title: Impact of the Diet Fertility : A Case-control Multicentric Study

acronym: ALIFERT

summary: This case-control multicentric study involving fertile and infertile couples aims at evaluating the impact on conception rate of nutritional parameters (biologic, clinic, anthropometric, and food questionnaire).

ReferenceCitation: Bachelot G, Levy R, Bachelot A, Faure C, Czernichow S, Dupont C, Lamaziere A; Alifert Collaborative Group. Proof of concept and development of a couple-based machine learning model to stratify infertile patients with idiopathic infertility. Sci Rep. 2021 Dec 14;11(1):24003. doi: 10.1038/s41598-021-03165-3.

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

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

ReferenceCitation: Talla P, Faure C, Rigourd V, Czernichow S, Sermondade N, Levy R, Dupont C; ALIFERT collaborative group. Is There an Association of Being Breastfed as an Infant and Fertility Status as an Adult? Breastfeed Med. 2021 May;16(5):414-418. doi: 10.1089/bfm.2020.0130. Epub 2021 Mar 30.

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

repositories_concat: HAL

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

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Dupont C, Hulot A, Jaffrezic F, Faure C, Czernichow S, di Clemente N, Racine C, Chavatte-Palmer P, Levy R; Alifert group. Female ponderal index at birth and idiopathic infertility. J Dev Orig Health Dis. 2020 Apr;11(2):154-158. doi: 10.1017/S2040174419000394. Epub 2019 Jul 16.

publisher_dissemination: Cambridge University Press

ReferenceCitation: Dupont C, Faure C, Daoud F, Gautier B, Czernichow S, Levy R; ALIFERT collaborative group. Metabolic syndrome and smoking are independent risk factors of male idiopathic infertility. Basic Clin Androl. 2019 Jul 1;29:9. doi: 10.1186/s12610-019-0090-x. eCollection 2019.

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

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

ReferenceCitation: Faure C, Dupont C, Chavatte-Palmer P, Gautier B, Levy R; ALIFERT Collaborative Group. Are semen parameters related to birth weight? Fertil Steril. 2015 Jan;103(1):6-10. doi: 10.1016/j.fertnstert.2014.11.027.

ReferenceCitation: Faure C, Leveille P, Dupont C, Julia C, Chavatte-Palmer P; Alifert Group; Sutton A, Levy R. Are superoxide dismutase 2 and nitric oxide synthase polymorphisms associated with idiopathic infertility? Antioxid Redox Signal. 2014 Aug 1;21(4):565-9. doi: 10.1089/ars.2014.5831. Epub 2014 Feb 25.

location_facility: Laboratoire d'Histologie- Embryologie - Cytogénétique - CECOS


type: Registry Identifier

title: Cardiovascular Consequences of Obstructive Sleep Apnea (OSA): Role of Endothelin and Preventive Effects of Bosentan

acronym: BOSAS

summary:
The study will compared the effects of bosentan, an endothelin receptor antagonist, and nasal continuous positive airway pressure (nCPAP), obstructive sleep apnea current reference treatment, on diastolic blood pressure in untreated mildly hypertensive sleep apnea patients.

The hypothesis is that blocking endothelin receptors with a drug will have the same systemic blood pressure lowering effect than nCPAP in sleep apnea patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital, Grenoble

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

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: FORCE: Rituximab (CD 20+-B Cell-depleting Monoclonal Antibody) for the Treatment of Refractory Inflammatory Myopathies With Specific Antibodies and Refractory Myasthenia Gravis

acronym: FORCE

summary: The traditional treatment of inflammatory myopathies (IM) and generalized myasthenia gravis (MG) is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70% of treated patients show an incomplete response, including 10 - 30% who are unresponsive. Corticosteroids and other immunosuppressive therapies presented also many side effects. We propose to evaluate in a pilot, open, prospective, multicentric, phase II study, the interest of rituximab in the treatment of patients with primary IM associated with specific AAb (anti-synthetase and anti-SRP AAbs), or MG (with anti-AchR AAbs), refractory to conventional therapies. Twenty fourth patients with primary IM (12 with anti-synthetase, 12 with anti-SRP AAbs), and 12 with MG will be included in the study.

ReferenceType: derived

ReferenceCitation: Allenbach Y, Guiguet M, Rigolet A, Marie I, Hachulla E, Drouot L, Jouen F, Jacquot S, Mariampillai K, Musset L, Grenier P, Devilliers H, Hij A, Boyer O, Herson S, Benveniste O. Efficacy of Rituximab in Refractory Inflammatory Myopathies Associated with Anti- Synthetase Auto-Antibodies: An Open-Label, Phase II Trial. PLoS One. 2015 Nov 5;10(11):e0133702. doi: 10.1371/journal.pone.0133702. eCollection 2015.

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_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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

location_facility: Service de Médecine Interne 1 / Groupe Hospitalier Pitié-Salpêtrière


title: Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

summary: The purpose of this study is to compare the effect of bolus of either sodium-lactate or mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive episodes (IHE)

status: Terminated

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes

lead_sponsor_type: industriel

status_simplified: Unknown


title: Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression

summary: The hypothesis of this study was that transcranial magnetic stimulation (TMS) focused on hyperfunctional cerebral areas should be more effective in treating depressive symptoms than stimulations not taking into account the functional specificity of the patient. The goal was to compare the effects of "guided" TMS, using neuroimaging to guide TMS on dysfunctional cortical regions individually detected by neuroimaging, with "standard TMS", as used in most studies, over the left prefrontal cortex, and with sham TMS, in patients with resistant depression.

location_facility: Albert Chenevier Hospital, Department of psychiatry

intervention_type: Device


title: Evaluation of the Respiratory Impact of Post-operative Chest Wall Anomalies After Conventional or Minimally Invasive Esophageal Atresia Surgery

acronym: RestriMIS

summary:
Right thoracotomy, conventional approach to esophageal atresia repair, leads to up to 60% radiological chest wall sequelae anomalies. The impact of these anomalies on the patient's respiratory function remains unknown. Minimally invasive thoracic surgery considerably reduces this rate.

The primary objective of this study is to assess the occurrence of restrictive lung disease in patients with type III esophageal atresia depending on the type of surgical approach (Conventional or minimally invasive).

The primary endpoint will be he occurrence of restrictive lung disease , objectified by pulmonary function tests (PFTs), carried out according to the current national guidelines (PNDS = protocole national de diagnostic et de soins).

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Bastard F, Bonnard A, Rousseau V, Gelas T, Michaud L, Irtan S, Piolat C, Ranke-Chretien A, Becmeur F, Dariel A, Lamireau T, Petit T, Fouquet V, Le Mandat A, Lefebvre F, Allal H, Borgnon J, Boubnova J, Habonimana E, Panait N, Buisson P, Margaryan M, Michel JL, Gaudin J, Lardy H, Auber F, Borderon C, De Vries P, Jaby O, Fourcade L, Lecompte JF, Tolg C, Delorme B, Schmitt F, Podevin G. Thoracic skeletal anomalies following surgical treatment of esophageal atresia. Lessons from a national cohort. J Pediatr Surg. 2018 Apr;53(4):605-609. doi: 10.1016/j.jpedsurg.2017.07.013. Epub 2017 Jul 21.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Angers

collaborators: Institut de Recherche en Santé, Environnement et le Travail, France

collaborators: Filière des Maladies Rares Abdomino-THOraciques : FIMATHO

location_facility: CRACMO - centre de référence des atrésies de l'oesophage


title: Valedia Dietary Supplement Tolerance Study Based on Blood, Urinary and Hemodynamic Biological Parameters

summary:
The objectives of this clinical study are to determine the tolerance of dietary supplement Valedia (blend of plant extracts) through the evaluation of several parameters :

Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine, urea.
Urinary parameters: urea, creatinine.
Hemodynamic parameters: heart rate and blood pressure.
Cardiac function: ECG.
Weight.

ipd_sharing: Yes

lead_sponsor: Valbiotis

collaborators: Centre d'Investigation Clinique INSERM 501, Clermont-Ferrand, France

collaborators: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

intervention_type: Dietary Supplement


title: The Influence of Metabolic Syndrome and Circulating Bile Acid Levels on the Development of Hepatocellular Carcinoma and Biliary Tract Cancers

acronym: METSLIVER

summary:
Increasing rates of highly malignant hepatocellular carcinoma (HCC) and biliary tract cancers (GBTC) observed in Western populations may be related to obesogenic lifestyle factors and their metabolic consequences, such as metabolic syndrome (MetS), inflammation and altered production of bile acids (BA). Such lifestyle behaviours may induce changes in the gut microflora which in turn affect BA profiles, increasing their carcinogenicity. Some elevated BA may be oncogenic in exposed liver, bile ducts and gall bladder. Vertical sleeve gastrectomy may change bile acid composition.

