title: Effect of Neuromuscular Electrostimulation on Sympathetic Nerve Activity in Patients With Type 2 Diabetes (ELECTROSYMP2)

summary: Physical activity (PA) is recommended for the treatment of subjects with type 2 diabetes to increase insulin sensitivity and improve metabolic control. However, adherence to PA is often poor, due to a lack of motivation or due to disabling complications or comorbidities. Neuromuscular electrostimulation (NMES) is a physical treatment commonly used to improve muscle strength and volume in several situations: after stroke, after limb trauma or during chest rehabilitation in deconditioned patients. The investigators have already shown in a first pilot study (manuscript in preparation) that NMES improves insulin sensitivity : in the study ELECTRODIAB (No. ID-RCB: 2011-A00930-41), the investigators showed a 25% insulin sensitivity improvement after a week of daily 25-min bi-quadricipital NMES session, in a population of patients with orally-treated type 2 diabetes. Insulin sensitivity increased up to 50% in the most deconditioned subjects. Discrepancy between this result and the very low energy expenditure measured during sessions suggests that the metabolic effect was not solely mediated by muscle contractions. The investigators hypothesize the involvement of neurological pathways. Indeed, it is demonstrated that the autonomic nervous system is an important regulator of glucose metabolism with pancreatic action, a key role in energy metabolism and a complex relationship with insulin resistance. Muscle activity, whether static (isometric) or dynamic causes changes in sympathetic nerve activity in healthy subjects but its effect in type 2 diabetic subjects is not known. The investigators hypothesize that, in type 2 diabetic subjects, the modulation of sympathetic nerve activity by NMES could be involved in the improvement of insulin sensitivity. To address this question, the investigators propose to assess sympathetic nerve activity with the gold standard method of microneurography before and after a single bi-quadricipital NMES session. The impact of neuro-electro-stimulation (NES) (a sensitive stimulation under muscular threshold) and the impact of voluntary isometric muscle contractions (VC) will also be evaluated. These procedures will also be applied in healthy control subjects.

lead_sponsor: University Hospital, Caen

location_facility: Clinical Research Center Caen University Hospital


title: Effect of Sub-mental Sensitive Transcutaneous Electrical Stimulation on Pharyngeal Muscles Control

acronym: TENSVIRT

summary:
Swallowing is a complex phenomenon that allows oral feeding while protecting the airway. It involves many brain areas, including primary motor and sensory areas. Its dysfunction, called oropharyngeal dysphagia is present in approximately 60% of patients with a stroke. In this case, it is conventionally translated by a swallow response time delay of the swallowing reflex.

Pathophysiology of dysphagia is explained by impairment of the dominant swallowing, function that representation center is bi-hemispheric but asymmetric (Hamdy, 1997). Half of patients with a stroke supra-tentoriel with oropharyngeal dysphagia (about 55 % of strokes) regain normal swallowing in a few weeks ( Barer, 1989). Mechanisms that determine the recovery appear to be related to a reorganization of the motor cortex intact. Patients who retain disorders are those who have not cortical reorganization.

With this in mind a team used different methods known to modulate brain plasticity, which electrotherapy with an application endo- pharyngeal sensory threshold. This stimulation increases the excitability of the cortico- bulbar reflex, which improves swallowing function in the clinical application.

The hypothesis of this work is that the transcutaneous electrical stimulation applied submental, noninvasive technique, would also have an impact on cortical plasticity may explain the improved coordination of swallowing observed in earlier studies (Verin , 2011) ( Gallas , 2010).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

enrollment_type: Actual

lead_sponsor: University Hospital, Rouen

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Effect of Pharyngeal Cortical Area Inhibition Induced by rTMS on Swallowing Function in Healthy Subject: Video Fluoroscopic Study.

acronym: rTMSvideoSS

summary: The aim of this study is to test the hypothesis that rTMS on the dominant swallowing hemisphere is able to modify swallowing coordination.

design_allocation: Randomized

primary_purpose: Basic Science

intervention_type: Procedure


title: The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects

summary: The purpose of this study is to determine the effect of repeated dosing of once-daily 25, 50 and 75 mg opicapone (OPC, development code BIA 9-1067) on the levodopa pharmacokinetics (PK), in comparison to placebo and 200 mg entacapone (ENT).

primary_purpose: Treatment

lead_sponsor: Bial - Portela C S.A.

