBI study. Predictors of informal care burden 1 year after a severe traumatic brain injury: results from the PariS-TBI study. J Head Trauma Rehabil. 2013 Nov-Dec;28(6):408-18. doi: 10.1097/HTR.0b013e31825413cf.

family: Bayen

full_name: Eleonore Bayen

given: Eleonore

family: Pradat-Diehl

full_name: Pascale Pradat-Diehl

given: Pascale

family: Jourdan

full_name: Claire Jourdan

given: Claire

family: Ghout

full_name: Idir Ghout

given: Idir

family: Bosserelle

full_name: Vanessa Bosserelle

given: Vanessa

family: Azerad

full_name: Sylvie Azerad

given: Sylvie

family: Weiss

full_name: Jean-Jacques Weiss

given: Jean-Jacques

family: Joël

full_name: Marie-Eve Joël

given: Marie-Eve

family: Aegerter

full_name: Philippe Aegerter

given: Philippe

family: Azouvi

full_name: Philippe Azouvi

title: Predictors of Informal Care Burden 1 Year After a Severe Traumatic Brain Injury

ReferenceCitation: Fugate LP, Spacek LA, Kresty LA, Levy CE, Johnson JC, Mysiw WJ. Measurement and treatment of agitation following traumatic brain injury: II. A survey of the Brain Injury Special Interest Group of the American Academy of Physical Medicine and Rehabilitation. Arch Phys Med Rehabil. 1997 Sep;78(9):924-8.

ReferenceCitation: Osiurak F, Jarry C, Allain P, Aubin G, Etcharry-Bouyx F, Richard I, Bernard I, Le Gall D. Unusual use of objects after unilateral brain damage: the technical reasoning model. Cortex. 2009 Jun;45(6):769-83. doi: 10.1016/j.cortex.2008.06.013. Epub 2008 Nov 8.

family: Osiurak

full_name: François Osiurak

given: François

family: Jarry

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

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

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

title: Unusual use of objects after unilateral brain damage. The technical reasoning model


title: Identification of the Blood Microbiota in Patient Suffering From Myocardial Infraction

acronym: FLORINF

summary: The investigators want to compare blood microbiota profile between patients with documented coronary lesions and patients free of coronary disease.

ReferenceCitation: Amar J, Lelouvier B, Servant F, Lluch J, Burcelin R, Bongard V, Elbaz M. Blood Microbiota Modification After Myocardial Infarction Depends Upon Low-Density Lipoprotein Cholesterol Levels. J Am Heart Assoc. 2019 Oct;8(19):e011797. doi: 10.1161/JAHA.118.011797. Epub 2019 Sep 28.

name: Department of Therapeutics Rangueil Hospital CHU Toulouse Toulouse France

family: Amar

full_name: Jacques Amar

given: Jacques

family: Lelouvier

full_name: Benjamin Lelouvier

given: Benjamin

family: Servant

full_name: Florence Servant

given: Florence

family: Lluch

full_name: Jérôme Lluch

given: Jérôme

family: Burcelin

full_name: Rémy Burcelin

given: Rémy

name: Epidemiology Department Rangueil Hospital CHU Toulouse Toulouse France

name: Toulouse 3 Paul Sabatier University Toulouse France

family: Bongard

full_name: Vanina Bongard

given: Vanina

name: Metabolic and Cardiovascular Diseases Department Rangueil Hospital CHU Toulouse Toulouse France

family: Elbaz

full_name: Meyer Elbaz

given: Meyer

journal_name: Journal of the American Heart Association

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Blood Microbiota Modification After Myocardial Infarction Depends Upon Low‐Density Lipoprotein Cholesterol Levels

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse


title: Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects

acronym: SCINTIK

summary:
The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects.

These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS).