The aims of this study are:

whether specific presurgical bila acid profiles are predictive of efficacy of vertical sleeve gastrectomy, reflective of liver function and metabolic dysfunction;
whether specific presurgical bile acid profiles are predictive of the efficacy of sleeve gastrectomy

study_start_date_type: Actual

time_perspective: Prospective

ipd_sharing: No

collaborators: Centre International de la Recherche sur le Cancer


lead_sponsor: Fresenius Kabi

summary: The main focus of the study is to show that SmofKabiven® extra Nitrogen, in a realistic clinical setting, enables to meet high protein requirements in patients during the first week after onset of critical illness, without risk of overfeeding with energy.

location_facility: SP ZOZ Wojewódzki Szpital Zespolony im. J. Śniadeckiego

location_facility: Klinikum rechts der Isar, Klinik für Anaesthesiologie

location_facility: Hôpital Saint-Antoine, Département d'Anesthésie-Réanimation

title: Reaching Protein Target With SmofKabiven® Extra Nitrogen Versus Olimel N9E: A Prospective, Randomised, Active-controlled, Patient-blinded, Multicentre Clinical Trial During the Early Phase of Acute Critical Illness

primary_purpose: Supportive Care

type: EudraCT Number

source: euctr

location_country: Germany Poland France


type: Other Identifier

title: Study of Bipolar Disorders and Retinal Electrophysiological Markers

acronym: BIMAR

summary:
The BIMAR study aims to compare electrophysiological data measured with electroretinogram (ERG) and electroencephalogram (EEG) between a group of euthymic patients with bipolar disorder (BD) and a group of healthy controls subjects.

Secondarily, the investigators also want to:

Compare combined electrophysiological measurements with ERG and EEG between the two groups.
Identify relations between clinical, neuropsychological and circadian phenotypes in patients with BD and electrophysiological measurements measured with ERG and EEG.

The main hypothesis of the investigators is that differences exist in the ERG and EEG measurements between subjects with BD and healthy subjects. Those differences could be identified as candidate markers for BD which, if confirmed in later studies, could be used in current practice to guide the management of patients with BD.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Schwitzer T, Schwan R, Bubl E, Lalanne L, Angioi-Duprez K, Laprevote V. Looking into the brain through the retinal ganglion cells in psychiatric disorders: A review of evidences. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jun 2;76:155-162. doi: 10.1016/j.pnpbp.2017.03.008. Epub 2017 Mar 20.

ReferenceCitation: Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. Study of retinal structure and function in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature. J Fr Ophtalmol. 2020 May;43(5):e157-e166. doi: 10.1016/j.jfo.2020.04.004. Epub 2020 May 4.

ReferenceCitation: Hebert M, Merette C, Gagne AM, Paccalet T, Moreau I, Lavoie J, Maziade M. The Electroretinogram May Differentiate Schizophrenia From Bipolar Disorder. Biol Psychiatry. 2020 Feb 1;87(3):263-270. doi: 10.1016/j.biopsych.2019.06.014. Epub 2019 Jun 27.

ReferenceCitation: Gross G, Tursini K, Albuisson E, Angioi-Duprez K, Conart JB, Louis Dorr V, Schwan R, Schwitzer T. Bipolar disorders and retinal electrophysiological markers (BiMAR): Study protocol for a comparison of electroretinogram measurements between subjects with bipolar disorder and a healthy control group. Front Psychiatry. 2022 Sep 8;13:960512. doi: 10.3389/fpsyt.2022.960512. eCollection 2022.

repositories_concat: PubMed Central

publisher_dissemination: Frontiers

lead_sponsor: Centre Psychothérapique de Nancy

sponsor_collaborators:
Centre Psychothérapique de Nancy
BioSerenity

status_simplified: Ongoing


title: LUMIERE on the PLACENTA : A Study on the Added Value of MRI

summary: The frequency of IUGR is between 3 and 10% of births. The etiologies and mechanisms of IUGR are multiple. The placental insufficiency, that is the defect of perfusion, is, however, the principal mechanism, far in front of other maternal or fetal causes. This placental insufficiency is also now recognized as an essential risk factor for cardiovascular and metabolic diseases, such as diabetes, in adulthood. The interest in understanding in utero development is thus further increased by the short-, medium- and long-term consequences of placental dysfunction. However, there are few ways to evaluate uteroplacental vascularization in vivo. MRI is an imaging technique used routinely in the exploration of the fetus in addition to ultrasound. Its safety on the fetus and the mother is largely demonstrated at 1.5T. There are also MRI sequences used daily in the clinic to evaluate perfusion and organ structure in children and adults (brain, kidney, heart, etc.). Their application for evaluation of perfusion and placental structure, although still confined to research, is very promising. The investigator's team has extensive experience, in animals or in children, in the use of these sequences that could be used to evaluate placental function in vivo. The ASL (Arterial Spin Labeling) in particular is the most encouraging functional imaging technique because it allows today to measure an organ blood flow quantitatively and without injection of contrast medium.

status: Withdrawn

collaborators: LUMIERE Fondation ( fondation-lumiere.org) under the aegis of Fondation de France

intervention_type: Other


title: Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.

acronym: KP-CARAIBES

summary: The course and progression of prostate cancer is highly variable, depending on the individual characteristics, the aggressiveness of the disease at the time of diagnosis as well as the ethno-geographic origins of the individuals. The general objective of the project is to identify the clinical, genetic and environmental determinants (risk factors) of the evolution, progression and complications of the disease according to the treatment options. Identifying modifiable and non-modifiable prognostic determinants of disease progression is a major challenge. This knowledge will help guide treatment choices but also, especially in high-risk populations (high incidence of disease) to better tailor prevention policies and possibly screening .

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre

location_country: Guadeloupe France

location_facility:
CHU of Rennes
CHU of Guadeloupe


title: Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors

acronym: MANGUE

summary: Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Our objective is to determine the prevalence of NCC activation three months after transplantation in patient treated by CNI.

lead_sponsor: University Hospital, Bordeaux

location_country: Réunion France

location_facility: Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse

location_facility: Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales


title: Assessment of the Efficacy and Tolerance, and Health Economic Study of a Single Administration of Pegfilgrastim in Lymphoma or Myeloma Patients Treated With Intensive Chemotherapy and Autologous Peripheral Stem Cell Transplantation

acronym: PALM

summary:
The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred.

Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months.

The number of patients required in this multicentric and prospective study is 150 (13 participating centers).

This is a phase II, controlled, randomized, non comparative and open-label multicentric study.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Amgen

location_facility:
CHU Nantes
Centre Hospitalier Lyon Sud
Hôpital Lapeyronnie
CHU Toulouse - Hôpital Purpam
Centre Leon Berard
CHU Brest
CHU Tours - Hôpital Bretonneau
Institut Gustave Roussy
Hopital Edouard Herriot
CHU Angers
Centre Henri Becquerel


title: Investigation of Neurophysiological Functioning During Oral Comprehension Task. An Exploratory Study in Second Language (Italian) Learning in French Students Using Autonomic and Cerebral Investigation

acronym: COraIL

summary: The oral comprehension (OC) of a second language (L2) involves different cognitive processes, specially during the learning phase. This study aims at investigating the neurophysiological functioning of different steps involved in this oral understanding.

time_perspective: Cross-Sectional

ipd_sharing: Undecided

ipd_sharing_description: anonymised, processed data will be shared after publication acceptance on dedicated sites

intervention_type: Diagnostic Test


title: Multimodal Study of the Human Brain Epilepsy Tissue

summary:
The TIPI2 study is a blood and tissue collection protocol to create an annotated biorepository to support research in drug-resistant epilepsy.

The aim of the study will be to identify new pathophysiological pathways. For this purpose, the investigators will investigate with a multimodal approach blood and brain samples from patients undergoing a surgery for focal drug-resistant epilepsy. The adult patients will be enrolled either during the pre-surgical evaluation or right before the surgery.

status: Not yet recruiting

primary_purpose: Basic Science

ipd_sharing_description:
Data are available upon reasonable request

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

location_facility: Department of Neurology, Epilepsy Unit, Pitié-Salpêtrière Hospital


title: Systemic Lupus Erythematosus and Accelerated Aging

acronym: LUPAGE

summary: The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus.

location_facility: CHU de Bordeaux - Médecine Interne et Immunologie Clinique

intervention_type: Biological


title: Impact de Programmes de Marche Active Sur la Marche en Situation de Vie Quotidienne et la qualité de Vie Dans la Maladie de Parkinson

acronym: ACTI-PARK

summary:
The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD).

Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point.

The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function.

Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.

intervention_type: Behavioral


title: REtinal and VIsual Cortical Response in Early PSYchosis

acronym: REVIPSY

summary: The purpose of the REVIPSY study is to measure retinal and the visual cortical electrophysiological responses in situations at risk of psychosis in patients who have experienced a first psychotic episode. A perspective of this project will be to create new electrophysiological biomarkers predictive of the risk of conversion to psychosis

ReferenceCitation: Laprevote V, Heitz U, Di Patrizio P, Studerus E, Ligier F, Schwitzer T, Schwan R, Riecher-Rossler A. [Why and how to treat psychosis earlier?]. Presse Med. 2016 Nov;45(11):992-1000. doi: 10.1016/j.lpm.2016.07.011. Epub 2016 Aug 21. French.

