title: Effect of Early 48-hour Sevoflurane Inhalation on Gas Exchange and Inflammation in Patients Presenting With Acute Respiratory Distress Syndrome (ARDS) : a Monocentric, Prospective, Randomized Study.

acronym: SEGA

summary:
Numerous trials support the efficacy and safety of volatile anesthetic agents, namely inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients. Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and decreases pulmonary and systemic inflammation in experimental models of acute respiratory distress syndrome (ARDS).

The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in patients with ARDS.

ReferenceCitation: Jabaudon M, Boucher P, Imhoff E, Chabanne R, Faure JS, Roszyk L, Thibault S, Blondonnet R, Clairefond G, Guerin R, Perbet S, Cayot S, Godet T, Pereira B, Sapin V, Bazin JE, Futier E, Constantin JM. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome. A Randomized Controlled Pilot Study. Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. doi: 10.1164/rccm.201604-0686OC.

publisher_dissemination: American Thoracic Society

lead_sponsor: University Hospital, Clermont-Ferrand


title: Intensity and Dependence to Physical Activity and Its Links With Clinical and Emotional Statuses in Comparison With Healthy Controls.

acronym: HAP-AM

summary:
Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un échantillon clinique à un échantillon de témoins issus de la population générale.

Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de patients pris en charge pour anorexie mentale dans des unités de soins spécialisées, les caractéristiques de l'activité physique et la dépendance à l'exercice physique en comparaison avec des sujets issus de la population générale appariés pour l'âge et le sexe.

Nous faisons l'hypothèse que les patients anorexiques mentaux sont plus actifs et plus dépendants à l'exercice physique que des sujets de la population générale de même âge et de même sexe.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Institut Mutualiste Montsouris

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: MRI Study of Cerebral Blood Flow in Development Disorders in Children

acronym: IRM-Aut

summary: The purpose of this study is reproduce the individual detection results by PET with Arterial Spin Labeling (ASL) MRI, to establish a biomarker useful in autism diagnosis.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Necker-Enfants Malades Service de Radiologie Pédiatrique

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: Hypofractionated Radiotherapy for Prostate Cancer (62 Gy in 20 Fractions of 3.1 Gy) With Hyaluronic Acid Injection

summary: The present Phase II study aims to assess the rates of late rectal toxicities of grade ≥ 2 after hypofractionated radiotherapy of prostate cancer of 62 Gy in 20 fractions of 3.1 Gy with an injection of hyaluronic acid (HA) in the space between the rectum and the prostate. Thirty-six patients with a low- to intermediate-risk prostate cancer according to the D'Amico classification are included in the present protocol. The main characteristics of the study are that the patients benefit of a reduction of the treatment duration from 40 to 20 fractions, due to the hypofractionated irradiation, and of an injection of 3 to 10 cc of hyaluronic acid in the perirectal fat between the rectum and the prostate.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Hospices Civils de Lyon

intervention_type: Device

status_simplified: Unknown


title: Pharmacokinetics of Micafungin in Patients of Intensive Care Units

acronym: MI-K

summary:
Invasive fungal infections (IFIs) are a frequent cause of morbidity and mortality in high-risk patients, such as immunocompromised patients. Candida is currently the predominant fungal pathogen in these patient populations and is associated with significant morbidity and a high mortality.

Micafungin (MCF) is a semisynthetic compound belonging to the new class of antifungal agents, the echinocandin lipopeptides, that has potent in vitro and experimental in vivo activity against a variety of pathogenic Candida species and Aspergillus species. Its applied indications are so the treatment and/or the prophylaxis of Candida and Aspergillus infections. MCF is currently licensed for the treatment of candidiasis at doses of either 100 or 150 mg a day.

The efficacy of MCF is linked to the area under the concentration-time curve over 24 h in the steady state divided by the MIC (AUC0-24/ MIC ratio).

On one hand:

- It was demonstrated that 98% of invasive candidiasis patients with a MCF AUC/MIC ratio between 3 and 12 achieve microbiological clearance, as opposed to only 85% of those with an AUC/MIC ratio < 3. In the case of infections by Candida parapsilosis, which exhibits drug MICs that are 50- to100-fold higher, 100% of patients with an AUC/MIC ratio >285 achieve microbiological clearance, as opposed to 82% of those below that exposure level.(1)

On the other hand:

It is well known that patients of intensive care units (ICU) are characterized by particular pharmacokinetic parameters with higher apparent volume of distribution (VC/F) and/or higher apparent systemic clearance (CL/F). In a population of healthy volunteers, it was observed that CL/F of MCF presents a high interpatient variability.(2)
Whether most ICUs patients achieve optimal AUC/MIC ratio thresholds at standard doses has not been investigated so far. In particular, lower AUCs might be reached in patients having the highest VC/F values. Such patients would then be at risk of therapy failure and would benefit from individualized-dosing strategies.

In this context, the study of the pharmacokinetics of MCF in critically ill patients seems to be necessary.

primary_purpose: Other

lead_sponsor: University Hospital, Limoges

intervention_type: Other


type: EudraCT Number

title: Feasibility and Safety Pilot Therapeutic Study of the Iron Chelator Deferiprone in Amyotrophic Lateral Sclerosis

acronym: SAFEFAIRALS

summary:
The FAIR-ALS study is to investigate the safety and efficacy of a scavenger treatment of iron deferiprone, which would reduce the brain iron to limit the development of amyotrophic lateral sclerosis.

It has been shown an excess of iron in the central nervous system carrying a sporadic ALS patients. Iron overload associated with a loss of motor neurons may explain the signs of the disease (atrophy).

The investigators discuss the hypothesis that reducing excess iron, the investigators can reduce the loss of neurons and thus the progression of signs of the disease.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Bensimon G, Lacomblez L, Meininger V. A controlled trial of riluzole in amyotrophic lateral sclerosis. ALS/Riluzole Study Group. N Engl J Med. 1994 Mar 3;330(9):585-91. doi: 10.1056/NEJM199403033300901.

ReferenceCitation: Boddaert N, Le Quan Sang KH, Rotig A, Leroy-Willig A, Gallet S, Brunelle F, Sidi D, Thalabard JC, Munnich A, Cabantchik ZI. Selective iron chelation in Friedreich ataxia: biologic and clinical implications. Blood. 2007 Jul 1;110(1):401-8. doi: 10.1182/blood-2006-12-065433. Epub 2007 Mar 22.

ReferenceCitation: Danzeisen R, Achsel T, Bederke U, Cozzolino M, Crosio C, Ferri A, Frenzel M, Gralla EB, Huber L, Ludolph A, Nencini M, Rotilio G, Valentine JS, Carri MT. Superoxide dismutase 1 modulates expression of transferrin receptor. J Biol Inorg Chem. 2006 Jun;11(4):489-98. doi: 10.1007/s00775-006-0099-4. Epub 2006 Apr 26.

ReferenceCitation: Felice KJ. A longitudinal study comparing thenar motor unit number estimates to other quantitative tests in patients with amyotrophic lateral sclerosis. Muscle Nerve. 1997 Feb;20(2):179-85. doi: 10.1002/(sici)1097-4598(199702)20:23.0.co;2-9.

ReferenceCitation: Goodall EF, Greenway MJ, van Marion I, Carroll CB, Hardiman O, Morrison KE. Association of the H63D polymorphism in the hemochromatosis gene with sporadic ALS. Neurology. 2005 Sep 27;65(6):934-7. doi: 10.1212/01.wnl.0000176032.94434.d4.

ReferenceCitation: Kwiatkowski A, Ryckewaert G, Jissendi Tchofo P, Moreau C, Vuillaume I, Chinnery PF, Destee A, Defebvre L, Devos D. Long-term improvement under deferiprone in a case of neurodegeneration with brain iron accumulation. Parkinsonism Relat Disord. 2012 Jan;18(1):110-2. doi: 10.1016/j.parkreldis.2011.06.024. Epub 2011 Aug 6. No abstract available.

ReferenceCitation: Kong J, Xu Z. Massive mitochondrial degeneration in motor neurons triggers the onset of amyotrophic lateral sclerosis in mice expressing a mutant SOD1. J Neurosci. 1998 May 1;18(9):3241-50. doi: 10.1523/JNEUROSCI.18-09-03241.1998.

ReferenceCitation: Langkammer C, Enzinger C, Quasthoff S, Grafenauer P, Soellinger M, Fazekas F, Ropele S. Mapping of iron deposition in conjunction with assessment of nerve fiber tract integrity in amyotrophic lateral sclerosis. J Magn Reson Imaging. 2010 Jun;31(6):1339-45. doi: 10.1002/jmri.22185.

ReferenceCitation: Lin J, Diamanduros A, Chowdhury SA, Scelsa S, Latov N, Sadiq SA. Specific electron transport chain abnormalities in amyotrophic lateral sclerosis. J Neurol. 2009 May;256(5):774-82. doi: 10.1007/s00415-009-5015-8. Epub 2009 Feb 25.

ReferenceCitation: Miller R, Bradley W, Cudkowicz M, Hubble J, Meininger V, Mitsumoto H, Moore D, Pohlmann H, Sauer D, Silani V, Strong M, Swash M, Vernotica E; TCH346 Study Group. Phase II/III randomized trial of TCH346 in patients with ALS. Neurology. 2007 Aug 21;69(8):776-84. doi: 10.1212/01.wnl.0000269676.07319.09.

ReferenceCitation: Moreau C, Gosset P, Kluza J, Brunaud-Danel V, Lassalle P, Marchetti P, Defebvre L, Destee A, Devos D. Deregulation of the hypoxia inducible factor-1alpha pathway in monocytes from sporadic amyotrophic lateral sclerosis patients. Neuroscience. 2011 Jan 13;172:110-7. doi: 10.1016/j.neuroscience.2010.10.040. Epub 2010 Oct 25.

ReferenceCitation: Moreau C, Devos D, Gosset P, Brunaud-Danel V, Tonnel AB, Lassalle P, Defebvre L, Destee A. [Mechanisms of deregulated response to hypoxia in sporadic amyotrophic lateral sclerosis: a clinical study]. Rev Neurol (Paris). 2010 Mar;166(3):279-83. doi: 10.1016/j.neurol.2009.05.018. Epub 2009 Aug 5. French.

