title: Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN)

acronym: GEMRITUX

summary:
The Membranous Nephropathy is one of the most common cause of Nephrotic Syndrome of adults. In 2/3 of patients the cause of the disease is idiopathic. This can also be referred to as idiopathic membranous nephropathy (IMN).The most of these patients are treated by non immunosuppressive symptomatic treatment (NIST): antiproteinuric and antihypertensive blocking the rennin-angiotensine system. However, the patients resistant to antiproteinuric treatment risk to develop an end stage renal disease (ESRD).

Rituximab has been recently used in patients suffering of nephrotic syndrome related to IMN in four international studies. Rituximab appears effective and safe in reducing proteinuria in nearly 60% of patients.

The primary outcome of the investigators prospective randomized study is to determine whether or not the Rituximab associated with NIST is more effective than non immunologic symptomatic treatment alone in inducing long term remission of proteinuria.

ReferenceCitation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11:CD004293. doi: 10.1002/14651858.CD004293.pub4. Review.

name: Department of Anaesthesiology, Intensive Care and Pain Medicine; University Hosptial Münster; Münster Germany

family: von Groote

full_name: Thilo C von Groote

given: Thilo C

name: Analytics Assist; NSW Ministry of Health; North Sydney Australia

family: Williams

full_name: Gabrielle Williams

given: Gabrielle

name: Sydney School of Public Health; The University of Sydney; Sydney Australia

name: Department of Renal Medicine; Westmead Hospital; Westmead Australia

family: Au

full_name: Eric H Au

given: Eric H

name: Department of Nephrology, Hainan Hospital of Chinese PLA General Hospital; Hainan Provincial Academician Team Innovation Center; Sanya China

name: Senior Department of Nephrology, the First Medical Center of Chinese PLA General Hospital; Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Beijing Key Laboratory of Kidney Disease Research; Beijing China

family: Chen

full_name: Yizhi Chen

given: Yizhi

name: Department of Nephrology; McMaster University; Hamilton Canada

family: Mathew

full_name: Anna T Mathew

given: Anna T

name: Cochrane Kidney and Transplant, Centre for Kidney Research; The Children's Hospital at Westmead; Westmead Australia

family: Hodson

full_name: Elisabeth M Hodson

given: Elisabeth M

family: Tunnicliffe

full_name: David J Tunnicliffe

given: David J

ReferenceCitation: Seitz-Polski B, Dahan K, Debiec H, Rousseau A, Andreani M, Zaghrini C, Ticchioni M, Rosenthal A, Benzaken S, Bernard G, Lambeau G, Ronco P, Esnault VLM. High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy. Clin J Am Soc Nephrol. 2019 Aug 7;14(8):1173-1182. doi: 10.2215/CJN.11791018. Epub 2019 Jul 24.

family: Seitz-Polski

full_name: Barbara Seitz-Polski

given: Barbara

family: Dahan

full_name: Karine Dahan

given: Karine

family: Debiec

full_name: Hanna Debiec

given: Hanna

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

family: Andreani

full_name: Marine Andreani

given: Marine

family: Zaghrini

full_name: Christelle Zaghrini

given: Christelle

family: Ticchioni

full_name: Michel Ticchioni

given: Michel

family: Rosenthal

full_name: Alessandra Rosenthal

given: Alessandra

family: Benzaken

full_name: Sylvia Benzaken

given: Sylvia

family: Bernard

full_name: Ghislaine Bernard

given: Ghislaine

family: Lambeau

full_name: Gérard Lambeau

given: Gérard

family: Ronco

full_name: Pierre Ronco

given: Pierre

family: Esnault

full_name: Vincent L.M. Esnault

given: Vincent L.M.

journal_name: Clinical Journal of the American Society of Nephrology

ReferenceCitation: Dahan K, Debiec H, Plaisier E, Cachanado M, Rousseau A, Wakselman L, Michel PA, Mihout F, Dussol B, Matignon M, Mousson C, Simon T, Ronco P; GEMRITUX Study Group. Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up. J Am Soc Nephrol. 2017 Jan;28(1):348-358. doi: 10.1681/ASN.2016040449. Epub 2016 Jun 27.

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

location_facility: Department of Nephrology , Tenon hospital - APHP


title: Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients

summary:
Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.

Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

enrollment_type: Actual

lead_sponsor: Centre Jean Perrin

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Talk Therapy After Stroke. PS-POST AVC

acronym: PS-POST AVC

summary: Strokes are the first cause of acquired physical disability among adults. Some studies proved that depression is often an unrecognized complication from stroke, associated with a vital prognosis, functional and cognitive pejorative diagnosis. It led us to pose the hypothesis of the existence of a particular psychological state after stroke particularly favorable to a psychotherapeutic alliance. So, this longitudinal monocentric study aims to estimate the feasibility of a talk therapy and its impact on the anxio-depressive symptomatology after stroke.

status: Terminated

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Unknown


title: Predictive Study of Radiation Induced Sarcoma From the GSF-GETO Data Base.

acronym: SARI

summary: Development of sarcoma within or adjacent to radiation field is a well known event of poor prognosis and unknown risk factors. Advanced techniques of radiation therapy including intensity modulated radiation therapy, tomotherapy or Arc therapy are providing new modalities of radiation delivery that could be responsible for developing these induced tumors. There is little data on molecular biology of radiation induced sarcoma even if some tools are still available to characterize these types of tumors aiming to compare their profile to a sarcoma observed in non irradiated area. An update of the GETO-GCSF registry, currently called CONTICANET data base in the framework of EORTC, represents the backbone of the project. The next step should follow two axes, a clinical one based on the dosimetric analysis of the characteristics of delivered radiation therapy and the second one based on a molecular characterization of the sarcomas developed in irradiated field.The data base will be updated and organized through the CONTICANET network and the radiation oncologists involved in the treatment of soft tissue sarcoma. A retrospective analysis of the clinical data and the parameters describing the initial treatment will be registered using the methodology proposed by I. Diallo for radiation induced tumors developed in childhood. The most recent data will be extracted in DICOM format for intercomparison in a dedicated software.A centralized review of pathological specimens is planned to validate the correct classification of the tumors inside the current staging system developed for soft tissue sarcoma.

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Genetic


type: EudraCT Number

title: A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

summary: This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug


type: Other Identifier

title: French Observational Survey to Assess Hypoglycaemia in Insulin-treated Diabetic Patients

acronym: DIALOG

summary:
This non-interventional study is conducted in Europe. The study is both retrospective and prospective.

The purpose of the study is to assess the frequency of hypoglycaemia (low blood glucose) in insulin-treated patients with type 1 and type 2 diabetes.

study_type: Observational

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Cariou B, Fontaine P, Eschwege E, Lièvre M, Gouet D, Huet D, Madani S, Lavigne S, Charbonnel B. Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: results from the DIALOG study. Diabetes Metab. 2015 Apr;41(2):116-25. doi: 10.1016/j.diabet.2014.10.007. Epub 2014 Nov 24.

family: Cariou

full_name: B. Cariou

given: B.

sequence: first

family: Fontaine

full_name: P. Fontaine

given: P.

sequence: additional

family: Eschwege

full_name: E. Eschwege

given: E.

family: Lièvre

full_name: M. Lièvre

given: M.

family: Gouet

full_name: D. Gouet

given: D.

family: Huet

full_name: D. Huet

family: Madani

full_name: S. Madani

given: S.

family: Lavigne

full_name: S. Lavigne

family: Charbonnel

full_name: B. Charbonnel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes & Metabolism

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Frequency and predictors of confirmed hypoglycaemia in type 1 and insulin-treated type 2 diabetes mellitus patients in a real-life setting: Results from the DIALOG study

lead_sponsor: Novo Nordisk A/S


title: Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease With Vaso-occlusive Crisis and Morphinic Treatment

acronym: VPACS

summary:
Acute chest syndrome is a severe respiratory complication of sickle cell disease.

The standard prevention of this dangerous complication is spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.

The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than spirometry and may improve pain and quality of sleep.

Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly assigned with either spirometry or ventilation and the investigators will monitor for occurrence of acute chest syndrome, pain and quality of sleep.

design_allocation: Randomized

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Necker - Enfants Malades Hospital

intervention_type: Device


title: Phenotype of Pulmonary Fibrosis Associated With a Mutation of Telomerase

summary:
This study is an observational and retrospective study of patients with pulmonary fibrosis associated or not with telomerase mutation.

The purpose of this study is to describe in detail the cases with telomerase mutation in terms of features on CT scan, respiratory function and evolution, in comparison to control subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family history.

ipd_sharing: Yes

ipd_sharing_description: Under analysis, publication in preparation

lead_sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires


title: Treatment of Methicillin-sensitive Staphylococcus Aureus Orthopaedic Infections With Clindamycin in Combination With Rifampin or Levofloxacin: a Randomized Pharmacological and Clinical Study (the CLINDOS Trial)

acronym: CLINDOS

summary:
Background:

One of the leading causes of peri-operative osteoarticular infections (OAI) is Staphylococcus aureus. Treatment usually requires surgical debridement in association with appropriate antibiotic therapy. After surgery, an intravenous (IV) antibiotic therapy is routinely indicated for 10 to 15 days, followed by a minimal one-month oral treatment. In this protocol, the latter includes clindamycin in combination with rifampin or levofloxacin. Clindamycin is considered a good option in staphylococcal infections, because of its action against biofilm formation and bacterial adherence, its high level of joint and bone penetration and its good tolerance. Rifampin, a potent cytochrome P-450 inducer, enhances the elimination of a large number of drugs. Therefore, an influence of rifampin on clindamycin pharmacokinetics must be considered.

