title: Thalamic LFPs and VIM DBS in Essential Tremor: Correlation, Evolution, and Therapeutic Perspectives

acronym: VIM-CLT

summary: The objective of this study is to characterize through spectral analysis intra-thalamic local field potentials (LFPs) recorded through implanted DBS leads during periods with and without tremor in patients suffering from severe essential tremor.

ReferenceCitation: Barbe MT, Liebhart L, Runge M, Pauls KA, Wojtecki L, Schnitzler A, Allert N, Fink GR, Sturm V, Maarouf M, Timmermann L. Deep brain stimulation in the nucleus ventralis intermedius in patients with essential tremor: habituation of tremor suppression. J Neurol. 2011 Mar;258(3):434-9. doi: 10.1007/s00415-010-5773-3. Epub 2010 Oct 8.

ReferenceCitation: Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6.

ReferenceCitation: Blomstedt P, Hariz GM, Hariz MI, Koskinen LO. Thalamic deep brain stimulation in the treatment of essential tremor: a long-term follow-up. Br J Neurosurg. 2007 Oct;21(5):504-9.

ReferenceCitation: Brown P, Williams D. Basal ganglia local field potential activity: character and functional significance in the human. Clin Neurophysiol. 2005 Nov;116(11):2510-9. Epub 2005 Jul 18. Review.

ReferenceCitation: Garcia Ruiz P, Muñiz de Igneson J, Lopez Ferro O, Martin C, Magariños Ascone C. Deep brain stimulation holidays in essential tremor. J Neurol. 2001 Aug;248(8):725-6.

ReferenceCitation: Hariz MI, Shamsgovara P, Johansson F, Hariz G, Fodstad H. Tolerance and tremor rebound following long-term chronic thalamic stimulation for Parkinsonian and essential tremor. Stereotact Funct Neurosurg. 1999;72(2-4):208-18.

ReferenceCitation: Limousin P, Speelman JD, Gielen F, Janssens M. Multicentre European study of thalamic stimulation in parkinsonian and essential tremor. J Neurol Neurosurg Psychiatry. 1999 Mar;66(3):289-96.

ReferenceCitation: Schuurman PR, Bosch DA, Bossuyt PM, Bonsel GJ, van Someren EJ, de Bie RM, Merkus MP, Speelman JD. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor. N Engl J Med. 2000 Feb 17;342(7):461-8.

ReferenceCitation: Stacy MA, Elble RJ, Ondo WG, Wu SC, Hulihan J; TRS study group. Assessment of interrater and intrarater reliability of the Fahn-Tolosa-Marin Tremor Rating Scale in essential tremor. Mov Disord. 2007 Apr 30;22(6):833-8.

ReferenceCitation: Yoshida F, Martinez-Torres I, Pogosyan A, Holl E, Petersen E, Chen CC, Foltynie T, Limousin P, Zrinzo LU, Hariz MI, Brown P. Value of subthalamic nucleus local field potentials recordings in predicting stimulation parameters for deep brain stimulation in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Aug;81(8):885-9. doi: 10.1136/jnnp.2009.190918. Epub 2010 May 12.

lead_sponsor: University Hospital, Bordeaux


intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Assistance Publique - Hôpitaux de Paris

enrollment_type: Anticipated

primary_purpose: Treatment

acronym: HTLP Necker

location_facility: Unité d'Immunologie Hématologie Rhumatologie Pédiatrique (UIHR),

ipd_sharing: No

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase I/II Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Partially HLA Compatible Allogeneic Hematopoietic Stem Cell Transplantation in SCID Patients

summary: The purpose of this study is to evaluate the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after partially HLA compatible allogeneic hematopoietic stem cell transplantation in SCID patients.

lead_sponsor_type: academique

status_simplified: Ongoing


title: Prognostic Value of Copeptin Level Before Cardiac Surgery and Involvement in Systemic Inflammatory Response Syndrome After Cardiopulmonary Bypass

acronym: MicorSIRS

summary: The purpose of this study is to find a preoperative biomarker before cardiac surgery with cardiopulmonary bypass related to severe postoperative inflammatory response and circulatory complications. The investigators hypothesize that an increase of the preoperative stimulation of vasopressinergic system (in response to acute or chronic conditions) could lead to a microcirculatory dysfunction and favor the occurrence of vasodilatation during and after CPB and increase the symptoms of an inflammatory response after CPB. By defining a high risk population, a targeted strategy of monitoring and early or preventive treatment could improve postoperative prognosis.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: MacCallum NS, Finney SJ, Gordon SE, Quinlan GJ, Evans TW. Modified criteria for the systemic inflammatory response syndrome improves their utility following cardiac surgery. Chest. 2014 Jun;145(6):1197-1203. doi: 10.1378/chest.13-1023.

family: MacCallum

full_name: Niall S. MacCallum

given: Niall S.

sequence: first

family: Finney

full_name: Simon J. Finney

given: Simon J.

sequence: additional

family: Gordon

full_name: Sarah E. Gordon

given: Sarah E.

family: Quinlan

full_name: Gregory J. Quinlan

given: Gregory J.

family: Evans

full_name: Timothy W. Evans

given: Timothy W.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Modified Criteria for the Systemic Inflammatory Response Syndrome Improves Their Utility Following Cardiac Surgery

ReferenceCitation: Colson PH, Bernard C, Struck J, Morgenthaler NG, Albat B, Guillon G. Post cardiac surgery vasoplegia is associated with high preoperative copeptin plasma concentration. Crit Care. 2011;15(5):R255. doi: 10.1186/cc10516. Epub 2011 Oct 25.

family: Colson

full_name: Pascal H Colson

given: Pascal H

family: Bernard

full_name: Cedric Bernard

given: Cedric

family: Struck

full_name: Joachim Struck

given: Joachim

family: Morgenthaler

full_name: Nils G Morgenthaler

given: Nils G

family: Albat

full_name: Bernard Albat

given: Bernard

family: Guillon

full_name: Gilles Guillon

given: Gilles

currency_apc_doaj: GBP

journal_name: Critical Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

location_facility: Department of critical care, Arnaud de Villeneuve Hospital


type: Other Identifier

title: Effect of Type 1 Diabetes on Sleep Fragmentation

summary: The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.

ReferenceType: background

ReferenceCitation: Larcher S, Gauchez AS, Lablanche S, Pépin JL, Benhamou PY, Borel AL. Impact of sleep behavior on glycemic control in type 1 diabetes: the role of social jetlag. Eur J Endocrinol. 2016 Nov;175(5):411-9. doi: 10.1530/EJE-16-0188. Epub 2016 Aug 16.

ReferenceCitation: Larcher S, Benhamou PY, Pépin JL, Borel AL. Sleep habits and diabetes. Diabetes Metab. 2015 Sep;41(4):263-271. doi: 10.1016/j.diabet.2014.12.004. Epub 2015 Jan 23. Review.

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

family: Borel

full_name: A.-L. Borel

family: Pepin

full_name: J.-L. Pepin

family: Nasse

full_name: L. Nasse

given: L.

family: Baguet

full_name: J.-P. Baguet

family: Netter

full_name: S. Netter

given: S.

family: Benhamou

full_name: P.-Y. Benhamou

journal_name: Diabetes Care

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Short Sleep Duration Measured by Wrist Actimetry Is Associated With Deteriorated Glycemic Control in Type 1 Diabetes

ReferenceCitation: Borel AL, Benhamou PY, Baguet JP, Debaty I, Levy P, Pépin JL, Mallion JM. Short sleep duration is associated with a blood pressure nondipping pattern in type 1 diabetes: the DIAPASOM study. Diabetes Care. 2009 Sep;32(9):1713-5. doi: 10.2337/dc09-0422. Epub 2009 Jun 19.

ipd_sharing: Undecided

ipd_sharing_description:
There is a plan to make IPD and related data dictionaries available to perform meta-analyses based on individual data.

The sharing of data will need the acceptation by the Principal Investigator.

lead_sponsor: University Hospital, Grenoble

intervention_type: Other


title: Impact of Fatigue on Physical Performance During a Pulmonary Rehabilitation Program in Patients With COPD

acronym: PROMOD

summary: Patients with COPD benefit from pulmonary rehabilitation (PR), but a ceiling effect of performance (ie. absence of additional exercise tolerance increase) is observed in 80% of patients from only 20 sessions. An imbalance between intensity, duration and frequency of PR sessions, leading to fatigue development in the course of the PR, could explain this ceiling effect. However, previous studies having evaluated the impact of a PR program on fatigue scores reported either a decrease or no changing, but never an increase. To date, no study has evaluated intermediate variations of fatigue score during a PR program, but were limited to a pre-post PR assessment. Therefore, fatigue fluctuations during PR are unknown. Furthermore, most studies had only unidimensional fatigue assessment. Since fatigue is a multifactorial and a multidimensional process, it cannot be accurately estimated through a unique assessment. Given that most of COPD patients do not increase their exercise tolerance from 20 PR sessions, the investigators hypothesize a significant increase of multidimensional fatigue score between the 1st and the 20th PR session during an inpatient rehabilitation program lasting 4 weeks (40 sessions).

lead_sponsor: 5 Santé

location_facility:
Clinique du Souffle Les Clarines
Clinique du Souffle La Vallonie
Clinique du Souffle La Solane

lead_sponsor_type: industriel

status_simplified: Completed


title: Hematogenous Osteomyelitis in Childhood Can Relapse Dozens of Years in Adulthood

summary: To our knowledge, few cases of relapse in adulthood are described in the literature except in patients with sickle cell disease and the epidemiological, clinical, laboratory, radiological features and the management of osteomyelitis relapsing in adulthood are not described. The aim of this retrospective multicentric cohort study : in France is to describe the epidemiological, clinical, laboratory, and radiological features and the management of adult patients who experienced a relapse between 2003-2015 of an acute hematogenous osteomyelitis acquired in the childhood (description of characterization of the period between the first episode of osteomyelitis and the second episode, description of signs of relapse and description of treatments used in the relapse). The data are analysed with non-comparative descriptive statistics.

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

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


type: Registry Identifier

title: Superior Colliculus Activity in Parkinson Disease: a Potential Marker? fMRI Brain Activation in Response to Visual Stimuli.

acronym: AGIRPARK

summary:
The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier Parkinson's disease, using the superior colliculus as a biomarker.

Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest that the superior colliculus, a sensory structure, show an early deficit in visual processing. The investigator's data also suggests that with the evolution of the disease, this structure presents a neuronal re-organisation leading which causes a sensory rebound after the introduction of the treatment. The light responses in the superior colliculus were faster, bigger in amplitude and lasted longer (Rolland et al., 2012). Those results raise an important question about the superior colliculus functional state in Parkinson's patients. If this structure have a similar neuroplasticity, the investigators could hypothesize that the superior colliculus may also present a sensory rebound when introducing the treatment. If this hypothesis is true, the accelerated and amplified light responses of this structure may explain the difficulties felt by the patients to inhibit reflexive saccades induced by the appearance of unexpected visual stimuli. Indeed, the superior colliculus is involved in the orientation of the head and eye toward any sudden changes in our environment (Wurtz and Albano, 1980) and the light responses of this structure are strongly correlated with the speed of the saccade (Marino et al., 2012).

Therefore, the investigators want to test if a similar deficit could be observed in the superior colliculus of newly diagnosed PD patients. Data will be compared to matching controls.

ReferenceCitation: Marino RA, Levy R, Boehnke S, White BJ, Itti L, Munoz DP. Linking visual response properties in the superior colliculus to saccade behavior. Eur J Neurosci. 2012 Jun;35(11):1738-52. doi: 10.1111/j.1460-9568.2012.08079.x. Epub 2012 May 28.

family: Marino

full_name: Robert A. Marino

given: Robert A.

family: Levy

full_name: Ron Levy

given: Ron

family: Boehnke

full_name: Susan Boehnke

given: Susan

family: White

full_name: Brian J. White

given: Brian J.

family: Itti

full_name: Laurent Itti

given: Laurent

family: Munoz

full_name: Douglas P. Munoz

given: Douglas P.

bso_classification: Biology (fond.)

journal_name: European Journal of Neuroscience

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Wurtz RH, Albano JE. Visual-motor function of the primate superior colliculus. Annu Rev Neurosci. 1980;3:189-226. Review.

ReferenceCitation: Rolland M, Carcenac C, Overton PG, Savasta M, Coizet V. Enhanced visual responses in the superior colliculus and subthalamic nucleus in an animal model of Parkinson's disease. Neuroscience. 2013 Nov 12;252:277-88. doi: 10.1016/j.neuroscience.2013.07.047. Epub 2013 Jul 31.

family: Rolland

full_name: M. Rolland

given: M.

family: Carcenac

full_name: C. Carcenac

given: C.

family: Overton

full_name: P.G. Overton

family: Savasta

full_name: M. Savasta

family: Coizet

full_name: V. Coizet

given: V.

journal_name: Neuroscience

title: Enhanced visual responses in the superior colliculus and subthalamic nucleus in an animal model of Parkinson’s disease

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
IRMAGE
CHU de Grenoble
Grenoble Institute of Neurosciences


title: Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study

acronym: PRESAGE-ACO

summary:
The aim of the study is to compare, in real life, the risk benefit (including both major bleeding and thrombotic events (TE) and death from any cause) associated with direct oral anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering from non valvular atrial fibrillation and living in community or nursing home settings.

An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in France involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults. GPs and pharmacists will prospectively include all octo+ patients they care for, newly treated with an oral anticoagulant (VKA or DOA) for nv AF and will follow them during 2 years at least.


title: Interest of ST2 to Diagnosis and Management of Patients With Heart Failure (HF)

acronym: STADE-HF

summary:
Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). It is also a major cause of health burden representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these costs are due to hospitalization.

Besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters.

This study aims to assess the value of ST2 in the management of patients admitted for HF to reduce readmission at one month.

design_allocation: Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Montpellier

location_facility: University Regional Hospital Arnaud de Villeneuve


title: Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain

acronym: CHEVILLE

summary: Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. Therefore, an early management and follow up treatment is necessary. Now, functional treatment is clinically the treatment strategy of choice for ankle sprain. It is based on rest, ice, compression, elevation and can use a functional support (like an ankle brace). To evaluate gravity and improve management, a clinical assessment delayed between 4 and 5 days post injury is necessary.

lead_sponsor: University Hospital, Lille


title: Impact of On-site Evaluation of Substances Consumption on Opiate Maintenance in the Context of Family Practice

acronym: ESUB-MG

summary:
In France, General Practitioners (GPs) are widely involved in opiate maintenance treatment (OMT) by initially prescribing buprenorphine and monitoring patients under buprenorphine and methadone. Number of treated patients is around 150,000 with 75% of them treated by buprenorphine. Among the guidelines for improving OMT, urine testing is mandatory for initiating methadone, whereas it is recommended for initiating buprenorphine and during follow-up. Urine drug tests are based on immunoassay techniques and enable a qualitative analysis of the recent drug consumption, with detection based on designated thresholds, allow a better appraisal of drug exposure, before initiating and during OMT. While intrinsic diagnostic value of these tests is already demonstrated, the consequences of carrying out these tests on OMT have not been clearly established. Some studies suggest that patients exposed to drug tests may have a better OMT retention and in patients treated by methadone, performing urine screening tests has been shown to be associated with a mortality risk reduction in a Scottish retrospective cohort of opioid addicts. Actually, despite the recommendations to perform these tests, few GP prescribe tests, and few patients are regularly screened. Availability of commercial kits for urine drug testing in the medical office should improve their utilisation.

The widespread of urine drug screening tests use in ambulatory care is a reality for some GPs working in addictology networks. Despite a global benefit reported in the literature with a better control in prescribing OMT and a better patients' adherence, as far as the investigators know, no study has yet explored the impact of the use of urine drug screening test in decision making in general practice with an intervention study.

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: ESUB-MG Study Group. Study protocol of the ESUB-MG cluster randomized trial: a pragmatic trial assessing the implementation of urine drug screening in general practice for buprenorphine maintained patients. BMC Fam Pract. 2016 Mar 1;17:24. doi: 10.1186/s12875-016-0413-3.

journal_name: BMC Family Practice

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Toulouse

location_facility: Service de Pharmacologie Médicale et Clinique - Centre d'addictovigilance - CHU de Toulouse


title: Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Patients Treated by Veno-arterial Extra-Corporeal Membrane Oxygenation

acronym: ADRECMO

summary: Refractory cardiogenic shock is characterized by a decreased in cardiac output with hypo-responsiveness to increasing doses of catecholamines resulting in a profound tissular ischemia. VAECMO, by restoring a circulatory flow, could be associated to a major reperfusion syndrome which may lead some patients to multiple organ failures and death. Pathophysiology of this syndrome includes 1/an hyper-adrenergic state secondary to the over activation of the sympathetic system and 2/ a major release of pro-inflammatory cytokines. As adrenoreceptors are also exhibited on immunes cells, the pro-inflammatory state might be enhanced by the over-activation of the sympathetic system.

status: Unknown status

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Analysis of Chilblains Profile During COVID-19 Epidemic

acronym: ACROVID

summary: Cases of chilblains have been reported with an unusual frequency in France in the context of the COronaVirus Infectious Disease 2019 (COVID-19) epidemic. Some of these cases have been linked to a virological status in favour of a recent Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection. Chilblains are acral inflammatory lesion typically reactive to cold (primary form). There are secondary forms acquired during autoimmune connectivitis such as lupus chilblain or hereditary forms related to type I Interferonopathy. An interferon type I signature has been described in these secondary forms of frostbite but also during the cytokine storm of severe forms of CoV-2 SARS infection. If cases of frostbite are indeed secondary to an SARS-CoV-2 infection, comparative analysis of their immunopathological profiles could provide a better understanding of the inflammatory mechanisms during COVID-19.

lead_sponsor: Poitiers University Hospital


title: Generation of Clinical Grade Adenovirus Specific T Cells for Adoptive Immunotherapy After Allogeneic Stem Cell Transplantation : Clinical Trial

acronym: CTL-ADV

summary: Fourteen patients will be included for infusion of adenovirus-specific T-cells generated by a clinical grade IFN-γ based immunomagnetic isolation from a leukapheresis from their original donor or a haploidentical donor, in case of Umbilical cord blood transplantation, in the event of refractory ADV infection or disease.

ReferenceCitation: Aïssi-Rothé L, Decot V, Venard V, Jeulin H, Salmon A, Clement L, Kennel A, Mathieu C, Dalle JH, Rauser G, Cambouris C, de Carvalho M, Stoltz JF, Bordigoni P, Bensoussan D. Rapid generation of full clinical-grade human antiadenovirus cytotoxic T cells for adoptive immunotherapy. J Immunother. 2010 May;33(4):414-24. doi: 10.1097/CJI.0b013e3181cc263b.

ReferenceCitation: Feucht J, Opherk K, Lang P, Kayser S, Hartl L, Bethge W, Matthes-Martin S, Bader P, Albert MH, Maecker-Kolhoff B, Greil J, Einsele H, Schlegel PG, Schuster FR, Kremens B, Rossig C, Gruhn B, Handgretinger R, Feuchtinger T. Adoptive T-cell therapy with hexon-specific Th1 cells as a treatment of refractory adenovirus infection after HSCT. Blood. 2015 Mar 19;125(12):1986-94. doi: 10.1182/blood-2014-06-573725. Epub 2015 Jan 23.

ReferenceCitation: Feuchtinger T, Matthes-Martin S, Richard C, Lion T, Fuhrer M, Hamprecht K, Handgretinger R, Peters C, Schuster FR, Beck R, Schumm M, Lotfi R, Jahn G, Lang P. Safe adoptive transfer of virus-specific T-cell immunity for the treatment of systemic adenovirus infection after allogeneic stem cell transplantation. Br J Haematol. 2006 Jul;134(1):64-76.