ReferenceCitation: Demmin DL, Davis Q, Roche M, Silverstein SM. Electroretinographic anomalies in schizophrenia. J Abnorm Psychol. 2018 May;127(4):417-428. doi: 10.1037/abn0000347.

ReferenceCitation: Moghimi P, Torres Jimenez N, McLoon LK, Netoff TI, Lee MS, MacDonald A 3rd, Miller RF. Electoretinographic evidence of retinal ganglion cell-dependent function in schizophrenia. Schizophr Res. 2020 May;219:34-46. doi: 10.1016/j.schres.2019.09.005. Epub 2019 Oct 12.

ReferenceCitation: Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. [Retinal investigations in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature]. J Fr Ophtalmol. 2020 Sep;43(7):586-597. doi: 10.1016/j.jfo.2019.10.029. Epub 2020 Jul 4. French.

ReferenceCitation: Butler PD, Martinez A, Foxe JJ, Kim D, Zemon V, Silipo G, Mahoney J, Shpaner M, Jalbrzikowski M, Javitt DC. Subcortical visual dysfunction in schizophrenia drives secondary cortical impairments. Brain. 2007 Feb;130(Pt 2):417-30. doi: 10.1093/brain/awl233. Epub 2006 Sep 19.

ReferenceCitation: Knebel JF, Javitt DC, Murray MM. Impaired early visual response modulations to spatial information in chronic schizophrenia. Psychiatry Res. 2011 Sep 30;193(3):168-76. doi: 10.1016/j.pscychresns.2011.02.006. Epub 2011 Jul 20.

ReferenceCitation: Kim DW, Shim M, Song MJ, Im CH, Lee SH. Early visual processing deficits in patients with schizophrenia during spatial frequency-dependent facial affect processing. Schizophr Res. 2015 Feb;161(2-3):314-21. doi: 10.1016/j.schres.2014.12.020. Epub 2014 Dec 29.


title: Genes Modulating the Severity of Aortic Aneurysms (MSF1-TGFBR2)

summary:
This project concerns a population at risk of sudden death by dissection of the thoracic aorta. Its interest is to make it possible to recognize the genes that protect or worsen the evolution of aneurysms, to better understand the mechanisms involved, to detect and treat aneurysms of the thoracic aorta, wich is a pathology that is completely silent clinically until life-threatening complications.

The variability in the severity of the disease within the same family is related to modifier genes.

The objective is to find the modifying factors that account for the variability in the severity of the progression of aneurysms of the thoracic aorta.

lead_sponsor: French Cardiology Society


title: Cell Signaling, Reinnervation and Metabolism in Kennedy Disease and Amyotrophic Lateral Sclerosis (ALS)

acronym: CERMALS

summary:
Amyotrophic lateral sclerosis (ALS), is a rapidly progressive neurodegenerative disorder, usually leading to death from respiratory failure in 3-5 years. Riluzole, the only drug currently available, only modestly prolongs survival and does not improve muscle strength or function. In ALS, loss of functional motor neurons is initially compensated for by collateral reinnervation and strength is preserved. In the majority of ALS patients, as the disease progresses, compensation fails leading to progressive muscle weakness. Conversely, in long-term ALS survivors, slow functional decline is correlated with their ability to maintain a successful compensatory response to denervation over time. Compensatory collateral reinnervation is thus essential for functional motor preservation and survival, and elucidation of the molecular mechanisms involved is crucial to help identify new therapeutic targets. Energy metabolism and glucose homeostasis modifications also influence disease clinical course but the mechanisms by which they contribute to the progression of ALS are unknown. Weight loss is an independent negative prognostic factor for survival and, by contrast, ALS risk and progression are decreased in individuals with high body mass index and non-insulin-dependent diabetes mellitus. Insulin shares many common steps in its signaling pathways with insulin-like growth factor 1 (IGF-1), and is thus at the interface between glucose homeostasis regulation and maintenance of muscle mass. However, the contribution of insulin signaling to preservation of muscle innervation and function in ALS has never been investigated.

With this study, we aim to determine the role of insulin signaling pathways in maintenance of collateral reinnervation and muscle function in ALS. We will also investigate the link with the disease-modifying effect of metabolic and glucose homeostasis perturbations, by identifying the contribution of metabolic profiles to preservation of skeletal muscle innervation and motor function in patients with ALS. For this purpose, we will determine the whole-body and skeletal muscle metabolic profiles of 20 patients with ALS and correlate these results to collateral reinnervation ability quantified on muscle biopsy specimens. For each patient, we will use both clinical and electrophysiological methods to evaluate motor function and motor neuron loss over time. Body composition, insulin secretion, insulin resistance level and serum concentrations of IGF-1 axis components will be determined. A motor point muscle biopsy will be performed for morphological analysis of neuromuscular junctions and quantification of innervation by confocal microscopy. Activation of insulin/IGF-1 canonical signaling pathways and metabolic pathways of glucose homeostasis will be quantified in muscle specimens. Skeletal muscle and whole-body metabolic parameters will be analyzed together and correlated with clinical assessment of motor function, electrophysiological data, and innervation quantification results. For comparison, 10 healthy subjects of similar age and 10 patients with spinal and bulbar muscular atrophy - a slowly progressive motor neuron disorder with maintenance of effective collateral reinnervation - will be used as controls. This study will be the first to address the question of the contribution of insulin signaling pathways and metabolic profiles in maintenance of muscle reinnervation and function in ALS patients. The molecular mechanisms identified will be new targets for future treatments promoting compensatory reinnervation and slowing disease progression in ALS. Ultimately, this translational project could have a significant therapeutic impact in disorders with muscle denervation and collateral reinnervation as a compensatory mechanism, such as spinal muscle atrophy or peripheral neuropathies.

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

intervention_type: Procedure


title: Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock

acronym: REPTILOS

summary: Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1

location_facility: Intensive care department, Hôpital Saint Antoine


acronym: MIRACLE

summary:
Crohn's disease (CD) is a chronic inflammatory bowel disease. CD pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota in predisposed hosts.

The purpose of this study is to evaluate de clinical efficacy of the fecal microbiota transplantation (FMT) as a maintenance treatment following anti-TNF agent withdrawal in CD's patient.

ReferenceCitation: Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015 Apr;12(4):205-17. doi: 10.1038/nrgastro.2015.34. Epub 2015 Mar 3.

ReferenceCitation: Angelberger S, Reinisch W, Makristathis A, Lichtenberger C, Dejaco C, Papay P, Novacek G, Trauner M, Loy A, Berry D. Temporal bacterial community dynamics vary among ulcerative colitis patients after fecal microbiota transplantation. Am J Gastroenterol. 2013 Oct;108(10):1620-30. doi: 10.1038/ajg.2013.257. Epub 2013 Sep 24.

ReferenceCitation: Beaugerie L, Itzkowitz SH. Cancers Complicating Inflammatory Bowel Disease. N Engl J Med. 2015 Jul 9;373(2):195. doi: 10.1056/NEJMc1505689. No abstract available.

ReferenceCitation: Ben-Horin S, Chowers Y. Review article: loss of response to anti-TNF treatments in Crohn's disease. Aliment Pharmacol Ther. 2011 May;33(9):987-95. doi: 10.1111/j.1365-2036.2011.04612.x. Epub 2011 Mar 2.

ReferenceCitation: Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.

ReferenceCitation: Borody T, Fischer M, Mitchell S, Campbell J. Fecal microbiota transplantation in gastrointestinal disease: 2015 update and the road ahead. Expert Rev Gastroenterol Hepatol. 2015;9(11):1379-91. doi: 10.1586/17474124.2015.1086267. Epub 2015 Sep 28.

ReferenceCitation: Colman RJ, Rubin DT. Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis. J Crohns Colitis. 2014 Dec;8(12):1569-81. doi: 10.1016/j.crohns.2014.08.006. Epub 2014 Sep 13. Erratum In: J Crohns Colitis. 2022 Aug 16;:

ReferenceCitation: Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.

ReferenceCitation: Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.

ReferenceCitation: D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.

ReferenceCitation: Debast SB, Bauer MP, Kuijper EJ; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014 Mar;20 Suppl 2:1-26. doi: 10.1111/1469-0691.12418.

ReferenceCitation: Grinspan AM, Kelly CR. Fecal Microbiota Transplantation for Ulcerative Colitis: Not Just Yet. Gastroenterology. 2015 Jul;149(1):15-8. doi: 10.1053/j.gastro.2015.05.030. Epub 2015 May 27. No abstract available.

ReferenceCitation: Kennedy NA, Warner B, Johnston EL, Flanders L, Hendy P, Ding NS, Harris R, Fadra AS, Basquill C, Lamb CA, Cameron FL, Murray CD, Parkes M, Gooding I, Ahmad T, Gaya DR, Mann S, Lindsay JO, Gordon J, Satsangi J, Hart A, McCartney S, Irving P; UK Anti-TNF withdrawal study group; Lees CW. Relapse after withdrawal from anti-TNF therapy for inflammatory bowel disease: an observational study, plus systematic review and meta-analysis. Aliment Pharmacol Ther. 2016 Apr;43(8):910-923. doi: 10.1111/apt.13547. Epub 2016 Feb 19.