The investigators want to determine if brain functional imaging and cognitive abnormalities persist during asymptomatic period in a large series of patients with KLS, and to find predictors of these abnormalities.

intervention_type: Radiation


title: Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial

acronym: FISCLOSE

summary:
Anal fistulas are the main etiology of perianal abscesses and suppurations. They are common and generally associated with pain, anal incontinence, impaired quality of life and work incapacity. The therapeutic management of this disease has a double objective: heal the suppuration and preserve the sphincter function. Each year, anal fistulas affect 1 in 10 000 in the normal population, with a difference in prevalence between men and women (1.23 per 10 000 men and 0.56 per 10 000 women). The average age of the patients was 40 years (Simpson et al., 2012).

In about 80% of cases, anal fistulas are secondary to an infection of Hermann and Desfosses' anal glands (cryptogenic or cryptoglandular). Infection of the anal gland can result in an abscess between the internal and external sphincters, which in turn can spread to other parts of the perianal region. The infection can follow many directions from this point in the intersphincteric plan. When the pus reaches the skin, the fistula is formed. Anal fistula therefore has always an intraductal origin, cryptic, with a primary port at this level, and the disregard of which causes the recurrence of the fistula; and usually a secondary port in the skin.

Fistulas are usually divided into two groups. The first group contains fistulas called "simple", which are intersphincteric fistulas or trans-sphincteric involving only the lower third of the sphincter complex. Fistulas usually didn't affect any muscle. The second group contains fistulas called "complex". These are intersphincteric, trans-sphincteric, or even suprasphincteric, extrasphincteric fistulas.

For many years, the treatment of choice was to open the fistula (fistulotomy), but this procedure was associated with a risk of incontinence, the consequences could be potentially devastating. Other surgical treatments include setons, fibrin glue, collagen plugs and advancement flap technique to cover internal opening of the fistula. The success of these therapies remains variable.

The advancement flap technique remains a strategy of choice in the treatment of anal fistulas and particularly in the case of complex fistulas. The success rate of the advancement flap technique remains variable across studies but a recent meta-analysis finds a success rate of around 60%.

A new technique for closing anal fistula is currently in development with the use of a closure clip nitinol (OTSC® Proctology Laboratory: OVESCO and French Distributor: Life Partners). This new technique has been validated in a porcine model of anal fistula, ensuring the safety of the device. A first case was published in a patient with complex anal fistula (high trans-sphincteric). After erosion fistula tract with a special brush, a nitinol clip (OTSC® Proctology) was deposited on the internal opening of the fistula. Eight months after surgery, the fistula was healed and the clip was removed by cutting with special pliers. This technique is currently being broadcast and dozens of patients were treated with this clip without any further scientific validation of the process.

To date, this innovative technique of the closure clip has not yet been assessed in a randomized controlled trial. It is therefore essential to carry out a prospective evaluation in order to determine the effectiveness and safety of this new device in the case of complex anal fistulas.

ReferenceCitation: Dubois A, Carrier G, Pereira B, Gillet B, Faucheron JL, Pezet D, Balayssac D. Therapeutic management of complex anal fistulas by installing a nitinol closure clip: study protocol of a multicentric randomised controlled trial--FISCLOSE. BMJ Open. 2015 Dec 16;5(12):e009884. doi: 10.1136/bmjopen-2015-009884.

family: Dubois

full_name: Anne Dubois

given: Anne

family: Carrier

full_name: Guillaume Carrier

given: Guillaume

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Gillet

full_name: Brigitte Gillet

given: Brigitte

family: Faucheron

full_name: Jean-Luc Faucheron

given: Jean-Luc

family: Pezet

full_name: Denis Pezet

given: Denis

family: Balayssac

full_name: David Balayssac

given: David

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Therapeutic management of complex anal fistulas by installing a nitinol closure clip: study protocol of a multicentric randomised controlled trial—FISCLOSE: Table 1


title: Metabolic Intervention Using Resveratrol in Patients With Huntington Disease

acronym: REVHD

summary: The purpose of this study is to evaluate the therapeutic potential of Resveratrol on the caudate volume in HD patients, using volumetric MRI.