Objectives:

The primary objective is to compare the influence of rifampin and levofloxacin respectively on the pharmacokinetics of clindamycin in a randomized series of peri-operative staphylococcal OAI. The investigators then seek to determine the optimal drug association with regard to infection control and drug tolerance.

Study design:

Monocentric, randomized, open label, comparative study

Study period:

From November 2010 to October 2011.

Materials and Methods:

Following surgical debridement and after 10 to 15 days of IV antibiotherapy, patients are randomly assigned either to the "clindamycin/rifampin" arm either to the "clindamycin/levofloxacin" arm, according to the antimicrobial susceptibility testing. Peak and trough serum concentrations of clindamycin are measured at day-1, day-15 and day-30 of oral treatment. Rifampin and levofloxacin serum concentrations are measured at the same intervals to monitor patient compliance.

ReferenceType: derived

ReferenceCitation: Bernard A, Kermarrec G, Parize P, Caruba T, Bouvet A, Mainardi JL, Sabatier B, Nich C. Dramatic reduction of clindamycin serum concentration in staphylococcal osteoarticular infection patients treated with the oral clindamycin-rifampicin combination. J Infect. 2015 Aug;71(2):200-6. doi: 10.1016/j.jinf.2015.03.013. Epub 2015 Apr 30.

full_name: Aurélie Bernard

given: Aurélie

family: Kermarrec

full_name: Gwénolé Kermarrec

given: Gwénolé

family: Parize

full_name: Perrine Parize

given: Perrine

family: Caruba

full_name: Thibaut Caruba

given: Thibaut

family: Bouvet

full_name: Anaïs Bouvet

given: Anaïs

family: Mainardi

full_name: Jean-Luc Mainardi

given: Jean-Luc

family: Sabatier

full_name: Brigitte Sabatier

given: Brigitte

family: Nich

full_name: Christophe Nich

given: Christophe

journal_name: Journal of Infection


title: New Oral Anticoagulant Drugs Dabigatran Etexilate and Rivaroxaban: Influence of Genetic Factors in Healthy Volunteers

acronym: DRIVING

summary: The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

ReferenceCitation: Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V. Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months. Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28.

name: Innovations Thérapeutiques en Hémostase Université de ParisINSERM Paris France

name: Service d’Hématologie Biologique Hôpital LariboisièreAssistance Publique‐Hôpitaux de Paris (AP‐HP) Paris France

family: Foulon‐Pinto

full_name: Geoffrey Foulon‐Pinto

given: Geoffrey

name: Service d’Hématologie Biologique Hôpital CochinAssistance Publique‐Hôpitaux de Paris (AP‐HP) Paris France

family: Jourdi

full_name: Georges Jourdi

given: Georges

name: Université de LorraineINSERM, DCAC Nancy France

name: Service d’Hématologie Biologique Pôle Laboratoires CHRU Nancy Nancy France

family: Perrin

full_name: Julien Perrin

given: Julien

family: Abdoul

full_name: Johan Abdoul

given: Johan

family: Paris

full_name: Guillaume Paris

given: Guillaume

name: INSERM, CIC 1414 (Centre d'Investigation Clinique de Rennes) Université de RennesCHU de Rennes Rennes France

name: Service d’Hématologie Biologique CHU de Rennes Rennes France

family: Gouin‐Thibault

full_name: Isabelle Gouin‐Thibault

given: Isabelle

name: UR 7537 BioSTM Faculté de Pharmacie Université de Paris Paris France

name: Service de Biostatistique et Information Médicale AP‐HPHôpital Saint‐Louis Paris France

family: Curis

full_name: Emmanuel Curis

given: Emmanuel

name: Département de Médecine Faculté de Médecine ‐ GpG Hôpitaux Universitaires de GenèveUnité d'hémostaseUniversité de Genève Geneva Switzerland

family: Lecompte

full_name: Thomas Lecompte

given: Thomas

family: Siguret

full_name: Virginie Siguret

given: Virginie

journal_name: International Journal of Laboratory Hematology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Marques P, Courand PY, Gouin-Thibault I, Zhygalina V, Bergerot D, Salem JE, Funck-Brentano C, Loriot MA, Azizi M, Blanchard A. P-glycoprotein influences urinary excretion of aldosterone in healthy individuals. J Hypertens. 2019 Nov;37(11):2225-2231. doi: 10.1097/HJH.0000000000002150.

family: Marques

full_name: Pedro Marques

given: Pedro

family: Courand

full_name: Pierre-Yves Courand

given: Pierre-Yves

family: Gouin-Thibault

full_name: Isabelle Gouin-Thibault

family: Zhygalina

full_name: Valentina Zhygalina

given: Valentina

family: Bergerot

full_name: Damien Bergerot

given: Damien

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

family: Funck-Brentano

full_name: Christian Funck-Brentano

given: Christian

family: Loriot

full_name: Marie-Anne Loriot

given: Marie-Anne

family: Azizi

full_name: Michel Azizi

given: Michel

family: Blanchard

full_name: Anne Blanchard

given: Anne

bso_classification: Biology (fond.)

journal_name: Journal of Hypertension

oa_host_type: repository

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

host_type: repository

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

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

publisher: Ovid Technologies (Wolters Kluwer Health)


title: De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis: A Randomized Clinical Trial (DEA Study)

summary:
Rational: Severe sepsis is one of the leading cause of mortality in intensive care unit patients. Early initiation of an appropriate empirical antimicrobial therapy is associated with improved outcomes. In order to avoid an increase of selection pressure and the emergence of multidrug resistant pathogens, guidelines recommend to streamline the antimicrobial therapy after the identification of the pathogen responsible for infection. This strategy has been evaluated in several observational studies. However, at the bedside, few randomized clinical trials tested this strategy prospectively.

Method: the investigators conduct a randomized clinical trial comparing a strategy based on de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative strategy (continuation of the empirical antimicrobial therapy). The investigators first aim was to show that a strategy based on de-escalation is not inferior to a conservative strategy in terms of intensive care unit length of stay. Secondary aims are to compare the rate of mortality rate, the emergence of multidrug resistant pathogens, and the feasibility of de-escalation. The study is performed in nine intensive care units from four institutions, and 120 patients are required to validate the investigators hypothesis. New technologies for the rapid diagnosis of severe infections are investigated in an ancillary study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Procedure


title: Evaluation of Ticagrelor Anti Platelet and Pleiotropic Effects in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome.

summary:
Ticagrelor is a new P2Y12 ADP receptor antagonist. This drug demonstrated a faster onset of action and a higher potency compared to clopidogrel standard regimen. Consistently these properties were associated in the PLATO trial, and particularly in the percutaneous coronary intervention (PCI) arm of the study, with a lower incidence of thrombotic complications at one year follow-up but at a price of increased major bleedings (7,8). The major finding of the trial was a significant reduction in one year mortality in patients treated with ticagrelor. This reduction in mortality may not be related to the anti-platelet effect of the drug since another potent anti-platelet agent which was recently commercialized a did not exhibit any improvement in death compared to clopidogrel. Therefore there may be non anti platelet directed properties, or pleiotropic effects, of ticagrelor that could be involved in a reduction in mortality in acute coronary syndrome (ACS) patients. In fact together with its anti platelet properties, ticagrelor, has been shown to inhibit the uptake of adenosine by red cells, leading to an increase in adenosine plasma level and then activating the low affinity adenosine receptor thus potentially affecting the vascular homeostasis including endothelial cells. Therefore, it is hypothesis that the side effects and its benefit on mortality may be related to its interaction with adenosine metabolism. In line with this hypothesis, some adverse effects of ticagrelor (bradycardia and modulation of bronchoconstriction) are compatible with the activation of low affinity A1 or A2A adenosine receptors.

In addition the investigators have recently demonstrated that P2Y12 ADP blockade did impact the endothelial compartment during PCI (9). In fact the investigators have observed that the level of PR inhibition achieved by clopidogrel before PCI correlated with the extent of endothelial damage during PCI. More potent anti platelet drugs such as ticagrelor may thus be associated with reduced peri-procedural endothelial lesion which could further improve the clinical prognosis of patients. The investigators have previously observed that endothelial marker of lesion and regeneration could be measured in the blood post PCI (10).

Finally, in the response trial no patients in the ticagrelor arm had HTPR compared to 50% in the clopidogrel arm (7). This finding is surprising since recent data suggest that some patients still exhibit HTPR following the use of the very potent third generation thienopyridine prasugrel. This may be related to the fact that in the response trial only stable patients were included.

The investigators aimed to evaluate the anti-platelet efficacy and pleiotropic effects of ticagrelor in acute coronary syndromes patients undergoing percutaneous coronary intervention.


title: Prevalence of Transthyretin Amyloidosis in Hypertrophic Cardiomyopathy

acronym: Amylo

summary: Cardiac amyloidosis are related to the accumulation of fibrillar proteins in the extracellular leading to disruption of the cardiac tissue architecture. Amyloidosis in transthyretin (TTR) are the most common hereditary amyloidosis but remain poorly studied at heart. This is serious and deadly. The prevalence of TTR amyloidosis is probably underestimated in hypertrophic cardiomyopathy (HCM) often of unknown etiology because of the lack of systematic implementation of myocardial biopsy because of their side effects.

study_start_date_type: Actual

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Christoph DC, Boese D, Johnson KT, Schlosser TW, Hunold P, Baba HA, Erbel R, Philipp S. Heart failure and cardiac involvement as isolated manifestation of familial form of transthyretin amyloidosis resulting from Val30Met mutation with no clinical signs of polyneuropathy. Circ Heart Fail. 2009 Sep;2(5):512-5. doi: 10.1161/CIRCHEARTFAILURE.109.853697.

