title: Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).

acronym: DIAPASON

summary: The aim of the project is to evaluate the efficacy of a web-based psycho-educational programme designed to support informal caregivers of patients with Alzheimer's disease (AD).This program focuses on information about the illness, her progression, how to prevent psychological strain using anticipation and relaxation techniques and providing a virtual space (forum) to discuss with other caregivers.

primary_purpose: Supportive Care

ReferenceCitation: Ankri J, Andrieu S, Beaufils B, Grand A, Henrard JC. Beyond the global score of the Zarit Burden Interview: useful dimensions for clinicians. Int J Geriatr Psychiatry. 2005 Mar;20(3):254-60.

ReferenceCitation: Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. Review.

ReferenceCitation: Bourgeois MS, Schulz R, Burgio L. Interventions for caregivers of patients with Alzheimer's disease: a review and analysis of content, process, and outcomes. Int J Aging Hum Dev. 1996;43(1):35-92. Review.

ReferenceCitation: Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia. J Am Geriatr Soc. 2003 May;51(5):657-64.

ReferenceCitation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96.

ReferenceCitation: Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14.

ReferenceCitation: Eisdorfer C, Czaja SJ, Loewenstein DA, Rubert MP, Argüelles S, Mitrani VB, Szapocznik J. The effect of a family therapy and technology-based intervention on caregiver depression. Gerontologist. 2003 Aug;43(4):521-31.

ReferenceCitation: Gallagher-Thompson D, Coon DW. Evidence-based psychological treatments for distress in family caregivers of older adults. Psychol Aging. 2007 Mar;22(1):37-51. Review.

ReferenceCitation: Gottlieb BH, Wolfe J. Coping with family caregiving to persons with dementia: a critical review. Aging Ment Health. 2002 Nov;6(4):325-42. Review.

ReferenceCitation: Livingston G, Manela M, Katona C. Depression and other psychiatric morbidity in carers of elderly people living at home. BMJ. 1996 Jan 20;312(7024):153-6.

ReferenceCitation: Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. Mental and behavioral disturbances in dementia: findings from the Cache County Study on Memory in Aging. Am J Psychiatry. 2000 May;157(5):708-14.

ReferenceCitation: McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44.

ReferenceCitation: Mahoney DF, Tarlow BJ, Jones RN. Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study. Gerontologist. 2003 Aug;43(4):556-67.

ReferenceCitation: Magnusson L, Hanson E, Brito L, Berthold H, Chambers M, Daly T. Supporting family carers through the use of information and communication technology--the EU project ACTION. Int J Nurs Stud. 2002 May;39(4):369-81. Review.

ReferenceCitation: Mittelman MS, Roth DL, Haley WE, Zarit SH. Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: results of a randomized trial. J Gerontol B Psychol Sci Soc Sci. 2004 Jan;59(1):P27-34.

ReferenceCitation: Moniz-Cook E, Vernooij-Dassen M, Woods R, Verhey F, Chattat R, De Vugt M, Mountain G, O'Connell M, Harrison J, Vasse E, Dröes RM, Orrell M; INTERDEM group. A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health. 2008 Jan;12(1):14-29. doi: 10.1080/13607860801919850.

ReferenceCitation: Ramaroson H, Helmer C, Barberger-Gateau P, Letenneur L, Dartigues JF; PAQUID. [Prevalence of dementia and Alzheimer's disease among subjects aged 75 years or over: updated results of the PAQUID cohort]. Rev Neurol (Paris). 2003 Apr;159(4):405-11. French.

ReferenceCitation: Schulz R, O'Brien AT, Bookwala J, Fleissner K. Psychiatric and physical morbidity effects of dementia caregiving: prevalence, correlates, and causes. Gerontologist. 1995 Dec;35(6):771-91. Review.

ReferenceCitation: Schulz R, Beach SR. Caregiving as a risk factor for mortality: the Caregiver Health Effects Study. JAMA. 1999 Dec 15;282(23):2215-9.

ReferenceCitation: Schulz R, Martire LM, Klinger JN. Evidence-based caregiver interventions in geriatric psychiatry. Psychiatr Clin North Am. 2005 Dec;28(4):1007-38, x. Review.

ReferenceCitation: Sörensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002 Jun;42(3):356-72. Review.

ReferenceCitation: Teri L. Behavior and caregiver burden: behavioral problems in patients with Alzheimer disease and its association with caregiver distress. Alzheimer Dis Assoc Disord. 1997;11 Suppl 4:S35-8. Review.

ReferenceCitation: Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. Review.

ReferenceCitation: Yesavage JA. Geriatric depression scale: consistency of depressive symptoms over time. Percept Mot Skills. 1991 Dec;73(3 Pt 1):1032.

ReferenceCitation: Zarit SH, Todd PA, Zarit JM. Subjective burden of husbands and wives as caregivers: a longitudinal study. Gerontologist. 1986 Jun;26(3):260-6.

ReferenceCitation: González-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozúa B, Solà I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1:CD006440. doi: 10.1002/14651858.CD006440.pub3.

name: Department of Health; International University of La Rioja; Logroño Spain

family: González-Fraile

full_name: Eduardo González-Fraile

given: Eduardo

name: Department of Neuroscience; University of the Basque Country, CIBER Salud Mental (CIBERSAM); Leioa Spain

family: Ballesteros

full_name: Javier Ballesteros

given: Javier

name: Department of Preventive Medicine and Public Health; University of the Basque Country; Leioa Spain

family: Rueda

full_name: José-Ramón Rueda

given: José-Ramón

name: Scientific coordination Unit; Biocruces Health Research Institute, Cruces University Hospital; Barakaldo Spain

family: Santos-Zorrozúa

full_name: Borja Santos-Zorrozúa

given: Borja

name: Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau); CIBER Epidemiología y Salud Pública (CIBERESP); Barcelona Spain

family: Solà

full_name: Ivan Solà

given: Ivan

name: Oxford Health NHS Foundation Trust; Banbury UK

family: McCleery

full_name: Jenny McCleery

given: Jenny

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Cristancho-Lacroix V, Wrobel J, Cantegreil-Kallen I, Dub T, Rouquette A, Rigaud AS. A web-based psychoeducational program for informal caregivers of patients with Alzheimer's disease: a pilot randomized controlled trial. J Med Internet Res. 2015 May 12;17(5):e117. doi: 10.2196/jmir.3717.

family: Cristancho-Lacroix

full_name: Victoria Cristancho-Lacroix

given: Victoria

family: Wrobel

full_name: Jérémy Wrobel

given: Jérémy

family: Cantegreil-Kallen

full_name: Inge Cantegreil-Kallen

given: Inge

family: Dub

full_name: Timothée Dub

given: Timothée

family: Rouquette

full_name: Alexandra Rouquette

given: Alexandra

family: Rigaud

full_name: Anne-Sophie Rigaud

given: Anne-Sophie

journal_name: Journal of Medical Internet Research

title: A Web-Based Psychoeducational Program for Informal Caregivers of Patients With Alzheimer’s Disease: A Pilot Randomized Controlled Trial

ReferenceCitation: Cristancho-Lacroix V, Kerhervé H, de Rotrou J, Rouquette A, Legouverneur G, Rigaud AS. Evaluating the efficacy of a web-based program (diapason) for informal caregivers of patients with Alzheimer's disease: protocol for a randomized clinical trial. JMIR Res Protoc. 2013 Dec 6;2(2):e55. doi: 10.2196/resprot.2978.

title: Evaluating the Efficacy of a Web-Based Program (Diapason) for Informal Caregivers of Patients With Alzheimer’s Disease: Protocol for a Randomized Clinical Trial

location_facility: Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic


type: Registry Identifier

title: Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease: T2* Measurement in the Cortex and the Basal Ganglia

summary: Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing neuronal activations during motor or cognitive tasks. The MRI sequences used are currently optimized for the study of cortex activations, particularly concerning the echo time (TE).Very few studies are interested in optimizing the fMRI for the study of the basal ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The T2 * is a tissue parameter dependent of iron content, which differs with brain structures and probably also with age and in case of neurodegenerative disease. Optimal TE s should correspond to the T2 * of studied brain structure The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Pilot Study of Feasibility of the Effect of Treatment With tDCS in Patients Suffering From Resistant Depression

acronym: DEPRESCO

summary: The purpose of the study is to investigate the effect of tDCS applied at the anodic left DLPFC of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in resistant depression.

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Bennabi D, Nicolier M, Monnin J, Tio G, Pazart L, Vandel P, Haffen E. Pilot study of feasibility of the effect of treatment with tDCS in patients suffering from treatment-resistant depression treated with escitalopram. Clin Neurophysiol. 2015 Jun;126(6):1185-1189. doi: 10.1016/j.clinph.2014.09.026. Epub 2014 Oct 5.

family: Bennabi

full_name: D. Bennabi

given: D.

sequence: first

family: Nicolier

full_name: M. Nicolier

given: M.

sequence: additional

family: Monnin

full_name: J. Monnin

given: J.

family: Tio

full_name: G. Tio

given: G.

family: Pazart

full_name: L. Pazart

given: L.

family: Vandel

full_name: P. Vandel

given: P.

family: Haffen

full_name: E. Haffen

given: E.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Neurophysiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: CHU Besancon - Clinical Psychaitric Department


type: EudraCT Number

title: Single Dose Comparison of 3 Doses of Olodaterol in Double Fixed Dose Combination With BI54903 vs. 3 Doses of Olodaterol Mono in Free Combination

summary: The aim of the study is to establish the olodaterol dose in the ethanolic fixed dose combination (FDC) with BI 54903 which is equivalent in bronchodilator effect and systemic exposure to the 5 µg olodaterol reference dose in the aqueous inhalation solution (AIS).

status: Withdrawn

lead_sponsor: Boehringer Ingelheim

location_facility: 1249.7.33003 Boehringer Ingelheim Investigational Site

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Prospective Epidemiological Research on Functioning Outcomes Related to Major Depressive Disorder

acronym: PERFORM

summary: The purpose of this study is to describe patient functioning and examine associations between depressive symptoms and measures of the various roles of functioning.