ReferenceCitation: Moreau C, Gosset P, Brunaud-Danel V, Lassalle P, Degonne B, Destee A, Defebvre L, Devos D. CSF profiles of angiogenic and inflammatory factors depend on the respiratory status of ALS patients. Amyotroph Lateral Scler. 2009 Jun;10(3):175-81. doi: 10.1080/17482960802651725.

ReferenceCitation: Moreau C, Devos D, Brunaud-Danel V, Defebvre L, Perez T, Destee A, Tonnel AB, Lassalle P, Just N. Paradoxical response of VEGF expression to hypoxia in CSF of patients with ALS. J Neurol Neurosurg Psychiatry. 2006 Feb;77(2):255-7. doi: 10.1136/jnnp.2005.070904.

ReferenceCitation: Moreau C, Devos D, Brunaud-Danel V, Defebvre L, Perez T, Destee A, Tonnel AB, Lassalle P, Just N. Elevated IL-6 and TNF-alpha levels in patients with ALS: inflammation or hypoxia? Neurology. 2005 Dec 27;65(12):1958-60. doi: 10.1212/01.wnl.0000188907.97339.76.

ReferenceCitation: Noto Y, Misawa S, Kanai K, Shibuya K, Isose S, Nasu S, Sekiguchi Y, Fujimaki Y, Nakagawa M, Kuwabara S. Awaji ALS criteria increase the diagnostic sensitivity in patients with bulbar onset. Clin Neurophysiol. 2012 Feb;123(2):382-5. doi: 10.1016/j.clinph.2011.05.030. Epub 2011 Jul 20.

ReferenceCitation: Schrooten M, Smetcoren C, Robberecht W, Van Damme P. Benefit of the Awaji diagnostic algorithm for amyotrophic lateral sclerosis: a prospective study. Ann Neurol. 2011 Jul;70(1):79-83. doi: 10.1002/ana.22380. Epub 2011 Mar 17.

ReferenceCitation: Shefner JM, Cudkowicz ME, Zhang H, Schoenfeld D, Jillapalli D; Northeast ALS Consortium. Revised statistical motor unit number estimation in the Celecoxib/ALS trial. Muscle Nerve. 2007 Feb;35(2):228-34. doi: 10.1002/mus.20671.

ReferenceCitation: Shefner JM, Watson ML, Simionescu L, Caress JB, Burns TM, Maragakis NJ, Benatar M, David WS, Sharma KR, Rutkove SB. Multipoint incremental motor unit number estimation as an outcome measure in ALS. Neurology. 2011 Jul 19;77(3):235-41. doi: 10.1212/WNL.0b013e318225aabf. Epub 2011 Jun 15.

ReferenceCitation: Yuen EC, Olney RK. Longitudinal study of fiber density and motor unit number estimate in patients with amyotrophic lateral sclerosis. Neurology. 1997 Aug;49(2):573-8. doi: 10.1212/wnl.49.2.573.

ReferenceCitation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
ApoPharma

intervention_type: Drug


title: DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)?

summary: TWEAK (TNF weakly inducer of apoptosis) is a type II-transmembrane protein, member of the TNF ligand superfamily that can be cleaved to function as a soluble cytokine. Depending on target cell type, TWEAK triggers multiple cellular responses ranging from modulation of inflammation to cell death when it binds to its main receptor, Fn 14. Our team has been the first to describe pro-inflammatory effects of TWEAK during central nervous system inflammation. Various data support the possibility that TWEAK produced by synovial macrophages may contribute to chronic synovitis in animal models and in humans. In psoriatic arthritis (PsoA), anti-TNF therapy has been successful concording with the key role of TNF in the pathogenesis of this disease and the generation by psoriatic patients of neutralizing anti-TNF autoantibodies referred as "beneficial autoimmunity to pro-inflammatory mediators". In 2010, Van Kuijk et al. have described a high expression of TWEAK in the inflammatory synovial of PsoA and rheumatoid arthritis (RA) patients before and after anti-TNF therapy. The role of TNF-alpha in the regulation of TWEAK expression remains unclear.

ReferenceType: derived

ReferenceCitation: Guis S, Berbis P, Stephan D, Bertin D, Amatore F, Balandraud N, Lesavre N, Desplat-Jego S. TWEAK-binding autoantibodies are generated during psoriatic arthritis and are not influenced by anti-TNF therapy. J Transl Med. 2016 Jun 23;14(1):185. doi: 10.1186/s12967-016-0923-8.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Dietary Restrictions Implications on Metabolic Changes in Obese Men : Comparison Between Two Groups of Different Ages (60-70 Years Old Versus 30-40 Years Old)

acronym: MONA

summary:
The prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue.

The major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. The MONA study main aim is to assess the metabolic changes in this population, after dietary restrictions, compared to young people.

lead_sponsor: University Hospital, Toulouse


title: Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study

acronym: Fertiline

summary:
cFEE peptide improves the IVF fertilization rate in mouse and fertilization index in human. It improves sperm movement's parameters.

It has been studied over 3 generations of mice and appears without any side effects. The Agence de la BioMédecine has given the authorization for testing the peptide in human IVF.

It is expected to improve the fertilization rate, and thus provide more embryos per IVF attempt.

160 couples will be included over 15 months. Patient sperm parameters should be suitable for IVF. Female should be between 18 and 43 year old. Each cohort of eggs will be randomly distributed to one of the 2 groups The first group will be inseminated with 100000/ml motile spermatozoa. The second will be similarly inseminated but in a middle which will be supplemented with cFEE 100µM.

Criteria: number of embryos in each group

status: Terminated

design_allocation: Randomized

ReferenceCitation: Yuan R, Primakoff P, Myles DG. A role for the disintegrin domain of cyritestin, a sperm surface protein belonging to the ADAM family, in mouse sperm-egg plasma membrane adhesion and fusion. J Cell Biol. 1997 Apr 7;137(1):105-12. doi: 10.1083/jcb.137.1.105.

ReferenceCitation: Ziyyat A, Naud-Barriant N, Barraud-Lange V, Chevalier F, Kulski O, Lemkecher T, Bomsel M, Wolf JP. Cyclic FEE peptide increases human gamete fusion and potentiates its RGD-induced inhibition. Hum Reprod. 2005 Dec;20(12):3452-8. doi: 10.1093/humrep/dei241. Epub 2005 Aug 11.

ReferenceCitation: Barraud-Lange V, Naud-Barriant N, Ducot B, Chambris S, Bomsel M, Wolf JP, Ziyyat A. Cyclic QDE peptide increases fertilization rates and provides healthy pups in mouse. Fertil Steril. 2009 May;91(5 Suppl):2110-5. doi: 10.1016/j.fertnstert.2008.05.088. Epub 2008 Aug 9.

ReferenceCitation: Wolf JP, Bomsel M. Brevet international "Peptide augmentant la capacité fusiogène d'une gamète" Université Paris 13 et CNRS. N° d'enregistrement 03 13545 ; N° de publication 2 862 225. 2003


title: Fructosamines and Gestational Diabetes (FRUCTO)

acronym: FRUCTO

summary:
The prevalence of gestational diabetes is estimated at between 2 and 6%, but can be much higher in specific populations.

The specific treatment of gestational diabetes (diet, control weight gain, self monitoring glucose , insulin therapy) reduces complications severe perinatal, fetal macrosomia, and preeclampsia compared with abstention therapy, without additional risk of caesarean section.

Several early studies have shown that the determination of fructosamine is a very bad way of diagnosis for Gestational Diabetes. However, few studies have investigated the relationship between the determination of serum fructosamine and put under insulin in case of Gestational Diabetes.

The purpose of this study is to determine if serum fructosamines rate can be a predictive marker of the starting insulin at the patients suffering from Gestational Diabetes

primary_purpose: Prevention

ReferenceCitation: Ducarme G, Desroys du Roure F, Grange J, Vital M, Le Thuaut A, Crespin-Delcourt I. Predictive factors of subsequent insulin requirement for glycemic control during pregnancy at diagnosis of gestational diabetes mellitus. Int J Gynaecol Obstet. 2019 Mar;144(3):265-270. doi: 10.1002/ijgo.12753. Epub 2019 Jan 11.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Study of the T CD8 Immune Response in Horton's Disease

acronym: Horton CD8

summary:
The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's disease.

At the inclusion visit, patients will have, as is the case in the usual strategy:

A complete clinical examination carried out by the doctor in charge of the patient
ESR, and CRP and fibrinogen assay
A full blood count for leukocytes and lymphocytes
A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting Horton's disease. The clinician in charge of the patient will decide if a second biopsy is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological cytology service. Immunohistochemical analyses will be done if the TAB is positive.

In addition to the standard clinical examination and complementary examinations relative to the patients' pathology, the following will be done:

Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4) and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it possible to calculate the absolute value for different T lymphocyte populations.
A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which will be stored at -80°C for future assays for cytokines and other biomarkers of interest for Horton's disease.
16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used immediately for cytometric and functional analyses.

ReferenceCitation: Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.

