title: Evaluation of the Benefit of the Use of Platelet-Rich Plasma (PRP) Combined to Hyaluronic Acid (HA) for Vulvovaginal Dryness

summary:
Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia.

This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments (hormonal therapies).To achieve this, 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva, the posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value, and secondarily through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6 months after the treatment.

lead_sponsor: Regen Lab SA

location_facility: Centre Hospitalier Universitaire Henri Mondor


type: Other Identifier

title: Effect of the Oral Route of Magnesium on Pre and Post-mastectomy on the Post-surgery Pain

summary: In breast cancer patients undergoing a mastectomy, the aim of this study is to evaluate if the magnesium administered for 6 weeks starting two weeks before the surgery induces a decrease of pain intensity one month post-mastectomy compared to the placebo group.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Morel V, Joly D, Villatte C, Pereira B, Pickering G. Preventive effect of oral magnesium in postmastectomy pain: protocol for a randomised, double-blind, controlled clinical trial. BMJ Open. 2018 Oct 4;8(9):e017986. doi: 10.1136/bmjopen-2017-017986.

family: Morel

full_name: Véronique Morel

given: Véronique

sequence: first

family: Joly

full_name: Dominique Joly

given: Dominique

sequence: additional

family: Villatte

full_name: Christine Villatte

given: Christine

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


title: Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass

acronym: DYVA

summary:
Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension, atherosclerosis, dyslipidemia, chronic renal failure ...).

It is likely that a significant number of patients suffering from a preexisting endothelial dysfunction. This endothelial dysfunction can be assessed by a molecular approach (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as ischemia-reperfusion injury is. No studies have evaluated the time course of the infringement, and its association with the immediate post-operative complications (SIRS, coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an association between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac surgery vasoplegic syndrome. A study in noncardiac surgery has regained an association between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal failure. Thus there is some data in the literature to suggest that the occurrence of postoperative complications (SIRS, coagulopathy, capillary leak syndrome, acute circulatory failure vasoplegic and acute renal failure) may result from the interaction between a pre-existing endothelial dysfunction and "operative" aggression (extracorporeal circulation). The onset of complications result from an interaction that depends on the importance of endothelial dysfunction at baseline.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Personalized Therapy of Cystic Fibrosis: Set-up of Response Markers

acronym: BIO-CFTR

summary: The purpose of this study is to determine which biological marker, or association of biological markers, best predict clinical response of cystic fibrosis patients to CFTR modulators.

study_start_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: Ramsey BW, Davies J, McElvaney NG, Tullis E, Bell SC, Dřevínek P, Griese M, McKone EF, Wainwright CE, Konstan MW, Moss R, Ratjen F, Sermet-Gaudelus I, Rowe SM, Dong Q, Rodriguez S, Yen K, Ordoñez C, Elborn JS; VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011 Nov 3;365(18):1663-72. doi: 10.1056/NEJMoa1105185.

ReferenceCitation: Graeber SY, Hug MJ, Sommerburg O, Hirtz S, Hentschel J, Heinzmann A, Dopfer C, Schulz A, Mainz JG, Tümmler B, Mall MA. Intestinal Current Measurements Detect Activation of Mutant CFTR in Patients with Cystic Fibrosis with the G551D Mutation Treated with Ivacaftor. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1252-5. doi: 10.1164/rccm.201507-1271LE.

ReferenceCitation: Quittner A, Suthoff E, Rendas-Baum R, Bayliss MS, Sermet-Gaudelus I, Castiglione B, Vera-Llonch M. Effect of ivacaftor treatment in patients with cystic fibrosis and the G551D-CFTR mutation: patient-reported outcomes in the STRIVE randomized, controlled trial. Health Qual Life Outcomes. 2015 Jul 2;13:93. doi: 10.1186/s12955-015-0293-6.

family: Quittner

full_name: Alexandra Quittner

given: Alexandra

family: Suthoff

full_name: Ellison Suthoff

given: Ellison

family: Rendas-Baum

full_name: Regina Rendas-Baum

given: Regina

family: Bayliss

full_name: Martha S. Bayliss

given: Martha S.

family: Sermet-Gaudelus

full_name: Isabelle Sermet-Gaudelus

given: Isabelle

family: Castiglione

full_name: Brenda Castiglione

given: Brenda

family: Vera-Llonch

full_name: Montserrat Vera-Llonch

given: Montserrat

journal_name: Health and Quality of Life Outcomes

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: De Boeck K, Munck A, Walker S, Faro A, Hiatt P, Gilmartin G, Higgins M. Efficacy and safety of ivacaftor in patients with cystic fibrosis and a non-G551D gating mutation. J Cyst Fibros. 2014 Dec;13(6):674-80. doi: 10.1016/j.jcf.2014.09.005. Epub 2014 Sep 26.

ReferenceCitation: Boyle MP, Bell SC, Konstan MW, McColley SA, Rowe SM, Rietschel E, Huang X, Waltz D, Patel NR, Rodman D; VX09-809-102 study group. A CFTR corrector (lumacaftor) and a CFTR potentiator (ivacaftor) for treatment of patients with cystic fibrosis who have a phe508del CFTR mutation: a phase 2 randomised controlled trial. Lancet Respir Med. 2014 Jul;2(7):527-38. doi: 10.1016/S2213-2600(14)70132-8. Epub 2014 Jun 24.

family: Boyle

full_name: Michael P Boyle

given: Michael P

family: Bell

full_name: Scott C Bell

given: Scott C

family: Konstan

full_name: Michael W Konstan

given: Michael W

family: McColley

full_name: Susanna A McColley

given: Susanna A

family: Rowe

full_name: Steven M Rowe

given: Steven M

family: Rietschel

full_name: Ernst Rietschel

given: Ernst

family: Huang

full_name: Xiaohong Huang

given: Xiaohong

family: Waltz

ReferenceCitation: Wainwright CE, Elborn JS, Ramsey BW, Marigowda G, Huang X, Cipolli M, Colombo C, Davies JC, De Boeck K, Flume PA, Konstan MW, McColley SA, McCoy K, McKone EF, Munck A, Ratjen F, Rowe SM, Waltz D, Boyle MP; TRAFFIC Study Group; TRANSPORT Study Group. Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. N Engl J Med. 2015 Jul 16;373(3):220-31. doi: 10.1056/NEJMoa1409547. Epub 2015 May 17.

repository_institution: The University of Queensland - Queensland's institutional digital repository

title: Lumacaftor–Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR

ReferenceCitation: De Boeck K, Kent L, Davies J, Derichs N, Amaral M, Rowe SM, Middleton P, de Jonge H, Bronsveld I, Wilschanski M, Melotti P, Danner-Boucher I, Boerner S, Fajac I, Southern K, de Nooijer RA, Bot A, de Rijke Y, de Wachter E, Leal T, Vermeulen F, Hug MJ, Rault G, Nguyen-Khoa T, Barreto C, Proesmans M, Sermet-Gaudelus I; European Cystic Fibrosis Society Clinical Trial Network Standardisation Committee. CFTR biomarkers: time for promotion to surrogate end-point. Eur Respir J. 2013 Jan;41(1):203-16. doi: 10.1183/09031936.00057512. Epub 2012 Aug 9. Review.

ReferenceCitation: Dekkers JF, Wiegerinck CL, de Jonge HR, Bronsveld I, Janssens HM, de Winter-de Groot KM, Brandsma AM, de Jong NW, Bijvelds MJ, Scholte BJ, Nieuwenhuis EE, van den Brink S, Clevers H, van der Ent CK, Middendorp S, Beekman JM. A functional CFTR assay using primary cystic fibrosis intestinal organoids. Nat Med. 2013 Jul;19(7):939-45. doi: 10.1038/nm.3201. Epub 2013 Jun 2.

ReferenceCitation: Pranke I, Hatton A, Masson A, Flament T, Le Bourgeois M, Chedevergne F, Bailly C, Urbach V, Hinzpeter A, Edelman A, Sermet-Gaudelus I. Might Brushed Nasal Cells Be a Surrogate for CFTR Modulator Clinical Response? Am J Respir Crit Care Med. 2019 Jan 1;199(1):123-126. doi: 10.1164/rccm.201808-1436LE.

name: Institut Necker-Enfants MaladesParis, France

name: Hôpital Necker-Enfants MaladesParis, France

journal_name: American Journal of Respiratory and Critical Care Medicine


title: Registry on the EXperience of Extracorporeal CO2 Removal in Intensive Care Units

acronym: REXECOR

summary:
Investigators will aim to conduct an observational study in order to assess very thoroughly all patients implanted by Extracorporeal carbon dioxide removal (ECCO2R) in 10 critical care units of Paris and its surburb (APHP, Assistance Publique des hôpitaux de Paris).