location_facility: Institut du Cerveau et de la Moelle, Hôpital de la Pitié Salpêtrière


title: Efficacy and Safety of Mexiletine in Non-dystrophic Myotonias

acronym: MYOMEX

summary:
Treatment strategies in non-dystrophic myotonias are based on selective case reports, clinical experience and theoretical benefit. Presently, the most promising antimyotonic medication is mexiletine (MEX) but its manufacturing was stopped. The proposed randomized, double-blind, placebo-controlled, crossover trial is designed to:

study the safety and efficacy of mexiletine for the treatment of non-dystrophic myotonias
validate electromyographic tests as a standardized outcome measure of myotonia
assess the reliability and validity of a new clinical rating scale for myotonia


title: Impact of DYSpnea on the ouTcome of Patients Admitted for an Acute RESpiratory Failure in the intenSive Care Unit

acronym: DYSTRESS

summary: Although pain has been extensively studied in ICU patients, only a few studies have focused on dyspnea, which is experienced by 50% of mechanically ventilated patients. The purpose of the present study is to determine whether dyspnea in intensive care unit patients is associated with a higher length of stay in the ICU and a higher incidence of post traumatic stress disorders.


title: Impact Hypercortisolism on Adipose Epicardial and on Myocardial Function

acronym: Hyper-Cor

summary: Identifying hypercortisolism patients at risk for cardio-vascular events despite biological cure, and determine which patients should be particularly followed. Hypercortisolic patients represent an ideal in vivo model to determine the interactions between glucocorticoids and ectopic fat development.


title: Technology and Human Help at Home After Hospitalisation (T4H): a Randomized Clustered Controlled Trial

summary: Elderly people are still at risk for falling at home. The objective of the study is to evaluate at home the impact of an intervention for 3 months combining technologies for autonomy and tailored physical activity program. The study is performed among patients aged 75 years and over leaving Charles Foix Geriatrics hospital or already supported by carer of professional home-care service Ages & Vie and with a loss of autonomy requiring physiotherapy and home support workers. It is a prospective, randomized, single-center, in cluster study which compares a Patient group (interventional group) with the intervention program (technologies + physical activities) with a control group benefiting from usual care home. Our hypothesis is that in the interventional group fewer falls were observed and improved different scores (Timed Up and Go Test,Barthel index, Quality of Life questionnaire of Duke) were reported compared to the control group.

ReferenceCitation: Mézière A, Oubaya N, Michel-Pellegrino V, Boudin B, Neau M, Robert H, Cara I, Salgado Sanchez L, Baloul S, Piette F, Pautas E, Picou Y, Curtis V, Schonheit C, Canouï-Poitrine F, Moreau C. Exercise Interventions With Trained Home Helpers for Preventing Loss of Autonomy and Falls in Community-Dwelling Older Adults Receiving Home Heath Physical Therapy T4H: A Randomized Controlled Pilot Study. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):E138-E149. doi: 10.1519/JPT.0000000000000287.

family: Mézière

full_name: Anthony Mézière

given: Anthony

family: Oubaya

full_name: Nadia Oubaya

given: Nadia

family: Michel-Pellegrino

full_name: Valérie Michel-Pellegrino

given: Valérie

family: Boudin

full_name: Bertrand Boudin

given: Bertrand

family: Neau

full_name: Marine Neau

given: Marine

family: Robert

full_name: Hervé Robert

given: Hervé

family: Cara

full_name: Isabelle Cara

given: Isabelle

family: Salgado Sanchez

full_name: Laura Salgado Sanchez

given: Laura

family: Baloul

full_name: Samia Baloul

given: Samia

family: Piette

full_name: François Piette

family: Pautas

full_name: Eric Pautas

given: Eric

family: Picou

full_name: Yannick Picou

given: Yannick

family: Curtis

full_name: Valentine Curtis

given: Valentine

family: Schonheit

full_name: Claire Schonheit

given: Claire

family: Canouï-Poitrine

full_name: Florence Canouï-Poitrine

family: Moreau

full_name: Caroline Moreau

given: Caroline

journal_name: Journal of Geriatric Physical Therapy

lead_sponsor: Ages et Vies Association


title: Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.

acronym: ACTIVIH

summary: Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome).

lead_sponsor: University Hospital, Montpellier


title: Betaine METABOLISM OF PATIENTS With Homocystinuria

acronym: HCTBETAINE

summary:
Oral treatment with betaine is conventionally used for patients with inherited homocystinurias.