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Haro JM, Hammer-Helmich L, Saragoussi D, Ettrup A, Larsen KG. Patient-reported depression severity and cognitive symptoms as determinants of functioning in patients with major depressive disorder: a secondary analysis of the 2-year prospective PERFORM study. Neuropsychiatr Dis Treat. 2019 Aug 13;15:2313-2323. doi: 10.2147/NDT.S206825. eCollection 2019.

family: Haro

full_name: Josep Maria Haro

given: Josep Maria

family: Hammer-Helmich

full_name: Lene Hammer-Helmich

given: Lene

family: Saragoussi

full_name: Delphine Saragoussi

given: Delphine

family: Ettrup

full_name: Anders Ettrup

given: Anders

family: Larsen

full_name: Klaus Groes Larsen

given: Klaus Groes

currency_apc_doaj: USD

journal_name: Neuropsychiatric Disease and Treatment

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Haro JM, Lamy FX, Jönsson B, Knapp M, Brignone M, Caillou H, Chalem Y, Hammer-Helmich L, Rive B, Saragoussi D. Characteristics of patients with depression initiating or switching antidepressant treatment: baseline analyses of the PERFORM cohort study. BMC Psychiatry. 2018 Mar 27;18(1):80. doi: 10.1186/s12888-018-1657-3.

family: Lamy

full_name: François-Xavier Lamy

given: François-Xavier

family: Jönsson

full_name: Bengt Jönsson

given: Bengt

family: Knapp

full_name: Martin Knapp

given: Martin

family: Brignone

full_name: Mélanie Brignone

given: Mélanie

family: Caillou

full_name: Hugo Caillou

given: Hugo

family: Chalem

full_name: Ylana Chalem

given: Ylana

family: Rive

full_name: Benoît Rive

given: Benoît

currency_apc_doaj: GBP

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: London School of Economics and Political Science - London School of Economics and Political Science Research Online


title: The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient

acronym: EP46 NOVAA

summary:
Main objective :

To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative individuals who had not been given YFV before.

Secondary objectives :

To develop and assess ELISPOT technology for yellow fever and to measure the response within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia and (5) diversity of viral quasi-species.
To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and viral load.

primary_purpose: Prevention

ReferenceCitation: Colin de Verdiere N, Durier C, Samri A, Meiffredy V, Launay O, Matheron S, Mercier-Delarue S, Even S, Aboulker JP, Molina JM, Autran B, Simon F; ANRS EP46 NOVAA Group. Immunogenicity and safety of yellow fever vaccine in HIV-1-infected patients. AIDS. 2018 Oct 23;32(16):2291-2299. doi: 10.1097/QAD.0000000000001963.

family: Colin de Verdiere

full_name: Nathalie Colin de Verdiere

given: Nathalie

family: Durier

full_name: Christine Durier

given: Christine

family: Samri

full_name: Assia Samri

given: Assia

family: Meiffredy

full_name: Vincent Meiffredy

given: Vincent

family: Launay

full_name: Odile Launay

given: Odile

family: Matheron

full_name: Sophie Matheron

given: Sophie

family: Mercier-Delarue

full_name: Séverine Mercier-Delarue

given: Séverine

family: Even

full_name: Sophie Even

family: Aboulker

full_name: Jean-Pierre Aboulker

given: Jean-Pierre

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Autran

full_name: Brigitte Autran

given: Brigitte

family: Simon

full_name: François Simon

given: François

journal_name: AIDS

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

intervention_type: Biological


title: Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

summary:
Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode.

The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA.

ReferenceCitation: Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.

family: Bertrand

full_name: Pierre-Marie Bertrand

given: Pierre-Marie

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Coisel

full_name: Yannael Coisel

given: Yannael

family: Matecki

full_name: Stefan Matecki

given: Stefan

family: Jaber

full_name: Samir Jaber

given: Samir

family: Constantin

full_name: Jean-Michel Constantin

journal_name: Chest

oa_host_type: repository

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

repository_normalized: HAL

title: Neurally Adjusted Ventilatory Assist vs Pressure Support Ventilation for Noninvasive Ventilation During Acute Respiratory Failure


title: Respiratory Outcome at Adolescence of Very Low Birthweight Infants : the EPIPAGE Cohort

acronym: EPIPAGEADO

summary: EPIPAGEADO is an observational study. Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.

ReferenceCitation: Hadchouel A, Rousseau J, Rozé JC, Arnaud C, Bellino A, Couderc L, Marret S, Mittaine M, Pinquier D, Verstraete M, Ancel PY, Delacourt C; EPIPAGEADO study group. Association between asthma and lung function in adolescents born very preterm: results of the EPIPAGE cohort study. Thorax. 2018 Dec;73(12):1174-1176. doi: 10.1136/thoraxjnl-2017-211115. Epub 2018 Mar 31.

family: Hadchouel

full_name: Alice Hadchouel

given: Alice

family: Rousseau

full_name: Jessica Rousseau

given: Jessica

family: Rozé

full_name: Jean-Christophe Rozé

given: Jean-Christophe

family: Arnaud

full_name: Catherine Arnaud

given: Catherine

family: Bellino

full_name: Adèle Bellino

given: Adèle

family: Couderc

full_name: Laure Couderc

given: Laure

family: Marret

full_name: Stéphane Marret

given: Stéphane

family: Mittaine

full_name: Marie Mittaine

given: Marie

family: Pinquier

full_name: Didier Pinquier

given: Didier

family: Verstraete

full_name: Marie Verstraete

family: Ancel

full_name: Pierre-Yves Ancel

given: Pierre-Yves

family: Delacourt

full_name: Christophe Delacourt

given: Christophe

journal_name: Thorax

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other


title: Safety of a Maintenance Therapy With Lenalidomide After Reduced-intensity Allogeneic Stem Cell Transplantation for Chemosensitive Relapsed Multiple Myeloma

acronym: REVALLO

summary: Allogeneic stem cell transplantation (Allo-SCT) in multiple myeloma (MM) remains a controversial topic because of a high risk of relapse and a significant transplant-related mortality (TRM). In an effort to reduce the TRM, most allogeneic transplants in MM are now performed after reduced-intensity conditioning regimens. In these conditions, TRM usually range from 10 to 20%. However, reducing the intensity of the conditioning invariably increases the incidence of relapse to 45 to 60%. As a consequence, post-transplant strategies to reduce the incidence of relapse after reduced-intensity Allo-SCT should be considered and evaluated.

lead_sponsor: University Hospital, Bordeaux

intervention_type: Drug


title: Phase II Pilot Study Evaluating the Efficacy of Dual Therapy With Raltegravir Plus Maraviroc in Patients Receiving Suppressive Antiretroviral Therapy and Presenting With Lipohypertrophy (ANRS 157 ROCnRAL).

acronym: ROCnRAL

summary: Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.

status: Terminated

ReferenceCitation: Soulié C, Assoumou L, Darty M, Rodriguez C, Donati F, Sayon S, Peytavin G, Valantin MA, Caby F, Schneider L, Canestri A, Costagliola D, Katlama C, Calvez V, Marcelin AG; ROCnRAL ANRS-157 Study Group. Virological factors associated with outcome of dual maraviroc/raltegravir therapy (ANRS-157 trial). J Antimicrob Chemother. 2015 Dec;70(12):3339-44. doi: 10.1093/jac/dkv280. Epub 2015 Sep 22.

name: Sorbonne Universités, UPMC Université Paris 06, INSERM, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), F-75013 Paris, France

name: AP-HP, Groupe hospitalier Pitié Salpêtrière, Laboratoire de Virologie, Paris F-75013, France

family: Soulié

full_name: Cathia Soulié

given: Cathia

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

name: National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Hôpital Henri Mondor, Université Paris-Est, Créteil, France

family: Darty

full_name: Mélanie Darty

given: Mélanie

family: Rodriguez

full_name: Christophe Rodriguez

family: Donati

full_name: Flora Donati

given: Flora

family: Sayon

full_name: Sophie Sayon

given: Sophie

name: IAME, UMR 1137, Univ Paris Diderot, Sorbonne Paris Cité, INSERM, F-75018 Paris, France

name: AP-HP, Hôpital Bichat, Laboratoire de Pharmacologie, F-75018 Paris, France

family: Peytavin

full_name: Gilles Peytavin

given: Gilles

name: AP-HP, Groupe hospitalier Pitié Salpêtrière, Service de maladies infectieuses, F-75013 Paris, France

family: Valantin

full_name: Marc-Antoine Valantin

given: Marc-Antoine

family: Caby

full_name: Fabienne Caby

given: Fabienne

family: Schneider

full_name: Luminita Schneider

given: Luminita

name: AP-HP, Hôpital Kremlin-Bicêtre, Service de maladies infectieuses, F-94270 Kremlin-Bicêtre, France

family: Canestri

full_name: Ana Canestri

given: Ana

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

family: Katlama

full_name: Christine Katlama

given: Christine

family: Calvez

full_name: Vincent Calvez

given: Vincent

family: Marcelin

full_name: Anne-Geneviève Marcelin

given: Anne-Geneviève

full_name: C. Katlama

given: C.

family: Simon

full_name: A. Simon

given: A.

full_name: M.-A. Valantin

full_name: L. Assoumou

given: L.

full_name: D. Costagliola

given: D.

full_name: C. Soulié

full_name: V. Calvez

given: V.

full_name: A.-G. Marcelin

full_name: G. Peytavin

name: on behalf of the ROCnRAL ANRS-157 Study Group

ReferenceCitation: Katlama C, Assoumou L, Valantin MA, Soulié C, Duvivier C, Chablais L, Kolta S, Pialoux G, Mercié P, Simon A, Costagliola D, Peytavin G, Marcelin AG; ROCnRAL ANRS 157 Study Group. Maraviroc plus raltegravir failed to maintain virological suppression in HIV-infected patients with lipohypertrophy: results from the ROCnRAL ANRS 157 study. J Antimicrob Chemother. 2014 Jun;69(6):1648-52. doi: 10.1093/jac/dkt536. Epub 2014 Feb 16.

name: on behalf of the ROCnRAL ANRS 157 Study Group


type: Other Identifier

title: Is a Low Salt Diet and Low Sugar Content Necessary When Corticosteroid Treatment is Prescribed?

acronym: Cortisel

summary:
Few recommendations concerning the diet and dosage to be administered to patients treated with corticosteroids are established.

It therefore seems important to study prospectively the indication of a diet low in salt and sugar in patients undergoing corticosteroid therapy, to record side effects observed and to measure their frequency.


title: Evaluation of Bevacizumab Combined With First Line Chemotherapy in Patients Aged 75 and Over Suffering From Metastatic Colorectal Adenocarcinoma. Phase II Randomized - Intergroup Trial: FFCD, FNCLCC, GERICO

summary:
RATIONALE: Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bevacizumab together with combination chemotherapy may be a better way to block tumor growth. It is not yet known whether combination chemotherapy is more effective when given together with or without bevacizumab in treating patients with colorectal cancer.

PURPOSE: This randomized phase II trial is studying the side effects of giving bevacizumab together with first-line chemotherapy and to see how well it works in treating older patients with metastatic colorectal cancer.