Secondary objectives will be:

to assess efficacy and safety of ECCO2R,
to compare the data issue from the registry to others studies assessing the same population and to other centers and
to compare the different ECCOR devices in terms of efficacy and adverse events.

status: Recruiting

ReferenceCitation: Augy JL, Aissaoui N, Richard C, Maury E, Fartoukh M, Mekontso-Dessap A, Paulet R, Anguel N, Blayau C, Cohen Y, Chiche JD, Gaudry S, Voicu S, Demoule A, Combes A, Megarbane B, Charpentier E, Haghighat S, Panczer M, Diehl JL. A 2-year multicenter, observational, prospective, cohort study on extracorporeal CO(2) removal in a large metropolis area. J Intensive Care. 2019 Aug 20;7:45. doi: 10.1186/s40560-019-0399-8. eCollection 2019.

family: Augy

full_name: J. L. Augy

given: J. L.

family: Aissaoui

full_name: N. Aissaoui

given: N.

family: Richard

full_name: C. Richard

given: C.

family: Maury

full_name: E. Maury

given: E.

family: Fartoukh

full_name: M. Fartoukh

given: M.

family: Mekontso-Dessap

full_name: A. Mekontso-Dessap

given: A.

family: Paulet

full_name: R. Paulet

given: R.

family: Anguel

full_name: N. Anguel

family: Blayau

full_name: C. Blayau

family: Cohen

full_name: Y. Cohen

given: Y.

family: Chiche

full_name: J. D. Chiche

given: J. D.

family: Gaudry

full_name: S. Gaudry

given: S.

family: Voicu

full_name: S. Voicu

family: Demoule

full_name: A. Demoule

family: Combes

full_name: A. Combes

family: Megarbane

full_name: B. Megarbane

given: B.

family: Charpentier

full_name: E. Charpentier

family: Haghighat

full_name: S. Haghighat

family: Panczer

full_name: M. Panczer

family: Diehl

full_name: J. L. Diehl

currency_apc_doaj: EUR

journal_name: Journal of Intensive Care

title: A 2-year multicenter, observational, prospective, cohort study on extracorporeal CO2 removal in a large metropolis area


title: Biomarkers in Dyspnea

acronym: BIODYSPNEE

summary: To explore biological mechanisms in human model of induced dyspnea, in order to remove the source of dyspnoea, to modify cerebral impact and to allow the development of targeted therapies.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

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

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

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter Prospective Study on Failed Back Surgery Syndrome Pathway Optimization: A Focus on Patient Identification, Chronicization Factors and Outcome Predictors

acronym: PREDIBACK

summary:
This pilot study is part of a global project that aims to better define and understand features of FBSS/POPS "post-operative persistent syndrome patients (shortened as "FBSS" in the following project). FBSS is the acronym for Failed Back Surgery Syndrome, which has been defined as a chronic condition resulting from spinal interventions. Despite anatomically successful spine surgery, a significant proportion of patients is experiencing chronic refractory back and leg pain. In a recent multicentre study conducted on more than 100 refractory FBSS patients, (ESTIMET Study), the mean delay between pain occurrence and FBSS diagnosis was 5 years. Therefore, FBSS pattern and potential responder stratification might guide us to eventually develop a decision tool for identifying FBSS patients. Easing and helping diagnosis of FBSS should improve referral yield to specialists and accelerate patient flow through the care pathway. Hence, FBSS patients, who usually present a long standing history of pain, would have access to "appropriate" therapies earlier. This could lead to better outcomes. The aim of this multicentre, prospective study is to collect specific data that are not collected in routine in order to better define and understand the potential FBSS population and to accelerate the diagnostic and optimize the choice of appropriate treatment.

A multidisciplinary approach through a pain management clinical network, as it has been structured in Poitiers, will ensure that an exhaustive characterization of FBSS patients and their care pathway will be collected. In addition, since the cooperation between orthopaedic and neuro spine surgeons is not a common relationship found all over Europe (as it is observed in Poitiers), this study also aims to better understand the development of interactions between physicians/professionals and the substantial advantage which would result from bridging this gap. The N3MT (NeuroMapping Tools) software developed in Poitiers to collect data and assess objectively pain surface and intensity changes, before/after any treatment, with quantitative measurements, will be used as the central key of this project.

primary_purpose: Diagnostic

lead_sponsor: Poitiers University Hospital


title: Neurophysiological Impact of a Fronto-temporal Transcranial Direct Current Stimulation (tDCS) in Healthy Subjects: a Multimodal Imaging Approach

acronym: COMBI-STIM

summary:
tDCS is a technique emerging as a prospective therapy for neurologic, psychiatric and addictive disorders. Specifically, fronto-temporal tDCS, with anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the left temporo-parietal junction (TPJ), has been reported to reduce treatment-resistant auditory hallucinations (AH), negative symptoms and insight of the illness in schizophrenia. However, despite an increasing use in clinical settings, tDCS suffers from limitations, especially regarding the strength and the duration of therapeutic effects.

Some imaging reports suggest that tDCS effects are not restricted to the brain areas located under the electrodes, but spread through distributed cortical networks functionally connected with the targets and reach subcortical areas. Overall, these studies suggest that tDCS modulates functional connectivity within and across resting-state networks and brain activity. However, these effects are currently described at different levels depending on the imaging technique used. Moreover, the majority of studies have focused on motor cortex stimulation, while the specific effects of fronto-temporal tDCS are scarce. Finally, effects of the stimulation applied online are rarely inspected.

According to the therapeutic effects of fronto-temporal tDCS on schizophrenia and the dopaminergic pathophysiological hypothesis of schizophrenia, the effect of fronto-temporal tDCS on dopaminergic transmission is of major interest. As the cortex is densely connected with basal ganglia areas, tDCS effects are probably capable to reach subcortical dopaminergic areas. Indeed, recent fMRI studies highlighted subcortical effects of tDCS applied at the cortical level including modulations of cortico-striatal and thalamo-cortical functional connectivity. In addition, some studies suggest that cortical stimulation by other approaches, such as transcranial magnetic stimulation (rTMS) modulates dopaminergic transmission. However, tDCS effects on dopaminergic transmission have been investigated only indirectly.

Finally, information about biological effects of tDCS is scattered and creating a coherent ensemble is a mandatory and critical step to understand the mechanisms of action of tDCS.

According to the hypothesis that fronto-temporal tDCS modulates brain activity, connectivity and dopaminergic transmission, the aim of this project is to reveal the combined neurobiological impact of an online single session of fronto-temporal tDCS in a unique experiment by developing a simultaneous multimodal imaging approach (PET-MRI). The online implementation of the stimulation will allow deciphering changes induced during and after stimulation. As a first step before investigating patients with schizophrenia, healthy subjects will be involved in the present study.

The distributed changes will be explored at rest through:

Spontaneous functional connectivity assessed by functional magnetic resonance imagery (fMRI).
Brain activity assessed by cerebral blood flow quantitatively and directly measured by arterial spin labelling (ASL).
Connectivity assessed by diffusion tensor imaging (DTI).
Specific and localized dopaminergic transmission evaluated by positron emission tomography (PET) using dopaminergic D2 subtype receptor availability via [11C]raclopride binding.

The pioneering aspects of the project are to use an innovative simultaneous multimodal imaging system, adopt the tDCS montage used in our validated therapeutic context and apply tDCS online. We expect that our unique approach will provide an imaging biomarker essential to improve our understanding of:

the "normal brain" and further deficient mechanisms underlying schizophrenia as well as neurological disorders.

neurobiological effects of tDCS in order to:

Bring key element of the proof of concept of tDCS
Optimize tDCS in a therapeutic context
Suggest a marker of the therapeutic response

lead_sponsor: Hospices Civils de Lyon

intervention_type: Device


title: Prospective Study of Natural Killer Cells in Patients With Metastatic Prostate Cancer: Relationship With Survival and Response Time to Castration

acronym: NKPROSTATE

summary: Prospective research of Natural Killer cells as predictive biomarkers to stratify patients likely to have longer response time to castration.

status: Active, not recruiting

ReferenceCitation: Pasero C, Gravis G, Granjeaud S, Guerin M, Thomassin-Piana J, Rocchi P, Salem N, Walz J, Moretta A, Olive D. Highly effective NK cells are associated with good prognosis in patients with metastatic prostate cancer. Oncotarget. 2015 Jun 10;6(16):14360-73.

ReferenceCitation: Gannon PO, Poisson AO, Delvoye N, Lapointe R, Mes-Masson AM, Saad F. Characterization of the intra-prostatic immune cell infiltration in androgen-deprived prostate cancer patients. J Immunol Methods. 2009 Aug 31;348(1-2):9-17. doi: 10.1016/j.jim.2009.06.004. Epub 2009 Jun 22.

ReferenceCitation: Mamessier E, Sylvain A, Thibult ML, Houvenaeghel G, Jacquemier J, Castellano R, Gonçalves A, André P, Romagné F, Thibault G, Viens P, Birnbaum D, Bertucci F, Moretta A, Olive D. Human breast cancer cells enhance self tolerance by promoting evasion from NK cell antitumor immunity. J Clin Invest. 2011 Sep;121(9):3609-22. doi: 10.1172/JCI45816. Epub 2011 Aug 15.

lead_sponsor: Institut Paoli-Calmettes

status_simplified: Ongoing


title: Anorectal Function and Neuronal-glial-epithelial Unit in Healthy Subjects

acronym: ANOSAIN

summary:
This study aims to assess the phenotype of the enteric nervous system (enteric neurons) in healthy subjects.

The enteric nervous system (ENS) is composed by enteric neurons and enteric glial cells. There is a cross-talk between ENS and the intestinal epithelial barrier (IEB). ENS and IEB together constitute the neuronal-glial-epithelial unit. This unit has a key role in gut functions. The characteristics and the phenotype of the ENS also change according to age and environmental factors. Similar study is ongoing for patients with Spina Bifida. Anorectal data and phenotype of the neuronal-glial-epithelial unit in healthy subjects is required to assess abnormality of these items in patients with neurological disease including Spina Bifida.

primary_purpose: Other

lead_sponsor: Rennes University Hospital

intervention_type: Procedure


title: Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates: TRIPLEAD Trial

acronym: TRIPLEAD

summary:
Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (NYHA class, Packer clinical composite score) or on ventricular remodeling parameters assessed by echography (Left ventricle end of systole volume). This rate has remained remarkably stable since the therapy started and has motivated many studies to better understand the underlying physiopathology and the CRT action mechanisms.

