title: Randomized, Open-label Economic and Medical Study on the Lymph Node Management of Squamous Cell Carcinoma of the Oral Cavity and Oropharynx T1-T2N0 Operable : Comparison of the Reference Strategy Based on a the Systematic Lymph Node Dissection Versus the Strategy Based on the Technique of Sentinel Lymph Node.

acronym: SentiMERORL

summary:
Currently, patients with cancer of oral cavity or oropharynx T1-T2N0 classified, are treated surgically with systematic lymph node dissection while in 70%, there is no lymph node metastasis. The technique of identifying the sentinel node (GS) is validated for these tumors because the status of the sentinel node is predictive of the other nodes status in the neck. This helps to diagnose the presence of metastases without lymph node dissection and thus select patients requiring a treatment node. However, the oncological and functional results of a therapeutic strategy based on identifying the GS is unknown.

This open-label randomized multicenter clinical trial aims to compare the oncologic and functional outcome of two strategies : the current management versus the management based on the sentinel lymph node.

The hypothesis is based on a nodal control difference at 2 years in both arms not exceeding 10%. The medico-economic analysis will be conducted in two stages : a classic stage on 2 years with estimated incremental cost-effectiveness and incremental cost-utility, then a step with log term modeling.

A reduction in morbidity and treatment costs in the sentinel node arm are expected in this study.

ReferenceCitation: Garrel R, Poissonnet G, Moyà Plana A, Fakhry N, Dolivet G, Lallemant B, Sarini J, Vergez S, Guelfucci B, Choussy O, Bastit V, Richard F, Costes V, Landais P, Perriard F, Daures JP, de Verbizier D, Favier V, de Boutray M. Equivalence Randomized Trial to Compare Treatment on the Basis of Sentinel Node Biopsy Versus Neck Node Dissection in Operable T1-T2N0 Oral and Oropharyngeal Cancer. J Clin Oncol. 2020 Dec 1;38(34):4010-4018. doi: 10.1200/JCO.20.01661. Epub 2020 Oct 14.

name: Head Neck Surgery Department, Montpellier University Hospital Center, Montpellier, France

family: Garrel

full_name: Renaud Garrel

given: Renaud

name: Head Neck Surgery Department, Antoine Lacassagne Center, Nice, France

family: Poissonnet

full_name: Gilles Poissonnet

given: Gilles

name: Head Neck Surgery Department, Institut Gustave Roussy, Villejuif, France

family: Moyà Plana

full_name: Antoine Moyà Plana

given: Antoine

name: Head Neck Surgery Department, Marseille University Hospital Center, Marseille, France

family: Fakhry

full_name: Nicolas Fakhry

name: Head Neck Surgery Department, Alexis Vautrin Center, Vandœuvre-lès-Nancy, France

family: Dolivet

full_name: Gilles Dolivet

name: Head Neck Surgery Department, Nîmes University Hospital Center, Nîmes, France

family: Lallemant

full_name: Benjamin Lallemant

given: Benjamin

name: Head Neck Surgery Department, Toulouse Oncopole, Toulouse, France

family: Sarini

full_name: Jérôme Sarini

given: Jérôme

family: Vergez

full_name: Sebastien Vergez

given: Sebastien

name: Head Neck Surgery Department, Toulon Hospital Center, Toulon, France

family: Guelfucci

full_name: Bruno Guelfucci

given: Bruno

name: Head Neck Surgery Department, Curie Institute, Paris, France

family: Choussy

full_name: Olivier Choussy

given: Olivier

name: Head Neck Surgery Department, François Baclesse Center, Caen, France

family: Bastit

full_name: Vianney Bastit

given: Vianney

family: Richard

full_name: Fanny Richard

given: Fanny

name: Pathology Department, Montpellier University Hospital Center, Montpellier, France

family: Costes

full_name: Valérie Costes

given: Valérie

name: Clinical Research University Institute, UPRES EA 2415, Montpellier, France

family: Landais

full_name: Paul Landais

given: Paul

family: Perriard

full_name: Françoise Perriard

given: Françoise

family: Daures

full_name: Jean Pierre Daures

given: Jean Pierre

name: Nuclear Medicine Department, Montpellier University Hospital Center, Montpellier, France

family: de Verbizier

full_name: Delphine de Verbizier

given: Delphine

family: Favier

full_name: Valentin Favier

given: Valentin

family: de Boutray

full_name: Marie de Boutray

given: Marie

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)


title: Rhythm Game Park: a Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease

acronym: RGP

summary: This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. Overall, we propose to test a low-cost tool for rehabilitation.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


summary:
The discovery in 2003 by isolation of amoebas Mimivirus, the world's largest virus at the Research Unit on Tropical and Emerging Diseases in Marseille revealed fascinating information about the definition and evolution of viruses. Its genome encodes about 1,000 proteins. Three other viruses were then isolated from amoebas in this unit:Two other giant viruses, Mamavirus Marseillevirus then, and the first virus a virus, named virophage, which led to highlight the role of amoeba (Acanthamoeba spp. ) such as spawning giant viruses and compounds of bacterial origin or cellular proteins This project focuses on the detection and analysis of new viral agents (viruses and virophages giant amoeba environmental) and their involvement in human pathology.

The objectives of this study are observational: detect and document the presence of giant viruses and virophages of amoebae in the faeces of children presenting to the pediatric emergency reception service of the North Hospital in AP -HM with or without clinical evidence of gastroenteritis.

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


summary:
It is commonly accepted that the characteristics of the organ donor impact on the future post transplant. In lung transplantation (LP), the defining characteristics of the "ideal" donor includes an age less than 55 years. However, before the pulmonary graft shortage with a corresponding mortality still too high waiting list, the lung graft acceptance criteria were reassessed permitting criteria "extension" ( "marginal" graft). And were grafted, depending on the urgency and accessibility problems in the registry of potential candidate, organs from donors aged 55 and older with quite comparable to those obtained from younger donors . Nevertheless, it is common practice that the grafts from older donors are more readily allocated to older candidates and the most severe, as many confounding factors to assess the real impact of donor age on post-transplant evolution on small cohorts.

The main goal of this study is to compare the survival of lung transplant patients depending on the age difference between donor and recipient.

The study will be conducted from a broad national cohort of lung transplant patients registered in COLT ( Lung Transplantation COhort). Established in September 2009, promoted by the University Hospital of Nantes, COLT involves 11 lung transplant centers authorized on French territory. It provides a standardized common longitudinal monitoring of the recipient from his transplant. Currently more than 1,000 patients included in this study are transplanted.

time_perspective: Retrospective

location_facility: Assistance Publique Hôpitaux de Marseille, Hôpital Nord

intervention_type: Procedure


title: Efficiency of a Nurse-led Self-management Education Intervention in Promoting Safety Knowledge and Skills of Patients With Arthritis Treated Par Biologics

acronym: BIOSAFE

summary:
Background : Inflammatory arthritis (rheumatoid arthritis (RA) or spondyloarthritis (SpA) are painful chronic diseases which impair quality of life and work capacity. Biologics are very effective and widely used therapies. However, they are known to entail risks, particularly of infections. The risk of severe infections is of 5%/patient-year with a maximum during the first six month after the initiation of the first biologic therapy.