ReferenceCitation: Merlini G, Bellotti V. Molecular mechanisms of amyloidosis. N Engl J Med. 2003 Aug 7;349(6):583-96. Review.

ReferenceCitation: Mörner S, Hellman U, Suhr OB, Kazzam E, Waldenström A. Amyloid heart disease mimicking hypertrophic cardiomyopathy. J Intern Med. 2005 Sep;258(3):225-30.

ReferenceCitation: Jacobson DR, Pastore RD, Yaghoubian R, Kane I, Gallo G, Buck FS, Buxbaum JN. Variant-sequence transthyretin (isoleucine 122) in late-onset cardiac amyloidosis in black Americans. N Engl J Med. 1997 Feb 13;336(7):466-73.

ReferenceCitation: Planté-Bordeneuve V, Ferreira A, Lalu T, Zaros C, Lacroix C, Adams D, Said G. Diagnostic pitfalls in sporadic transthyretin familial amyloid polyneuropathy (TTR-FAP). Neurology. 2007 Aug 14;69(7):693-8.

ReferenceCitation: Planté-Bordeneuve V. [The diagnosis and management of familial amyloid polyneuropathy]. Rev Neurol (Paris). 2006 Nov;162(11):1138-46. Review. French.

ReferenceCitation: Rapezzi C, Merlini G, Quarta CC, Riva L, Longhi S, Leone O, Salvi F, Ciliberti P, Pastorelli F, Biagini E, Coccolo F, Cooke RM, Bacchi-Reggiani L, Sangiorgi D, Ferlini A, Cavo M, Zamagni E, Fonte ML, Palladini G, Salinaro F, Musca F, Obici L, Branzi A, Perlini S. Systemic cardiac amyloidoses: disease profiles and clinical courses of the 3 main types. Circulation. 2009 Sep 29;120(13):1203-12. doi: 10.1161/CIRCULATIONAHA.108.843334. Epub 2009 Sep 14.

ReferenceCitation: Said G, Planté-Bordeneuve V. Familial amyloid polyneuropathy: a clinico-pathologic study. J Neurol Sci. 2009 Sep 15;284(1-2):149-54. doi: 10.1016/j.jns.2009.05.001. Epub 2009 May 24.

ReferenceCitation: Saraiva MJ. Sporadic cases of hereditary systemic amyloidosis. N Engl J Med. 2002 Jun 6;346(23):1818-9.

lead_sponsor: Thibaud Damy


type: Registry Identifier

title: A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.

acronym: APAD

summary: Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.

primary_purpose: Supportive Care

ReferenceCitation: Carayol M, Ninot G, Senesse P, Bleuse JP, Gourgou S, Sancho-Garnier H, Sari C, Romieu I, Romieu G, Jacot W. Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial. BMC Cancer. 2019 Jul 25;19(1):737. doi: 10.1186/s12885-019-5896-6.

family: Carayol

full_name: Marion Carayol

given: Marion

family: Ninot

full_name: Gregory Ninot

given: Gregory

family: Senesse

full_name: Pierre Senesse

given: Pierre

family: Bleuse

full_name: Jean-Pierre Bleuse

given: Jean-Pierre

family: Gourgou

full_name: Sophie Gourgou

given: Sophie

family: Sancho-Garnier

full_name: Hélène Sancho-Garnier

given: Hélène

family: Sari

full_name: Chakib Sari

given: Chakib

family: Romieu

full_name: Isabelle Romieu

full_name: Gilles Romieu

given: Gilles

family: Jacot

full_name: William Jacot

given: William

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the “APAD1” randomized controlled trial

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE VALPROATE ON THE PHARMACOKINETICS OF RO4917838 AND VICE VERSA IN HEALTHY MALE VOLUNTEERS

summary: This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.


title: Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer

acronym: VOSETEP

summary:
Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume.

To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or moving organ by the patient position and belonging to a primary surgery.

The used methodology is based on lesion volume measure in preoperative time, obtained with PET, and on the measure of specimen volume by the anatomic laboratory after surgery.

This study's main objective is to compare this two measure of tumour size and secondarily to compare TEP with or without respiratory gating.

The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3 times:

A whole body acquisition in supine position, follow by a centered tumour acquisition with respiratory gating, then an acquisition in prone position to immobilise the lesion.

This study is monocentric and descriptive. It provides to include 30 patients in 1 year.

lead_sponsor: Centre Henri Becquerel


title: Monitoring of Encephalopathy in Cirrhotic Patients Admitted in Intensive Care Unit : Standardization of Critical Care Nursing

acronym: STANDAREA

summary: This study seeks to assess the impact of the standardization of nursing supervision of patients with hepatic encephalopathy using a grid of appropriate surveillance for the prevention of complications in the ICU.


title: BRD/11/02-Y "LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns".

summary:
The aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old.

The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Boquien CY, Billard H, Simon L, Boscher C, Legrand A, Joram E, Moyon T, Alexandre-Gouabau MC, Darmaun D, Rozé JC. Breast milk protein content at week 3 after birth and neurodevelopmental outcome in preterm infants fed fortified breast milk. Eur J Nutr. 2021 Oct;60(7):3959-3969. doi: 10.1007/s00394-021-02562-8. Epub 2021 Apr 30.

lead_sponsor: Nantes University Hospital

status_simplified: Ongoing


title: Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication

acronym: GGST

summary: In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.

ReferenceCitation: Scholtes C, André P, Trépo C, Cornu C, Remontet L, Ecochard R, Bejan-Angoulvant T, Gueyffier F. Farnesoid X receptor targeting for hepatitis C: study protocol for a proof-of-concept trial. Therapie. 2012 Sep-Oct;67(5):423-7. doi: 10.2515/therapie/2012058. Epub 2012 Dec 18.

family: Scholtes

full_name: Caroline Scholtes

given: Caroline

family: André

full_name: Patrice André

given: Patrice

family: Trépo

full_name: Christian Trépo

family: Cornu

full_name: Catherine Cornu

given: Catherine

family: Remontet

full_name: Laurent Remontet

given: Laurent

family: Ecochard

full_name: René Ecochard

given: René

family: Bejan-Angoulvant

full_name: Theodora Bejan-Angoulvant

given: Theodora

family: Gueyffier

full_name: François Gueyffier

given: François

journal_name: Therapies

title: Farnesoid X Receptor Targeting for Hepatitis C: Study Protocol for a Proof-of-concept Trial

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu


title: Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients

summary: This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of hepatocellular carcinoma (HCC) by studying their variation following curative treatment of HCC. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence.

status: Unknown status

ReferenceCitation: Henry L, Lavabre-Bertrand T, Vercambre L, Ramos J, Carillo S, Guiraud I, Pouderoux P, Bismuth M, Valats JC, Demattei C, Duny Y, Chaze I, Funakoshi N, Bureau JP, Daurès JP, Blanc P. Plasma proteasome level is a reliable early marker of malignant transformation of liver cirrhosis. Gut. 2009 Jun;58(6):833-8. doi: 10.1136/gut.2008.157016. Epub 2009 Feb 6.

lead_sponsor: University Hospital, Montpellier

intervention_type: Biological


title: LEft Atrial Pacing in Diastolic Heart Failure

acronym: LEAD

summary: The purpose of this study is to assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of the Enteric Nervous System Using Colonic Biopsies in Parkinson Patients With LRRK2 Mutation

acronym: EnteroLarc

summary: The clinical and pathological similarities between LRRK2 related parkinsonism and idiopathic Parkinson's disease (PD) indicate that monogenetic LRRK2 parkinsonism may be a paradigm for the development of Lewy bodies disease, and a careful look at discrepancies between these two conditions may provide insight into the pathogenesis of PD. The early involvement of the enteric nervous system (ENS) during PD led to theories that an as yet unidentified external agent entering the ENS causes PD . If lesions of the ENS are found in patients who present with a genetic form of parkinsonism would go against this notion, and thus provide insight to the pathophysiology of the disease.

primary_purpose: Diagnostic


ReferenceCitation: Goutagny S, Raymond E, Esposito-Farese M, Trunet S, Mawrin C, Bernardeschi D, Larroque B, Sterkers O, Giovannini M, Kalamarides M. Phase II study of mTORC1 inhibition by everolimus in neurofibromatosis type 2 patients with growing vestibular schwannomas. J Neurooncol. 2015 Apr;122(2):313-20. doi: 10.1007/s11060-014-1710-0. Epub 2015 Jan 8.

location_facility: Hôpital Beaujon, 100 boulevard du Général Leclerc

source: euctr

title: A Single Arm, Single Center, Phase II Trial of RAD001 as Monotherapy in the Treatment of Neurofibromatosis Type 2 - Related Vestibular Schwannoma

summary: The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients.


title: Study Accelerometer Signals to Measure Daily Activities: a Pilot Study

summary: The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.

primary_purpose: Basic Science

lead_sponsor: AdministrateurCIC


title: Etude Clinique Observationnelle, Prospective, Ouverte, Monocentrique Sur l'Utilisation d'un Mode Ventilatoire entièrement automatisé Chez Les Patients de réanimation de l'Intubation Jusqu'au Sevrage.

acronym: intellivent

summary:
Rational: Intellivent is a ventilation mode completely automated which controls ventilation and oxygenation parameters. Safety and performance of IntelliVent has still been demonstrated in post operative heart surgery for patient with a controlled ventilation on short period (2 to 4 hours). This feasibility study evaluate the use of Intellivent for Intensive care unit patients from intubation to coming off.

Primary objective : Compare parameters which have been selected by automated mod (Intellivent) to those selected by clinical practitioner in a conventional mode

Secondary objectives: Record oxygenation , gaseous interchange and ventilation parameters. Record complications, number of manual adjustments and prognostic signs.