intervention_type: Drug

lead_sponsor_type: industriel


title: Pilot, Monocentric, Non-comparative Study of the Effectiveness and Safety of High Intensity Focused Ultrasound Device in Patients With Autonomous Hyperfunctioning Thyroid Nodules

summary: The purpose of this study is to assess the efficacy and safety of High Intensity Focalized Ultrasound (HIFU) in the treatment for toxic Thyroids nodules

status: Terminated

lead_sponsor: Theraclion

status_simplified: Unknown


title: Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy Subjects

summary: The purpose of this study is to determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in steady-state conditions on the levodopa pharmacokinetics of a single dose of immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release levodopa/benserazide 100/25 mg.


title: Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA

acronym: ANTiCIPe

summary: The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Rennes University Hospital

intervention_type: Other


title: Bioavailability of DHA-TG (Docosahexaenoic Triglyceride), DHA-PC (Docosahexaenoic Phosphatidylcholine) and AcedoPC (1-acetyl-2-docosahexaenoic-glycerophosphocholine) in Human

acronym: AceDoPC

summary:
The purpose of this study is to compare three lipidic forms of DHA in their metabolic pathway in human by using 13C labeled molecules.

The circulating form of DHA plays a major role in his cerebral incorporation. The aim of this research is to confirm that some lipidic forms are best carriers for the cerebral incorporation in studying 13C-DHA distribution in plasma lipids and blood cells.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes, 165 chemin du Grand Revoyet,


title: Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients

summary: The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.

study_start_date_type: Actual

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Exploratory Study to Assess the Pharmacokinetics in Relation to Blood Glucose and Insulin Levels After Intake of a Plant-based Ingredient in Healthy Subjects

summary: The study is designed to explore the pharmacokinetics of a Plant-based ingredient in two different matrices, at different dose levels.

lead_sponsor: Unilever R&D

intervention_type: Dietary Supplement


title: Impact of Hand Osteoarthritis on Arterial Stiffness

summary: Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the general population, mainly due to cardiovascular diseases. OA patients without cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular mechanisms are still not well known, the structure and function of the vessel wall can be affected by several inflammatory and metabolic parameters during OA.These functional and structural changes of the arterial wall leads to arterial stiffness, measured by the pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness and has been shown to have predictive value for morbidity and mortality. In our study, we planned to compare arterial stiffness in OA patients with healthy subjects.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Screening

enrollment_type: Anticipated

lead_sponsor: University Hospital, Montpellier


title: Confrontation Phenotypic (Clinical, Radiological, Histological) and Genotypic Epithelial Odontogenic Tumors Isolated or Syndromic Jaws

acronym: TEIOS

summary:
Systematically compare the phenotype and genotype of epithelial odontogenic tumors in children and adults with a clinical, radiographic, pathologic and molecular level.

Either:

establish an observatory of this multidisciplinary tumor establish a tumor bank annotated scale unparalleled testing pathophysiological hypotheses search for prognostic factors.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Stomatologie et Chirurgie Maxillofaciale - Pitie Salpetriere


title: Corpus Callosum Agenesis and Intellectual Disability: Genetic and Phenotypic Characterization

acronym: ACCREM

summary:
Corpus callosum agenesis or dysgenesis (CCA) is a major brain malformation (˜1/4000 births) presently diagnosed by prenatal ultrasonography. In about half of the cases, CCA is associated with other anomalies (complex CCA), which usually leads to medical abortion. Syndromes including a CCA are many (hundreds), most of which are also associated with intellectual deficiency (ID). Several genes are involved in such complex CCA. On the other hand, several studies pointed to the favorable cognitive outcome of individuals/fetuses with an apparently isolated CCA (ICCA) during pregnancy in about 70% of cases. However, there are still 30% of cases with ID or developmental delay. The precise incidence and severity of these disorders are presently unclear. Therefore, prenatal counseling of couples facing a prenatal diagnosis of ICCA is still elusive.