ReferenceCitation: Aparicio T, Bouché O, Taieb J, Maillard E, Kirscher S, Etienne PL, Faroux R, Khemissa Akouz F, El Hajbi F, Locher C, Rinaldi Y, Lecomte T, Lavau-Denes S, Baconnier M, Oden-Gangloff A, Genet D, Paillaud E, Retornaz F, François E, Bedenne L; for PRODIGE 20 Investigators. Bevacizumab+chemotherapy versus chemotherapy alone in elderly patients with untreated metastatic colorectal cancer: a randomized phase II trial-PRODIGE 20 study results. Ann Oncol. 2018 Nov 1;29(11):2270. doi: 10.1093/annonc/mdx808.

family: Aparicio

full_name: T. Aparicio

given: T.

family: Bouché

full_name: O. Bouché

given: O.

family: Taieb

full_name: J. Taieb

given: J.

family: Maillard

full_name: E. Maillard

given: E.

family: Kirscher

full_name: S. Kirscher

given: S.

family: Etienne

full_name: P -L Etienne

given: P -L

family: Faroux

full_name: R. Faroux

given: R.

family: Khemissa Akouz

full_name: F. Khemissa Akouz

given: F.

family: El Hajbi

full_name: F. El Hajbi

family: Locher

full_name: C. Locher

family: Rinaldi

full_name: Y. Rinaldi

given: Y.

family: Lecomte

full_name: T. Lecomte

family: Lavau-Denes

full_name: S. Lavau-Denes

family: Baconnier

full_name: M. Baconnier

given: M.

family: Oden-Gangloff

full_name: A. Oden-Gangloff

family: Genet

full_name: D. Genet

family: Paillaud

full_name: E. Paillaud

family: Retornaz

full_name: F. Retornaz

family: François

full_name: E. François

family: Bedenne

full_name: L. Bedenne

journal_name: Annals of Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

license: elsevier-specific: oa user license

title: Corrections to “Bevacizumab+chemotherapy versus chemotherapy alone in elderly patients with untreated metastatic colorectal cancer: a randomized phase II trial—PRODIGE 20 study results”

lead_sponsor: Federation Francophone de Cancerologie Digestive


title: Pharmacogenetics of Gemcitabine: Study of the Impact of Genetic Polymorphism of Cytidine Deaminase (CDA) on Toxicity in Resected Pancreatic Adenocarcinomas

summary:
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying gemcitabine hydrochloride in treating patients with pancreatic cancer that has been removed by surgery.

ReferenceCitation: Serdjebi C, Gagnière J, Desramé J, Fein F, Guimbaud R, François E, André T, Seitz JF, Montérymard C, Arsene D, Volet J, Abakar-Mahamat A, Lecomte T, Guerin-Meyer V, Legoux JL, Deplanque G, Guillet P, Ciccolini J, Lepage C, Dahan L. FFCD-1004 Clinical Trial: Impact of Cytidine Deaminase Activity on Clinical Outcome in Gemcitabine-Monotherapy Treated Patients. PLoS One. 2015 Aug 26;10(8):e0135907. doi: 10.1371/journal.pone.0135907. eCollection 2015.

family: Serdjebi

full_name: Cindy Serdjebi

given: Cindy

family: Gagnière

full_name: Johan Gagnière

given: Johan

family: Desramé

full_name: Jérôme Desramé

given: Jérôme

family: Fein

full_name: Francine Fein

given: Francine

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

full_name: Eric François

given: Eric

family: André

full_name: Thierry André

given: Thierry

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

family: Montérymard

full_name: Carole Montérymard

given: Carole

family: Arsene

full_name: Dominique Arsene

given: Dominique

family: Volet

full_name: Julien Volet

given: Julien

family: Abakar-Mahamat

full_name: Abakar Abakar-Mahamat

given: Abakar

full_name: Thierry Lecomte

family: Guerin-Meyer

full_name: Véronique Guerin-Meyer

given: Véronique

family: Legoux

full_name: Jean-Louis Legoux

given: Jean-Louis

family: Deplanque

full_name: Gaël Deplanque

given: Gaël

family: Guillet

full_name: Pierre Guillet

given: Pierre

family: Ciccolini

full_name: Joseph Ciccolini

given: Joseph

family: Lepage

full_name: Côme Lepage

given: Côme

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

journal_name: PLOS ONE

license: cc-by

license_normalized: cc-by

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org


title: Implanted Functional Electrical Stimulation of the Levators of the Ankle Versus Orthosis in the Treatment of Chronic Foot Neurological STEPPAGE-gait by Central Attack

acronym: STEPSTIM

summary:
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.

The aim of this study is to compare the results of the implementation of an implanted stimulator in the levator muscles of the foot to the results obtained by wearing a splint-type reliever, which is considered standard treatment, in order to determine if the implanted stimulation may be proposed in the treatment of foot drop off a neurological center.


title: Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre

summary:
The objective of this study is to uncover the prevalence of vulnerability among patients aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the short screening test Vulnerable Elders Survey 13 (VES-13).

The objective is to better understand the value of routine screening of patients before the consultation, it was proposed as a secondary objective of this study to assess the correlation between the identification of the vulnerability in the screening test VES-13 and the identification made by the clinician during the consultation. The correlation between VES-13 and opinion of the clinician for three categories of patients (self - intermediate - fragile) will also be studied.

lead_sponsor: Centre Oscar Lambret


title: Interest of Calcineurin Activity for the Therapeutic Tacrolimus Monitoring in Renal Recipients

summary: The purpose is to define if calcineurin activity is a better biological parameter than blood concentration for the therapeutic tacrolimus monitoring.


title: EVALUATION DU RISQUE RESIDUEL DE TRANSMISSION DU VIH CHEZ DES HSH TRAITES AYANT UNE CHARGE VIRALE PLASMATIQUE INDETECTABLE

acronym: EP 49 EVARIST

summary:
The main objective of this one year multidisciplinary research is to estimate the frequency of seropositive men having sex with men (MSM) under antiretroviral therapy (ART) having an undetectable blood viral load (VL) and a detectable VL in semen.

Design: Participants'inclusion (n=150) will be done in 6 HIV hospital departments participating to the research project. To warrant feasibility and diversity of participants needed, the centers will be located in Paris and nearby suburbs. The study design is based on one blood and semen sample taken at day 0 and at day 30. Blood and semen samples will be taken in the enrolment centers. Biological and virological analyses will be performed by the laboratory of microbiology at Necker hospital, on blood and semen samples. Pharmacological analyses are planned in a subsequent study. Socio-behavioral data will be collected through a self-administered questionnaire at day 0 and day 30.

Schedule: Patients' enrolment, collection of biological samples and questionnaires will last 10 months (end of first quarter 2012). Biological and virological analyses will be performed until the end of the first semester 2012. Quantitative and socio-behavioral data will be analyzed during the third quarter 2012. Results will be released at the beginning of year 2013.


title: A Single Arm, Multicenter Phase II a Trial of RAD001 as Monotherapy in the Treatment of Neurofibromatosis 1 Related Internal Plexiform Neurofibromas That Cannot be Removed by Surgery

acronym: NFitor

summary:
Background:

Patients with the genetic disorder neurofibromatosis Type 1 (NF1) are at increased risk of developing tumors of the central and peripheral nervous system. These include plexiform neurofibromas. The conventional treatment of these internal plexiform neurofibromas is surgery. This surgery can be possible on a single and limited tumor. On the other hand these tumors are often surgically intractable due to their multiplicity and their infiltrating characteristics Increased activity of mammalian target of rapamycin(mTOR) protein is seen in neurofibromas. mTOR inhibitor rapamycin , or its derivatives such as everolimus may slow or stop tumor growth in patients with NF1.

Objectives:

Primary objectives To determine whether everolimus has an effect on the volume of surgically intractable and life-threatening internal plexiform neurofibromas in patients with neurofibromatosis 1.

Secondary objectives To determine whether everolimus has an effect on the number and the volume of cutaneous neurofibromas; to determine whether everolimus modify the signaling pathways in cutaneous neurofibromas.

Eligibility:

- Adults with neurofibromatosis type 1 with at least one internal plexiform neurofibroma, life-threatening or causing significant morbidity through compression of organs. This or these internal plexiform neurofibroma(s) should be intractable by surgery.

Design:

An open-label, single arm, non-randomized, single stage phase IIa study. Baseline phase: Baseline evaluations will be performed within 2 weeks, and up to a maximum of 4 weeks for specific exams, before the first dose of study drug.

Treatment phase/duration of treatment: All patients will be treated with RAD001 10 mg p.o daily dose for one year except in case of unacceptable toxicity, death, or discontinuation from the study for any other reason.

Follow-up phase: All patients will have two follow-up visits scheduled at 18 and 24 months after the first dose of the study drug to follow for adverse events (AEs) and serious adverse events (SAEs) that may have occurred after discontinuation from the study and for internal plexiform neurofibromas assessment.

Radiological review: All Magnetic Resonance Imaging (MRIs) obtained at baseline, during the treatment period and the follow-up period will be reviewed by the Neuroradiologist of the study.

ReferenceType: background

ReferenceCitation: Bissler JJ, McCormack FX, Young LR, Elwing JM, Chuck G, Leonard JM, Schmithorst VJ, Laor T, Brody AS, Bean J, Salisbury S, Franz DN. Sirolimus for angiomyolipoma in tuberous sclerosis complex or lymphangioleiomyomatosis. N Engl J Med. 2008 Jan 10;358(2):140-51. doi: 10.1056/NEJMoa063564.

ReferenceCitation: Zehou O, Ferkal S, Brugieres P, Barbarot S, Bastuji-Garin S, Combemale P, Valeyrie-Allanore L, Sbidian E, Wolkenstein P. Absence of Efficacy of Everolimus in Neurofibromatosis 1-Related Plexiform Neurofibromas: Results from a Phase 2a Trial. J Invest Dermatol. 2019 Mar;139(3):718-720. doi: 10.1016/j.jid.2018.09.016. Epub 2018 Oct 16.

family: Zehou

full_name: Ouidad Zehou

given: Ouidad

family: Ferkal

full_name: Salah Ferkal

given: Salah

family: Brugieres

full_name: Pierre Brugieres

family: Barbarot

full_name: Sébastien Barbarot

given: Sébastien

family: Bastuji-Garin

full_name: Sylvie Bastuji-Garin

given: Sylvie

family: Combemale

full_name: Patrick Combemale

given: Patrick

family: Valeyrie-Allanore

full_name: Laurence Valeyrie-Allanore

given: Laurence

family: Sbidian

full_name: Emilie Sbidian

given: Emilie

family: Wolkenstein

full_name: Pierre Wolkenstein

journal_name: Journal of Investigative Dermatology

license_normalized: elsevier-specific

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


title: Evaluation of the Response to Irradiation With MR-Spectroscopy for Localised Prostate Cancer Patients (The ERIS Trial)

acronym: ERIS

summary:
Context:

Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men.