Among the various research axes to improve CRT response and responders rate, increasing the number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three studies. In all cases, it demonstrated a significant improvement of cardiac performance whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility of this approach for long term CRT delivery was demonstrated during a previous study. First results with triple-site ventricular stimulation are encouraging and its clinical efficacy should now be tested on a larger population in order to conclude on its interest for CRT candidates.

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: University Hospital, Rouen


title: An Open Label Non-randomized Phase II Study Exploring "Chemo-free " Treatment Association With Idelalisib + Obinutuzumab in Patient With Relapsed/Refractory Waldenstrom's Macroglobulinemia

summary: Prospective national multicenter open label phase II Remodel WM3 trial

ReferenceCitation: Tomowiak C, Poulain S, Herbaux C, Perrot A, Mahé B, Morel P, Aurran T, Tournilhac O, Leprêtre S, Assaad S, Villemagne B, Casasnovas O, Nollet D, Roos-Weil D, Chevret S, Leblond V. Obinutuzumab and idelalisib in symptomatic patients with relapsed/refractory Waldenström macroglobulinemia. Blood Adv. 2021 May 11;5(9):2438-2446. doi: 10.1182/bloodadvances.2020003895.

name: Hematology Department and Centre d’Investigations Cliniques (CIC) 1402 INSERM, University Hospital, Poitiers, France;

family: Tomowiak

full_name: Cécile Tomowiak

given: Cécile

name: INSERM 1277–Centre National de la Recherche Scientifique 9020 Unite Mixte de Recherche 12, University of Lille, Laboratory of Hematology, Biology, and Pathology Center, Centre Hospitalier Universitaire de Lille, Lille, France;

family: Poulain

full_name: Stéphanie Poulain

given: Stéphanie

name: Department of Blood Diseases, University Hospital, Lille, France;

family: Herbaux

full_name: Charles Herbaux

given: Charles

name: Hematology Department, University Hospital, Institut Universitaire du Cancer–Oncopole, Université de Toulouse, Université Paris-Saclay, Toulouse, France;

family: Perrot

full_name: Aurore Perrot

given: Aurore

name: Hematology Department, University Hospital, Nantes, France;

family: Mahé

full_name: Béatrice Mahé

given: Béatrice

name: Hematology Department, University Hospital Amiens-Picardie, Amiens, France;

family: Morel

full_name: Pierre Morel

given: Pierre

name: Department of Hematology, Institut Paoli Calmettes, Marseille, France;

family: Aurran

full_name: Thérèse Aurran

given: Thérèse

name: Hematology Department, University Hospital Estaing, University Clermont Auvergne EA 7453, CIC1405, Clermont-Ferrand, France;

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

name: INSERM U1245 and Department of Hematology, Centre Henri Becquerel and Normandie University UNIROUEN, Rouen, France;

family: Leprêtre

full_name: Stéphane Leprêtre

given: Stéphane

family: Assaad

full_name: Souad Assaad

given: Souad

name: Hematology Department, Centre Hospitalier Départemental, La Roche sur Yon, France;

family: Villemagne

full_name: Bruno Villemagne

given: Bruno

name: Department of Hematology, University Hospital Dijon Bourgogne and INSERM 1231, Dijon, France;

family: Casasnovas

full_name: Olivier Casasnovas

name: Hematology Department, University Hospital Bretonneau, Tours, France;

family: Nollet

full_name: Delphine Nollet

given: Delphine

name: Hematology Department, Sorbonne Université, Hôpital Pitié Salpêtrière APHP, Paris, France; and

family: Roos-Weil

full_name: Damien Roos-Weil

given: Damien

name: U1153 Centre de Recherche en Épidémiologie et Statistiques, Equipe de Recherche en Biostatistiques et Epidémiologie Clinique

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Leblond

full_name: Véronique Leblond

given: Véronique

journal_name: Blood Advances

evidence: open (via free article)

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: American Society of Hematology


title: Impact of Donor and Recipient ST2 / IL-33 Pathway on Recipient Survival and Acute Rejection After Heart Transplantation

acronym: ISIDORE

summary: Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day recipient mortality in order to improve graft screening.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Department of Thoracic and Cardiovascular Surgery, Cardiac Institute, Groupe Hospitalier La Pitié Salpêtrière


title: Study of Arterial Recanalization of the Central Retinal Artery Occlusions

acronym: RECANAL

summary: Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke (IS) at the retinal level. They share the same risk factors and common pathology. Their incidence is lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with visual acuity (VA) <1/10. The diagnosis of an CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. There is no data on early retinal arterial recanalization after CRAO, nor on the relationship between early recanalization (spontaneous or post-thrombolysis) and visual prognosis.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Pathway Taking Into Account PeriConceptional Environment for Infertile Couple

acronym: PEPCI

summary: Infertility is defined as the inability to conceive after 12 months of unprotected intercourse, It affects approximately one in six couples pregnancy. Many lifestyle factors of the couple's pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee, drugs, exercise, stress, sleep, pollution...) are risk factors for infertility. Weight gain, in both members of the couple, is associated with an increased risk of Assisted Reproduction Technology (ART) failure and adverse pregnancy outcome, while healthy lifestyle makes the risk of infertility three times less likely to happen. Idiopathic infertility may greatly benefit from lifestyle factors optimization.

primary_purpose: Supportive Care

ReferenceCitation: Dupont C, Aegerter P, Foucaut AM, Reyre A, Lhuissier FJ, Bourgain M, Chabbert-Buffet N, Cédrin-Durnerin I, Selleret L, Cosson E, Lévy R. Effectiveness of a therapeutic multiple-lifestyle intervention taking into account the periconceptional environment in the management of infertile couples: study design of a randomized controlled trial - the PEPCI study. BMC Pregnancy Childbirth. 2020 May 26;20(1):322. doi: 10.1186/s12884-020-2855-9.

family: Dupont

full_name: Charlotte Dupont

given: Charlotte

family: Aegerter

full_name: Philippe Aegerter

given: Philippe

family: Foucaut

full_name: Aude-Marie Foucaut

given: Aude-Marie

family: Reyre

full_name: Aymeric Reyre

given: Aymeric

family: Lhuissier

full_name: François J. Lhuissier

given: François J.

family: Bourgain

full_name: Marie Bourgain

given: Marie

family: Chabbert-Buffet

full_name: Nathalie Chabbert-Buffet

given: Nathalie

family: Cédrin-Durnerin

full_name: Isabelle Cédrin-Durnerin

given: Isabelle

family: Selleret

full_name: Lise Selleret

given: Lise

family: Cosson

full_name: Emmanuel Cosson

given: Emmanuel

family: Lévy

full_name: Rachel Lévy

given: Rachel

journal_name: BMC Pregnancy and Childbirth

repository_institution: University of Geneva - Archive ouverte UNIGE

title: Effectiveness of a therapeutic multiple-lifestyle intervention taking into account the periconceptional environment in the management of infertile couples: study design of a randomized controlled trial – the PEPCI study

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evolution of REM Sleep Behavior Disorder in Parkinson's Disease Patients RBD Diagnosed Three Years Earlier

summary:
About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a parasomnia characterized by partial or complete loss of REM sleep muscle atonia and dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia is the polysomnographic hallmark of RBD, and its quantification is necessary for the diagnosis.

RBD in PD is believed to be a marker of a more widespread degenerative process and a marker of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired in both motor and non-motor domains, compared to those without RBD, with an increased risk of dementia. However, little is know about the relationship between the evolution of RBD, clinic and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal vPSG study has been performed in PD-RBD population.

Thus, the main objective of this study is to longitudinally evaluate clinical and video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.


title: Reproducibility Inter-session of the Measurement Elastography of the Passive Stiffness of Medial Beams of Gastrocnemius Muscle of the Hemiplegic Cerebral Child.

acronym: ELASTOREPRO

summary: Muscles, paretics and spastics, of cerebral palsy children have very early, for growth (three at five aged), every alteration of theirs properties. Gastrocnemius muscle, often reaches on the cerebral palsy, characterised by a modification of the structure (volume decrease) and the elasticity (increase of the passive stiffness). Every alterations of the muscular property have impact clinic and functional important. The many treatments of orthopaedic targeting (lengthening of cast, injections of botulinic toxin), repeated to a multiple recovery during the growth influences the muscular characteristics. There is a real interest to measure the muscular property development during children's growth.