ReferenceCitation: Qian C, Campidelli A, Wang Y, Cai H, Venard V, Jeulin H, Dalle JH, Pochon C, D'aveni M, Bruno B, Paillard C, Vigouroux S, Jubert C, Ceballos P, Marie-Cardine A, Galambrun C, Cholle C, Clerc Urmes I, Petitpain N, De Carvalho Bittencourt M, Decot V, Reppel L, Salmon A, Clement L, Bensoussan D. Curative or pre-emptive adenovirus-specific T cell transfer from matched unrelated or third party haploidentical donors after HSCT, including UCB transplantations: a successful phase I/II multicenter clinical trial. J Hematol Oncol. 2017 May 8;10(1):102. doi: 10.1186/s13045-017-0469-0.

family: Qian

full_name: Chongsheng Qian

given: Chongsheng

family: Campidelli

full_name: Arnaud Campidelli

given: Arnaud

family: Wang

full_name: Yingying Wang

given: Yingying

family: Cai

full_name: Huili Cai

given: Huili

family: Venard

full_name: Véronique Venard

given: Véronique

family: Jeulin

full_name: Hélène Jeulin

given: Hélène

family: Dalle

full_name: Jean Hugues Dalle

given: Jean Hugues

family: Pochon

full_name: Cécile Pochon

given: Cécile

family: D’aveni

full_name: Maud D’aveni

given: Maud

family: Bruno

full_name: Benedicte Bruno

given: Benedicte

family: Paillard

full_name: Catherine Paillard

given: Catherine

family: Vigouroux

full_name: Stéphane Vigouroux

given: Stéphane

family: Jubert

full_name: Charlotte Jubert

given: Charlotte

family: Ceballos

full_name: Patrice Ceballos

given: Patrice

family: Marie-Cardine

full_name: Aude Marie-Cardine

given: Aude

family: Galambrun

full_name: Claire Galambrun

given: Claire

family: Cholle

full_name: Clément Cholle

given: Clément

family: Clerc Urmes

full_name: Isabelle Clerc Urmes

given: Isabelle

family: Petitpain

full_name: Nadine Petitpain

given: Nadine

family: De Carvalho Bittencourt

full_name: Marcelo De Carvalho Bittencourt

given: Marcelo

family: Decot

full_name: Véronique Decot

family: Reppel

full_name: Loïc Reppel

given: Loïc

family: Salmon

full_name: Alexandra Salmon

location_facility: Centre Hospitalier Universitaire de Nancy


title: Acceptability of a Strategy Including Acupuncture in the Treatment of MusculoSkeletal Pain in Hospitalised Elderly

acronym: ACUPUNCTURE

summary: The aim is to investigate the feasibility and efficacy of an acupuncture intervention on persistent MusculoSkeletar pain in a long-term geriatric hospital care ward population. The main issue is the acceptability of this type of complementary and alternative medicine in older people, although the efficacy on pain is assessed too.

design_allocation: Non-Randomized

ReferenceCitation: Couilliot MF, Darees V, Delahaye G, Ercolano P, Carcaillé M, Vytopilova P, Tenenbaum B, Vicaut E. Acceptability of an acupuncture intervention for geriatric chronic pain: an open pilot study. J Integr Med. 2013 Jan;11(1):26-31. doi: 10.3736/jintegrmed2013005.

family: Couilliot

full_name: Marie-France Couilliot

given: Marie-France

family: Darees

full_name: Véronique Darees

given: Véronique

family: Delahaye

full_name: Gérard Delahaye

given: Gérard

family: Ercolano

full_name: Philippe Ercolano

given: Philippe

family: Carcaillé

full_name: Maud Carcaillé

family: Vytopilova

full_name: Pavla Vytopilova

given: Pavla

family: Tenenbaum

full_name: Bruno Tenenbaum

given: Bruno

family: Vicaut

full_name: Eric Vicaut

given: Eric

journal_name: Journal of Integrative Medicine

location_facility: HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.


title: Critical Limb Ischemia Treatment by Local Intra-Muscular Injection of Autologous Mononuclear Cells

summary: The primary focus of the trial is safety and efficacy of the intra-muscular implantation of either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as judged by the proportion of patients which are alive without major amputation 6 months after inclusion.

ReferenceCitation: Pignon B, Sevestre MA, Chatelain D, Albertini JN, Sevestre H. Histological changes after implantation of autologous bone marrow mononuclear cells for chronic critical limb ischemia. Bone Marrow Transplant. 2007 May;39(10):647-8. Epub 2007 Mar 26.

ReferenceCitation: Al-Rifai R, Nguyen P, Bouland N, Terryn C, Kanagaratnam L, Poitevin G, François C, Boisson-Vidal C, Sevestre MA, Tournois C. In vivo efficacy of endothelial growth medium stimulated mesenchymal stem cells derived from patients with critical limb ischemia. J Transl Med. 2019 Aug 9;17(1):261. doi: 10.1186/s12967-019-2003-3.

family: Al-Rifai

full_name: Rida Al-Rifai

given: Rida

family: Nguyen

full_name: Philippe Nguyen

family: Bouland

full_name: Nicole Bouland

given: Nicole

family: Terryn

full_name: Christine Terryn

given: Christine

family: Kanagaratnam

full_name: Lukshe Kanagaratnam

given: Lukshe

family: Poitevin

full_name: Gaël Poitevin

given: Gaël

family: François

full_name: Caroline François

given: Caroline

family: Boisson-Vidal

full_name: Catherine Boisson-Vidal

given: Catherine

family: Sevestre

full_name: Marie-Antoinette Sevestre

given: Marie-Antoinette

family: Tournois

full_name: Claire Tournois

journal_name: Journal of Translational Medicine

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

ReferenceCitation: Capiod JC, Tournois C, Vitry F, Sevestre MA, Daliphard S, Reix T, Nguyen P, Lefrère JJ, Pignon B. Characterization and comparison of bone marrow and peripheral blood mononuclear cells used for cellular therapy in critical leg ischaemia: towards a new cellular product. Vox Sang. 2009 Apr;96(3):256-65. doi: 10.1111/j.1423-0410.2008.01138.x. Epub 2008 Dec 15.

family: Capiod

full_name: J.-C. Capiod

full_name: C. Tournois

given: C.

family: Vitry

full_name: F. Vitry


title: Etude Fruits et Légumes à la Maison (FLAM)

acronym: FLAM

summary: The purpose of this study is to assess whether fruit and vegetables vouchers combined with educational support may increase fruits and vegetables consumption of children aged 3 to 10 living in vulnerable families in Saint-Denis, France.

ReferenceCitation: Buscail C, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Julia C. Impact of fruits and vegetables vouchers on food insecurity in disadvantaged families from a Paris suburb. BMC Nutr. 2019 Apr 4;5:26. doi: 10.1186/s40795-019-0289-4. eCollection 2019.

family: Buscail

full_name: Camille Buscail

given: Camille

family: Gendreau

full_name: Judith Gendreau

given: Judith

family: Daval

full_name: Paul Daval

given: Paul

family: Lombrail

full_name: Pierre Lombrail

given: Pierre

family: Hercberg

full_name: Serge Hercberg

given: Serge

family: Latino-Martel

full_name: Paule Latino-Martel

given: Paule

family: Julia

full_name: Chantal Julia

given: Chantal

journal_name: BMC Nutrition

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

repository_institution: INRA Bordeaux-Aquitaine - Prodinra

repositories:
HAL
PubMed Central
prodinra.inra.fr

ReferenceCitation: Buscail C, Margat A, Miszkowicz T, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Maurice A, Julia C. Recruitment of precarious families in an interventional study: Lessons from the French "Fruits and vegetables at home" (FLAM) trial. Contemp Clin Trials Commun. 2018 Nov 2;12:161-168. doi: 10.1016/j.conctc.2018.10.008. eCollection 2018 Dec.

apc_source: openAPC

family: Margat

full_name: Aurore Margat

given: Aurore

family: Miszkowicz

full_name: Thibaut Miszkowicz

given: Thibaut

journal_name: Contemporary Clinical Trials Communications

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

title: Recruitment of precarious families in an interventional study: Lessons from the French “Fruits and vegetables at home” (FLAM) trial

ReferenceCitation: Buscail C, Margat A, Petit S, Gendreau J, Daval P, Lombrail P, Hercberg S, Latino-Martel P, Maurice A, Julia C. Fruits and vegetables at home (FLAM): a randomized controlled trial of the impact of fruits and vegetables vouchers in children from low-income families in an urban district of France. BMC Public Health. 2018 Aug 28;18(1):1065. doi: 10.1186/s12889-018-5908-5.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet


title: Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)

acronym: BIOoSE

summary:
Osteoarthritis is a chronic disease affecting millions of people worldwide, and knee is the second most affected site. Knee osteoarthritis is characterized by knee pain, loss of motion, disability, and muscle weakness, all factors contributing to gait alterations, and impacting greatly the patients quality of life. In the absence of curative treatment, pharmacological and non-pharmacological symptomatic treatments are prescribed to maintain this QoL, and therefore delay surgery to more appropriate window of opportunity later in life.

The aim of the study was to investigate the acute effects of three braces, using different unloading strategies, on gait kinematic and kinetic parameters, as well as pain in patients with medial knee ostoeoarthritis.

lead_sponsor: Thuasne

intervention_type: Device


title: Research of Molecular Markers for Diagnosis and/or Prognosis in Lymph Node Metastasis of Resected Non-small Cell Lung Cancer

summary: This is a prospective study of surgically resected samples and lymph nodes of lung cancer patients. For histopathologically positive lymph nodes from a complete resection, the investigators would like to analyse tumor tissue by allelotyping and comparing these results with those observed in the primary lung tumor to establish a cartography of molecular alteration in resected lung cancer. For non histopathologically positive lymph nodes, the investigators would like to research the presence (or not) of micrometastasis by allele-specific PCR (polymerase chain reaction).