These conditions include a first group of patients with a cystathionine β-synthase (CBS) deficiency and a second group of patients with remethylation defects.

The aim of betaine therapy is to reduce level of total plasma homocysteine. Daily dosages and rhythm of administration proposed in the literature vary between 100 to 250 mg / kg / d in 2 to 4 doses. These dosages are not based on validated data and several publications mention much higher dosages particularly when total homocysteine is not controlled. These practices may be unnecessary or even detrimental given the fact that high doses of betaine could for example lead to secondary folate deficiency.


title: Effects of an Adapted Physical Activity Program on Health and Physical Condition After Sleeve Gastrectomy

acronym: PEEPSO

summary: This study compares the ratio of lean mass losses over total body mass losses between patients undergoing sleeve gastrectomy followed by physical activity training versus patients undergoing sleeve gastrectomy only

status: Withdrawn

lead_sponsor: Lille Catholic University


title: Reduced Toxicity Conditioning Prior to Unrelated Cord Cell Transplantation for High Risk Myeloid Malignancies

acronym: TBF-Cord

summary: Allogeneic cord blood stem cell transplantation is a potentially curative therapy for patients with haematological malignancies. We have extensive experience with the use of Cord Blood Transplantation (CBT) in patients with advanced myeloid malignancies. In adults however, the 40% Non-Relapse Mortality (NRM) rate observed after CBT conditioned with a myeloablative conditioning has encouraged the development of CBT with Reduced Intensity Conditioning (RIC). Our previous national CBT protocol (the Minicord French protocol - NCT00797758) showed that RIC CBT can reduce NRM, but relapse remains the main post-transplant event (>30% at one year). Thus, the development of reduced toxicity rather than RIC conditioning for CBT is warranted in order to improve the outcome of such transplants by limiting NRM and reducing relapse rate. The Fludarabine, ATG and intensified doses of IV Busulfan (9.6 mg/Kg total dose) regimen is a well-established preparative regimen for reduced-intensity/toxicity conditioning prior to allogeneic stem cell transplantation using peripheral blood stem cells mobilized with G-CSF (ClinicalTrials.gov Identifier: NCT00841724). However, such regimen is likely not sufficient to allow for CB cell engraftment. Thiotepa is an alkylating and radio-mimetic agent with a large anti-tumor activity including leukemic cells, the ability to cross the blood-brain barrier and to improve engraftment of hematopoietic stem cells. This drug has been combined to usual conditioning regimen without increasing the toxicity but improving the engraftment rate and potentially reducing the relapse rate. Thus, in the context of adult CBT for high risk myeloid malignancies, we propose to prospectively evaluate a reduced toxicity conditioning based on the association of Thiotepa, Fludarabine, IV Busulfan and ATG with the objective to achieve acceptable NRM rates, and to allow for improved anti-leukemic control based on the cytotoxic component of the conditioning regimen itself, while waiting for the long term immune-mediated disease control (GVL effect).

ReferenceCitation: Rocha V, Labopin M, Sanz G, Arcese W, Schwerdtfeger R, Bosi A, Jacobsen N, Ruutu T, de Lima M, Finke J, Frassoni F, Gluckman E; Acute Leukemia Working Party of European Blood and Marrow Transplant Group; Eurocord-Netcord Registry. Transplants of umbilical-cord blood or bone marrow from unrelated donors in adults with acute leukemia. N Engl J Med. 2004 Nov 25;351(22):2276-85.

ReferenceCitation: Arcese W, Rocha V, Labopin M, Sanz G, Iori AP, de Lima M, Sirvent A, Busca A, Asano S, Ionescu I, Wernet P, Gluckman E; Eurocord-Netcord Transplant group. Unrelated cord blood transplants in adults with hematologic malignancies. Haematologica. 2006 Feb;91(2):223-30.