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

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

repository_normalized: bioRxiv

version: submittedVersion

repositories:
HAL
PubMed Central
bioRxiv

repositories_concat: HAL;PubMed Central;bioRxiv

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

publisher_dissemination: Public Library of Science

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose

acronym: EROSB

summary: Epistaxis are present in over 90 % of patients with Rendu - Osler . They involve no significant difference 2 sexes. They often appear in childhood and adolescence and are present in three-quarters of patients at the age of 20 years. These epistaxis increasing in frequency and volume to the age of 60 in 2/3 of patients. Epistaxis are spontaneous , repetitive and recurring . They are highly variable in duration, intensity and frequency of occurrence . Some patients may have more than 40 monthly episodes with mean duration of 5 minutes of bleeding and chronic anemia and can sometimes acute anemia with transfusions need to be source. These epistaxis stigmatize patients and inevitably affect their quality of life and social skills . The various proposed ( cauterization , intra- mucosal injections, laser selective hémostatses , embolization or surgical dermoplasties ) allow for some short-term remissions . Bevacizumab is an antiangiogenic use in the treatment of colorectal cancers . It is also used in ophthalmology intravitreal to reduce vascular proliferation in glaucoma retinopathy and certain corneal neovascularization. In 2009, Prithviraj reported the use of bevacizumab injection to treat pulmonary arteriovenous malformations in a patient with Rendu - Osler . The result is doubly interesting including a saving action on epistaxis which decrease in frequency and duration. This communication prompted the authors to focus more on this medication. The product has been used in local submucosal injection intranasal laser was coupled with satisfactory results objectified by a decrease in the number of epistaxis , reducing blood transfusions and improved social lives. The use of local instillation bevacuzimab represents a way forward for the treatment of these epistaxis.

lead_sponsor: University Hospital, Caen

appel_a_projets: PHRCI

region: Normandie

nom_etablissement: CHU DE CAEN NORMANDIE

type_etablissement: CH

acronyme: EROSB

titre: Traitement des épistaxis de patients atteints de maladie de rendu-Osler avec un spray intranasal de bevacizumab : recherche de la dose efficace

discipline_principale: rendu-osler , qualite de vie , inhibiteur de l'angiogenese , mr

nom_porteur: HUMBERT

prenom_porteur: Maxime


type: Registry Identifier

title: Effect of Technological Processes on Nutritional Quality of Meat Proteins

summary: This project aims to assess the impact of technological processes of meat, as cooking conditions, on amino acid bioavailability and protein metabolism. The hypothesis is that, even if meat is considered as a good provider of fast proteins and so could be useful to prevent sarcopenia in aged people, the manner it is cooked can change its digestion rate and amino acids bioavailability for muscle synthesis.

ReferenceCitation: Buffiere C, Gaudichon C, Hafnaoui N, Migne C, Scislowsky V, Khodorova N, Mosoni L, Blot A, Boirie Y, Dardevet D, Sante-Lhoutellier V, Remond D. In the elderly, meat protein assimilation from rare meat is lower than that from meat that is well done. Am J Clin Nutr. 2017 Nov;106(5):1257-1266. doi: 10.3945/ajcn.117.158113. Epub 2017 Sep 13.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne


title: Role of Staphylococcus Aureus on Folliculitis Decalvans. A Comparative Bacteriological Study.

acronym: SAFE

summary:
The folliculitis decalvans (FD) is an orphan disease , common in consultation specialized on scalp. This disease is currently not curable, responsible for significant for patients. The pathophysiology is poorly understood, Staphylococcus aureus (SA) appears to play a role, never previously studied, and the study will attempt to clarify it.

Controversies in the literature on the pathophysiological hypotheses can be summed up as follows :

FD is it an infectious folliculitis where SA (almost always found on the lesions plays a direct role possibly aided by a lack of local immune protection , or is it a pustular inflammatory unknown cause where the SA has no direct role but is a cofactor or a simple germ superinfection.

Our study has plans to bring new evidence to help decide between these two opposite but not mutually exclusive concepts .

ReferenceCitation: Matard B, Donay JL, Resche-Rigon M, Tristan A, Farhi D, Rousseau C, Mercier-Delarue S, Cavelier-Balloy B, Assouly P, Petit A, Bagot M, Reygagne P. Folliculitis decalvans is characterized by a persistent, abnormal subepidermal microbiota. Exp Dermatol. 2020 Mar;29(3):295-298. doi: 10.1111/exd.13916. Epub 2019 May 15.


title: Post-exercise Food Intake Regulation in a Hot Environment

acronym: APPA

summary: The potential of physical activity and other non-medicinal methods for the care and prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a potential influence of environmental heat in energetic balance regulation. However, the existing knowledge is insufficient to optimize physical activity programs based on the impact of exercise on energy intake regulation in hot climates. The aim of the present study is to define the major physiological determinants of short-term food intake regulation in young active and healthy men, when exposed to different levels of metabolic activity and environmental temperatures. We will thus explore the biological mechanisms related to post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will be analysed in these different environmental conditions, with a special focus on the effect of the birth weight. This study should open interesting ways to define adequate nutritional and exercising programs in hot environments.

primary_purpose: Basic Science

ReferenceCitation: Faure C, Charlot K, Henri S, Hardy-Dessources MD, Hue O, Antoine-Jonville S. Effect of heat exposure and exercise on food intake regulation: A randomized crossover study in young healthy men. Metabolism. 2016 Oct;65(10):1541-9. doi: 10.1016/j.metabol.2016.07.004. Epub 2016 Jul 11.

oa_host_type: repository

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

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

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

repositories_concat: HAL

unpaywall_oa_status: green

lead_sponsor: University of the French West Indies and French Guiana

intervention_type: Behavioral


title: Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)

summary:
It is generally estimated that 5 % of patients with thyroid cancer will develop distant metastases, and most of them had an advanced stage of the disease at presentation. Thirty per cent of them are resistant to radio iodine therapy and are called "refractory". Their long term survival is estimated to be less than 10 %.

The objective of this study is to identify the factors associated with poor outcome in a cohort of patients with advanced thyroid cancer followed during 5 years. Anaplastic and medullary thyroid carcinomas were excluded.

location_facility: Hospices Civils de Lyon-Centre de Médecine Nucléaire Groupement Hospitalier Est 59 boulevard Pinel


title: Etude de l'Impact Clinique de la télésurveillance à Domicile Par télémédecine de paramètres biométriques de la Personne âgée Polypathologique

acronym: e-COBAHLT

summary:
The elderly or people with disabilities want to remain in their homes even when their health condition has been getting worse.

This project aims to demonstrate that home automation and telemonitoring can lead to develop a home safety environment that could help the elderly and individual with disability live independently in their own home.

In this study, the automation sensors containing devices follow up chronic disease clinical factors to monitor their biometrical parameters and detect any abnormal prodromal disease decompensation via telemonitoring and geriatric expertise.

The purpose of this study is:

to provide clinical evidence of the effectiveness of automation tools and telemonitoring/expertise for the home support for people at risk of loss of autonomy
to demonstrate the clinical benefit of combining the automation and telemonitoring and geriatric teleexpertise


title: Impact on Functional Status of Early Oral Nutritional Supplementation (ONS) in Amyotrophic Lateral Sclerosis (ALS) Patients

acronym: NUTRALS

summary: The purpose of this study is to determine whether an early oral nutritional supplementation (ONS) in amyotrophic lateral sclerosis (ALS) patients is effective on the treatment of this rapidly progressive disease.

sponsor_collaborators:
University Hospital, Limoges
Laboratoires NUTRICIA

intervention_type: Dietary Supplement

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: NUTRALS

titre: Impact sur l'état fonctionnel d'une complémentation nutritionnelle orale (CNO) précoce des patients atteints de Sclérose Latérale Amyotrophique (SLA)

discipline_principale: neurologie

nom_porteur: COURATIER

prenom_porteur: Philippe


acronym: PROPECS

summary:
Communication in the operating room (OR) is a key factor to prevent deleterious events for the patient. French national health authority made the implementation of safety checklist mandatory in operating rooms. The goal of this checklist is to improve teamwork and share key elements for better patient outcomes. Observational studies in the OR showed low compliance to this checklist, either on the way it is used or on the information implemented.

The primary objective of this project is to assess the efficacy of a simulation-based curriculum involving OR medical and non-medical personnel in order to improve communication in the OR.

lead_sponsor: University Hospital, Grenoble

location_facility: Operating rooms of Grenoble University Hospital


acronym: PTH

summary: The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of ventilator-free days at Day 60.

ReferenceCitation: Luyt CE, Forel JM, Hajage D, Jaber S, Cayot-Constantin S, Rimmele T, Coupez E, Lu Q, Diallo MH, Penot-Ragon C, Clavel M, Schwebel C, Timsit JF, Bedos JP, Hauw-Berlemont C, Bourenne J, Mayaux J, Lefrant JY, Mira JP, Combes A, Wolff M, Chastre J, Papazian L; Preemptive Treatment for Herpesviridae Study Group, Reseau Europeen de recherche en Ventilation Artificielle Network. Acyclovir for Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):263-272. doi: 10.1001/jamainternmed.2019.5713.

oa_colors: green other

evidence: open (via free pdf)

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

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

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

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille

title: Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial

source: euctr


title: Pharmacoepidemiology Study on Real Life Impact of Chloroprocaine (CLOROTEKAL®) on the Eligibility for Discharge From Hospital of Patients Requiring Short Outpatient Surgery Under Spinal Anesthesia

acronym: CLOCK

summary: The purpose of this study is to assess, in real life, the efficacy and the eligibility for discharge of a local anesthetic, CLOROTEKAL®, used for spinal anesthesia in short outpatient surgery.

ReferenceCitation: Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.

ReferenceCitation: Capdevila X, Aveline C, Delaunay L, Bouaziz H, Zetlaoui P, Choquet O, Jouffroy L, Herman-Demars H, Bonnet F. Impact of Chloroprocaine on the Eligibility for Hospital Discharge in Patients Requiring Ambulatory Surgery Under Spinal Anesthesia: An Observational Multicenter Prospective Study. Adv Ther. 2020 Jan;37(1):541-551. doi: 10.1007/s12325-019-01172-5. Epub 2019 Dec 11.

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

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

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

lead_sponsor: Nordic Pharma SAS


title: Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

summary:
Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.

The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.

lead_sponsor: Poitiers University Hospital


lead_sponsor: bluebird bio

summary: This is a Phase 1/2, open label, safety, and efficacy study of the administration of LentiGlobin BB305 Drug Product to participants with either transfusion dependent beta-thalassemia (TDT) or sickle cell disease (SCD).

ReferenceCitation: Magrin E, Semeraro M, Hebert N, Joseph L, Magnani A, Chalumeau A, Gabrion A, Roudaut C, Marouene J, Lefrere F, Diana JS, Denis A, Neven B, Funck-Brentano I, Negre O, Renolleau S, Brousse V, Kiger L, Touzot F, Poirot C, Bourget P, El Nemer W, Blanche S, Treluyer JM, Asmal M, Walls C, Beuzard Y, Schmidt M, Hacein-Bey-Abina S, Asnafi V, Guichard I, Poiree M, Monpoux F, Touraine P, Brouzes C, de Montalembert M, Payen E, Six E, Ribeil JA, Miccio A, Bartolucci P, Leboulch P, Cavazzana M. Long-term outcomes of lentiviral gene therapy for the beta-hemoglobinopathies: the HGB-205 trial. Nat Med. 2022 Jan;28(1):81-88. doi: 10.1038/s41591-021-01650-w. Epub 2022 Jan 24.