Methodology: Patients in the intensive care unit who need invasive ventilation. They will be included after a detailed information (information note). Oxygenation and ventilation parameters will be recorded 2 times by day from intubation to coming off. The investigator in charge will determine daily at the bedside of the patient the adjustments he should make in a conventional mode. These adjustments will be compared to the IntelliVent automated adjustments.

Experimental study, observational, prospective, comparative, opened, monocentric in an intensive care unit.

Number of patients: 100

ReferenceCitation: Arnal JM, Wysocki M, Nafati C, Donati S, Granier I, Corno G, Durand-Gasselin J. Automatic selection of breathing pattern using adaptive support ventilation. Intensive Care Med. 2008 Jan;34(1):75-81. Epub 2007 Sep 11.

ReferenceCitation: Arnal JM, Garnero A, Novonti D, Demory D, Ducros L, Berric A, Donati S, Corno G, Jaber S, Durand-Gasselin J. Feasibility study on full closed-loop control ventilation (IntelliVent-ASV™) in ICU patients with acute respiratory failure: a prospective observational comparative study. Crit Care. 2013 Sep 11;17(5):R196. doi: 10.1186/cc12890.

family: Arnal

full_name: Jean-Michel Arnal

given: Jean-Michel

family: Garnero

full_name: Aude Garnero

given: Aude

family: Novonti

full_name: Dominik Novonti

given: Dominik

family: Demory

full_name: Didier Demory

given: Didier

family: Ducros

full_name: Laurent Ducros

family: Berric

full_name: Audrey Berric

given: Audrey

family: Donati

full_name: Stéphane Donati

given: Stéphane

family: Corno

full_name: Gaëlle Corno

given: Gaëlle

family: Jaber

full_name: Samir Jaber

given: Samir

family: Durand-Gasselin

full_name: Jacques Durand-Gasselin

given: Jacques

journal_name: Critical Care

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Randomized Open Label Study Evaluating the Coverage by Teleconsultation Versus Standard Follow-up of Renal Transplant Patients According to a Risk Score of Early Graft Failure (KTFS)

acronym: TELEGRAFT

summary: The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations.

primary_purpose: Other


title: Evaluation of the Cerebral Responses to Exercise in Hypoxia

acronym: CERVOX

summary: While the exercise responses are classically described at the cardiorespiratory and muscle levels, recent data suggest that the brain is also significantly stressed by exercise and may even participate to performance limitation. In hypoxia in particular, cerebral responses to exercise may be altered and promote performance reduction during endurance exercise. In the present study, the investigators used innovative approaches to assess cerebral perturbations associated with exercise in hypoxia.

lead_sponsor: University Hospital, Grenoble


title: Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies

summary: Elastography is a emerging imaging technique that has demonstrated high reliability in the assessment of tissues stiffness and quantification of fibrosis particularly in adult's livers. This ultrasound exploration has no secondary effects. There is no study published in the pediatric population concerning the role of ultrasound elastrography in kidney. The aim of this study is to look for a correlation between the elastography's results and the kidney fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential diagnostic and/or prognostic role in the management of these patients which would limit invasive biopsy procedures.

enrollment_type: Anticipated


acronym: confuriv

title: A Randomized, Double-blind, Placebo-controlled Study of an Acetylcholinesterase Inhibitor in the Management of Delirium in Hospitalized Patients Aged 75 Years and Over

summary:
The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium.

Study type : Interventional Study design: randomized, double-blind, placebo-controlled study during one month and a 11-month follow-up


title: Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors

summary: Major surgery is associated with a postoperative hypercoagulable state related to the surgical trauma that may lead to thromboembolic complications. To the investigators knowledge, only two series have reported the risk of PE after liver surgery with an incidence of up to 6.3% The purpose of this study is to identify the independent risk factors associated with the development of PE after elective liver surgery.

lead_sponsor: Beaujon Hospital

intervention_type: Radiation


title: Assessment of the Tumor Vascular Effects of the Pan-vegfr Tyrosine Kinase Inhibitor Axitinib Using Dynamic Contrast-enhanced Ultrasonography (Dce-us) in Patients With Refractory Metastatic Colorectal Cancer

acronym: AXUS

summary: The purpose of this study is to evaluate and quantify the dynamic modifications of tumor blood perfusion on axitinib therapy in patients with refractory mCRC for each dose of Axitinib.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings

summary: The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone.

lead_sponsor: Laboratoires Innothera


title: Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections: a Multicentric, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial

acronym: CHLORHEX

summary:
Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases.

Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.

ReferenceCitation: D'Journo XB, Falcoz PE, Alifano M, Le Rochais JP, D'Annoville T, Massard G, Regnard JF, Icard P, Marty-Ane C, Trousse D, Doddoli C, Orsini B, Edouard S, Million M, Lesavre N, Loundou A, Baumstarck K, Peyron F, Honoré S, Dizier S, Charvet A, Leone M, Raoult D, Papazian L, Thomas PA. Oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate in lung cancer surgery: a randomized clinical trial. Intensive Care Med. 2018 May;44(5):578-587. doi: 10.1007/s00134-018-5156-2. Epub 2018 Apr 18.

family: D’Journo

full_name: Xavier Benoit D’Journo

given: Xavier Benoit

family: Falcoz

full_name: Pierre-Emmanuel Falcoz

given: Pierre-Emmanuel

family: Alifano

full_name: Marco Alifano

given: Marco

family: Le Rochais

full_name: Jean-Philippe Le Rochais

given: Jean-Philippe

family: D’Annoville

full_name: Thomas D’Annoville

given: Thomas

family: Massard

full_name: Gilbert Massard

given: Gilbert

family: Regnard

full_name: Jean Francois Regnard

given: Jean Francois

family: Icard

full_name: Philippe Icard

given: Philippe

family: Marty-Ane

full_name: Charles Marty-Ane

given: Charles

family: Trousse

full_name: Delphine Trousse

given: Delphine

family: Doddoli

full_name: Christophe Doddoli

given: Christophe

family: Orsini

full_name: Bastien Orsini

given: Bastien

family: Edouard

full_name: Sophie Edouard

given: Sophie

family: Million

full_name: Matthieu Million

given: Matthieu

family: Lesavre

full_name: Nathalie Lesavre

given: Nathalie

family: Loundou

full_name: Anderson Loundou

given: Anderson

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Peyron

full_name: Florence Peyron

given: Florence

family: Honoré

full_name: Stephane Honoré

given: Stephane

family: Dizier

full_name: Stéphanie Dizier

given: Stéphanie

family: Charvet

full_name: Aude Charvet

family: Leone

full_name: Marc Leone

given: Marc

family: Raoult

full_name: Didier Raoult


title: Evaluation of Positron Emission Tomography in Extrapulmonary Tuberculosis

acronym: TUBOGTEP

summary: Tuberculosis (TB) remains a major public health problem. In extra-pulmonary forms, evidence of bacteriological cure is difficult to be obtained raising the need for other therapeutic assessment tools. 18F-Fluoro-deoxy-glucose (FDG) is a glucose analogue widely used in Positron Emission Tomography (PET). Its uptake is high in cancer cells and in inflammatory cells, especially in active TB foci. The hypothesis is a decrease in the uptake of FDG in the foci of TB during treatment permitting a non-invasive monitoring of therapeutic response. The main objective is to describe the evolution under treatment of the FDG uptake in PET imaging in TB foci in patients cured from lymph node and bone TB. Secondary objectives are to compare the decrease of FDG uptake according to type of location, to define the frequency of localizations revealed by FDG-PET and their impact on therapeutic management at the beginning and the end of treatment, and to describe the evolution of PET in patients not cured.

ipd_sharing: Undecided


title: Phase II Salvage Treatment With Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in Relapsed B-cell Chronic Lymphocytic Leukemia (B-CLL)

acronym: BOMP

summary:
ICLL01 The BOMP trial: Phase II study of salvage treatment with Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL).

A study of the GOELAMS / GCFLLC-MW intergroup

lead_sponsor: French Innovative Leukemia Organisation


title: Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1

acronym: TB Dermatest

summary:
The only test available for in vivo diagnosis of tuberculosis is the intradermal injection of tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin test).

The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However, this test needs to be performed by trained personnel, presents problem of reproducibility, and its interpretation is not well standardized (measure in millimeters of skin induration 48 to 72 hours after the PPD skin test).

The new generation BD micro needle used in this study should solve the technical difficulties; intradermal administration of tuberculin could then be made by any personnel.

A non-invasive and objective instrumental method of reading the test will be also tested .

location_facility: Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie-Centre Hospitalier Lyon Sud -Hospices Civils de Lyon


title: Comparison of Helmet NEXT, Helmet Standard and Facemask for Noninvasive Ventilation: a Physiological Study in Healthy Volunteers

summary: Noninvasive ventilation (NIV) is a well established, safe, and effective technique in improving gas exchange while reducing dyspnea and inspiratory effort in patients with either hypoxemic and hypercapnic acute respiratory failure (ARF) and averts the risk secondary to endotracheal intubation.Crucial factors for NIV success, in any forms of respiratory failure, are the tolerance to the interface used and the ability of the interface to unload inspiratory-muscle. Helmet is better tolerated over time, allowing continuous application of NIV for longer periods, while face mask has been proved to be more efficient at iso-support in unloading the respiratory muscles and improving patient-ventilator synchrony. Helmet NEXT (CaStar, NIV model, Starmed, Mirandola, Italy) is a novel type of helmet with a better compliant wall, that avoid the use of armpit braces potentially improving, compared to the standard helmet, both pressurization and patient-ventilator interaction and tolerance. The objective of this study is to compare the effects of NIV delivered via face mask, standard helmet, and NEXT helmet in terms of work of breathing, patient-ventilator interaction, and comfort.