ReferenceCitation: Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.

ReferenceCitation: Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.

ReferenceCitation: Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209.

ReferenceCitation: Lamas B, Richard ML, Leducq V, Pham HP, Michel ML, Da Costa G, Bridonneau C, Jegou S, Hoffmann TW, Natividad JM, Brot L, Taleb S, Couturier-Maillard A, Nion-Larmurier I, Merabtene F, Seksik P, Bourrier A, Cosnes J, Ryffel B, Beaugerie L, Launay JM, Langella P, Xavier RJ, Sokol H. CARD9 impacts colitis by altering gut microbiota metabolism of tryptophan into aryl hydrocarbon receptor ligands. Nat Med. 2016 Jun;22(6):598-605. doi: 10.1038/nm.4102. Epub 2016 May 9.

ReferenceCitation: Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.

ReferenceCitation: Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098.

ReferenceCitation: Lennard-Jones JE. Classification of inflammatory bowel disease. Scand J Gastroenterol Suppl. 1989;170:2-6; discussion 16-9. doi: 10.3109/00365528909091339.

ReferenceCitation: Manichanh C, Borruel N, Casellas F, Guarner F. The gut microbiota in IBD. Nat Rev Gastroenterol Hepatol. 2012 Oct;9(10):599-608. doi: 10.1038/nrgastro.2012.152. Epub 2012 Aug 21.

ReferenceCitation: Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.

ReferenceCitation: Paramsothy S, Kamm MA, Kaakoush NO, Walsh AJ, van den Bogaerde J, Samuel D, Leong RWL, Connor S, Ng W, Paramsothy R, Xuan W, Lin E, Mitchell HM, Borody TJ. Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial. Lancet. 2017 Mar 25;389(10075):1218-1228. doi: 10.1016/S0140-6736(17)30182-4. Epub 2017 Feb 15.

ReferenceCitation: Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30.

ReferenceCitation: Sokol H, Leducq V, Aschard H, Pham HP, Jegou S, Landman C, Cohen D, Liguori G, Bourrier A, Nion-Larmurier I, Cosnes J, Seksik P, Langella P, Skurnik D, Richard ML, Beaugerie L. Fungal microbiota dysbiosis in IBD. Gut. 2017 Jun;66(6):1039-1048. doi: 10.1136/gutjnl-2015-310746. Epub 2016 Feb 3.

ReferenceCitation: Sokol H, Galperine T, Kapel N, Bourlioux P, Seksik P, Barbut F, Scanzi J, Chast F, Batista R, Joly F, Joly AC, Collignon A, Guery B, Beaugerie L; French Group of Faecal microbiota Transplantation (FGFT). Faecal microbiota transplantation in recurrent Clostridium difficile infection: Recommendations from the French Group of Faecal microbiota Transplantation. Dig Liver Dis. 2016 Mar;48(3):242-7. doi: 10.1016/j.dld.2015.08.017. Epub 2015 Sep 7.

ReferenceCitation: Sokol H. Toward Rational Donor Selection in Faecal Microbiota Transplantation for IBD. J Crohns Colitis. 2016 Apr;10(4):375-6. doi: 10.1093/ecco-jcc/jjw005. Epub 2016 Jan 7. No abstract available.

ReferenceCitation: Sokol H, Lalande V, Landman C, Bourrier A, Nion-Larmurier I, Rajca S, Kirchgesner J, Seksik P, Cosnes J, Barbut F, Beaugerie L. Clostridium difficile infection in acute flares of inflammatory bowel disease: A prospective study. Dig Liver Dis. 2017 Jun;49(6):643-646. doi: 10.1016/j.dld.2017.01.162. Epub 2017 Jan 30.

ReferenceCitation: Suskind DL, Singh N, Nielson H, Wahbeh G. Fecal microbial transplant via nasogastric tube for active pediatric ulcerative colitis. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):27-9. doi: 10.1097/MPG.0000000000000544.

ReferenceCitation: Toruner M, Loftus EV Jr, Harmsen WS, Zinsmeister AR, Orenstein R, Sandborn WJ, Colombel JF, Egan LJ. Risk factors for opportunistic infections in patients with inflammatory bowel disease. Gastroenterology. 2008 Apr;134(4):929-36. doi: 10.1053/j.gastro.2008.01.012. Epub 2008 Jan 11.

ReferenceCitation: van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

ReferenceCitation: Vermeire S, Joossens M, Verbeke K, Wang J, Machiels K, Sabino J, Ferrante M, Van Assche G, Rutgeerts P, Raes J. Donor Species Richness Determines Faecal Microbiota Transplantation Success in Inflammatory Bowel Disease. J Crohns Colitis. 2016 Apr;10(4):387-94. doi: 10.1093/ecco-jcc/jjv203. Epub 2015 Oct 29.

ReferenceCitation: Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20. Erratum In: Gastroenterology. 2013 Jan;144(1):250.

ReferenceCitation: Youngster I, Mahabamunuge J, Systrom HK, Sauk J, Khalili H, Levin J, Kaplan JL, Hohmann EL. Oral, frozen fecal microbiota transplant (FMT) capsules for recurrent Clostridium difficile infection. BMC Med. 2016 Sep 9;14(1):134. doi: 10.1186/s12916-016-0680-9.

location_facility: Gastroenterology Department of Saint Antoine Hospital

title: Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal


title: Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis

acronym: PROSTA-PAP

summary: The purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy.


acronym: REMOMEPO

summary: Chronic airway changes, such as smooth muscle hypertrophy/hyperplasia, reticular basement membrane (RBM) thickening, goblet cells hyperplasia characterize severe asthma. Chronic inflammation, and especially eosinophilia and T2 cytokines are involved in these structural changes. The aim of this prospective observational study is to assess airway changes, assessed by bronchial biopsies before treatment, then after 6 months and 12 months, induced by mepolizumab in 40 severe asthma patients who will receive the treatment as part of their standard care. Changes in RBM thickening, in airway smooth muscle (ASM) area, in the number of PGP9 sections will be assessed on bronchial biopsies after 6 months and 12 months of mepolizumab treatment. Bronchoalveolar lavage (BAL) levels of inflammatory and remodeling mediators and of extra-cellular matrix (ECM) components will be measured after 6 months and 12 months of mepolizumab treatment. Relationship between clinical response to mepolizumab and remodeling changes after 6 months and 12 months will be assessed.

title: Airway Remodeling Changes Induced by Mepolizumab in Severe Eosinophil Asthma


title: An Interventional, Phase II, Non Randomized, Mono-centric Study on the Clinical Efficacy and Safety of the Medical Device PAGETEX® as a Photodynamic Therapy Device in the Treatment of Extra-Mammary Paget's Disease of the Vulva (EMPV)

acronym: PAGETEX

summary:
Vulvar Paget's disease is a rare skin tumour which affect Caucasian post-menopausal women. The disease is revealed by erythematous, eczematous, pruritus and vulvar burns. The diagnosis is often late (from a few months to several years) because the symptoms are neglected by patients or misinterpreted by doctors. The reference treatment is based on surgical excision but unfortunately local recurrences are very frequent (17 to 38% of cases).

Photodynamic therapy (PDT) is already used in some dermatological pathologies and could therefore be an alternative treatment.

The objective of this study is to assess the efficacy and evaluate the safety of the new PDT device "PAGETEX" for the treatment of vulvar Paget's disease.

ReferenceCitation: Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Maire C, Staumont-Salle D, Mordon S, Mortier L. Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e15026. doi: 10.2196/15026.

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

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

publisher_dissemination: JMIR Publications

lead_sponsor: University Hospital, Lille


title: Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial

acronym: REBALANCE-UC

summary:
Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. UC pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts.

The purpose of this study is to determine the effect of the fecal microbiota transplantation on UC.

ReferenceCitation: Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015 Apr;12(4):205-17. doi: 10.1038/nrgastro.2015.34. Epub 2015 Mar 3.

ReferenceCitation: Angelberger S, Reinisch W, Makristathis A, Lichtenberger C, Dejaco C, Papay P, Novacek G, Trauner M, Loy A, Berry D. Temporal bacterial community dynamics vary among ulcerative colitis patients after fecal microbiota transplantation. Am J Gastroenterol. 2013 Oct;108(10):1620-30. doi: 10.1038/ajg.2013.257. Epub 2013 Sep 24.

ReferenceCitation: Beaugerie L, Itzkowitz SH. Cancers Complicating Inflammatory Bowel Disease. N Engl J Med. 2015 Jul 9;373(2):195. doi: 10.1056/NEJMc1505689. No abstract available.

ReferenceCitation: Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.

ReferenceCitation: Borody T, Fischer M, Mitchell S, Campbell J. Fecal microbiota transplantation in gastrointestinal disease: 2015 update and the road ahead. Expert Rev Gastroenterol Hepatol. 2015;9(11):1379-91. doi: 10.1586/17474124.2015.1086267. Epub 2015 Sep 28.