After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is often fluctuating and PSA nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation. Moreover, PSA bounces and blips render patients and physicians very anxious about any possibility of a relapse. In this context, biomarkers that could predict the response to radiation earlier than PSA for patients with prostate cancer appear long overdue.

Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines and Citrate within the prostate gland.

Objectives:

The investigators are conducting a French prospective study on the Evaluation of the Response to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early response of radiation with 3D MR Spectroscopy during the first year after completion of radiation and its impact on biochemical control. Therefore, the ERIS trial aims to investigate whether or not there could be a correlation between the time course of PSA and that of Choline and Citrate.

study_start_date_type: Actual

lead_sponsor: Centre Georges Francois Leclerc


title: Prevention of Postsurgical Uterine Synechia With HyalobarrierR Gel Endo in Hysteroscopic Myomectomy : a Prospective Multicenter Study

acronym: HYGEM

summary: The purpose of this study is to evaluate the intrauterine adhesion rate after the application of HYALOBARRIER Gel at the end of hysteroscopic myomectomy. Secondary endpoints were tolerance and side effect and subsequent fertility.

location_facility: Service de Gynecologie-Obstetrique, Hopital Lariboisière


title: Influence of Cardio-ventilatory Factors on Exercise Intolerance in Obese Adolescents: Effects of Exercise Training

acronym: VENTILOBE

summary:
Worldwide, childhood and adolescent obesity has reached epidemic proportions despite major efforts to promote weight reduction. Pediatric obesity commonly presages adult obesity and is associated with the development of weight-related comorbid conditions and increased morbidity.

Regular physical activity is an important modality of obesity management. Despite controversies, poor exercise tolerance has frequently been reported in youth obesity and the cause of this limited exercise tolerance remains unknown. Several factors accompanying obesity may interfere with exercise tolerance in obese populations. Respiratory factors, such as decreased thoracic compliance, increased airway resistance and breathing at low pulmonary volumes are associated with obesity and may impact exercise intolerance in this population. Moreover, even in people with otherwise normal lungs, the normal ventilatory responses to exercise can become constrained in obesity. A thorough understanding of the mechanisms underlying this exercise intolerance remains fundamental in order to favour long term adherence to exercise training. This is especially true in youth populations, in which the management of overweight and obesity must be undertaken as soon as possible, due to the early onset of cardiovascular risk factors.

The main purpose of this study is to determine early-onset cardio-respiratory mortality factors in obese adolescents as well as their relation with exercise intolerance (i.e. dyspnea) when compared with age and gender-paired normal-weight volunteers.

lead_sponsor: University Hospital, Grenoble

intervention_type: Behavioral


title: Cryopreservation of Ovarian Cortex in Girls With Turner Syndrome : Karyotypic, Clinical and Hormonal Criteria to Screen Patients

summary: Ovarian insufficiency is common in Turner syndrome related to premature and rapid follicular apoptosis and spontaneous pregnancies are rare in this population. Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency. This study aims to assess the relevance of ovarian tissue cryopreservation in girls with Turner syndrome. Based on ovarian follicular density as primary outcome and karyotypic, clinical and hormonal markers as secondary outcomes, analysis of the study will allow to select the patients to whom the procedure would benefit the most.

status: Active, not recruiting

study_completion_date_type: Anticipated

intervention_type: Procedure

status_simplified: Ongoing


ReferenceCitation: Cavazzana-Calvo M, Hacein-Bey S, de Saint Basile G, Gross F, Yvon E, Nusbaum P, Selz F, Hue C, Certain S, Casanova JL, Bousso P, Deist FL, Fischer A. Gene therapy of human severe combined immunodeficiency (SCID)-X1 disease. Science. 2000 Apr 28;288(5466):669-72.

ReferenceCitation: Hacein-Bey-Abina S, Le Deist F, Carlier F, Bouneaud C, Hue C, De Villartay JP, Thrasher AJ, Wulffraat N, Sorensen R, Dupuis-Girod S, Fischer A, Davies EG, Kuis W, Leiva L, Cavazzana-Calvo M. Sustained correction of X-linked severe combined immunodeficiency by ex vivo gene therapy. N Engl J Med. 2002 Apr 18;346(16):1185-93.

ReferenceCitation: Hacein-Bey-Abina S, Hauer J, Lim A, Picard C, Wang GP, Berry CC, Martinache C, Rieux-Laucat F, Latour S, Belohradsky BH, Leiva L, Sorensen R, Debré M, Casanova JL, Blanche S, Durandy A, Bushman FD, Fischer A, Cavazzana-Calvo M. Efficacy of gene therapy for X-linked severe combined immunodeficiency. N Engl J Med. 2010 Jul 22;363(4):355-64. doi: 10.1056/NEJMoa1000164.

ReferenceCitation: Hacein-Bey-Abina S, Pai SY, Gaspar HB, Armant M, Berry CC, Blanche S, Bleesing J, Blondeau J, de Boer H, Buckland KF, Caccavelli L, Cros G, De Oliveira S, Fernández KS, Guo D, Harris CE, Hopkins G, Lehmann LE, Lim A, London WB, van der Loo JC, Malani N, Male F, Malik P, Marinovic MA, McNicol AM, Moshous D, Neven B, Oleastro M, Picard C, Ritz J, Rivat C, Schambach A, Shaw KL, Sherman EA, Silberstein LE, Six E, Touzot F, Tsytsykova A, Xu-Bayford J, Baum C, Bushman FD, Fischer A, Kohn DB, Filipovich AH, Notarangelo LD, Cavazzana M, Williams DA, Thrasher AJ. A modified γ-retrovirus vector for X-linked severe combined immunodeficiency. N Engl J Med. 2014 Oct 9;371(15):1407-17. doi: 10.1056/NEJMoa1404588.

family: Hacein-Bey-Abina

full_name: Salima Hacein-Bey-Abina

given: Salima

family: Pai

full_name: Sung-Yun Pai

given: Sung-Yun

family: Gaspar

full_name: H. Bobby Gaspar

given: H. Bobby

family: Armant

full_name: Myriam Armant

given: Myriam

family: Berry

full_name: Charles C. Berry

given: Charles C.

family: Blanche

full_name: Stephane Blanche

given: Stephane

family: Bleesing

full_name: Jack Bleesing

given: Jack

family: Blondeau

full_name: Johanna Blondeau

given: Johanna

family: de Boer

full_name: Helen de Boer

given: Helen

family: Buckland

full_name: Karen F. Buckland

given: Karen F.

family: Caccavelli

full_name: Laure Caccavelli

given: Laure

family: Cros

full_name: Guilhem Cros

given: Guilhem

family: De Oliveira

full_name: Satiro De Oliveira

given: Satiro

family: Fernández

full_name: Karen S. Fernández

given: Karen S.

family: Guo

full_name: Dongjing Guo

given: Dongjing

family: Harris

full_name: Chad E. Harris

given: Chad E.

family: Hopkins

full_name: Gregory Hopkins

given: Gregory

family: Lehmann

full_name: Leslie E. Lehmann

given: Leslie E.

family: Lim

full_name: Annick Lim

given: Annick

family: London

full_name: Wendy B. London

given: Wendy B.

family: van der Loo

full_name: Johannes C.M. van der Loo

given: Johannes C.M.

family: Malani

full_name: Nirav Malani

given: Nirav

family: Male

full_name: Frances Male

given: Frances

family: Malik

full_name: Punam Malik

given: Punam

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

repository_institution: California Digital Library - eScholarship

title: A Modified γ-Retrovirus Vector for X-Linked Severe Combined Immunodeficiency

ReferenceCitation: Clarke EL, Connell AJ, Six E, Kadry NA, Abbas AA, Hwang Y, Everett JK, Hofstaedter CE, Marsh R, Armant M, Kelsen J, Notarangelo LD, Collman RG, Hacein-Bey-Abina S, Kohn DB, Cavazzana M, Fischer A, Williams DA, Pai SY, Bushman FD. T cell dynamics and response of the microbiota after gene therapy to treat X-linked severe combined immunodeficiency. Genome Med. 2018 Sep 28;10(1):70. doi: 10.1186/s13073-018-0580-z.

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

repository_institution: University of California - eScholarship University of California

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

title: Protocol No. 2 of Gene Therapy for X-linked Severe Combined Immunodeficiency (SCID-X1) Using a Self Retroviral Vector - SCID2

summary: X-linked severe combined immunodeficiency (SCID-X1) is an inherited disorder that results in failure of development of the immune system in boys. This trial aims to treat SCID-X1 patients using gene therapy to replace the defective gene.


title: The Impact of Red Packed Cells Transfusion on the Main Biological Markers to Determine the Etiology of Anemias

acronym: BÉA/T

summary: The aim of this work is to study the changes of key assays useful for the understanding of anemia mechanism before and after red packed cells transfusion: iron status, vitamin assays, hemolysis markers.


title: Evaluation d'Une stratégie thérapeutique d'Association médicamenteuse Pour la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées au Stade modéré

acronym: AD-IDEA

summary: The purpose of this study is to compare the effect after 24 weeks of the oral intake of vitamin D3 (cholecalciferol) with the effect of a placebo on the change of cognitive performance in patients suffering from moderate Alzheimer's disease or related disorders (ADRD) and receiving memantine.