ReferenceCitation: Boulard C, Gautheron V, Lapole T. Reliability outcomes and inter-limb differences in ankle joint stiffness in children with unilateral cerebral palsy depend on the method of analysis. J Electromyogr Kinesiol. 2019 Dec;49:102353. doi: 10.1016/j.jelekin.2019.102353. Epub 2019 Aug 23.

family: Boulard

full_name: C. Boulard

given: C.

family: Gautheron

full_name: V. Gautheron

given: V.

family: Lapole

full_name: T. Lapole

given: T.

journal_name: Journal of Electromyography and Kinesiology

oa_host_type: publisher

evidence: open (author manuscript)

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


summary: The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.

status: Terminated

lead_sponsor: University Hospital, Montpellier


title: Preliminary Study About the Efficacy of an α1 Blocker (Prazosin) in Preventing the Occurrence of Post-traumatic Stress Disorder (PTSD) in Patients With Acute Stress

acronym: PRAZOSTRESS

summary: After a traumatic event such as an accident or an assault, victims may experience intense stress symptoms that may evolve into "post-traumatic stress disorder" (PTSD). It is a frequent and serious pathology, which can be complicated by depression, addiction or suicide. Few means are available to prevent PTSD in people who have just undergone trauma. Prazosin is an antihypertensive drug that blocks α1 adrenaline receptors which could help to stop the vicious circle of stress and prevent the development of the disease. The objective of this study is to demonstrate the efficacy of prazosin to prevent PTSD in patients who visit an emergency department after trauma.

location_facility: Groupement Hospitalier Edouard Herriot - Emergency Psychiatry Department


title: Cervical Preparation of Abortions Under Paracervical Block in the First Trimester: A Randomized Clinical Trial

acronym: BPCEN

summary:
Surgical abortion is one of the most frequently surgery of women in the world. 43 millions are annually performed in the world.

90% of the abortions are performed during the first trimester of pregnancy before 13 weeks. Legal surgical abortion during the first trimester of pregnancy is a low risk intervention with a mortality rate lower than 1/100 000 abortions, with a risk of complications from 0.3 % to 3.4 %.

ReferenceCitation: Hamdaoui N, Cardinale C, Fabre C, Baumstarck K, Agostini A. Pain Associated With Cervical Priming for First-Trimester Surgical Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):1055-1060. doi: 10.1097/AOG.0000000000004376.

family: Hamdaoui

full_name: Naima Hamdaoui

given: Naima

family: Cardinale

full_name: Chloé Cardinale

given: Chloé

family: Fabre

full_name: Cyprien Fabre

given: Cyprien

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Agostini

full_name: Aubert Agostini

given: Aubert

journal_name: Obstetrics & Gynecology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la conception Assistance Publique Hôpitaux de Marseille


title: Retrospective Study With Botulinic Toxin in Neurogenic Detrusor Overactivity

acronym: NDOTOX

summary: Aims of this study were to assess the long-term outcomes of detrusor injection of OnabotulinumtoxinA (Botox® injection) associated with clean intermittent-catheterization (CIC) for the treatment of neurogenic detrusor overactivity (NDO) and to identify risk factors for failure.

time_perspective: Retrospective

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery

acronym: ISO

summary: The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known. The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and risk factors of these infections in a french University Hospital.

ReferenceCitation: Kalmeijer MD, van Nieuwland-Bollen E, Bogaers-Hofman D, de Baere GA. Nasal carriage of Staphylococcus aureus is a major risk factor for surgical-site infections in orthopedic surgery. Infect Control Hosp Epidemiol. 2000 May;21(5):319-23.

ReferenceCitation: Korol E, Johnston K, Waser N, Sifakis F, Jafri HS, Lo M, Kyaw MH. A systematic review of risk factors associated with surgical site infections among surgical patients. PLoS One. 2013 Dec 18;8(12):e83743. doi: 10.1371/journal.pone.0083743. eCollection 2013. Review.

ReferenceCitation: Marimuthu K, Eisenring MC, Harbarth S, Troillet N. Epidemiology of Staphylococcus aureus Surgical Site Infections. Surg Infect (Larchmt). 2016 Apr;17(2):229-35. doi: 10.1089/sur.2015.055. Epub 2015 Dec 31.

ReferenceCitation: Lepelletier D, Saliou P, Lefebvre A, Lucet JC, Grandbastien B, Bruyère F, Stahl JP, Keita-Perse O, Berthelot P, Aho S; workgroup SF2H. "Preoperative risk management: strategy for Staphylococcus aureus preoperative decolonization" (2013 update). French society of Hospital Hygiene. Med Mal Infect. 2014 Jun;44(6):261-7. doi: 10.1016/j.medmal.2014.04.003. Epub 2014 May 14.

ReferenceCitation: Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev. 2015 Feb 20;(2):CD004985. doi: 10.1002/14651858.CD004985.pub5. Review.

lead_sponsor: University Hospital, Grenoble


title: Development of a Visio-behavioral Scale to Evaluate Visual Abilities of Patients With Profound Multiple Intellectual Disabilities (PLH-Vision)

acronym: PLH-Vision

summary:
The main objective of this study is to develop and validate a visio-behavioral scale of visual abilities for subjects with profound multiple intellectual disabilities.

The secondary objectives of the study are:

to validate the structure of the scale.
to evaluate the reproducibility of scale with the intra- and inter-examiners, and the influence of the different professions of examiners.
to evaluate the feasibility of visio-behavioral scale.
to evaluate the sensitivity to change.
to study the uniformity of use of the scale depending on the type of patients (age, disability level, pathology).
to study the prevalence of the visual disorder in profound multiple intellectual disabilities subjects.

intervention_type: Behavioral


title: Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)

acronym: ASSESS

summary: The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome "SS") was set up in 2006 thanks to a grant of the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included consecutive patients with Primary Sjögren's Syndrome "pSS" fulfilling American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This study was followed for 5 years with the grant of the French Ministry of Health and this study will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for a duration of 20 years, a thorough standardized paper case report form (CRF) was filled prospectively by clinicians.


title: Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage

acronym: HEMAPIC

summary:
In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.

A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.

The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with a standard imaging method (TDM).

The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes patient clinical worsening and / or imaging.


title: Measuring the Impact of the French Version of the Whiplash Book on Both Treatment Approach and Fears and Beliefs Among Emergency Physicians

acronym: WHIPLASH

summary:
Whiplash trauma and the resulting whiplash associated disorders have been the subject of much attention in the scientific literature and remain a major public health problem.

The most commonly encountered symptoms are neck pain, headache, low back pain, shoulder pain, as well as visual impairment. It is not unusual for neck pain to become chronic, and when this occurs, there may be serious consequences on a social, professional and financial level.

Even though the role of the initial episode should not be ignored, progression to chronic pain is probably multifactorial and, like non-specific low back pain, psycho-social factors, and in particular patient fears and belief, seem to play a relevant role, as do environmental factors. The professional consensus is that it is useful to provide targeted information at an early stage in whiplash settings in order to reduce mistaken fears and beliefs. A preliminary study enabled the investigators to validate a French version of an information booklet that draws on validated data from evidence-based medicine. The booklet was "Le guide du coup de fouet cervical," the French version of The Whiplash Book. This study showed that fears and beliefs were considerably high in a population without neck problems who were working in hospitals. It also revealed that simply providing information could help lessen them.

Management following whiplash injury can make use of the recommendations as published in the literature. Healthcare professionals must reassure and educate their patients that post-traumatic pain is normal, and that they need to remain active and maintain physical activity in order to improve their prognosis.

Only very few studies have evaluated the adherence of physicians or healthcare professionals to the guidelines and to ways of changing their approach to treatment.

The main aim of this study was to determine what fears and beliefs physicians have about the consequences of whiplash. The secondary aim was to measure the impact of a validated information booklet on emergency physicians' approach to management following a whiplash injury.

time_perspective: Other


title: Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI

summary:
the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on functional dysfunction not directly related to each disease, but that could induce common syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.

The objective here is to test this hypothesis and provides better understandings on pathophysiological processes affecting those highly connected regions in 'diffuse' and 'focal' neurological diseases.

The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS, cognitive rehabilitation ...).

Practically, the investigators will explore 200 patients classified in 5 cohorts of 40 patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to assess structural and functional brain connectivity implemented on the human 7T MR scanner equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).

In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium) mapping will complement the MR protocol to characterize the pathophysiological processes of hub injury. Sixty healthy controls will also be explored wih the same protocol for normal database.

The proposal aims at characterizing and comparing from a morphological-functional point of view, the hub regions of patients suffering from these five diseases, to demonstrate the pertinence to preserve hub integrity as a major therapeutic target whatever the disease.

status: Not yet recruiting

location_facility: Assiatnce Publique Hopitaux de Marseille


title: Mediastinal Grey Zone Lymphoma: Clinico-pathological Characteristics and Outcomes of 99 Patients From the LYSA

summary: Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the literature. Investigators report the clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a consensus established for the diagnosis.


title: Diffusion Tensor Imaging of the Thalamo-cortical Network in Epilepsy With Continuous Spikes and Waves During Sleep

acronym: POCS-DTI

summary:
Continuous Spikes and Waves during Sleep (CSWS) is a rare paediatric epileptic encephalopathy. Even if the correlation between the severity of the epilepsy and the cognitive consequences is well established, the mechanisms involved in epileptic cognitive degradation are complex and poorly understood. In CSWS, there are many arguments for the implication of cortical and subcortical cerebral structures. Among them the thalamus seems to play a crucial role. In fact it is strongly implicated in the sleep and this function is determining for learning. Moreover, it is part of the propagation pathway of generalized forms of epilepsy like absences in animal studies. Unfortunately there is no animal model for CSWS to confirm this theory. In human studies, few cases are caused by thalamic injuries but most of the time conventional MRI is normal. Despite few literature on CSWS, some studies reported abnormal functional connectivity especially in the thalamus.