ReferenceCitation: Thompson AA, Walters MC, Kwiatkowski J, Rasko JEJ, Ribeil JA, Hongeng S, Magrin E, Schiller GJ, Payen E, Semeraro M, Moshous D, Lefrere F, Puy H, Bourget P, Magnani A, Caccavelli L, Diana JS, Suarez F, Monpoux F, Brousse V, Poirot C, Brouzes C, Meritet JF, Pondarre C, Beuzard Y, Chretien S, Lefebvre T, Teachey DT, Anurathapan U, Ho PJ, von Kalle C, Kletzel M, Vichinsky E, Soni S, Veres G, Negre O, Ross RW, Davidson D, Petrusich A, Sandler L, Asmal M, Hermine O, De Montalembert M, Hacein-Bey-Abina S, Blanche S, Leboulch P, Cavazzana M. Gene Therapy in Patients with Transfusion-Dependent beta-Thalassemia. N Engl J Med. 2018 Apr 19;378(16):1479-1493. doi: 10.1056/NEJMoa1705342.

evidence: open (via free article)

repository_institution: California Digital Library - eScholarship

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Ribeil JA, Hacein-Bey-Abina S, Payen E, Magnani A, Semeraro M, Magrin E, Caccavelli L, Neven B, Bourget P, El Nemer W, Bartolucci P, Weber L, Puy H, Meritet JF, Grevent D, Beuzard Y, Chretien S, Lefebvre T, Ross RW, Negre O, Veres G, Sandler L, Soni S, de Montalembert M, Blanche S, Leboulch P, Cavazzana M. Gene Therapy in a Patient with Sickle Cell Disease. N Engl J Med. 2017 Mar 2;376(9):848-855. doi: 10.1056/NEJMoa1609677.

title: A Phase 1/2 Open Label Study Evaluating the Safety and Efficacy of Gene Therapy of the β-Hemoglobinopathies (Sickle Cell Anemia and β-Thalassemia Major) by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo With a Lentiviral β-A-T87Q Globin Vector (LentiGlobin BB305 Drug Product)


title: Evaluation of PET-CT Using Somatostatin Agonists Labeled With Gallium68 in Neuroendocrine Tumors

acronym: DOTATATENET

summary:
Gastro-Entero-Pancreatic tumors (GEPs) are a subset of Neuroendocrine tumors (NETs) derived from the primitive gut and include digestive and bronchial NETs.

Historically, the gold standard in their functional exploration is the "conventional" somatostatin receptors scintigraphy (SRS) labeled with Indium-111 (Octreoscan®). This reference imaging is complementary to Tomography (CT) and liver MRI. However SRS sensitivity is moderate (60 %), because of its intrinsic detection limits, which could delay the diagnosis or lead to inappropriate therapy.

The use of somatostatin agonists (DOTATOC, DOTATATE, DOTANOC), radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of TNE with a gain in sensitivity of over 20% compared to SRS. Furthermore, patient irradiation and imaging protocol are significantly reduced.


title: Effect of Non Invasive Ventilation on Lung Volumes Determined by Electrical Impedance Tomography

acronym: NIVIT

summary: Effect of Non Invasive Ventilation on end-expiratory lung volumes determined by electrical impedance tomography

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
University Hospital, Estaing


title: FIRBladd - Use of Infrared Spectroscopy in the Diagnosis of Bladder Tumors

acronym: FIRBladd

summary: The purpose of this study is too assess infrared spectroscopy ability to discriminate urine of a patient affected by bladder cancer from urine of reference patient.

lead_sponsor: Rennes University Hospital


title: Lung Imaging for Ventilatory Setting in ARDS

summary:
To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used.

The investigators made the hypothesis that ventilation according to Lung morphology my decrease mortality at D90.

ReferenceCitation: Blanchard F, Godet T, Pons S, Kapandji N, Jabaudon M, Degos V, Borao L, Bougle A, Monsel A, Futier E, Constantin JM, James A. One-year patient outcomes based on lung morphology in acute respiratory distress syndrome: secondary analysis of LIVE trial. Crit Care. 2022 Jun 4;26(1):159. doi: 10.1186/s13054-022-04036-7.

repositories_concat: PubMed Central

ReferenceCitation: Constantin JM, Jabaudon M, Lefrant JY, Jaber S, Quenot JP, Langeron O, Ferrandiere M, Grelon F, Seguin P, Ichai C, Veber B, Souweine B, Uberti T, Lasocki S, Legay F, Leone M, Eisenmann N, Dahyot-Fizelier C, Dupont H, Asehnoune K, Sossou A, Chanques G, Muller L, Bazin JE, Monsel A, Borao L, Garcier JM, Rouby JJ, Pereira B, Futier E; AZUREA Network. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial. Lancet Respir Med. 2019 Oct;7(10):870-880. doi: 10.1016/S2213-2600(19)30138-9. Epub 2019 Aug 6.

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

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

ReferenceCitation: Jabaudon M, Godet T, Futier E, Bazin JE, Sapin V, Roszyk L, Pereira B, Constantin JM; AZUREA group. Rationale, study design and analysis plan of the lung imaging morphology for ventilator settings in acute respiratory distress syndrome study (LIVE study): Study protocol for a randomised controlled trial. Anaesth Crit Care Pain Med. 2017 Oct;36(5):301-306. doi: 10.1016/j.accpm.2017.02.006. Epub 2017 Mar 18.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

sponsor_collaborators:
University Hospital, Clermont-Ferrand
AZUREA group

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

acronyme: LIVE

titre: Lung Imaging Morphology for Ventilator Settings in ARDS. Live study

discipline_principale: réanimation

nom_porteur: CONSTANTIN

prenom_porteur: Jean-Michel


title: Comparative Evaluation of IRM and Autopsy in the Evaluation of Intra Uterine Fetal Death.

acronym: COMPER

summary:
Fetal intra uterine death is a rare event (incidence 2/1000 births) , unexpected and psychologically painful for the couple and the healthcare team. In this difficult context, it is essential to understand the etiology of death to guide the management of subsequent pregnancies. Among the investigations, foetopathologic examination is essential, but the examination of the brain is not possible in more than half of the cases due to the cerebral maceration due to the incompressible delay between death and expulsion.

The use of MRI as a diagnostic tool fetal post- mortem " virtual autopsy " performed before expulsion of the fetus is interesting because it would permit to obtain a macroscopic examination of the fetal brain, archivable, and a gain concerning the diagnosis. Thus, a normal MRI will exclude cerebral anatomical abnormality , stroke or bleeding . If MRI abnormalities are found , it will not only guide the foetopathologic review, but mainly to guide the etiology . On the other hand , it is a non-invasive tool and acceptability by the couple would be better than autopsy which is often refused by the couple in this difficult psychological context.

In this study , MRI will be given in addition to conventional autopsy in the painful waiting time between the time of diagnosis of death and expulsion without delaying care . If this study is validated , MRI may be systematically proposed in this indication or alternative to autopsy when it will be refused by the parents.

lead_sponsor: University Hospital, Rouen


title: Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation

acronym: ELAPPS

summary: Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the effect of laser acupuncture in the treatment of perioperative pain during tracheal suction after patent ductus arteriosus ligation in preterm infants.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly. A Monocentric, Randomized, Cross-over, Double-blind Clinical Study Versus Placebo

summary: The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.

ReferenceCitation: Deplanque D, Machuron F, Waucquier N, Jozefowicz E, Duhem S, Somers S, Colin O, Duhamel A, Bordet R. Etifoxine impairs neither alertness nor cognitive functions of the elderly: A randomized, double-blind, placebo-controlled crossover study. Eur Neuropsychopharmacol. 2018 Aug;28(8):925-932. doi: 10.1016/j.euroneuro.2018.05.011. Epub 2018 Jun 29.

lead_sponsor: Biocodex

location_facility: Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU


type: Other Grant/Funding Number

title: Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1

acronym: GARRE

summary: The principal purpose is the study of the regulation of the expression of ephrin-B1 by immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy (CTG) compared to biopsies prior to the CTG, in same patients. Level of fluorescence in CTG biopsy will be the experimental reference value.

time_perspective: Retrospective

location_facility: Service d'Anatomie Pathologique et Histologie-Cytologie Hôpital Rangueil


title: Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms.

acronym: RESC

summary: The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to measure the benzodiazepine amount prescribed during the withdrawal time.

lead_sponsor: Hospices Civils de Lyon


title: Polyphenols: Protection From Overfeeding-induced Insulin Resistance?

acronym: Poly-Nut

summary:
Obesity is a complex and multifactorial disease representing a major public health challenge. Indeed, overweight and obese people carry a major risk of developing insulin resistance and type 2 diabetes mellitus. It has been demonstrated that polyphenols could be used to counteract some of the mechanisms involved in the generation of insulin resistance. The model of overfeeding represents a very good study model of the metabolic complications of obesity, since it has been shown to induce a transient state of insulin resistance in the human.

The purpose of this research is to study the effects of a overfeeding (+50% of daily caloric needs over 31 days) with or without polyphenols supplementation (2g/days over 31 days) on insulin sensitivity measured in the setting of a hyperinsulinemic euglycemic clamp and on post prandial partitioning of exogenous lipids after a test meal.

During 31 days, the volunteers will consume chocolate bars, chips, chocolate breads and cola in addition to their usual diet and will be supplemented with 2g of grape polyphenols extract or with placebo.

ReferenceCitation: Bartova S, Madrid-Gambin F, Fernandez L, Carayol J, Meugnier E, Segrestin B, Delage P, Vionnet N, Boizot A, Laville M, Vidal H, Marco S, Hager J, Moco S. Grape polyphenols decrease circulating branched chain amino acids in overfed adults. Front Nutr. 2022 Oct 26;9:998044. doi: 10.3389/fnut.2022.998044. eCollection 2022.