Our aims are to unravel the genetic causes of CCA by combining phenotypic and genetic analyses in a prospective cohort of patients with CCA and intellectual disability, in order to improve prenatal information.

intervention_type: Genetic


type: Other Identifier

title: Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.

acronym: PANNIV

summary:
the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation.

the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.

primary_purpose: Supportive Care

ReferenceType: derived

ReferenceCitation: Abou-Arab O, Guinot PG, Dimov E, Diouf M, de Broca B, Biet A, Zaatar R, Bernard E, Dupont H, Lorne E. Low-positive pressure ventilation improves non-hypoxaemic apnoea tolerance during ear, nose and throat pan-endoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):269-74. doi: 10.1097/EJA.0000000000000394.

family: Abou Arab

full_name: Osama Abou Arab

given: Osama

sequence: first

family: Guinot

full_name: Pierre-Grégoire Guinot

given: Pierre-Grégoire

sequence: additional

family: Dimov

full_name: Evgeny Dimov

given: Evgeny

family: Diouf

full_name: Momar Diouf

given: Momar

family: de Broca

full_name: Bruno de Broca

given: Bruno

family: Biet

full_name: Aurélie Biet

given: Aurélie

family: Zaatar

full_name: Rody Zaatar

given: Rody

family: Bernard

full_name: Eugénie Bernard

given: Eugénie

family: Dupont

full_name: Hervé Dupont

given: Hervé

family: Lorne

full_name: Emmanuel Lorne

given: Emmanuel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique for Esophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus

summary: Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic approach had already been described for complex stenoses but never for disruption with loss of tissue and SES. Patients and methods: This is a retrospective observationnal study about patients referred for complete esophageal disruption and classified in two groups: 1/ Long disruption (> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS removal; 2/ Short disruption (< 5cm), consecutive to radiation therapy. All the procedures are performed according the anterograde retrograde approach, using CO2 and under X-rays guidance. We report the characteristeristics of the procedures, the efficacy, the time before discharge and refeeding, the complications, and the follow-up, especially the number of dilatation sessions for each group. The hypothesis is that anterograde retrograde endoscopic technique is safe and effective for the management of esophageal disruptions in patients for which the surgical treatment confers a high risk of morbidity and mortality.

time_perspective: Retrospective

lead_sponsor: Société Française d'Endoscopie Digestive

location_facility: APHM, North Hospital, Department of gastroenterology


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

acronym: SEGA

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

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

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

name: Clermont Université, Université d'Auvergne, Clermont-Ferrand, France

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

family: Boucher

full_name: Pierre Boucher

given: Pierre

family: Imhoff

full_name: Etienne Imhoff

given: Etienne

family: Chabanne

full_name: Russell Chabanne

given: Russell

family: Faure

full_name: Jean-Sébastien Faure

given: Jean-Sébastien

name: Department of Medical Biochemistry and Molecular Biology, and

family: Roszyk

full_name: Laurence Roszyk

given: Laurence

name: Department of Clinical Research and Innovation (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France; and

family: Thibault

full_name: Sandrine Thibault

given: Sandrine

family: Blondonnet

full_name: Raiko Blondonnet

given: Raiko

family: Clairefond

full_name: Gael Clairefond

given: Gael

family: Guérin

full_name: Renaud Guérin

given: Renaud

family: Perbet

full_name: Sébastien Perbet

given: Sébastien

family: Cayot

full_name: Sophie Cayot

given: Sophie

family: Godet

full_name: Thomas Godet

given: Thomas

family: Pereira

full_name: Bruno Pereira

family: Sapin

full_name: Vincent Sapin

given: Vincent

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Futier

full_name: Emmanuel Futier

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

lead_sponsor: University Hospital, Clermont-Ferrand


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

acronym: HAP-AM

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

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

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

lead_sponsor: Institut Mutualiste Montsouris


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

acronym: IRM-Aut

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

primary_purpose: Diagnostic

location_facility: Hôpital Necker-Enfants Malades Service de Radiologie Pédiatrique


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

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


title: Pharmacokinetics of Micafungin in Patients of Intensive Care Units

acronym: MI-K

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

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

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

On one hand:

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

On the other hand:

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

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

primary_purpose: Other

lead_sponsor: University Hospital, Limoges


type: EudraCT Number

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

acronym: SAFEFAIRALS

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

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

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

ReferenceType: background

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

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

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

ReferenceCitation: Felice KJ. A longitudinal study comparing thenar motor unit number estimates to other quantitative tests in patients with amyotrophic lateral sclerosis. Muscle Nerve. 1997 Feb;20(2):179-85.