The investigators hypothesize that the first utilisation of diffusion tensor imaging (DTI) and tractography will be useful in CSWS to confirm the implication of a cortico-thalamo-cortical network showing an abnormal structural connectivity. The investigators will try to determinate if a particular thalamic nucleus is concerned and demonstrate a link between the disease severity (duration and cognitive consequences) and the importance of structural abnormalities.

Using resting state functional MRI (fMRI), the investigators will also try to investigate the default mode network. Its implication was also suggested in the literature.

time_perspective: Cross-Sectional


title: Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA

acronym: PANDA

summary:
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".

Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.

After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.

The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Sequential Chemotherapy Prior to Reduced Intensity Conditioning: Interventional Study in Haploidentical Hematopoietic Stem Cells Transplantation for Patients With Refractory Acute Myeloid Leukemia

acronym: SET-HAPLO

summary: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option with a significant chance of healing in acute myeloid leukemia (AML) or refractory multiple relapses after chemotherapy. However, all patients with an indication of allo-HSC can not benefit because of two limitations: the toxicity of the treatment and graft shortage available.

lead_sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation

location_facility: Service d'hématologie Clinique Hôpital Saint Antoine


title: Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years

acronym: CELL

summary: The purpose of this study is to compare the postoperative global morbidity between patients who have been operated on for a colon cancer by laparotomy and those operated on by laparoscopy

ReferenceCitation: Manceau G, Brouquet A, Chaibi P, Passot G, Bouché O, Mathonnet M, Regimbeau JM, Lo Dico R, Lefèvre JH, Peschaud F, Facy O, Volpin E, Chouillard E, Beyert-Berjot L, Verny M, Karoui M, Benoist S. Multicenter phase III randomized trial comparing laparoscopy and laparotomy for colon cancer surgery in patients older than 75 years: the CELL study, a Fédération de Recherche en Chirurgie (FRENCH) trial. BMC Cancer. 2019 Dec 4;19(1):1185. doi: 10.1186/s12885-019-6376-8.

family: Manceau

full_name: Gilles Manceau

given: Gilles

family: Brouquet

full_name: Antoine Brouquet

given: Antoine

family: Chaibi

full_name: Pascal Chaibi

given: Pascal

family: Passot

full_name: Guillaume Passot

given: Guillaume

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Mathonnet

full_name: Murielle Mathonnet

given: Murielle

family: Regimbeau

full_name: Jean-Marc Regimbeau

given: Jean-Marc

family: Lo Dico

full_name: Rea Lo Dico

given: Rea

family: Lefèvre

full_name: Jérémie H. Lefèvre

given: Jérémie H.

family: Peschaud

full_name: Frédérique Peschaud

given: Frédérique

family: Facy

full_name: Olivier Facy

family: Volpin

full_name: Enrico Volpin

given: Enrico

family: Chouillard

full_name: Elie Chouillard

given: Elie

family: Beyert-Berjot

full_name: Laura Beyert-Berjot

given: Laura

family: Verny

full_name: Marc Verny

given: Marc

family: Karoui

full_name: Mehdi Karoui

given: Mehdi

family: Benoist

full_name: Stéphane Benoist

given: Stéphane

journal_name: BMC Cancer

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

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


title: Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity (Repeated Botulinum Toxin Injections and Physiotherapy) on Impairment and Activity Limitation in Patients With Spastic Hemiparesis Following Stroke

acronym: ADJU-TOX

summary: The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional physiotherapy), in post stroke out-patients with spasticity.

ReferenceCitation: Bonnyaud C, Gallien P, Decavel P, Marque P, Aymard C, Pellas F, Isner ME, Boyer FC, Muller F, Daviet JC, Dehail P, Perrouin-Verbe B, Bayle N, Coudeyre E, Perennou D, Laffont I, Ropers J, Domingo-Saidji NY, Bensmail D, Roche N; ADJU-TOX Study Group. Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study. BMJ Open. 2018 Aug 30;8(8):e020915. doi: 10.1136/bmjopen-2017-020915.

family: Bonnyaud

full_name: Celine Bonnyaud

given: Celine

family: Gallien

full_name: Philippe Gallien

given: Philippe

family: Decavel

full_name: Pierre Decavel

given: Pierre

family: Marque

full_name: Philippe Marque

family: Aymard

full_name: Claire Aymard

given: Claire

family: Pellas

full_name: Frédéric Pellas

given: Frédéric

family: Isner

full_name: Marie-Eve Isner

given: Marie-Eve

family: Boyer

full_name: François Constant Boyer

given: François Constant

family: Muller

full_name: François Muller

given: François

family: Daviet

full_name: Jean-Christophe Daviet

given: Jean-Christophe

family: Dehail

full_name: Patrick Dehail

given: Patrick

family: Perrouin-Verbe

full_name: Brigitte Perrouin-Verbe

given: Brigitte

family: Bayle

full_name: Nicolas Bayle

given: Nicolas

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

family: Perennou

full_name: Dominic Perennou

given: Dominic

family: Laffont

full_name: Isabelle Laffont

given: Isabelle

family: Ropers

full_name: Jacques Ropers

given: Jacques

family: Domingo-Saidji

full_name: Nabila-Yasmine Domingo-Saidji

given: Nabila-Yasmine

family: Bensmail

full_name: Djamel Bensmail

given: Djamel

family: Roche

full_name: Nicolas Roche

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

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


title: Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)

acronym: REaLAX

summary:
Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its occurrence can be related to several causes, mainly dominated by invasive procedures.

anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Touch massage is one of them and that has been evaluated in various medical conditions.

The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill patients during potentially painful nursing procedures.

lead_sponsor: Versailles Hospital


title: Evaluation of New Histoprognostic Criteria in a Retrospective Study of Colon Cancers Operated at Amiens University Hospital

summary: Colon cancer is a very common cancer. Prognosis and adjuvant treatment depend on the pathological results. Histoprognostic new factors have recently been published by several authors, but their validity is still debated.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


acronym: CLEARPICCO

summary:
In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.

Today, the most commonly used technique for estimating the stroke volume is the transpulmonary thermodilution and the arterial waveform analysis in the radial artery by PICCO®.

This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.

The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). This continuous monitoring of blood pressure was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.

The objective of this study is to compare the use of non-invasive monitoring of stroke volume by ClearSight® with the transpulmonary thermodilution and the arterial waveform analysis in radial artery by PICCO® in abdominal major surgery.

lead_sponsor: Poitiers University Hospital


title: Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Specific Marker of the Cellular Captation of Glucose: the IRAP Protein (Insulin Regulated AminoPeptidase)

acronym: IRAP

summary: The purpose of this study is on one hand to verify the measurement conformity of the IRAP dosage and on the other hand to obtain normal values of the blood IRAP concentration on healthy volunteers.


title: Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy

acronym: PROTOMEN

summary:
Urinary incontinence (UI) is defined by the International Continence Society as "any involuntary loss of urine complained by the patient". The anatomical and histological specificities of the pelvic floor muscles (PFM) give them a key role in the control of urination but also in the control of postural stability. These activities are involuntary automatisms and the mechanisms that lead to post-prostatectomy stress urinary incontinence are not only due to the loss of voluntary contraction of the pelvic floor muscles. The mechanisms that lead to UI are more complex and may involve the loss of efficacy of all deep muscle stabilizing lumbo-pelvic region. Rehabilitation of pelvic floor muscles is recommended in the treatment of urinary incontinence after prostatectomy (Grade A), but there is a lack of evidence to define the best treatment regimen for PFM rehabilitation.

Two kinds of PFM rehabilitation are are commonly practiced by specialized physiotherapists.

The first one is made in individual box, in supine position. By analytic contractions of the PFM, (exercises of Kegel type) +/- associated with an instrumental biofeedback. This method used voluntary contractions of MPP.
The second is realized in various positions following a gravity progression, in individual and /or common room. This technique aims to restore a stabilization of the entire lumbo-pelvic region by postural recruitment involving synergistic contractions of the PFM.

These trials propose to compare these two rehabilitation programs on populations with postoperative follow-up of more than 12 months.

We chose to objectify the urine leaks with the pad test (weighing of the protections urinary over a period of 3 times 24h) which will be our main evaluation criterion. The home test pad of 3 times in 24 hours has been used by numerous studies and its reproducibility and reliability are established.

Urinary incontinence is a recognized factor of sedentary lifestyle, fatigue, impaired mental health and decreased of physical fitness. We therefore wish to observe these parameters for each of our two randomized groups


title: Validation in a Non-targeted Population (Screening) of Single Ultrasound Doppler Signs of Liver Fibrosis

summary:
The diagnosis of liver fibrosis lesions remains an important issue in patients with chronic liver diseases. The early detection of fibrosis is important for determining disease progression and postponing the evolution of chronic hepatitis into cirrhosis via the implementation of prompt and specific treatment. However, as chronic liver disease can remain asymptomatic for a long time, numerous cirrhotic patients are diagnosed belatedly, when life-threatening complications start appearing.

Noninvasive methods for liver fibrosis diagnosis have been developed over the last decade. In this setting, blood fibrosis tests and transient elastography have been shown to be accurate, and are now commonly used as first-intention tests for liver fibrosis diagnosis in chronic liver diseases. However, these tests are usually performed by a hepatologist to whom the patient has been referred following the appearance of symptoms suggestive of chronic liver disease. Thus the number of patient diagnosed early by these new tools, that is in the period before symptoms start appearing and during which preventative measures may be particularly beneficial, remains quite low in relation to the prevalence of the disease. This prevalence has been estimated to 0.5 to 2.8 % in general population.