Patient education (PE) is recommended for the management of chronic diseases. In the case of biologics, PE aims to help patients to learn specific skills particularly on safety issues, e.g stopping the biologic treatment in case of fever or surgery. Safety skills are assessed by the validated BIOSECURE questionnaire. PE seems efficient for safety skills in a few non-randomized studies. In 2010 a national cross sectional survey on 677 patients showed that the risk of incorrect answers in the BIOSECURE questionnaire was 4 times lower among patients who had benefited from an education by a nurse or other kind of educational process (OR =3,8 IC95% :[1,68-8,8].

Aims and Hypothesis: this trial aims to investigate the effects of a nurse-led self-management education face to face intervention on safety skills of patients with arthritis treated par sub cutaneous biologics. Our hypothesis is that the intervention group will report better skills at the 6 months follow up compared to usual care i.e information by the rheumatologist in current consultation.

Methods : multicentric randomized controlled open trial with blinded assessment of the primary outcome. The intervention group will have a nurse education consultation at M 0 and M3 in addition to the usual care by the rheumatologist. The nurse will assess the patients' health beliefs and educational needs, focusing on safety skills, self-injections and motivation. The control group will have usual care by the rheumatologist.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

primary_purpose: Supportive Care

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Rhumatologie Hôpital Saint Antoine

status_simplified: Completed


title: The Prognostic Value of PGF and sFlt1 Variations Induced by the First Low-molecular-weight-heparin Injections in Women With Obstetrical Antiphospholipids Antibody Syndrome Starting a New Pregnancy and Following Treatment in Accordance With International Recommendations

acronym: NOH-ANGIO

summary:
The primary objective of this study is to evaluate plasmatic concentrations of free PGF and sFlt1 for blood samples taken before a first low-molecular-weight-heparin injection and also for blood samples taken on the 4th day of injections (the latter correspond to the first systematic control of platelet counts) in women who have an obstetric antiphospholipid antibody syndrome and who are initiating a new pregnancy with recommended treatment. Our goal is to test the prognostic value of these data on the occurrence of:

pregnancy loss categorized as embryonic loss (before 10 weeks gestation), fetal death (before 20 weeks gestation), stillbirths (from 20 weeks gestation to delivery), and neonatal death defined before reaching 28 days of age.
ischemic placental pathology (pre-eclampsia, retro-placental hematoma, birth of a small-for-gestational-age infant)

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémea


type: Other Identifier

title: Evaluation of Discriminating Power of Two Biomarkers (Protein S100B/Copeptin) in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children

summary:
Head injury is a frequent motive of consultation in paediatric emergency units and the first cause of mortality in infants of more than one year old in developped countries. The indication of performing cerebral CT scans currently depends on clinical decision based on recommendations used in adults. In this way, 60 to 90% of scans are normal in children with head injury. CT scan is expensive and irradiating with the risk of increasing the cancer in children. Protein S100B and copeptin are biomarkers which have shown their ability to detect cerebral lesion in children with head injury. (protein S100B and /or in adults protein S100B and copetin).

It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B.

Furthermore, the evaluation of the biomarkers GFAP, NFL, Tau and UCHL-1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined. Indeed, these protein biomarkers are biologically linked to the protein S100B and copeptin, and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level. More specifically, the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin, NFL, Tau and UCHL1 proteins will allow evaluation of neuronal damage. The assay of these different biomarkers will also be carried out on a control population, without head injury or neurological or inflammatory pathologies, in order to establish the standards of these biomarkers on a pediatric population of similar age.

status: Recruiting

primary_purpose: Diagnostic

status_simplified: Ongoing


title: Prediction of Dementia in Parkinson's Disease by Measuring Cerebral Metabolism With PET Scan

acronym: PREDEMPARK

summary:
Parkinson's disease (PD) is a common disease. Dementia will affect 80% of these patients during their evolution. In addition, treatments of motor signs have a potential impact on these disorders and conversely.

The purpose of this study is to show focal abnormalities in brain metabolism in the precuneus and posterior cingulate region are predictive of the onset of dementia within 2 years.


title: Near Death Experience (NDE) and Migraine

summary: Migraine is a common disabling primary headache disorder. Epidemiological studies have documented its high prevalence and high socio-economic and personal impacts. Migraine affects more than 20% of the French population. However, the physiopathology of migraine is always partially known. Cortical spreading depression (CSD) is the widely accepted as the electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep intrusion have been discussed. However, the role of DCE has never been discussed. The goals of this study are : to see if there is an epidemiological link between NDE and migraine/ to specify if NDE was followed by a migrainous headache.

location_facility: Assistance Publique Hôpitaux de Marseille Hôpital de la Timone


acronym: CAPSIVU

summary: This study aims to assess the pain on contact in provoked vestibulodynia, measured with Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Drug


title: Study of the Anti-tumoral Immune Response T Cells Cluster of Differentiation 4 (TCD4): Proof of the Concept in Breast Cancer and Glioma

acronym: ERISA

summary: This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.

design_allocation: Non-Randomized

primary_purpose: Basic Science

location_facility: Centre Hospitalier Régional Universitaire


title: Study of the Immune Response T Anti-tumoral Cluster of Differentiation 4 (CD4) for Patients Treated for a Metastatic Breast Cancer by Everolimus Within the Framework of Its Marketing Authorization

acronym: EVERIMMUN

summary: This study evaluates the immune response for patients affected by metastatic breast cancer treated by everolimus


title: Preliminary Study Concerning the Validity of Parathyroid Exploration on a Discovery NM 530c CZT Camera

acronym: PARAT-CZT

summary: The goal of this study is to assess the performance of parathyroid imaging on a cardiac-dedicated CZT camera, compared to planar pinhole imaging, in patients referred for primary hyperparathyroidism.

intervention_type: Device


title: Evaluation of Repetitive Magnetic Stimulation Versus Direct Current Stimulation, in Chronic Neuropathic and Drug-resistant Pain Treatment

acronym: DOLORIS

summary:
Prevalence of neuropathic pain raise to 6.9 % in the general population and can reach more than 58 % for patients that carry a lesion of the spinal cord. This pathological condition stays a major health problem, particularly as the efficacity of available treatments is currently limited. Only 30 to 40% of patients are relieved of more than 50% of their pain by a pharmacological approach.