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Pneumologie, Hôpital de Hautepierre

location_facility: Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre

location_facility: Service d'Anatomie Pathologique, Hôpital de Hautepierre

location_facility: Service de Chirurgie Thoracique, Hôpital Civil


title: ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers

acronym: EPF

summary: The purpose of this study is to provide a surveillance system to monitor changes in the rate of mother to child HIV transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

ReferenceCitation: Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E, Matheron S, Khuong MA, Garrait V, Reliquet V, Devidas A, Berrebi A, Allisy C, Elleau C, Arvieux C, Rouzioux C, Warszawski J, Blanche S; ANRS-EPF Study Group. No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis. 2015 Dec 1;61(11):1715-25. doi: 10.1093/cid/civ578. Epub 2015 Jul 21.

family: Mandelbrot

full_name: Laurent Mandelbrot

given: Laurent

family: Tubiana

full_name: Roland Tubiana

given: Roland

family: Le Chenadec

full_name: Jerome Le Chenadec

given: Jerome

family: Dollfus

full_name: Catherine Dollfus

family: Faye

full_name: Albert Faye

given: Albert

family: Pannier

full_name: Emmanuelle Pannier

given: Emmanuelle

family: Matheron

full_name: Sophie Matheron

given: Sophie

family: Khuong

full_name: Marie-Aude Khuong

given: Marie-Aude

family: Garrait

full_name: Valerie Garrait

given: Valerie

family: Reliquet

full_name: Veronique Reliquet

given: Veronique

family: Devidas

full_name: Alain Devidas

given: Alain

family: Berrebi

full_name: Alain Berrebi

family: Allisy

full_name: Christine Allisy

family: Elleau

full_name: Christophe Elleau

given: Christophe

family: Arvieux

full_name: Cedric Arvieux

given: Cedric

family: Rouzioux

full_name: Christine Rouzioux

family: Warszawski

full_name: Josiane Warszawski

given: Josiane

family: Blanche

full_name: Stéphane Blanche

given: Stéphane

journal_name: Clinical Infectious Diseases

oa_host_type: publisher

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: No Perinatal HIV-1 Transmission From Women With Effective Antiretroviral Therapy Starting Before Conception

ReferenceCitation: Taron-Brocard C, Le Chenadec J, Faye A, Dollfus C, Goetghebuer T, Gajdos V, Labaune JM, Perilhou A, Mandelbrot L, Blanche S, Warszawski J; France REcherche Nord&Sud Sida-HIV Hepatites - Enquete Perinatale Francaise - CO1/CO11 Study Group. Increased risk of serious bacterial infections due to maternal immunosuppression in HIV-exposed uninfected infants in a European country. Clin Infect Dis. 2014 Nov 1;59(9):1332-45. doi: 10.1093/cid/ciu586. Epub 2014 Jul 22.

family: Taron-Brocard

full_name: C. Taron-Brocard

full_name: J. Le Chenadec

name: for the France REcherche Nord&Sud Sida-HIV Hepatites - Enquete Perinatale Francaise - CO1/CO11 Study Group

title: Increased Risk of Serious Bacterial Infections Due to Maternal Immunosuppression in HIV-Exposed Uninfected Infants in a European Country

ReferenceCitation: Sibiude J, Mandelbrot L, Blanche S, Le Chenadec J, Boullag-Bonnet N, Faye A, Dollfus C, Tubiana R, Bonnet D, Lelong N, Khoshnood B, Warszawski J. Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1/CO11). PLoS Med. 2014 Apr 29;11(4):e1001635. doi: 10.1371/journal.pmed.1001635. eCollection 2014 Apr.

title: Association between Prenatal Exposure to Antiretroviral Therapy and Birth Defects: An Analysis of the French Perinatal Cohort Study (ANRS CO1/CO11)

ReferenceCitation: Briand N, Jasseron C, Sibiude J, Azria E, Pollet J, Hammou Y, Warszawski J, Mandelbrot L. Cesarean section for HIV-infected women in the combination antiretroviral therapies era, 2000-2010. Am J Obstet Gynecol. 2013 Oct;209(4):335.e1-335.e12. doi: 10.1016/j.ajog.2013.06.021. Epub 2013 Jun 18.

journal_name: American Journal of Obstetrics and Gynecology

title: Cesarean section for HIV-infected women in the combination antiretroviral therapies era, 2000–2010

ReferenceCitation: Briand N, Warszawski J, Mandelbrot L, Dollfus C, Pannier E, Cravello L, Nguyen R, Matheron I, Winer N, Tubiana R, Rouzioux C, Faye A, Blanche S; ANRS-EPF CO1-CO11 Study Group. Is intrapartum intravenous zidovudine for prevention of mother-to-child HIV-1 transmission still useful in the combination antiretroviral therapy era? Clin Infect Dis. 2013 Sep;57(6):903-14. doi: 10.1093/cid/cit374. Epub 2013 May 31.

title: Is Intrapartum Intravenous Zidovudine for Prevention of Mother-to-Child HIV-1 Transmission Still Useful in the Combination Antiretroviral Therapy Era?

ReferenceCitation: Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Jasseron C, Mandelbrot L, Dollfus C, Trocmé N, Tubiana R, Teglas JP, Faye A, Rouzioux C, Blanche S, Warszawski J. Non-disclosure of a pregnant woman's HIV status to her partner is associated with non-optimal prevention of mother-to-child transmission. AIDS Behav. 2013 Feb;17(2):488-97. doi: 10.1007/s10461-011-0084-y.

title: Non-Disclosure of a Pregnant Woman’s HIV Status to Her Partner is Associated with Non-Optimal Prevention of Mother-to-Child Transmission

ReferenceCitation: Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P, Foissac F, Laborde K, Tréluyer JM, Firtion G, Layouni I, Munzer M, Bavoux F, Polak M, Blanche S; ANRS French Perinatal Cohort Study Group. Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers. JAMA. 2011 Jul 6;306(1):70-8. doi: 10.1001/jama.2011.915.

full_name: for the ANRS French Perinatal Cohort Study Group

title: Association of Prenatal and Postnatal Exposure to Lopinavir-Ritonavir and Adrenal Dysfunction Among Uninfected Infants of HIV-Infected Mothers

ReferenceCitation: Sibiude J, Warszawski J, Tubiana R, Dollfus C, Faye A, Rouzioux C, Teglas JP, Ekoukou D, Blanche S, Mandelbrot L. Premature delivery in HIV-infected women starting protease inhibitor therapy during pregnancy: role of the ritonavir boost? Clin Infect Dis. 2012 May;54(9):1348-60. doi: 10.1093/cid/cis198. Epub 2012 Mar 28.

title: Premature Delivery in HIV-Infected Women Starting Protease Inhibitor Therapy During Pregnancy: Role of the Ritonavir Boost?

ReferenceCitation: Tubiana R, Le Chenadec J, Rouzioux C, Mandelbrot L, Hamrene K, Dollfus C, Faye A, Delaugerre C, Blanche S, Warszawski J. Factors associated with mother-to-child transmission of HIV-1 despite a maternal viral load <500 copies/ml at delivery: a case-control study nested in the French perinatal cohort (EPF-ANRS CO1). Clin Infect Dis. 2010 Feb 15;50(4):585-96. doi: 10.1086/650005.

title: Factors Associated with Mother‐to‐Child Transmission of HIV‐1 Despite a Maternal Viral Load <500 Copies/mL at Delivery: A Case‐Control Study Nested in the French Perinatal Cohort (EPF‐ANRS CO1)

ReferenceCitation: Briand N, Mandelbrot L, Le Chenadec J, Tubiana R, Teglas JP, Faye A, Dollfus C, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. No relation between in-utero exposure to HAART and intrauterine growth retardation. AIDS. 2009 Jun 19;23(10):1235-43. doi: 10.1097/QAD.0b013e32832be0df.

ReferenceCitation: Mandelbrot L, Jasseron C, Ekoukou D, Batallan A, Bongain A, Pannier E, Blanche S, Tubiana R, Rouzioux C, Warszawski J; ANRS French Perinatal Cohort (EPF). Amniocentesis and mother-to-child human immunodeficiency virus transmission in the Agence Nationale de Recherches sur le SIDA et les Hépatites Virales French Perinatal Cohort. Am J Obstet Gynecol. 2009 Feb;200(2):160.e1-9. doi: 10.1016/j.ajog.2008.08.049. Epub 2008 Nov 4.

ReferenceCitation: Jasseron C, Mandelbrot L, Tubiana R, Teglas JP, Faye A, Dollfus C, Le Chenadec J, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. Prevention of mother-to-child HIV transmission: similar access for sub-Sahara African immigrants and for French women? AIDS. 2008 Jul 31;22(12):1503-11. doi: 10.1097/QAD.0b013e3283065b8c.

ReferenceCitation: Benhammou V, Warszawski J, Bellec S, Doz F, André N, Lacour B, Levine M, Bavoux F, Tubiana R, Mandelbrot L, Clavel J, Blanche S; ANRS-Enquête Périnatale Française. Incidence of cancer in children perinatally exposed to nucleoside reverse transcriptase inhibitors. AIDS. 2008 Oct 18;22(16):2165-77. doi: 10.1097/QAD.0b013e328311d18b. Erratum in: AIDS. 2012 May 15;26(8):1047. Carbillon, François F [corrected to Carbillon, L].

ReferenceCitation: Warszawski J, Tubiana R, Le Chenadec J, Blanche S, Teglas JP, Dollfus C, Faye A, Burgard M, Rouzioux C, Mandelbrot L; ANRS French Perinatal Cohort. Mother-to-child HIV transmission despite antiretroviral therapy in the ANRS French Perinatal Cohort. AIDS. 2008 Jan 11;22(2):289-99.

location_country:
Martinique
French Guiana
France
Guadeloupe

location_facility: Centre Hospitalier Régional Universitaire de Brest

location_facility: Centre Hospitalier de Saint Nazaire-Cité Sanitaire


title: Predictive Criteria of Acute Heart Failure (AHF) in Patients Admitted to Emergency Department for Dyspnea.

acronym: PREDICA

summary: No studies have analyzed the predictive value of different anamnestic and clinical signs for the diagnosis of acute heart failure (AHF) in patients admitted to emergency department. That's why the expert group of the AHF of South West of France mobilizes to conduct this study to evaluate the diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of AHF to emergencies.

location_facility:
University Hospital
Hospital
University Hospital Toulouse


title: Predicting the Risk of Readmission in Patients With Chronic Heart Failure

acronym: PREDIC

summary:
Heart failure (HF) is a frequent, serious, and costly chronic disease: it leads to 150,000 hospitalizations each year in France at a cost of 525 million Euros.

It is estimated that 20-40% of these hospitalizations are preventable by known interventions: home telemonitoring, care coordination, therapeutic intensification and therapeutic education. But these interventions only work if patients at high risk of rehospitalization are targeted to individualize management. In these patients, the risk of rehospitalization depends on clinical, biological, socioeconomic, care pathway, and location-related data. Existing predictive tools perform poorly due to three important limitations: non-use of unstructured clinical data, lack of integration of multimodal data, and weakness of the algorithmic approach.

The objective is to design and validate a predictive algorithm for the risk of rehospitalization in heart failure patients, using multiple data sources

ipd_sharing_description: NC


title: Proteasis Evaluation in COPD

acronym: Pro-BPCO

summary: The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients. Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be included: Healthy smoker subjects, stable COPD patients and COPD patients with acute exacerbation. Kallicrein levels in sputum will be compared in these groups.


title: Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment

acronym: LITHUTHERM

summary:
Current urological therapeutic modalities are represented by extracorporeal lithotripsy (ECL), rigid (URS) or flexible (URSsple) uretero-renoscopy and percutaneous nephrolithotomy (PCNL).