Many studies have identified the value of hemodynamic and morphological ultrasound parameter in providing information on liver fibrosis degree. Moreover, abdominal ultrasound is widely used for various symptoms, and thus could be an excellent way to detect patients with signs evoking liver fibrosis or cirrhosis, who could then be referred to a liver specialist for confirmation of the diagnosis by blood fibrosis tests and/or transient elastography. To be feasible during a nonspecific US examination, and by any radiologist, these signs should be easy and quick to collect. Addition of a quick measure of hepatic stiffness could increase the screening interest of ultrasound examination.

The main aim of the present study was thus to validate 3 simple US signs in patients referred for ultrasound abdominal examination for reasons other than suspicion of liver disease.

primary_purpose: Screening

lead_sponsor: University Hospital, Angers


title: Database on Ross Operation Failures and Outcomes

acronym: ROFDA

summary: A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure phenomenon and feed more complex biomechanical models to be integrated with clinical imaging with the final aim to predict Ross operation's outcomes and define strategies to ameliorate its results.

ipd_sharing: Undecided

lead_sponsor: Centre Cardiologique du Nord


title: Comparison of Two Ventilatory Modes During Spontaneous Breathing Trial in Intubated Patients

acronym: WEANING

summary:
Patients who are intubated and mechanically ventilated for acute respiratory failure in the Intensive Care Unit (ICU) are at some point eligible for weaning. The common way to wean them from mechanical ventilation is to screen criteria for feasibility and, if present, to test feasibility by performing spontaneous breathing trial. This latter can be done either by setting a low pressure support level (expected to compensate the airflow resistance due to endotracheal tube) or by allowing the patient to breathe spontaneously through the tube without any support from the ventilator. Combination of low pressure assistance strategy (7 cm H2O) and positive expiratory pressure (PEP) of 4 cm H2O is the strategy used in our unit. Such a low pressure support level should actually result in a real assistance and, hence this is not the real spontaneous breathing capacity that is tested. Some ICU ventilators offer the option of compensating for the airflow resistance due to endotracheal tube, automatic tube compensation (ATC). Therefore, investigators aimed at comparing in patients ready to wean the usual procedure in our ICU and the ATC mode. In the ATC arm, the patients are breathing spontaneously through the endotracheal tube and are connected to the ventilator set at inspiratory pressure support of 0 cm H2O, PEP 4 cm H2O and ATC on.

Two parallel arms depending on the order of allocation of each mode: pressure support 7 cm H2O + PEP 4 cm H2O then ATC or the opposite. The primary endpoint is the power of the work of breathing. The hypothesis is that the power of the work of breathing is greater in ATC than in the usual procedure, and hence this latter is a real ventilator support.

lead_sponsor: Hospices Civils de Lyon


title: Population Pharmacokinetic (PK) Study of Zinforo (Ceftaroline) in Critical Care Patients With Early-onset Pneumonia and Normal or Augmented Renal Clearance

acronym: CEFTAREA

summary:
Pneumonia is the most frequent infection in critically ill patients and remains a significant challenge to intensivists world-wide due to persisting high mortality and morbidity. Compelling evidence suggests that appropriate antibiotic therapy remains the most important intervention to improve patients' outcome, including the administration of a suitable molecule at an optimized dosage regimen. A vast array of pathophysiological changes can occur in critically ill patients that can complicate antibiotic dosing. Knowledge of the pharmacokinetic and pharmacodynamic properties of the antibiotics used for the management of critically ill patients is essential for selecting the antibiotic dosing regimens, which will optimize patient outcomes. Changes in volume of distribution (Vd) and clearance (CL) of antibiotics have been noted in these patients, which may affect the antibiotic concentration at the target site. It follows that the pharmacodynamic parameters that determine antibiotic efficacy, which can vary between antibiotic classes, may also be affected. Optimization of these parameters is necessary to maximize the rate of response through patient recovery and minimized antibiotic resistance.

In a multicenter observational study in critically ill patients with normal plasma renal indices at admission, about 65% of patients manifested augmented creatinine clearance on at least one occasion in the first seven study days. Augmented creatinine clearance may significantly impact drug pharmacokinetics for a variety of renally eliminated pharmaceuticals (such as low-molecular weight heparins, aminoglycosides, glycopeptides, and β-lactams), leading to subtherapeutic concentrations and potentially adverse clinical outcomes. Currently little data exist that describe the consequences of augmented creatinine clearance on antibiotics PK.

Ceftaroline (600 mg bid) is a cephalosporin with expanded gram-positive activity, including MRSA and penicillin-resistant streptococcus, which was approved by the US Food and Drug Administration (FDA) on October 29, 2010 for the treatment of acute bacterial SSSIs and community-acquired bacterial pneumonia. Ceftaroline showed also good activity against some of the common gram-negative respiratory pathogens (eg, Haemophilus influenzae, Moraxella catarrhalis, Neisseria meningitidis, and Pasteurella multocida). However, it does not display clinically relevant activity against Pseudomonas aeruginosa, Stenotrophomonas maltophilia, or Acinetobacter baumannii. Ceftaroline also lacks activity against gram-negative organisms with extended-spectrum β-lactamases. Importantly, because ceftaroline appears to induce AmpC β-lactamases despite MIC values in susceptible range, ittheoretically should be avoided in gram-negative bacteria known to harbor inducible AmpC β-lactamases (eg, Serratia, Proteus, Citrobacter, Morganella, Enterobacter, Providencia, and P. aeruginosa). In patients, ceftaroline is given as a prodrug, ceftaroline fosamil. After intravenous administration, the prodrug is rapidly transformed by plasma phosphatase enzymes to its bioactive metabolite. The pharmacokinetics of ceftaroline has been evaluated in single and multiple dose studies in healthy volunteers, in subjects with various degrees of renal impairment and in healthy elderly subjects. The volume of distribution is equal to 20.3 L, which corresponds to extracellular fluid volume. The protein binding is low (20%). The main route of elimination is via renal excretion, with a clearance estimated to160 mL/min close to the creatinine clearance. The elimination half-live is 2.6 h in adults with normal renal function. Unfortunately, no PK study has been performed in infected critically ill patients with augmented creatinine clearance. The best PK-PD index predicting drug efficacy is %Time>CMI. A bacteriostatic effect is achieved when free drug concentrations exceed the MIC for 30 to 40% of the dose administration interval (30 to 40%T>MIC). Near maximum organism kill is achieved at 50 to 60%T>MIC (30%T>MIC for Staphylococcus aureus).

This project aims to characterize ceftaroline PK in patients with early-onset pneumonia and augmented creatinine clearance. The choice of ceftaroline is justified by its spectrum suitable for micro-organisms commonly encountered in early onset pneumonia, including methicillin-resistant Staphylococcus aureus. Secondary main objective is to predict the probably of reaching PK-PD targets using Monte Carlo simulations under various scenario in order to identify optimal ceftaroline administration schemes in critical care patients with various degrees of renal impairment.


title: Investigation of the Relationship Between Alpha-linolenic Acid and Arterial, Biochemical, Biological Parameters in Older Persons With History of Cardiovascular Events and/or Moderate Cognitive Impairment

summary: The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential of an adequate intake of alpha-linolenic acid in elderly.

ReferenceCitation: Giallauria F, Vigorito C, Tramarin R, Fattirolli F, Ambrosetti M, De Feo S, Griffo R, Riccio C, Piepoli M; ISYDE-2008 Investigators of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Prevention. Cardiac rehabilitation in very old patients: data from the Italian Survey on Cardiac Rehabilitation-2008 (ISYDE-2008)--official report of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Epidemiology. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1353-61. doi: 10.1093/gerona/glq138. Epub 2010 Jul 28.

ReferenceCitation: Rodriguez-Leyva D, Dupasquier CM, McCullough R, Pierce GN. The cardiovascular effects of flaxseed and its omega-3 fatty acid, alpha-linolenic acid. Can J Cardiol. 2010 Nov;26(9):489-96. Review.

ReferenceCitation: Salvà A, Corman B, Andrieu S, Salas J, Vellas B; International Association Of Gerontology/International Academy Of Nutrition And Aging Task Force. Minimum data set for nutritional intervention studies in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):724-9. Review.

ReferenceCitation: Bischoff HA, Staehelin HB, Willett WC. The effect of undernutrition in the development of frailty in older persons. J Gerontol A Biol Sci Med Sci. 2006 Jun;61(6):585-9.

ReferenceCitation: Abbatecola AM, Cherubini A, Guralnik JM, Andres Lacueva C, Ruggiero C, Maggio M, Bandinelli S, Paolisso G, Ferrucci L. Plasma polyunsaturated fatty acids and age-related physical performance decline. Rejuvenation Res. 2009 Feb;12(1):25-32. doi: 10.1089/rej.2008.0799.

intervention_type: Dietary Supplement


title: Impact of a Training Program on the Body Composition of Overweight and Obese Young Adults : Concentric Versus Eccentric Exercise

acronym: OPEX

summary:
Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle wich permits eccentric (ECC) lower limbs contractions at a defined power output. With this type of ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the same power output. Consequently, ECC program could be used in chronic disorders with limited capacities, such as obesity.