In case of failure, drug treatments or in addition of these ones, stimulation of the motor cortex is a therapeutic path proposed by Tsubokawa since the beginning of 1990s, but that found its place for neuropathic drug-resistant pain management only since a decade. Neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are still little understood. This stimulation can be realised in a chronic and invasive way with implanted electrodes. This process allow a lasting relief for about half of operated persons, without the possibility to identify clinical selection criterion reliable for potentially responding patients for this technique.

Recently, two electrophysiological non invasive techniques have been developed, allowing to get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic stimulation (rTMS) and the direct current transcranial magnetic stimulation (tDCS).

The main goal of this study is to compare the importance of analgesic effect of tDCS in chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of stimulation non invasive of the motor cortex, the rTMS whose analgesic effect is already validated by data of the literature.

ReferenceType: background

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lead_sponsor: University Hospital, Grenoble


title: Psycho-sensorial Mindfulness and Top-down Control : Mindfulness Program for Obese Patients in Preparation to Bariatric Surgery

acronym: PConscience

summary:
Mindfulness is a common practice already widely used, that has shown benefits in terms of psychological and physical health. It is about learning or learn again to be self present and aware to the environment, across breathing, sensations, emotions and thought centering exercises, in the present moment without any judgement.

The goal is to evaluate the efficacy of "mindfulness" versus an active control group in bariatric surgery.

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title: Brain During Effort : Effects of Hypoxia With Respiratory Patients

acronym: NEUROX

summary:
Brain oxygenation is determined by the product of CaO2 and the cerebral blood flow (CBF), the modification of one or the other can affect the neuronal O2 availability.

Besides the effect of the PaO2, the CBF is also regulated by the PaCO2. During effort in state of hypoxia, the drop of the PaO2 associated to a potential decrease of the PaCO2 and therefore of the CBF, can create an important dizziness between the demand and the supply of cerebral O2.

It seems that hypoxia can trouble in a significant way the response of central neurons, just as the production of a motor cortex generated motor command.

Studies suggest that exercise in severe hypoxia condition can constitute a necessary threat for brain oxygenation and the motor command, with the consequence a decrease of the exercise performance.

This projects aim to study effects of hypoxia on the brain function for patients suffering from chronic respiratory disease. Neurophysiologic responses of the brain while resting or exercising, including drip and cerebral oxygenation, cortical excitation and motor command resulting for hypoxic subjects before and after a treatment to correct abnormalities of gaz in blood.

The study will use a multidisciplinary and supplementary methodological approach : the near-infrared spectroscopy (NIRS) to appreciate the drip and cerebral oxygenation, CBF, neurostimulation procedures and electromyography (EMG) to appreciate the cortical excitability, measure the level of central activation and motor command.

The goals of this study will be :

Measure the drip and cerebral oxygenation, the cortical excitability, mechanisms of voluntary activation and central fatigue to the effort for the chronic hypoxemic patient compared to healthy control subjects.
Analyse disruptions of locomotion parameters and posturographyc, in simple and double task, involving different levels of cerebral task.
Analyse acute effects of an improvement of arterial oxygenation for patients suffering from chronic obstructive pulmonary disease (COPD) on drip and cerebral oxygenation, cortical excitability, mechanisms of voluntary activation and central fatigue.
Evaluate effects of a treatment by continuous positive airway pressure (CPAP) for patients suffering from obstructive sleep apnea (OSA) with the same parameters.

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ReferenceType: derived

ReferenceCitation: Marillier M, Gruet M, Baillieul S, Wuyam B, Tamisier R, Levy P, Pepin JL, Verges S. Impaired cerebral oxygenation and exercise tolerance in patients with severe obstructive sleep apnea syndrome. Sleep Med. 2018 Nov;51:37-46. doi: 10.1016/j.sleep.2018.06.013. Epub 2018 Jul 4.

family: Marillier

full_name: Mathieu Marillier

given: Mathieu

sequence: first

family: Gruet

full_name: Mathieu Gruet

sequence: additional

family: Baillieul

full_name: Sébastien Baillieul

given: Sébastien

title: Impaired cerebral oxygenation and exercise tolerance in patients with severe obstructive sleep apnea syndrome


title: Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin

acronym: CANEVAS

summary: A dedicated guide for physicians and organ procurement nurses meeting with the next of kin could be associated with a reduction in organ donation refusal rate, and in anxiety of professionals involved in such meetings


title: Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing

acronym: EXOSPINA

summary: The main objective is to improve genetic counseling in patients with Spina Bifida, by the characterization of variants in new genes using high throughput sequencing either on a panel of targeted genes or on exome in families.

lead_sponsor: Rennes University Hospital

location_facility: Centre hospitalier universitaire de RENNES

intervention_type: Genetic


title: Epidemiology of ST131 in Besançon University Hospital

summary: The sequence type 131 (ST131) is a predominant lineage among extraintestinal pathogenic Escherichia coli. It plays a major role in the worldwide dissemination of E. coli that produce extended-spectrum beta-lactamase (ESBL). The aim of this study was to describe the epidemiology of ESBL producing ST131clonal group in our university hospital. All patients with an infection due to ESBL E. coli will be prospectively included for a 2-year period. ST131 isolates will be identified and risk factors associated to ST131 will be determined in comparison to non-ST131 ESBL E. coli.

ReferenceCitation: Nicolas-Chanoine MH, Bertrand X, Madec JY. Escherichia coli ST131, an intriguing clonal group. Clin Microbiol Rev. 2014 Jul;27(3):543-74. doi: 10.1128/CMR.00125-13. Review.

ReferenceCitation: Lafolie J, Nicolas-Chanoine MH, Grenouillet F, Hocquet D, Bertrand X. Prevalence of Escherichia coli sequence type 131 and its H30 subclone among E. coli isolates in a French hospital. Int J Antimicrob Agents. 2014 Nov;44(5):466-8. doi: 10.1016/j.ijantimicag.2014.07.016. Epub 2014 Sep 3.

ReferenceCitation: Lafolie J, Sauget M, Cabrolier N, Hocquet D, Bertrand X. Detection of Escherichia coli sequence type 131 by matrix-assisted laser desorption ionization time-of-flight mass spectrometry: implications for infection control policies? J Hosp Infect. 2015 Jul;90(3):208-12. doi: 10.1016/j.jhin.2014.12.022. Epub 2015 Feb 28.