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

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

repository_institution: Ecole Polytechnique Fédérale de Lausanne - Infoscience

publisher_dissemination: Frontiers

ReferenceCitation: Segrestin B, Delage P, Nemeth A, Seyssel K, Disse E, Nazare JA, Lambert-Porcheron S, Meiller L, Sauvinet V, Chanon S, Simon C, Ratiney H, Beuf O, Pralong F, Yassin NA, Boizot A, Gachet M, Burton-Pimentel KJ, Vidal H, Meugnier E, Vionnet N, Laville M. Polyphenol Supplementation Did Not Affect Insulin Sensitivity and Fat Deposition During One-Month Overfeeding in Randomized Placebo-Controlled Trials in Men and in Women. Front Nutr. 2022 May 9;9:854255. doi: 10.3389/fnut.2022.854255. eCollection 2022.

location_facility: Rhône Alpes Human Nutrition Center (CRNH Rhône-Alpes)


title: Completely Automated Robotic Pharmacological Anesthesia System for Patients Undergoing Elective Cardiac Surgery: a Pilot Study

summary:
Closed loop systems for anaesthesia have been shown to be more efficient than manual administration and than Target Control Infusion systems (TCI). So far, there is only one single-center study demonstrating that a system using simultaneously three closed loops for each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe and is more efficient than manual administration of anaesthetic drugs. Although the results of this study are very encouraging, they are limited by its sample of patients recruited for non-cardiac surgery only.

The hypothesis of the present trial is that cardiac anesthesia using a completely automated anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia and muscle relaxation) is feasible, safe and reliable.

Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.

Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).

A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be determined clinically by recording the % of sedation time during which the actual BIS is within 10% of the target BIS (excellent control), within 11 -20% (good control), between 21-30% (fair control) and beyond 30% of target (inadequate control).

lead_sponsor: University Hospital, Bordeaux


title: Assessment and Impact of Portal Hypertension Before and During Liver Resection in Patients With Hepatocellular Carcinoma

summary:
According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating cirrhosis is restricted to patients with preserved liver function, single nodule without vascular invasion and with hepatic venous gradient below 10 mmHg.

However, other guideline treatment, especially from eastern countries demonstrated that surgical resection is safe and feasible and provides better survival than the treatment recommended by the BCLC system for patients with similar stage.

The primary goal of this study is to assess the impact of HVPG on short and long-term outcomes in HCC patients who undergo liver resection.

ReferenceCitation: Ishizawa T, Hasegawa K, Aoki T, Takahashi M, Inoue Y, Sano K, Imamura H, Sugawara Y, Kokudo N, Makuuchi M. Neither multiple tumors nor portal hypertension are surgical contraindications for hepatocellular carcinoma. Gastroenterology. 2008 Jun;134(7):1908-16. doi: 10.1053/j.gastro.2008.02.091. Epub 2008 Mar 8.

ReferenceCitation: Lim C, Salloum C, Chalaye J, Lahat E, Costentin CE, Osseis M, Itti E, Feray C, Azoulay D. 18F-FDG PET/CT predicts microvascular invasion and early recurrence after liver resection for hepatocellular carcinoma: A prospective observational study. HPB (Oxford). 2019 Jun;21(6):739-747. doi: 10.1016/j.hpb.2018.10.007. Epub 2018 Nov 3.

ReferenceCitation: Lim C, Osseis M, Lahat E, Doussot A, Sotirov D, Hemery F, Lanteri-Minet M, Feray C, Salloum C, Azoulay D. Safety of laparoscopic hepatectomy in patients with hepatocellular carcinoma and portal hypertension: interim analysis of an open prospective study. Surg Endosc. 2019 Mar;33(3):811-820. doi: 10.1007/s00464-018-6347-1. Epub 2018 Jul 12.

ReferenceCitation: Lim C, Salloum C, Osseis M, Lahat E, Gomez-Gavara C, Compagnon P, Luciani A, Feray C, Azoulay D. Short-term outcomes following hepatectomy for hepatocellular carcinoma within and beyond the BCLC guidelines: A prospective study. HPB (Oxford). 2018 Mar;20(3):222-230. doi: 10.1016/j.hpb.2017.08.027. Epub 2017 Sep 19.

ipd_sharing: Undecided

lead_sponsor: Henri Mondor University Hospital


title: Evolution of Sperm Parameters and Study of Risk Factors of Impairment of Sperm Quality in Spinal Cord Injuries. Longitudinal Prospective Study.

acronym: FertiSCI

summary:
Spinal cord injured (SCI) men, para or tetraplegic, most often have an infertility, caused among others by a deficiency of sperm quality particularly motility and vitality. Several mechanisms have been proposed: low frequency of ejaculation, recurrent urinary tract and seminal infections, presence of an inflammatory syndrome (IS) and an oxidative stress (OS). However, no French study of sperm quality has been conducted in this population that could identify aggravating factors of sperm quality and a way to prevent them.

Hypothesis: Sperm parameters decrease rapidly following spinal cord injury and next stabilise. However, unidentified yet risk factors could influence long-term evolution of sperm parameters.

The objective is to study the evolution of sperm parameters during 18 months taking into account bladder management, recurrent urinary tract and bladder infections, IS and OS. The evaluation of these parameters and their consequences will be indicative to determine one or more risk factors of sperm degradation and determine a strategy for long term support to avoid the use of ART either by sperm cryopreservation and/or by preventing risk factors

ReferenceCitation: Iremashvili V, Brackett NL, Ibrahim E, Aballa TC, Lynne CM. Semen quality remains stable during the chronic phase of spinal cord injury: a longitudinal study. J Urol. 2010 Nov;184(5):2073-7. doi: 10.1016/j.juro.2010.06.112. Epub 2010 Sep 17.

ReferenceCitation: Padron OF, Brackett NL, Sharma RK, Lynne CM, Thomas AJ Jr, Agarwal A. Seminal reactive oxygen species and sperm motility and morphology in men with spinal cord injury. Fertil Steril. 1997 Jun;67(6):1115-20. doi: 10.1016/s0015-0282(97)81448-3.

ReferenceCitation: Brackett NL, Ibrahim E, Grotas JA, Aballa TC, Lynne CM. Higher sperm DNA damage in semen from men with spinal cord injuries compared with controls. J Androl. 2008 Jan-Feb;29(1):93-9; discussion 100-1. doi: 10.2164/jandrol.107.003574. Epub 2007 Sep 5.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Agence de La Biomédecine

location_facility: Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Department of Biology of Reproduction


title: Effectiveness of Wearing a Compression Garment (SED CICATREX® Model) for Patients With Hypermobility Type of Ehlers-Danlos Syndrome

acronym: VETCOSED

summary:
The Ehlers-Danlos syndrome (EDS) is a rare genetic disease caused by an anomaly of the connective tissue. This syndrome has different forms. Hypermobility type is the most common. It is characterized by generalized joint hypermobility, associated with a chronic pain syndrome. Pains appear as the most frequent demonstration of this syndrome, the worst lived and the most crippling.

Faced with insufficient effect of drug treatment, other alternatives have been proposed to relieve these patients. Compression garments have been developed. They appear as medical devices targeted specifically for patients with hypermobility EDS type: in the symptomatic treatment of joint pain, in stabilizing joints by proprioceptive effect and of muscle globulization, and in the functional improvement.

The VETCOSED study is a quasi-experimental study of type "Before / After", monocentric, open. The study is realized in the Centre Médico-Chirurgical et de Réadaptation des Massues - Croix Rouge Française de Lyon, in association with the Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon. This study concerns about 40 patients with EDS hypermobility type, which will be followed for 8 weeks: 4 weeks during which they will wear a compression custom-made garment (short-sleeved vest CICATREX SED®), and 4 weeks during which they do not carry this garment.

The main objective is to demonstrate the effectiveness of compression garments in the EDS hypermobility type, especially in terms of symptomatic improvement joint pain.

The main outcomes expected of this study are:

an improvement of the power and the peaks of couple of muscles rotators of shoulders.
a decrease of the pains and the defects of articular stability of the shoulder
an improvement of the quality of life and the functional independence of these patients

location_facility: Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française


title: Perioperative Body Composition Changes in Patients Undergoing Gastrointestinal or Lung Cancer Surgery

acronym: ECCOP

summary:
Denutrition and Obesity are risk factors for perioperative surgical complications.

In patient with cancer, incidence of denutrition is markedly increased. Surgical resection of cancer induces a high intensity cellular stress response and catabolism reinforcing the risk for perioperative denutrition.

In this study, we thought to investigate the change in body composition during the perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis (BIA).

lead_sponsor: Hôpital Européen Marseille


title: Prospective Study Evaluating the Usefulness of Sprayshield as Adhesion Barrier System in Two Steps Laparoscopic Bariatric Surgery for Obese Patients

acronym: Sprayshield

summary: The application of SprayShield during a laparoscopic band removal (first surgical step) will be evaluated to see if the postoperative adhesions between the stomach, the left liver and the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or a sleeve gastrectomy.

ReferenceType: result

ReferenceCitation: Nocca D, Guillaume F, Noel P, Picot MC, Aggarwal R, El Kamel M, Schaub R, de Seguin de Hons C, Renard E, Fabre JM. Impact of laparoscopic sleeve gastrectomy and laparoscopic gastric bypass on HbA1c blood level and pharmacological treatment of type 2 diabetes mellitus in severe or morbidly obese patients. Results of a multicenter prospective study at 1 year. Obes Surg. 2011 Jun;21(6):738-43. doi: 10.1007/s11695-011-0385-2.

ReferenceCitation: Fezzi M, Kolotkin RL, Nedelcu M, Jaussent A, Schaub R, Chauvet MA, Cassafieres C, Lefebvre P, Renard E, Bringer J, Fabre JM, Nocca D. Improvement in quality of life after laparoscopic sleeve gastrectomy. Obes Surg. 2011 Aug;21(8):1161-7. doi: 10.1007/s11695-011-0361-x.

ReferenceCitation: Blanc PM, Lagoutte JM, Picot MC, Deneve E, de Seguin C, Fabre JM, Nocca D. Preliminary results of the laparoscopic adjustable gastric banding procedure by a new generation of silicone band: MIDBAND. Obes Surg. 2008 May;18(5):569-72. doi: 10.1007/s11695-008-9441-y.