The investigators hypothesis that an eccentric training program, as it will induce higher mechanical constraints, would improve body composition, especially by reducing fat mass. This effect could be explained by an increased rest energy expenditure and a better improvement in biological parameters (particularly lipid profile and insulin-resistance) after ECC training (versus CON training).

This study aims to compare the modification of fat mass after an ECC program versus a CON program at the same VO2. The secondary goal is to assess the physiological mechanisms involved in the modification of body composition

lead_sponsor: University Hospital, Clermont-Ferrand


lead_sponsor: Rennes University Hospital

acronym: MITOX-REBIF

type: EudraCT Number

source: euctr

title: National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Beta-1a (REBIF 44mg 3 Times / Week) Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple Sclerosis

summary:
The relative effectiveness of current treatments and their different mechanisms of action yield to consider more and more that the multiple sclerosis (MS) therapeutic approach must use multiple molecules, both combined and sequential.

In this sense, one can assume that the combination of two molecules with different but complementary mechanisms of action, can delay progression of the disease. Mitoxantrone has a powerful action, immediate and total, whereas interferon a selective action, immunomodulatory and delayed.


summary: This study evaluates antral ultrasonography for the diagnosis of full stomach before surgical emergencies in pediatric population. Preoperative ultrasonographic antral evaluation is compared to peroperative gastric aspirate with nasogastric tube.

lead_sponsor: Hôpital Necker-Enfants Malades

location_facility: Necker Enfants-Malades University Hospital - APHP


title: Study Evaluating the Efficacy of Loco-regional Anaesthesia PECS on the Rate of Chronic Pains 6 Month After a Mastectomy Associated or Not With Axillary Node Dissection and/or a Reconstruction Prosthesis.

acronym: PECS

summary: A non-randomized, mono-centric, prospective interventional study that will assess the efficacy of the loco-regional anesthesia PECS on the rate of chronic pain, 6 month after a patient will have either received a mastectomy or a mastectomy associated with axillary nodes dissection, and/or a reconstruction by prosthesis.

lead_sponsor: Centre Oscar Lambret


title: Tau Brain Imaging in Typical and Atypical Alzheimer's Disease (AD)

acronym: TEPTAU

summary:
Recently revised Alzheimer Disease (AD) diagnostic1described nonamnestic presentations: 1/ language presentation (logopenic progressive aphasia) 2/ visuospatial presentation (posterior cortical atrophy or PCA) and 3/ executive dysfunction. AD pathological changes may precede the clinical diagnosis of dementia of AD type for a while2. Biomarkers have been developed: biomarkers of brain amyloid-beta (Aß) (CerebroSpinal Fluid CSF concentration ßamyloid, molecular imaging with amyloid targeted PET ligands), biomarkers of neural degeneration (MRI hippocampal volume, regional metabolism as assessed by PET with [18F]-FDG) and may be used to made early detection of the neuropathology associated with AD Even if CSF biomarkers (tau, p-tau and β amyloïd are interesting to improve diagnosis of AD, they cannot provide topographic information. PET tau imaging seems to be promise to evaluate quantitative and spatial assessment of tau lesions both in AD and fronto-temporal lobar dementia.

The hypothesis of the research is that it exists a different regional pattern of tracer retention across brain regions according to clinical symptoms : temporal for logopenic aphasia and occipital for posterior cortical atrophy.

lead_sponsor: University Hospital, Tours


title: Prediction of Recruitment Potential of Participating Centers in Clinical Trials by Standardized Translation of Selection Criteria and Queries From the French DRG Database (PMSI)

acronym: Pred-Inclus

summary:
This retrospective study aims to assess, on a large number of clinical trials (CT), the usefulness of converting CT eligibility criteria into standardized queries performed on commonly available data, i.e. Diagnosis Related Groups (DRG) databases in order to estimate the potential recruitment of clinical trials centers.

Efficacy of this Clinical Trial Recruitment Support Systems (CTRSS) will be checked against thorough examination of patient files.

Primary objective is to estimate the precision of the prediction system, i.e. ratio of numbers of eligible patient files / numbers of candidate patient files.

As secondary objectives, the study aims:

to measure the recall rate or sensitivity of the system: ratio of number of candidates patient files / number of recruited patients;
to measure the ability of coding: proportion of codable criteria (inclusion criteria or non inclusion criteria) into normalized language;
to measure the time required for coding criteria and the time required to execute the queries on the national DRG database;
to evaluate the reliability of coding process by an independent coding of a random sample of 30 protocols;
to analyse influence of characteristics of the clinical study (design, disease, ...) and of the investigation site (volume, teaching status, ...) on the precision and sensitivity of the prediction system.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Public Health - Hôpital Ambroise Paré


title: Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique

acronym: HYBRID ESD

summary: For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)

lead_sponsor: Institut Paoli-Calmettes


title: Evaluation of Trabecular Microarchitecture of the Alveolar Bone by Micro-computed Tomography and of Osseointegration of Dental Implants by Resonance Frequency Analysis: Correlation Study.

summary:
Dental implants are a prosthetic rehabilitation device whose success depends of the bone morphology and quality, in more the surgical procedure.

This study aims to assess whether the parameters of the trabecular microarchitecture of alveolar bone taken from the site of the placement of the dental implant, calculated by micro-CT are correlated with ISQ (implant stability quotient) using the Osstell according the principle of the resonance frequency analysis at the 10th postoperative week during the osseointegration of dental implants (secondary stability).

The cortical alveolar bone is a recognized factor in the phase of primary stability of osseointegration. The role of trabecular bone in the secondary stability is not clearly determined.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prospective Observational Study on Picclines' Complications at Brest Hospital

acronym: COMPLI-PICC

summary:
This is a prospective monocentric study of PICC Line complications use in 5 medical and one surgical units of Brest Medical University Hospital.

To evaluate the incidence of the following complications: infections, thromboses, mechanical and hemorrhagic, at month 3 post-intervention.

Also evaluating:

the management of these PICC Line related complications,
risk factors for such complications,
and the mortality-related outcomes.

ReferenceCitation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum in: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.

name: Division of Infectious Diseases, Warren Alpert Medical School of Brown University, Providence, Rhode Island

family: Mermel

full_name: Leonard A. Mermel

given: Leonard A.

name: University of Alabama-Birmingham Hospital, Birmingham, Alabama

family: Allon

full_name: Michael Allon

given: Michael

name: Servicio de Microbiología Cliínica y E. Infecciosas Hospital General “Gregorio Marañón,”  Madrid, Spain

family: Bouza

full_name: Emilio Bouza

given: Emilio

name: Tufts University School of Medicine, Lahey Clinic Medical Center, Burlington, Massachusetts

family: Craven

full_name: Donald E. Craven

given: Donald E.

name: St. Jude Children's Research Hospital, Children's Infection Defense Center, Memphis, Tennessee

family: Flynn

full_name: Patricia Flynn

given: Patricia

name: National Institutes of Health, Critical Care Medicine Department, Bethesda, Maryland

family: O'Grady

full_name: Naomi P. O'Grady

given: Naomi P.

name: Section of Infectious Diseases, University of Texas-Cancer Center, Houston

family: Raad

full_name: Issam I. Raad

given: Issam I.

name: Internal Medicine and Infectious Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands

family: Rijnders

full_name: Bart J. A. Rijnders

given: Bart J. A.

name: Section of Infectious Diseases, Wake Forest University School of Medicine, Winston-Salem, North Carolina

family: Sherertz

full_name: Robert J. Sherertz

given: Robert J.

name: Division of Infectious Diseases, Washington University School of MedicineSt Louis, Missouri

family: Warren

full_name: David K. Warren

given: David K.

journal_name: Clinical Infectious Diseases

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection: 2009 Update by the Infectious Diseases Society of America

ReferenceCitation: O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003.

ReferenceCitation: Safdar N, Maki DG. Risk of catheter-related bloodstream infection with peripherally inserted central venous catheters used in hospitalized patients. Chest. 2005 Aug;128(2):489-95. Review.

ReferenceCitation: Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17.

ReferenceCitation: Chemaly RF, de Parres JB, Rehm SJ, Adal KA, Lisgaris MV, Katz-Scott DS, Curtas S, Gordon SM, Steiger E, Olin J, Longworth DL. Venous thrombosis associated with peripherally inserted central catheters: a retrospective analysis of the Cleveland Clinic experience. Clin Infect Dis. 2002 May 1;34(9):1179-83. Epub 2002 Apr 3.

ReferenceCitation: Vidal V, Muller C, Jacquier A, Giorgi R, Le Corroller T, Gaubert J, Champsaur P, Bartoli J, Moulin G. [Prospective evaluation of PICC line related complications]. J Radiol. 2008 Apr;89(4):495-8. French.

lead_sponsor: University Hospital, Brest


title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients at 3 Years of Follow-up. CIRCUS II Study

acronym: CIRCUS II

summary: Infarct size is a major determinant of vital prognosis after AMI. We recently reported that cyclosporine A, when administered immediately prior to PCI reperfusion, can significantly reduce infarct size in STEMI patients. The CIRCUS study aimed at determining the impact of cyclosporine on the combined incidence of (death, hospitalization for heart failure, LV remodelling) at one year after AMI. However, many patients may display increased adverse LV remodelling beyond year 1 and develop heart failure thereafter. The present CIRCUS II trial aims at examining the 3-year clinical outcome of all patients recruited in the CIRCUS study.


title: Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation

acronym: STIM-INSULA

summary: The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by tDCS will be assessed using both laser stimuli and cold pressor test. In patients the assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular cortex). In patients, three separate conditions (two active and one sham) will be tested in randomised order. In healthy subjects, two other conditions are added to control for attention and distraction confounders.

location_facility: Hospices Civils de Lyon - NeuroPain lab - CRNL


title: Effect of Telephone Follow-up on Repeated Suicide Attempt in Patients Discharged From an Emergency Psychiatry Department: a Controlled Study

acronym: EXBRAYAT

summary:
Attempted suicide is a major public health problem, and the efficacies of current postvention protocols vary. The investigators evaluated the effectiveness of telephone follow-up of patients referred to an emergency psychiatric unit for attempted suicide on any further attempt/s over the following year.