They make it possible to extract the vast majority of stones by minimally invasive techniques but leave behind small residual lithic fragments (FR) that can always cause pain, infection, or promote the development of a larger stone.

A non-invasive technique that can help eliminate them would be of great benefit to many patients by avoiding painful recurrences and limiting reprocessing; combined with appropriate medical management, it would limit the rate of remote recurrences and long-term complications.

The treatment called "hydro-posturotherapy" has been developed in some spas that are approved for kidney diseases such as Vittel or Capvern. It includes several modalities: posturotherapy, lumbar percussion and hyperdiuresis.

The main objective is to compare at 3 months, on the unprepared abdomen (ASP) and the low-dose scanner without injection, the elimination of kidney stone fragments under the effect of a short spa treatment with posturotherapy, lumbar percussion and controlled hyperdiuresis compared to the recommended standard treatment. The result will be assessed in 3 categories: complete elimination (SF: "without fragments" or "stone-free"), elimination of more than 50% of the fragments; elimination of less than 50% of the fragments.

lead_sponsor: GUILLEMIN Francis, MD


title: Intense Pulsed Light in Meibomian Gland Dysfunctions: Retrospective Study

acronym: LACRYSTIM

summary:
Dry eye disease (DED) is an extremely common disease whose meibomian gland dysfunction is the main etiology.

Polychromatic intense pulsed light (IPL) is a promising new therapeutic alternative but few clinical data have been published.

A new IPL device has recently been marketed: LACRYSTIM (QUANTEL, France). The investigators have been using it in our clinical practice since June 2019.

The investigators present a retrospective study on our first clinical results.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: 4D Flow Cardiac MRI Velocity Mapping in Patients With Hypertrophic Cardiomyopathy: Assessment of the Severity of the Left Ventricular Obstruction and Comparison With Echocardiography

acronym: HCMFLOW

summary:
Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. To date, the only method allowing a reliable assessment of the extent of left ventricular obstruction is Doppler echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire volume with the ability to simultaneously measure the outputs of all vessels within that volume in a single sequence and might be able to quantify left ventricular obstruction.

The main objective of this study is to compare the quantification of left ventricular obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Impact of Socio-economic Vulnerability on Initial Severity and Prognosis in Patients Admitted to an ICU. Prospective, Multi-centre Cohort Study

acronym: IVOIRE

summary: A gravity admission largest resuscitation and a poorer prognosis are expected for patients experiencing socio-economic vulnerability. This is the first study in France and investigating the field of resuscitation which will allow us to have a vision of the French health system and its consequences. The frequency of PTSD is expected to be more important in this vulnerable population itself with quality of life at discharge worse. The results of this study are a prerequisite for the implementation of preventive measures targeted and more suitable for those patients experiencing socio-economic vulnerability remediation.

ReferenceCitation: Quenot JP, Helms J, Labro G, Dargent A, Meunier-Beillard N, Ksiazek E, Bollaert PE, Louis G, Large A, Andreu P, Bein C, Rigaud JP, Perez P, Clere-Jehl R, Merdji H, Devilliers H, Binquet C, Meziani F, Fournel I; IVOIRE Trial Investigators and the CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). Influence of deprivation on initial severity and prognosis of patients admitted to the ICU: the prospective, multicentre, observational IVOIRE cohort study. Ann Intensive Care. 2020 Feb 11;10(1):20. doi: 10.1186/s13613-020-0637-1.

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Helms

full_name: Julie Helms

given: Julie

family: Labro

full_name: Guylaine Labro

given: Guylaine

family: Dargent

full_name: Auguste Dargent

given: Auguste

family: Meunier-Beillard

full_name: Nicolas Meunier-Beillard

given: Nicolas

family: Ksiazek

full_name: Elea Ksiazek

given: Elea

family: Bollaert

full_name: Pierre-Edouard Bollaert

given: Pierre-Edouard

family: Louis

full_name: Guillaume Louis

given: Guillaume

family: Large

full_name: Audrey Large

given: Audrey

family: Andreu

full_name: Pascal Andreu

given: Pascal

family: Bein

full_name: Christophe Bein

family: Rigaud

full_name: Jean-Philippe Rigaud

given: Jean-Philippe

family: Perez

full_name: Pierre Perez

given: Pierre

family: Clere-Jehl

full_name: Raphaël Clere-Jehl

given: Raphaël

family: Merdji

full_name: Hamid Merdji

given: Hamid

family: Devilliers

full_name: Hervé Devilliers

given: Hervé

family: Binquet

full_name: Christine Binquet

given: Christine

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Fournel

full_name: Isabelle Fournel

given: Isabelle

family: Lévy

full_name: Bruno Lévy

given: Bruno

family: Lemarié

full_name: Jérémie Lemarié

given: Jérémie

family: Cadoz

full_name: Cyril Cadoz

given: Cyril

family: Marchalot

full_name: Antoine Marchalot

given: Antoine

name: the IVOIRE Trial Investigators and the CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis)


title: Severe Intraocular Infection

summary:
The host-immune reaction to infection is essential for the comprehension of the disease and the development of new therapies.

The aim of the study is to describe intraocular cytokines network in aqueous humor using multiplex immunoassay, during severe intraocular infection.

location_facility: Service d'Ophtalmologie, Hôpital Pasteur

location_facility: Service d'Ophtalmologie, Centre Hospitalier de Mulhouse

location_facility: Service d'Ophtalmologie, Hôpital Michallon

location_facility: Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service d'Ophtalmologie, Hôpital de Brabois

location_facility: Service d'Ophtalmologie, Hôpital Général de Dijon

intervention_type: Biological


title: Study of the Impact of Daily Bread Consumption Enriched With a Fibre Mix on Intestinal Microbiota and Metabolic Profile in Subjects at Metabolic Risk

acronym: Breath

summary: The level of fibre consumption in France is lower than the national and international recommendations (mean 18.8 g/d for men, 16.4 g/d for women (INCA 2007 Study) instead of 30g/d recommended). Fibre have beneficial effects on health and interact with the intestinal microbiota diversity: a diet fortified with different structure fibres increase of 25 % the dysbiotic intestinal microbiota in obese patient (Cotillard et al, Dietary intervention impact on gut microbial gene richness. Nature, August 2013). The study aim is to evaluate the impact of daily consumption of bread (150 g ) enriched with a mixture of fibres of different structure (15g) during two months on the intestinal microbiota composition in metabolic risk subjects (abdominal overweight or obese) and also, to assess the correlation between the microbiota change and their metabolic profile improvement.It is a mono centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes)

primary_purpose: Basic Science

lead_sponsor: Bridor


title: Symptoms and Treatment Assessment of Ano-Rectal Disorders in Multiple Sclerosis Patients : STAR-Q (STAR Questionnaire): Validation of a New Tool to Better Explore and Manage Bowel Dysfunction.

acronym: STAR-Q

summary:
Multiple sclerosis (MS) is known to cause urinary disorders, sexual and bowel dysfunction. Urinary symptoms due to MS are well known and profit of multiple questionnaire or tool developed in MS patients.

Prevalence of bowel disorders in MS is difficult to assess. Some studies up to 70% bowel disorders in MS patients. Constipation and fecal incontinence are the two main symptoms in neurogenic bowel dysfunction and frequently coexist in this population, generally in association with urinary disorders.

Because of the high prevalence of bowel disorders their and the major impact on the quality of life of patients with Multiple sclerosis (PwMS) , and the cross-talk bladder-rectum (persistence of anorectal dysfunction leading to poor neurogenic bladder control) assessment of bowel disorders in MS is necessary. But this evaluation is difficult as no specific score exist. The neurogenic Bowel Dysfunction score (NBD) is often used. The NBD was developed and validated for spinal cord injury (SCI) population but not for PwMS MS. Yet NBD is often used in research for all neurologic patients despite its lack of sensibility in various neurogenic population other than spinal cord injury patient. As recommended in a Cochrane revue in 2014, there is a need of a specific evaluation for bowel symptoms in neurogenic population, especially for PwMS.

The aim of the study was to create and validate a new multidimensional questionnaire to assess bowel dysfunction and impact on quality of life in patients with MS.

The investigators conducted a prospective multicenter study (8 centers) between June 2019 to April 2021. This study was developed in 3 steps. First step was literature review and qualitative interview. Then the second step was the feasibility study to evaluate comprehension, acceptability of the different items. The last part of the study was the validation study of the questionnaire. This part of the study was performed between June2020 and April 2021. Validation study allowed to determine the psychometric properties of the new tool.

Patients aged over 18 years with multiple sclerosis diagnosed on the 2017 revised McDonald's criteria were included. Patients not able to read or understand the objectives and procedures for conducting the protocol and patient who had a recent relapse of MS were excluded.

lead_sponsor: Pierre and Marie Curie University

location_facility: Department of Neuro- Urology, Hôpital Tenon


title: Evaluation of a Shared Health Information System for Home-hospital Management of Febrile NEUTROpenia After Cytotoxic Chemotherapy

acronym: NEUTROSIS

summary:
The use of e-health in improving the quality of health services is a rapidly expanding research area, in particular its usefulness in patient management of the home-hospital care pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy and better identification of low-risk patients who can be treated at home could be made possible by these technologies.

The objective of this study is to evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims to compare the average length of hospital stay for febrile neutropenia among patients receiving NEUTROSIS and those receiving standard care

Materials and methods A shared information system (NEUTROSIS) has been developed to connect a smartphone web application for the patient to the existing shared medical record of the Paris Sud hospital group (AP-HP, France - 4D software).

The study consists of conducting a randomized controlled trial to compare a cohort of patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by the hospital's standard care over a treatment period of six months (n=100). During the 15 days following each chemotherapy cycle, the 2 groups of patients must take their temperature daily. Both groups are trained like any patient under chemotherapy to contact the team in case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other symptoms on the smartphone application. This information is then transmitted instantly to the hospital care team who will be alerted in case of fever and will contact the patient. The control group will indicate these same data in a paper diary and will have to contact the health team in case of fever as done in the usual care.

The two groups of patients will be followed 6 months through a questionnaire asked to the patient at each hospital visit for chemotherapy cycle. The questionnaire collects information on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study will take place in two hospital sites of the Paris University hospital (A Béclère and Kremlin-Bicètre).

primary_purpose: Health Services Research

lead_sponsor: Marie-Helene METZGER

location_facility:
Hôpital BICETRE
Hôpital Antoine Béclère


title: Phenotypic Features and Prognostic Value of Anti-Ro52 (TRIM-21) Antibodies in Connective Tissue Diseases

summary: Anti-Ro52 autoantibodies can be detected in patients with several autoimmune diseases. Clinical significance of anti-Ro52 is controversial. The presence of anti-Ro52 may be a factor associated with disease severity (interstitial lung disease, vasculopathy) and cancers. The aim of this study is to assess interstitial lung disease and vasculopathy prevalence and severity, cancers occurence and others clinical features of connective tissue disease patients with anti-Ro52 autoantibodies.