ReferenceCitation: Colman RJ, Rubin DT. Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis. J Crohns Colitis. 2014 Dec;8(12):1569-81. doi: 10.1016/j.crohns.2014.08.006. Epub 2014 Sep 13. Erratum In: J Crohns Colitis. 2022 Aug 16;:

ReferenceCitation: Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2.

ReferenceCitation: D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available.

ReferenceCitation: Debast SB, Bauer MP, Kuijper EJ; European Society of Clinical Microbiology and Infectious Diseases. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014 Mar;20 Suppl 2:1-26. doi: 10.1111/1469-0691.12418.

ReferenceCitation: Grinspan AM, Kelly CR. Fecal Microbiota Transplantation for Ulcerative Colitis: Not Just Yet. Gastroenterology. 2015 Jul;149(1):15-8. doi: 10.1053/j.gastro.2015.05.030. Epub 2015 May 27. No abstract available.

ReferenceCitation: Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3.

ReferenceCitation: Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.

ReferenceCitation: Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209.

ReferenceCitation: Lamas B, Richard ML, Leducq V, Pham HP, Michel ML, Da Costa G, Bridonneau C, Jegou S, Hoffmann TW, Natividad JM, Brot L, Taleb S, Couturier-Maillard A, Nion-Larmurier I, Merabtene F, Seksik P, Bourrier A, Cosnes J, Ryffel B, Beaugerie L, Launay JM, Langella P, Xavier RJ, Sokol H. CARD9 impacts colitis by altering gut microbiota metabolism of tryptophan into aryl hydrocarbon receptor ligands. Nat Med. 2016 Jun;22(6):598-605. doi: 10.1038/nm.4102. Epub 2016 May 9.

ReferenceCitation: Le Chatelier E, Nielsen T, Qin J, Prifti E, Hildebrand F, Falony G, Almeida M, Arumugam M, Batto JM, Kennedy S, Leonard P, Li J, Burgdorf K, Grarup N, Jorgensen T, Brandslund I, Nielsen HB, Juncker AS, Bertalan M, Levenez F, Pons N, Rasmussen S, Sunagawa S, Tap J, Tims S, Zoetendal EG, Brunak S, Clement K, Dore J, Kleerebezem M, Kristiansen K, Renault P, Sicheritz-Ponten T, de Vos WM, Zucker JD, Raes J, Hansen T; MetaHIT consortium; Bork P, Wang J, Ehrlich SD, Pedersen O. Richness of human gut microbiome correlates with metabolic markers. Nature. 2013 Aug 29;500(7464):541-6. doi: 10.1038/nature12506.

ReferenceCitation: Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098.

location_facility: Service de Gastroentérologie et Nutrition Hôpital Saint Antoine

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: RebalanceUC

titre: Impact de la Transplantation de microbiote fécale dans la rectocolite Hémorragique : un essai randomisé contrôlé

discipline_principale: gastro-entérologie

nom_porteur: SOKOL

prenom_porteur: Harry


title: Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

acronym: VASCIP

summary: Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.

lead_sponsor: University Hospital, Montpellier


title: Modulation of Lactase Expression by a New Synthetic PPARgamma Ligand in Ex-vivo Cultures of Duodenal Biopsies

summary: This study is designed to assess the effect of a new PPARgamma modulator on the expression and activity of the lactase enzyme in human intestinal epithelial cells. Based on their previous experimental results, the investigators hypothesized that modulating intestinal PPARgamma activity is a new pharmacological mechanism allowing the control of lactase expression and activity in the gut

collaborators: French National Society of Gastroenterology


title: DNA Methylation and Lung Disease in Cystic Fibrosis

acronym: METHYLCF

summary: Lung disease progression is variable among cystic fibrosis (CF) patients and depends on DNA mutations in the CFTR gene, polymorphic variations in disease-modifier genes and environmental exposure. The contribution of genetic factors has been extensively investigated, whereas the mechanism whereby environmental factors modulate the lung disease is unknown. Because these factors can affect the epigenome, investigators hypothesized that DNA methylation variations at disease-modifier genes modulate the lung function in CF patients.

ReferenceCitation: Magalhaes M, Tost J, Pineau F, Rivals I, Busato F, Alary N, Mely L, Leroy S, Murris M, Caimmi D, Claustres M, Chiron R, De Sario A. Dynamic changes of DNA methylation and lung disease in cystic fibrosis: lessons from a monogenic disease. Epigenomics. 2018 Aug;10(8):1131-1145. doi: 10.2217/epi-2018-0005. Epub 2018 Jul 27.

publisher_dissemination: Future Science Ltd


title: Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

acronym: MRAB

summary: In this diagnostic study, the aim is at evaluating the diagnostic accuracy of MRI (Magnetic Resonance Imaging) to detect allergic broncho-pulmonary aspergillosis in patients with cystic fibrosis.

lead_sponsor: Hôpital Haut Lévêque


title: Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection

acronym: MONALISABABY

summary: The purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal sepsis, of prematurity and of the known neurological tropism of the involved pathogen, Listeria monocytogenes.


title: Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis

acronym: TRANSTEATOSE

summary:
Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition.

This proof of concept validation is made up of two steps:

Step 1: feasibility study of the method on 10 healthy volunteers
Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an liver biopsy et whom the histological answer is clean steatosis (NAFLD).

Experimental procedures consist in:

Fibroscan measure, preceded by tracking ultrasonography.
liver MRI (for substudy about MRI comparison, in step 2)
a blood test for biological assessment of liver functions

lead_sponsor: University Hospital, Tours


title: Genetic and Environmental Risk Factors of Type 1 Autoimmune Diabetes and Its Early Complications. French Multicentric Cohort of Diabetic Patients.

acronym: ISIS-DIAB

summary:
The aim of this study is to complete the identification of genetic factors (G) and to undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G analysis (whole genome genotyping done once a patient using methods conually updated at Centre National de Genotype) and innovative E analysis to develop the following long term objectives :

Identify G and E factors influencing the process of remaining beta cells' destruction during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years diabetes duration);
Identify G factors (pharmacogenomics) of the individual response to insulin using the effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D patients with negative C-peptide and well managed diabetes);
Undertake a prospective research of G and E risk factors of "death in bed" syndrome in diabetic adolescents;
Undertake a prospective research of G and E risk factors of incipient glomerular microangiopathy (regule measurement of microalbuminuria).

ReferenceCitation: Balazard F, Le Fur S, Valtat S, Valleron AJ, Bougneres P; Isis-Diab collaborative group; Thevenieau D, Chatel CF, Desailloud R, Bony-Trifunovic H, Ducluzeau PH, Coutant R, Caudrelier S, Pambou A, Dubosclard E, Joubert F, Jan P, Marcoux E, Bertrand AM, Mignot B, Penformis A, Stuckens C, Piquemal R, Barat P, Rigalleau V, Stheneur C, Fournier S, Kerlan V, Metz C, Fargeot-Espaliat A, Reznic Y, Olivier F, Gueorguieva I, Monier A, Radet C, Gajdos V, Terral D, Vervel C, Bendifallah D, Signor CB, Dervaux D, Benmahammed A, Loeuille GA, Popelard F, Guillou A, Benhamou PY, Khoury J, Brossier JP, Bassil J, Clavel S, Le Luyer B, Bougneres P, Labay F, Guemas I, Weill J, Cappoen JP, Nadalon S, Lienhardt-Roussie A, Paoli A, Kerouedan C, Yollin E, Nicolino M, Simonin G, Cohen J, Atlan C, Tamboura A, Dubourg H, Pignol ML, Talon P, Jellimann S, Chaillous L, Baron S, Bortoluzzi MN, Baechler E, Salet R, Zelinsky-Gurung A, Dallavale F, Larger E, Laloi-Michelin M, Gautier JF, Guerin B, Oilleau L, Pantalone L, Lukas C, Guilhem I, De Kerdanet M, Wielickzo MC, Priou-Guesdon M, Richard O, Kurtz F, Laisney N, Ancelle D, Parlier G, Boniface C, Bockel DP, Dufillot D, Razafimahefa B, Gourdy P, Lecomte P, Pepin-Donat M, Combes-Moukhovsky ME, Zymmermann B, Raoulx M, Dumont AG. Association of environmental markers with childhood type 1 diabetes mellitus revealed by a long questionnaire on early life exposures and lifestyle in a case-control study. BMC Public Health. 2016 Sep 29;16(1):1021. doi: 10.1186/s12889-016-3690-9.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

evidence: oa repository (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_normalized: bioRxiv

repositories:
HAL
PubMed Central
bioRxiv

repositories_concat: HAL;PubMed Central;bioRxiv

publisher_dissemination: Springer-Nature

intervention_type: Genetic


title: Transient Elastography DEdicated to Cosmetology And Dermatology (TEDECAD)

acronym: TEDECAD

summary:
Explorative study on a medical device with two steps. The first pilot step will be on 8 patients (4 with lymphedema and 4 with venous insufficiency). The main objective is to assess the feasibility of measures by high resolution transient elastography on these pathologic skins, and to define 3 areas for measures.