ReferenceCitation: Vaschetto R, De Jong A, Conseil M, Galia F, Mahul M, Coisel Y, Prades A, Navalesi P, Jaber S. Comparative evaluation of three interfaces for non-invasive ventilation: a randomized cross-over design physiologic study on healthy volunteers. Crit Care. 2014 Jan 3;18(1):R2. doi: 10.1186/cc13175.

family: Vaschetto

full_name: Rosanna Vaschetto

given: Rosanna

family: De Jong

full_name: Audrey De Jong

given: Audrey

family: Conseil

full_name: Matthieu Conseil

family: Galia

full_name: Fabrice Galia

given: Fabrice

family: Mahul

full_name: Martin Mahul

given: Martin

family: Coisel

full_name: Yannael Coisel

given: Yannael

family: Prades

full_name: Albert Prades

given: Albert

family: Navalesi

full_name: Paolo Navalesi

given: Paolo

family: Jaber

full_name: Samir Jaber

given: Samir

location_facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital


title: Effect of Spacing of Anti-TNF Drugs in Ankylosing Spondylitis With Low Disease Activity: a Randomized Controlled Trial

acronym: SPACING

summary: Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.


title: COPARIME: Pilot Study of a Target Detection of Malignant Melanoma

summary: Melanoma is nowadays an important public health problem because its growing incidence. Mass screening for melanoma is not recommended worldwide because of its low cost-effectiveness. Nevertheless targeted screening for patients at high risk for melanoma is promoted. This study is designed to assess the effectiveness and the acceptability of a melanoma targeted screening of melanoma, to estimate the risk function to develop a melanoma among patients at high risk according to the SAMScore and to estimate the ratio cost/ efficacy of the melanoma targeted screening. A cohort of 7700 patients is carried out in 2 departments covered by a registry of cancers. The recruitment had began in April 2011. Patients assessed at high risk according to the SAMScore were proposed a skin examination by their GP every year.

ReferenceCitation: Rat C, Hild S, Gaultier A, Khammari A, Bonnaud-Antignac A, Quereux G, Dreno B, Nguyen JM. Anxiety, locus of control and sociodemographic factors associated with adherence to an annual clinical skin monitoring: a cross-sectional survey among 1000 high-risk French patients involved in a pilot-targeted screening programme for melanoma. BMJ Open. 2017 Oct 5;7(10):e016071. doi: 10.1136/bmjopen-2017-016071.

family: Rat

full_name: Cédric Rat

given: Cédric

family: Hild

full_name: Sandrine Hild

given: Sandrine

family: Gaultier

full_name: Aurelie Gaultier

given: Aurelie

family: Khammari

full_name: Amir Khammari

given: Amir

family: Bonnaud-Antignac

full_name: Angelique Bonnaud-Antignac

given: Angelique

family: Quereux

full_name: Gaelle Quereux

given: Gaelle

family: Dreno

full_name: Brigitte Dreno

given: Brigitte

family: Nguyen

full_name: Jean Michel Nguyen

given: Jean Michel

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

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

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

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Rat C, Grimault C, Quereux G, Dagorne M, Gaultier A, Khammari A, Dreno B, Nguyen JM. Proposal for an annual skin examination by a general practitioner for patients at high risk for melanoma: a French cohort study. BMJ Open. 2015 Jul 29;5(7):e007471. doi: 10.1136/bmjopen-2014-007471.

family: Grimault

full_name: Charlotte Grimault

given: Charlotte

family: Dagorne

full_name: Maelenn Dagorne

given: Maelenn

full_name: Aurélie Gaultier

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

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

ReferenceCitation: Rat C, Quereux G, Grimault C, Gaultier A, Khammari A, Dreno B, Nguyen JM. Melanoma incidence and patient compliance in a targeted melanoma screening intervention. One-year follow-up in a large French cohort of high-risk patients. Eur J Gen Pract. 2015 Jun;21(2):124-30. doi: 10.3109/13814788.2014.949669. Epub 2014 Aug 20.


title: Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

summary: The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

time_perspective: Other

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP Robert-Debré, Department of Pediatric Nephrology


title: Benefit of Rehabilitation Program in Colorectal Laparoscopic Surgery

acronym: REHAB

summary: Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.

location_facility: Service de chirurgie Colorectale / Hôpital Beaujon


title: Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study

summary: Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.


title: IClyCO Influence of Chemotherapy (Carboplatin and Taxol) on the ex Vivo Expansion and Functional Capacity of Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer

acronym: IClyCO

summary:
In patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy.

The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.

The long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on Vgamma9Vdelta2 T cells.

status: Withdrawn

lead_sponsor: Rennes University Hospital


title: Effects of Sleep Deprivation on Driving Performance and Central Fatigue

acronym: PrivSom

summary: The effects of sleep deprivation (SD) on performance, while contradictory at first glance, are in reality rather clear when exercise duration is considered, i.e. intense/supramaximal versus prolonged exercises. This latter type of exercise leads to the most important performance decrements after SD.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients

summary: The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same sensitivity to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment is limited. The first line optimal treatment has to be defined by a prospective and randomized evaluation of other strategies. The primary endpoint will be adapted to the specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to the classical triple therapy, shows an immunovirological response, at least, as good as the one obtained with the triple therapy. The hypothesis is that the low ART response observed in HIV-2 infection is due to a low virological strength of the ARTs used and that the combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at week 48.

ReferenceCitation: Matheron S, Descamps D, Gallien S, Besseghir A, Sellier P, Blum L, Mortier E, Charpentier C, Tubiana R, Damond F, Peytavin G, Ponscarme D, Collin F, Brun-Vezinet F, Chene G; France REcherche Nord&Sud Sida-Hiv Hépatites (ANRS) 159 HIV-2 Trial Study Group. First-line Raltegravir/Emtricitabine/Tenofovir Combination in Human Immunodeficiency Virus Type 2 (HIV-2) Infection: A Phase 2, Noncomparative Trial (ANRS 159 HIV-2). Clin Infect Dis. 2018 Sep 28;67(8):1161-1167. doi: 10.1093/cid/ciy245.

apc_source: openAPC

name: Hopital Bichat-Claude Bernard, Assistance Publique–Hôpitaux de Paris (AP-HP)

name: Institut national de la santé et de la recherche médicale (INSERM), Infection, Antimicrobiens, Modélisation, Evolution, Unité Mixte de Recherche (UMR) 1137

name: Université Paris Diderot, Sorbonne Paris Cité

family: Matheron

full_name: Sophie Matheron

given: Sophie

family: Descamps

full_name: Diane Descamps

given: Diane

family: Gallien

full_name: Sebastien Gallien

given: Sebastien

name: INSERM, Bordeaux Population Health Research Center, UMR 1219, Université Bordeaux, Institut de santé publique, d'épidémiologie et de développement, Centre Hospitalier Universitaire Bordeaux

family: Besseghir

full_name: Amel Besseghir

given: Amel

family: Sellier

full_name: Pierre Sellier

given: Pierre

family: Blum

full_name: Laurent Blum

given: Laurent

family: Mortier

full_name: Emmanuel Mortier

given: Emmanuel

family: Charpentier

full_name: Charlotte Charpentier

name: Hopital Pitié-Salpetriere, AP-HP, Université Paris 6, INSERM, Institut Pierre-Louis Epidémiologie et Santé Publique, UMR en Santé 1136, Paris, France

family: Tubiana

full_name: Roland Tubiana

given: Roland

family: Damond

full_name: Florence Damond

given: Florence

family: Peytavin

full_name: Gilles Peytavin

given: Gilles

family: Ponscarme

full_name: Diane Ponscarme

family: Collin

full_name: Fideline Collin

given: Fideline

family: Brun-Vezinet

full_name: Francoise Brun-Vezinet

given: Francoise

family: Chene

full_name: Genevieve Chene

given: Genevieve

full_name: S Matheron

given: S

family: Boue

full_name: F Boue

given: F

family: Goujard

full_name: C Goujard

given: C

family: Weiss

full_name: L Weiss

given: L

family: Rami

full_name: A Rami

given: A

full_name: E Mortier

given: E

full_name: R Tubiana

given: R

family: Campa

full_name: P Campa

given: P

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

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


title: Retinal Sensitivity and Optical Coherence Tomography Findings in Eyes With Idiopathic Epiretinal Membrane

summary:
Purpose: To evaluate macular sensitivity and its correlation with visual acuity and Spectral Domain Optical Coherence Tomography (SD-OCT) in eyes with idiopathic epiretinal membrane (ERM).

Design: Cross sectional case-control series.

Methods:

Setting: Dijon University Hospital. Patients: Forty nine patients (49 eyes) with idiopathic ERM and twenty-seven healthy patients (27 eyes) as a control group.

Main outcome measurement: Microperimetry, Spectral Domain Optical Coherence Tomography (SD-OCT).


title: Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.

acronym: BACLOVILLE

summary: The main objective of this study is to show the effectiveness to a year of baclofen compared to placebo, on the proportion of patients with a low risk alcohol consumption or no, according to the WHO standards.