ReferenceCitation: Ghillani P, André C, Toly C, Rouquette AM, Bengoufa D, Nicaise P, Goulvestre C, Gleizes A, Dragon-Durey MA, Alyanakian MA, Chretien P, Chollet-Martin S, Musset L, Weill B, Johanet C. Clinical significance of anti-Ro52 (TRIM21) antibodies non-associated with anti-SSA 60kDa antibodies: results of a multicentric study. Autoimmun Rev. 2011 Jul;10(9):509-13. doi: 10.1016/j.autrev.2011.03.004. Epub 2011 Apr 5.

ReferenceCitation: Lee AYS. A review of the role and clinical utility of anti-Ro52/TRIM21 in systemic autoimmunity. Rheumatol Int. 2017 Aug;37(8):1323-1333. doi: 10.1007/s00296-017-3718-1. Epub 2017 Apr 17. Review.

ReferenceCitation: Hudson M, Pope J, Mahler M, Tatibouet S, Steele R, Baron M; Canadian Scleroderma Research Group (CSRG), Fritzler MJ. Clinical significance of antibodies to Ro52/TRIM21 in systemic sclerosis. Arthritis Res Ther. 2012 Mar 6;14(2):R50. doi: 10.1186/ar3763.

ReferenceCitation: Gunnarsson R, El-Hage F, Aaløkken TM, Reiseter S, Lund MB, Garen T; Norwegian MCTD study group, Molberg Ø. Associations between anti-Ro52 antibodies and lung fibrosis in mixed connective tissue disease. Rheumatology (Oxford). 2016 Jan;55(1):103-8. doi: 10.1093/rheumatology/kev300. Epub 2015 Aug 28.

ReferenceCitation: Murng SHK, Thomas M. Clinical associations of the positive anti Ro52 without Ro60 autoantibodies: undifferentiated connective tissue diseases. J Clin Pathol. 2018 Jan;71(1):12-19. doi: 10.1136/jclinpath-2015-203587. Epub 2017 Jun 29.

ReferenceCitation: Reiseter S, Gunnarsson R, Mogens Aaløkken T, Lund MB, Mynarek G, Corander J, Haydon J, Molberg Ø. Progression and mortality of interstitial lung disease in mixed connective tissue disease: a long-term observational nationwide cohort study. Rheumatology (Oxford). 2018 Feb 1;57(2):255-262. doi: 10.1093/rheumatology/kex077.

ReferenceCitation: Bauhammer J, Blank N, Max R, Lorenz HM, Wagner U, Krause D, Fiehn C. Rituximab in the Treatment of Jo1 Antibody-associated Antisynthetase Syndrome: Anti-Ro52 Positivity as a Marker for Severity and Treatment Response. J Rheumatol. 2016 Aug;43(8):1566-74. doi: 10.3899/jrheum.150844. Epub 2016 Jun 1.

location_facility:
Private Hospital
Central Hospital


title: Medico-economic Study of Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During Knee Arthroplasty GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About Medical Device.

summary:
Total knee arthroplasty represents over 70 000 surgical procedures per year in France, increasing about 10% each year since the early 1990s. Clinical experience shows a strong rate of success on pain relieve and improvement of knee articular function for these patients.

Longevity of the implants had been proved to depend on the biomechanical design and implantation techniques, particularly the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta company allows to adapt bone cuts to the patient anatomy improving the reliability of these procedure. A reduction of surgical time and bleeding would be another benefit expected with this type of ancillary. The objective of this study is to demonstrate the advantage of patient matched cutting blocks for total knee arthroplasty on realiability for both clinical and radiological criteria, morbidity reduction during and after the procedure and also a benefit on an economic point of view.

lead_sponsor: Nantes University Hospital


title: Evaluation of Fractional Bipolar Radiofrequency, and Bipolar Radiofrequency Potentiated by Infrared, in Monotherapy or Combined, for the Treatment of Striae

summary:
This is an interventional open prospective randomized study, done in two sites.

The main purpose of this study is to evaluate the efficacy of the combination of bipolar radiofrequency potentiated by an infrared light followed by fractional bipolar radiofrequency for the treatment of striae on the abdomen.

In order to have a more complete and accurate study, each technology will also be evaluated separately. This will allow the comparison of the effect of each treatment, in monotherapy or combined.

lead_sponsor: Candela France

location_facility:
CHU Archet II, Service de Dermatologie
Aesthetics


title: Impact of a Procedure for the Information and Active Participation of the Patient in the Primary Care Prescription of Antihypertensives : InPAct Study (Information for Participating Actively in Cardiovascular Treatment)

acronym: InPAct

summary: Adverse drug events (ADEs) are responsible for 3.6% of the hospitalisations in France. 50% of these ADEs could be preventable. Cardiovascular drugs are frequently involved in ADEs. A common underlying factor of such events is inadequate communication between patients and medical personnel. General practitioners (GP) often initiate the treatment of hypertension, being generally the first prescribers of these medications. 12.6% of the patients present an ADE with hypertensive drug after 3 months. The InPAct procedure is a tool to facilitate communication in order to improve patient safety in primary care. In the context of the primary care prescription of an antihypertensive drug, the GP informs the patient about hypertension, cardiovascular risk, and the benefits and risks of antihypertensive drugs, which helps the patient to detect and declare situations involving a heightened risk of antihypertensive-related ADEs. The aim of the InPAct study is to evaluate the efficiency of the InPAct intervention in primary care.

ReferenceCitation: Buchet-Poyau K, Occelli P, Touzet S, Langlois-Jacques C, Figon S, Dubois JP, Duclos A, Chanelière M, Colin C, Rabilloud M, Keriel-Gascou M. Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial. BMC Fam Pract. 2021 Aug 7;22(1):165. doi: 10.1186/s12875-021-01478-w.

family: Buchet-Poyau

full_name: Karine Buchet-Poyau

given: Karine

family: Occelli

full_name: Pauline Occelli

given: Pauline

family: Touzet

full_name: Sandrine Touzet

given: Sandrine

family: Langlois-Jacques

full_name: Carole Langlois-Jacques

given: Carole

family: Figon

full_name: Sophie Figon

given: Sophie

family: Dubois

full_name: Jean-Pierre Dubois

given: Jean-Pierre

family: Duclos

full_name: Antoine Duclos

family: Chanelière

full_name: Marc Chanelière

given: Marc

family: Colin

full_name: Cyrille Colin

given: Cyrille

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Keriel-Gascou

full_name: Maud Keriel-Gascou

given: Maud

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

ReferenceCitation: Keriel-Gascou M, Buchet-Poyau K, Duclos A, Rabilloud M, Figon S, Dubois JP, Brami J, Vial T, Colin C. Evaluation of an interactive program for preventing adverse drug events in primary care: study protocol of the InPAct cluster randomised stepped wedge trial. Implement Sci. 2013 Jun 19;8:69. doi: 10.1186/1748-5908-8-69.


title: Medico-economic Interest of the Patient Matched Cutting Blocks (Ancillary) MyKnee ® LBS During the Poses of Complete Prosthesis of Knee GMK ®. Multicentric, Prospective, Controlled, Opened, Randomised Study About a Medical Device.

acronym: MY Knee

summary: Over 70.000 total knee arthroplasty (TKA) are performed in France every year, with a 10% yearly increase since the early 1990s. The clinical experience shows a strong rate of success on pain relief and on function. Longevity of the implants has been shown to be determined by the biomechanical design of the prosthesis, and by the implantation technique, especially the correct positioning of the bone cuts during the surgery. To improve the precision of these cuts, the patient matched cutting blocks developed by Medacta allow to adapt the bone cuts to the patient's anatomy, improving the reliability of this procedure. A reduction of the surgery time lengh and bleeding would be other benefits expected with this type of ancillary. The objective of this trial is to study the reliability of patient matched cutting blocks for total knee arthroplasty, by both clinical and radiological assessment, the effect on morbidity reduction during and after the procedure and also the benefit it could bring on an economic point of view.

status: Active, not recruiting


title: Title: Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy.

acronym: BICS

summary:
Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000 suicide attempts every year. SB management is therefore a major public health issue.

Evidence associated dysregulation of the serotonergic system and the hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity. There is a need to better understand the physiopathology and develop diagnostic and therapeutic tools in SB.

The investigators hypothesize that increased peripheral biomarkers of inflammation would correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially in suicidal patients.

Our aim is to compare rates of cerebral metabolites, in particular the complex glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with and without suicidal attempt.

primary_purpose: Other


title: Detection of Long Term Toxicity of Monoclonal Agents Combined With Chemotherapy in Non-Hodgkin Lymphoma - the SIMONAL Project

acronym: SIMONAL

summary:
Non Hodgkin lymphoma (NHL) is the 5th cancer in France. Advances in NHL therapy have resulted in improved cure rates with a 5 year relative survival rate estimated at 55% and a 5-year prevalence estimate of 27,750 cases. Since 2000, the addition of anti-CD20 antibody to the standard treatment regimen composed of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) led for the first time to decline of the specific mortality.

After treatment, patients with NHL experienced elevated risks for therapy-related leukemia, several solid tumors and late toxicities such as cardiovascular or neuro-psychiatric diseases which impact on quality of life. However little is known concerning long-term toxicity of this class of new agents so called "targeted drugs" such as anti-CD20.

The primary objective of this cohort study is to estimate long term toxicity in NHL patients (i.e. 10 to 20 years) using data already collected (i.e. internal analysis) and to compare drugs consumption to that of controls (i.e. external analysis).

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of a Millimeter Wave Emission Bracelet -Type Medical Device for Improving Parkinson's Disease Symptoms: Multicenter, Double-blind Randomized Controlled Trial

acronym: BOMP

summary:
Idiopathic Parkinson's disease is a common neurodegenerative disease, with a prevalence of around 2% in people over 65 years of age in France.

This pathology affects the dopaminergic pathway but also other systems: cholinergic, noradrenergic and serotoninergic.