ReferenceCitation: Can F, Azap OK, Seref C, Ispir P, Arslan H, Ergonul O. Emerging Escherichia coli O25b/ST131 clone predicts treatment failure in urinary tract infections. Clin Infect Dis. 2015 Feb 15;60(4):523-7. doi: 10.1093/cid/ciu864. Epub 2014 Nov 6.


title: Characterization of Endothelial Dysfunction as a Function of Hyperaemia of the Brachial Artery During Cardiac Surgery

acronym: GLYNO

summary: The glycocalyx is a layer of proteins and complex sugars covering the endothelium of vessels. Its role as capillary filtration control is important. In case of alteration of the glycocalyx, experimental models and some clinical studies show an increased capillary leak responsible for interstitial edema. The analysis of glycocalyx in routine care is important to guide volume expansion. Indeed, the literature provides evidence about the poor prognosis of excess water and its impact on organ. This analysis challenge is to justify filling solution of choice according to the characteristic of this capillary leakage.

ReferenceCitation: Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. Erratum in: J Am Coll Cardiol 2002 Mar 20;39(6):1082.

ReferenceCitation: Becker BF, Jacob M, Leipert S, Salmon AH, Chappell D. Degradation of the endothelial glycocalyx in clinical settings: searching for the sheddases. Br J Clin Pharmacol. 2015 Sep;80(3):389-402. doi: 10.1111/bcp.12629. Epub 2015 May 22. Review.

ReferenceCitation: Chawla LS, Ince C, Chappell D, Gan TJ, Kellum JA, Mythen M, Shaw AD; ADQI XII Fluids Workgroup. Vascular content, tone, integrity, and haemodynamics for guiding fluid therapy: a conceptual approach. Br J Anaesth. 2014 Nov;113(5):748-55. doi: 10.1093/bja/aeu298. Epub 2014 Sep 17.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Biological


title: Measurement of Antibodies in Adults With a History of Kawasaki Disease

acronym: KAWASAKI Ac

summary:
Kawasaki disease (KD) is an acute systemic vasculitic syndrome with coronary tropism. It has been reported worldwide, but it is ten times more common in Asian population. It is the second vasculitis of the child by its frequency after rheumatoid purpura. It occurs in 80% of cases between 1 and 5 years, with a maximal incidence around the age of 12 months.

KD is not well understood and the cause is yet unknown. It may be an autoimmune disorder. The problem affects the mucous membranes, lymph nodes, walls of the blood vessels, and the heart.The clinical picture of KD associate a persistent fever and an antipyretics resistance with mucocutaneous signs and bulky cervical lymphadenopathy usually unilateral.

There is currently no vaccine available against Kawasaki disease so it is extremely important to be able to recognize symptoms before they set in and become too severe.

Chagas disease (CD) is caused by the parasite Trypanosoma cruzi. Acute CD occurs immediately after infection, may last up to a few weeks or months. Infection may be mild or asymptomatic. There may be fever or swelling around the site of inoculation, and acute infection may result in severe inflammation of the heart muscle. The notion that the pathology of CD has an autoimmune component was initially based on the finding of circulating antibodies binding heart tissue antigens in patients chronically infected with T. cruzi.

A recent study reports a possible antigen (non-cruzi-related antibody NCRA) mimicry characterized by a serological reactivity to a well-defined T. cruzi antigen in blood samples from individuals not exposed to the parasite. The measured seroprevalence of such cross-reactivity is in favor of a highly prevalent immunogen acquired in childhood.

There are similarities in mechanism of CD and KD: it could be interesting to explore the presence of NCRA in blood samples from adults with a history of KD.

The objective of the study is the measurement of the biomarker NCRA in serum in adults with a history of KD compare to a control population. This measurement and the prevalence may permit to associate the NCRA to a possible pathogenic agent.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Louis Pradel - Service de Pharmacologie Clinique


type: EudraCT Number

title: Transversal Monocentric Study of the Anatomophysiological Effect of Botulinum Toxin on the Spastic Muscle of Children With Cerebral Palsy

summary:
Cerebral palsy (CP) is a group of non-progressive motor dysfunction but often changing, secondary to injury or brain abnormalities that occur in early stages of development. In children with CP, the brain injury lead to a delayed motor development in the first weeks, associated with muscular spasticity. Drug treatments include oral treatments (baclofen and tizanidine) and injectable treatments like Botox (intramuscular injection) and neurolysis with alcohol or phenol (local injection into the nerve).

Regarding botulinum toxin, there is no study questioning its effectiveness. However, no publication on the pathophysiology of human muscle of the CP child after toxin injection was found. The action of the toxin on the neuromuscular junction (NMJ) and muscle structure is unknown in children with CP.

The primary objective of this study is to describe structural abnormalities of the CP child's muscle following multiple toxin injections in terms of NMJ fragmentation and axonal sprouting.

Secondary objectives:

To evaluate the relationship between:

The severity of the motor impairment and muscle structural abnormalities.
The clinical measure of spasticity and muscle structural abnormalities.
To compare the structure spastic muscles with toxin injections and spastic muscle without toxin injections

For muscles with multiple toxin injections, assessing the relationship between :

The number of toxin injections and muscle structural abnormalities.
The date of the first injection and muscle structural abnormalities.
The total dose of injected toxin in the muscle and its structural abnormalities.
The nature of the product injected in the muscle and its structural abnormalities.

This innovative study will improve the knowledge on the effects of long-term botulinum toxin injections on the muscle (and therefore its safety in usual care), on the spastic muscle NMJ of CP children, on the pathophysiology of the CP child's muscle.

All the visits all acts will be performed according to usual patient follow-up. Only a biopsy will be performed in addition, taken from an injected muscle during a planned operation. A biopsy may also be performed on a muscle without toxin injection if the act is made possible by the planned surgery. No biopsy will be made on a muscle that would not require surgery.


title: Efficacy and Safety of Estracyt® in Metastatic Breast Cancer Hormonal Estrogen Receptor (HER 2) Negative, Hormone Receptor (HR) Positive.

acronym: BEST

summary: This study evaluates efficacy, safety and quality of life in patients affected by metastatic breast cancer RH+/ HER2- and treated by estramustine phosphate.

status: Withdrawn

ipd_sharing: Yes

ipd_sharing_description: The Committee shall meet twice a year


title: Study on Fluids Associated to Lung Cancer, of the Ectopic Expression of Cancer Testis Gene and Mutation as Diagnostics and Prognosis Biomarkers

acronym: ECTOPIC/MUTAS

summary:
The diagnosis of lung cancer is the first cause of cancer deaths for man and woman. It requires invasive procedures (at least endoscopy, transthoracic puncture, or surgery).

This study is about the set up of an innovative test for lung cancer prognosis, based on biopsies and surgical material : LungCancerTest, with the creation of a start-up in progress.

The main goal of this study is to approve the diagnostic value of the molecular signature of the 26 genes (LungCancerTest) revealed in blood and respiratory fluids among patients with lung cancer.