In a single-center, controlled study with intent to treat, they evaluated the efficacy of a protocol of telephone follow-up of patients at 8, 30, and 60 days after they had been treated for attempted suicide. For comparison, they evaluated as controls patients with similar social and demographic characteristics referred to their emergency psychiatric unit in the year prior to the study who did not receive telephone follow-up after their initial hospitalization. Data were analyzed using logistic regression.


title: Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status

acronym: HORM

summary: The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment

status: Withdrawn

lead_sponsor: Hopital Foch


title: Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)

acronym: ECO-COPD

summary: The principal objective of the study is to measure parameters of inflammation, oxidative stress, and vascular, respiratory, and peripheral muscle function parameters, and identify parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using multivariate analysis.

ReferenceType: result

ReferenceCitation: Gan WQ, Man SF, Senthilselvan A, Sin DD. Association between chronic obstructive pulmonary disease and systemic inflammation: a systematic review and a meta-analysis. Thorax. 2004 Jul;59(7):574-80. Review.

ReferenceCitation: Mallia P, Johnston SL. Mechanisms and experimental models of chronic obstructive pulmonary disease exacerbations. Proc Am Thorac Soc. 2005;2(4):361-6; discussion 371-2. Review.

ReferenceCitation: de Torres JP, Cordoba-Lanus E, López-Aguilar C, Muros de Fuentes M, Montejo de Garcini A, Aguirre-Jaime A, Celli BR, Casanova C. C-reactive protein levels and clinically important predictive outcomes in stable COPD patients. Eur Respir J. 2006 May;27(5):902-7. Epub 2006 Feb 2.

ReferenceCitation: Malo O, Sauleda J, Busquets X, Miralles C, Agustí AG, Noguera A. [Systemic inflammation during exacerbations of chronic obstructive pulmonary disease]. Arch Bronconeumol. 2002 Apr;38(4):172-6. Spanish.

ReferenceCitation: Dekhuijzen PN, Aben KK, Dekker I, Aarts LP, Wielders PL, van Herwaarden CL, Bast A. Increased exhalation of hydrogen peroxide in patients with stable and unstable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1996 Sep;154(3 Pt 1):813-6.

ReferenceCitation: Rahman I. The role of oxidative stress in the pathogenesis of COPD: implications for therapy. Treat Respir Med. 2005;4(3):175-200. Review.

ReferenceCitation: Heunks LM, Viña J, van Herwaarden CL, Folgering HT, Gimeno A, Dekhuijzen PN. Xanthine oxidase is involved in exercise-induced oxidative stress in chronic obstructive pulmonary disease. Am J Physiol. 1999 Dec;277(6):R1697-704. doi: 10.1152/ajpregu.1999.277.6.R1697.

name: Department of Pulmonary Diseases, University Hospital Nijmegen, 6500 HB Nijmegen, The Netherlands; and

family: Heunks

full_name: Leo M. A. Heunks

given: Leo M. A.

name: Department of Physiology, Faculty of Medicine, University of Valencia, 46010 Valencia, Spain

family: Viña

full_name: Jose Viña

given: Jose

family: van Herwaarden

full_name: Cees L. A. van Herwaarden

given: Cees L. A.

family: Folgering

full_name: Hans T. M. Folgering

given: Hans T. M.

family: Gimeno

full_name: Amparo Gimeno

given: Amparo

family: Dekhuijzen

full_name: P. N. Richard Dekhuijzen

given: P. N. Richard

bso_classification: Biology (fond.)

journal_name: American Journal of Physiology-Regulatory, Integrative and Comparative Physiology

publisher: American Physiological Society

publisher_dissemination: American Physiological Society

publisher_group: American Physiological Society

publisher_normalized: American Physiological Society

ReferenceCitation: Yende S, Waterer GW, Tolley EA, Newman AB, Bauer DC, Taaffe DR, Jensen R, Crapo R, Rubin S, Nevitt M, Simonsick EM, Satterfield S, Harris T, Kritchevsky SB. Inflammatory markers are associated with ventilatory limitation and muscle dysfunction in obstructive lung disease in well functioning elderly subjects. Thorax. 2006 Jan;61(1):10-6. Epub 2005 Nov 11.

ReferenceCitation: Carter R, Holiday DB, Nwasuruba C, Stocks J, Grothues C, Tiep B. 6-minute walk work for assessment of functional capacity in patients with COPD. Chest. 2003 May;123(5):1408-15.

ReferenceCitation: Mador MJ, Kufel TJ, Pineda LA, Sharma GK. Diaphragmatic fatigue and high-intensity exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 Jan;161(1):118-23.

ReferenceCitation: Saey D, Debigare R, LeBlanc P, Mador MJ, Cote CH, Jobin J, Maltais F. Contractile leg fatigue after cycle exercise: a factor limiting exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2003 Aug 15;168(4):425-30. Epub 2003 Apr 24.

ReferenceCitation: Engelen MP, Schols AM, Does JD, Wouters EF. Skeletal muscle weakness is associated with wasting of extremity fat-free mass but not with airflow obstruction in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2000 Mar;71(3):733-8.

ReferenceCitation: Barreiro E, de la Puente B, Minguella J, Corominas JM, Serrano S, Hussain SN, Gea J. Oxidative stress and respiratory muscle dysfunction in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 15;171(10):1116-24. Epub 2005 Feb 25.

ReferenceCitation: Debigaré R, Côté CH, Maltais F. Peripheral muscle wasting in chronic obstructive pulmonary disease. Clinical relevance and mechanisms. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1712-7. Review.

ReferenceCitation: Heunks LM, Dekhuijzen PN. Respiratory muscle function and free radicals: from cell to COPD. Thorax. 2000 Aug;55(8):704-16. Review.

ReferenceCitation: Hunninghake DB. Cardiovascular disease in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2005;2(1):44-9. Review.

ReferenceCitation: Rennard SI. Clinical approach to patients with chronic obstructive pulmonary disease and cardiovascular disease. Proc Am Thorac Soc. 2005;2(1):94-100. Review.

ReferenceCitation: Gan WQ, Man SF, Sin DD. The interactions between cigarette smoking and reduced lung function on systemic inflammation. Chest. 2005 Feb;127(2):558-64.

ReferenceCitation: MacCallum PK. Markers of hemostasis and systemic inflammation in heart disease and atherosclerosis in smokers. Proc Am Thorac Soc. 2005;2(1):34-43. Review.

ReferenceCitation: Vassilakopoulos T, Karatza MH, Katsaounou P, Kollintza A, Zakynthinos S, Roussos C. Antioxidants attenuate the plasma cytokine response to exercise in humans. J Appl Physiol (1985). 2003 Mar;94(3):1025-32. Epub 2002 Nov 27.

ReferenceCitation: Lerman A, Zeiher AM. Endothelial function: cardiac events. Circulation. 2005 Jan 25;111(3):363-8. Review.

ReferenceCitation: Vivodtzev I, Minet C, Wuyam B, Borel JC, Vottero G, Monneret D, Baguet JP, Lévy P, Pépin JL. Significant improvement in arterial stiffness after endurance training in patients with COPD. Chest. 2010 Mar;137(3):585-92. doi: 10.1378/chest.09-1437. Epub 2009 Oct 31.

family: Vivodtzev

full_name: Isabelle Vivodtzev

family: Minet

full_name: Clémence Minet

given: Clémence

family: Wuyam

full_name: Bernard Wuyam

given: Bernard

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

family: Vottero

full_name: Gabrielle Vottero

given: Gabrielle

family: Monneret

full_name: Denis Monneret

given: Denis

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

title: Significant Improvement in Arterial Stiffness After Endurance Training in Patients With COPD

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title: Arterial Stiffness in COPD

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name: From the University Clinic of Internal Medicine I/Center for Cardiovascular Disease (F.W., S.H., S.S., M.N., S.F., W.V., G.E., J.M.S.), Clinic for Heart Surgery (V.L.), Clinic for Radiology (M.B.), and Institute of Pathology (S.G.), University of Würzburg, Würzburg, Germany.

title: Impact of Myocardial Fibrosis in Patients With Symptomatic Severe Aortic Stenosis

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title: Outcomes in Patients with Chronic Obstructive Pulmonary Disease and Obstructive Sleep Apnea

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ReferenceCitation: Patel AR, Kowlessar BS, Donaldson GC, Mackay AJ, Singh R, George SN, Garcha DS, Wedzicha JA, Hurst JR. Cardiovascular risk, myocardial injury, and exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Nov 1;188(9):1091-9. doi: 10.1164/rccm.201306-1170OC.

title: Cardiovascular Risk, Myocardial Injury, and Exacerbations of Chronic Obstructive Pulmonary Disease

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