The symptoms of Parkinson's disease are motor but also non-motor with sleep, smell, cognitive, psychiatric, digestive, urinary, dysautonomic, painful disorders. The discomfort can be such that invasive and expensive solutions have been developed. Invasive or expensive techniques (deep brain stimulation, lesional microsurgery by gamma knife or ultrasound, duodopa or apokinon pumps) brought significant benefits to patients. Opportunities for clinical improvement using less expensive and lighter devices should be sought.

The Remedee endorphin band device is a device that emits millimeter-band electromagnetic waves on the wrist. The device stimulates subcutaneous nerve endings and activates a physiological response leading to the release of endorphins in the brain. Endorphins are involved in several physiological processes, including pain control.

Mu-opioid receptor (MOR) agonists do not only relieve pain, but have effects related to mesolimbic dopaminergic pathways. Indeed, the opioid and dopaminergic systems are closely linked at the cellular level. Endorphins, through inhibition of the release of the neurotransmitter GABA upon binding to the μ receptor, are also linked to an increase in dopamine.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hopital Fondation Adolphe de Rothschild
Centre Hospitalier de Voiron


title: This is a Non-randomized, Single-center, Prospective Investigation on Exercise Capacities of Left Ventricular Assist Devices Recipients

acronym: REVADE

summary:
Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths, 1% of public health expenditure each year in France. Heart transplantation remains the standard of care in patients for which medical therapy is not sufficient. But heart transplantation is a limited resource, as a result of donor shortages. It is therefore possible to consider mechanical circulatory support for patients awaiting heart transplantation or for those who are not suitable for transplantation. Left Ventricular Assist Devices (LVAD) are portable pumps which help the left side of the heart to provide appropriate "cardiac" output. in this type of device, right heart is not assisted and must work on its own, LVADs are thus implanted in patients whose right ventricular function is normal.

The aim of the REVADE study is to assess right ventricular echocardiographic parameters in this population, especially on physical exercise, for a better understanding of right ventricular adaptation to this long-term modified pressure pattern.

ReferenceCitation: Aymami M, Donal E, Guihaire J, Le Helloco A, Federspiel M, Galli E, Carré F, Lelong B, Chabanne C, Corbineau H, Leguerrier A, Verhoye JP, Flécher E. Rest and Exercise Adaptation of the Right Ventricular Function in Long-Term Left Ventricular Assist Device Patients: A Prospective, Pilot Study. J Card Fail. 2016 Mar;22(3):240-1. doi: 10.1016/j.cardfail.2015.12.009. Epub 2015 Dec 17.

family: Aymami

full_name: Marie Aymami

given: Marie

family: Donal

full_name: Erwan Donal

given: Erwan

family: Guihaire

full_name: Julien Guihaire

given: Julien

family: Le Helloco

full_name: Alain Le Helloco

given: Alain

family: Federspiel

full_name: Marie Federspiel

family: Galli

full_name: Elena Galli

given: Elena

family: Carré

full_name: François Carré

given: François

family: Lelong

full_name: Bernard Lelong

given: Bernard

family: Chabanne

full_name: Céline Chabanne

given: Céline

family: Corbineau

full_name: Hervé Corbineau

given: Hervé

family: Leguerrier

full_name: Alain Leguerrier

family: Verhoye

full_name: Jean-Philippe Verhoye

given: Jean-Philippe

family: Flécher

full_name: Erwan Flécher

journal_name: Journal of Cardiac Failure

oa_host_type: repository

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

version: submittedVersion

lead_sponsor: Rennes University Hospital

location_facility: Service de cardiologie - Rennes university hospital


title: Epidemiological Study of the Progress of Puberty in Girls Followed for Cystic Fibrosis

acronym: EPIMUCO

summary:
In the general population, age of puberty, and age of menarche in girls, are closely correlated with those of their mother. The severity of chronic disease has an impact on the stature, the weight gain and the onset of puberty: age of menarche is even later that chronic illness is serious. Cystic fibrosis is one of the major chronic diseases of children.

Neonatal screening is organized since 2002, most girls with cystic fibrosis therefore currently have a very specialized and early care. Older patients were diagnosed during childhood. The optimization of the nutritional and respiratory management has allowed over the past two decades a significant improvement in the survival of these patients. Most young people reach adulthood, puberty and reproductive desire are a crucial issue in the care of these young adults.

In literature, it is often noted an age of menarche delayed an average of 2 years compared to the general population, but correlated with the age of menstruation from the mothers.

The factors involved in the conduct of cycles in the girl followed for cystic fibrosis are poorly known and there are few data on the characteristics of cycles. The menstrual irregularity and amenorrhoea episodes concern nearly half of women.

On the pathophysiological level, studies in animals show that there is a direct effect of CFTR (Cystic Fibrosis Transmembrane Regulator) on the hypothalamic pituitary gonadal and reproductive capacity in mice.

The literature data on the pubertal development, fertility and hormonal profile of these girls are for studies with low numbers and are very old. There is to date no French cohort study on this topic.

The study is a multicenter cross-sectional descriptive study for pubertal and gynecological characteristics in girls followed annually in the reference centers Cystic Fibrosis two inter-region.

location_facility:
CHU Besançon St Jacques
Hôpital de Hautepierre
American Memorial Hospital
Hôpital des enfants Purpan
Hôpital d'Enfants
Hôpital des Enfants-Pellegrin
Canton- Hôpitaux de Brabois

intervention_type: Procedure


title: Preoperative Evaluation of Gastric Contents by Antral Ultrasound in Diabetic Patients: a Prospective Observational Study

acronym: PEGASED

summary:
Gastric aspiration represents the third cause of perioperative death in France. In scheduled surgery, it can be prevented by preoperative fasting. The French and American guidelines recommend a fasting of 2 hours for clear liquids and 6 hours for solid food. However, these durations could be too short in case of delayed gastric emptying due to medications of diabetes for example. This latter condition has an increasing incidence. Numerous complications are related to chronic hyperglycemia including delayed gastric emptying also known as gastroparesis. Around one third of diabetic patients presents this complication.

Gastric ultrasound represents a non-invasive method to explore the stomach. It allows the qualitative and quantitative evaluations of gastric content.

As diabetic patients present a risk of non-empty stomach despite fasting,investigators decided to conduct a prospective observational study compare the appearance of the stomach assessed by ultrasonography between diabetic and non-diabetic patients before scheduled surgery


title: Impact of a Truthful Information Concerning Chemotherapy on Chemotherapy Prescription at the End of Life : a Randomized Controlled Study in Non-curable Lung Cancer Patients

acronym: HIPPOCRATE

summary:
Patients with metastatic cancer have a substantial symptom burden and may receive aggressive care at the end of life. There is evidence that the use of chemotherapy near the end of life is not related to its likelihood of providing benefit and the overuse of aggressive anticancer therapies near the end of life may result in more toxicity than clinical benefit. Moreover, proposing new lines of treatment after successive therapeutic failures may be a way of avoiding discussion of prognosis and advance care planning. It has been proposed that systems not providing overly aggressive care near the end of life would be the ones in which less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the first consultation between patient and oncologist is ruled in France by the first "Plan Cancer" and the "Dispositif d'annonce" (announcement planning). Oncologists are supposed to explain the diagnosis of cancer and to present a treatment plan. In routine practice for metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and its side effects are explained. The use of chemotherapy has been associated with the worsening of two major competitive life-threatening conditions for cancer patients: cachexia and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is hardly explained in routine practice.

This study proposes to examine in a monocentric interventional prospective randomized trial, the impact of a particular way for the oncologist to present chemotherapy at the diagnosis stage on the easiness of timely chemotherapy interruption at the end of life. The main objective is to determine whether or not the explanation of the potential role of anticancer chemotherapy in worsening life-threatening conditions impacts the proportion of patients receiving chemotherapy in the last 30 days of life compared with usual presentation. Secondary objectives are to determine the impact of this communication strategy on overall survival and other indicators of aggressiveness of care and palliative care resources use.

The hypothesis is that the intervention will allow 15% of patients receiving anticancer therapy during the last 30 days of life, as compared to 30% in the control group.

The investigators expect that the intervention evaluated in this study will reduce the rate of patients receiving chemotherapy during the last 30 days of life hopefully improving the quality of end of life care. A secondary objective is overall survival and this study will therefore verify that the intervention arm is not associated with poorer overall survival. But more probably investigators expect patients in the intervention arm to have an improved overall survival mainly link to a decrease in harms due to chemotherapy given near the end of life and to better palliative care. In effect the hypothesis is that showing the life-threatening risks associated with chemotherapy and thus reducing for patients the importance of this treatment will leave room for improved palliative care as shown notably by earlier and more frequent referral to palliative care specialists. If this trial is positive, it will prove the capital role of patient-doctor communication in cancer care and that few differences in communication strategy could improve end of life care and maybe even survival. The impact on the oncology community would be major since the intervention could be easily transposed in all practices at no additional cost. It would also emphasize the importance of communication skills and human relationship in the very technical field of medical oncology.

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Behavioral


lead_sponsor: University Hospital, Lille

acronym: MesoPDT

title: Pilot Study of the Feasibility of Intrapleural Photodynamic Therapy in a Multimodal Treatment Combining Extended Pleurectomy/Decortication, Adjuvant Chemotherapy and Prophylactic Radiotherapy in Patients With Malignant Pleural Mesothelioma

summary:
Malignant pleural mesothelioma (MPM) is an aggressive tumour with poor prognosis (median survival <13 months), and high resistance to chemotherapy. Extended pleurectomy/decortication (eP/D) is a debulking surgery of MPM but cannot be considered as a curative treatment. Therefore it has been suggested that eP/D may be of interest if combined with intra-operative treatment and adjuvant therapies.

Photodynamic Therapy (PDT) is an innovative treatment based on the rationale that tumour cells, if previously treated with photosensitizing drugs (Photofrin), will die when exposed to light at a particular wavelength. Interestingly PDT might also stimulate anti-tumour immune response through the release of tumour antigens and induced inflammation.

PDT was tested in phase I-II trials for MPM in combination with EPP or eP/D, and chemotherapy. US studies from J Friedberg et al found very promising survival results in MPM when combining eP/D, but not EPP, intra-operative PDT and chemotherapy (cisplatin-pemetrexed), with a median overall survival of 31.7 months.