ReferenceCitation: Toffart AC, Timsit JF, Couraud S, Merle P, Moro-Sibilot D, Perol M, Mastroianni B, Souquet PJ, Girard N, Jeannin G, Romand P, Chatellain P, Vesin A, Brambilla C, Brambilla E. Immunohistochemistry evaluation of biomarker expression in non-small cell lung cancer (Pharmacogenoscan study). Lung Cancer. 2014 Feb;83(2):182-8. doi: 10.1016/j.lungcan.2013.12.003. Epub 2013 Dec 21.

ReferenceCitation: Rousseaux S, Debernardi A, Jacquiau B, Vitte AL, Vesin A, Nagy-Mignotte H, Moro-Sibilot D, Brichon PY, Lantuejoul S, Hainaut P, Laffaire J, de Reyniès A, Beer DG, Timsit JF, Brambilla C, Brambilla E, Khochbin S. Ectopic activation of germline and placental genes identifies aggressive metastasis-prone lung cancers. Sci Transl Med. 2013 May 22;5(186):186ra66. doi: 10.1126/scitranslmed.3005723.

ReferenceCitation: BRAMBILLA C., ROUSSEAUX S., DE BERNARDI A., JACQUIAU B., VITTE A.L., ARBIB F., LEMAITRE N., LANTUEJOUL S., MIGNOTTE H, MORO-SIBILOT D., TOFFART A.C., BRAMBILLA E., KOCHBIN S. A PCR-based test detecting ectopic expressions of placenta/germline genes can predict aggressive lung tumours. J. Thor. Oncol. • Volume 8, Supplement 2, November 2013 S1048

ReferenceCitation: Vignot S, Frampton GM, Soria JC, Yelensky R, Commo F, Brambilla C, Palmer G, Moro-Sibilot D, Ross JS, Cronin MT, André F, Stephens PJ, Lazar V, Miller VA, Brambilla E. Next-generation sequencing reveals high concordance of recurrent somatic alterations between primary tumor and metastases from patients with non-small-cell lung cancer. J Clin Oncol. 2013 Jun 10;31(17):2167-72. doi: 10.1200/JCO.2012.47.7737. Epub 2013 Apr 29.

ReferenceCitation: PEIFER M, FERNÁNDEZ-CUESTA L, SOS ML, GEORGE J, SEIDEL D, KASPER LH, PLENKER D, LEENDERS F, SUN R, ZANDER T, MENON R, KOKER M, DAHMEN I, MÜLLER C, DI CERBO V, SCHILDHAUS HU, ALTMÜLLER J, BAESSMANN I, BECKER C, DE WILDE B, VANDESOMPELE J, BÖHM D, ANSÉN S, GABLER F, WILKENING I, HEYNCK S, HEUCKMANN JM, LU X, CARTER SL, CIBULSKIS K, BANERJI S, GETZ G, PARK KS, RAUH D, GRÜTTER C, FISCHER M, PASQUALUCCI L, WRIGHT G, WAINER Z, RUSSELL P, PETERSEN I, CHEN Y, STOELBEN E, LUDWIG C, SCHNABEL P, HOFFMANN H, MULEY T, BROCKMANN M, ENGEL-RIEDEL W, MUSCARELLA LA, FAZIO VM, GROEN H, TIMENS W, SIETSMA H, THUNNISSEN E, SMIT E, HEIDEMAN DA, SNIJDERS PJ, CAPPUZZO F, LIGORIO C, DAMIANI S, FIELD J, SOLBERG S, BRUSTUGUN OT, LUND-IVERSEN M, SÄNGER J, CLEMENT JH, SOLTERMANN A, MOCH H, WEDER W, SOLOMON B, SORIA JC, VALIDIRE P, BESSE B, BRAMBILLA E, BRAMBILLA C, LANTUEJOUL S, LORIMIER P, SCHNEIDER PM, HALLEK M, PAO W, MEYERSON M, SAGE J, SHENDURE J, SCHNEIDER R, BÜTTNER R, WOLF J, NÜRNBERG P, PERNER S, HEUKAMP LC, BRINDLE PK, HAAS S, THOMAS RK. Integrative genome analyses identify key somatic driver mutations of small-cell lung cancer.Nat Genet. 2012;44(10):1104-10

ReferenceCitation: Nagy-Mignotte H, Guillem P, Vignoud L, Coudurier M, Vesin A, Bonneterre V, Toffart AC, Sakhri L, Brambilla C, Brambilla E, Timsit JF, Moro-Sibilot D; Multidisciplinary Thoracic Oncology Group. Outcomes in recurrent small-cell lung cancer after one to four chemotherapy lines: a retrospective study of 300 patients. Lung Cancer. 2012 Oct;78(1):112-20. doi: 10.1016/j.lungcan.2012.06.006. Epub 2012 Jul 12.

ReferenceCitation: Lecourtois B, Jankowski A, Arbib F, Lantuejoul S, Brichon PY, Moro-Sibilot D, Brambilla C, Ferretti G. Endobronchial tumours in a campaign for early detection of bronchial cancer: Computed tomography versus endoscopy. Diagn Interv Imaging. 2012 Jul;93(7-8):604-11. doi: 10.1016/j.diii.2012.05.002. Epub 2012 Jul 6.

ReferenceCitation: Mortamais M, Chevrier C, Philippat C, Petit C, Calafat AM, Ye X, Silva MJ, Brambilla C, Eijkemans MJ, Charles MA, Cordier S, Slama R. Correcting for the influence of sampling conditions on biomarkers of exposure to phenols and phthalates: a 2-step standardization method based on regression residuals. Environ Health. 2012 Apr 26;11:29. doi: 10.1186/1476-069X-11-29.

ReferenceCitation: Brambilla C, Sánchez-Chardi A, Pérez-Trujillo M, Julián E, Luquin M. Cyclopropanation of α-mycolic acids is not required for cording in Mycobacterium brumae and Mycobacterium fallax. Microbiology (Reading). 2012 Jun;158(Pt 6):1615-1621. doi: 10.1099/mic.0.057919-0. Epub 2012 Apr 5.

ReferenceCitation: Han N, Dol Z, Vasieva O, Hyde R, Liloglou T, Raji O, Brambilla E, Brambilla C, Martinet Y, Sozzi G, Risch A, Montuenga LM; EUELC Consortium, Brass A, Field JK. Progressive lung cancer determined by expression profiling and transcriptional regulation. Int J Oncol. 2012 Jul;41(1):242-52. doi: 10.3892/ijo.2012.1421. Epub 2012 Mar 28.

ReferenceCitation: Pajares MJ, Agorreta J, Larrayoz M, Vesin A, Ezponda T, Zudaire I, Torre W, Lozano MD, Brambilla E, Brambilla C, Wistuba II, Behrens C, Timsit JF, Pio R, Field JK, Montuenga LM. Expression of tumor-derived vascular endothelial growth factor and its receptors is associated with outcome in early squamous cell carcinoma of the lung. J Clin Oncol. 2012 Apr 1;30(10):1129-36. doi: 10.1200/JCO.2011.37.4231. Epub 2012 Feb 21.