ReferenceCitation: Atsuta Y, Suzuki R, Nagamura-Inoue T, Taniguchi S, Takahashi S, Kai S, Sakamaki H, Kouzai Y, Kasai M, Fukuda T, Azuma H, Takanashi M, Okamoto S, Tsuchida M, Kawa K, Morishima Y, Kodera Y, Kato S; Japan Cord Blood Bank Network. Disease-specific analyses of unrelated cord blood transplantation compared with unrelated bone marrow transplantation in adult patients with acute leukemia. Blood. 2009 Feb 19;113(8):1631-8. doi: 10.1182/blood-2008-03-147041. Epub 2008 Dec 22.

ReferenceCitation: Eapen M, Rocha V, Sanz G, Scaradavou A, Zhang MJ, Arcese W, Sirvent A, Champlin RE, Chao N, Gee AP, Isola L, Laughlin MJ, Marks DI, Nabhan S, Ruggeri A, Soiffer R, Horowitz MM, Gluckman E, Wagner JE; Center for International Blood and Marrow Transplant Research; Acute Leukemia Working Party Eurocord (the European Group for Blood Marrow Transplantation); National Cord Blood Program of the New York Blood Center. Effect of graft source on unrelated donor haemopoietic stem-cell transplantation in adults with acute leukaemia: a retrospective analysis. Lancet Oncol. 2010 Jul;11(7):653-60. doi: 10.1016/S1470-2045(10)70127-3.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital de Brabois, Hématologie Clinique et thérapie cellulaire


title: Treatment of Multiple Sclerosis With Mesenchymal Stem Cells: Phase I/II Study

acronym: MESEMS

summary:
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS), which ultimately leads to myelin damage and axonal loss. The disease is complex and multifactorial, but the key pathogenic event appears to be an uncontrolled response of components of the immune system (T and B lymphocytes) to myelin proteins. No definitive treatment is available for MS, however immunomodulatory and immunosuppressant drugs act as disease-modifying agents (DMDs).

Unfortunately, the current treatments demonstrate partial efficacy in targeting the deleterious immune reactions. According to the present knowledge of the pathophysiology of MS, an ideal therapeutic strategy would be to modulate or suppress the aggressive immune process, to protect axons and neurons from degeneration, and to enhance repair and facilitate remyelination.

A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown remarkable ability to modulate the immune response. This study will evaluate the safety of injecting MSCs in people with MS.

ReferenceCitation: Uccelli A, Laroni A, Brundin L, Clanet M, Fernandez O, Nabavi SM, Muraro PA, Oliveri RS, Radue EW, Sellner J, Soelberg Sorensen P, Sormani MP, Wuerfel JT, Battaglia MA, Freedman MS; MESEMS study group. MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis. Trials. 2019 May 9;20(1):263. doi: 10.1186/s13063-019-3346-z.

family: Uccelli

full_name: Antonio Uccelli

given: Antonio

family: Laroni

full_name: Alice Laroni

given: Alice

family: Brundin

full_name: Lou Brundin

given: Lou

family: Clanet

full_name: Michel Clanet

given: Michel

family: Fernandez

full_name: Oscar Fernandez

given: Oscar

family: Nabavi

full_name: Seyed Massood Nabavi

given: Seyed Massood

family: Muraro

full_name: Paolo A. Muraro

given: Paolo A.

family: Oliveri

full_name: Roberto S. Oliveri

given: Roberto S.

family: Radue

full_name: Ernst W. Radue

given: Ernst W.

family: Sellner

full_name: Johann Sellner

given: Johann

family: Soelberg Sorensen

full_name: Per Soelberg Sorensen

given: Per

family: Sormani

full_name: Maria Pia Sormani

given: Maria Pia

family: Wuerfel

full_name: Jens Thomas Wuerfel

given: Jens Thomas

family: Battaglia

full_name: Mario A. Battaglia

given: Mario A.

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

journal_name: Trials

repository_institution: University of Ottawa - uO Research

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)


title: Evaluation of Biomechanical and Functional Effects of a Positive Slope Treadmill Training in Individuals After Stroke.

acronym: Hemislope

summary:
The main objective of this study is to determine if a single session of treadmill training with a positive slope improves the kinematic parameters of the hip, knee and ankle on the paretic lower limb.