The second step will be on 136 participants (48 healthy volunteers, 48 with venous insufficiency and 40 with unilateral lymphedema of a limb). The main objective is to quantify, by high resolution transient elastography, the dermal and hypodermal cutaneous fibrosis in limbs with lymphedema and venous insufficiency, and to compare it to healthy skin.


title: Differential Study of Muscle Transcriptome in Patients With Neuromuscular Disease and Control Subjects

acronym: TRANE

summary: To isolate biomarkers of ALS in muscle

location_facility: Centre d'évaluation Thérapeutique, Dr LACOMBLEZ


title: Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

summary: To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage (probably related to hypertension).

ReferenceCitation: Planton M, Pariente J, Nemmi F, Albucher JF, Calviere L, Viguier A, Olivot JM, Salabert AS, Payoux P, Peran P, Raposo N. Interhemispheric distribution of amyloid and small vessel disease burden in cerebral amyloid angiopathy-related intracerebral hemorrhage. Eur J Neurol. 2020 Aug;27(8):1664-1671. doi: 10.1111/ene.14301. Epub 2020 May 31.

publisher_dissemination: Wiley

ReferenceCitation: Planton M, Saint-Aubert L, Raposo N, Branchu L, Lyoubi A, Bonneville F, Albucher JF, Olivot JM, Peran P, Pariente J. High prevalence of cognitive impairment after intracerebral hemorrhage. PLoS One. 2017 Jun 1;12(6):e0178886. doi: 10.1371/journal.pone.0178886. eCollection 2017.

repositories_concat: PubMed Central;pdfs.semanticscholar.org

lead_sponsor: University Hospital, Toulouse


title: Neuro Anatomic Basis of Psychic Pain in Depression and Suicidal Behaviour

summary: Suicidal behaviour (SB) represents a major public health problem, costing life in more that one million people every year worldwide. Even if SB is considered as a consequence of social adversity and depression, these stress factors are often necessary but not sufficient to explain the occurrence of a suicidal act. A preliminary study suggests that an increased perception of psychic pain during a major depressive disorder increases the risk of suicide behaviour. The investigators aimed to investigate the relationship between social exclusion (a classic trigger of psychic pain) and SB and improve our knowledge about the physiopathology of this domain.

primary_purpose: Prevention


title: Selections of Subjects With Dramatic Changes in Their Cardiac Repolarization Parameters After a Pharmacologic Stimulus Aiming to Collect Their Skin Biopsy and Blood Cells

acronym: iQTEST

summary: The study main objective is to assess the changes in the ventricular repolarization (measure by the delta QTcf) after drug induced stimulation, compare to placebo, in order to identify subjects with extreme responses and collecting their skin and blood samples.

ReferenceCitation: Stillitano F, Hansen J, Kong CW, Karakikes I, Funck-Brentano C, Geng L, Scott S, Reynier S, Wu M, Valogne Y, Desseaux C, Salem JE, Jeziorowska D, Zahr N, Li R, Iyengar R, Hajjar RJ, Hulot JS. Modeling susceptibility to drug-induced long QT with a panel of subject-specific induced pluripotent stem cells. Elife. 2017 Jan 30;6:e19406. doi: 10.7554/eLife.19406.

endpoint_id: HAL

repository_institution: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

publisher_dissemination: eLife Sciences Publications, Ltd

lead_sponsor: Ectycell SASU


type: Other Grant/Funding Number

title: Impact of a Proactive Strategy of Communication With Patients Hospitalized in ICU and Their Families With the Aim of Reducing Their Anxious and Depressive Symptoms and Their Post Traumatic Stress Symptoms

acronym: FAMIREAXV

summary: The investigators propose an interventional multicentric (23 ICUs) study measuring the impact of a consultation at the end of ICU stay for the patients and his/her families on the prevalence of symptoms of PTSD and anxiety or depression 3 months and one year after discharge. Patients will be randomly assigned to a intervention or control group. In the intervention group, the patient and his/her family will benefit from an conference by the intensivist at the end of the ICU stay, regarding information about the progress of his stay in ICU, his orientation after discharge, the possibility of consulting a GP, etc. Patients and proxies will be interviewed by phone three months and one year after discharge from ICU. Main instruments are Hospital Anxiety and Depression Scale, and Impact of Events Scale Revised.


title: Prospective Pilot Study Assessing Safety and Efficacy of Single Pass Albumin Dialysis in Patients With Acute on Chronic Liver Failure

acronym: DACAR

summary: The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

collaborators: Laboratoire français de Fractionnement et de Biotechnologies


title: Dosing of Antibiotics (Serum and Periprosthetic Tissues) During Reimplantation of Infected Knee and Hip Prostheses

acronym: DOSOS

summary: The purpose of the study is to evaluate the concentrations of antibiotics used as empirical treatment in serum and periprosthetic tissues during reimplantation of infected hip and knee prostheses

lead_sponsor: Tourcoing Hospital

location_facility:
Dron Hospital
CHU
CHRU


lead_sponsor: GlaxoSmithKline

summary:
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.

ReferenceCitation: Wysocki J, Tejedor JC, Grunert D, Konior R, Garcia-Sicilia J, Knuf M, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S77-88. doi: 10.1097/INF.0b013e318199f609.

ReferenceCitation: Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.

ReferenceCitation: Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.

ReferenceCitation: Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.

ReferenceCitation: Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsene JP, Lommel P, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S66-76. doi: 10.1097/INF.0b013e318199f8ef.

title: To Assess the Safety, Reactogenicity & Immunogenicity of a 4th Dose of GSK Biologicals' Pneumococcal Vaccine or Prevenar™ in Children (12-18 Months) Previously Vaccinated in the Primary Study NCT00307554 With Either Pneumococcal Vaccine or Prevenar™

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country: Finland Poland France


title: Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

acronym: DREAM

summary: The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

lead_sponsor: LivaNova

location_country: Spain France


title: Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale

acronym: WISUDO

summary: The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.

lead_sponsor: Withings

location_facility:
Lariboisière Hospital
Cochin Hospital
Henri-Mondor Hospital
Bichat-Claude Bernard Hospital


title: Assessment of the Safety and Performance of Elbow Supports in the Context of Epicondylitis or a Return to Sport After Sprain

summary:
Decathlon has developed elbowMID500 and elbowSTRAP products which are medical devices that must be positioned around the elbow during sport practice, in order to limit symptoms related to epicondylitis or previous sprains (elbowMID500 only).

The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon elbowMID500 and elbowSTRAP products to demonstrate safety and performance of these devices in a real-world setting.

Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon elbowMID500 and elbowSTRAP devices and support peer-reviewed publications on products performance and safety.

lead_sponsor: Decathlon SE

sponsor_collaborators:
Decathlon SE
EFOR, France

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre de rééducation et de balnéothérapie Kinés Faches


title: Assessment of the Safety and Performance of a Compression Ankle Support in the Prevention of Injuries During Sports Practice

summary: Decathlon has developed ankleSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon ankleSOFT100 product to demonstrate safety and performance of this device in a real-world setting.


title: Assessment of the Safety and Performance of a Patellofemoral Brace

summary: Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT500 product to demonstrate safety and performance of this device in a real-world setting.


title: Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.

summary: The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.

ReferenceCitation: Bartelmaos T, Chabanel A, Leger J, Villalon L, Gillon MC, Rouget C, Gomola A, Denninger MH, Tardivel R, Naegelen C, Courtois F, Bardiaux L, Giraudeau B, Ozier Y. Plasma transfusion in liver transplantation: a randomized, double-blind, multicenter clinical comparison of three virally secured plasmas. Transfusion. 2013 Jun;53(6):1335-45. doi: 10.1111/j.1537-2995.2012.03895.x. Epub 2012 Sep 24.

lead_sponsor: Etablissement Français du Sang


title: A Dose Ranging Study Investigating the Efficacy and Safety of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma

summary: The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.

lead_sponsor: Stallergenes Greer

location_facility: Universitätsmedizin Berlin - Allergie-Centrum-Charité

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi

location_facility: NHC, Hôpitaux Universitaires de Strasbourg


acronym: ENDEAVOR II

summary: To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in diameter.

ReferenceCitation: Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006 Aug 22;114(8):798-806. doi: 10.1161/CIRCULATIONAHA.105.591206. Epub 2006 Aug 14.

ReferenceCitation: Mauri L, Massaro JM, Jiang S, Meredith I, Wijns W, Fajadet J, Kandzari DE, Leon MB, Cutlip DE, Thompson KP. Long-term clinical outcomes with zotarolimus-eluting versus bare-metal coronary stents. JACC Cardiovasc Interv. 2010 Dec;3(12):1240-9. doi: 10.1016/j.jcin.2010.08.021. Erratum In: JACC Cardiovasc Interv. 2011 Feb;4(2):260.

ReferenceCitation: Remak E, Manson S, Hutton J, Brasseur P, Olivier E, Gershlick A. Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data. EuroIntervention. 2010 Feb;5(7):826-32. doi: 10.4244/eijv5i7a138.