ReferenceCitation: Hammerman PS, Sos ML, Ramos AH, Xu C, Dutt A, Zhou W, Brace LE, Woods BA, Lin W, Zhang J, Deng X, Lim SM, Heynck S, Peifer M, Simard JR, Lawrence MS, Onofrio RC, Salvesen HB, Seidel D, Zander T, Heuckmann JM, Soltermann A, Moch H, Koker M, Leenders F, Gabler F, Querings S, Ansén S, Brambilla E, Brambilla C, Lorimier P, Brustugun OT, Helland A, Petersen I, Clement JH, Groen H, Timens W, Sietsma H, Stoelben E, Wolf J, Beer DG, Tsao MS, Hanna M, Hatton C, Eck MJ, Janne PA, Johnson BE, Winckler W, Greulich H, Bass AJ, Cho J, Rauh D, Gray NS, Wong KK, Haura EB, Thomas RK, Meyerson M. Mutations in the DDR2 kinase gene identify a novel therapeutic target in squamous cell lung cancer. Cancer Discov. 2011 Jun;1(1):78-89. doi: 10.1158/2159-8274.CD-11-0005.

ReferenceCitation: Scoccianti C, Vesin A, Martel G, Olivier M, Brambilla E, Timsit JF, Tavecchio L, Brambilla C, Field JK, Hainaut P; European Early Lung Cancer Consortium. Prognostic value of TP53, KRAS and EGFR mutations in nonsmall cell lung cancer: the EUELC cohort. Eur Respir J. 2012 Jul;40(1):177-84. doi: 10.1183/09031936.00097311. Epub 2012 Jan 20.

ReferenceCitation: Philippat C, Mortamais M, Chevrier C, Petit C, Calafat AM, Ye X, Silva MJ, Brambilla C, Pin I, Charles MA, Cordier S, Slama R. Exposure to phthalates and phenols during pregnancy and offspring size at birth. Environ Health Perspect. 2012 Mar;120(3):464-70. doi: 10.1289/ehp.1103634. Epub 2011 Sep 7. Erratum in: Environ Health Perspect. 2012 Mar;120(3):470.

ReferenceCitation: Thunnissen FB, Prinsen C, Hol B, Van der Drift M, Vesin A, Brambilla C, Montuenga L, Field JK; EUELC consortium. Smoking history and lung carcinoma: KRAS mutation is an early hit in lung adenocarcinoma development. Lung Cancer. 2012 Feb;75(2):156-60. doi: 10.1016/j.lungcan.2011.07.013. Epub 2011 Aug 11.

ReferenceCitation: Nagy-Mignotte H, Guillem P, Vesin A, Toffart AC, Colonna M, Bonneterre V, Brichon PY, Brambilla C, Brambilla E, Lantuejoul S, Timsit JF, Moro-Sibilot D; Multidisciplinary Thoracic Oncology Group at Grenoble University Hospital. Primary lung adenocarcinoma: characteristics by smoking habit and sex. Eur Respir J. 2011 Dec;38(6):1412-9. doi: 10.1183/09031936.00191710. Epub 2011 Aug 4.

ReferenceCitation: Bousquet J, Anto JM, Sterk PJ, Adcock IM, Chung KF, Roca J, Agusti A, Brightling C, Cambon-Thomsen A, Cesario A, Abdelhak S, Antonarakis SE, Avignon A, Ballabio A, Baraldi E, Baranov A, Bieber T, Bockaert J, Brahmachari S, Brambilla C, Bringer J, Dauzat M, Ernberg I, Fabbri L, Froguel P, Galas D, Gojobori T, Hunter P, Jorgensen C, Kauffmann F, Kourilsky P, Kowalski ML, Lancet D, Pen CL, Mallet J, Mayosi B, Mercier J, Metspalu A, Nadeau JH, Ninot G, Noble D, Oztürk M, Palkonen S, Préfaut C, Rabe K, Renard E, Roberts RG, Samolinski B, Schünemann HJ, Simon HU, Soares MB, Superti-Furga G, Tegner J, Verjovski-Almeida S, Wellstead P, Wolkenhauer O, Wouters E, Balling R, Brookes AJ, Charron D, Pison C, Chen Z, Hood L, Auffray C. Systems medicine and integrated care to combat chronic noncommunicable diseases. Genome Med. 2011 Jul 6;3(7):43. doi: 10.1186/gm259.

ReferenceCitation: Edmond V, Brambilla C, Brambilla E, Gazzeri S, Eymin B. SRSF2 is required for sodium butyrate-mediated p21(WAF1) induction and premature senescence in human lung carcinoma cell lines. Cell Cycle. 2011 Jun 15;10(12):1968-77. Epub 2011 Jun 15.

ReferenceCitation: Travis WD, Brambilla E, Noguchi M, Nicholson AG, Geisinger KR, Yatabe Y, Beer DG, Powell CA, Riely GJ, Van Schil PE, Garg K, Austin JH, Asamura H, Rusch VW, Hirsch FR, Scagliotti G, Mitsudomi T, Huber RM, Ishikawa Y, Jett J, Sanchez-Cespedes M, Sculier JP, Takahashi T, Tsuboi M, Vansteenkiste J, Wistuba I, Yang PC, Aberle D, Brambilla C, Flieder D, Franklin W, Gazdar A, Gould M, Hasleton P, Henderson D, Johnson B, Johnson D, Kerr K, Kuriyama K, Lee JS, Miller VA, Petersen I, Roggli V, Rosell R, Saijo N, Thunnissen E, Tsao M, Yankelewitz D. International association for the study of lung cancer/american thoracic society/european respiratory society international multidisciplinary classification of lung adenocarcinoma. J Thorac Oncol. 2011 Feb;6(2):244-85. doi: 10.1097/JTO.0b013e318206a221. Review.

ReferenceCitation: Garelli M, Righini C, Faure C, Jankowski A, Brambilla C, Ferretti GR. Imaging of a case of extramedullary solitary plasmacytoma of the trachea. Case Rep Radiol. 2011;2011:687203. doi: 10.1155/2011/687203. Epub 2011 Sep 22.