ReferenceCitation: Annweiler C, Beauchet O. Possibility of a new anti-alzheimer's disease pharmaceutical composition combining memantine and vitamin D. Drugs Aging. 2012 Feb 1;29(2):81-91. doi: 10.2165/11597550-000000000-00000. Review.

family: Annweiler

full_name: Cédric Annweiler

given: Cédric

family: Beauchet

full_name: Olivier Beauchet

given: Olivier

journal_name: Drugs & Aging

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Possibility of a New Anti-Alzheimerʼs Disease Pharmaceutical Composition Combining Memantine and Vitamin D

ReferenceCitation: Annweiler C, Fantino B, Parot-Schinkel E, Thiery S, Gautier J, Beauchet O. Alzheimer's disease--input of vitamin D with mEmantine assay (AD-IDEA trial): study protocol for a randomized controlled trial. Trials. 2011 Oct 20;12:230. doi: 10.1186/1745-6215-12-230.

family: Fantino

full_name: Bruno Fantino

given: Bruno

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

family: Thiery

full_name: Samuel Thiery

given: Samuel

family: Gautier

full_name: Jennifer Gautier

given: Jennifer

journal_name: Trials

title: Alzheimer's disease - input of vitamin D with mEmantine assay (AD-IDEA trial): study protocol for a randomized controlled trial

lead_sponsor: University Hospital, Angers


title: A Single-Center, Open-Label, Two-Period Crossover Study to Investigate the Effect of Multiple Doses of Activated Charcoal on the Pharmacokinetics of a Single Oral Dose of RO4995819 in Healthy Subjects.

summary: This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.

lead_sponsor: Hoffmann-La Roche


title: Evaluation of the Analgesic Effect of a Prototype Device of Virtual Reality in a Population of Patients With Chronic Low Back Pain. A Randomized Controlled Trial Using a Modified ZELEN Method

acronym: REVLOC

summary: Chronic low back pain and sciatica in adults represent a major medical and economic problem. During the chronic back pain (persisting continuously over 3 months), therapeutic responses to conventional pharmacologic type are often ineffective and the impact of pain is often heavy in terms of disability, social and professional avulsion and loss of quality of life. This failure has led in recent years to propose innovative strategies such as application of relaxation therapy techniques. An example is a virtual reality which is a technology to immerse someone in a 3D virtual environment. Our hypothesis is that the hypnotic suggestion combined with virtual reality can be effective on chronic pain. The main purpose is to measure the impact on the intensity of pain at 4 months after using of a new method for virtual environment, mimicking the colors from low to high frequencies (World Patent Filed, WO2007/057601) in patients with chronic disabling low back pain and sciatica resistant to therapeutic drugs.


title: Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial

acronym: SIGMA

summary:
BACKGROUND: One couple out of 6 consults for infertility during their sexual life. In 60% of cases a male factor is associated or is the main infertility factor. Inflammatory Syndrome (IS), characterized by the presence of a leukocytospermia is found in 12% of the cases. Leukocyte degranulation causes oxidative stress (OS) through the formation of free radicals attacking the sperm cell functions.

HYPOTHESIS: To establish the responsibility of the IS, and OS, in chronicle inflammatory male infertility, the investigators hypothesize that its treatment (as well as its possible cause) must restore or improve the fertilizing capacity of patients sperm.

METHODS: This prospective randomized study will test the response to the treatment. The investigators shall measure cellular degradation products due to the OS, thereby certifying that it does have a deleterious effect on sperm cell. Seminal biochemistry will also assess the impact of the syndrome on the genital tract glands and follow its evolution.

The patients will be included in the study as soon as the leukocytospermia will be > 0,5*106/ml or as soon as the elastase will be > 500 ng/mL.

The examinations will be performed using flow cytometry, CASA (Computer Assisted Semen Analysis). The analysis of sperm morphology will be centralized.

Primary endpoint will be a reduction in the percentage of 8OH-dG below 35 %. We anticipate that it should arrive to 20 % of the patients included in the arm treatment by corticosteroid therapy. All in all will thus be needed 50 patients in the group placebo and 50 in the group treated.

Secondary endpoint the improvement of the spermatic parameters and the reduction of the fragmentation of the DNA of sperm cells to the treated subjects.

All these biological markers will be evaluated 6 month after the treatment:

Fragmentation of the spermatic DNA below 37 % during the follow-up in 6 months
Leukocytospermia and elastase
Seminal biochemistry
Other markers of the inflammatory syndrome and oxidative stress (protein carbonyl, 8OHd-Guanosine)
Possibly the radiological examinations (Ultrasound and MRI of the genital tract)

In addition it would allow us to propose a policy of prevention towards acquired post-infectious male infertility.


title: Interest of Topical Spironolactone's Administration to Prevent Corticoid-induced Epidermal Atrophy

acronym: SPIREPI

summary: The purpose of this study is to determine whether spironolactone could significantly reduce cutaneous atrophy due to corticosteroids.

ReferenceCitation: Farman N, Maubec E, Poeggeler B, Klatte JE, Jaisser F, Paus R. The mineralocorticoid receptor as a novel player in skin biology: beyond the renal horizon? Exp Dermatol. 2010 Feb;19(2):100-7. doi: 10.1111/j.1600-0625.2009.01011.x. Epub 2009 Nov 18. Review.

ReferenceCitation: Bayo P, Sanchis A, Bravo A, Cascallana JL, Buder K, Tuckermann J, Schütz G, Pérez P. Glucocorticoid receptor is required for skin barrier competence. Endocrinology. 2008 Mar;149(3):1377-88. Epub 2007 Nov 26.

ReferenceCitation: Sainte Marie Y, Toulon A, Paus R, Maubec E, Cherfa A, Grossin M, Descamps V, Clemessy M, Gasc JM, Peuchmaur M, Glick A, Farman N, Jaisser F. Targeted skin overexpression of the mineralocorticoid receptor in mice causes epidermal atrophy, premature skin barrier formation, eye abnormalities, and alopecia. Am J Pathol. 2007 Sep;171(3):846-60. Epub 2007 Aug 3.

ReferenceCitation: Stojadinovic O, Lee B, Vouthounis C, Vukelic S, Pastar I, Blumenberg M, Brem H, Tomic-Canic M. Novel genomic effects of glucocorticoids in epidermal keratinocytes: inhibition of apoptosis, interferon-gamma pathway, and wound healing along with promotion of terminal differentiation. J Biol Chem. 2007 Feb 9;282(6):4021-34. Epub 2006 Nov 9.

ReferenceCitation: Leyvraz C, Charles RP, Rubera I, Guitard M, Rotman S, Breiden B, Sandhoff K, Hummler E. The epidermal barrier function is dependent on the serine protease CAP1/Prss8. J Cell Biol. 2005 Aug 1;170(3):487-96.

ReferenceCitation: List K, Haudenschild CC, Szabo R, Chen W, Wahl SM, Swaim W, Engelholm LH, Behrendt N, Bugge TH. Matriptase/MT-SP1 is required for postnatal survival, epidermal barrier function, hair follicle development, and thymic homeostasis. Oncogene. 2002 May 23;21(23):3765-79.

ReferenceCitation: Mauro T, Guitard M, Behne M, Oda Y, Crumrine D, Komuves L, Rassner U, Elias PM, Hummler E. The ENaC channel is required for normal epidermal differentiation. J Invest Dermatol. 2002 Apr;118(4):589-94.

ReferenceCitation: Pérez P, Page A, Bravo A, Del Río M, Giménez-Conti I, Budunova I, Slaga TJ, Jorcano JL. Altered skin development and impaired proliferative and inflammatory responses in transgenic mice overexpressing the glucocorticoid receptor. FASEB J. 2001 Sep;15(11):2030-2. Epub 2001 Jul 24.

ReferenceCitation: Brouard M, Casado M, Djelidi S, Barrandon Y, Farman N. Epithelial sodium channel in human epidermal keratinocytes: expression of its subunits and relation to sodium transport and differentiation. J Cell Sci. 1999 Oct;112 ( Pt 19):3343-52.

ReferenceCitation: Roudier-Pujol C, Rochat A, Escoubet B, Eugène E, Barrandon Y, Bonvalet JP, Farman N. Differential expression of epithelial sodium channel subunit mRNAs in rat skin. J Cell Sci. 1996 Feb;109 ( Pt 2):379-85.

ReferenceCitation: Kenouch S, Lombes M, Delahaye F, Eugene E, Bonvalet JP, Farman N. Human skin as target for aldosterone: coexpression of mineralocorticoid receptors and 11 beta-hydroxysteroid dehydrogenase. J Clin Endocrinol Metab. 1994 Nov;79(5):1334-41.

ReferenceCitation: Messina M, Manieri C, Musso MC, Pastorino R. Oral and topical spironolactone therapies in skin androgenization. Panminerva Med. 1990 Apr-Jun;32(2):49-55.

ReferenceCitation: Maubec E, Laouénan C, Deschamps L, Nguyen VT, Scheer-Senyarich I, Wackenheim-Jacobs AC, Steff M, Duhamel S, Tubiana S, Brahimi N, Leclerc-Mercier S, Crickx B, Perret C, Aractingi S, Escoubet B, Duval X, Arnaud P, Jaisser F, Mentré F, Farman N. Topical Mineralocorticoid Receptor Blockade Limits Glucocorticoid-Induced Epidermal Atrophy in Human Skin. J Invest Dermatol. 2015 Jul;135(7):1781-1789. doi: 10.1038/jid.2015.44. Epub 2015 Feb 10.


title: Impact of Folates in the Care of the Male Infertility

acronym: FOLFIV

summary: Unexplained male infertility is increasing, and, nowadays, the investigators only can propose palliative treatment, as In VITRO Fertilization (IVF). The folate metabolism is a key for the maintenance of genome integrity. A dysfunction in this pathway can be responsible of spermatogenesis defects, and further, of infertility. Few assays have shown that folate treatment can improve sperm parameters and fertility, till 30% in some of theses studies. The purpose of the investigators study is to demonstrate the impact of folates treatment on improvement of sperm parameters and on the rate of success of in VITRO fertilization procedures.

ReferenceCitation: Bentivoglio G, Melica F, Cristoforoni P. Folinic acid in the treatment of human male infertility. Fertil Steril. 1993 Oct;60(4):698-701.

ReferenceCitation: Bezold G, Lange M, Peter RU. Homozygous methylenetetrahydrofolate reductase C677T mutation and male infertility. N Engl J Med. 2001 Apr 12;344(15):1172-3.

ReferenceCitation: Blount BC, Mack MM, Wehr CM, MacGregor JT, Hiatt RA, Wang G, Wickramasinghe SN, Everson RB, Ames BN. Folate deficiency causes uracil misincorporation into human DNA and chromosome breakage: implications for cancer and neuronal damage. Proc Natl Acad Sci U S A. 1997 Apr 1;94(7):3290-5.

ReferenceCitation: Boxmeer JC, Smit M, Weber RF, Lindemans J, Romijn JC, Eijkemans MJ, Macklon NS, Steegers-Theunissen RP. Seminal plasma cobalamin significantly correlates with sperm concentration in men undergoing IVF or ICSI procedures. J Androl. 2007 Jul-Aug;28(4):521-7. Epub 2007 Feb 7.

ReferenceCitation: Boxmeer JC, Macklon NS, Lindemans J, Beckers NG, Eijkemans MJ, Laven JS, Steegers EA, Steegers-Theunissen RP. IVF outcomes are associated with biomarkers of the homocysteine pathway in monofollicular fluid. Hum Reprod. 2009 May;24(5):1059-66. doi: 10.1093/humrep/dep009. Epub 2009 Feb 15.

ReferenceCitation: Boxmeer JC, Smit M, Utomo E, Romijn JC, Eijkemans MJ, Lindemans J, Laven JS, Macklon NS, Steegers EA, Steegers-Theunissen RP. Low folate in seminal plasma is associated with increased sperm DNA damage. Fertil Steril. 2009 Aug;92(2):548-56. doi: 10.1016/j.fertnstert.2008.06.010. Epub 2008 Aug 22.