ReferenceCitation: Nocca D, Krawczykowsky D, Bomans B, Noel P, Picot MC, Blanc PM, de Seguin de Hons C, Millat B, Gagner M, Monnier L, Fabre JM. A prospective multicenter study of 163 sleeve gastrectomies: results at 1 and 2 years. Obes Surg. 2008 May;18(5):560-5. doi: 10.1007/s11695-007-9288-7.

ReferenceCitation: Nocca D, Aggarwal R, Blanc P, Gallix B, Di Mauro GL, Millat B, Seguin des De Hons C, Deneve E, Rodier JG, Tincani G, Pierredon MA, Fabre JM. Laparoscopic vertical banded gastroplasty. A multicenter prospective study of 200 procedures. Surg Endosc. 2007 Jun;21(6):870-4. doi: 10.1007/s00464-006-9048-0. Epub 2006 Nov 14.

lead_sponsor: University Hospital, Montpellier

location_facility: Department of Digestive Surgery A, Saint Eloi Hospital


title: Assessment of Wheelchair Positioning and Pain in Adults Patients With Neuromuscular Disorder

summary: A retrospective study with the patients having a positioning consultation at hospital, between 2009 and 2014. In every neuromuscular disorder, the investigators describe the population seen in consultation, the aim of consultation, the postural problem observed in wheelchair, pain when sitting in wheelchair, and pressure ulcer.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

collaborators: Association Française contre les Myopathies (AFM), Paris


title: Hemodynamic and Biological Effects of 3 Increasing Doses of Fludrocortisone in Healthy Volunteers

summary:
Fludrocortisone, in association with hydrocortisone, has demonstrated an improvement in survival in septic shock patients with relative adrenal insufficiency. However, the utility of low doses of steroids and in particular of mineralocorticoids in septic shock is still discussed.

The purpose of the investigators study is to investigate the effects of 3 increasing doses of fludrocortisone (100 μg, 200 μg, 400 μg) in order to determine which dose allows the best pressor response to phenylephrine in healthy volunteers, and simultaneously assess their respective hemodynamic and biological effects.


title: REVECHO Study (REmission Véritable en ECHOgraphie) Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?

acronym: REVECHO

summary:
Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks to a large choice of therapies, early treatment and tight control (30% relapse).

Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may improve the prognosis of RA in remission by increasing the duration of sustained remission and by preventing radiographic structural progression.

The tested hypothesis is: The US coverage of RA allows to increase the duration of sustained clinical remission.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Pfizer

location_facility: Rheumatology Department, Ambroise Paré Hospital


title: A Cardiac Ultrasound Evaluation of Two Types of Weaning Trials of Mechanical Ventilation for a First Weaning Trial

acronym: CARWEAN

summary: Comparing the hemodynamic and cardiac effects of two types of weaning trials of mechanical ventilation in ICU patients of two French ICU.


title: Efficacy of Lidocaine Versus Placebo in Palliative Care Patients With Opioid-refractory Cancer Pain With Neuropathic Component: a Multicenter, Prospective, Double-blind Randomized Placebo-controlled Study.

acronym: LIDOSP

summary: This is a multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel groups study comparing lidocaine (experimental group) to placebo (control group). The study protocol was elaborated using the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) Statement.

ReferenceCitation: Salas S, Auquier P, Duffaud F, Garnier SR, Deschamps M, Honore S, Sudour P, Baumstarck K. Efficacy of lidocaine in patients receiving palliative care with opioid-refractory cancer pain with a neuropathic component: study protocol for a randomized controlled study. Trials. 2014 Aug 12;15:318. doi: 10.1186/1745-6215-15-318.

publisher_dissemination: Springer

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: - Service d'Oncologie Médicale et de Soins Palliatifs Assistance Publique Hopitaux de Marseille


title: Stress Management Programs in Fire-fighters of Paris: a Randomized Controlled Trial

summary:
Chronic stress at work is a public health problem increasing morbidity and mortality, especially in men. Among the men military populations, the firefighters of Paris (FFPs) are particularly exposed. To deal with this stress and to improve stress management is challenging. Psychological fitness is required to regulate emotions which improve effectiveness under stress and enhance recovery from stressful events. The heart coherence (HC) program uses feedback from a simple pulse sensor to reflect changes of the emotional/psychological state, and to learn how to reduce stress and stabilize emotions. Another kind of psychological fitness focuses on cognitive training to regulate emotions, with the use of techniques to optimize potential (TOP). The TOP consists of learning easy techniques in mental skills to improve cognitive-based problem-solving using respiration, relaxation, and visualization. Although never published in a peer-review journal, the procedure of TOP training is structured and standardized for individuals and groups, and is widely practiced in air traffic controllers, with apparently good effects.

Moreover, any event can be emotionally ambiguous, providing both negative and positive outcomes. The interpretation of such ambiguity is linked with an individual's emotional state, such as anxiety or mood. Individuals with a high level of trait anxiety are likely to interpret an event negatively.

However, no studies have compared the effect of HC or TOP in the perceived stress of FFPs. Nor have long-term effects of these stress management programs (SMP) been investigated. Furthermore, the influence of trait anxiety on stress levels in FFPs needs to be clarified. Finally, no trials have assessed levels of biomarkers stress following these SMP.

From these observations, we hypothesized that 1) young recruits aiming to become FFPs will be particularly exposed to stress, 2) SMP will be effective in reducing perceived stress, 3) SMP will mainly benefit FFPs who have high anxiety, and 4) the effects of SMP will lower levels of biomarkers of stress.

The aim of this randomized control trial is to evaluate the effectiveness of stress management programs on perceived stress (primary outcome variable), and on negative mood, mindfulness, and biomarkers of stress (secondary outcome variables) in FFPs. We also aim to investigate the influence of anxiety on the stress management programs effectiveness long-term.

primary_purpose: Screening

lead_sponsor: French Defence Health Service


title: A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

acronym: COUGHELP

summary: The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

ReferenceCitation: Lacombe M, Bore A, Amo Castrillo LD, Boussaid G, Falaize L, Vlachos E, Orlikowski D, Prigent H, Lofaso F. Peak Cough Flow Fails to Detect Upper Airway Collapse During Negative Pressure Titration for Cough-Assist. Arch Phys Med Rehabil. 2019 Dec;100(12):2346-2353. doi: 10.1016/j.apmr.2019.06.012. Epub 2019 Jul 24.

sponsor_collaborators: Centre d'Investigation Clinique et Technologique 805


summary: To determine the feasibility of representative urologic procedures as measured by the rate of conversions

ReferenceCitation: Kaouk JH, Haber GP, Autorino R, Crouzet S, Ouzzane A, Flamand V, Villers A. A novel robotic system for single-port urologic surgery: first clinical investigation. Eur Urol. 2014 Dec;66(6):1033-43. doi: 10.1016/j.eururo.2014.06.039. Epub 2014 Jul 17.

lead_sponsor: Intuitive Surgical


title: Phase II Study, Multicentric, Randomized Studying the Effect of the Rehabilitation Effort at Home in Patients With Head and Neck Tumor Treated With Curative Intent

acronym: NUTRIMOUV

summary: Improvement exercise tolerance

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

location_facility: Institut régional du Cancer - Montpellier - Val d'Aurelle


title: A Phase I Study to Evaluate the Feasibility of Different Sequences of Combined Trastuzumab Emtansine (T-DM1) and Whole-brain Radiotherapy in Patients With Brain Metastases From HER2-positive Breast Cancer

acronym: BIRTH

summary: The purpose of this study is to determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute toxicities and blood/cerebrospinal fluid T-DM1 pharmacokinetics.

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

location_facility: Institut regional du Cancer - Val d Aurelle


title: An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease

acronym: EVERKYSTE

summary: The investigators multicenter randomized open-labelled study will investigate the efficacy of an everolimus based immunosuppression in reducing total native kidney volume in kidney recipients with autosomal dominant polycystic kidney disease compared to a calcineurin inhibitor-based immunosuppression.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Novartis


title: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis

acronym: MOUVSCO

summary:
The hypothesis of this study is that moderate scoliosis patients have postural and kinematic differences (static and dynamic) compared with healthy volunteers and it is possible to characterize and quantify.

The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis patients compared with healthy volunteers

lead_sponsor: University Hospital, Grenoble

collaborators: Clinical Investigation Centre for Innovative Technology Network


acronym: GALTEP

summary: Through the investigators involvement in an international consortium, the investigators had the opportunity to acquire a new type of synthetizer for the radiolabelling of such tracers. The investigators propose in this project to develop on their site, the radiosynthesis of 68Ga-DOTATOC and to evaluate prospectively the diagnosis of neuroendocrine tumors, compared with the current imaging OctreoScan®. The objectives of this project are: - to validate the radiosynthesis of 68Ga-DOTATOC on their site with a new synthetizer - and clinically evaluate, through a prospective preliminary study, the diagnostic accuracy of PET-CT with 68Ga-DOTATOC in comparison with other standard imaging examinations.

title: Development of an Innovative Gallium 68 Radiolabeling of DOTATOC (68Ga-DOTATOC) for PET-CT Imaging of Neuro-endocrine Tumors and Preliminary Clinical Evaluation


title: Prospective Cohort Study of Clinical and Laboratory Data of Patients With Hemopathy in Languedoc-Roussillon

acronym: HemoDiag

summary: Prospective Cohort Study of clinical and laboratory data of patients with hemopathy.

location_facility: Hematology department - UHMontpellier Saint éloi

intervention_type: Biological


acronym: PREHUNT

summary: The purpose of this study is to assess the psychological, cognitive and social resources of applicants for Huntington's Disease and Presymptomatic Testing.

lead_sponsor: University Hospital, Angers


title: Identification of Early Predictive Factors of Cardiac and Cerebral Involvement in Thrombotic Microangiopathies

acronym: MATRISK

summary:
The aim of this study is to determine the frequency of cardiac and cerebral involvements in patients with idiopathic thrombotic microangiopathies on diagnosis. Patients will be assessed for cardiac involvement (troponin Ic level and cardiac ultrasonography) and cerebral involvement (cerebral MRI). The investigators will assess whether serum troponin Ic on diagnosis can predict morbidity and mortality of patients with a thrombotic microangiopathy at the acute phase.