ReferenceCitation: Eisenstein EL, Wijns W, Fajadet J, Mauri L, Edwards R, Cowper PA, Kong DF, Anstrom KJ. Long-term clinical and economic analysis of the Endeavor drug-eluting stent versus the Driver bare-metal stent: 4-year results from the ENDEAVOR II trial (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv. 2009 Dec;2(12):1178-87. doi: 10.1016/j.jcin.2009.10.011.

lead_sponsor: Medtronic Vascular


title: Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease

summary: This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.

sponsor_collaborators:
University Hospital, Lille
France Parkinson Association

location_facility:
Hôpital Roger Salengro, CHRU de Lille
Hopital Charles Nicolle Chu Rouen
Hopital Purpan Chu Toulouse
Chu Cote de Nacre


title: Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Anti-Retroviral TX in HIV Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm(3) Who Have Received Anti-Retroviral TX

acronym: ILIADE

summary:
This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not taking ARV treatment and also preserve CD4 counts above 350 cells per microliter. There will be an evaluation of the toxicity, or extremely harmful effects, of ARV, and the effect on quality of life.

The use of ARV medications has greatly improved the condition and mortality of HIV-infected patients. But when used long term, those medications have been associated with great toxicities and medication fatigue. As a result, patients may not adhere to ARV use, and resistance to viruses may grow. The CD4 molecule is on the surface of helper T-lymphocytes, or T-helper cells. It serves as the primary receptor for HIV-1 and HIV-2, allowing the virus to gain entry into its host. The CD4 count increases immediately in response to ARV, giving an estimate of the state of a patient's immune system. Thus, it is a strong marker of the immediate risk of an opportunistic infection, one that takes advantage of a person's weakened immune system. IL-2 is a molecule naturally produced by activated T cells. In patients with HIV, IL-2 treatment can increase CD4 counts but the clinical importance of this increase is not clear. This study will compare the decline in CD4 count, when ARV is interrupted, in two random groups of participants: (1) those who will receive three cycles of IL-2 (one every 8 weeks) in combination with ARV therapy for the first 24 weeks of the study before stopping ARV and (2) those who will receive ARV therapy without IL-2 for 24 weeks before stopping ARV.

Patients 18 years of age or older who have HIV-1 infection and who have been on ARV therapy for at least 1 year, and who currently have a CD4 count 500 cells per microliter or higher and never had a CD4 count of less than 200 cells per microliter and a viral load less than the limit of detection, may be eligible for this study.

Participants will undergo the following procedures and tests:

Physical examination.
Blood tests to measure blood lipids (fats), sugar, complete blood count including platelets, and chemistries.
Assessment of fat distribution.
Questionnaire about quality of life.

In addition, those participants who are randomly placed in the group receiving IL-2 and ARV will get an echocardiogram at the beginning of the study and at week 24. They will receive a starting dose of 6 million units of IL-2 as an injection under the skin twice a day. Each of the three IL-2 cycles will last 5 days. After the 24-week period, participants in both groups will stop taking ARV medications if their CD4 count is still equal to or greater than 500 cells per microliter. The study will continue into 120 weeks. Participants will be asked to continue to visit the clinic every 8 weeks for evaluation of their viral load and CD4 counts. Every 24 weeks, they will be asked to answer a questionnaire about their quality of life. Blood tests and other measurements will also be done as follow-up.

ReferenceCitation: Arno A, Ruiz L, Juan M, Jou A, Balague M, Zayat MK, Marfil S, Martinez-Picado J, Martinez MA, Romeu J, Pujol-Borrell R, Lane C, Clotet B. Efficacy of low-dose subcutaneous interleukin-2 to treat advanced human immunodeficiency virus type 1 in persons with </=250/microL CD4 T cells and undetectable plasma virus load. J Infect Dis. 1999 Jul;180(1):56-60. doi: 10.1086/314831.

ReferenceCitation: Carr A, Emery S, Lloyd A, Hoy J, Garsia R, French M, Stewart G, Fyfe G, Cooper DA. Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group. J Infect Dis. 1998 Oct;178(4):992-9. doi: 10.1086/515653.

ReferenceCitation: Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2000 Oct 21;356(9239):1423-30. doi: 10.1016/S0140-6736(00)02854-3.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
United States
France

location_facility: National Institutes of Health Clinical Center, 9000 Rockville Pike


title: Segmentation of Structural Abnormalities in Chronic Lung Diseases

summary: Lung structural abnormalities are complex, time-consuming, and may lack reproducibility to evaluate visually on CT scans. The study's aim is to perform automated recognition of structural abnormalities in CT scans of patients with chronic lung diseases by using dedicated software.

status: Active, not recruiting

time_perspective: Other

ReferenceCitation: Dournes G, Hall CS, Willmering MM, Brody AS, Macey J, Bui S, Denis de Senneville B, Berger P, Laurent F, Benlala I, Woods JC. Artificial intelligence in computed tomography for quantifying lung changes in the era of CFTR modulators. Eur Respir J. 2022 Mar 3;59(3):2100844. doi: 10.1183/13993003.00844-2021. Print 2022 Mar.

oa_host_type: repository

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

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

unpaywall_oa_status: green

publisher_dissemination: European Respiratory Society

ipd_sharing_description: Automated software measurements

collaborators: Centre National de la Recherche Scientifique, France


title: Clinical Trial Comparing Neurologic Development of Temporal Voice Area in Cochlear Implanted Deaf Infant and in Normally Hearing Infant.

acronym: Implaneuro

summary:
Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear implanted profound congenital deaf infant would be different to the development of a normally hearing infant.

At 24 months of age, the neurologic development of TVA of deaf infant implanted before the age of 18 months would be similar to the development of a normally hearing infant.

Main aim The main aim of the research is to study, by means of functional near infrared spectroscopy (fNIRS), the neurologic development of the TVA at 24 months of age (+/- 1 month) in a group (n=40) of normally hearing infant and in a group (n=40) of profound congenital deaf children implanted before the age of 18 months.

Main outcome Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type. Comparison of the results between groups at 24 months of age +/- 1 month allows to analyse eventual differences.

Secondary aims and outcomes To study by means of functional near infrared spectroscopy the neurologic development of the temporal voice area at 12 months of age (+/- 1 month) in a group of normally hearing infant and in a group of profound congenital deaf infant wearing a standard hearing device between the age of 11 and 13 months and who will receive a cochlear implant between 12 and 18 months of age.

To study the association between fNIRS data and clinical data of the evaluation of comprehension of the spoken language at 24 months of age.

Methods Two groups of 40 infants matching in age will be constituted. Less than 13 months old children will be included during a medical consultation in the ENT department of Necker hospital after complete information of both parents. Written consent of both parents will be required. An audiophonological checking will be done.

Then a fNIRS examination will be programmed at the maternity of the Robert Debré hospital and done at the age of 12 months (+/- 1 month) and 24 months (+/-1 month). A fNIRS examination will be programmed at 36 months of age (+/- 1 month) for patinets included in the first year of the study.

This fNIRS examination measures the modifications in brain blood flow during the listening of human voice sound and environmental sound.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators: Centre National de la Recherche Scientifique, France

location_facility: Hôpital Necker Enfants malades Service d'ORL


title: Etude en Imagerie Par résonance magnétique Fonctionnelle et Structurelle Des mécanismes de Suppression mnésique Dans Les Troubles Obsessionnels Compulsifs

acronym: SUPTOC

summary: Mental-health conditions affect million people worldwide. The economic burden of mental illness is enormous and the economic health of both developing and developed nations will depend on controlling the staggering growth in costs from mental disorders. Obsessive-compulsive disorder (OCD) is a relatively common and frequent form of anxiety that affects approximately 2-3% of the population. OCD is characterized by anxiety, obsessions (persistent intrusive thoughts and images with highly distressing contents) and compulsions (repetitive activity), and severely impairs the lives of those affected. Despite their interest as effective and affordable care and rehabilitation, cognitive therapeutic profits too little from the increasing accumulation of knowledge in neuroscience, and neuroscientists pay too little attention to the challenges faced by clinical psychologists and psychiatrists. To reduce this cultural gap, two teams specialized in the study and multimodal imaging of healthy participants and clinical patients with mental health disorders, the UMR-S INSERM-EPHE-UNICAEN U1077 unit led by Francis Eustache, and ISTS team (UMR-S 6301 CNRS-CEA-UCBN) led by Sonia Dollfus, will joint their efforts to develop an integrated approach of the neural mechanisms at stake from basic neuroscience using state-of-art neuroimaging techniques, to novel and ground breaking psychological intervention. Both teams evolve at the brain imaging Cyceron center in Caen in connection with the Mental Health and Addictology Center, offering unique opportunities for such translational research. This project will capitalize on recent evidence showing that healthy participants can prevent unwanted images from entering consciousness using inhibitory control and memory suppression techniques, disrupting traces of the memories in sensory areas of the brain, and weakening their vividness and later reentrance. OCD is characterized by aberrant and excessive visual intrusions, usually extremely vivid, detailed, and unpleasant. These distressing images are particularly uncontrollable and may frequently initiate compulsive rituals. In a first phase of this proposal will use functional magnetic resonance imaging (fMRI) to develop a neurobiological model of the cognitive computations achieved by inhibition network to suppress memory. To achieve this goal we will develop an attentional model of healthy memory inhibition functioning, simulating the deployment of attentional resources and the different mental processes at stake during suppression. Using sophisticated analyzing tools of fMRI data, we will use this model to decode and infer the representational content of the brain inhibition network, and further refine the connectivity pathways which underlie such control. The lack of a strong neurobiological model prevents the development of therapies which would increase functionality of this network and optimize intervention aiming to disrupt mental intrusions and obsessions. In a second phase, we will assess whether memory suppression may be transferred and trained in OCD patients using images depicting their own obsessions, as a promising avenue to reduce their symptoms on the long run. In addition, fMRI and other brain structural acquisitions will be collected before and after cognitive training to memory suppression, offering a unique opportunity to observe the online dysfunction of intrusion control in OCD patients and to identify neurobiological markers predictive of training outcome and network reconfiguration with training. A fundamental goal of motivated forgetting involves not only to exclude unwelcome content from consciousness but also to reduce their later emotional impact by doing so. In parallel of these two main phases, we will thus also measure physiological markers of autonomic nervous system activity changes in response to suppressed images to better identify the consequences of memory suppression on emotional states, anxiety, and mental health in general.