ReferenceCitation: Chen J, Ma J, Stampfer MJ, Palomeque C, Selhub J, Hunter DJ. Linkage disequilibrium between the 677C>T and 1298A>C polymorphisms in human methylenetetrahydrofolate reductase gene and their contributions to risk of colorectal cancer. Pharmacogenetics. 2002 Jun;12(4):339-42.

ReferenceCitation: Choi SW, Mason JB. Folate and colorectal carcinogenesis: is DNA repair the missing link? Am J Gastroenterol. 1998 Nov;93(11):2013-6.

ReferenceCitation: Doerksen T, Benoit G, Trasler JM. Deoxyribonucleic acid hypomethylation of male germ cells by mitotic and meiotic exposure to 5-azacytidine is associated with altered testicular histology. Endocrinology. 2000 Sep;141(9):3235-44.

ReferenceCitation: Ebisch IM, van Heerde WL, Thomas CM, van der Put N, Wong WY, Steegers-Theunissen RP. C677T methylenetetrahydrofolate reductase polymorphism interferes with the effects of folic acid and zinc sulfate on sperm concentration. Fertil Steril. 2003 Nov;80(5):1190-4.

ReferenceCitation: Eskenazi B, Kidd SA, Marks AR, Sloter E, Block G, Wyrobek AJ. Antioxidant intake is associated with semen quality in healthy men. Hum Reprod. 2005 Apr;20(4):1006-12. Epub 2005 Jan 21.

ReferenceCitation: Goyette P, Sumner JS, Milos R, Duncan AM, Rosenblatt DS, Matthews RG, Rozen R. Human methylenetetrahydrofolate reductase: isolation of cDNA mapping and mutation identification. Nat Genet. 1994 Aug;7(4):551.

ReferenceCitation: Heijmans BT, Gussekloo J, Kluft C, Droog S, Lagaay AM, Knook DL, Westendorp RG, Slagboom EP. Mortality risk in men is associated with a common mutation in the methylene-tetrahydrofolate reductase gene (MTHFR). Eur J Hum Genet. 1999 Feb-Mar;7(2):197-204.

ReferenceCitation: Kelly TL, Li E, Trasler JM. 5-aza-2'-deoxycytidine induces alterations in murine spermatogenesis and pregnancy outcome. J Androl. 2003 Nov-Dec;24(6):822-30.

ReferenceCitation: Kelly TL, Neaga OR, Schwahn BC, Rozen R, Trasler JM. Infertility in 5,10-methylenetetrahydrofolate reductase (MTHFR)-deficient male mice is partially alleviated by lifetime dietary betaine supplementation. Biol Reprod. 2005 Mar;72(3):667-77. Epub 2004 Nov 17.

ReferenceCitation: Kim YI, Pogribny IP, Basnakian AG, Miller JW, Selhub J, James SJ, Mason JB. Folate deficiency in rats induces DNA strand breaks and hypomethylation within the p53 tumor suppressor gene. Am J Clin Nutr. 1997 Jan;65(1):46-52.

ReferenceCitation: Koury MJ, Horne DW, Brown ZA, Pietenpol JA, Blount BC, Ames BN, Hard R, Koury ST. Apoptosis of late-stage erythroblasts in megaloblastic anemia: association with DNA damage and macrocyte production. Blood. 1997 Jun 15;89(12):4617-23.

ReferenceCitation: Kundu TK, Rao MR. CpG islands in chromatin organization and gene expression. J Biochem. 1999 Feb;125(2):217-22. Review.

ReferenceCitation: Lengauer C, Kinzler KW, Vogelstein B. DNA methylation and genetic instability in colorectal cancer cells. Proc Natl Acad Sci U S A. 1997 Mar 18;94(6):2545-50.

ReferenceCitation: Ma J, Stampfer MJ, Giovannucci E, Artigas C, Hunter DJ, Fuchs C, Willett WC, Selhub J, Hennekens CH, Rozen R. Methylenetetrahydrofolate reductase polymorphism, dietary interactions, and risk of colorectal cancer. Cancer Res. 1997 Mar 15;57(6):1098-102.

ReferenceCitation: Matsushita S, Muramatsu T, Arai H, Matsui T, Higuchi S. The frequency of the methylenetetrahydrofolate reductase-gene mutation varies with age in the normal population. Am J Hum Genet. 1997 Dec;61(6):1459-60.

ReferenceCitation: Oliva A, Dotta A, Multigner L. Pentoxifylline and antioxidants improve sperm quality in male patients with varicocele. Fertil Steril. 2009 Apr;91(4 Suppl):1536-9. doi: 10.1016/j.fertnstert.2008.09.024. Epub 2008 Nov 5.

ReferenceCitation: Ravel C, Chantot-Bastaraud S, Chalmey C, Barreiro L, Aknin-Seifer I, Pfeffer J, Berthaut I, Mathieu EE, Mandelbaum J, Siffroi JP, McElreavey K, Bashamboo A. Lack of association between genetic polymorphisms in enzymes associated with folate metabolism and unexplained reduced sperm counts. PLoS One. 2009 Aug 6;4(8):e6540. doi: 10.1371/journal.pone.0006540.

ReferenceCitation: Rosenberg N, Murata M, Ikeda Y, Opare-Sem O, Zivelin A, Geffen E, Seligsohn U. The frequent 5,10-methylenetetrahydrofolate reductase C677T polymorphism is associated with a common haplotype in whites, Japanese, and Africans. Am J Hum Genet. 2002 Mar;70(3):758-62. Epub 2002 Jan 4.

ReferenceCitation: Rozen R, Fraser FC, Shaw G. Decreased proportion of female newborn infants homozygous for the 677 C-->T mutation in methylenetetrahydrofolate reductase. Am J Med Genet. 1999 Mar 12;83(2):142-3.

ReferenceCitation: Skjelbred CF, Svendsen M, Haugan V, Eek AK, Clausen KO, Svendsen MV, Hansteen IL. Influence of DNA repair gene polymorphisms of hOGG1, XRCC1, XRCC3, ERCC2 and the folate metabolism gene MTHFR on chromosomal aberration frequencies. Mutat Res. 2006 Dec 1;602(1-2):151-62. Epub 2006 Sep 25. Erratum in: Mutat Res. 2007 Nov 1;624(1-2):133.

ReferenceCitation: Stegmann K, Ziegler A, Ngo ET, Kohlschmidt N, Schröter B, Ermert A, Koch MC. Linkage disequilibrium of MTHFR genotypes 677C/T-1298A/C in the German population and association studies in probands with neural tube defects(NTD). Am J Med Genet. 1999 Nov 5;87(1):23-9.

ReferenceCitation: Szymański W, Kazdepka-Ziemińska A. [Effect of homocysteine concentration in follicular fluid on a degree of oocyte maturity]. Ginekol Pol. 2003 Oct;74(10):1392-6. Polish.

ReferenceCitation: Wong WY, Merkus HM, Thomas CM, Menkveld R, Zielhuis GA, Steegers-Theunissen RP. Effects of folic acid and zinc sulfate on male factor subfertility: a double-blind, randomized, placebo-controlled trial. Fertil Steril. 2002 Mar;77(3):491-8.

location_facility: Service of gynaecology-obstetrics and medicine of the reproduction, Tenon Hospital - APHP


title: PARAMETRES GLOBAUX DE REFERENCE DU RACHIS CALCULES SUR DES PATIENTS ASYMPTOMATIQUES PAR IMAGERIE EOS™

acronym: EOS-SPINE

summary:
The lumbar pain caring consists from a 3D reconstruction of the spine obtained to scan or radiography, determining the lumbar pain cause and gravity, to propose a conservative treatment in first intention or a adapted spine surgery in first or second intention (Fritzell and al ., on 2001).

The analysis and the correction of postural disorders pass inevitably by a good knowledge of the not pathological posture. The validation of the acquisition 2D / 3D reconstruction by EOS ™ technology demonstrated its interest for the diagnosis and the lumbar pain caring.

However, the EOS technology ™ is recent and few data were acquired with this technology for healthy population.

So, this clinical study with EOS ™technology would allow to obtain a precise knowledge of the standing skeleton in position (to an asymptomatic adult population), by displaying the gravity constraints on the joints, and the compensation phenomena in normal situation. This functional information for a given age bracket would allow to propose to the patients with lumbar pain, adapted interventions to the gravity constraints considering the skeleton evolution for age bracket.

ReferenceCitation: Borenstein D. Low back pain: epidemiology, etiology, diagnostic evaluation, and therapy. Curr Opin Rheumatol. 1991 Apr;3(2):207-17. Review.

ReferenceCitation: Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. Review.

ReferenceCitation: Cats-Baril WL, Frymoyer JW. Identifying patients at risk of becoming disabled because of low-back pain. The Vermont Rehabilitation Engineering Center predictive model. Spine (Phila Pa 1976). 1991 Jun;16(6):605-7.

ReferenceCitation: Dubousset J, Charpak G, Dorion I, Skalli W, Lavaste F, Deguise J, Kalifa G, Ferey S. [A new 2D and 3D imaging approach to musculoskeletal physiology and pathology with low-dose radiation and the standing position: the EOS system]. Bull Acad Natl Med. 2005 Feb;189(2):287-97; discussion 297-300. Review. French.

ReferenceCitation: Kalifa G, Charpak Y, Maccia C, Fery-Lemonnier E, Bloch J, Boussard JM, Attal M, Dubousset J, Adamsbaum C. Evaluation of a new low-dose digital x-ray device: first dosimetric and clinical results in children. Pediatr Radiol. 1998 Jul;28(7):557-61.

ReferenceCitation: Fritzell P, Hägg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4.

ReferenceCitation: Geijer H, Verdonck B, Beckman KW, Andersson T, Persliden J. Digital radiography of scoliosis with a scanning method: radiation dose optimization. Eur Radiol. 2003 Mar;13(3):543-51. Epub 2002 Jun 14.

ReferenceCitation: Glassman S, Gornet MF, Branch C, Polly D Jr, Peloza J, Schwender JD, Carreon L. MOS short form 36 and Oswestry Disability Index outcomes in lumbar fusion: a multicenter experience. Spine J. 2006 Jan-Feb;6(1):21-6.

ReferenceCitation: Hansen J, Jurik AG, Fiirgaard B, Egund N. Optimisation of scoliosis examinations in children. Pediatr Radiol. 2003 Nov;33(11):752-65. Epub 2003 Sep 5.

ReferenceCitation: Legaye J, Duval-Beaupère G, Hecquet J, Marty C. Pelvic incidence: a fundamental pelvic parameter for three-dimensional regulation of spinal sagittal curves. Eur Spine J. 1998;7(2):99-103.

ReferenceCitation: Pellisé F, Hernández A, Vidal X, Minguell J, Martínez C, Villanueva C. Radiologic assessment of all unfused lumbar segments 7.5 years after instrumented posterior spinal fusion. Spine (Phila Pa 1976). 2007 Mar 1;32(5):574-9.