The primary outcome measurement is the event free survival at day 30, as defined by death, myocardial ischemia, arrhythmia, severe cerebral injury and disease exacerbation. An increase in troponin Ic on diagnosis is defined as at least one result above 0.2 ng/ml among the three daily analyses performed after TMA diagnosis.


title: Impact of Transcranial Direct Current Stimulation (tDCS) on Locomotion and Bipedal Equilibrium in Hemiplegic Patients: a Crossover Randomized Controlled Trial

acronym: HEMILOCOSTICOR

summary: The aim of this trial is to quantify the improvement of locomotion and equilibrium induced par tDCS in anode polarity position in post stroke hemiplegic patients.

ReferenceCitation: Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials. 2017 Oct 23;18(1):492. doi: 10.1186/s13063-017-2219-6.

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


title: Neurally Adjusted Ventilatory Assist (NAVA) Levels Titration During Weaning Using Ventilatory Comfort Scales: a Physiological Evaluation

summary: Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains challenging, and several methods have been suggested. However none of them seems easily utilisable. Thus the investigators propose to test a way of NAVA level titration according to ventilator comfort.

lead_sponsor: University Hospital, Caen

collaborators: Centre d'Investigation Clinique et Technologique 805


title: Circulating Cell-free DNA in Metastatic Melanoma Patient: Mutational Analyses in Consecutive Measurement Before and After Chemotherapy.

acronym: AMMAM

summary: Therapies that target specific molecules markedly inhibit cancer growth in several malignancies, and provide valuable strategies for the treatment of advanced melanoma. In recent years, BRAF and KIT have become established therapeutic targets in melanoma patients showing activating mutations in these oncogenes. However, it is crucial that genetic mutations present in the melanoma lesions are identified if the investigators are to design tailormade therapies for individual patients. The tumour genotypes that determine the selection of molecular-targeted therapies are usually identified in primary tumours; however, primary tumours are not always representative of metastases. Circulating free DNA may be a source of valuable information because it can be obtained via routine blood sampling, it provides real-time information about a patient's current disease state, and it allows monitoring and molecular characterization before and after chemotherapy. The aim of the study is to determine the mutational status in circulating DNA in melanoma metastatic patients, with the Sequenom Mass Array, a next generation sequencing technology. Results obtained before and after treatment will be compared with the primary tumor genotype.

lead_sponsor: Centre Hospitalier Universitaire de Nice


acronym: The PSO-ABLE trial

lead_sponsor: LEO Pharma

summary: The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

ReferenceCitation: Veverka KA, Hansen JB, Yaloumis M, Kircik L, Stein Gold L. Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials. J Drugs Dermatol. 2021 Aug 1;20(8):822-828. doi: 10.36849/JDD.5743.

publisher_dissemination: SanovaWorks

ReferenceCitation: Iversen L, Kurvits M, Snel-Prento AM, Menter A. Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA >/= 3: Post-Hoc Analysis From Three Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Oct;10(5):1111-1120. doi: 10.1007/s13555-020-00419-2. Epub 2020 Aug 12.

ReferenceCitation: Paul C, Leonardi C, Menter A, Reich K, Gold LS, Warren RB, Moller A, Lebwohl M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study. Am J Clin Dermatol. 2017 Jun;18(3):405-411. doi: 10.1007/s40257-017-0258-0. Erratum In: Am J Clin Dermatol. 2017 May 24;:

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

ReferenceCitation: Paul C, Stein Gold L, Cambazard F, Kalb RE, Lowson D, Bang B, Griffiths CE. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):119-126. doi: 10.1111/jdv.13859. Epub 2016 Aug 17.

location_facility: Service de Dermatologie, Hôspital Larrey

title: LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris


title: PC MIROIR : Effects of Mirror Therapy in Children With Hemiplegic Cerebral Palsy

acronym: PC MIROIR

summary: This is a randomized and comparative prospective test, monocentric and controlled (mirror therapy versus bimanual rehabilitation exercises), in single-blind (investigator and occupational therapist " 1 " do not know the type of rehabilitation performed).

ReferenceCitation: Gaillard F, Cretual A, Cordillet S, Le Cornec C, Gonthier C, Bouvier B, Heyman R, Marleix S, Bonan I, Rauscent H. Kinematic motion abnormalities and bimanual performance in children with unilateral cerebral palsy. Dev Med Child Neurol. 2018 Aug;60(8):839-845. doi: 10.1111/dmcn.13774. Epub 2018 Apr 27.

lead_sponsor: Rennes University Hospital


title: A Multicentric Phase II Trial Studying Efficacy of Doxorubicin Associated With Trabectedin (Yondelis) in First Line Treatment on Patients With Metastatic Leiomyosarcoma (Uterus or Soft Tissue) and/or Inoperable Relapse

summary:
Uterine leiomyosarcomas and soft tissues are rare tumors with a poor prognosis when metastatic or locally advanced. They have an average chemosensitivity mainly to doxorubicin, ifosfamide, cisplatin, gemcitabine and trabectedin but response rates in combination in first line does not exceed 55% for uterine leiomyosarcomas and 35% for leiomyosarcomas of soft tissue.

The trabectedin is a new cancer drug that has obtained marketing authorization after failure of anthracyclines and ifosfamide in the treatment of soft tissue sarcomas (STM) in Europe. It has especially shown efficacy in myxoid liposarcomas, leiomyosarcomas and synoviosarcoma.

This study aims to evaluate the usefulness of the combination of trabectedin with doxorubicin in first-line treatment of uterine or soft tissue leiomyosarcoma.

ReferenceCitation: Pautier P, Floquet A, Chevreau C, Penel N, Guillemet C, Delcambre C, Cupissol D, Selle F, Isambert N, Piperno-Neumann S, Saada-Bouzid E, Bertucci F, Bompas E, Alexandre J, Collard O, Lebrun-Ly V, Soulier P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F; French Sarcoma Group. A single-arm multicentre phase II trial of doxorubicin in combination with trabectedin in the first-line treatment for leiomyosarcoma with long-term follow-up and impact of cytoreductive surgery. ESMO Open. 2021 Aug;6(4):100209. doi: 10.1016/j.esmoop.2021.100209. Epub 2021 Jul 26.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

ReferenceCitation: Pautier P, Floquet A, Chevreau C, Penel N, Guillemet C, Delcambre C, Cupissol D, Selle F, Isambert N, Piperno-Neumann S, Thyss A, Bertucci F, Bompas E, Alexandre J, Collard O, Lavau-Denes S, Soulie P, Toulmonde M, Le Cesne A, Lacas B, Duffaud F; French Sarcoma Group. Trabectedin in combination with doxorubicin for first-line treatment of advanced uterine or soft-tissue leiomyosarcoma (LMS-02): a non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2015 Apr;16(4):457-64. doi: 10.1016/S1470-2045(15)70070-7. Epub 2015 Mar 18.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Non-invasive Prenatal Diagnosis (NIPD) of Cystic Fibrosis by Quantitative Real Time MEMO-PCR

summary: The purprose of this study is to develop and validate an analytical and clinical NIPD test for cystic fibrosis from maternal blood by analysis circulating free fetal DNA (cff-DNA), searching for the paternal mutation in families with CFTR compound heterozygosity

location_facility: Centre hospitalier Universitaire de Montpellier


title: Echographie de Contraste Pour l'Analyse de la Perfusion Musculaire Dans l'ischémie Critique

acronym: Echomuscle

summary: The primary objective of our work is to show that quantification of muscular microvascularisation evaluated by injection of contrast agent is different between chronic critical limb ischemia (before revascularization) and after (healing of ischemia) and thus make the proof of its utility in evaluation of PAD therapeutics.


title: Controlled, Randomized, Parallel, Double-blind Study of the Effect of NUTRALYS® Pea Protein Supplementation Versus Whey Protein and Placebo on the Muscle Mass and Strength of Volunteers Engaged in Training

acronym: nutralys

summary: this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an intermediate profile, rich in leucines and other essential amino acids, can significantly enhance muscle mass gain during strength training. This study will compare the efficacy of NUTRALYS® to a reference product. If the results of the study demonstrate a significant improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be considered as an alternative to sports nutrition products, to which many people are intolerant.

ReferenceCitation: Babault N, Paizis C, Deley G, Guerin-Deremaux L, Saniez MH, Lefranc-Millot C, Allaert FA. Pea proteins oral supplementation promotes muscle thickness gains during resistance training: a double-blind, randomized, Placebo-controlled clinical trial vs. Whey protein. J Int Soc Sports Nutr. 2015 Jan 21;12(1):3. doi: 10.1186/s12970-014-0064-5. eCollection 2015.

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

publisher_dissemination: Informa

lead_sponsor: Nicolas Babault

sponsor_collaborators:
Nicolas Babault
Roquette Freres


title: The Evaluation of a CONSORT Based Online Writing Tool: a Randomized Controlled Trial

acronym: COBWEB

summary:
Introduction: Inadequate reporting is a frequent cause of waste of research. For example, essential information for evaluating the risk of bias such as the method of randomization is lacking in 75% of published randomized controlled trials (RCTs), and over 30% of reports do not provide sufficient details to allow replication of the treatment evaluated in the trial in clinical practice. To overcome this issue, the CONSORT statement, an evidence-based, minimum set of recommendations for reporting RCTs was developed in 1996. These guidelines have since been updated in 2001 and more recently in 2010. In addition, extensions to the main CONSORT statement have been developed to give additional guidance for RCTs with specific designs (eg cluster), data (eg harm), and interventions (eg nonpharmacologic treatments). Many journals endorse the CONSORT statement. Some journals provide recommendations to authors to follow the CONSORT guidelines and some editors enforce the use of the CONSORT guidelines by requesting authors to submit a checklist in either the submission or acceptance stage. Nevertheless, inadequate reporting remains.

Our objective is to evaluate the impact of the CONSORT based online writing tool on the completeness of reporting.