ReferenceCitation: Braillon A, Naudet F. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean. Mayo Clin Proc. 2020 Oct;95(10):2294-2295. doi: 10.1016/j.mayocp.2020.08.005.

family: Braillon

full_name: Alain Braillon

given: Alain

family: Naudet

full_name: Florian Naudet

given: Florian

journal_name: Mayo Clinic Proceedings

oa_host_type: publisher

evidence: open (via free pdf)

ipd_sharing: No


title: Identification and Genetic, Clinical and Metabolic Characterization of Monogenic Forms of Insulin-dependent Diabetes

acronym: DIAGENE

summary: Type 1 Diabetes is a multifactorial disease, with a strong genetic contribution of HLA genes, and minor contributions of many additional genes. The investigators hypothesis is that in addition to multifactorial inheritance, there are subtypes of diabetes that are caused by defects in single genes (monogenic diabetes). The aim of this project is to identify these genes, based on detailed clinical and characterization of patients, and to describe the corresponding genetic diabetes entities with respect to the genetic and molecular defect, clinical features and biochemistry. Based on the investigators study design, most of these diabetes entities will be caused by mutations affecting the two copies of the corresponding gene. In addition, the investigators will study the relatives of the patients, and explore if carriers of these genetic defects (i.e. only one copy of the gene being defective) may have a predisposition to common forms of diabetes, mainly type 2 diabetes.


title: Antagonists NMDA in Relay to Ketamine in Neuropathic Pain

acronym: NMDA

summary:
The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity.

In clinical, after ketamine cure, clinicians have often difficulties to treat patients in order to maintain analgesia or suggest another treatment if analgesia induced by ketamine was not effective, which occurs in one quarter of patients. It will be very useful for monitoring of painful patients evaluate if memantine or dextromethorphan could be an effective therapeutic alternative in neuropathic pain treatment.

ReferenceCitation: Pickering G, Pereira B, Morel V, Tiberghien F, Martin E, Marcaillou F, Picard P, Delage N, de Montgazon G, Sorel M, Roux D, Dubray C. Rationale and design of a multicenter randomized clinical trial with memantine and dextromethorphan in ketamine-responder patients. Contemp Clin Trials. 2014 Jul;38(2):314-20. doi: 10.1016/j.cct.2014.06.004. Epub 2014 Jun 16.

family: Pickering

full_name: Gisèle Pickering

given: Gisèle

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Morel

full_name: Véronique Morel

given: Véronique

family: Tiberghien

full_name: Florence Tiberghien

family: Martin

full_name: Elodie Martin

given: Elodie

family: Marcaillou

full_name: Fabienne Marcaillou

given: Fabienne

family: Picard

full_name: Pascale Picard

given: Pascale

family: Delage

full_name: Noémie Delage

given: Noémie

family: de Montgazon

full_name: Géraldine de Montgazon

given: Géraldine

family: Sorel

full_name: Marc Sorel

given: Marc

family: Roux

full_name: Delphine Roux

given: Delphine

family: Dubray

full_name: Claude Dubray

given: Claude

journal_name: Contemporary Clinical Trials

lead_sponsor: University Hospital, Clermont-Ferrand


title: Acute and Chronic Problems Associated With the Practice of Mountain Ultramarathon

summary: Acute physiological consequences of ultramarathon running are still unknown, particularly in women. Results from the investigators first studies conducted in 2009 have shown that a large part of fatigue induced by a mountain ultramarathon could be attributed to central fatigue. The investigators have investigated the biological consequences and neuromuscular fatigue only in male runners. Data from the literature suggest that amplitude and etiology of fatigue after prolonged exercise might be gender-dependant.The main purpose of the present project is thus to quantify supraspinal central fatigue and associated changes in cortical excitability after an extreme exercise such as a mountain ultramarathon: the Ultra-Trail du Mont-blanc, by using TMS.


title: Multicentre Investigation of the Efficacy and Safety of Adacolumn® GMA in Patients With Steroid-Dependent Active Ulcerative Colitis and Insufficient Response or Intolerance to Immunosuppressants and/or Biological Therapies

acronym: ART

summary: The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients. The patient subset of interest is those with moderate/severe, steroid-dependent, active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biological agents.

lead_sponsor: Otsuka Pharmaceutical Europe Ltd


title: Screening and Risk Factors of Pulmonary Arterial Hypertension in BMPR2 Mutation Asymptomatic Carriers

summary:
In this prospective study, the investigators will implement a systematic screening program and 3-year follow-up in a cohort of asymptomatic BMPR2 mutation carriers. This study is designed to:

determine predictive factors (biological, functional, radiological and hemodynamic) of development of PAH
monitor these subjects' clinical, functional, biological, echocardiographic and hemodynamic characteristics
assess the risk of occurrence of PAH
screen patients with PAH at an early stage of disease and offer them an early management
constitute a collection of biological samples (0, 12, 24 months follow-up) of asymptomatic BMPR2 mutation carriers.

ReferenceCitation: Montani D, Girerd B, Jaïs X, Laveneziana P, Lau EMT, Bouchachi A, Hascoët S, Günther S, Godinas L, Parent F, Guignabert C, Beurnier A, Chemla D, Hervé P, Eyries M, Soubrier F, Simonneau G, Sitbon O, Savale L, Humbert M. Screening for pulmonary arterial hypertension in adults carrying a BMPR2 mutation. Eur Respir J. 2021 Jul 22;58(1). pii: 2004229. doi: 10.1183/13993003.04229-2020. Print 2021 Jul.

family: Montani

full_name: David Montani

given: David

family: Girerd

full_name: Barbara Girerd

given: Barbara

family: Jaïs

full_name: Xavier Jaïs

given: Xavier

family: Laveneziana

full_name: Pierantonio Laveneziana

given: Pierantonio

family: Lau

full_name: Edmund M.T. Lau

given: Edmund M.T.

family: Bouchachi

full_name: Amir Bouchachi

given: Amir

family: Hascoët

full_name: Sébastien Hascoët

given: Sébastien

family: Günther

full_name: Sven Günther

given: Sven

family: Godinas

full_name: Laurent Godinas

given: Laurent

family: Parent

full_name: Florence Parent

given: Florence

family: Guignabert

full_name: Christophe Guignabert

given: Christophe

family: Beurnier

full_name: Antoine Beurnier

given: Antoine

family: Chemla

full_name: Denis Chemla

given: Denis

family: Hervé

full_name: Philippe Hervé

given: Philippe

family: Eyries

full_name: Mélanie Eyries

given: Mélanie

family: Soubrier

full_name: Florent Soubrier

given: Florent

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: Sitbon

full_name: Olivier Sitbon

given: Olivier

family: Savale

full_name: Laurent Savale

family: Humbert

full_name: Marc Humbert

journal_name: European Respiratory Journal

oa_colors: green hybrid

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


title: Effect of Consumption of Eggs Rich in Xanthophyll Carotenoids and Omega-3 Fatty Acids on the Macular Pigment in Healthy People

acronym: ALGOVUE

summary: This study is to determine the impact of the consumption of eggs rich in lutein/zeaxanthin from lucerne protein concentrate and DHA from microalgae on the plasma levels of these compounds but also on the macular pigment optical density, whose elevation may be beneficial in the prevention of Age-related Macular Degeneration (AMD).

lead_sponsor: Institut Pasteur de Lille


title: Effects Of A Recruitment Maneuver On Plasma Levels of sRAGE, The Soluble Form of The Receptor For Advanced Glycation End Products, In Patients With Diffuse Acute Respiratory Distress Syndrome (ARDS)

acronym: DAMAGE

summary: RAGE, the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type I cell injury, and soluble RAGE (sRAGE) is elevated in the plasma and in the pulmonary edema fluid from patients with ALI/ARDS. Few data are available about the influence of ventilatory interventions on levels of sRAGE in the setting of ALI/ARDS. The purpose of this prospective monocentric randomized controlled cross-over study is to describe the effects of a recruitment maneuver (RM) on plasma sRAGE levels during diffuse ARDS.

ReferenceCitation: Jabaudon M, Hamroun N, Roszyk L, Guérin R, Bazin JE, Sapin V, Pereira B, Constantin JM. Effects of a recruitment maneuver on plasma levels of soluble RAGE in patients with diffuse acute respiratory distress syndrome: a prospective randomized crossover study. Intensive Care Med. 2015 May;41(5):846-55. doi: 10.1007/s00134-015-3726-0. Epub 2015 Mar 20.

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

family: Hamroun

full_name: Nacim Hamroun

given: Nacim

family: Roszyk

full_name: Laurence Roszyk

given: Laurence

family: Guérin

full_name: Renaud Guérin

given: Renaud

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Sapin

full_name: Vincent Sapin

given: Vincent

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

journal_name: Intensive Care Medicine


title: Determination of Optimal PEEP Level Under Patient Control in Tracheostomized Ventilated Patients

acronym: OptiPEP

summary:
Adequate communication is a major part of the quality of life of tracheostomized ventilator dependent patients. Maintaining speech is therefore major goal in the management of these patients.

The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the improvement of speech. The best level for speech may vary from one patient to the other The purpose of this study is to determine individually the most efficient PEEP level in terms of speech while obtaining the most secure condition and the best possible respiratory tolerance. In order to improve the latter, the investigators will use a device which allows the patients to control the activation of PEEP so that they can use it only when needed (i.e. when they wish to speak). The investigators will compare the effect of different PEEP level to try to determine the best compromise to improve speech in tracheostomized ventilator-dependent patients.

ReferenceCitation: Prigent H, Samuel C, Louis B, Abinun MF, Zerah-Lancner F, Lejaille M, Raphael JC, Lofaso F. Comparative effects of two ventilatory modes on speech in tracheostomized patients with neuromuscular disease. Am J Respir Crit Care Med. 2003 Jan 15;167(2):114-9. Epub 2002 Oct 4.

ReferenceCitation: Prigent H, Garguilo M, Pascal S, Pouplin S, Bouteille J, Lejaille M, Orlikowski D, Lofaso F. Speech effects of a speaking valve versus external PEEP in tracheostomized ventilator-dependent neuromuscular patients. Intensive Care Med. 2010 Oct;36(10):1681-7. doi: 10.1007/s00134-010-1935-0. Epub 2010 Jun 10.