ReferenceCitation: Rossignol M, Suissa S, Abenhaim L. Working disability due to occupational back pain: three-year follow-up of 2,300 compensated workers in Quebec. J Occup Med. 1988 Jun;30(6):502-5.

ReferenceCitation: Roussouly P, Berthonnaud E, Dimnet J. [Geometrical and mechanical analysis of lumbar lordosis in an asymptomatic population: proposed classification]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):632-9. French.

ReferenceCitation: Spengler DM, Bigos SJ, Martin NA, Zeh J, Fisher L, Nachemson A. Back injuries in industry: a retrospective study. I. Overview and cost analysis. Spine (Phila Pa 1976). 1986 Apr;11(3):241-5.

ReferenceCitation: Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine (Phila Pa 1976). 1987 Sep;12(7 Suppl):S1-59. Review.

ReferenceCitation: Tournier C, Aunoble S, Le Huec JC, Lemaire JP, Tropiano P, Lafage V, Skalli W. Total disc arthroplasty: consequences for sagittal balance and lumbar spine movement. Eur Spine J. 2007 Mar;16(3):411-21. Epub 2006 Sep 8.


title: Evaluation of the Occurrence of Acute Complications Caused by a Central Venous Catheter Placement: Observational, Prospective, Monocentric Study

acronym: VVC

summary:
It is an observational, prospective, monocentric study. The purpose of the study is to assess the acute complications rate caused by a central venous catheter placement.

All the patients who require a central venous placement could be enrolled in the study.

The study will not change the usual practice. The placement will be on day 1 and patients will be contacted by phone on day 7 to identify potential complications and to assess pain.

Anaesthesia staff will keep patients under surveillance to control the absence of late complications.

ReferenceCitation: Gambotti L, Pérol D, Frering B, Kaemmerlen P, Coronel B, Sebban H, Bulso V, Bachelot V, Chauvin F, Bachmann P. Safety of percutaneous internal jugular catheterization in cancer patients: prospective observational study. J Vasc Access. 2004 Oct-Dec;5(4):161-7.

ReferenceCitation: Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infection in adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006 Sep;81(9):1159-71. Review.

ReferenceCitation: Burns KE, McLaren A. Catheter-related right atrial thrombus and pulmonary embolism: a case report and systematic review of the literature. Can Respir J. 2009 Sep-Oct;16(5):163-5. Review.

ReferenceCitation: Kim HJ, Yun J, Kim HJ, Kim KH, Kim SH, Lee SC, Bae SB, Kim CK, Lee NS, Lee KT, Park SK, Won JH, Park HS, Hong DS. Safety and effectiveness of central venous catheterization in patients with cancer: prospective observational study. J Korean Med Sci. 2010 Dec;25(12):1748-53. doi: 10.3346/jkms.2010.25.12.1748. Epub 2010 Nov 24.

ReferenceCitation: Centers for Disease Control and Prevention (CDC). Vital signs: central line-associated blood stream infections--United States, 2001, 2008, and 2009. MMWR Morb Mortal Wkly Rep. 2011 Mar 4;60(8):243-8.

ReferenceCitation: Yacopetti N, Alexandrou E, Spencer TR, Frost SA, Davidson PM, O'Sullivan G, Hillman KM. Central venous catheter insertion by a clinical nurse consultant or anaesthetic medical staff: a single-centre observational study. Crit Care Resusc. 2010 Jun;12(2):90-5.

lead_sponsor: Centre Leon Berard


title: Posttraumatic Stress Disorder (PTSD) Among Victims of Sexual Abuse and Changes in Structural and Functional Brain Connectivity: A Cognitive and Neuroanatomical Markers Study Using fMRI,(DTI) and(ASL)

acronym: COPTSD

summary: The goal of this study is to identify the early modifications in fronto-temporal connectivity in female victims who developed PTSD, compared to female victims who did not develop the disorder, and to healthy control females. The investigators will compare between all these groups, structural and functional differences using different techniques (MRI, fMRI, DTI and ASL), and paradigms (cognitive tasks or at rest).

lead_sponsor: University Hospital, Tours

location_facility: Bretonneau Regional Universitary Hospital


title: Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

summary: The objective of this study is to show that, in patients undergoing carotid endarterectomy, brain damage, assessed by the determination of S100B before removing the clamp, is less severe with a balanced anesthesia consisting of remifentanil combined with Xenon (experimental arm) compared with remifentanil anesthesia associated with propofol (reference arm).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Double Blind Randomized Trial of Wound Infiltration With Ropivacaine After Breast Cancer Surgery

summary: Prospective double blind randomized evaluation of the effect of surgical wound infiltration with ropivacaine versus placebo in patients scheduled for breast surgery with axillary lymph node dissection

ReferenceCitation: Vigneau A, Salengro A, Berger J, Rouzier R, Barranger E, Marret E, Bonnet F. A double blind randomized trial of wound infiltration with ropivacaine after breast cancer surgery with axillary nodes dissection. BMC Anesthesiol. 2011 Nov 24;11:23. doi: 10.1186/1471-2253-11-23.

family: Vigneau

full_name: Axelle Vigneau

given: Axelle

family: Salengro

full_name: Anne Salengro

given: Anne

family: Berger

full_name: Joelle Berger

given: Joelle

family: Rouzier

full_name: Roman Rouzier

given: Roman

family: Barranger

full_name: Emmanuel Barranger

given: Emmanuel

family: Marret

full_name: Emmanuel Marret

family: Bonnet

full_name: Francis Bonnet

given: Francis

journal_name: BMC Anesthesiology

lead_sponsor: Tenon Hospital, Paris


title: Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery in Non-obese American Soceity of Anesthesiologists (ASA) 1-3 Patients

summary: The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.


title: Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study

acronym: PROSPER

summary: In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of postoperative anastomotic leakage. The aim of the study was to assess the benefit of an optimal care, i.e., both psychological and enterostomal therapy care.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Association de Recherche Experimentale et Clinique en Chirurgie Digestive


title: Comparison of Dosimetry Following Preparation With Either rhTSH or After Withdrawal of Thyroid Hormone Suppression Therapy in Patients With Metastatic or Locally Advanced Differentiated Thyroid Cancer

acronym: DOSIMETA

summary: Metastases of thyroid cancer with iodine uptake are treated with repeated activity of I-131 administered after thyroid hormone withdrawal. The goal of thyroid hormone withdrawal is to treat patients with elevated thyrotropin stimulated hormone (TSH), a hormone secreted by the pituitary, a gland just located under the brain. Another way to obtain elevated TSH levels is to perform intramuscular injection of recombinant human TSH, a hormone produced pharmaceutically. The goal of this study is to know whether the radioiodine uptake by the metastases is similar after rhTSH administration or after thyroid hormone withdrawal.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study

summary: The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.

ReferenceCitation: Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Brüggemann RJ, Lefrant JY, Roberts JA. Caspofungin Population Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-Venous Haemofiltration or Haemodiafiltration. Clin Pharmacokinet. 2017 Sep;56(9):1057-1068. doi: 10.1007/s40262-016-0495-z.

family: Roger

full_name: Claire Roger

given: Claire

family: Wallis

full_name: Steven C. Wallis

given: Steven C.

family: Muller

full_name: Laurent Muller

given: Laurent

family: Saissi

full_name: Gilbert Saissi

given: Gilbert

family: Lipman

full_name: Jeffrey Lipman

given: Jeffrey

family: Brüggemann

full_name: Roger J. Brüggemann

given: Roger J.

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Roberts

full_name: Jason A. Roberts

given: Jason A.

journal_name: Clinical Pharmacokinetics

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Roger C, Wallis SC, Muller L, Saissi G, Lipman J, Lefrant JY, Roberts JA. Influence of Renal Replacement Modalities on Amikacin Population Pharmacokinetics in Critically Ill Patients on Continuous Renal Replacement Therapy. Antimicrob Agents Chemother. 2016 Jul 22;60(8):4901-9. doi: 10.1128/AAC.00828-16. Print 2016 Aug.

name: Service des Réanimations, Pôle Anesthésie Réanimation Douleur Urgence, CHU Nîmes, Nîmes, France

name: Burns, Trauma, and Critical Care Research Centre, The University of Queensland, Brisbane, Queensland, Australia

name: School of Pharmacy, The University of Queensland, Brisbane, Queensland, Australia

name: Department of Intensive Care Medicine, Royal Brisbane and Womens' Hospital, Brisbane, Queensland, Australia

name: Pharmacy Department, Royal Brisbane and Womens' Hospital, Brisbane, Queensland, Australia

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via free pdf)

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


title: Comparative Evaluation of Osteopathy Treatment Efficacy in Pain Support After Breast Surgery in Oncology

acronym: OSTEOPATHIE

summary:
This is an open, prospective, controlled, randomized, comparative study with 2 arms.

The purpose of the study is to assess the efficacy of osteopathy after breast surgery.

80 patients will be enrolled, 40 per arm. Patients will be randomized at inclusion and will be followed during one year.

ReferenceCitation: Fassoulaki A, Patris K, Sarantopoulos C, Hogan Q. The analgesic effect of gabapentin and mexiletine after breast surgery for cancer. Anesth Analg. 2002 Oct;95(4):985-91, table of contents.

ReferenceCitation: Ivens D, Hoe AL, Podd TJ, Hamilton CR, Taylor I, Royle GT. Assessment of morbidity from complete axillary dissection. Br J Cancer. 1992 Jul;66(1):136-8.

ReferenceCitation: Jung BF, Ahrendt GM, Oaklander AL, Dworkin RH. Neuropathic pain following breast cancer surgery: proposed classification and research update. Pain. 2003 Jul;104(1-2):1-13. Review.

ReferenceCitation: Labrèze L, Dixmérias-Iskandar F, Monnin D, Bussières E, Delahaye E, Bernard D, Lakdja F. [Postmastectomy pain syndrome evidence based guidelines and decision trees]. Bull Cancer. 2007 Mar;94(3):275-85. Review. French.

ReferenceCitation: Dirks J, Fredensborg BB, Christensen D, Fomsgaard JS, Flyger H, Dahl JB. A randomized study of the effects of single-dose gabapentin versus placebo on postoperative pain and morphine consumption after mastectomy. Anesthesiology. 2002 Sep;97(3):560-4.

ReferenceCitation: Eija K, Tiina T, J NP. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain. 1996 Feb;64(2):293-302. doi: 10.1016/0304-3959(95)00138-7.

ReferenceCitation: Attal N, Cruccu G, Haanpää M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69.

ReferenceCitation: Vick DA, McKay C, Zengerle CR. The safety of manipulative treatment: review of the literature from 1925 to 1993. J Am Osteopath Assoc. 1996 Feb;96(2):113-5. Review.