Secondarily we will quantify the efficiency of a such training on kinetic and functional parameters.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Effect of the Transcranial Direct Current Stimulation on the Dopaminergic

acronym: DOPA-STIM

summary:
Transcranial direct current stimulation (tDCS) is a technique that is emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) is associated with improvement of cognitive functions and mood. Despite an increased use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects. Strategies to optimize the conditions for tDCS application suffer from the lack of knowledge about its neurophysiological impact. Moreover, tDCS is increasingly used in private settings through commercial apparatus and tutorials to make a "do-it-yourself" device delivering tDCS now available on the Internet. This private use worries neuroscientists and health authorities. Even if the general impression is that, in controlled conditions, tDCS is safe with only mild and transient adverse effects, whether and how tDCS could be used for enhancing cognition in healthy subjects are needed to investigate in more detail. The investigators believe that a better understanding of some neurobiological effects of tDCS is crucial to further tailor tDCS for experimental and therapeutic applications and to define recommendations for a private use.

As the cortex is densely connected with basal ganglia areas, including dopaminergic areas, tDCS is probably not only capable to target cortical but also subcortical structures remote from the stimulation sites. Some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) leads to an increased dopaminergic transmission. The involvement of dopaminergic systems in tDCS effects has been investigated only indirectly in pharmacological studies. Thus, the direct effect of the DLPFC stimulation by tDCS on dopaminergic transmission is still unknown.

The aim of this project is to reveal the online impact of a single-session of tDCS applied bilaterally over the DLPFC in healthy subjects on the dopaminergic transmission measured by PET, combined with the [11C]raclopride bolus-plus-continuous-infusion method.

lead_sponsor: Hôpital le Vinatier


ReferenceCitation: Rheims S, Valton L, Michel V, Maillard L, Navarro V, Convers P, Bartolomei F, Biraben A, Crespel A, Derambure P, de Toffol B, Hirsch E, Kahane P, Martin ML, Tourniaire D, Boulogne S, Mercier C, Roy P, Ryvlin P; ENALEPSY study group. Efficacy of naloxone in reducing postictal central respiratory dysfunction in patients with epilepsy: study protocol for a double-blind, randomized, placebo-controlled trial. Trials. 2016 Nov 3;17(1):529.

acronym: ENALEPSY

location_facility: Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies Hôpital Neurologique

title: Efficacy of Naloxone in Reducing Postictal Central Respiratory Dysfunction in Patients With Epilepsy

summary:
Sudden unexpected death in epilepsy (SUDEP) primarily affects young adults with drug-resistant epilepsy, with an incidence of about 0.4%/year. The diagnosis of SUDEP requires that anamnestic data and post-mortem examination do not reveal a structural or toxicological cause for death. Generalized tonic-clonic seizures (GTCS) are the main risk factor for SUDEP, which they appear to trigger in most instances. Indeed, experimental and clinical data strongly suggest that most SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea, later followed by cardiac arrest.

Postictal apnea could partly derive from a seizure-induced massive release of endogenous opioids. Animal studies suggest that such seizure-related release of endogenous opioid peptides participate to termination of seizures. In patients with epilepsy, functional imaging studies have confirmed that seizures induce release of endogenous opioids. The brainstem respiratory centers contain the highest density in opioid receptors, accounting for respiratory depression being one of the cardinal symptoms of opioid overdose.

The investigators hypothesis is that SUDEP partly results from a post-ictal apnea promoted by a GTCS-induced massive release of endogenous opioids, and that an opioid antagonist could represent an effective preventive treatment of SUDEP. This could be achieved by chronic administration of Naltrexone, an opioid antagonist that has been used in a large population of patients with chronic alcoholism at high risk of seizures, without showing any pro-convulsant effect. This is a crucial feasibility issue since antagonising a mechanism thought to participate to seizure termination could theoretically aggravate seizures.