ReferenceCitation: Pellegrini N, Pelletier A, Orlikowski D, Lolierou C, Ruquet M, Raphaël JC, Lofaso F. Hand versus mouth for call-bell activation by DMD and Becker patients. Neuromuscul Disord. 2007 Jul;17(7):532-6. Epub 2007 May 29.

ReferenceCitation: Bach JR, Alba AS. Tracheostomy ventilation. A study of efficacy with deflated cuffs and cuffless tubes. Chest. 1990 Mar;97(3):679-83.

ReferenceCitation: Hoit JD, Banzett RB, Lohmeier HL, Hixon TJ, Brown R. Clinical ventilator adjustments that improve speech. Chest. 2003 Oct;124(4):1512-21.

ReferenceCitation: Hoit JD, Shea SA, Banzett RB. Speech production during mechanical ventilation in tracheostomized individuals. J Speech Hear Res. 1994 Feb;37(1):53-63.

ReferenceCitation: Garguilo M, Leroux K, Lejaille M, Pascal S, Orlikowski D, Lofaso F, Prigent H. Patient-controlled positive end-expiratory pressure with neuromuscular disease: effect on speech in patients with tracheostomy and mechanical ventilation support. Chest. 2013 May;143(5):1243-1251. doi: 10.1378/chest.12-0574.

family: Garguilo

full_name: Marine Garguilo

given: Marine

family: Leroux

full_name: Karl Leroux

given: Karl

family: Lejaille

full_name: Michèle Lejaille

given: Michèle

family: Pascal

full_name: Sophie Pascal

given: Sophie

family: Orlikowski

full_name: David Orlikowski

given: David

family: Lofaso

full_name: Frédéric Lofaso

given: Frédéric

family: Prigent

full_name: Hélène Prigent

given: Hélène

journal_name: Chest

title: Patient-Controlled Positive End-Expiratory Pressure With Neuromuscular Disease

lead_sponsor: University of Versailles


title: Evaluation of the Efficacy and Tolerance of B-Back® on the Burnout Syndrome. Double-blind, Randomized, Monocentric Trial With Two Parallel Groups (B-Back® Verum Versus B-Back® Placebo)

summary: The purpose of this study is to determine the efficacy and the tolerance of the food supplement B-Back®, containing α-casozepine, taurine, eleutherococcus senticosus and Extramel®, on the burnout syndrome.

ReferenceCitation: Malach-Pines A. The Burnout Measure Short version (BMS). International Journal of Stress Management. 2005;12:78-88

ReferenceCitation: Benezech M, Mullens E, Lalonde R, Desor D, Messaoudi M. Un anxiolytique naturel : l'hydrolysat trypsique de caséine alpha-s1 de lait bovin. Son intérêt en médecine humaine et vétérinaire. Annales Médico-Psychologiques. 2009;167:605-10.

ReferenceCitation: Kim JH, Desor D, Kim YT, Yoon WJ, Kim KS, Jun JS, Pyun KH, Shim I. Efficacy of alphas1-casein hydrolysate on stress-related symptoms in women. Eur J Clin Nutr. 2007 Apr;61(4):536-41. Epub 2006 Nov 29.

ReferenceCitation: Milesi MA, Lacan D, Brosse H, Desor D, Notin C. Effect of an oral supplementation with a proprietary melon juice concentrate (Extramel) on stress and fatigue in healthy people: a pilot, double-blind, placebo-controlled clinical trial. Nutr J. 2009 Sep 15;8:40. doi: 10.1186/1475-2891-8-40.

ReferenceCitation: Kong WX, Chen SW, Li YL, Zhang YJ, Wang R, Min L, Mi X. Effects of taurine on rat behaviors in three anxiety models. Pharmacol Biochem Behav. 2006 Feb;83(2):271-6. Epub 2006 Mar 15.

ReferenceCitation: Facchinetti F, Neri I, Tarabusi M. Eleutherococcus senticosus reduces cardi-ovascular stress response in healthy subjects: a randomized, placebo-controlled trial. Stress and Health. 2002;18:11-7.

ReferenceCitation: Hartz AJ, Bentler S, Noyes R, Hoehns J, Logemann C, Sinift S, Butani Y, Wang W, Brake K, Ernst M, Kautzman H. Randomized controlled trial of Siberian ginseng for chronic fatigue. Psychol Med. 2004 Jan;34(1):51-61.

lead_sponsor: Université Victor Segalen Bordeaux 2

location_facility: Cinical Pharmacology Department - Université Victor Segalen Bordeaux 2

intervention_type: Dietary Supplement


ReferenceCitation: Madelaine T, Cour M, Roy P, Vivien B, Charpentier J, Dumas F, Deye N, Bonnefoy E, Gueugniaud PY, Coste J, Cariou A, Argaud L. Prediction of Brain Death After Out-of-Hospital Cardiac Arrest: Development and Validation of the Brain Death After Cardiac Arrest Score. Chest. 2021 Jul;160(1):139-147. doi: 10.1016/j.chest.2021.01.056. Epub 2021 Jun 8.

family: Madelaine

full_name: Thomas Madelaine

given: Thomas

family: Cour

full_name: Martin Cour

given: Martin

family: Roy

full_name: Pascal Roy

given: Pascal

family: Vivien

full_name: Benoît Vivien

given: Benoît

family: Charpentier

full_name: Julien Charpentier

given: Julien

family: Dumas

full_name: Florence Dumas

given: Florence

family: Deye

full_name: Nicolas Deye

given: Nicolas

family: Bonnefoy

full_name: Eric Bonnefoy

given: Eric

family: Gueugniaud

full_name: Pierre-Yves Gueugniaud

given: Pierre-Yves

family: Coste

full_name: Joël Coste

given: Joël

family: Cariou

full_name: Alain Cariou

given: Alain

family: Argaud

full_name: Laurent Argaud

given: Laurent

ReferenceCitation: Argaud L, Cour M, Dubien PY, Giraud F, Jossan C, Riche B, Hernu R, Darmon M, Poncelin Y, Tchénio X, Quenot JP, Freysz M, Kamga C, Beuret P, Usseglio P, Badet M, Anette B, Chaulier K, Alasan E, Sadoune S, Bobbia X, Zéni F, Gueugniaud PY, Robert D, Roy P, Ovize M; CYRUS Study Group. Effect of Cyclosporine in Nonshockable Out-of-Hospital Cardiac Arrest: The CYRUS Randomized Clinical Trial. JAMA Cardiol. 2016 Aug 1;1(5):557-65. doi: 10.1001/jamacardio.2016.1701.

name: Hospices Civils de Lyon, Hôpital Edouard Herriot, Service de Réanimation Médicale, Lyon, France2Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1060, Carmen, Equipe Cardioprotection, Lyon, France3Université de Lyon, Uni

family: Dubien

full_name: Pierre-Yves Dubien

family: Giraud

full_name: François Giraud

given: François

name: Hospices Civils de Lyon, Hôpital Louis Pradel, Explorations Fonctionnelles Cardiovasculaires et Centre d’Investigation Clinique de Lyon, Lyon, France

family: Jossan

full_name: Claire Jossan

given: Claire

name: Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France7Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Service de Biostatistique, Lyon, France8Centre National de la Recherche Scientifique Unité Mixte de Recherche 5558, Laboratoire de Bio

family: Riche

full_name: Benjamin Riche

given: Benjamin

family: Hernu

full_name: Romain Hernu

given: Romain

family: Darmon

full_name: Michael Darmon

given: Michael

name: Centre Hospitalier de Bourg-en-Bresse, Hôpital Fleyriat, Service d’Aide Médicale Urgente 01, Bourg-en-Bresse, France

family: Poncelin

full_name: Yves Poncelin

given: Yves

name: Centre Hospitalier de Bourg-en-Bresse, Hôpital Fleyriat, Service de Réanimation Polyvalente, Bourg-en-Bresse, France

family: Tchénio

full_name: Xavier Tchénio

given: Xavier

name: Centre Hospitalier Universitaire de Dijon, Hôpital François Mitterand, Service de Réanimation Médicale, Dijon, France

family: Quenot

name: Centre Hospitalier Universitaire de Dijon, Service d’Aide Médicale Urgente 21, Dijon, France

name: Centre Hospitalier de Roanne, Service d’Aide Médicale Urgente 42B, Roanne, France

name: Centre Hospitalier de Roanne, Service de Réanimation et Soins Continus, Roanne, France

name: Centre Hospitalier Métropole Savoie, Service d’Aide Médicale Urgente 73, Chambéry, France

name: Centre Hospitalier Métropole Savoie, Service de Réanimation Polyvalente, Chambéry, France

name: Centre Hospitalier de Villefranche-sur-Saône, Service Mobile d’Urgence et de Réanimation de Villefranche-sur-Saône, Villefranche-sur-Saône, France

name: Centre Hospitalier de Villefranche-sur-Saône, Service de Réanimation, Villefranche-sur-Saône, France

name: Centre Hospitalier d’Ardèche Nord, Service Mobile d’Urgence et de Réanimation d’Annonay, Annonay, France

name: Centre Hospitalier Régional Universitare, Service d’Aide Médicale Urgente 54, Nancy, France

name: Centre Hospitalier Universitaire de Nîmes, Pôle Anesthésie Réanimation Douleur Urgences, Nîmes, France

name: Centre Hospitalier Universitaire de Saint-Etienne, Service d’Aide Médicale Urgente 42A, Saint-Etienne, France9Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord, Service de Réanimation Polyvalente, Saint-Etienne, France

name: Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France4Hospices Civils de Lyon, Service d’Aide Médicale Urgente 69, Lyon, France

name: Hospices Civils de Lyon, Hôpital Edouard Herriot, Service de Réanimation Médicale, Lyon, France3Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France

name: Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1060, Carmen, Equipe Cardioprotection, Lyon, France3Université de Lyon, Université Claude Bernard Lyon 1, Lyon, France6Hospices Civils de Lyon, Hôpital Louis Pradel, Explo

location_facility: Medical intensive care unit, Edouard Herriot Hospital

title: CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation

summary: The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.