ReferenceCitation: Weiss J, Sos ML, Seidel D, Peifer M, Zander T, Heuckmann JM, Ullrich RT, Menon R, Maier S, Soltermann A, Moch H, Wagener P, Fischer F, Heynck S, Koker M, Schöttle J, Leenders F, Gabler F, Dabow I, Querings S, Heukamp LC, Balke-Want H, Ansén S, Rauh D, Baessmann I, Altmüller J, Wainer Z, Conron M, Wright G, Russell P, Solomon B, Brambilla E, Brambilla C, Lorimier P, Sollberg S, Brustugun OT, Engel-Riedel W, Ludwig C, Petersen I, Sänger J, Clement J, Groen H, Timens W, Sietsma H, Thunnissen E, Smit E, Heideman D, Cappuzzo F, Ligorio C, Damiani S, Hallek M, Beroukhim R, Pao W, Klebl B, Baumann M, Buettner R, Ernestus K, Stoelben E, Wolf J, Nürnberg P, Perner S, Thomas RK. Frequent and focal FGFR1 amplification associates with therapeutically tractable FGFR1 dependency in squamous cell lung cancer. Sci Transl Med. 2010 Dec 15;2(62):62ra93. doi: 10.1126/scitranslmed.3001451. Erratum in: Sci Transl Med. 2011 Jan 19;3(66):66er2. Sci Transl Med. 2012 Apr 18;4(130):130er2.

ReferenceCitation: Edmond V, Moysan E, Khochbin S, Matthias P, Brambilla C, Brambilla E, Gazzeri S, Eymin B. Acetylation and phosphorylation of SRSF2 control cell fate decision in response to cisplatin. EMBO J. 2011 Feb 2;30(3):510-23. doi: 10.1038/emboj.2010.333. Epub 2010 Dec 14.

ReferenceCitation: Larrieu D, Ythier D, Brambilla C, Pedeux R. ING2 controls the G1 to S-phase transition by regulating p21 expression. Cell Cycle. 2010 Oct 1;9(19):3984-90. Epub 2010 Oct 1.

ReferenceCitation: Ythier D, Larrieu D, Binet R, Binda O, Brambilla C, Gazzeri S, Pedeux R. Sumoylation of ING2 regulates the transcription mediated by Sin3A. Oncogene. 2010 Nov 4;29(44):5946-56. doi: 10.1038/onc.2010.325. Epub 2010 Aug 2.

ReferenceCitation: Bryant CM, Albertus DL, Kim S, Chen G, Brambilla C, Guedj M, Arima C, Travis WD, Yatabe Y, Takahashi T, Brambilla E, Beer DG. Clinically relevant characterization of lung adenocarcinoma subtypes based on cellular pathways: an international validation study. PLoS One. 2010 Jul 22;5(7):e11712. doi: 10.1371/journal.pone.0011712.

ReferenceCitation: Merdzhanova G, Gout S, Keramidas M, Edmond V, Coll JL, Brambilla C, Brambilla E, Gazzeri S, Eymin B. The transcription factor E2F1 and the SR protein SC35 control the ratio of pro-angiogenic versus antiangiogenic isoforms of vascular endothelial growth factor-A to inhibit neovascularization in vivo. Oncogene. 2010 Sep 30;29(39):5392-403. doi: 10.1038/onc.2010.281. Epub 2010 Jul 19.

ReferenceCitation: Van den Berg RM, Brokx H, Vesin A, Field JK, Brambilla C, Meijer CJ, Sutedja GT, Heideman DA, Postmus PE, Smit EF, Snijders PJ. Prognostic value of hTERT mRNA expression in surgical samples of lung cancer patients: the European Early Lung Cancer Project. Int J Oncol. 2010 Aug;37(2):455-61.

ReferenceCitation: Caron C, Lestrat C, Marsal S, Escoffier E, Curtet S, Virolle V, Barbry P, Debernardi A, Brambilla C, Brambilla E, Rousseaux S, Khochbin S. Functional characterization of ATAD2 as a new cancer/testis factor and a predictor of poor prognosis in breast and lung cancers. Oncogene. 2010 Sep 16;29(37):5171-81. doi: 10.1038/onc.2010.259. Epub 2010 Jun 28.

ReferenceCitation: Lantuejoul S, Raynaud C, Salameire D, Gazzeri S, Moro-Sibilot D, Soria JC, Brambilla C, Brambilla E. Telomere maintenance and DNA damage responses during lung carcinogenesis. Clin Cancer Res. 2010 Jun 1;16(11):2979-88. doi: 10.1158/1078-0432.CCR-10-0142. Epub 2010 Apr 19.

ReferenceCitation: Ythier D, Brambilla E, Binet R, Nissou D, Vesin A, de Fraipont F, Moro-Sibilot D, Lantuejoul S, Brambilla C, Gazzeri S, Pedeux R. Expression of candidate tumor suppressor gene ING2 is lost in non-small cell lung carcinoma. Lung Cancer. 2010 Aug;69(2):180-6. doi: 10.1016/j.lungcan.2009.11.006. Epub 2009 Dec 4.

ReferenceCitation: Wattrelot P, Brion JP, Labarère J, Billette de Villemeur A, Girard-Blanc MF, Stahl JP, Brambilla C. [Vaccination practices following the end of compulsory BCG vaccination. A cross-sectional survey of general practitioners and pediatricians]. Arch Pediatr. 2010 Feb;17(2):118-24. doi: 10.1016/j.arcped.2009.10.025. Epub 2009 Dec 2. French.

ReferenceCitation: Binet R, Ythier D, Robles AI, Collado M, Larrieu D, Fonti C, Brambilla E, Brambilla C, Serrano M, Harris CC, Pedeux R. WNT16B is a new marker of cellular senescence that regulates p53 activity and the phosphoinositide 3-kinase/AKT pathway. Cancer Res. 2009 Dec 15;69(24):9183-91. doi: 10.1158/0008-5472.CAN-09-1016.

ReferenceCitation: Field JK, Liloglou T, Niaz A, Bryan J, Gosney JR, Giles T, Brambilla C, Brambilla E, Vesin A, Timsit JF, Hainaut P, Martinet Y, Vignaud JM, Thunnissen FB, Prinsen C, Snijders PJ, Smit EF, Sozzi G, Roz L, Risch A, Becker HD, Elborn JS, Magee ND, Montuenga LM, Pajares MJ, Lozano MD, O'Byrne KJ, Harrison DJ, Niklinski J, Cassidy A; EUELC Collaborators. EUELC project: a multi-centre, multipurpose study to investigate early stage NSCLC, and to establish a biobank for ongoing collaboration. Eur Respir J. 2009 Dec;34(6):1477-86. doi: 10.1183/09031936.00077809.

ReferenceCitation: Felix L, Serra-Tosio G, Lantuejoul S, Timsit JF, Moro-Sibilot D, Brambilla C, Ferretti GR. CT characteristics of resolving ground-glass opacities in a lung cancer screening programme. Eur J Radiol. 2011 Mar;77(3):410-6. doi: 10.1016/j.ejrad.2009.09.008. Epub 2009 Oct 4.