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

ReferenceCitation: Kwiatkowski A, Ryckewaert G, Jissendi Tchofo P, Moreau C, Vuillaume I, Chinnery PF, Destée A, Defebvre L, Devos D. Long-term improvement under deferiprone in a case of neurodegeneration with brain iron accumulation. Parkinsonism Relat Disord. 2012 Jan;18(1):110-2. doi: 10.1016/j.parkreldis.2011.06.024. Epub 2011 Aug 6.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ReferenceCitation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.

lead_sponsor: University Hospital, Lille


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

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

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

family: Guis

full_name: Sandrine Guis

family: Berbis

full_name: Philippe Berbis

given: Philippe

family: Stephan

full_name: Delphine Stephan

given: Delphine

family: Bertin

full_name: Daniel Bertin

given: Daniel

family: Amatore

full_name: Florent Amatore

given: Florent

family: Balandraud

full_name: Nathalie Balandraud

given: Nathalie

family: Lesavre

full_name: Nathalie Lesavre

family: Desplat-Jégo

full_name: Sophie Desplat-Jégo

currency_apc_doaj: GBP

journal_name: Journal of Translational Medicine

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

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: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


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

acronym: MONA

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

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

lead_sponsor: University Hospital, Toulouse


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

acronym: Fertiline

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

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

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

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

Criteria: number of embryos in each group

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

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

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

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


title: Fructosamines and Gestational Diabetes (FRUCTO)

acronym: FRUCTO

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

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

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

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

primary_purpose: Prevention

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

name: Department of Obstetrics and GynecologyCentre Hospitalier Departemental La Roche sur Yon France

family: Ducarme

full_name: Guillaume Ducarme

given: Guillaume

name: Department of BiologyCentre Hospitalier Departemental La Roche sur Yon France

family: Desroys du Roure

full_name: François Desroys du Roure

given: François

family: Grange

full_name: Joséphine Grange

given: Joséphine

family: Vital

full_name: Mathilde Vital

given: Mathilde

name: Clinical Research CenterCentre Hospitalier Departemental La Roche sur Yon France

family: Le Thuaut

full_name: Aurélie Le Thuaut

given: Aurélie

name: Department of EndocrinologyCentre Hospitalier Departemental La Roche sur Yon France

family: Crespin‐Delcourt

full_name: Ingrid Crespin‐Delcourt

given: Ingrid

journal_name: International Journal of Gynecology & Obstetrics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Centre Hospitalier Departemental Vendee


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

acronym: Horton CD8

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

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

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

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

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

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

family: Maldiney

full_name: Thomas Maldiney

family: Greigert

full_name: Hélène Greigert

given: Hélène

family: Martin

full_name: Laurent Martin

given: Laurent

family: Benoit

full_name: Emilie Benoit

given: Emilie

family: Creuzot-Garcher

full_name: Catherine Creuzot-Garcher

given: Catherine

family: Gabrielle

full_name: Pierre-Henry Gabrielle

given: Pierre-Henry

family: Chassot

full_name: Jean-Marie Chassot

given: Jean-Marie

family: Boccara

full_name: Claude Boccara

given: Claude

family: Balvay

full_name: Daniel Balvay

family: Tavitian

full_name: Bertrand Tavitian

given: Bertrand

family: Clément

full_name: Olivier Clément

given: Olivier

family: Audia

full_name: Sylvain Audia

given: Sylvain

family: Bonnotte

full_name: Bernard Bonnotte

given: Bernard

family: Samson

full_name: Maxime Samson

given: Maxime

currency_apc_doaj: USD

journal_name: PLOS ONE

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

repository_normalized: HAL

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

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

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

repository_normalized: bioRxiv

version: submittedVersion

repositories:
HAL
PubMed Central
bioRxiv

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science


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

acronym: EROSB

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

status: Recruiting

lead_sponsor: University Hospital, Caen

status_simplified: Ongoing


type: Registry Identifier

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

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

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

family: Buffière

full_name: Caroline Buffière

given: Caroline

family: Gaudichon

full_name: Claire Gaudichon

given: Claire

family: Hafnaoui

full_name: Noureddine Hafnaoui

given: Noureddine

family: Migné

full_name: Carole Migné

given: Carole

family: Scislowsky

full_name: Valérie Scislowsky

given: Valérie

family: Khodorova

full_name: Nadezda Khodorova

given: Nadezda

family: Mosoni

full_name: Laurent Mosoni

family: Blot

full_name: Adeline Blot

given: Adeline

family: Boirie

full_name: Yves Boirie

given: Yves

family: Dardevet

full_name: Dominique Dardevet

given: Dominique

family: Santé-Lhoutellier

full_name: Véronique Santé-Lhoutellier

given: Véronique

family: Rémond

full_name: Didier Rémond

given: Didier

journal_name: The American Journal of Clinical Nutrition

oa_host_type: publisher

evidence: open (via free article)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine


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

acronym: SAFE

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

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

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

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

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

name: Centre Sabouraud Hôpital Saint‐Louis Paris France

family: Matard

full_name: Bruno Matard

given: Bruno

name: Service de Bactériologie Hôpital Saint‐Louis Paris France

family: Donay

full_name: Jean Luc Donay

given: Jean Luc

name: Biostatistics Unit, SBIM, Hôpital Saint‐Louis APHP Paris France

family: Resche‐Rigon

full_name: Matthieu Resche‐Rigon

given: Matthieu

name: CNR des Staphylocoques, Faculté de Médecine Lyon Est INSERM U111 Lyon France

family: Tristan

full_name: Anne Tristan

given: Anne

family: Farhi

full_name: David Farhi

given: David

family: Rousseau

full_name: Clotilde Rousseau

given: Clotilde

family: Mercier‐Delarue

full_name: Severine Mercier‐Delarue

given: Severine

name: Service D'anatomopathologie Hôpital Saint‐Louis Paris France

family: Cavelier–Balloy

full_name: Bénédicte Cavelier–Balloy

given: Bénédicte

family: Assouly

full_name: Philippe Assouly

given: Philippe

name: Service de Dermatologie Hôpital Saint Louis Paris France

family: Petit

full_name: Antoine Petit

given: Antoine

family: Bagot

full_name: Martine Bagot

given: Martine

family: Reygagne

full_name: Pascal Reygagne

given: Pascal

journal_name: Experimental Dermatology


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

acronym: APPA

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

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

family: Faure

full_name: Cécile Faure

given: Cécile

family: Charlot

full_name: Keyne Charlot

given: Keyne

family: Henri

full_name: Stéphane Henri

given: Stéphane

family: Hardy-Dessources

full_name: Marie-Dominique Hardy-Dessources

given: Marie-Dominique

family: Hue

full_name: Olivier Hue

given: Olivier

family: Antoine-Jonville

full_name: Sophie Antoine-Jonville

given: Sophie

bso_classification: Biology (fond.)

journal_name: Metabolism

oa_host_type: repository

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

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University of the French West Indies and French Guiana

intervention_type: Behavioral


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

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

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

status: Active, not recruiting

lead_sponsor: Hospices Civils de Lyon

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


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

acronym: e-COBAHLT

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

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

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

The purpose of this study is:

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


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

acronym: NUTRALS

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


acronym: PROPECS

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

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

lead_sponsor: University Hospital, Grenoble

location_facility: Operating rooms of Grenoble University Hospital


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

name: Sorbonne Université, INSERM, Médecine Intensive Réanimation, Institut de Cardiologie, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Luyt

full_name: Charles-Edouard Luyt

given: Charles-Edouard

name: Médecine Intensive Réanimation, Aix-Marseille Université, Hôpital Nord, Assistance Publique–Hôpitaux de Marseille, Marseille, France

family: Forel

full_name: Jean-Marie Forel

given: Jean-Marie

name: Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie, Paris, France

family: Hajage

full_name: David Hajage

name: Réanimation Chirurgicale, Centre Hospitalier Universitaire de Montpellier, Hôpital St-Eloi, Montpellier, France

family: Jaber

full_name: Samir Jaber

given: Samir

name: Département de médecine periopératoire, Centre Hospitalier Universitaire Clermont-Ferrand, Clermont-Ferrand, France

family: Cayot-Constantin

full_name: Sophie Cayot-Constantin

name: Réanimation Chirurgicale, Hôpital Edouard-Herriot, Hospices Civils de Lyon, Lyon, France

family: Rimmelé

full_name: Thomas Rimmelé

given: Thomas

name: Réanimation Médicale, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France

family: Coupez

full_name: Elisabeth Coupez

given: Elisabeth

name: Réanimation Chirurgicale Polyvalente, Département d’Anesthésie-Réanimation, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Lu

full_name: Qin Lu

given: Qin

name: Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, AP-HP, Hôpitaux Universitaires Pitié Salpêtrière Charles Foix, Unité de Recherche Clinique, Paris, France

family: Diallo

full_name: Mamadou Hassimiou Diallo

given: Mamadou Hassimiou

name: Pharmacie, Hôpitaux Sud, Assistance Publique–Hôpitaux de Marseille, Marseille, France

family: Penot-Ragon

full_name: Christine Penot-Ragon

given: Christine

name: Réanimation Polyvalente, Centre Hospitalier Universitaire Dupuytren, Limoges, France

family: Clavel

full_name: Marc Clavel

given: Marc

name: Médecine Intensive Réanimation, Centre Hospitalier Universitaire Grenoble Alpes, La Tronche, France