title: Behavior During Experimentally Induced Pain

summary: Numerous factors can influence the processing of pain message: the affective or emotional, the sensorial and the cognitive components. Interindividual variations at the emotional and cognitive levels may interfere with the pain message and the consecutive behavior. Some modifications in these components are observed in psychiatric troubles, but their influences on the behavior to pain have not been studied, although they have been studied in some populations characterized as non communicating, with obvious cognitive degradations (subject with dementia, older, newborns,…).In an other study in course, the past pain experience is explored in relation to results to experimental pain tests, emotional and anxious characteristics. This present pilot study aims at studying the infra-verbal behavioural signs during experimentally induced pain in subjects with schizophrenia, major depression, and controls.

lead_sponsor: Centre Hospitalier Esquirol


title: Third Trimester Routine Ultrasound in Low-risk Pregnancies : Comparison of Two Timing Periods Procedure for Screening Intrauterine Growth Restriction

acronym: RECRET

summary: Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. The investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.

lead_sponsor: University Hospital, Rouen


title: An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of the CYP2D6 Substrate Desipramine in Healthy Subjects

summary: The study aims to evaluate if blood levels of desipramine change whilst being dosed at the same time with daily mirabegron.

ReferenceCitation: Krauwinkel W, Dickinson J, Schaddelee M, Meijer J, Tretter R, van de Wetering J, Strabach G, van Gelderen M. The effect of mirabegron, a potent and selective β3-adrenoceptor agonist, on the pharmacokinetics of CYP2D6 substrates desipramine and metoprolol. Eur J Drug Metab Pharmacokinet. 2014 Mar;39(1):43-52. doi: 10.1007/s13318-013-0133-1. Epub 2013 Jun 1.

lead_sponsor: Astellas Pharma Inc


title: A Pilot Placebo-Controlled, Randomized and Double Blind Monocenter Study Evaluating CACIPLIQ20 Efficacy On Neuropathic Perforating Foot Ulcer Healing In Diabetic Patients Wearing An Irremovable Windowed Resin Cast

acronym: DIAPLIQ

summary:
CACIPLIQ20 is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are implied 1) in the stabilization of the micro-environment of cells, known as extracellular matrix, by binding to structural proteins, and 2) in the cell communication by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, CACIPLIQ20 provides a protective function and restores the matrix architecture and the cell communication, a process known as Matrix Therapy.

As for now, three non-controlled pilot studies have been carried out on small populations. They have shown a substantial enhancement of chronic wounds state after treatment with CACIPLIQ20. Therefore, the purpose of this new controlled study is to determine whether CACIPLIQ20 can shorten diabetic neuropathic plantar ulcers healing when the off-loading is mandatory.

The study's main hypothesis is that CACIPLIQ20 application on a non-healing diabetic plantar ulcer in an off-loading mandatory context would reinitiate the natural process of tissue regeneration and lead to total wound closure faster than following standard wound care.

lead_sponsor: Organ, Tissue, Regeneration, Repair and Replacement


title: Evaluation of Efficacy and Tolerance of Cladribine in Symptomatic Patients With Pulmonary Langerhans Cell Histiocytosis and Impairment of Lung Function

acronym: ECLA

summary: ECLA is a phase II, multicenter study testing sub cutaneous cladribine 0.1mg/kg/j during 5 days, administrated every month for 4 courses, in symptomatic adult patients with pulmonary Langerhans cell histiocytosis and impairment of lung function patients.


title: Personalized Haemodynamic Management of Septic Shock: Influence of Mean Arterial Pressure Level on Renal Function: Randomized Controlled Trial

acronym: DORESEP

summary: Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury (AKI) is commonly encountered in critically ill patients and independently predicts poor outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI. To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated by renal Doppler could lead to a better renal perfusion, and then less AKI.

location_facility: Reanimation Chirurgicale - Hôpital Kremlin Bicêtre


title: Efficacy of Preemptive Volume Loading to Prevent Arterial Hypotension During Induction of General Anesthesia

acronym: NICOM-MAP

summary: Induction of general anesthesia induces frequently arterial hypotension. The short term goal of this study is to evaluate if preemptive volume loading prevents such complication.

lead_sponsor: Hopital Foch


title: Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study

acronym: PERIDIGE

summary:
Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units.

Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of stay in intensive care unit after abdominal surgery under laparotomy.

lead_sponsor: University Hospital, Limoges

location_facility: CHU de Limoges - Service d'anesthésie-réanimation


title: Evaluation of States in Major Depressive Patients With Cancer, Hospitalized in a Hospital Palliative

acronym: DECAPAL

summary: The investigators propose a study that aims to develop a methodology for assessing this risk and the psychological consequences of the malignancy in the palliative phase.

lead_sponsor: Centre Francois Baclesse


title: Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock

acronym: IVT NonVent

summary: The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: A Phase Ib/II Open-label Study Evaluating Safety and Efficacy of Oral BKM120 in Combination With Lapatinib in HER2+/PI3K-activated, Trastuzumab-resistant Locally Advanced, Recurrent and Metastatic Breast Cancer. PIKHER2/IPC 2011-001

summary:
This study is based upon the following points:

Resistance to trastuzumab, either primary or secondary, is a clinically relevant issue.

PI3K/AKT activation, due to loss of expression/function of PTEN and/or activating mutations of PIK3CA, is a mechanism of resistance with clinical relevance in breast cancer. Such activation can be detected by:

IHC evaluation of PTEN protein expression
genotyping of PIK3CA exon 9 and 20
IHC evaluation of phospho-AKT expression
BKM120 is an effective PI3K inhibitor. BKM120 and anti-HER2 therapy may have a synergistic antitumor activity in preclinical model of HER2+ breast cancer.
Lapatinib is an effective anti-HER2 therapy in trastuzumab-resistant disease.
For the evaluation of novel targeted therapies, selecting a patient population enriched for activation of the target to be modulated should allow to maximize the differences in clinical outcome that are expected in the experimental arm, and thus to minimize the patient number to include.
We propose to test in a phase I/II study the combination of lapatinib and BKM120 in trastuzumab-resistant HER2+ MBC patients, enriched for activation of PI3K/AKT as detected by loss of expression of PTEN (IHC), and/or mutation of PIK3CA and/or overexpression of phospho-AKT (IHC). Only for phase II patients, mutational status will be an inclusion criteria. For phase I patients molecular status will be a retrospective exploratory analysis.

status: Suspended

ReferenceCitation: Guerin M, Rezai K, Isambert N, Campone M, Autret A, Pakradouni J, Provansal M, Camerlo J, Sabatier R, Bertucci F, Charafe-Jauffret E, Hervieu A, Extra JM, Viens P, Lokiec F, Boher JM, Gonçalves A. PIKHER2: A phase IB study evaluating buparlisib in combination with lapatinib in trastuzumab-resistant HER2-positive advanced breast cancer. Eur J Cancer. 2017 Nov;86:28-36. doi: 10.1016/j.ejca.2017.08.025. Epub 2017 Sep 23.

family: Guerin

full_name: Mathilde Guerin

given: Mathilde

family: Rezai

full_name: Keyvan Rezai

given: Keyvan

family: Isambert

full_name: Nicolas Isambert

family: Campone

full_name: Mario Campone

given: Mario

family: Autret

full_name: Aurélie Autret

given: Aurélie

family: Pakradouni

full_name: Jihane Pakradouni

given: Jihane

family: Provansal

full_name: Magali Provansal

given: Magali

family: Camerlo

full_name: Jacques Camerlo

given: Jacques

family: Sabatier

full_name: Renaud Sabatier

given: Renaud

family: Bertucci

full_name: François Bertucci

family: Charafe-Jauffret

full_name: Emmanuelle Charafe-Jauffret

given: Emmanuelle

family: Hervieu

full_name: Alice Hervieu

given: Alice

family: Extra

full_name: Jean-Marc Extra

given: Jean-Marc

family: Viens

full_name: Patrice Viens

given: Patrice

family: Lokiec

full_name: François Lokiec

family: Boher

full_name: Jean-Marie Boher

given: Jean-Marie

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

journal_name: European Journal of Cancer

lead_sponsor: Institut Paoli-Calmettes


title: Evaluation of the Impact of Symptoms of Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives

acronym: StressRéa

summary: The main objective of this study is to compare the rate of reported anxiety / depression (HADS >= 8) among spouses and other family members in ICU patients.


title: Renal Denervation in Patients With Diabetic Nephropathy and Persistent Proteinuria

acronym: DERENEDIAB

summary: The DERENEDIAB study is a proof-of-concept, multi-center, prospective, open, randomized, controlled study of the effectiveness of renal denervation in addition to standardized medical treatment compared to medical treatment alone in diabetic subjects with diabetic nephropathy and resistant proteinuria. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

ReferenceCitation: Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323.

family: Persu

full_name: Alexandre Persu

given: Alexandre

family: Sapoval

full_name: Marc Sapoval

given: Marc

family: Azizi

full_name: Michel Azizi

given: Michel

family: Monge

full_name: Matthieu Monge

given: Matthieu

family: Danse

full_name: Etienne Danse

given: Etienne

family: Hammer

full_name: Frank Hammer

given: Frank

family: Renkin

full_name: Jean Renkin

given: Jean

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Assistance Publique - Hôpitaux de Paris