ReferenceCitation: Larrieu D, Ythier D, Binet R, Brambilla C, Brambilla E, Sengupta S, Pedeux R. ING2 controls the progression of DNA replication forks to maintain genome stability. EMBO Rep. 2009 Oct;10(10):1168-74. doi: 10.1038/embor.2009.180. Epub 2009 Sep 4.

ReferenceCitation: Cassidy A, Balsan J, Vesin A, Wu X, Liloglou T, Brambilla C, Timsit JF, Field JK; EUELC Consortium. Cancer diagnosis in first-degree relatives and non-small cell lung cancer risk: results from a multi-centre case-control study in Europe. Eur J Cancer. 2009 Nov;45(17):3047-53. doi: 10.1016/j.ejca.2009.05.006. Epub 2009 May 29.

ReferenceCitation: Delloye-Bourgeois C, Brambilla E, Coissieux MM, Guenebeaud C, Pedeux R, Firlej V, Cabon F, Brambilla C, Mehlen P, Bernet A. Interference with netrin-1 and tumor cell death in non-small cell lung cancer. J Natl Cancer Inst. 2009 Feb 18;101(4):237-47. doi: 10.1093/jnci/djn491. Epub 2009 Feb 10.

ReferenceCitation: Brambilla C. From surgical to molecular scalpel: ERJ lung cancer series for 2009. Eur Respir J. 2009 Jan;33(1):9-10.

ReferenceCitation: Verri C, Roz L, Conte D, Liloglou T, Livio A, Vesin A, Fabbri A, Andriani F, Brambilla C, Tavecchio L, Calarco G, Calabrò E, Mancini A, Tosi D, Bossi P, Field JK, Brambilla E, Sozzi G; EUELC Consortium. Fragile histidine triad gene inactivation in lung cancer: the European Early Lung Cancer project. Am J Respir Crit Care Med. 2009 Mar 1;179(5):396-401. doi: 10.1164/rccm.200807-1153OC. Epub 2008 Dec 18.

ReferenceCitation: Van Den Broeck A, Brambilla E, Moro-Sibilot D, Lantuejoul S, Brambilla C, Eymin B, Gazzeri S. Loss of histone H4K20 trimethylation occurs in preneoplasia and influences prognosis of non-small cell lung cancer. Clin Cancer Res. 2008 Nov 15;14(22):7237-45. doi: 10.1158/1078-0432.CCR-08-0869. Epub 2008 Oct 30. Erratum in: Clin Cancer Res. 2020 Jun 1;26(11):2767. Clin Cancer Res. 2020 Jun 1;26(11):2768.

ReferenceCitation: Merdzhanova G, Edmond V, De Seranno S, Van den Broeck A, Corcos L, Brambilla C, Brambilla E, Gazzeri S, Eymin B. E2F1 controls alternative splicing pattern of genes involved in apoptosis through upregulation of the splicing factor SC35. Cell Death Differ. 2008 Dec;15(12):1815-23. doi: 10.1038/cdd.2008.135. Epub 2008 Sep 19.

ReferenceCitation: Ythier D, Larrieu D, Brambilla C, Brambilla E, Pedeux R. The new tumor suppressor genes ING: genomic structure and status in cancer. Int J Cancer. 2008 Oct 1;123(7):1483-90. doi: 10.1002/ijc.23790. Review.

ReferenceCitation: Bertrand D, Righini C, Ferretti G, Brambilla C, Moro-Sibilot D. [Early diagnosis of bronchial carcinoma after head and neck cancer]. Rev Mal Respir. 2008 May;25(5):559-68. French.

ReferenceCitation: Ferretti GR, Jankowski A, Rodière M, Brichon PY, Brambilla C, Lantuejoul S. CT-guided biopsy of nonresolving focal air space consolidation. J Thorac Imaging. 2008 Feb;23(1):7-12. doi: 10.1097/RTI.0b013e3181453e04.

ReferenceCitation: Brambilla C, Colonna M. Cannabis: the next villain on the lung cancer battlefield? Eur Respir J. 2008 Feb;31(2):227-8. doi: 10.1183/09031936.00157607.


title: Retrospective Study to Estimate Screening of the Type 2 Diabetes of Women Who Had Childbirth in the Hospital Center Rene Dubos and Having Gestational Diabetes

summary: Retrospective study to estimate screening of the type 2 diabetes of women who had childbirth in the Hospital center Rene Dubos and having gestational diabetes.

lead_sponsor: Centre Hospitalier René Dubos


title: A Double-Blind, Placebo-Controlled Single Dose Escalating Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2151 in Healthy Male Subjects, Followed by an Open, Two-Period Crossover Study to Assess the Effect of Fed Conditions on the Safety, Tolerability and Pharmacokinetics of ASP2151

summary:
The objective of this study is to evaluate the safety and tolerability of single rising doses of ASP2151 under fasted condition in healthy male subjects.

The study will also evaluate the pharmacokinetics (PK) of a single dose of ASP2151 under fasted versus fed conditions in healthy male subjects.

ReferenceCitation: Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.

family: Kusawake

full_name: Tomohiro Kusawake

given: Tomohiro

family: Keirns

full_name: James J. Keirns

given: James J.

family: Kowalski

full_name: Donna Kowalski

given: Donna

family: den Adel

full_name: Martin den Adel

given: Martin

family: Groenendaal-van de Meent

full_name: Dorien Groenendaal-van de Meent

given: Dorien

family: Takada

full_name: Akitsugu Takada

given: Akitsugu

family: Ohtsu

full_name: Yoshiaki Ohtsu

given: Yoshiaki

family: Katashima

full_name: Masataka Katashima

given: Masataka

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Advances in Therapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Astellas Pharma Europe Ltd.

lead_sponsor_type: industriel


title: Does Micro-albuminuria is a Predictive Factor for Cognitive Impairment in Persons Living With HIV (PLHIV) Who Achieve cART-sustained Immunovirological Control ?

acronym: ALCOVE

summary: Chronic kidney disease (CKD), frequent in PLHIV, is a risk factor for cognitive impairment. Micro-albuminuria is an early manifestation of CKD and a marker of vascular risk, notably affecting the small vessels. In the older general population microalbuminuria is associated with greater annual cognitive decline and has been proposed as an easily and inexpensive measured marker predicting future cognitive function decline. Ageing of the PLH leads to an increase of cognitive disorders and chronic renal failure incidence and could imply a common underlying mechanism affecting the renal and cerebral microvasculature. In this setting the investigators undertake this prospective, cross-sectional, case-control study to determine whether the presence of a microalbuminuria at least 5 years ago in PLHs with sustained good combination antiretroviral therapy (cART)-controlled immunovirological parameters could be a marker predicting future cognitive impairment. They chose PLHs infected for at least 5 years and with cART-sustained immunovirological control for at least 1 year.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Behavioral