However, the definitive value of intra-pleural PDT combined to eP/D in the treatment of MPM still need to be validated. The same multimodal treatment has been established in Lille, the French national expert centre for MPM, with the help of our american colleagues. Therefore, this phase II trial proposes to patients to benefit from the combination of eP/D, intra-operative PDT then chemotherapy by cisplatin-pemetrexed and prophylactic radiotherapy.

Primary endpoint is the feasibility for the patients to have the full multimodal treatment of MPM including intrapleural PDT without unacceptable or unexpected grade III-IV toxicities. Secondary endpoints are PFS, OS, ORR, and quality of life. If the feasibility of such treatment would be confirmed in France, a multicentric, randomized trial comparing this experimental treatment vs control arm (same multimodal treatment without PDT) is planned.


title: Medical Students and Psychoactive Substances Use: For Whom to Worry?

acronym: NC

summary:
Medical students are heavy users of psychoactive substances, and even if levels of use vary depending on the universities, the average levels are higher than most other students.

In France, however, the use of licit or illicit substance has not been precisely described in medical students. The aim of this study was therefore to define the different modes of consumption of medical students.

Methods: This study was a cross-sectional survey in medical students from the University of Montpellier, and the investigators performed a cluster analysis of data. Both medical students and residents were included. Socio-demographic, medico-psychological and addictological data were collected.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Montpellier


title: TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study

acronym: TELE-PEACE

summary:
More than 20,000 patients benefit from coronary bypass surgery in France each year. Median discharge without complication is eight days postoperatively, whereas by day four after surgery, hospitalization is only necessary for medical supervision of the occurrence of complications (scar infection, atrial fibrillation, pericardial effusion), waiting for a downstream bed in cardiac rehabilitation.

Some studies have shown the feasibility of a return home from day 4 after CABG in the United States and England under some conditions of selection and monitoring of patients.

However, there is currently no validated telemonitoring tool for patients in early postoperative coronary bypass surgery.

In this pilot study, during hospitalization for early postoperative coronary bypass surgery, a combination of connected devices for the measurement of physiological parameters and for clinical self-evaluation by the patient will be evaluated. The results of this project will be used as a basis for a future larger study in which an early home discharge can be proposed to patients.


title: Impact of the Shape of Plates on the Conservation of Praxis in the Food at the Old Persons Suffering From Severe Insanities of Chap Alzheimer or Mixed in Institution.

acronym: PRAXALIM

summary:
The insanities, priority of public health in 2008, have significant prevalency in Limousin, region in the ageing demography (1/3 of the population is more than 60 years old against 1/5th of average in France). To prevent the lack of therapeutic solutions, for these evolutionary diseases, the new plan Alzheimer 2008-2012 encourages the research.

The insanities deprive gradually the individual of their autonomy, their personality and their identity. The help of an institution is sometimes inevitable. In the middle of this stressful environment, the patient affected by severe insanity, need marks.

The aspect of their old objects, significant for them, has to be prioritized because the institutional universe, often depersonalized doesn't mean anything for them. In front of repeated failures, they're hurt in their self respect.

The prevention of the undernutrition, comes by a preservation of praxis and pleasure at table. The institutional plate used in certain hospital sectors, is unpersonal (rectangular, divided) and can be destabilizing for the mentally ill person.

lead_sponsor: University Hospital, Limoges


title: Analysis of the Specific Onco-geriatric Multidisciplinary Team Meeting (RCP) at E.Herriot Hospital (Hospices Civils de Lyon)

acronym: EROG

summary:
In France, cancer incidence increases over the course of life and therefore it is considered as an important pathology of the elderly. Cancers are the second leading cause of death for patients over 70 years old.

In 2015, 233,343 new cases of cancer were estimated for patients of 65 years and over (60.9% of estimated cancers of all ages), 42,547 new cases for older people over 85 years old (about 11% of all diagnosed cancer cases).

With the expected aging of the population in the coming years, the number of patients over the age of 70 will continue to increase. Life expectancy will also increase (12 years for the people above 75 years old and more than 8 years for the people above 80 years old).

The elderly are a heterogeneous population. Some people age well with few chronic diseases and a preserved autonomy. Others have several pathologies, geriatric syndromes (malnutrition, functional disorders, sensory deficits or psycho-cognitive diseases). Poly-medication is therefore common with an increased risk of iatrogenic disease. All these factors, in addition to social and economic conditions, determine the health status of the elderly. The presence of comorbidities decreases life expectancy and may itself be a contraindication to treatment. Patients in this age group are therefore particularly exposed to the risks of over- or under-treatment.

The multidisciplinary team meeting (RCP) is widely used for decision making in oncology. Various official texts govern it (Plan Cancer, HAS). However, the onco-geriatric decision is usually only a complementary opinion after a RCP of a specific organ.

Since 2006, the E. Herriot Hospital's Multidisciplinary team meeting has been organized to discuss cases of patients over 70 years old. The specificity is the association of a real multidisciplinary geriatric oncology discussion. The latter between medical specialist : geriatrician, oncologist, surgeon, radiotherapist, pharmacist, onco-geriatric nurse allows the development of an appropriate individualized therapeutic project for the patient.

The onco-geriatric multidisciplinary team is implementing a descriptive study of the RCP for the management of patients above 70 with cancer. The Regional Network of Oncology Auvergne-Rhône-Alpes is a partner.

The main aim is to describe the feasibility of the assessment of the follow-up of onco-geriatric recommendations 4 months after the onco-geriatric RCP of E. Herriot Hospital concerning patients with or with suspicion of cancer.

The secondary aims are : 1/ To describe the process of RCP: participants, patient's characteristics and conclusions with recommendations, 2/ To assess the implementation of oncological and geriatric recommendations 4 months after RCP 3/ To assess the survival, autonomy and quality of life of patients 4 months after RCP.

The hypothesis is that onco-geriatric RCP's recommendations improve the outcome for the patient.

The purpose of this pilot study is to ensure that the assessment of the recommendations' follow-up at 4 months is feasible.

lead_sponsor: Hospices Civils de Lyon

location_facility: Médecine Gériatrique/équipe mobile de gériatrie - Hôpital Edouard Herriot

location_facility: Oncologie radiothérapie - Hôpital Privé Jean Mermoz Ramsay Général de Santé Lyon


title: Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection

acronym: ImmuCoV

summary:
The SARS-CoV-2 (COVID-19) infection is causing a global pandemic and a major health crisis in France.

Immunity is the body's ability to defend itself against infectious agents such as viruses. The progressive acquisition by a large part of the population of immunity to defend itself against the COVID-19 virus is one of the main mechanisms by which a resolution of this pandemic is hoped for. Recovery from infection and protection from the virus is likely to depend on the development of antibodies (proteins produced by the body to neutralize infectious agents) and T-cells (a type of white blood cell in the immune system) that can stop the virus from multiplying and killing it.

To date, the way and speed at which the T-lymphocytes active against the virus appear are not known. The development of biological tests to detect T-cells active against the virus in the blood of infected patients is therefore necessary.

In this context, we propose you to participate in a study that will study the immune system's response against the sars-CoV-2 virus during and after COVID-19 infection.

lead_sponsor: University Hospital, Rouen


title: Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve: a Single-center Prospective Study

summary:
Objectives:

This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.

Methods:

All consecutive patients who underwent an aortic valve replacement with an Edwards Intuity TM bioprosthesis at La Timone Hospital, Marseille, France, were prospectively included between July 2012 and June 2015 and were followed for 5 years. The primary outcome was overall mortality at 5 years.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Neuro-anatomical Correlates on Volumetric MRI on the Impact of Brain Reserve and Cognitive Reserve on Ischemic Strokes in Elderly

acronym: BCN

summary:
Ischemic strokes are one of the leading causes of handicap and death in elderly people in France.

Cognitive reserve (CR) is an active model, defined as a function of lifetime intellectual activities and other environmental factors that explain differential susceptibility to functional impairment in the presence of pathology or other neurological insult. CR is estimated using variables for cognitive activity: years of education, professional status, socioeconomic status… Furthermore, brain reverse (BR) is a passive and quantitative model that depend on brain size and other quantitative aspects of the brain that explain differential susceptibility to functional impairment in the presence of pathology.

Firstly, volume and localization of ischemic strokes have a great impact on CR and BR due to brain injury. On the other hand, CR influences the severity and the expression of cognitive diseases.

The investigators realize a prospective study in order to assess the impact of CR and BR on cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.


title: Evaluating the Link Between Active Neovascularization Found on OCT and Eye Fixation Quality Measured With Microperimetry in ARMD Patients Treated With antiVEGF

acronym: CORFI

summary:
ARMD is the main cause of visual disability after 50 years old in France. Patients with active neovascular ARMD are treated with intravitreal injections of antiVEGF. Reinjections criteria are decrease of best corrected visual acuity or active neovascularization's signs (mostly found on macular OCT but also on angiography when necessary).

The aim of this study is to evaluate the link between active neovascularization found on OCT and eye fixation quality measured with microperimetry in ARMD patients treated with antiVEGF.

Quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up for each patient. The mean central retinal sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will also be gathered.

In case no link will be found, for instance bad fixation quality without exudative signs on OCT or good fixation stability despite exudative signs on OCT, microperimetry should have an interest to improve reinjections criteria with a treatment more suitable to the patient.


title: Efficacy of PRADO Heart Failure in Occitania

acronym: PRADO-IC

summary:
Patients with heart failure (IC), after hospitalization, have a marked fragility: in France, in the first year, 29% die and 45% are readmitted to IC. Interventions improving the coordination of care providers at the time of discharge from hospitalization were tested; they showed a reduction in readmissions for IC (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87). The Patient Return Program IC (PRADO IC), set up by the Health Insurance, offers assistance in the initiation of outpatient medical monitoring, and a nursing follow-up of 2 to 6 months depending on the patient's severity. The trial of PRADO began in the second half of 2013, and the first evaluation showed that the time to first treatment was significantly shorter, and that the readmissions rate and the 6-month death rate were unchanged.

This study was of epidemiological type, comparative before-elsewhere. The difficulty of controlling for confounders in this type of study limits the scope of these conclusions. The efficacy hypothesis of PRADO IC is therefore always posed in the French context


title: BIOREN (Predictive BIOmarkers in Metastatic RENal Cancer) - A Translational Study on Immunotherapy for Metastatic Renal Cancer

acronym: BIOREN

summary: The BIOREN project aims are to characterize the genetic background of renal cell carcinomas and their immune environment, to try and identify biomarkers of response and to better understand the mechanisms of resistance to nivolumab in renal cancer.

lead_sponsor: Centre Leon Berard