family: Schwebel

full_name: Carole Schwebel

given: Carole

name: Médecine Intensive Réanimation, Hôpital Bichat, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

name: Service de Réanimation, Hôpital Mignot, Versailles, France

family: Bedos

full_name: Jean-Pierre Bedos

given: Jean-Pierre

name: Médecine Intensive Réanimation, Hôpital Européen Georges-Pompidou, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Hauw-Berlemont

full_name: Caroline Hauw-Berlemont

given: Caroline

name: Réanimation des Urgences et Médicale, Aix-Marseille Université, Hôpital Timone, Assistance Publique–Hôpitaux de Marseille, Marseille, France

family: Bourenne

full_name: Jérémy Bourenne

given: Jérémy

name: Pneumologie, Médecine Intensive Réanimation, Hôpitaux Universitaires Pitié Salpêtrière-Charles Foix, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Mayaux

full_name: Julien Mayaux

given: Julien

name: Réanimation Chirurgicale, Centre Hospitalier Universitaire Nîmes, Nîmes, France

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

name: Médecine Intensive Réanimation, Hôpital Cochin, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Combes

full_name: Alain Combes

given: Alain

name: Réanimation Neurochirurgicale, Hôpital Sainte-Anne, Paris, France

family: Wolff

full_name: Michel Wolff

given: Michel

family: Chastre

full_name: Jean Chastre

given: Jean

family: Papazian

full_name: Laurent Papazian

given: Laurent

name: for the Preemptive Treatment for Herpesviridae Study Group, Réseau Européen de recherche en Ventilation Artificielle Network

journal_name: JAMA Internal Medicine

oa_colors: green other

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

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

location_facility: Assistance Publique - Hôpitaux de Marseille

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

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


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

acronym: CLOCK

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

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

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

family: Capdevila

full_name: Xavier Capdevila

given: Xavier

family: Aveline

full_name: Christophe Aveline

given: Christophe

family: Delaunay

full_name: Laurent Delaunay

family: Bouaziz

full_name: Hervé Bouaziz

given: Hervé

family: Zetlaoui

full_name: Paul Zetlaoui

given: Paul

family: Choquet

full_name: Olivier Choquet

given: Olivier

family: Jouffroy

full_name: Laurent Jouffroy

family: Herman-Demars

full_name: Hélène Herman-Demars

given: Hélène

family: Bonnet

full_name: Francis Bonnet

given: Francis

journal_name: Advances in Therapy

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

lead_sponsor: Nordic Pharma SAS


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

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

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

lead_sponsor: Poitiers University Hospital


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

name: From the Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago (A.A.T., M.K.); University of California, San Francisco, Benioff Children’s Hospital, Oakland (M.C.W., E.V.), Lucile Salter Packard Children’s Hospital at Stanford, Palo Alto (S.S.), and David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (G.J.S.) — all in California; Children’s Hospital of Philadelphia and University of Pennsylvania Perelman School...

family: Thompson

full_name: Alexis A. Thompson

given: Alexis A.

family: Walters

full_name: Mark C. Walters

given: Mark C.

family: Kwiatkowski

full_name: Janet Kwiatkowski

given: Janet

family: Rasko

full_name: John E.J. Rasko

given: John E.J.

family: Ribeil

full_name: Jean-Antoine Ribeil

given: Jean-Antoine

family: Hongeng

full_name: Suradej Hongeng

given: Suradej

family: Magrin

full_name: Elisa Magrin

given: Elisa

family: Schiller

full_name: Gary J. Schiller

given: Gary J.