ReferenceCitation: Ernst E. Manipulation of the cervical spine: a systematic review of case reports of serious adverse events, 1995-2001. Med J Aust. 2002 Apr 15;176(8):376-80. Review.

ReferenceCitation: Licht PB, Christensen HW, Høilund-Carlsen PF. Is cervical spinal manipulation dangerous? J Manipulative Physiol Ther. 2003 Jan;26(1):48-52.

ReferenceCitation: Vickers A, Zollman C. ABC of complementary medicine. The manipulative therapies: osteopathy and chiropractic. BMJ. 1999 Oct 30;319(7218):1176-9. Review.

ReferenceCitation: Noll DR, Degenhardt BF, Stuart M, McGovern R, Matteson M. Effectiveness of a sham protocol and adverse effects in a clinical trial of osteopathic manipulative treatment in nursing home patients. J Am Osteopath Assoc. 2004 Mar;104(3):107-13.

ReferenceCitation: Hayes NM, Bezilla TA. Incidence of iatrogenesis associated with osteopathic manipulative treatment of pediatric patients. J Am Osteopath Assoc. 2006 Oct;106(10):605-8.


title: Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema. International, Multicentric, Randomised, Controlled, Double Blind Study, in Two Parallel Groups v0322 bc Versus Placebo

summary:
Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). Item C3 of this classification relates to patients suffering from chronic venous disease and permanent oedema. Literature mentions only one study in which volume reduction in venous-induced oedema was primary endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative measure considered nowadays as being gold standard when objectifying oedema variation. It is therefore particularly relevant in a C3-patient trial (CEAP classification).

The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.

lead_sponsor: Pierre Fabre Medicament


title: Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

acronym: DYSEXTRIOSE

summary: The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.


title: Interface Pressure Measures for Matresses: a Randomized, Cross-over, Non-inferiority Study Comparing the Nimbus 3 Versus Summit Matresses

summary: The primary objective of this study is to compare the distribution of pressure among pressure interfaces between two anti-bedsore mattresses.


title: STOB-ACTIV: The Efficacy of Exercise and Counseling for Depressed Patients as an Aid for Smoking Cessation, a Randomized Controlled Trial

acronym: STOB-ACTIV

summary: This study investigated the efficacy of an exercise and counseling intervention for depressed smokers (depression subscale of the Hospital Anxiety and Depression Scale, HADS-D score ≥ 8) in term of likelihood of smoking abstinence. Participants were randomized to 8 weeks of intervention: individually delivered exercise and counseling (for smoking cessation and physical activity) or control: health education contact control condition.

ReferenceCitation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10:CD006219. doi: 10.1002/14651858.CD006219.pub4. Review.

name: Nuffield Department of Primary Care Health Sciences; University of Oxford; Oxford UK

family: Hartmann-Boyce

full_name: Jamie Hartmann-Boyce

given: Jamie

family: Theodoulou

full_name: Annika Theodoulou

given: Annika

name: Public Health, Epidemiology and Biostatistics; University of Birmingham; Birmingham UK

family: Farley

full_name: Amanda Farley

given: Amanda

name: Wolfson Institute of Preventive Medicine; Barts & The London School of Medicine and Dentistry, Queen Mary University of London; London UK

family: Hajek

full_name: Peter Hajek

given: Peter

family: Lycett

full_name: Deborah Lycett

given: Deborah

family: Jones

full_name: Laura L Jones

given: Laura L

family: Kudlek

full_name: Laura Kudlek

given: Laura

family: Heath

full_name: Laura Heath

family: Hajizadeh

full_name: Anisa Hajizadeh

given: Anisa

family: Schenkels

full_name: Marika Schenkels

given: Marika

family: Aveyard

full_name: Paul Aveyard

given: Paul

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Bernard P, Ninot G, Cyprien F, Courtet P, Guillaume S, Georgescu V, Picot MC, Taylor A, Quantin X. Exercise and Counseling for Smoking Cessation in Smokers With Depressive Symptoms: A Randomized Controlled Pilot Trial. J Dual Diagn. 2015;11(3-4):205-16. doi: 10.1080/15504263.2015.1113842.

family: Bernard

full_name: Paquito Bernard

given: Paquito

family: Ninot

full_name: Gregory Ninot

given: Gregory

family: Cyprien

full_name: Fabienne Cyprien

given: Fabienne

family: Courtet

full_name: Philippe Courtet

given: Philippe

family: Guillaume

full_name: Sebastien Guillaume

given: Sebastien

family: Georgescu

full_name: Vera Georgescu

given: Vera

family: Picot

full_name: Marie-Christine Picot

given: Marie-Christine

family: Taylor

full_name: Adrian Taylor

given: Adrian

family: Quantin

full_name: Xavier Quantin

given: Xavier


title: Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis

acronym: Cardioplégie

summary:
An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.

High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Sleep Apnea in Early to Mid-Stage Alzheimer's Disease: What Impact of Treatment on the Cognitive Functions of Elderly Patients With Memory Loss?

acronym: AZAP

summary:
Obstructive sleep apnea (OSA) is much more common in the elderly than in the young; the latest studies show prevalence between 45% and 62% in individuals over 60. It is even higher in patients with dementia such as Alzheimer patients.

Several trials in elderly patients showed modified cognitive functions, particularly executive and attentional functions, in patients with respiratory sleep disorder. However the benefit of CPAP (Continuous Positive Airway Pressure) ventilation for Alzheimer patients is still controversial, as there are few studies documenting its effects on dementia patients' cognitive abilities, and clinicians appear reluctant to prescribe this type of treatment.

The investigators must keep in mind that Alzheimer patients suffer significant sleep disorders; advanced- stage patients spend 40% of the night awake and are drowsy a large part of the day. In dementia patients, sleep disorder is a major cause of hospitalization and institutionalization. The prevalence of obstructive sleep apnea (OSA) in this population is estimated at over 50%, and appears to be higher the more advanced the dementia. Trials on obstructive sleep apnea syndromes in Alzheimer patients show significatively improved scores on the apnea-hypopnea index (AHI), as well as satisfactory treatment tolerance. However, any impact on cognitive abilities has yet to be demonstrated.

In addition, cardiovascular pathologies such as arterial hypertension, cardiac arrhythmias, and strokes are strongly correlated to OSA. In light of its consequences on morbidity and mortality, OSA should be considered a public health issue.

In this context, the investigators wish to address the impact of CPAP treatment implementation on the cognitive parameters of patients diagnosed with OSA, particularly on their executive functions. This should provide evidence for mid-term assessment of the benefits of CPAP in caring for elderly patients with dementia.

In light of the prevalence of obstructive sleep pathologies in elderly patients reported in various studies and of the potential impact of CPAP treatment on cognitive abilities, the investigators propose a study to evaluate the impact of OSA treatment on elderly Alzheimer patients' cognitive abilities, particularly on their executive functions.

Executive functions are a rather heterogenous group of high-level cognitive processes which enable individuals to adopt a flexible, context-appropriate behavior. They also include planning abilities, working memory, cognitive control, abstract thought, rule learning, selective attention, motor response selection, etc... Executive functions are mainly associated to the functioning of the brain's frontal lobes, although subcortical structures also play a role. When the executive functions are affected by disease, daily life is significantly impeded as the individual becomes unable to perform complex tasks or regulate his/her behavior. Many tests can help evaluate these functions in dementia patients. A number of "ecological" tests, such as the zoo map test from the Behavioural Assessment of the Dysexecutive Syndrome (BADS) arsenal, are quite relevant for evaluating executive functions.

This project aims to improve the daily life of Alzheimer patients with sleep apnea by improving their executive cognitive functions through CPAP treatment.

According to the Paquid's trial, there are 12,400 Alzheimer patients in the French Loire department. [27] The study population will therefore be recruited in the "La Charité" center of CHU Saint-Etienne. The target population is older individuals (≥ 65) suffering from cognitive disorders similar to Alzheimer's disease.

OSA will be diagnosed based on polysomnography, on an outpatient basis. Apnea patients will receive CPAP treatment for 4 months, which is the minimum duration required to implement and accept treatment, and to measure its impact on patients' neurocognitive abilities.


title: Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer: Fatigue and Quality of Life During and Waning of Treatment, Psychosocial Aspects (Environment, Work)

acronym: HER-ception

summary:
Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families.

The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.

lead_sponsor: Centre Francois Baclesse


title: An Open-label Naturalistic Pragmatic Study to Assess the Long Term Safety of BF2.649 (Pitolisant) in the Treatment of Excessive Daytime Sleepiness (EDS) in Narcolepsy (12 Months Follow-up, Followed by a Prolonged Follow up)

acronym: HARMONYIII

summary: This is a multicentric International Phase III,Long term open label study(12 months)assessing the long-term safety and efficacy of BF2.649 (Pitolisant)in the treatment of Excessive Daytime Sleepiness (EDS) in narcoleptic patients with or without cataplexy.

lead_sponsor: Bioprojet


title: A Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of Danoprevir With Low Dose Ritonavir (DNV/r) on the QT/QTc Interval in Healthy Subjects

summary: This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.


title: Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO5267683 in an Adaptive, Randomized, Investigator-blind and Subject-blind, Multiple-ascending Dose, Placebo-controlled, Study Following Oral Administrations in Healthy Subjects for 28 Days

summary: This investigator-blind, subject-blind, randomized, placebo-controlled study will evaluate the safety, pharmacokinetics and pharmacodynamics of multiple ascending doses of RO5267683 in healthy volunteers. Subjects will be randomized to receive either RO5267683 or placebo orally daily for 28 days. Follow-up will be 10 weeks after the last dose.


title: Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®

summary: Ultra-sound study to assess changes in intragastric volume after bowel preparation.

primary_purpose: Basic Science

ReferenceCitation: Coriat R, Polin V, Oudjit A, Henri F, Dhooge M, Leblanc S, Delchambre C, Esch A, Tabouret T, Barret M, Prat F, Chaussade S. Gastric emptying evaluation by ultrasound prior colonoscopy: an easy tool following bowel preparation. World J Gastroenterol. 2014 Oct 7;20(37):13591-8. doi: 10.3748/wjg.v20.i37.13591.

family: Coriat

full_name: Romain Coriat

given: Romain

journal_name: World Journal of Gastroenterology

evidence: open (via page says license)

publisher: Baishideng Publishing Group Inc.

publisher_dissemination: Baishideng Publishing Group Inc.

publisher_group: Baishideng Publishing Group Inc.

publisher_normalized: Baishideng Publishing Group Inc.

title: Gastric emptying evaluation by ultrasound prior colonoscopy: An easy tool following bowel preparation

lead_sponsor: Laboratoires Mayoly Spindler