ReferenceCitation: Barnes C, Boutron I, Giraudeau B, Porcher R, Altman DG, Ravaud P. Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial. BMC Med. 2015 Sep 15;13:221. doi: 10.1186/s12916-015-0460-y.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hotel Dieu, 1, place du parvis de notre dame


title: Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care: Pharmacodynamic Evaluation and Impact.

acronym: TARGET-REA

summary: this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact of these pharmacodynamic parameters on the clinical and microbiological VAP will be evaluated.


title: Non Invasive Prenatal Testing of Down Syndrome From Maternal Blood Sample

acronym: SAFE 21

summary: This is a randomized controlled trial in women at risk following combined prenatal screening for Down Syndrome. Women will be asked about their preferences between NIPT and routine prenatal diagnosis based on a dedicated questionnaire. Women will then be randomized between NIPT and standard invasive prenatal diagnosis.

ReferenceCitation: Malan V, Bussieres L, Winer N, Jais JP, Baptiste A, Le Lorc'h M, Elie C, O'Gorman N, Fries N, Houfflin-Debarge V, Sentilhes L, Vekemans M, Ville Y, Salomon LJ; SAFE 21 Study Group. Effect of Cell-Free DNA Screening vs Direct Invasive Diagnosis on Miscarriage Rates in Women With Pregnancies at High Risk of Trisomy 21: A Randomized Clinical Trial. JAMA. 2018 Aug 14;320(6):557-565. doi: 10.1001/jama.2018.9396.


title: Impact of a Pharmaceutical Consultation at Hospital Discharge on Adherence to Anti-infective Treatment After Returning Home

acronym: CPS-INFECTIO

summary:
The main objective of this study is to evaluate the impact of a pharmaceutical consultation at the time of hospital discharge on the adherence of patients ; non-adherence is determined by the following criteria:

As concerns prescribed anti-infectious treatments, at least one of the following 4 criteria is true:

. the patient did not go and get his/her treatment at the pharmacy;
. the number of treatment units dispensed by the pharmacy is < the number of treatment units prescribed;
. the patient stopped taking a treatment before the recommended time, or continued taking a treatment after the recommended time;
. the number of treatment units taken by the patient (self-declaration) is < or > to the number of units prescribed.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: FACEFI : Cardiac Fatigue During Intense Exercises - Pilot Study

acronym: FACEFI

summary:
To attest if a cardiac fatigue appears (and to measure it if it does) during intense physical exercises in two groups of subjects:

Canoeists from a training center of the French canoeing team during an intensive session of three weeks of endurance training;
Young recruits in military school of officers in ground forces of the French army during an intensive.


title: A MULTICENTER, RANDOMIZED, CONTROLLED STUDY OF EPIDURAL ANALGESIA FOR SEVERE ACUTE PANCREATITIS

acronym: EPIPAN

summary:
Acute pancreatitis (AP) is a common disease whose incidence in the US reaches 35 per 100,000 population annually. Its main causes in adults are gallstone migration into the common bile duct and alcohol abuse. Approximately 80% of patients with AP will develop a mild disease for which the management is mainly conservative. However 20% will develop a severe form, which is known to be associated with the development of local complications, such as pancreatic and peripancreatic necrosis, pseudocysts, and systemic complications, such as adult respiratory distress syndrome or renal failure. In the severe form of AP the mortality rate can reach 17% mainly due to multiple organ failure and pancreatic necrosis. In particular, pancreatic necrosis is associated with a death rate of up to 40%.

Epidural anesthesia (EA) is widely used to induce analgesia in the perioperative period and has also been used to decrease pain in patients with AP. In addition, experimental studies have shown a specific beneficial effect of EA in AP, attributed to an anti-inflammatory effect of local anesthetics administered in the epidural space combined with a sympathetic nerve blockade, which redistributes splanchnic blood flow to non-perfused pancreatic regions.

To date, EA has not been adequately tested in intensive care unit (ICU) patients with severe AP, with regards to clinical outcome. The objective of our study is therefore to test the effect of EA on lung dysfunction during severe AP, as we hypothesize that EA could limit lung failure requiring invasive mechanical ventilation (MV) or the duration of invasive MV

ReferenceCitation: Bulyez S, Pereira B, Caumon E, Imhoff E, Roszyk L, Bernard L, Buhler L, Heidegger C, Jaber S, Lefrant JY, Chabanne R, Bertrand PM, Laterre PF, Guerci P, Danin PE, Escudier E, Sossou A, Morand D, Sapin V, Constantin JM, Jabaudon M; EPIPAN Study Group; AzuRea network. Epidural analgesia in critically ill patients with acute pancreatitis: the multicentre randomised controlled EPIPAN study protocol. BMJ Open. 2017 May 29;7(5):e015280. doi: 10.1136/bmjopen-2016-015280. Erratum In: BMJ Open. 2018 Feb 10;8(2):e015280corr1.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Clermont-Ferrand


title: Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir (GS-5885) Fixed-dose Combination in NS3/4A Protease Inhibitor-experienced Subjects With HCV Genotype 1 Infection and HIV Co-infection

summary: Aim of the study is to assess the efficacy and safety of 24 weeks of oral Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated interferon /ribavirin regimen or stopped prematurely their treatment for intolerance.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Centre de Méthodologie et de Gestion de Rennes


title: Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain: an MRI Study

acronym: PERINE

summary: This project aims at evaluating the consequences of prenatal exposure to neurotoxicants (solvents, organophosphate pesticides) on the developing brain, in children aged from 10 to 12 years.

ReferenceCitation: Binter AC, Bannier E, Simon G, Saint-Amour D, Ferre JC, Barillot C, Monfort C, Cordier S, Chevrier C, Pele F. Prenatal exposure to glycol ethers and motor inhibition function evaluated by functional MRI at the age of 10 to 12 years in the PELAGIE mother-child cohort. Environ Int. 2019 Dec;133(Pt A):105163. doi: 10.1016/j.envint.2019.105163. Epub 2019 Sep 11.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3


title: Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy

acronym: WIN IN WEAN

summary: Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.

collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Long Term Evaluation of Tubal Expansion on Obstructive Dysfunctions of Eustachian Tube

summary: The study aim is to evaluate the tubal score on patients who suffer from obstructive dysfunction of eustachian tube before and after the eustachian tube dilatation.

ReferenceCitation: Kaderbay A, Karkas A, Schmitt D, Mura T, Lavieille JP, Venail F. Balloon dilation for persistent unilateral chronic obstructive Eustachian tube dysfunction is effective: a prospective multicentre study. Eur Arch Otorhinolaryngol. 2023 Mar;280(3):1101-1109. doi: 10.1007/s00405-022-07578-2. Epub 2022 Aug 6.

lead_sponsor: University Hospital, Montpellier

region: Occitanie

nom_etablissement: CHU MONTPELLIER

acronyme: EDITO

titre: Evaluation a long terme de la dilatation tubaire dans les dysfonctions obstructives chroniques de la trompe d'eustache

discipline_principale: orl cmf

nom_porteur: VENAIL

prenom_porteur: Frédéric


title: Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects

summary: To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).

lead_sponsor: H. Lundbeck A/S


title: To Evaluate the Safety and Outcome of the Parietal Peritoneum as a Substitute Graft for Venous Reconstruction in Hepatobiliary and Pancreatic Surgery

summary: To evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB surgery. Although the parietal peritoneum had already been used and published for the reconstruction of the vena cava, however this one was never described or described in HPB surgery

ReferenceCitation: Dokmak S, Aussilhou B, Sauvanet A, Nagarajan G, Farges O, Belghiti J. Parietal Peritoneum as an Autologous Substitute for Venous Reconstruction in Hepatopancreatobiliary Surgery. Ann Surg. 2015 Aug;262(2):366-71. doi: 10.1097/SLA.0000000000000959.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Beaujon Hospital

location_facility: Departement HPB surgery, Beaujon Hospital


title: Nurse Screening Tool for Fall Risk : Prediction of Falls in Older Inpatients Hospitalized at Angers University Hospital

acronym: EPRIC

summary: The primary objective of this study is to elaborate a new simple clinical tool for the risk of falls among older inpatients.

location_facility: University Memory Center, Angers University Hospital


title: Effect of Observation Plus Imagination of Gait on Stride Variability in Young and Older Adults

acronym: OBI

summary: The aim of study is to examine the combined effect of observation and imagination of gait on stride time variability of stride time among in healthy young and older adults.

primary_purpose: Health Services Research


title: Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial

acronym: PANORAMIX

summary:
More than 2 million French people suffer from the widespread disability of edentulism, with large consequences on function, nutrition, aesthetics and well-being. Complete denture is a common therapeutic strategy.

The immediate complete denture technique consists in placing the denture in the same clinical session as last anterior teeth extractions. With this technique, aesthetic and function are immediately reintroduced and the patient is never left toothless or without any denture.

After teeth extractions, alveolar healing process leads to ridge resorption with bone volume modifications and reduction in height and width.

However ridge bone volume is an essential factor in removable denture stability. With implantology as an alternative prosthetic strategy, ridge volume is also a most important factor to place dental implants in a situation close to previous dental roots position. In order to preserve bone volume, a current alternative strategy proposes to place bone substitute materials in tooth sockets after extraction. This strategy was never evaluated with the immediate complete denture technique.

Hypothesis: A new strategy associating immediate complete denture and bone substitute material is more effective than conventional immediate complete denture in a bone preservation perspective.

ReferenceCitation: Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.

ReferenceCitation: Tallgren A, Lang BR, Walker GF, Ash MM Jr. Roentgen cephalometric analysis of ridge resorption and changes in jaw and occlusal relationships in immediate complete denture wearers. J Oral Rehabil. 1980 Jan;7(1):77-94. doi: 10.1111/j.1365-2842.1980.tb01466.x.

ReferenceCitation: Park JB. Healing of extraction socket grafted with deproteinized bovine bone and acellular dermal matrix: histomorphometric evaluation. Implant Dent. 2010 Aug;19(4):307-13. doi: 10.1097/ID.0b013e3181e5abbc.

ReferenceCitation: Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x.

ReferenceCitation: Rignon-Bret C, Rignon-Bret JM. Prothèse amovible complète, prothèse immédiate, prothèse supra-radiculaire et implantaire. Ed CdP, Collection JPIO 2002.

ReferenceCitation: Rignon-Bret C, Hadida A, Aidan A, Nguyen TH, Pasquet G, Fron-Chabouis H, Wulfman C. Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial. Trials. 2016 May 20;17(1):255. doi: 10.1186/s13063-016-1380-7.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Geistlich Pharma AG