family: Payen

full_name: Emmanuel Payen

given: Emmanuel

family: Semeraro

full_name: Michaela Semeraro

given: Michaela

family: Moshous

full_name: Despina Moshous

given: Despina

family: Lefrere

full_name: Francois Lefrere

given: Francois

family: Puy

full_name: Hervé Puy

family: Bourget

full_name: Philippe Bourget

given: Philippe

family: Magnani

full_name: Alessandra Magnani

given: Alessandra

family: Caccavelli

full_name: Laure Caccavelli

given: Laure

family: Diana

full_name: Jean-Sébastien Diana

given: Jean-Sébastien

family: Suarez

full_name: Felipe Suarez

given: Felipe

family: Monpoux

full_name: Fabrice Monpoux

given: Fabrice

family: Brousse

full_name: Valentine Brousse

given: Valentine

family: Poirot

full_name: Catherine Poirot

given: Catherine

family: Brouzes

full_name: Chantal Brouzes

given: Chantal

family: Meritet

full_name: Jean-François Meritet

given: Jean-François

family: Pondarré

full_name: Corinne Pondarré

given: Corinne

family: Beuzard

full_name: Yves Beuzard

given: Yves

repository_institution: California Digital Library - eScholarship

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

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

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


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

acronym: DOTATATENET

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

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

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


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

acronym: NIVIT

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

time_perspective: Cross-Sectional


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

acronym: FIRBladd

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

lead_sponsor: Rennes University Hospital


title: Lung Imaging for Ventilatory Setting in ARDS

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

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

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

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Jaber

full_name: Samir Jaber

given: Samir

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Langeron

full_name: Olivier Langeron

given: Olivier

family: Ferrandière

full_name: Martine Ferrandière

given: Martine

family: Grelon

full_name: Fabien Grelon

given: Fabien

family: Seguin

full_name: Philippe Seguin

family: Ichai

full_name: Carole Ichai

given: Carole

family: Veber

full_name: Benoit Veber

given: Benoit

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Uberti

full_name: Thomas Uberti

given: Thomas

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Legay

full_name: François Legay

given: François

family: Leone

full_name: Marc Leone

given: Marc

family: Eisenmann

full_name: Nathanael Eisenmann

given: Nathanael

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

given: Claire

family: Dupont

full_name: Hervé Dupont

given: Hervé

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Sossou

full_name: Achille Sossou

given: Achille

family: Chanques

full_name: Gérald Chanques

given: Gérald

family: Muller

full_name: Laurent Muller

given: Laurent

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

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

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

journal_name: Anaesthesia Critical Care & Pain Medicine

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

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


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

acronym: COMPER

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

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

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

lead_sponsor: University Hospital, Rouen


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

acronym: ELAPPS

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris


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

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

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

family: Deplanque

full_name: D. Deplanque

given: D.

family: Machuron

full_name: F. Machuron

given: F.

family: Waucquier

full_name: N. Waucquier

given: N.

family: Jozefowicz

full_name: E. Jozefowicz

given: E.

family: Duhem

full_name: S. Duhem

given: S.

family: Somers

full_name: S. Somers

family: Colin

full_name: O. Colin

given: O.

family: Duhamel

full_name: A. Duhamel

given: A.

family: Bordet

full_name: R. Bordet

given: R.

journal_name: European Neuropsychopharmacology

lead_sponsor: Biocodex

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


type: Other Grant/Funding Number

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

acronym: GARRE

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

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


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

acronym: RESC

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


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

acronym: Poly-Nut

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

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

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

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


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

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

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

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

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

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

lead_sponsor: University Hospital, Bordeaux


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

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

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

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

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

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

family: Lim

full_name: Chetana Lim

given: Chetana

family: Salloum

full_name: Chady Salloum

given: Chady

family: Chalaye

full_name: Julia Chalaye

given: Julia

family: Lahat

full_name: Eylon Lahat

given: Eylon

family: Costentin

full_name: Charlotte E. Costentin

given: Charlotte E.

family: Osseis

full_name: Michael Osseis

given: Michael

family: Itti

full_name: Emmanuel Itti

given: Emmanuel

family: Feray

full_name: Cyrille Feray

given: Cyrille

family: Azoulay

full_name: Daniel Azoulay

given: Daniel

journal_name: HPB

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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

family: Doussot

full_name: Alexandre Doussot

given: Alexandre

family: Sotirov

full_name: Dobromir Sotirov

given: Dobromir

family: Hemery

full_name: Francois Hemery

given: Francois

family: Lantéri-Minet

full_name: Marc Lantéri-Minet

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


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

acronym: FertiSCI

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

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

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

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

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

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

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


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

acronym: VETCOSED

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

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

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

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

The main outcomes expected of this study are:

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

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


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

acronym: ECCOP

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

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

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

lead_sponsor: Hôpital Européen Marseille


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

acronym: Sprayshield

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

ReferenceType: result

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

family: Nocca

full_name: David Nocca

given: David

family: Guillaume

full_name: Fabre Guillaume

given: Fabre

family: Noel

full_name: Patrick Noel

given: Patrick

family: Picot

full_name: Marie Christine Picot

given: Marie Christine

family: Aggarwal

full_name: Rajesh Aggarwal

given: Rajesh

family: El Kamel

full_name: Moez El Kamel

given: Moez

family: Schaub

full_name: Roxanne Schaub

given: Roxanne

family: de Seguin de Hons

full_name: Charles de Seguin de Hons

given: Charles

family: Renard

full_name: Eric Renard

given: Eric

family: Fabre

full_name: Jean Michel Fabre

given: Jean Michel

journal_name: Obesity Surgery

publisher_dissemination: Springer

publisher_group: Springer

title: Impact of Laparoscopic Sleeve Gastrectomy and Laparoscopic Gastric Bypass on HbA1c Blood Level and Pharmacological Treatment of Type 2 Diabetes Mellitus in Severe or Morbidly Obese Patients. Results of a Multicenter Prospective Study at 1 Year

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

family: Fezzi

full_name: Margherita Fezzi

given: Margherita

family: Kolotkin

full_name: Ronnette L. Kolotkin

given: Ronnette L.

family: Nedelcu

full_name: Marius Nedelcu

given: Marius

family: Jaussent

full_name: Audrey Jaussent

given: Audrey

full_name: Roxane Schaub

given: Roxane

family: Chauvet

full_name: Marie Aude Chauvet

given: Marie Aude

family: Cassafieres

full_name: Claire Cassafieres

given: Claire

family: Lefebvre

full_name: Patrick Lefebvre

family: Bringer

full_name: Jacques Bringer

given: Jacques

title: Improvement in Quality of Life After Laparoscopic Sleeve Gastrectomy

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

title: Preliminary Results of the Laparoscopic Adjustable Gastric Banding Procedure by a New Generation of Silicone Band: MIDBAND

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

title: A Prospective Multicenter Study of 163 Sleeve Gastrectomies: Results at 1 and 2 Years

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

location_facility: Department of Digestive Surgery A, Saint Eloi Hospital


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

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

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


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

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

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


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

acronym: REVECHO

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

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

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

location_facility: Rheumatology Department, Ambroise Paré Hospital


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

acronym: CARWEAN

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

lead_sponsor: University Hospital, Clermont-Ferrand


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

acronym: LIDOSP

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

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

family: Salas

full_name: Sébastien Salas

given: Sébastien

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Duffaud

full_name: Florence Duffaud

given: Florence

family: Garnier

full_name: Stéphanie Ranque Garnier

given: Stéphanie Ranque

family: Deschamps

full_name: Mélanie Deschamps

given: Mélanie

family: Honoré

full_name: Stéphane Honoré

given: Stéphane

family: Sudour

full_name: Patrick Sudour

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

journal_name: Trials

lead_sponsor: Assistance Publique Hopitaux De Marseille

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


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

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

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

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

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

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

lead_sponsor: French Defence Health Service


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

acronym: COUGHELP

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

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

family: Lacombe

full_name: Matthieu Lacombe

given: Matthieu

family: Boré

full_name: Aurélien Boré

given: Aurélien

family: Amo Castrillo

full_name: Lorena Del Amo Castrillo

given: Lorena Del

family: Boussaïd

full_name: Ghilas Boussaïd

given: Ghilas

family: Falaize

full_name: Line Falaize

given: Line

family: Vlachos

full_name: Erica Vlachos

given: Erica

family: Orlikowski

full_name: David Orlikowski

given: David

family: Prigent

full_name: Hélène Prigent

given: Hélène

family: Lofaso

full_name: Frédéric Lofaso

given: Frédéric

journal_name: Archives of Physical Medicine and Rehabilitation


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

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

family: Kaouk

full_name: Jihad H. Kaouk

given: Jihad H.

family: Haber

full_name: Georges-Pascal Haber

given: Georges-Pascal

family: Autorino

full_name: Riccardo Autorino

given: Riccardo

family: Crouzet

full_name: Sebastien Crouzet

given: Sebastien

family: Ouzzane

full_name: Adil Ouzzane

given: Adil

family: Flamand

full_name: Vincent Flamand

given: Vincent

family: Villers

full_name: Arnauld Villers

given: Arnauld

journal_name: European Urology

title: A Novel Robotic System for Single-port Urologic Surgery: First Clinical Investigation

lead_sponsor: Intuitive Surgical


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

acronym: NUTRIMOUV

summary: Improvement exercise tolerance

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

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


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

acronym: BIRTH

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

location_facility: Institut regional du Cancer - Val d Aurelle

intervention_type: Radiation


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

acronym: EVERKYSTE

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


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

acronym: MOUVSCO

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

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


acronym: GALTEP

source: euctr

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

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