Before evaluating the efficacy of chronic administration of naltrexone, it is legitimate to perform a proof of concept study by testing the acute effect of an equivalent injectable treatment (Naloxone) in the immediate aftermath of GTCS recorded inhospital during video-EEG monitoring of patients with refractory epilepsy. One third of these patients develop postictal respiratory dysfunction and hypoxemia, which should be reduced by the investigators intervention if the investigators hypothesis is correct.

The main objective of the study is to evaluate the efficacy of 0.4 mg intravenous naloxone, versus placebo, administered in the immediate aftermath of a GTCS, in reducing the severity of the postictal central respiratory dysfunction occurring after the end of the seizure, as measured by pulse oximetry.

About 25% of patients with drug-resistant partial epilepsy who undergo long-term video-EEG monitoring develop at least one partial secondary generalized tonic-clonic seizure. However, these patients cannot be individualized a priori. Therefore, all adult patients with drug-resistant epilepsy who will undergo long-term video-EEG monitoring in one of the participating centres, will lack all exclusion criteria, and will give their written informed consent to participate to the study if they develop GTCS, will be included in the study. They will all benefit from continuous monitoring of pulse oximetry (together with video, EEG, and respiration recordings), and will be equipped with a peripheral venous catheter throughout the video-EEG. The modalities of the video-EEG monitoring will be consistent with the current practices and similar across the 8 centres (apart from the venous catheter which is not standard practice).

In case of occurrence of a generalized tonic-clonic seizure, patients will be randomized (1:1) to receive intravenous naloxone (0.4 mg) or placebo. Placebo will be isotonic sodium chloride which preparation and packaging will be centralized to ensure its indistinguishability from naloxone. Randomization will be centralized and stratified by centre. The evolution from a partial seizure to a GTCS being gradual, and the total duration of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course of the seizure. Given the assumptions about the role of endogenous opioids release in the spontaneous termination of seizures, naloxone will be administrated immediately after the end of the GTCS and not before.

All digital data (video, EEG, respiration, SpO2) will be centralized and evaluated blind to other data by the PI of the study who will not be involved in the video-EEG monitoring of the included patients. The same automatic and objective analysis of SpO2 data than the one already developed in the PHRC REPOMSE will be performed.


title: A Phase I/II Study of Pazopanib in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme After Surgery and RT-CT

acronym: PAZOGLIO

summary: A phase I/II study of pazopanib in combination with temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and RT-CT (PAZOGLIO study)

lead_sponsor: Centre Antoine Lacassagne


title: Efficacy and Safety of Oral Corticosteroids for the Treatment of Acute Exacerbations of COPD in General Practice

acronym: BECOMEG

summary:
Primary objective:

The aim of this study is to determine the efficacy and safety of five days of oral corticosteroids (40 mg / day) for the treatment of acute exacerbations of COPD (AECOPD) in outpatients.

ReferenceCitation: Rabbat A, Guetta A, Lorut C, Lefebvre A, Roche N, Huchon G. [Management of acute exacerbations of COPD]. Rev Mal Respir. 2010 Oct;27(8):939-53. doi: 10.1016/j.rmr.2010.08.003. Review. French.

ReferenceCitation: Thompson WH, Nielson CP, Carvalho P, Charan NB, Crowley JJ. Controlled trial of oral prednisone in outpatients with acute COPD exacerbation. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):407-12.

ReferenceCitation: Walters JA, Wang W, Morley C, Soltani A, Wood-Baker R. Different durations of corticosteroid therapy for exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD006897. doi: 10.1002/14651858.CD006897.pub2. Review. Update in: Cochrane Database Syst Rev. 2014;12:CD006897.

ReferenceCitation: Walters JA, Gibson PG, Wood-Baker R, Hannay M, Walters EH. Systemic corticosteroids for acute exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001288. doi: 10.1002/14651858.CD001288.pub3. Review. Update in: Cochrane Database Syst Rev. 2014;9:CD001288.

ReferenceCitation: Société de Pneumologie de Langue Française. [Updated guidelines of the Société de Pneumologie de Langue Française for the management of chronic obstructive pulmonary disease: essential points]. Rev Mal Respir. 2003 Apr;20(2 Pt 1):294-9. French.