lead_sponsor: University Hospital, Caen


title: Genetic Characteristics and Determinants of Central Sensitization of Nociception in Fibromylagic Syndrome

acronym: FIDGIS

summary:
Fibromyalgia syndrome (FS) is characterized by widespread pain and affect 0.5 to 5 % of the general population, with a higher prevalence in women. Recognized as disease by World Health Organization since 1992, FS concern 1.2 to 2 million of French people and his etiology need to be clarified. This affection is characterized by a higher sensitivity to nociceptive stimulus, articular and muscular pain and associated to: fatigue, headache, sleep disorders, depression and irritated bowel syndrome. The presentation of this symptoms varied according to the patient with a heterogeneity of the clinical, physical, social and psychologic conditions and of the therapeutic responses.

Faced to the heterogeneity of FS, various hypotheses about the development mechanisms exist. Central sensitization could be one of the key mechanisms of FS, it is described as a loss of the natural balance between the transmission of a painful stimulus to the central nervous system and pain-inhibiting mechanisms, which results in permanent or chronic pain.

Moreover, work on the familial character of FS suggests that a genetic component may be involved in its development, but the identification of a genetic determinant is difficult given the multifactorial nature and complexity of FS.

The objective of this study is to characterize the predispositions of central sensitization and genetics in patients with FS compared to a control group, matched in age, sex and menopausal status.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Service de pharmacologie et toxicologie cliniques, Hôpitaux Universitaire Genève, Rue Gabrielle Perret-Gentil 4, 1205 Genève, SUISSE

collaborators: Association des Fibromyalgiques d'Auvergne, 19 Place de la Résistance, 63800 Cournon d'Auvergne, FRANCE


title: A 24-Week, Ph1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study, to Assess the Safety Profile of Olesoxime in Patients With Stable Relapsing Remitting Multiple Sclerosis Treated With Interferon Beta.

acronym: MSREPAIR

summary: This is a 24-week phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter safety study comparing the tolerance profile of olesoxime (495 mg, od) when administered on top of Interferon beta in patients with stable Relapsing Remitting Multiple Sclerosis. Patients will be randomly allocated to olesoxime (495 mg, od) or placebo in a 1:1 ratio.

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Hôpital de la Timone
SGS S.A.
STRAGEN Services

location_facility: Timone University Hospital, Neurology Department, UMR CRMBM CNRS 6612

location_facility: CHU Reims, Maison Blanche Hospital, Neurology Department & University of Reims


title: A Comparative Double Blind Placebo-Controlled Study of Immunogenicity and Safety of Two Doses 10^5 and 10^7 CFU of SC599 Oral Vaccine, a Live Attenuated Shigella Dysenteriae 1 Vaccine Strain in Healthy Human Adult Volunteers

summary: The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.

lead_sponsor: Institut Pasteur

location_country:
United Kingdom
France

location_facility: Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute


title: Fetoscopic Endoluminal Tracheal Occlusion (FETO) With Smart-TO Device in Fetuses With Congenital Diaphragmatic Hernia and Moderate to Severe Pulmonary Hypoplasia: Proof of Concept and Safety Evaluation.

acronym: Smart-FETO

summary: The purpose of this study is to make the proof of concept and to evaluate the safety of fetoscopic endoluminal tracheal occlusion (FETO) using Smart-TO device in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia

location_facility:
Hôpital Bicêtre
Hôpital Béclère


title: Controlled, Randomized Clinical Trial of the Circaid® Compression Sleeve Versus Short-stretching Bandage at the Reduction Phase of Upper Limb Lymphatic Edema and Versus Compression Sleeve and Short-stretching Bandages at the Initial Maintenance Phase

summary:
One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and experience to exert the pressure required to remove liquids from tissue spaces and reduce the volume of the arm or prevent it from increasing again.

The study aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.

ReferenceCitation: Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis, treatment, and impact: a review. J Clin Oncol. 2012 Oct 20;30(30):3726-33. doi: 10.1200/JCO.2012.41.8574. Epub 2012 Sep 24.

ReferenceCitation: Leone N, Voirin N, Roche L, Binder-Foucard F, Woronoff AS, Delafosse P, Remontet L, Bossard N, Uhry Z. Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2015. Rapport technique. Saint-Maurice (Fra): Institut de veille sanitaire, 2015. 62 p

ReferenceCitation: Grosclaude P, Remontet L, Belot A, Danzon A, Rasamimanana C, Bossard N. Survie des personnes atteintes de cancer en France, 1989-2007 - Etude à partir des registres des cancers du réseau Francim. Saint-Maurice: Institut de veille sanitaire; 2013. 412 p

ReferenceCitation: Hayes SC, Janda M, Cornish B, Battistutta D, Newman B. Lymphedema after breast cancer: incidence, risk factors, and effect on upper body function. J Clin Oncol. 2008 Jul 20;26(21):3536-42. doi: 10.1200/JCO.2007.14.4899.

ReferenceCitation: Campbell KL, Pusic AL, Zucker DS, McNeely ML, Binkley JM, Cheville AL, Harwood KJ. A prospective model of care for breast cancer rehabilitation: function. Cancer. 2012 Apr 15;118(8 Suppl):2300-11. doi: 10.1002/cncr.27464.

ReferenceCitation: Velanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg. 1999 Mar;177(3):184-7; discussion 188. doi: 10.1016/s0002-9610(99)00008-2.

ReferenceCitation: Shih YC, Xu Y, Cormier JN, Giordano S, Ridner SH, Buchholz TA, Perkins GH, Elting LS. Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study. J Clin Oncol. 2009 Apr 20;27(12):2007-14. doi: 10.1200/JCO.2008.18.3517. Epub 2009 Mar 16.

ReferenceCitation: Framework L. Best practice for the management of lymphoedema: an international consensus. London: MEP Ltd; 2006

ReferenceCitation: Chang CJ, Cormier JN. Lymphedema interventions: exercise, surgery, and compression devices. Semin Oncol Nurs. 2013 Feb;29(1):28-40. doi: 10.1016/j.soncn.2012.11.005.

ReferenceCitation: Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

ReferenceCitation: Lymphoedema Framework International consensus. Best Practice for the management of Lymphoedema London: MEP Ltd, 2006 and 2nd Edition 2012

ReferenceCitation: Vignes S, Porcher R, Arrault M, Dupuy A. Factors influencing breast cancer-related lymphedema volume after intensive decongestive physiotherapy. Support Care Cancer. 2011 Jul;19(7):935-40. doi: 10.1007/s00520-010-0906-x. Epub 2010 May 22.

lead_sponsor: CEN Biotech

sponsor_collaborators:
CEN Biotech
medi

location_facility:
Ghr Mulhouse Sud Alsace
Hopital Cognacq Jay
Chu Saint Eloi
Polyclinique Bordeaux Nord Aquitaine


title: A Phase I Dose-Escalation Study of PHA-793887 Administered as a 1-hour IV Infusion on Days 1, 8 and 15 in a 4-Week Cycle in Patients With Advanced/Metastatic Solid Tumors

summary: The purpose of this open-label, multi center, phase I study, was to determine the safety profile of PHA-793887 administered by intravenous infusion to patients with advanced/metastatic solid tumors. This was a dose-finding study to determine the maximum tolerated dose and the dose of PHA-793887 that can be safely used in phase II investigations.

lead_sponsor: Nerviano Medical Sciences

location_facility:
St. James University Hospital
Institut Gustave-Roussy


acronym: GADOXY

summary: The purpose of this study is to measure the tissular oxygen saturation in brain by magnetic resonance imaging on subjects and to correlate the results with near infrared spectroscopy measurements.

lead_sponsor: University Hospital, Grenoble


title: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers - Investigator and Subject Satisfaction

acronym: FRESH

summary: The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

lead_sponsor: Galderma R&D

location_country: Germany France